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January - March 2013 JSLS - JOURNAL OF THE SOCIETY OF LAPAROENDOSCOPIC SURGEONS VOLUME 17, NUMBER 1 PAGES 1-169 January–March 2013 Volume 17 Number 1 SCIENTIFIC PAPERS Extraperitoneal Closure of Persistent Gastrocutaneous Fistula in Children . . . . . . . . . . . . . . . . . . . . . . . . . 1 Stringel G, McBride W, Sweny A. Single-Port Laparoscopic Right Hemicolectomy: Intermediate Results . . . . . . . . . . . . . . . . . . . . . . . . 5 Hopping JR, Bardakcioglu O. Vacation Appendicitis . . . . . . . . . . . . . . . . . . . . . . . 9 Redan J, Tempel MB, Harrison S, Zhu X. Meta-analysis of Laparoscopic Versus Open Repair of Perforated Peptic Ulcer . . . . . . . . . . . . . . . . . . . . . 15 Antoniou SA, Antoniou GA, Koch OO, Pointner R, Granderath FA. Open Versus Laparoscopic Hiatal Hernia Repair . . . . . . 23 Fullum TM, Oyetunji TA, Ortega G, Tran DD, Woods IM, Obayomi-Davies O, Pessu O, Downing SR, Cornwell EE. Costs and Clinical Outcomes of Conventional, Single-Port and Micro-laparoscopic Cholecystectomy . . . . . . . . . . 30 Chekan E, Moore M, Hunter TD, Gunnarsson C. Complications of Liver Resection: Laparoscopic Versus Open Procedures . . . . . . . . . . . . . . . . . . . . . . . . . 46 Slakey DP, Simms E, Drew B, Yazdi F, Roberts B. Robotic Liver Resection: Experience with Three-Arm Robotic and Single-Port Robotic Technique . . . . . . . . . 56 Kandil E, Noureldine, Saggi B, Buell JF. Laparoscopic Appendectomy in Women Without Identifiable Pathology Undergoing Laparoscopy for Chronic Pelvic Pain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Lal AK, Weaver AL, Hopkins MR, Famuyide AO. A Pilot Feasibility, Multicenter Study of Patients After Excision of Endometriosis . . . . . . . . . . . . . . . . . . . 88 Yeung P, Tu F, Bajzak K, Lamvu G, Gusovsky O, Agnelli R, Peavey M, Winer W, Albee R, Sinervo K. Robotic-Assisted Hysterectomy for the Management of Severe Endometriosis: A Retrospective Review of Short-Term Surgical Outcomes . . . . . . . . . . . . . . . . . 95 Bedaiwy MA, AbdelRahman MY, Chapman M, Frasure H, Mahajan S, von Gruenigen VE, Hurd W, Zanotti K. Perioperative Outcomes of Robotic Versus Laparoscopic Hysterectomy for Benign Disease . . . . . . . . . . . . . . 100 Patzkowsky KE, As-Sanie S, Smorgick N, Song AH, Advincula AP. Postoperative Patient Satisfaction After Laparoscopic Supracervical Hysterectomy . . . . . . . . . . . . . . . . . . 107 Tchartchian G, Gardanids K, Bojahr B, deWilde RL. Total Microlaparoscopic Radical Hysterectomy in Early Cervical Cancer . . . . . . . . . . . . . . . . . . . . . . . . . 111 Fanfani F, Gallotta V, Fagottti A, Rossitto C, Piovano E, Scambia G. Comparison of Robotic, Laparoscopic, and Abdominal Myomectomy in a Community Hospital . . . . . . . . . . . 116 Gobern JM, Rosemeyer CJ, Barter JF, Steren AJ. Sleeve Gastrectomy as a Stand-alone Bariatric Procedure for Severe, Morbid, and Super Obesity . . . . . . . . . . . . . . . 63 Eisenberg D, Bellatorre A, Bellatorre N. Laparoscopic Ureteroneocystostomy for Ureteral Injuries After Hysterectomy . . . . . . . . . . . . . . . . . . . . . . . 121 Pompeo A, Molina WR, Sehrt D, Tobias-Machado M, Mariano Costa RM, Pompeo ACL, Kim FJ. Pancreaticojejunostomy Sleeve Reconstruction After Pancreaticoduodenectomy in Laparoscopic and Open Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68 Lei Z, Zhifei W, Jun X, Chang L, Lishan X, Yinghui G, Bo Z. Laparoscopic Surgery for Kidney Orthotopic Transplant in the Pig Model . . . . . . . . . . . . . . . . . . . . . . . . . . . 126 He B, Musk GC, Mou L, Waneck GL, Delriviere L. Laparoscopic Inguinal Exploration and Mesh Implantation for Chronic Pelvic Pain . . . . . . . . . . . . . . . . . . . . . 74 Yong PJ, Williams C, Allaire C. CASE REPORTS . . . . . . . . . . . . . . . . . . . . . 132 ISSN: 1086-8089 January - March 2013 JSLS, Journal of the Society of Laparoendoscopic Surgeons (ISSN #1086 – 8089) is published quarterly by the Society of Laparoendoscopic Surgeons, 7330 SW 62nd Place, Suite 410, Miami, FL 33143-4825, USA. Subscription rates – Non-member: USA and its possessions: individuals $125; institutional $195; single copy $35; Outside USA: individuals and institutions $220; single copy $60. Institutional rates apply to hospitals, libraries, educational entities, group practices, or other such organizations where there are multiple readers. Individual subscriptions must be subscribed by, billed to and paid by individuals. Membership: $20.00 of annual membership dues are applied for member subscriptions to JSLS, Journal of the Society of Laparoendoscopic Surgeons. Periodicals Postage Paid at Miami, FL and at additional mailing offices. Subscription orders should be forwarded to SLS, 7330 SW 62nd Place, Suite 410, Miami, FL 33143-4825, USA. Reprint orders of over 100 copies should be forwarded to Cadmus Communications, Telephone (410) 943-3147, Facsimile (866) 4875625, E-Mail [email protected]. POSTMASTER: Send address changes to: JSLS, Journal of the Society of Laparoendoscopic Surgeons, 7330 SW 62nd Place, Suite 410, Miami, FL 33143-4825, USA. Telephone (305) 665-9959, Facsimile (305) 667-4123, E-Mail [email protected]. Send notice to the publisher including both old and new address. Manuscript Submission: Send all manuscripts and editorial contributions to Michael S. Kavic, MD, Editor-in-Chief, JSLS, Journal of the Society of Laparoendoscopic Surgeons, 7330 SW 62nd Place, Suite 410, Miami, FL 331434825, USA. Telephone (305) 665-9959, Facsimile (305) 667-4123, E-Mail [email protected]. Advertising Office: Send all advertising inquiries to the above address. Editorial Comments and Questions: Forward editorial comments and questions to Michael S. Kavic, MD, Editor-in-Chief, Telephone (330) 480-3124, Facsimile (330) 480-3640, E-Mail [email protected]. JSLS, Journal of the Society of Laparoendoscopic Surgeons publishes original articles on basic science and technical topics in all the fields involved with laparoendoscopic surgery. The journal seeks to advance understanding and practice of minimally invasive, image-guided surgery by providing a forum for all relevant disciplines and by promoting the exchange of information and ideas across specialties. The statements, opinions, conclusions and recommendations contained in this journal are solely those of the authors or advertisers and are not those of the publisher, editor, or editorial board of JSLS, Journal of the Society of Laparoendoscopic Surgeons or the Society of Laparoendoscopic Surgeons. Advertising appearing in JSLS, Journal of the Society of Laparoendoscopic Surgeons does not constitute a guarantee or endorsement of the product nor claims made by the manufacturer. References to a product within a paper published by JSLS, Journal of the Society of Laparoendoscopic Surgeons does not constitute a guarantee or endorsement of the product nor claims made by the manufacturer. Authors may cite dosages, products, companies or services based on clinical research and experience. No responsibility is assumed for the advice and information contained in JSLS, Journal of the Society of Laparoendoscopic Surgeons. The publisher makes no warranty, expressed or implied, with respect to the material contained herein. Readers should consult the manufacturers’ complete prescribing information before administering any drug. ⬁This paper meets the requirements of ANSI/NISO Z39.48 –1992 (Permanence of Paper) effective with Volume 1, Number 1, 1997. © Copyright 2013 JSLS, Journal of the Society of Laparoendoscopic Surgeons. i Volume 17 Number 1 International Advisory Committee Gerard B. Adhoute, MD France Bernard Dallemagne, MD Belgium Edvaldo Fahel, MD, PhD Brazil G. M. Filshie, MD United Kingdom Xianbo Fu, Prof. China JSLS Affiliates The Society of Laparoendoscopic Surgeons Paul Alan Wetter, MD Chairman Chinese Journal of Minimally Invasive Surgery Xianbo Fu, Prof. Executive Editor-in-Chief The International Pelvic Pain Society Fred Marion Howard, MD Chairman Jorge Cueto Garcia, MD Mexico Achille Lucio Gaspari, MD Italy Staff Hector E. Geninazzi, MD Uruguay Administrator of Publications Janice Gisele Muller Yasuo Idezuki, MD Japan Senior Editorial Assistant Patricia Fleck Kavic Ming-Chien Kao, MD Taiwan Operations Officer Janis Chinnock Liselotte Mettler, Prof. Dr. Med Germany Circulation Coordinator Lauren Frede Erich Mühe, MD Germany Sergio Roll, MD Brazil Copy Editor Ann Conti Morcos January - March 2013 Volume 17 Number 1 Editorial Board Maurice E. Arregui, MD Keith B. Isaacson, MD St. Vincent Hospitals and Health Center Indianapolis, Indiana Harvard Medical School Newton-Wellesley Hospital Newton, Massachusetts Charles Bellows, MD Volker R. Jacobs, MD, PhD, MBA Tulane University Health Sciences Center New Orleans, Louisiana Maurice K. Chung, RPh, MD Regional Center for Chronic Pelvic Pain and Female Pelvic Medicine University of Toledo School of Medicine Toledo, Ohio Sakti Das, MD Univ.-Klinik f ür Frauenheilkunde Paracelsus Medizinische Universität salzburg, Germany Samir Johna, MD Fontana Medical Center Loma Linda University School of Medicine Loma Linda, California William E. Kelley Jr., MD University of California Davis School of Medicine Sacramento, California The Richmond Surgical Group Richmond, Virginia Larry A. Demco, MD Reproductive Specialty Center Milwaukee, Wisconsin University of Calgary Calgary, Alberta, Canada Charles H. Koh, MD Jaime Landman, MD Peachtree Surgical and Bariatrics Atlanta, Georgia Columbia University School of Medicine New York, New York Edward L. Felix, MD Karl A. LeBlanc, MD, MBA Titus D. Duncan, MD California Institute of Minimally Invasive Surgery Fresno, California Minimally Invasive Surgery Institute Baton Rouge, Louisiana Morris E. Franklin Jr., MD Texas Endosurgery Institute San Antonio, Texas University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Michel Gagner, MD Farr Nezhat, MD Florida International University Mt. Sinai Medical Center Miami Beach, Florida W. Peter Geis, MD Northwest Hospital Center Baltimore, Maryland Herbert A. Goldfarb, MD New York University School of Medicine New York, New York Harrith M. Hasson, MD Louis A. Weiss Memorial Hospital Chicago, Illinois B. Todd Heniford, MD Carolinas Medical Center Charlotte, North Carolina James D. Luketich, MD St. Luke’s-Roosevelt Hospital Center University Hospital of Columbia University, College of Physicians and Surgeons New York, New York Douglas E. Ott, MD, MBA Mercer University Macon, Georgia EDITOR-IN-CHIEF Michael S. Kavic, MD Department of Surgery Northeastern Ohio Universities College of Medicine Rootstown, Ohio Department of Surgery University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania MANAGING EDITOR Paul Alan Wetter, MD University of Miami School of Medicine Miami, Florida ASSOCIATE EDITORS Camran Nezhat, MD Stanford University School of Medicine Stanford, California Richard M. Satava, MD University of Washington Medical Center Seattle, Washington ASSISTANT EDITORS Raymond J. Lanzafame, MD, MBA Rochester, New York Elspeth M. McDougall, MD, MHPE University of California Irvine Medical Center Orange, California Francis J. Podbielski, MD University of Massachusetts Worcester, Massachusetts Gustavo Stringel, MD, MBA New York Medical College Westchester Medical Center Valhalla, New York James C. Rosser Jr., MD Morehouse School of Medicine Atlanta, Georgia Steven D. Wexner, MD Cleveland Clinic Florida Weston, Florida Howard N. Winfield, MD DCH Regional Health System West Alabama Urology Associates Tuscaloosa, Alabama ii TABLE January–March 2013 GUIDELINES FOR CONTENTS Volume 17 Number 1 AUTHORS . . . . . . . . . . vi SCIENTIFIC PAPERS Extraperitoneal Closure of Persistent Gastrocutaneous Fistula in Children . . . . . . . . 1 Stringel G, McBride W, Sweny A. Extraperitoneal closure of gastrocutaneous fistula can be safe and effective. This approach can allow for rapid resumption of feeding and a shortened length of stay. Single-Port Laparoscopic Right Hemicolectomy: Intermediate Results . . . . . . . . . . . . . . . . . . . . 5 Hopping JR, Bardakcioglu O. Single-port right hemicolectomy may be safely performed in patients who are candidates for conventional laparoscopic hemicolectomy with similar efficacy, safety, and oncologic outcomes. Vacation Appendicitis . . . . . . . . . . . . . . . . . . . 9 Redan J, Tempel MB, Harrison S, Zhu X. This study suggests that developing appendicitis while on vacation to Walt Disney World, Florida is associated with a higher incidence of perforated appendicitis. Meta-analysis of Laparoscopic Versus Open Repair of Perforated Peptic Ulcer . . . . . . . . . 15 Antoniou SA, Antoniou GA, Koch OO, Pointner R, Granderath FA. A meta-analysis of four randomized trials comparing laparoscopic versus open repair of perforated ulcer did not demonstrate significant superiority of the laparoscopic or open approach. Open Versus Laparoscopic Hiatal Hernia Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Fullum TM, Oyetunji TA, Ortega G, Tran DD, Woods IM, Obayomi-Davies O, Pessu O, Downing SR, Cornwell EE. Laparoscopic repair of paraesophageal hiatal hernia where only a portion of the stomach is in the chest, is associated with a lower mortality rate than open repair. iii OF Costs and Clinical Outcomes of Conventional, Single-Port and Micro-laparoscopic Cholecystectomy . . . . . . . . . . . . . . . . . . . . . . 30 Chekan E, Moore M, Hunter TD, Gunnarsson C. Cost for single-port cholecystectomy in the outpatient setting was found to be greater than the cost for microlaparoscopic or conventional laparoscopic cholecystectomy. Complications of Liver Resection: Laparoscopic Versus Open Procedures . . . . 46 Slakey DP, Simms E, Drew B, Yazdi F, Roberts B. Complications appear to be lower in laparoscopic cases versus open cases for anterolateral and posterosuperior hepatic segment surgery. Robotic Liver Resection: Experience with ThreeArm Robotic and Single-Port Robotic Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Kandil E, Noureldine, Saggi B, Buell JF. Robotic liver surgery was found to offer advantages not inherent in conventional laparoscopic liver resection. Sleeve Gastrectomy as a Stand-alone Bariatric Procedure for Severe, Morbid, and Super Obesity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Eisenberg D, Bellatorre A, Bellatorre N. Laparoscopic sleeve gastrectomy was found to be a safe and effective stand-alone procedure for severe, morbid, and super obese patients in a high-risk veteran population. Pancreaticojejunostomy Sleeve Reconstruction After Pancreaticoduodenectomy in Laparoscopic and Open Surgery . . . . . . . . . . . . . . . . . . . . . 68 Lei Z, Zhifei W, Jun X, Chang L, Lishan X, Yinghui G, Bo Z. This report suggests that sleeve-joint pancreaticojejunostomy reduces the rate of postoperative pancreatic fistula. January–March 2013 Laparoscopic Inguinal Exploration and Mesh Implantation for Chronic Pelvic Pain . . . . . . 74 Yong PJ, Williams C, Allaire C. In selected female patients with chronic pelvic pain, laparoscopic inguinal exploration with mesh implantation resulted in a moderate improvement of symptoms. Laparoscopic Appendectomy in Women Without Identifiable Pathology Undergoing Laparoscopy for Chronic Pelvic Pain . . . . . . 82 Lal AK, Weaver AL, Hopkins MR, Famuyide AO. Laparoscopic appendectomy is suggested to be effective therapy for women with chronic pelvic pain of unknown etiology. Volume 17 Number 1 Postoperative Patient Satisfaction After Laparoscopic Supracervical Hysterectomy . . . 107 Tchartchian G, Gardanids K, Bojahr B, deWilde RL. This study demonstrates a high degree of postoperative patient satisfaction after laparoscopic supracervical hysterectomy. Total Microlaparoscopic Radical Hysterectomy in Early Cervical Cancer . . . . . . . . . . . . . . . 111 Fanfani F, Gallotta V, Fagottti A, Rossitto C, Piovano E, Scambia G. This report suggests that microlaparoscopy has a role in the management of early cervical cancer with results comparable with standard laparoscopy. A Pilot Feasibility, Multicenter Study of Patients After Excision of Endometriosis . . . . . . . . . . 88 Yeung P, Tu F, Bajzak K, Lamvu G, Gusovsky O, Agnelli R, Peavey M, Winer W, Albee R, Sinervo K. A multicenter prospective study evaluating the management of endometriosis comparing excision versus ablation is needed using primary outcomes other than chronic pelvic pain. Comparison of Robotic, Laparoscopic, and Abdominal Myomectomy in a Community Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116 Gobern JM, Rosemeyer CJ, Barter JF, Steren AJ. Laparoscopic and robotic-assisted laparoscopic myomectomies demonstrated shorter hospital stays, less blood loss, and fewer transfusions than abdominal myomectomies. Robotic myomectomy offers a minimally invasive alternative for management of symptomatic myoma in a community hospital setting. Robotic-Assisted Hysterectomy for the Management of Severe Endometriosis: A Retrospective Review of Short-Term Surgical Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 Bedaiwy MA, AbdelRahman MY, Chapman M, Frasure H, Mahajan S, von Gruenigen VE, Hurd W, Zanotti K. Robotic-assisted laparoscopic surgery appears to be safe and feasible for definitive management of patients with severe endometriosis. Laparoscopic Ureteroneocystostomy for Ureteral Injuries After Hysterectomy . . . . . 121 Pompeo A, Molina WR, Sehrt D, Tobias-Machado M, Mariano Costa RM, Pompeo ACL, Kim FJ. This report suggests that laparoscopic ureteral reimplantation offers an alternative surgical approach to open surgery after distal ureteral injuries. Perioperative Outcomes of Robotic Versus Laparoscopic Hysterectomy for Benign Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 Patzkowsky KE, As-Sanie S, Smorgick N, Song AH, Advincula AP. Robotic assistance appears to enable the successful completion of complex hysterectomies with perioperative outcomes equivalent to laparoscopy. Laparoscopic Surgery for Kidney Orthotopic Transplant in the Pig Model . . . . . . . . . . . . 126 He B, Musk GC, Mou L, Waneck GL, Delriviere L. The authors report that a laparoscopic technique could facilitate orthotopic kidney transplantation in selected patients. iv January–March 2013 CASE REPORTS Laparoscopic Excision of Splenic Artery Aneurysm . . . . . . . . . . . . . . . . . . . . . . . . . . 132 Kim Y, Johna S. Endovascular management of splenic artery aneurysm is the most applied therapy for this condition; however, laparoscopic intervention should be considered as an alternative option. Transvaginal Liver Surgery Using a Tethered Magnet and a Laparoscopic Rein . . . . . . . . . 135 Tsin DA, Dominguez G, Davila F, Alonso-Rivera JM, Safro B, Tinelli A. Hybrid transvaginal endoscopic surgery can be facilitated with additional instruments, techniques, and a flexible endoscope. Magnets are an aid to exposure using a laparoscopic rein. Gallstone-Related Abdominal Abscess 8 Years After Laparoscopic Cholecystectomy . . . . . . . 139 Dobradin A, Jugmohan S, Dabul L. An unusual collection of fluid in the perihepatic space needs to be investigated for abscess in patients with a remote history of cholecystectomy. Laparoscopic Completion Cholecystectomy and Common Bile Duct Exploration for Retained Gallbladder After Single-Incision Cholecystectomy . . . . . . . . . . . . . . . . . . . . . 143 Kroh M, Chalikonda S, Chand B, Walsh M. This report details laparoscopic remnant cholecystectomy and transcystic common duct exploration after previous single-port cholecystectomy. Catastrophic Bleeding From a Marginal Ulcer After Gastric Bypass . . . . . . . . . . . . . . . . . . . 148 Sidani S, Akkary E, Bell R. The authors describe a case of life-threatening hemorrhagic marginal ulcer eroding into the splenic artery that required surgical intervention. v Volume 17 Number 1 Endoclip Closure of a Colonic Perforation Following Colonoscopic Leiomyoma Excision . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152 Velchuru VR, Zawadzki M, Levin AL, Bouchard CM, Marecik S, Prasad LM, Park JJ. This report suggests that iatrogenic colon perforations in a prepped colon can be managed with endoclip closure. Robotic Repair of Uterine Dehiscence . . . . . 156 LaRosa MF, McCarthy S, Richter C, Azodi M. A pediatric robot and 5-mm trocars were used to effect a repair of a cesarean scar dehiscence, also known as a cesarean scar defect. Laparoscopic Removal of Abdominal Cerclage at 19 Weeks’ Gestation . . . . . . . . . . . . . . . . . . . 161 Carter JF, Savage A, Soper DE. The authors discuss laparoscopic removal of an abdominal cerclage in a female patient who presented at 19 weeks with ruptured membranes. Single-Incision Laparoscopic Adnexectomy in a Patient with Previous Laparotomies . . . . . . 164 Sesti F, Boccia C, Sorrenti G, Baffa A, Piccione E. Single-incision laparoscopic surgery appears to be feasible in obese patients who have undergone previous midline laparotomies. Small Bowel Injury During Laparoendoscopic Single-Site Surgery for Simple Nephrectomy . . . . . . . . . . . . . . . . . . . . . . . . 167 Joshi SS, Sundaram C. The authors conclude that single-site surgery is not without risk of serious complications and must be performed in selected cases by experienced surgeons. EDITORIAL POLICY JSLS, Journal of the Society of Laparoendoscopic Surgeons publishes original articles on basic science and technical topics in all the fields involved with laparoendoscopic surgery. The journal seeks to advance our understandings and practice of minimally invasive, image-guided surgery by providing a forum for all relevant disciplines and by promoting the exchange of information and ideas across specialties. JSLS is a peer-reviewed journal that employs a rapid review process for all submitted manuscripts so that significant scientific findings appear with minimal delay. All submitted manuscripts are initially reviewed by a JSLS editor. Manuscripts considered appropriate for publication are sent to expert reviewers for peer review. JSLS uses a “blinded” review process. The identities of authors and peer reviewers are kept confidential. All materials accepted for publication are copyedited and returned to the author for approval of significant recommended editorial changes. The editor reserves the right to make minor changes for clarity and accuracy without seeking author approval. JSLS, Journal of the Society of Laparoendoscopic Surgeons has joined many other medical journals endorsing the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals,” including the statements related to “Protection of Patients’ Rights to Privacy,” established by editors in the United States, Canada, and the United Kingdom.1 JSLS also endorses the revised CONSORT statement2 and the AMA Guidelines for web sites.3 Papers are invited in the following categories: • Clinical and experimental surgery • Operative technique • Review articles • Case reports • Laparoendoscopic education • Letters to the editor The journal, at the discretion of the editor, will also publish: • Editorials • Commentaries • Articles concerning emerging technology • Information (news) and events Online Only Publication: JSLS reserves the right to publish manuscripts online and not in a hardcopy format. Authors who wish to have their work published with color figures or who cannot provide high resolution figures may request online only publication. MANUSCRIPT SUBMISSION Please review the complete Guidelines for Authors before submitting. Manuscripts that do not adhere to the Guidelines may be rejected or returned to the author for correction before going through the review process. Authors must also follow the Ethical Policies and Procedures. Completion of the copyright transfer agreement is required in order to have your manuscript reviewed. Submit online at www.editorialmanager.com/jsls MANUSCRIPT FORMAT • All manuscripts must be typewritten in English with American spelling and submitted in an editable Microsoft Word OR rich text format document (PDFs and other document types are not acceptable.) • Authors whose primary language is not English should have their papers checked for linguistic accuracy by a person skilled in the English language and medical terminology. • For style, consult the American Medical Association Manual of Style4 and/or the Uniform Requirements for Manuscripts Submitted to Biomedical Journals.1 • Manuscripts should not exceed 4500 words, including references, tables, and figures. • Do not include a running header or footer. • Be concise and avoid medical jargon. Keep abbreviations and acronyms within the text to a minimum and spelled out, in parentheses, when first used. • Use Systéme International (SI) measurements only. • Use generic names for drugs. • Text should avoid sexual and racial bias and use gender inclusive language when possible. • All persons listed as authors must meet the criteria for authorship outlined in the American Medical Association Manual of Style4 and/or Uniform Requirements for Manuscripts Submitted to Biomedical Journals.1 Authorship requires substantial participation in the work, with the ability to take public responsibility for the content. Substantial contribution must be made in all three of following areas: conception and design or analysis and interpretation of data; drafting of the manuscript or its critical revision for important intellectual content; and approving the version of the manuscript to be published.4 Title Page Please include the following: • Title with no more than 75 characters. Do not use abbreviations. Avoid acronyms. • Date on which the manuscript was submitted. • Word count for the text, exclusive of the title, abstract, references, tables, figures, and illustrations. Author’s Contact Information in Byline Order • Full name(s) of all author(s). • Highest academic degree(s) of author(s). Do not include US fellow ship designations or honorary designations. • Affiliation(s). Include only the department, institution name, city, state, and country. • Address, e-mail address, telephone number and fax number for all authors. Designate one author as the corresponding author. Disclosure of Conflicts of Interest and Sources of Financial Support (Also see Ethical Policies and Procedures) Authors must state any financial interest they have in any commercial device, equipment, instrument, or drug that is a subject of the article. Relevant financial support and any conflicts of interest must be disclosed by all authors and reviewers. Authors must also disclose if the manuscript discussion includes the use of products for which they are not labeled (i.e., off-label use). Acknowledgments Acknowledge only those from whom permission to acknowledge has been obtained. For individuals, include their full names and highest academic degrees. Structured Abstract and Key Words The abstract should not exceed 250 words, and should not include abbreviations, acronyms, footnotes, or references. Original research abstract sections: • Background and Objectives • Methods • Results • Conclusion [or Discussion] • Key Words (from the standard Index Medicus MeSH terminology) Case report / Operative technique abstract sections: • Introduction • Case Description / Technique Description • Discussion vi • Key Words (from the standard Index Medicus MeSH terminology) Review article abstract sections: • Background • Database • Conclusion [or Discussion] • Key Words (from the standard Index Medicus MeSH terminology) Text Review Articles Authors of review articles should explain why the topic of the manuscript is important to the field. Scholarly review articles should be well referenced and should avoid anecdotal reports and personal opinions. The main arguments or points must proceed logically and coherently, and the manuscript must conclude with a discussion of recommendations and/or implications for the field. Case Reports Authors of case reports should state the purpose/ importance of the report, include all notable parts of the case presentation, describe how the case was assessed and managed, and include the outcome of the case. How the case can contribute to the literature / future patient care should be discussed. Research Articles Introduction: Typically the Introduction should include a brief review of the relevant literature to establish the need for the project. The research objectives and hypotheses should be explicitly stated. The author(s) should address the following questions: • What issue is being addressed in the research? • Why is the issue important? • How will the field benefit from having addressed the issue? Materials and Methods: The methods should be described in sufficient detail so readers can understand how the research was performed. For experimental investigation of human or animal subjects state in “Methods” that an appropriate institutional review board approved the project. For those investigators who do not have formal ethics review committees, follow the principles outlined in the Declaration of Helsinki. For investigation of human subjects, state the manner in which informed consent was obtained. Results: Results should be presented in a coherent fashion and should be specifically tied to the objectives and methods described earlier in the manuscript. Discussion: The discussion section should: • Reiterate the principal findings of the research • Comment on any methodological weaknesses of the study • Discuss the importance and/or implications of the findings Conclusion: The conclusion section should not contain any deductions or inferences that are not specifically supported by the data reported in the study, although reasonable speculations and implications for further research, when identified as such, may be appropriate. References Authors are responsible for bibliographic accuracy. References must be verified by the author against the original resources. Number the references in the order they are first mentioned. Cite, by arabic number, all references in the text. Do not use reference software such as Endnote. Format references according to the AMA Manual of Style or the Uniform Requirements for Manuscripts Submitted to Biomedical Journals.1 Review articles may use up to 100 references. Use no more than 30 references for other articles. Improperly referenced manuscripts will be returned to the author for correction. Abbreviate journal names as indicated in Index Medicus. List all journal authors when there are 6 or fewer. For journal references with 7 or more authors, list the first 3 and add “et al.” For printed articles that are a part of larger works, include the first and last page number of the referenced article or chapter. Manuscripts submitted, but not yet accepted for publication, can be noted as “unpublished data” in the text. However, do not include in the references any manuscripts that are in preparation, manuscripts submitted for publication but not yet accepted, or unpublished papers or vii observations. For articles in press, give the journal name and, if possible, the volume number and year followed by “in press.” For books in press, give the publishing company and, if possible, the year of publication. Example Journal Reference Kavic MS. 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SCIENTIFIC PAPER Extraperitoneal Closure of Persistent Gastrocutaneous Fistula in Children Gustavo Stringel, MD, MBA, Whitney McBride, MD, Allison Sweny, MD ABSTRACT Background and Objectives: Gastrostomy feeding in children is well established for nutritional support. Gastrostomy tubes may be permanent or temporary. After removal, spontaneous closure may occur, but persistence of the tract requires surgical repair. Laparotomy with gastric repair and fascial closure is the standard technique for treatment of a persistent gastrocutaneous fistula. We describe a technique of extraperitoneal excision of the fistulous tract and our results using this method. Methods: We reviewed 21 cases of extraperitoneal gastrocutaneous fistula closure in which a Foley catheter traction technique was used and were performed over the last 8 y. The technique involves insertion of a small Foley catheter with traction applied to the fistulous tract and core excision with electrocautery. Closure of the tract without fascial separation was accomplished and early feedings were allowed. Results: Ten males and 11 females underwent closure with this technique. The duration of the gastrostomy ranged from 1 y to 6 y, with a mean of 3.3 y. The time from removal to surgical repair was 3 wk to 1 y, with a mean of 4.3 mo; 15 had gastrostomy alone, and 6 had gastrostomy in combination with Nissen fundoplication. Open gastrostomy had been done in 10 patients and laparoscopic gastrostomy in 11 patients. Half of the patients had an ambulatory procedure. One patient developed a superficial wound infection, and there was 1 recurrence requiring intraperitoneal closure. Conclusion: Extraperitoneal closure for gastrocutaneous fistula is safe and effective. The technique allows for rapid resumption of feeds and a shortened length of stay. Min- Department of Pediatrics and Department of Surgery, NY Medical College, Maria Fareri Children’s Hospital at Westchester County Medical Center, Valhalla, NY, USA (all authors). Address correspondence to: Gustavo Stringel, MD, MBA, NY Medical College, Munger Pavilion Rm 321, Valhalla, NY 10595, Telephone: (914) 493-7620, Fax: (914) 594-4933, E-Mail: [email protected] DOI: 10.4293/108680812X13517013317590 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. imal morbidity occurs with this technique, and it is well tolerated in the pediatric population. Key Words: Gastrostomy, Gastrostomy closure, Gastrocutaneous fistula. INTRODUCTION Persistence of a gastrocutaneous fistula after removal of a gastrostomy tube is a well-known sequela occurring in 5% to 45% of patients.1– 4 These fistulas are managed expectantly for spontaneous closure in 1 to 3 mo after removal of the feeding tube. A gastrocutaneous fistula that persists requires surgical repair.3,4 The traditional operative technique widely used for treatment involves a layered closure. The fistula tract is excised, and the gastric wall is separated from the fascia and the gastric defect is primarily repaired. The abdominal wall is closed in a layered fashion. This procedure requires a period of bowel rest with nasogastric decompression and a 2-d to 5-d hospital stay. We describe an innovative approach that is performed entirely extraperitoneally, without the aid of endoscopy, and that can be performed in an ambulatory setting. MATERIALS AND METHODS This was a retrospective study reviewing 21 patients over an 8-y time span. The cases were performed by 2 pediatric surgeons at a children’s hospital. This technique involves inserting an 8 or 10 French Foley catheter into the fistula tract; the stomach is then pulled up and the tract exposed and excised using electrocautery. While under traction, interrupted polyglycolic acid sutures are placed to close the gastric and peritoneal defect without fascial separation. The skin is subsequently closed with interrupted nylon sutures (Figures 1 through 6). Patients were started on a diet 6 h postoperatively and were discharged home on the same day unless a preexisting medical condition required additional hospitalization. The amount of time the gastrostomy tube had been in place ranged from 1 y to 6 y. Indication for gastrostomy placement included failure to thrive, se- JSLS (2013)17:1– 4 1 Extraperitoneal Closure of Persistent Gastrocutaneous Fistula in Children, Stringel et al. Figure 1. Gastrocutaneous fistula. Figure 4. Fistulous tract excised and extraperitoneal suture placed. Figure 2. Foley traction on the GCF tract. Figure 5. Full thickness extraperitoneal closure. Figure 3. Excision of the fistula tract. Figure 6. Skin closure. 2 JSLS (2013)17:1– 4 tube; he had severe irritation around the stoma at the time of closure. He was 1 of the initial patients in our series. vere mental retardation, genetic disorders, and congenital malformations as described in Table 1. An open gastrostomy had been performed in 10 patients, while the remaining had undergone laparoscopic placement. Fifteen patients had a gastrostomy alone, and 6 had a gastrostomy in combination with fundoplication. The interval time from removal of the gastrostomy tube to closure ranged from 3 wk to 1 y, with an average of 4.3 mo. One patient, who was HIV/AIDS positive and immunocompromised, developed a superficial wound infection that resolved with conservative management. Eleven patients were ambulatory and were discharged on a regular diet the day of surgery. Nine patients were admitted for 2 to 3 d due to other comorbidities. One patient remained hospitalized for 7 d secondary to other medical comorbidities. All patients were started on a diet on postoperative day 1. A few patients were observed to have a small amount of leakage at the gastrocutaneous fistula site postoperatively. This resolved spontaneously after a short period of time. RESULTS All patients recovered uneventfully. There were 2 complications. One patient developed a recurrence of the gastrocutaneous fistula requiring intraperitoneal layered closure. This patient had the initial extraperitoneal closure 3 wk following removal of the gastrostomy Table 1. Patient Demographics Sex Age Comorbiditya Open Vs Lapa Duration of GT Interval to Closure NISSEN Length of Stay Days Complication M 8m FTT O 6y 3m Y 0 None F 5y Esophageal perforation O 5y 4 wks N 0 None F 19 m FTT L 3y 6m Y 0 None M 10 m Trisomy 21, GERD L 2y 2 wks Y 0 Recurrence F 3y S/p renal transplant O 1y 3 wks N 2 None M 2m Kabuki syndrome O 5y 2m Y 7 None M 1y CPMR O 7y 1y N 2 None F 22 m Unknown L 6y 3m N 0 None M 1 day Long gap EA O 2y 2m N 0 None M 5m CPMR L 2y 3m N 2 None F 2m Cardiac disease 1y 6m Y 3 None M 4y Small bowel transplant O 6y 1y N 2 None F 3 wks Tracheal mass O 4y 2m N 0 None M 6 wks Multiple medical problems L 2y 2m N 0 None F 2m Prader Willi syndrome L 2y 6m N 0 None F 2m Multiple medical problems L 2y 6m N 2 None F 6y HIV/AIDS O 4y 1y N 1 Wound infection M 3m Trisomy 21, AV canal defect L 3y 6m N 2 None M 5m CPMR L 4y 3m Y 0 None F 3m Gastroschisis O 15 m 2m N 0 None F 2y FTT L 1 year 3m N 1 None a FTT (failure to thrive), O (open), L (Laparoscopic), EA (esophageal Atresia), GERD (Gastroesophageal reflux), CPMR (cerebral palsy mental retardation). JSLS (2013)17:1– 4 3 Extraperitoneal Closure of Persistent Gastrocutaneous Fistula in Children, Stringel et al. DISCUSSION Gastrostomy tubes are commonly used in the pediatric population to manage enteral feeding. This can be temporary for short-term therapy or permanent. Gastrostomy feeding tubes can provide a safe and physiologic method of providing nutrition for patients with failure to thrive, neurological disorders, and other conditions that impair oral intake. If the underlying disease process can be corrected, gastrostomy tubes are removed and the tract allowed to close spontaneously. Previous studies1– 4 have demonstrated failure of closure with subsequent gastrocutaneous fistula formation 5% to 45% of the time. Nonsurgical management is initially attempted with the application of silver nitrate and a pressure dressing. H2 blockers and proton pump inhibitors are also used at the time of gastrostomy removal. Unfortunately, a number of patients fail conservative therapy and surgical intervention is indicated. The traditional layered closure technique involves a hospital stay of an average of 3 d to 5 d and requires nasogastric tube decompression and fasting for a period of time postoperatively. While this technique has proven to be quite successful in repairing the defect with low recurrence rates, it involves substantial health care costs and discomfort for patients and caregivers. More recently, endoscopic techniques are being advocated with placement of an endoclip to close the gastric defect in conjunction with chemical cauterization to de-epithelialize the fistula tract.5 Fibrin tissue glue has also been used with some success.6 Most the data available for the above- 4 mentioned techniques involves case studies or small-scale reviews, and the success of complete closure is questionable. The extraperitoneal technique we describe has lower morbidity, shorter hospital stay, and is more cost effective than the traditional layered closure. Furthermore, this approach is a simple technique that can be done without the use of costly endoscopic equipment that may not be readily available. Our data suggest that this technique is both safe and effective with low morbidity. References: 1. Janik TA, Hendrickson RJ, Janick JS, Landholm AE. Analysis of factors affecting the spontaneous closure of a gastrocutaneous fistula. J Pediatr Surg. 2004;39:1197–1199. 2. Gordon JM, Langer JC. Gastrocutaneous fistula in children after removal of gastrostomy tube: Incidence and predictive factors. J Pediatr Surg. 1999;34:1345–1346. 3. Arnbjornsson E, Backman T, Berglund Y, Kullendorff CM. Closure after gastrostomy button. Pediatr Surg Int. 2005;21:797–799. 4. El-Rifai N, Michaud L, Mention K, et al. Persistence of gastrocutaneous fistula after removal of gastrostomy tubes in children; prevalence and associated factors. Endoscopy. 2004;36:700–704. 5. Teitelbaum JE, Gorcey SA, Fox VL. Combined endoscopic cautery and clip closure of chronic gastrocutaneous fistula. Gastrointest Endosc. 2005;62:432– 435. 6. González-Ojeda A, Avalos-González J, Muciño-Hernández MI, et al. Fibrin glue as adjuvant treatment for gastrocutaneous fistula after gastrostomy tube removal. Endoscopy. 2004;36:337–341. JSLS (2013)17:1– 4 SCIENTIFIC PAPER Single-Port Laparoscopic Right Hemicolectomy: Intermediate Results Jacob R. Hopping, MD, Ovunc Bardakcioglu, MD ABSTRACT Background: Single-port laparoscopic colectomy was first described in 2008 as a new technique for colorectal surgery.1 No available reports have stated the intermediate- or long-term outcome. We report our intermediate results for the first 20 single-port laparoscopic right hemicolectomies performed by a single laparoscopically trained surgeon at our institution. Design: Between February 2009 and September 2010, 20 consecutive patients with an indication for right hemicolectomy who were candidates for laparoscopic surgery underwent a single-port laparoscopic approach. The only exclusion was a previous midline laparotomy. The patients were followed for outcomes after a median of 27 months (range: 15 to 35). Results: The mean age was 65 years (range: 59 to 88). The mean body mass index was 28 (range: 20 to 35). Seventyfive percent of patients had significant comorbidities, with an American Society of Anesthesiologists class of III or IV. The median estimated blood loss was 25 mL (range: 25 to 250). The mean number of lymph nodes was 13 (range: 0 to 29). There was one conversion to hand-assisted laparoscopic colectomy and one to open colectomy secondary to bleeding. The mean hospital stay was 5 days (range: 3 to 7). Thirty-day postoperative complications included 1 wound infection, 1 patient with alcohol withdrawal, and 1 incidence of colitis caused by Clostridium difficile infection. At a median follow-up of 27 months, there were no local recurrences or distant metastases. One death occurred at Department of Surgery, Saint Louis University, St. Louis, Missouri, USA. Jacob R. Hopping has no disclosures. Ovunc Bardakcioglu is currently a proctor with Intuitive Surgical and has received honoraria from Covidien and Niti Surgical solutions. Presented as a Poster at the meeting of the Society of Gastrointestinal and Endoscopic Surgeons, San Diego, California, USA, March 3–7, 2012 Address correspondence to: Ovunc Bardakcioglu, MD, FACS, Associate Professor of Surgery Chief Division Colon and Rectal Surgery Department of Surgery, University of Nevada School of Medicine, 2040 W. Charleston Blvd, Ste 601, Las Vegas, NV 89102, USA. E-mail: [email protected] DOI: 10.4293/108680812X13517013316997 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 17 months from myocardial infarction. Two patients developed incisional hernias, with one requiring a laparoscopic hernia repair. One patient required a completion proctocolectomy for a pathological diagnosis of hyperplastic polyposis syndrome. Conclusions: Single-port laparoscopic right hemicolectomy has been safely performed in patients who are candidates for conventional laparoscopic hemicolectomy. This small series indicates that intermediate-term results are similar to conventional laparoscopic surgery in efficacy, safety, and oncological outcomes. Larger datasets are necessary to determine cost-effectiveness, differences in postoperative outcomes, and patient satisfaction. Key Words: Single-port laparoscopic colectomy, Singleincision laparoscopic colectomy, Long-term outcome, Intermediate term. INTRODUCTION Many small case series are now available that show single-port laparoscopic (SPL) or single-incision laparoscopic (SIL) colectomy is a safe alternative to conventional laparoscopy. Single-incision techniques have been described since 2008.1 There are many proposed short-term benefits to laparoscopic colectomy, including less postoperative pain, quicker recovery, reduced ileus, lower rate of wound infections/complications, and rapid mobilization.2 Publications of long-term data on conventional laparoscopic colectomy for adenocarcinoma have shown similar oncological outcomes and no higher risks of port-site recurrence.2– 4 Similarly, long-term data for conventional laparoscopic colectomy indicate that patient satisfaction, incisional hernia rates, and rates of small bowel obstruction are not statistically different from those in open surgery.5 Now that short-term data for SIL for colon surgery exist showing its efficacy and safety, long-term parameters deserve focus. The primary aim of this study is to look at our intermediate-term morbidity and mortality data, including incisional hernia rate, which is considered to be a particular concern for SIL surgery. JSLS (2013)17:5– 8 5 Single-Port Laparoscopic Right Hemicolectomy: Intermediate Results, Hopping JR et al. MATERIALS AND METHODS Patient Selection Patients were selected from the practice of a single laparoscopic colorectal surgeon at a university institution from February 2009 through September 2010. Patient demographics are listed in Table 1. The only exclusion criterion was a previous midline laparotomy. Patients were selected if they had an indication for laparoscopic right hemicolectomy. Seven patients had a preprocedure pathological diagnosis of adenocarcinoma, 9 patients had adenomatous polyps, and 4 patients had unspecified polyps, one of which was found to have hyperplastic polyposis syndrome on pathological examination. All data were collected retrospectively. All patients were told of the alternative surgical approaches, including open surgery and conventional laparoscopic surgery beforehand, and all agreed to undergo SIL surgery. Operative Technique After induction of general endotracheal anesthesia, the patient was placed in a beanbag and lithotomy position using Allen Stirrups (Allen Medical, Acton, MA). A 4-cm incision was made through the umbilicus, and a singleport access device (Gelpoint, Applied Medical, Ranch Santa Margarita, CA) with one 12-mm and two 5-mm ports was introduced through this incision. A 5-mm flexible tip laparoscope (Olympus, Center Valley, PA), a straight bowel grasper, and a bipolar vessel sealer with a monopolar tip (Ligasure Advance, Covidien, Mansfield, MA) were used as instruments. The following description of the “colonic rollover” approach was reported previously.6 After a careful examination of the peritoneal cavity, a window in the small bowel mesentery was created 10 cm Table 1. Patient Demographics Mean age (y) 66 (range: 45–88) Sex (M:F) 18:2 Mean body mass index 28 (range: 20–35) ASA class I 1 II 4 III 13 VI 2 Preoperative diagnosis of cancer 6 7 proximal to the ileocecal valve and the small bowel divided using an endoscopic linear stapler (ETS45, Ethicon Endosurgery, Blue Ash, OH). The mesenteric cut edge of the small bowel was then serially divided with the vessel sealer toward the root of the ileocolic pedicle. This step was alternated with lateral mobilization of the cecum and ascending colon. Constant traction of the mobilized colon into the left upper quadrant allowed adequate tension and visualization of the mesentery and the lateral attachments. The duodenum was identified and dissected off the ileocolic pedicle, which was divided using the bipolar vessel sealer. Further traction of the mobilized colon to the left lower quadrant allowed division of the attachments of the hepatic flexure and dissection of the omentum off the transverse colon entering the lesser sac. The right branch of the middle colic artery was similarly divided from a supramesocolic approach. After complete mobilization and intracorporeal vessel ligation, the colon was exteriorized, and a standard stapled side-to-side functional endto-end anastomosis was performed. The fascial defect was closed using interrupted #1 Prolene sutures, and the skin was closed with a subcuticular 4 – 0 Monocryl suture (Ethicon, Somerville, NJ). RESULTS In the 18 months of patient selection, 20 right hemicolectomies were performed using the previously described SIL approach. The mean age was 65 years (range: 59 to 88). Eighteen patients were male and two were female. The average body mass index was 28 (range: 20 to 35). The median American Society of Anesthesiologists (ASA) score was III with a range of I to IV. Two cases were converted because of bleeding and difficulty of safe ligation of the ileocolic pedicle; one case was converted to a handassisted laparoscopic approach; and one was converted to open. Median blood loss was 25 mL (18 of 20 patients), with two cases reporting a 250-mL blood loss. The median operative time was 156.5 minutes (range: 98 to 272), which is consistent with those previously reported.7–9 There were no other intraoperative complications. Thirtyday postoperative complications included 1 case of alcohol withdrawal requiring a longer recovery and hospital length of stay, 1 wound infection, and 1 case of colitis caused by Clostridium difficile infection requiring appropriate antibiotic coverage (Table 2). Average hospital length of stay was 5 days (range: 2 to 7). There were no readmissions within a 30-day period. Pathological diagnosis was confirmed in all cases. Three patients had pathologically unspecified unresectable pol- JSLS (2013)17:5– 8 case series reporting intermediate-term outcomes in SIL colectomy. Table 2. Perioperative Data and Long-Term Complications Average length of surgery (min) 161 Conversion (for bleeding) 1 to hand assisted 1 to open Median blood loss (mL) 25 (range: 25–250) Mean intravenous narcotic use (d) 2.1 (range: 1–5) Median length of stay (d) 4.5 (range: 2–7) Postoperative complications (30 day) 1 ETOH withdrawal 1 surgical site infection 1 C difficile colitis Complications at follow up 4* *One death at 17 months from myocardial infarction, 2 incisional hernias, and 1 completion proctocolectomy for undiagnosed familial polyposis. yps preoperatively. Two of these were confirmed as villous adenoma, and the third was a T3 adenocarcinoma on final pathology. Of the cases of adenocarcinoma, there was 1 T1 lesion, 2 T2 lesions, and 5 T3 lesions. Three patients had positive lymph nodes. The median lymph node harvest was 13 (range: 0 to 29). Intermediate follow-up was achieved with a mean of 27 months (range: 15 to 35). There was one death, the result of a myocardial infarction at 17 months in a patient who was ASA class IV and also had a significant history of cardiovascular disease, including coronary artery bypass graft, congestive heart failure, and atrial flutter. One patient with a postoperative diagnosis of hyperplastic polyposis syndrome and multiple new unresectable polyps in the remaining colon and rectum on follow-up colonoscopy required a laparoscopic completion proctocolectomy. Two patients developed incisional hernias, one of which required laparoscopic repair. DISCUSSION Short-term outcomes for SIL colon resection for benign and malignant disease have been promising, showing hospital length of stay, time to oral intake, and intravenous pain medication use that is not significantly different from conventional laparoscopic surgery.10 –13 The technique has been used safely in patients who were candidates for conventional laparoscopy. Most case series report similar to decreased mean operating times.14 Currently, long-term data exist exclusively for conventional laparoscopic colectomies. It has been shown to be equal in safety, efficacy, and longterm oncological outcomes.2–5 Therefore, we present a One of the leading criticisms of SIL surgery is a potentially increased rate of hernia formation. On this issue here is conflict in the literature: some authors believe that because of the decreased number of incisions, the hernia rate should decrease as well.15 Data from long-term follow-up of single-incision cholecystectomies have not shown an increase in hernias.16 Some data report rates as low as 0.1%.17 One meta-analysis of 1100 SIL cholecystectomies did report a single umbilical hernia that was strangulated and required surgical intervention.18 It also reported that as a result of a mean follow-up time of only 72 hours to 24 months, the true hernia rate was likely underreported. Furthermore, incisional hernia rates of different SPL procedures may not be comparable. The incision needed for a SPL cholecystectomy is typically larger than the 12-mm periumbilical port and gallbladder extraction site used in conventional laparoscopic cholecystectomy. The single-port extraction site in our case series is smaller compared with conventional laparoscopy because of easier extraction of the colon after intracorporeal division of the small bowel. Because of cosmetic reasons, the incision was also made through the umbilicus, which is considered a weak spot prone to hernia formation by many surgeons. Therefore, technical details may play an important role to consistently compare incisional hernia rates. Two of our patients developed incisional hernias, leading to an incisional hernia rate of 10%. We believe that, given the small number of patients involved in this study, our hernia rate may not accurately predict the risk of incisional hernia in SIL colectomy. Our median lymph node harvest was 13, similar to that reported for conventional laparoscopy and open procedures.4 Many specimens harboring benign adenomas were not fully examined by the pathologists for lymph node counts, and secondary examination of the specimen was not requested by the surgeon because of the benign nature of the underlying polyp. The number of patients in this study is too small, and follow-up of up to 35 months is not adequate to comment on cancer recurrence or port-site recurrence rates. CONCLUSION SPL for colorectal surgery has been established to be safe and effective in the short term compared with conventional laparoscopy. In the hands of an experienced laparoscopic surgeon, SIL or SPL surgery could therefore be an JSLS (2013)17:5– 8 7 Single-Port Laparoscopic Right Hemicolectomy: Intermediate Results, Hopping JR et al. alternative to conventional laparoscopic surgery in patients who are otherwise candidates for a laparoscopic procedure. Given our success with 20 patients, it would appear that the intermediate- to long-term benefits are likewise comparable, with no increase in morbidity or mortality. Larger prospective case series and trials are needed to evaluate differences in long-term postoperative outcomes of SPL in colorectal surgery. References: 1. Bucher P, Pugin F, Morel P. Single port access laparoscopic right hemicolectomy. Int J Colorectal Dis. 2008;23:1013–1016. 2. Mehta PP, Griffin J, Ganta S, Rangraj M, Steichen F. Laparoscopic-assisted colon resections: Long-term results and survival. JSLS. 2005;9:184 –188. 3. Fleshman J, Sargent DJ, Green E, et al. Laparoscopic colectomy for cancer is not inferior to open surgery based on 5-year data from the COST Study Group Trial. Ann Surg. 2007;246:655– 664. 4. Kojima M, Konisha F, Okada M, Nagai H. Laparoscopic colectomy versus open colectomy for colorectal carcinoma: A retrospective analysis of patients followed up for at least 4 years. Surg Today. 2004;34:1020 –1024. 5. Thaler K, Dinnewitzer A, Mascha E, et al. Long-term outcome and health related quality of life after laparoscopic and open colectomy for benign disease. Surg Endosc. 2003;17:1404 –1408. 6. Bardakcioglu O, Ahmed S. Single incision laparoscopic total abdominal colectomy with ileorectal anastomosis for synchronous colon cancer. Tech Coloproctol. 2010;14:257–261. 7. Adair J, Gromski MA, Lim RB, Nagle DN. Single-incision laparoscopic right colectomy: Experience with 17 consecutive cases and comparison with multiport laparoscopic right colectomy. Dis Colon Rectum. 2010;53:1549 –1554. 9. Chen WT, Chang S, Chiang H, et al. Single-incision laparoscopic versus conventional laparoscopic right hemicolectomy: A comparison of short-term surgical results. Surg Endosc. 2011;25: 1887–1892. 10. Waters JA, Guzman MJ, Fajardo AD, et al. Single-port laparoscopic right hemicolectomy: A safe alternative to conventional laparoscopy. Dis Colon Rectum. 2010;53:1467–1472. 11. Waters J, Rapp BM, Guzman MJ, et al. Single-port laparoscopic right hemicolectomy: The first 100 resections. Dis Colon Rectum. 2012;55:134 –139. 12. Champagne BJ, Lee EC, Leblanc F, Stein SL, Delaney CP. Single-incision vs straight laparoscopic segmental colectomy: A case-controlled study. Dis Colon Rectum. 2011;54:183–186. 13. Ross H, Steele S, Whiteford M, et al. Early multi-institution experience with single-incision laparoscopic colectomy. Dis Colon Rectum. 2011;54:187–192. 14. Rijcken E, Mennigen R, Argyris I, Senninger N, Bruewer M. Single-incision laparoscopic surgery for ileocolic resection in Crohn’s disease. Dis Colon Rectum. 2012;55:140 –146. 15. Gaujoux S, Bretagnol F, Ferron M, Panis Y. Single-incision laparoscopic colonic surgery. Colorectal Dis. 2011;13:1066 – 1071. 16. Phillips MS, Marks JM, Roberts K, et al. Intermediate results of a prospective randomized controlled trial of traditional fourport laparoscopic cholecystectomy versus single incision laparoscopic cholecystectomy. Surg Endosc. 2012;26:1296 –1303. 17. Wong JSW, Cheung YS, Chong CCN, Lee KF, Wong J, Lai PBS. Single-incision laparoscopic cholecystectomy: From four wounds to one. Hong Kong Med J. 2011;17:465– 468. 18. Fransen S, Stassen L, Bouvy N. Single incision laparoscopic cholecystectomy: A review on the complications. J Min Access Surg. 2012;8:1–5. 8. Chambers WM, Bicsak M, Lamparellie M, Dixon AR. Singleincision laparoscopic surgery (SILS) in common colorectal surgery: A technique offering potential and not just cosmesis. Colorectal Dis. 2011;13:393–398. 8 JSLS (2013)17:5– 8 SCIENTIFIC PAPER Vacation Appendicitis Jay A. Redan, MD, Michael B. Tempel, MD, Shannon Harrison, RN, MBA, CCRC, Xiang Zhu, MS ABSTRACT INTRODUCTION Objective: When someone plans a vacation, one of the last things taken into consideration is the possibility of contracting an illness while away. Unfortunately, if people develop abdominal pain while planning for a vacation, they usually proceed with the vacation and do not consider getting medical attention for their pain. The purpose of this study was to examine the effect of being on vacation and its association with ruptured appendicitis. Appendicitis is one of the most common causes of abdominal pain and requires surgical treatment. Lifetime risk of appendicitis ranges from 6% to 7%.1 Delayed presentation can lead to prolonged inflammation and subsequent rupture of the appendix. Increasing duration between the onset of inflammation and surgical intervention increases the risk of perforation of the appendix. Retrospective chart reviews by Bicknell et al have shown that rupture risk was ⬍2% when symptoms were present for ⬍36 hours. Thereafter, rupture risk rises to 5%.2 This leads to prolonged hospitalization in addition to increased risk of postoperative morbidity. Methods: From January 1, 2007 to December 31, 2008, the incidence of ruptured appendicitis cases at Florida Hospital–Celebration Health, located 5 miles from Walt Disney World, was compared with that of Florida Hospital–Orlando, approximately 30 miles away from Walt Disney World. We evaluated whether patients “on vacation” versus residents of Orlando have an increased incidence of ruptured appendicitis. Results: Of patients treated for presumed appendicitis, 60.59% at Florida Hospital–Celebration Health had ruptured appendicitis during this time versus 20.42% at Florida Hospital–Orlando. Of those 266 patients seen at Florida Hospital–Celebration Health, 155 were on vacation versus only 21 at Florida Hospital–Orlando. Conclusion: Although there is not a direct cause and effect, it is clear that there is a higher incidence of ruptured appendicitis in patients on vacation versus in the regular community in the Orlando, Florida area. Key Words: Appendicitis, Ruptured appendicitis. Department of Surgery, Florida Hospital–Celebration Health, Celebration, Florida, USA (all authors). Presented as a poster at the American College of Surgeons, October 2011, San Francisco, CA. Address correspondence to: Jay A. Redan, MD, FACS, Director of Minimally Invasive General Surgery, Florida Hospital–Celebration Health, Associate Professor of Surgery, University of Central Florida Medical School, 400 Celebration Place, Suite A-140, Celebration, FL 34747. Telephone: 407-303-4602, Fax: 407-303-4602, E-mail: [email protected] DOI: 10.4293/108680812X13517013318355 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. Over 2 years, we analyzed patients who presented to our facility and required emergency surgery for presumed appendicitis. We divided our patients between those who were visiting on vacation and those who lived as residents in the area. Because of our location near Walt Disney World, Universal Studios, and many other resorts and hotels, we see a large number of patients on vacation with their families; this includes both domestic and international visitors. Because of the factors associated with taking a vacation, such as time off of work, arranging flights and hotels, saving money, and arranging children’s time away from school, people experiencing abdominal pain before their vacation may often delay treatment. Consequently, when they do present to the emergency department, pathology is often advanced, secondary to delay of treatment. As stated previously, this can add to both postoperative morbidity and cost of hospital stay. Our hypothesis is that, simply because of our location, we see a higher-than-average number of vacation emergencies versus emergencies in patients who live in the area. We compared this with the incidence of appendicitis (perforated and nonperforated) to a local teaching hospital in our health system, Florida Hospital–Orlando (FHO), a large tertiary care teaching hospital with 938 beds. MATERIALS AND METHODS This is a retrospective chart review using patient data from Florida Hospital–Celebration Health (FHCH), a small 112bed community hospital in Celebration, Florida, approxi- JSLS (2013)17:9 –14 9 Vacation Appendicitis, Redan JA et al. mately 5 miles from Walt Disney World. A request was made and granted from our institutional review board to conduct this chart review. The review uses data from January 1, 2007 to December 31, 2008. The study population consists of patients undergoing emergent or urgent surgery for presumed appendicitis. All patients in the study were ⬎18 years (all patients ⬍18 were sent to FHO). All appendectomies are performed laparoscopically at FHCH. Data regarding laparoscopic versus open procedures were not available at FHO. The conversion rate to open is ⬍1% among the experienced surgeons at FHCH. Only “positive appendectomies” were included in this study; however, negative appendectomies are unusual because of the high-quality imaging studies now available in most hospitals. These patients were analyzed with respect to age, sex, race, actual pathology, and length of hospital stay. More importantly, we analyzed the patients with respect to home geographic location indicated by zip codes. FHCH has a service area of 30 zip codes. For the purpose of this study and to allow for overlap of the comparative hospital zip codes, we assumed that any patient who came to FHCH whose home residence was not in Florida was considered to be “on vacation.” This obviously includes patients from other countries and those from out-of-state. Finally, we compared these data with those obtained over a similar period at FHO, the flagship hospital for the Florida Hospital Health System. It is a tertiary care and teaching hospital located in downtown Orlando with 938 beds. In the multiple regression analysis, we adopted multiple logistic regression models to analyze perforation rate. We designated perforation as a dependent variable and coded it as “1” for perforated and “0” for nonperforated. We designated all other factors as independent variables, including (1) patient type (binary variable, “1” for on-vacation patients who live outside the service area and “0” for resident patients who live in the service area); (2) campus (binary variable, “1” for FHCH and “0” for FHO); (3) age (continuous variable); (4) gender (binary variable, “1” for male and “0” for female); (5) race (binary, “1” for white and “0” for nonwhite; we grouped races into 2 categories because some races had too few observations); and (6) medical insurance status (binary variable, “1” for with insurance and “0” for without insurance). We estimated odds ratios of perforation versus nonperforation on the condition of patient type with other independent variables treated as adjustment factors. To investigate the relationship of LOS with perforation, we used multiple Poisson regression analysis. Poisson regression was applied because LOS was a count variable following a Poisson distribution (Figure 1). In the Poisson regression analysis, we designated LOS as a dependent variable and all other factors (perforation, age, gender, race, patient type) as independent variables. 400 300 Frequency 200 100 0 In this retrospective study, in addition to vacationers (ie, people visiting Orlando as nonresidents), there were also other factors examined, such as age, gender, medical insurance, and race, which might be associated with perforation development of appendicitis patients but not under control. This aggressive statistical analysis was performed to rule out the possibility that our high incidence of ruptured appendicitis was not a result of chance. In addition, hospital facility characteristics, such as location and size, as a whole might somehow affect the pattern of patients’ use of the emergency department and, hence, result in different levels of perforation rate in different patient populations. We first used univariate analysis, which included frequency 2 test for percentage number comparison, Student t test for age comparison, and Wilcoxon rank-sum test for length of stay (LOS) comparison, to investigate the association of perforation with campuses, patient type (resident patient vs on-vacation patient), age, gender, medical insurance status, and race, 500 Stata version 10.0 (StataCorp, College Station, TX) was used for all analyses. All data were presented as mean ⫾ Statistics 10 separately. Then we used multiple regression analysis to further isolate and evaluate the effect of each factor on the perforation rate with the rest factors under control. 0 2 4 6 8 10 12 LOS (day) 14 16 18 20 Figure 1. Frequency distribution of LOS ranging from 0 to 20 days. JSLS (2013)17:9 –14 standard error unless otherwise specified, and the significance level for all tests was set at P ⬍ .05. RESULTS Following are the new results based on the data where patients ⬍18 years are removed from both the FHCH and FHO campuses. In addition, to unify the criteria that both campuses used to distinguish on-vacation patients from resident patients, we classified the patients who lived in Florida as resident patients, and those who did not as on-vacation patients. If the patients ⬍18 years were excluded from this study (ie, removed from both campuses), the total number of patients included was 943, 439 (46.55%) of which were from the FHCH campus and 504 (53.45%) from the FHO campus. If the patients who lived in Florida were identified as resident patients, and the patients who lived outside as on-vacation patients, the total number of resident patients versus the total number of on-vacation patients was 767 (81.34%) versus 176 (18.66%). Table 1 shows the results of the association of perforation with age, race (as noted in the chart face sheet), and campus. The multiple Poisson regression analysis showed that LOS was significantly positively associated with perforation, age, gender, medical insurance status, and campus (Table 4). According to the model, we predict that if other conditions are held unchanged, patients with a perforated appendix have a 68% longer LOS than patients with a nonperforated appendix. With a patient age increase of 1 year, the LOS increases by 2%; male patients have a 7% longer LOS than female patients; patients with medical insurance have a 9% longer LOS than patients without medical insurance; and patients at FHCH have a 13% longer LOS than at Orlando campus. Race and patient type do not significantly affect LOS. To avoid multicollinearity among independent variables, we conducted Kendall test. We did not detect any high collinearity (⬎0.8) among the independent variables that we incorporated into our models, suggesting that the structure of our models is valid. From the period of January 2007 through December 2008, 439 patients were admitted to FHCH for presumed appendicitis. All patients were taken to the operating room. The appendix was removed and sent for pathological analysis. Final diagnoses were classified as acute appendicitis either with or without perforation. In contrast, 504 patients were admitted to FHO with presumed appendicitis. Table 5 summarizes these data. Table 6 further divides the totals from FHCH into those patients within the service area (ie, 30 surrounding zip codes) and those “on vacation.” As before, these patients were also grouped into acute versus perforated/ peritonitis. Finally, Table 7 displays the admission data for each campus as a function of percentage of acute and perforated appendicitis. Table 1. Comparison of Patient Populations between the Celebration Campus and the Orlando Campusa Celebration Orlando Overall Number of patients 439 504 943 On-vacation patients (%) 155 (35.31) 21 (4.17) 176 (18.66) 2 P Value 149.89 .000 Perforated (%) 266 (60.59) 113 (22.42) 483 (40.19) 142.22 .000 Male (%) 205 (46.70) 271 (53.77) 476 (50.48) 4.70 .030 Age (SD, min–max) 41.2 (15.4, 18–90) 38.7 (16.9, 18–97) 39.9 (16.2, 18–97) –2.34b .020 White (%) 436 (99.32) 404 (80.16) 840 (89.08) 88.51 .000 Medical insured (%) 384 (87.47) 381 (75.60) 765 (81.12) 21.61 .000 LOS (SD, min–max) 4.3 (6.5, 0–71) 2.9 (7.6, 0–147) 3.6 (7.1, 0–147) –6.12c .000 Patients ⬍18 years old were excluded, and patients who lived outside Florida State were identified as “on-vacation” patients. Two-tailed t test. c Wilcoxon rank-sum test. a b JSLS (2013)17:9 –14 11 Vacation Appendicitis, Redan JA et al. Table 2. Comparison of Patient Characteristics Between Those with Perforated Versus Nonperforated Appendixa 2 P Value 176 (18.66) 24.89 .000 173 (30.67) 439 (46.55) 142.22 .000 391 (69.33) 504 (53.45) 179 (47.23) 297 (52.67) 476 (50.48) 2.67 .102 43.2 (16.6, 18–91) 37.6 (15.6, 18–97) 39.9 (16.2, 18–97) –5.26b .000 White (%) 345 (91.03) 495 (87.77) 840 (89.08) 2.68 .115 Med. insured (%) 325 (85.75) 440 (78.01) 765 (81.12) 8.86 Perforated Nonperforated Overall Number of patients 379 564 943 On-vacation patients (%) 100 (26.39) 76(13.48) Celebration (%) 266 (70.18) Orlando (%) 113 (29.82) Male (%) Age (SD, min–max) LOS (SD, min–max) 5.1 (7.1, 0–71) 2.6 (6.9, 0–147) .003 c 3.6 (7.1, 0–147) .000 –9.60 Patients ⬍18 years old were excluded, and patients who lived outside Florida State were identified as “on-vacation” patients. Two-tailed t test. c Wilcoxon rank-sum test. a b Table 3. Estimation of Odds Ratio of Perforated versus Nonperforated Appendix in Relation to Age, Gender, Race, Medical Insurance Status, Patient Type, and Campus Using a Multiple Logistic Regression Modelab Odds Ratio SE Z P Value Incidence Rate Ratio SE Perforation 1.59 0.06 12.03 Age 1.03 0.00 Gender 1.06 0.04 Medical insurance 1.05 0.05 95% CI Lower Upper Age 1.02 0.00 4.61 .000 1.01 1.03 Gender 0.96 0.14 –0.28 .781 0.72 1.28 Medical insurance 1.15 0.23 0.69 .491 0.78 1.69 Race 0.49 0.12 –2.84 .005 0.30 0.80 Patient type 1.02 0.20 0.09 .931 0.69 1.49 Campus 6.03 1.04 10.45 .000 4.30 8.44 Patients ⬍18 years old were excluded, and patients who lived outside Florida were identified as “on-vacation” patients. b Pseudo R2 ⫽ 0.138, 2(6) ⫽ 175.9, P ⫽ .000. a DISCUSSION Appendicitis is one of the most common conditions requiring surgical intervention. Lifetime risk of appendicitis is estimated to be 6% to 7% overall. Although simple acute appendicitis requires a relatively simple operation with a short hospital stay (possibly even same-day discharge), delays in treatment lead to perforation of the appendix with subsequent localized abscess and/or peritonitis. 12 Table 4. Estimation of Effects of Perforation, Age, Gender, Medical Insurance, Race, Patient Type and Campus on LOS Using the Multiple Poisson Regression Modelab z P Value 95% C.I. Lower Upper .000 1.47 1.71 28.34 .000 1.03 1.03 1.62 .106 0.99 1.13 0.94 .347 0.95 1.16 Race 1.00 0.07 0.07 .943 0.88 1.14 Patient type 0.99 0.05 –0.17 .868 0.91 1.08 Campus 1.17 0.05 3.75 .000 1.08 1.28 Patients ⬍18 years old were excluded, and patients who lived outside Florida were identified as “on-vacation” patients. b Pseudo R2 ⫽ 0.162, 2(7) ⫽ 1194.36, P ⫽ .000. a It is our goal to study the effects of treatment delay— namely, vacation time away from home— on the course of appendicitis. Our small community hospital is located approximately 4 miles from the Walt Disney World and Resorts complex, with an estimated 50 million visitors annually. In addition to the 4 theme parks at Walt Disney World, Universal Studios, and Sea World, there are other theme parks, themed hotels, resorts, and local attractions. JSLS (2013)17:9 –14 Table 5. Patients Admitted with Presumel Appendicitis Orlando total 504 Acute appendicitis with perforation 113 Celebration total 439 Acute appendicitis with perforation 266 Table 6. Florida Hospital Celebration Health From Service Area vs On Vaction and Acute Appendicitis vs Perforated Appendicitis (n⫽439) 439 Appendicitis in service area 81 Appendicitis out of service area 92 Perforated appendicitis in service area 93 Perforated appendicitis out of service area 173 Of note, appendicitis is traditionally thought of as a disease of children. Our hospital policy directs us to send any patients ⬍18 years to FHO for treatment. Pediatric surgical patients at FHCH do not exist and may have skewed the data; however, the average age of patients at our hospital is 36.5 years. Table 7. Hospital and Appendix Pathology Orlando Perforated appendicitis Celebration Perforated appendicitis Total No. Admissions 2007–2008 (%) 504 439 266 (60.59) 121 (21.18) Perforated appendicitis out of service area 157 (65.04) CONCLUSIONS Perforation is significantly associated with age, race, and campus (FHCH vs FHO), and on-vacation patients have a 30% higher odds ratio of perforation rate than resident patients. 113 (22.42) Perforated appendicitis in service area During the period from 2007 to 2008, FHO admitted 504 patients with presumed appendicitis. Of those, 113 patients (22.42%) had perforation. During the same period, FHCH admitted 439 patients with the same diagnosis of presumed appendicitis. Of our 439 patients with presumed appendicitis, 266 (60.5%) had perforations at the time of operation. Our patients with perforated appendicitis were further divided into those inside the service area and those “on vacation.” It is interesting to note that 93 patients (21.18% of total) with perforated appendicitis were in our service area. In addition, 173 patients (65.04% of total) with perforated appendicitis were outside of our service area. In other words, based only on vacationing patients visiting our area, we had almost 3 times as many appendiceal perforations as did our flagship hospital. FHCH accepted a higher percentage of patients with perforations than did FHO, but this could not be explained by the fact that FHCH had a larger percentage of on-vacation patients compared with FHO. Given the time and finances needed to organize time away from home (as discussed previously), it is easy to see how someone may dismiss the initial vague abdominal pain of appendicitis as a hassle rather than a condition requiring surgical attention. Consequently, as time progresses and treatment is delayed, a simple procedure transforms into a more complicated one as patients arrive at their “vacation destination.” Our goal was to compare our data regarding perforated appendicitis with data from a large tertiary-care teaching hospital and to show that, based simply on location, our smaller hospital sees a proportionately larger number of perforated appendicitis cases than a larger hospital with more resources, a higher bed capacity, and a larger service area. Although factors such as age, gender, medical insurance status, race, and patient type were taken into account, the difference in perforation rates between campuses (ie, “campus effect”) was still significant. This part of effect at the campus level is still unclear, probably because of some unobserved reasons. The criteria used to classify on-vacation patients and resident patients at FHCH and FHO might not be the same “ruler” to reflect all aspects of their patient populations. This may have been problematic when all data were pooled to evaluate the effect of patient type on perforation rate. Of the patients with suspected appendicitis, 65.04% of the visitor patients at FHCH had perforated appendicitis versus 22.42% at FHO. All comparisons were statistically significant, P ⬍ .001 by 2 analysis. We concluded that JSLS (2013)17:9 –14 13 Vacation Appendicitis, Redan JA et al. developing appendicitis while on vacation is associated with a statistically significantly higher incidence of perforated appendicitis in Orlando, Florida, P ⬍ .001. Although there is no way to definitively prove cause and effect, we believe that patients planning an expensive vacation tend to “ignore” warning signs of a more serious illness than when they are “at home” and not planning a vacation. References: 1. Fischer JE, et al. Chapters 129 –230. In: Mastery of Surgery. Fifth edition. Philadelphia: Lippincott Williams & Wilkins; 2007. 2. Bicknell NA, Aufses AH Jr, Rojas M, Bodian C. How time affects the risk of rupture in appendicitis. J Am Coll Surg. 2006; 202(3):401– 406. 3. Bickell NA, Siu AL. Why do delays in treatment occur? Lessons learned from ruptured appendicitis. Health Serv Res. 2001;36(1):1–5. 4. Sicard N, Tousignant P, Pineault R, Dubé S. Non-patient factors related to rates of ruptured appendicitis. Br J Surg. 2007; 94:214 –221. 5. Eldar S, Nash E, Sabo E, et al. Delay of surgery in acute appendicitis. Am J Surg. 1997;173:194 –198. 14 6. Deck KB, Pettitt BJ, Harrison MR. The length-time correlate in appendicitis. JAMA. 1980;244:806 – 807. 7. Temple CL, Huchcroft SA, Temple WJ. The natural history of appendicitis in adults. A prospective study. Ann Surg. 1995;221: 278 –281. 8. Penfold RB, Chisolm DJ, Nwomeh BC, Kelleher KJ. Geographic disparities in the risk of perforated appendicitis among children in Ohio: 2001–2003. Int J Health Geogr. 2008;7:56. 9. Davies GM, Dasbach EJ, Teutsch S. The burden of appendicitis-related hospitalizations in the United States in 1997. Surg Infect (Larchmt). 2004;5:160 –165. 10. Kraemer M, Franke C, Ohmann C, Yang Q; Acute Abdominal Pain Study Group. Acute appendicitis in late adulthood: incidence, presentation, and outcome. Results of a prospective multicenter acute abdominal pain study and a review of the literature. Langenbecks Arch Surg. 2000;385(7):470 – 481. 11. Hansson LE, Laurell H, Gunnarsson U. Impact of time in the development of acute appendicitis. Dig Surg. 2008;25(5):394 – 399. 12. Papaziogas B, Tsiaousis P, Koutelidakis I, Glakoustidis A, Atmatzidis S, Atmatzidis K. Effect of time risk of perforation in acute appendicitis. Acta Chir Belg. 2009;109(1):75– 80. JSLS (2013)17:9 –14 SCIENTIFIC PAPER Meta-analysis of Laparoscopic Versus Open Repair of Perforated Peptic Ulcer Stavros A. Antoniou, MD, George A. Antoniou, MD, PhD, Oliver O. Koch, MD, Rudolph Pointner, MD, PhD, Frank A. Granderath, MD, PhD ABSTRACT INTRODUCTION Background and Objectives: Laparoscopic treatment of perforated peptic ulcer (PPU) has been introduced as an alternative procedure to open surgery. It has been postulated that the minimally invasive approach involves less operative stress and results in decreased morbidity and mortality. Laparoscopic repair of perforated peptic ulcer (PPU) was first reported with the introduction of laparoscopy.1,2 Nevertheless, the use of the procedure in routine practice has been rather limited during the 1990s, largely because of the low incidence of PPU after identification of Helicobacter pylori as a prime factor, and because of the effectiveness of pharmacologic treatment in eradication of the bacterium and prevention of ulcer recurrence.3 Nevertheless, several studies have reported the use of the laparoscopic approach in clinical practice. Minimally invasive treatment of PPU involves entering the abdominal cavity after establishing a pneumoperitoneum, closure of the gastric defect, and lavage of the abdomen. Closure of the defect is facilitated either by direct suturing with or without placement of an omental patch or by introduction of biological glue with or without placement of a gelatin sponge.4,5 The concept of sutured closure is the laparoscopic counterpart to the open technique, whereas nonsutured repair does not require laparoscopic suturing skills and has the advantage of shorter operative time.6 Methods: We conducted a meta-analysis of randomized trials to test this hypothesis. Medline, EMBASE, and the Cochrane Central Register of Randomized Trials databases were searched, with no date or language restrictions. Results: Our literature search identified 4 randomized trials, with a cumulative number of 289 patients, that compared the laparoscopic approach with open sutured repair of perforated ulcer. Analysis of outcomes did not favor either approach in terms of morbidity, mortality, and reoperation rate, although odds ratios seemed to consistently support the laparoscopic approach. Results did not determine the comparative efficiency and safety of laparoscopic or open approach for PPU. Conclusion: In view of an increased interest in the laparoscopic approach, further randomized trials are considered essential to determine the relative effectiveness of laparoscopic and open repair of PPU. Key Words: Peptic ulcer disease, Perforated peptic ulcer, Gastric ulcer, Duodenal ulcer, Laparoscopy, Metaanalysis. Center for Minimally Invasive Surgery, Hospital Neuwerk, Mönchengladbach, Germany (Drs. S. Antoniou, Granderath). Department of Vascular and Endovascular Surgery, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK (Dr. G. Antoniou). Department of General Surgery, Hospital Zell am See, Zell am See, Austria (Drs. Koch, Pointner). Address correspondence to: Stavros A. Antoniou, Souniou 11, 19001 Keratea Attikis, Athens, Greece. Telephone: (⫹49) 163-851-8279, Fax: (⫹30) 229-906-8845, E-mail: [email protected] The decreasing incidence of PPU has diminished the use of the laparoscopic treatment of this condition.7 Clinical data mostly report retrospective studies, whereas prospective trials are primarily uncontrolled,8 thereby providing a low level of evidence. In view of experimental data demonstrating the efficacy of pneumoperitoneum compared with laparotomy in experimental models of intra-abdominal sepsis,9 the laparoscopic approach to PPU is of considerable interest. The present study reviews the current literature to identify the highest-quality studies and performs a comparative analysis of the clinical outcomes in laparoscopic and open sutured treatment of peptic ulcer perforation. A metaanalysis of randomized controlled trials was undertaken to examine the relative risks of morbidity and mortality for both the laparoscopic and open approaches. MATERIALS AND METHODS Study Protocol and Eligibility Criteria DOI: 10.4293/108680812X13517013317752 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. An ad hoc study protocol was designed to address inclusion criteria and methods of analysis. Randomized controlled tri- JSLS (2013)17:15–22 15 Meta-analysis of Laparoscopic Versus Open Repair of Perforated Peptic Ulcer, Antoniou SA et al. als providing operative outcome data of laparoscopic sutured and open sutured repair of PPU were considered for inclusion. The primary outcome measure of the present meta-analysis was the relative risk of in-hospital mortality, whereas secondary outcome measures included operative morbidity, duration of surgery, postoperative pain, and length of in-hospital stay. Data sources were searched with no language or date restrictions. Only published material was included, whereas study abstracts presented in medical congresses and indexed in peerreviewed journals were evaluated for content. Data Sources and Study Selection The electronic databases of the National Library of Medicine (Medline; provider Ovid, from 1966 to July 2012), Excerpta Medica (EMBASE; provider Elsevier, from 1980 to July 2012), and the Cochrane Central Register of Controlled Trials were searched to identify relevant articles. The following search terms were used: “laparoscopy (MeSH)” AND “repair OR closure” AND “gastric OR duodenal” AND “ulcer (MeSH).” Study abstracts were reviewed and full-text articles on pertinent subjects were obtained. A second-level search included the reference lists of eligible studies and the bibliography of all relevant systematic reviews. Study eligibility was assessed independently by 2 authors in an unblinded manner. Disagreements between reviewers were resolved by consensus. The last search was run on July 14, 2012. Data Collection and Indexing Data were independently retrieved by the 2 reviewers upon selection of studies to include in this work. For this purpose, an electronic database was developed using Microsoft Excel (Microsoft Corp, Redmond, WA) and refined accordingly. Data items extracted from each study included author, year of publication, country of origin, period of treatment, number of participating centers, number of included patients, number of patients who received treatment, number of patients for whom operative and postoperative data were available, number of patients in each treatment arm, inclusion criteria, exclusion criteria, randomization method, blinded method (if applicable), number of patients who were evaluated after treatment, male-to-female ratio, mean age, mean American Society of Anesthesiologists score, mean Boey score, type of surgery (simple repair with or without omental patch), and mean size of perforation. Outcome measures extracted from each study included duration of surgery, conversion rate, visual analog score (VAS) at 24, 48, and 72 hours after surgery, diet toleration time, absolute number of major complications, absolute number of minor complications, and duration of in-hospital stay. Major complications 16 included suture line leakage, peritoneal abscess/collection, pancreatitis, fascial dehiscence, pneumonia or respiratory failure, and severe cardiac and cerebrovascular events. Wound infection or wound abscess, urinary tract infection, prolonged ileus, and incisional hernia were considered minor complications. If data were not reported, or were insufficient, the authors were contacted by e-mail, provided with information on the study, and invited to provide additional information. VAS at 48 and 72 hours after surgery were only provided by one study. A meta-analytical model for the continuous variables of duration of hospital stay and time to tolerate oral diet could not be applied because respective mean values were not provided. Quality Assessment and Methods of Analysis The Jadad score was calculated for each study to assess methodologic quality of the included trials. This 5-point scoring system takes a number of criteria into account, such as the randomization process, the blind assessment of investigated treatments, and reporting of dropouts.10 A Jadad score of 1 to 2 was considered poor quality, a score of 2 to 3 was considered fair, and a score of 4 to 5 indicated good methodologic quality. Study-specific estimates were combined using randomeffects or fixed-effects models as appropriate. Weighted mean differences with 95% confidence intervals were calculated to assess the size of the effect of each type of procedure on continuous variables. Pooled odds ratios with 95% CI were calculated to measure the effect of each type of procedure on categoric variables. Heterogeneity among trials was assessed using Cochrane’s Q-statistic, a null hypothesis test with a value of P⬍.05 to indicate the presence of significant heterogeneity. Publication bias was assessed using Egger regression intercept. Statistical analysis was performed using Comprehensive Meta Analysis Version 2.0 (Biostat, Englewood, NJ). Statistical expertise was provided by one of the study authors. The present meta-analysis conformed to the Preferred Reporting Items for Systematic reviews and Meta-Analyses statement standards, a methodologic protocol based on essential criteria for transparent reporting.11 RESULTS Search Results and Selection of Studies The electronic search of the databases returned 290 results (Figure 1). On the basis of the abstracts, 271 records were discarded because they were either confirmed retrospec- JSLS (2013)17:15–22 tive studies or they did not report whether they were prospective or retrospective (n⫽42); case series (n⫽58); case reports (n⫽22); letters, comments, or editorials (n⫽32); reviews (n⫽38); animal studies (n⫽6); or studies with unrelated subjects (n⫽73). Nineteen prospective studies with a control arm were identified and their full texts retrieved. Four randomized controlled trials fulfilling the eligibility criteria were identified and included in the meta-analysis.12–15 Manual search of the reference lists reported in the included studies and relevant systematic reviews did not identify any further eligible studies. Characteristics of Included Studies Table 1 reports the characteristics of the included randomized trials. All 4 studies were randomized controlled trials published in the English language between 1996 and 2009. One was a multicentric study with 9 participating centers.15 Three articles originated from China and one from the Netherlands, whereas 2 studies were designed by the same author team and reported on different study groups in distinct periods.12,13 One study focused its results on biochemical evaluation of stress-associated factors rather than on clinical outcomes.13 Nevertheless, this study was included in the analysis because it provided data on duration of surgery. Of 289 patients, 151 were included in the laparoscopic sutured repair arm and 138 in the open sutured repair arm. One study also compared the outcome of laparoscopic and open sutureless techniques, although respective data on treatments were excluded Figure 1. Flow chart of search history. Table 1. Characteristics of Randomized Trials Author Year of Country Publication No. of Period of Participating Treatment Centers Lau, et al.12 1996 China 1 August 1992– Clinical diagnosis of 1. September 1994 PPU 2. 3. 4. Lau et al.13 1998 China 1 September 1995–July 1996 Age between 17 and 69 years Siu et al.14 2002 China 1 January 1994– June 1997 1. Clinical diagnosis 1. Bleeding ulcer 3 of PPU 2. Prior abdominal surgery 2. Age ⬎16 years 3. Gastric outlet obstruction March 1999– July 2005 Clinical diagnosis of 1. Prior upper abdominal PPU surgery Bertleff et al.15 2009 The 9 Netherlands Inclusion Criteria Exclusion Criteria Jadad Score Complicated ulcer 3 Bleeding ulcer Prior abdominal surgery Severe cardiopulmonary disease 1. Bleeding ulcer 2. Immunosuppression 2 3 2. Pregnancy JSLS (2013)17:15–22 17 Meta-analysis of Laparoscopic Versus Open Repair of Perforated Peptic Ulcer, Antoniou SA et al. from this analysis.12 The main inclusion criteria entailed patients with the clinical diagnosis of PPU, whereas patients with bleeding ulcers and prior surgery in the upper abdomen were excluded by 3 studies. Male patients were predominant in the 3 studies that reported gender distribution, with an overall ratio of 1.5:1. The mean age was 54 years in the 2 studies reporting relevant data. In 3 studies, an omental patch was sutured on the repair site,12–14 whereas in 1 study, this was not included as a routine step for both laparoscopic and open procedures.15 Data on VAS, time to tolerate oral diet, and length of in-hospital stay could not be analyzed because several studies failed to report respective mean values or absolute numbers. quality, with a Jadad score of 3, and 1 study was poor quality, reaching a Jadad score of only 2. All reported results adhered to the intention-to-treat concept in all studies. Data collected from patients who underwent conversion to open surgery were analyzed as data of the laparoscopic cohort. A blinded approach was not applied in any of the studies, and one study did not specify any method of randomization.13 Hereby, 3 studies were considered to be of fair There were 3 deaths in the laparoscopic group and 8 deaths in the open group, giving rates of 2% and 6%, respectively (OR 0.36, 95% CI 0.10 –1.32, P⫽.124). There Synthesis of Results and Outcome Table 2 illustrates demographic data of the study populations, and Table 3 summarizes outcome measures. Mortality Table 2. Demographic and Operative Data of the Studied Patient Populations Author No. of Patients (Lap/Open) Age (Lap/ Open) Male-toFemale Ratio ASA Score (Lap/Open) Boey Score (Lap/Open) Size of Perforation (mm) (Lap/Open) Omental Patch Conversion Rate Lau et al.12 45 (24/21) 52 (52/53) 4.6:1 NR 0.27 (0.29/0.24) NR (6 mm/5 mm) Yes 25% (6/24) 13 Lau et al. 22 (12/10) NR NR NR NR NR Yes 25% (3/12) Siu et al.14 121 (63/58) 55 (54/56) 4.3:1 1.72 (1.7/1.7) 0.28 (0.24/0.33) 5.0 (5.2/4.7) Yes 14% (9/63) 101 (52/49) NR (66/59)* 1.5:1 NR (1.0/1.5)* NR NR (10.0/7.0)* Mixed cases 8% (4/52) 15 Bertleff et al. NR, not reported; ASA, American Society of Anesthesiologists; lap, laparoscopic. Numerical data are reported as mean values, unless otherwise indicated. *Median values. Table 3. Summary Data of Outcome Measures Author Lau et al.12 13 Lau et al. 14 Siu et al. Operative VAS† (Lap/ Time (Min) Open) (Lap/Open) Days After Surgery to Tolerate Oral Diet (Lap/ Open) Minor Complications, (Lap/Open), n (%) Major Reoperation, Duration of In- Mortality Complications (Lap/Open), Hospital Stay (Lap/Open), (Lap/Open), n n (%) (d) (Lap/Open) n (%) (%) 87 (113/57) NR (4/5)* NR (4/4)* 2/4 (8/19) 2/1 (8/5) 0/1 (0/5) NR (5/5)* 0/1 (0/5) NR (96/35)* NR NR NR NR NR NR NR 47 (42/52) 4.9 (3.5/6.4) NR (4/5)* Bertleff et al.15 NR (75/50)* (3.8/5.2)* NR 7/14 (11/24) 3/8 (5/14) 5/1 (8/5) NR (6/7) 1/3 (2/5) NR NR NR NR (6.5/8)* 2/4 (4/8) n, absolute number; NR, not reported; lap, laparoscopic. Numerical data are reported as mean values, unless otherwise indicated. *Median values. † 24 hours after surgery. 18 * JSLS (2013)17:15–22 was no evidence of between-study heterogeneity (P⫽.945) (Figure 2). Operative Time Mean duration of surgery was 62 minutes for the laparoscopic group and 53 minutes for the open group (weighted mean difference 0.38, 95% CI 1.22–1.99, P⫽ .639). There was significant evidence of between-study heterogeneity (P⬍.001) (Figure 3). Major Complications Incidence of major complications was 6% in the laparoscopic group and 11% in the open surgery group (OR 0.47, 95% CI 0.14 –1.58, P⫽.225). The level of betweenstudy heterogeneity was low (P⫽.223) (Figure 4). Reoperation One percent of patients of the laparoscopic group and 8% of patients of the open group underwent repeated surgery (OR 2.02, 95% CI 0.33–12.36, P⫽.446). Between-study heterogeneity was low (P⫽.151) (Figure 5). DISCUSSION The present meta-analysis does not support favorable outcomes for minimally invasive treatment of PPU over its open surgery counterpart, as reported in the currently studied variables. Several limitations have to be taken into account to evaluate these results. Our literature search identified only 4 randomized trials. Three of these studies were of fair methodologic quality, whereas the rest failed to provide adequate data for statistical evaluation. The Figure 2. Forest plot of mortality for laparoscopic and open repair of perforated ulcer. Figure 3. Forest plot of operative time for laparoscopic and open repair of perforated ulcer. JSLS (2013)17:15–22 19 Meta-analysis of Laparoscopic Versus Open Repair of Perforated Peptic Ulcer, Antoniou SA et al. Figure 4. Forest plot of major complications for laparoscopic and open repair of perforated ulcer. Figure 5. Forest plot of rate of reoperation for laparoscopic and open repair of perforated ulcer. cumulative study population was low, and the strength of the analysis was therefore limited. The set of available data demonstrated homogeneous results for the outcome variables of mortality, complications, and reoperation rate. All studies adhered to the intentionto-treat principle, thereby rendering the outcome for laparoscopic repair more reliable. Statistical significance could not be reached for any of these variables, although odd ratios were consistently in favor of the laparoscopic repair, suggesting a potential type II statistical error. Similarly, the laparoscopic approach resulted in a lower rate of minor complications (10% vs 23%, data not shown). These results are consistent with a meta-analytical approach of nonrandomized trials, which may reflect the standard health care delivery setting.8 20 Early evidence from prospective studies demonstrated longer operating times for laparoscopic repair of PPU. Two randomized studies provided relevant data, which were contradictory, however. Longer duration of surgery was reported by Lau et al12 in their trial conducted between 1992 and 1994, whereas a significantly reduced mean operating time was demonstrated in a more recent study by Siu et al,14 which introduced substantial heterogeneity into the analysis. It has been suggested that acquaintance with the laparoscopic concept and laparoscopic suturing skills may result in a reduction in the duration of surgery over time.8 A prospective analysis of more than 100 cases of laparoscopic treatment of PPU performed by surgical trainees has reported an acceptable mean operating time of 65 minutes, although most the JSLS (2013)17:15–22 study population consisted of low-risk patients.16 Peritoneal lavage is a factor of prolonged duration of surgery, although this has now been replaced with high-volume irrigation systems.8,17 Open repair of PPU remains the gold-standard treatment. It is simple and effective and provides long-term regression of the disease when combined with eradication of H pylori and recess of nonsteroidal anti-inflammatory medication.18,19 In these patients, mortality is frequently associated with underlying sepsis and inflammatory response, which correlates with patient risk factors rather than surgical complications.20 Considering the mitigated inflammatory reaction after elective laparoscopic procedures or laparoscopy for perforated appendicitis,21,22 a minimally invasive approach to this emergency condition seems appealing. Outcomes of 3 randomized trials on in-hospital mortality were consistently favorable of the laparoscopic approach, although statistical significance could not be reached. The maximum relative weight was provided by the study by Bertleff et al,15 which reported a higher peritonitis index for the laparoscopic cohort. Although there is evidence suggesting a decreased amount of operative stress in patients with peritonitis undergoing laparoscopic surgery, the true benefit of laparoscopic repair in specific patients remains to be identified. Centers with adequate experience and a community-based evaluation of laparoscopic repair of PPU have recognized old age, poor anesthesiologic status, and delayed presentation as predictive factors for mortality.23–25 Comparative data on laparoscopic and open repair of PPU in patients stratified according to risk factors as ASA score and Boey score are still unavailable. Systemic and procedure-related complications are a matter of concern in septic patients undergoing upper abdominal surgery. The theoretic advantage of laparoscopic treatment in terms of morbidity cannot be confirmed in the present analysis. The largest available randomized trial, which enrolled more than 100 patients, demonstrated a lower morbidity rate for the laparoscopic approach (5% vs 14%), but the data were not statistically significant.14 This finding correlates with a cumulative evaluation of prospective and retrospective studies in 2005.8 Because half of the studies included in this analysis were published before 2000, when laparoscopy experience was still limited, evaluation of surgery-related morbidity in the modern era of laparoscopy is a field for future investigation. Suture-site leakage is still an issue, and concerns have been raised regarding laparoscopic suturing of friable ulcer edges. An analysis of risk factors found that 84% of patients with a history of symptoms lasting longer than 9 hours developed leakage after laparoscopic Figure 6. Absolute numbers of prospective studies on laparoscopic treatment of PPU published from 1990 to 2010. repair.26 Nevertheless, high-quality comparative data of laparoscopic and open repair with regard to suture failure and intra-abdominal abscess are not available. Although the laparoscopic approach to PPU may offer significant advantages over open repair with regard to postoperative morbidity and mortality, the evidence of its efficacy is still inconclusive. A population-based study from China reported an increase in the frequency of laparoscopic repair of PPU.27 Interestingly, our literature review has retrieved a decreasing number of published prospective trials from 1996 to date (Figure 6). In view of the low incidence of ulcer perforation, interinstitutional collaboration is strongly recommended to evaluate the effect of laparoscopic repair of PPU on the setting of a randomized study. Current evidence does not clearly demonstrate the advantages of laparoscopic versus open repair of PPU for any of the examined outcome measures. Growing interest in the laparoscopic approach may encourage the design of additional randomized trials to analyze its efficacy compared with the open approach. References: 1. Nathanson LK, Easter WT, Cushieri A. Laparoscopic repair/ peritoneal toilet of perforated duodenal ulcer. Surg Endosc. 1990;4:232–233. 2. Mouret P, François Y, Vignal J, Barth X, Lombard-Platet R. Laparoscopic treatment of perforated peptic ulcer. Br J Surg. 1990;77:1006. 3. Coghlan JG, Gilligan D, Humphries H, et al. Campylobacter pylori and recurrence of duodenal ulcers—a 12-month follow-up study. Lancet. 1987;2:1109 –1111. JSLS (2013)17:15–22 21 Meta-analysis of Laparoscopic Versus Open Repair of Perforated Peptic Ulcer, Antoniou SA et al. 4. Bhogal RH, Athwal R, Durkin D, Deakin M, Cheruvu CN. Comparison between open and laparoscopic repair of perforated peptic ulcer disease. World J Surg. 2008;32:2371–2374. 16. Siu WT, Chau CH, Law BK, Tang CN, Ha PY, Li MK. Routine use of laparoscopic repair for perforated peptic ulcer. Br J Surg. 2004;91:481– 484. 5. Ates M, Sevil S, Bakircioglu E, Colak C. Laparoscopic repair of peptic ulcer perforation without omental patch versus conventional open repair. J Laparoendosc Adv Surg Tech. 2007;17: 615– 619. 17. Lagoo S, McMahon RL, Kahikara M, Pappas TN, Eubanks S. The sixth decision regarding perforated duodenal ulcer. JSLS. 2002;6:359 –368. 6. Lau WY, Leung KL, Zhu XL, Lam YH, Chung SC, Li AK. Laparoscopic repair of perforated peptic ulcer. Br J Surg. 1995; 82:814 – 816. 18. Ng EK, Lam YH, Sung JJ, et al. Eradication of Helicobacter pylori prevents recurrence of ulcer after simple closure of duodenal ulcer perforation: Randomized controlled trial. Ann Surg. 2000;231:153–158. 7. Bashinskaya B, Nahed BV, Redjal N, Kahle KT, Walcott BP. Trends in peptic ulcer disease and the identification of Helicobacter pylori as a causative organism: Population-based estimates from the US nationwide inpatient sample. J Glob Infect Dis. 2011;3:366 –370. 19. Tomtitchong P, Siribumrungwong B, Vilaichone RK, Kasetsuwan P, Matsukura N, Chaiyakunapruk N. Systematic review and meta-analysis: Helicobacter pylori eradication therapy after simple closure of perforated duodenal ulcer. Helicobacter. 2012; 17:148 –152. 8. Lunevicius R, Morkevicius M. Systematic review comparing laparoscopic and open repair for perforated peptic ulcer. Br J Surg. 2005;92:1195–1207. 20. Boey J, Choi SK, Poon A, Alagaratnam TT. Risk stratification in perforated duodenal ulcers. A prospective validation of predictive factors. Ann Surg. 1987;205:22–26. 9. Karantonis FF, Nikiteas N, Perrea D, et al. Evaluation of the effects of laparotomy and laparoscopy on the immune system in intra-abdominal sepsis–a review. J Invest Surg. 2008;21:330 –339. 21. Sammour T, Kahokehr A, Chan S, Booth RJ, Hill AG. The humoral response after laparoscopic versus open colorectal surgery: A meta-analysis. J Surg Res. 2010;164:28 –37. 10. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Control Clin Trials. 1996;17:1–12. 22. Schietroma M, Piccione F, Carlei F, et al. Peritonitis from perforated appendicitis: stress response after laparoscopic or open treatment. Am Surg. 2012;78:582–590. 11. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: Explanation and elaboration. BMJ. 2009;339:b2700. 23. Druart ML, Van Hee R, Etienne J, et al. Laparoscopic repair of perforated duodenal ulcer. A prospective multicenter clinical trial. Surg Endosc. 1997;11:1017–1020. 12. Lau WY, Leung KL, Kwong KH, et al. A randomized study comparing laparoscopic versus open repair of perforated peptic ulcer using suture or sutureless technique. Ann Surg. 1996;224: 131–138. 13. Lau JY, Lo SY, Ng EK, Lee DW, Lam YH, Chung SC. A randomized comparison of acute phase response and endotoxemia in patients with perforated peptic ulcers receiving laparoscopic or open patch repair. Am J Surg. 1998;175:325–327. 14. Siu WT, Leong HT, Law BK, et al. Laparoscopic repair for perforated peptic ulcer: A randomized controlled trial. Ann Surg. 2002;235:313–319. 15. Bertleff MJ, Halm JA, Bemelman WA, et al. Randomized clinical trial of laparoscopic versus open repair of the perforated peptic ulcer: the LAMA Trial. World J Surg. 2009;33: 1368 –1373. 22 24. Wong DC, Siu WT, Wong SK, Tai YP, Li MK. Routine laparoscopic single-stitch omental patch repair for perforated peptic ulcer: Experience from 338 cases. Surg Endosc. 2009;23:457– 458. 25. Kuwabara K, Matsuda S, Fushimi K, Ishikawa KB, Horiguchi H, Fujimori K. Community-based evaluation of laparoscopic versus open simple closure of perforated peptic ulcers. World J Surg. 2011;35:2485–2492. 26. Lunevicius R, Morkevicius M. Risk factors influencing the early outcome results after laparoscopic repair of perforated duodenal ulcer and their predictive value. Langenbecks Arch Surg. 2005;390:413– 420. 27. Lam CM, Yuen AW, Chik B, Wai AC, Fan ST. Laparoscopic surgery for common surgical emergencies: A population-based study. Surg Endosc. 2005;19:774 –779. JSLS (2013)17:15–22 SCIENTIFIC PAPER Open versus Laparoscopic Hiatal Hernia Repair Terrence M. Fullum, MD, Tolulope A. Oyetunji, MD, MPH, Gezzer Ortega, MD, MPH, Daniel D. Tran, MD, Ian M. Woods, BS, Olusola Obayomi-Davies, BS, Orighomisan Pessu, BS, Stephanie R. Downing, MD, Edward E. Cornwell, MD ABSTRACT INTRODUCTION Background: The literature reports the efficacy of the laparoscopic approach to paraesophageal hiatal hernia repair. However, its adoption as the preferred surgical approach and the risks associated with paraesophageal hiatal hernia repair have not been reviewed in a large database. Paraesophageal hiatal hernia (PHH) accounts for 5% of all hiatal hernias and occurs with increasing incidence in elderly patients.1– 4 Controversies exist regarding its management.5– 8 Historically, surgical repair has been advocated in all patients with PHH (symptomatic patients and incidental diagnoses). Elective PHH repair has been advocated in patients with mild symptoms for 2 reasons: to prevent potentially lethal complications, such as strangulation, incarceration, perforation, and volvulus, as detailed in the studies by Skinner and Hill,9,10 and to avoid the significant operative morbidity and mortality associated with emergent PHH repair.11–14 In recent years, physicians proposing conservative and nonsurgical management have scrutinized this dogma. Method: The Nationwide Inpatient Sample dataset was queried from 1998 to 2005 for patients who underwent repair of a complicated (the entire stomach moves into the chest cavity) versus uncomplicated (only the upper part of the stomach protrudes into the chest) paraesophageal hiatal hernia via the laparoscopic, open abdominal, or open thoracic approach. A multivariate analysis was performed controlling for demographics and comorbidities while looking for independent risk factors for mortality. Results: In total, 23,514 patients met the inclusion criteria. By surgical approach, 55% of patients underwent open abdominal, 35% laparoscopic, and 10% open thoracic repairs. Length of stay was significantly reduced for all patients after laparoscopic repair (P ⬍ .001). Age ⱖ60 years and nonwhite ethnicity were associated with significantly higher odds of death. Laparoscopic repair and obesity were associated with lower odds of death in the uncomplicated group. Conclusion: Laparoscopic repair of paraesophageal hiatal hernia is associated with a lower mortality in the uncomplicated group. However, older age and Hispanic ethnicity increased the odds of death. Key Words: Paraesophageal hiatal hernia repair, Preoperative risk factors, Laparoscopy. Division of Minimally Invasive and Bariatric Surgery, Department of Surgery, Howard University College of Medicine, Washington, DC, USA (Drs. Fullum, Tran). Department of Surgery, Howard University College of Medicine, Washington, DC, USA (Drs. Oyetunji, Ortega, Downing, Cornwell). Howard University College of Medicine, Washington, DC, USA (Drs. Woods, Obayomi-Davies, Pessu). Address correspondence to: Terrence M. Fullum, MD, Howard University College of Medicine, 2041 Georgia Avenue, NW, Washington, DC 20060. Telephone: 202-865-1286, Fax: 202-865-3063, E-mail: [email protected]. DOI: 10.4293/108680812X13517013316951 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. Proponents of nonsurgical management suggest that previous beliefs about the natural history and the worsening progression of mildly symptomatic PHH are rare in modern medicine, thus negating the need for elective surgery.15,16 Stylopoulos et al,17 using a complex decision analysis, concluded that watchful waiting is a better alternative to elective surgery in mildly symptomatic patients. In addition, a plethora of common comorbid conditions in affected elderly patients caused many surgeons to view surgical intervention as high risk in mildly symptomatic elderly patients.2,15,17,18 Additional controversy exists regarding the choice of surgical approach.1,5,6 Before the advent of minimally invasive techniques, open surgeries via transabdominal and transthoracic entry were the indicated management of PHH. Since its introduction in 1992, laparoscopic PHH repair (LPHHR) has emerged at the forefront of PHH treatment.19 A large dataset of patients across the United States treated with different approaches allows for evaluation of perioperative outcomes and has adequate power to determine factors influencing hospital outcome.16,20,21 We hypothesize that mortality is lower after laparoscopic repair than after open repair. To test this hypothesis, the Nationwide Inpatient Sample (NIS) was used to (1) determine whether there is a difference in mortality between the 2 approaches and (2) identify risk factors that may be associated with poor in-hospital outcomes after PHH repair. JSLS (2013)17:23–29 23 Open versus Laparoscopic Hiatal Hernia Repair, Fullum TM et al. METHODS Table 1. ICD-9 Codes Used for Patient Selection Overview The NIS is the largest all-payer inpatient care database that is publicly available in the United States. It contains data from 5 to 8 million hospital stays from approximately 1000 hospitals sampled to approximate a 20% stratified sample of US community hospitals. The NIS is drawn from states participating in the Healthcare Cost and Utilization Project, and weights are provided to calculate national estimates.22 Researchers and policy makers use the NIS to identify, track, and analyze national trends in health care use, access, charges, quality, and outcomes. The large sample size of the NIS enables analyses of rare conditions such as congenital anomalies, uncommon treatments such as organ transplantation, and special patient populations such as the uninsured. Data available within the NIS include patient and hospital demographics, payer information, treatment and concomitant diagnoses, inpatient procedures, inpatient mortality, and length of stay. Patient Selection The NIS dataset was queried for patients who underwent open or laparoscopic repair of a complicated or uncomplicated PHH between 1998 and 2005. Open repair included both the transthoracic and transabdominal approaches. Patients were identified according to the relevant International Classification of Diseases, Ninth Revision (ICD-9) diagnosis and procedure codes (Table 1). ICD-9 codes 553.3 and 552.3 were used to identify patients with uncomplicated PHH and complicated (ie, incarcerated, irreducible, strangulated, or obstructed) PHH, respectively. ICD-9 codes 53.70, 53.72, and 53.75 were used to identify patients who underwent open abdominal PHH repair, whereas ICD-9 codes 53.80 and 53.84 identified patients who underwent open thoracic PHH repair. Patients who underwent LPHHR were identified using ICD-9 codes 53.71, 53.83, and 54.21. Obese and morbidly obese patients were identified with ICD-9 codes 278.0 and 278.01. Code Description 555.3 Diaphragmatic hernia: paraesophageal hiatal hernia 555.2 Diaphragmatic hernia with obstruction: paraesophageal specified as incarcerated, irreducible, strangulated, or causing obstruction 53.70 Repair of diaphragmatic hernia, abdominal approach 53.72 Other and open repair of diaphragmatic hernia, abdominal approach 53.75 Repair of diaphragmatic hernia, abdominal approach, not otherwise specified 53.80 Repair of diaphragmatic hernia with thoracic approach, not otherwise specified 53.84 Other and open repair of diaphragmatic hernia, with thoracic approach 53.71 Laparoscopic repair of diaphragmatic hernia, abdominal approach 52.21 Laparoscopy, peritoneoscopy 52.83 Laparoscopic repair of diaphragmatic hernia, with thoracic approach 278.00 Obesity, unspecified 278.01 Morbid obesity logistic regression models, adjusting for age, sex, race, obesity, Charlson score, surgical approach, and complication status. A P value ⬍ .05 was considered statistically significant. The Charlson score is a comorbidity index that predicts the 10-year mortality for a patient who may have any one or a combination of 22 select comorbid conditions. RESULTS Statistical Analysis A total of 23,514 patients met the inclusion criteria. Patient demographics are shown in Table 1. In univariate analysis, mean (median) age was 56 (57) years. A majority of the patients were women (64%) and white (62%). AfricanAmerican and Hispanic patients each represented approximately 4% of the patient population. Seventeen percent of patients were obese. Statistical analysis was performed with STATA 10.0 statistical software (StataCorp, College Station, TX). Bivariate analysis of categorical data was performed using the 2 test. Analysis of continuous data was performed using the t test. Bivariate analysis compared length of stay (LOS) and mortality by surgical approach to treat complicated and uncomplicated hernias. Multivariate analysis was performed using multiple When we compared surgical approaches (Table 2) we found that 55% of the repairs were performed via the open abdominal approach, 35% by laparoscopy, and 10% by the open thoracic approach. There was no significant difference in odds of death between the open thoracic and open abdominal approaches. In addition, Hispanic ethnicity and age ⬎60 years (Figure 1) were associated 24 JSLS (2013)17:23–29 Table 2. Patient Demographics Overall Patient Demographics Patient Demographics by Surgical Approach and Year Variable N % All patients 23,514 In-hospital mortality 393 1.67 Open Abdominal 13,011 55.33 Laparoscopic 8281 35.22 Open thoracic 2222 9.45 15,119 64 Open Abdominal (%) Laparoscopic (%) Open Thoracic (%) Approach Gender Female Male Age (y) 8668 (57.3) 5114 (34) 1307 (8.6) 4321 (51.7) 3124 (37.38) 912 (10.9) 56.15 (Mean) 57 (Median) 58 54 57 ⬍60 16,796 71 8604 6604 1588 ⬎60 6700 28 4394 1673 633 Ethnicity White 14,575 62 7953 (54.5) 5254 (36.05) 1368 (9.39) Black 942 4.04 578 ( 61.36) 271 (28.77) 93 (9.87) Hispanic Obesity 899 3.82 455 (50.61) 324 (36.04) 120 (13.35) 3891 16.55 2742 (70.47) 922 (23.70) 227 (5.83) 19,921 84.72 10258 (51.49) 7859 (39.45) 1804 (9.06) 137 (1.34) 45 (0.57) 22 (1.22) 3593 15.28 2753 (76.62) 422 (11.75) 418 (11.63) 158 (5.75) 16 (3.79) 15 (3.6) 5.99 (Mean) 4 (Median) 6.91 3.81 8.75 Hernia status Uncomplicated Mortality Complicated Mortality LOS with significantly increased odds of death (Table 3). Male sex and obesity status did not influence odds of death. Mortality rate in the uncomplicated group was 1.02%. Fifty-one percent of uncomplicated hernias were repaired by the open abdominal approach (P ⬍ .001). Mortality with the laparoscopic approach (0.57%) was significantly less (P ⬍ .001) in the uncomplicated group compared with the open abdominal approach (1.34%) and the open thoracic approach (1.22%). In the uncomplicated hernia group, laparoscopic repair was associated with a 49% reduction in odds of death compared with the open abdominal approach (odds ratio [OR], 0.51 [95% confidence interval [CI], 0.34 – 0.75]; P ⫽ .001). Complicated hernias were present in 15% of the patients. The overall in-hospital mortality rate was 1.67%. Mortality in the complicated group was 5.26%. Seventy-seven percent of complicated hernias were repaired using the open abdominal approach (P ⬍ .001). On multivariate analysis, complicated hernia status was associated with a 2-fold increase in odds of death (OR, 2.02 [95% CI, 1.52–2.67]; P ⬍ .001) in the entire patient population (Figure 2). In the complicated hernia group, laparoscopic repair was associated with a 41% reduction in odds of death compared with open repair, but the reduction was not statistically significant (OR, 0.59 [95% CI, 0.30 –1.19]; P ⫽ .142). African-American ethnicity and age ⬎80 years were associated with increased odds of death. Compared with the open abdominal approach, LOS was significantly reduced for all patients who had laparoscopic repair and was increased for patients undergoing trans- JSLS (2013)17:23–29 25 Open versus Laparoscopic Hiatal Hernia Repair, Fullum TM et al. Figure 1. Mortality by age group: laparoscopic versus open, P ⫽ .000. Table 3. Risk Factors Associated with Poor Outcomes in Uncomplicated Versus Complicated Cases of PHH Risk Factors Uncomplicated Complicated Odds Ratio P Value (95% CI) Odds Ratio P Value (95% CI) Laparoscopic 0.509 .001 0.34–0.75 0.594 .142 0.29–1.19 Open thoracic 1.065 .816 0.62–1.83 0.966 .917 0.51–1.82 ⱖ40 to ⬍60 1.823 .212 0.71–4.68 0.816 .82 0.14–4.69 ⱖ60 to ⬍70 2.847 .042 1.04–7.82 2.78 .189 0.60–12.78 ⱖ70 to ⬍80 6.977 .000 2.79–17.37 4.07 .065 0.91–18.12 ⱖ80 to ⬍90 19.04 .000 7.57–47.88 11.477 .001 2.65–49.65 61.64 .000 22.37–169.84 14.999 .001 3.22–69.73 African American 1.77 .163 0.79–3.93 2.12 .048 1.00–4.46 Hispanic 2.65 .002 1.42–4.91 1.86 .104 0.88–3.93 0.899 .560 0.63–1.28 1.29 .183 0.89–1.87 0.52 .116 0.23–1.17 0.39 .367 0.05–2.99 Approach (reference open abdominal) Age (y) (reference ⬍40) ⬎90 Race (reference white) Sex (reference female) Male Obesity thoracic repair (Table 4). Patients with complicated hernias remained in the hospital 3.8 days longer (P ⬍ .001) than patients with uncomplicated hernias. Obesity and age ⬍60 years were associated with shorter hospital stays. Insured patients, male sex, and African-American and Hispanic ethnicities were associated with increased LOS. 26 DISCUSSION Hiatal hernias occur partly because of gradual enlargement of the diaphragmatic hiatus. They are generally classified as sliding hiatal hernias (type I), which result from the fixed location of the gastroesophageal junction (GEJ) JSLS (2013)17:23–29 Figure 2. Multivariate analysis: likelihood of death for PHH repair, 1.0 ⫽ comparison. above the hiatus, or as paraesophageal hiatal hernias (type II), in which the fundus of the stomach has herniated through the crural defect but the GEJ remains in its natural anatomic position. Mixed hiatal hernias (type III) are a mixture of type I and type II, in which there is migration of the GEJ into the chest and herniation of a portion of the fundus. Short esophagus (type IV) is caused by foreshortening as a result of esophagitis from gastroesophageal reflux. Type III-IV surgical correction of PHH improves symptoms and averts potentially lethal complications associated with PHH. However, significant operative morbidity and mortality have been reported in PHH repair.5,6,17 The analysis showed that surgical approach, age ⬎60 years, complicated hernia status, and ethnicity are independent risk factors for increased odds of inhospital mortality and increased LOS. Male sex and obesity did not affect the risk of in-hospital mortality. repairs. Although there was a clear advantage in mortality rates with LPHHR, it was not possible to identify specific patient circumstances that might have affected mortality given the nature of the collected data in this study. Observable differences (eg, comorbid conditions, geographical variables, complications) that could affect outcome were adjusted using multivariate analysis. LPHHR was found to significantly reduce the odds of death, by 48%. This finding largely agrees with previous studies comparing the open and laparoscopic approaches. Once a hernia became complicated, the overall mortality rate was lower with the laparoscopic approach, but the mortality difference compared with the open repair group was not significant. Therefore, the mortality advantage of LPHHR was lost once the hernia became complicated. This finding supports the opinion that early laparoscopic intervention in asymptomatic patients may be beneficial. Surgical Approach Age PHH repair was most commonly performed via the open abdominal approach. However, numerous studies have demonstrated the safety, efficacy, and durability of LPHHR, but its acceptance as the procedure of choice has not been universal, and no randomized controlled trials comparing the open versus laparoscopic approach exist.1,3,7,13,14,23–30 Proponents of the open approach argue that LPHHR is associated with a high recurrence rate and intraoperative and postoperative complications, and they tout open PHH repair’s comparable, if not superior, results.31–33 Among the 389 patients with in-hospital mortality, 85% had undergone open repair compared with 15% who had undergone laparoscopic repair. In complicated hernia cases, 92% of patients who died had open hernia On average, PHH was diagnosed in patients between ages 60 and 70 years.34 Advanced age was considered an increased operative risk because of the multiple comorbidities in the elderly population. In this study, 46% of patients undergoing PHH repair were older than 60 years. On multivariate analysis, patients aged 60 years or older had a 3-fold increase in the odds of death. These odds increased exponentially every decade thereafter. In patients aged 60 years and older, ⬍27% of repairs were performed laparoscopically despite the demonstrated safety and efficacy of LPHHR in elderly patients.3,35 Furthermore, nonelective PHH repair has been identified as an independent risk factor, with as high as a 7-fold increase in mortality specifically in elderly patients.8,36 Given these findings, 2 JSLS (2013)17:23–29 27 Open versus Laparoscopic Hiatal Hernia Repair, Fullum TM et al. issues require attention. First, a significant percentage of the elderly patients who underwent open repairs were predisposed to a higher morbidity and mortality. Second, in light of a significant increase in mortality associated with nonelective PHH repair, the benefit of “watchful waiting” for the asymptomatic uncomplicated hernia versus early elective repair deserves a reassessment. In this study, the overall mortality in patients older than 60 years was 26%. This translated to a 48-fold increase in mortality compared with that in individuals younger than 60 years. We theorized that with a patient’s advancing age, a previously uncomplicated hernia will likely become complicated, thus requiring urgent or emergent repair. Therefore, “watchful waiting” may prove a costly gamble for physician and patient alike, exchanging the lower risk of an early elective laparoscopic repair for the potentially time-dependent accumulating risk of significant morbidity and mortality. Complicated Hernia Status and there was an associated significant half-day increase in LOS. Although there is a general perception that obese individuals are at increased risk of adverse outcomes with operative intervention, once appropriate comorbidities are adjusted for, there is no difference in outcome. Study Limitations There are limitations to this study. Our assessment was limited to in-hospital morbidity and mortality. Patients who had adverse outcomes after discharge were not reported and thus could not be included in the study. Because of the nature of the collected data, specific clinical aspects of patients that might have contributed to poor outcomes were not able to be identified. Not all symptomatic hernias were complicated, and not all complicated hernias were symptomatic. Finally, there was no accounting for differences in patient management, the complex nature of the repair, and socioeconomic variables. PHHs found to be incarcerated, strangulated, or obstructed were classified as complicated hernias. These hernias made up 15.4% of all identified cases. The mortality rate in this group was 5.3%. With advancing age, the percentage of patients with complicated hernias increases, reaching 51% in the category of patients aged 90 years and older. Compared with uncomplicated hernias, complicated hernias resulted in a 2-fold increase in the odds of in-hospital mortality and increased LOS by 3 days. In the complicated hernia group, 88.3% of patients received open paraesophageal hiatal hernia repair compared with 60.6% of patients in the uncomplicated group. CONCLUSION Ethnicity 1. Lal DR, Pellegrini CA, Oelschlager BK. Laparoscopic repair of paraesophageal hernia. Surg Clin North Am. 2005;85:105–118, x. It is unclear why African-American and Hispanic patients had significantly increased odds of death compared with white patients. The exact nature of the problem is beyond the scope of this study. However, 29% of hernias in AfricanAmerican patients were repaired laparoscopically compared with 36% in white and Hispanic patients. In addition, it did not appear that African-American or Hispanic patients had significant differences in mortality from complicated hernias. Obesity and Sex It was unclear why obesity had a protective role in patients with PHH. Even though obese patients had a significantly reduced LOS compared with nonobese patients, the reduction in mortality odds was not significant. In addition, male sex did not appear to increase the risk of mortality in PHHR, 28 Surgical approach, age, complicated hernia status, and ethnicity are independent risk factors for mortality in patients undergoing PHHR. Watchful waiting, particularly for patients older than 60 years, may delay intervention when the hernia is uncomplicated or asymptomatic. Once the hernia becomes complicated, urgent surgical intervention subjects the patient to increased morbidity and mortality. It would be prudent to consider early elective LPHHR to maximize safety and reduce hospital LOS. References: 2. Kercher KW, Matthews BD, Ponsky JL, et al. Minimally invasive management of paraesophageal herniation in the highrisk surgical patient. Am J Surg. 2001;182:510 –514. 3. Gangopadhyay N, Perrone JM, Soper NJ, et al. Outcomes of laparoscopic paraesophageal hernia repair in elderly and highrisk patients. Surgery. 2006;140:491– 498. 4. Landreneau RJ, Johnson JA, Marshall JB, Hazelrigg SR, Boley TM, Curtis JJ. Clinical spectrum of paraesophageal herniation. Dig Dis Sci. 1992;37:537–544. 5. Draaisma WA, Gooszen HG, Tournoij E, Broeders IA. Controversies in paraesophageal hernia repair: a review of literature. Surg Endosc. 2005;19:1300 –1308. 6. Davis SS Jr. Current controversies in paraesophageal hernia repair. Surg Clin North Am. 2008;88:959 –978, vi. JSLS (2013)17:23–29 7. Ferri LE, Feldman LS, Stanbridge D, Mayrand S, Stein L, Fried GM. Should laparoscopic paraesophageal hernia repair be abandoned in favor of the open approach? Surg Endosc. 2005;19:4 – 8. 8. Hallissey MT, Ratliff DA, Temple JG. Paraoesophageal hiatus hernia: surgery for all ages. Ann R Coll Surg Engl. 1992;74:23–25. 9. Skinner DB, Belsey RH. Surgical management of esophageal reflux and hiatus hernia. Long-term results with 1,030 patients. J Thorac Cardiovasc Surg. 1967;53:33–54. 10. Hill LD. Incarcerated paraesophageal hernia. A surgical emergency. Am J Surg. 1973;126:286 –291. 11. Sihvo EI, Salo JA, Rasanen JV, Rantanen TK. Fatal complications of adult paraesophageal hernia: a population-based study. J Thorac Cardiovasc Surg. 2009;137:419 – 424. 12. Chang CC, Tseng CL, Chang YC. A surgical emergency due to an incarcerated paraesophageal hernia. Am J Emerg Med. 2009;27:134.e1– e3. 13. Luketich JD, Raja S, Fernando HC, et al. Laparoscopic repair of giant paraesophageal hernia: 100 consecutive cases. Ann Surg. 2000;232:608 – 618. 14. Schauer PR, Ikramuddin S, McLaughlin RH, et al. Comparison of laparoscopic versus open repair of paraesophageal hernia. Am J Surg. 1998;176:659 – 665. 22. HCUP NIS Database Documentation. Healthcare Cost and Utilization Project (HCUP). February 2013. Agency for Healthcare Research and Quality, Rockville, MD. Available at: http:// www.hcup-us.ahrq.gov/db/nation/nis/nisdbdocumentation.jsp. Accessed August 12, 2010. 23. Andujar JJ, Papasavas PK, Birdas T, et al. Laparoscopic repair of large paraesophageal hernia is associated with a low incidence of recurrence and reoperation. Surg Endosc. 2004;18:444 – 447. 24. Edye MB, Canin-Endres J, Gattorno F, Salky BA. Durability of laparoscopic repair of paraesophageal hernia. Ann Surg. 1998; 228:528 –535. 25. Nason KS, Luketich JD, Qureshi I, et al. Laparoscopic repair of giant paraesophageal hernia results in long-term patient satisfaction and a durable repair. J Gastrointest Surg. 2008;12:2066 –2075. 26. Willekes CL, Edoga JK, Frezza EE. Laparoscopic repair of paraesophageal hernia. Ann Surg. 1997;225:31–38. 27. Parameswaran R, Ali A, Velmurugan S, Adjepong SE, Sigurdsson A. Laparoscopic repair of large paraesophageal hiatus hernia: quality of life and durability. Surg Endosc. 2006;20:1221–1224. 28. Mattar SG, Bowers SP, Galloway KD, Hunter JG, Smith CD. Long-term outcome of laparoscopic repair of paraesophageal hernia. Surg Endosc. 2002;16:745–749. 29. Bawahab M, Mitchell P, Church N, Debru E. Management of acute paraesophageal hernia. Surg Endosc. 2009;23:255–259. 15. Treacy PJ, Jamieson GG. An approach to the management of para-oesophageal hiatus hernias. Aust N Z J Surg. 1987;57:813– 817. 30. Pierre AF, Luketich JD, Fernando HC, et al. Results of laparoscopic repair of giant paraesophageal hernias: 200 consecutive patients. Ann Thorac Surg. 2002;74:1909 –1915. 16. Allen MS, Trastek VF, Deschamps C, Pairolero PC. Intrathoracic stomach. Presentation and results of operation. J Thorac Cardiovasc Surg. 1993;105:253–258. 31. Low DE, Unger T. Open repair of paraesophageal hernia: reassessment of subjective and objective outcomes. Ann Thorac Surg. 2005;80:287–294. 17. Stylopoulos N, Gazelle GS, Rattner DW. Paraesophageal hernias: operation or observation? Ann Surg. 2002;236:492– 500. 32. Trus TL, Bax T, Richardson WS, et al. Complications of laparoscopic paraesophageal hernia repair. J Gastrointest Surg. 1997;1:221–227. 18. Larusson HJ, Zingg U, Hahnloser D, Delport K, Seifert B, Oertli D. Predictive factors for morbidity and mortality in patients undergoing laparoscopic paraesophageal hernia repair: age, ASA score and operation type influence morbidity. World J Surg. 2009;33:980 –985. 33. Dahlberg PS, Deschamps C, Miller DL, Allen MS, Nichols FC, Pairolero PC. Laparoscopic repair of large paraesophageal hiatal hernia. Ann Thorac Surg. 2001;72:1125–1129. 19. Cuschieri A, Shimi S, Nathanson LK. Laparoscopic reduction, crural repair, and fundoplication of large hiatal hernia. Am J Surg. 1992;163:425– 430. 20. Ellis FH Jr, Crozier RE, Shea JA. Paraesophageal hiatus hernia. Arch Surg. 1986;121:416 – 420. 21. Pearson FG, Cooper JD, Ilves R, Todd TR, Jamieson WR. Massive hiatal hernia with incarceration: a report of 53 cases. Ann Thorac Surg. 1983;35:45–51. 34. Williamson WA, Ellis FH Jr, Streitz JM Jr, Shahian DM. Paraesophageal hiatal hernia: is an antireflux procedure necessary? Ann Thorac Surg. 1993;56:447– 451. 35. Coelho JC, Campos AC, Costa MA, Soares RV, Faucz RA. Complications of laparoscopic fundoplication in the elderly. Surg Laparosc Endosc Percutan Tech. 2003;13:6 –10. 36. Poulose BK, Gosen C, Marks JM, et al. Inpatient mortality analysis of paraesophageal hernia repair in octogenarians. J Gastrointest Surg. 2008;12:1888 –1892. JSLS (2013)17:23–29 29 SCIENTIFIC PAPER Costs and Clinical Outcomes of Conventional Single Port and Micro-laparoscopic Cholecystectomy Edward Chekan, MD, Matthew Moore, MHA, Tina D. Hunter, PhD, Candace Gunnarsson, EdD ABSTRACT Background and Objective: This study compares hospital costs and clinical outcomes for conventional laparoscopic, single-port, and mini-laparoscopic cholecystectomy from US hospitals. Methods: Eligible patients were aged ⱖ18 years and undergoing laparoscopic cholecystectomy with records in the Premier Hospital Database from 2009 through the second quarter of 2010. Patients were categorized into 3 groups— conventional laparoscopic, single port, or minilaparoscopic— based on the International Classification of Diseases, Ninth Revision and Current Procedural Terminology codes and hospital charge descriptions for surgical tools used. A procedure was considered mini-laparoscopic if no single-port surgery products were identified in the charge master descriptions and the patient record showed that at least 1 product measuring ⬍5 mm was used, not more than 1 product measuring ⬎5 mm was used, and the measurements of the other products identified equaled 5 mm. Summary statistics were generated for all 3 groups. Multivariable analyses were performed on hospital costs and clinical outcomes. Models were adjusted for demographics, patient severity, comorbid conditions, and hospital characteristics. Results: In the outpatient setting, for single-port surgery, hospital costs were approximately $834 more than those for mini-laparoscopic surgery and $964 more than those for conventional laparoscopic surgery (P ⬍ .0001). AdEthicon Endo-Surgery, Inc., Cincinnati, OH, USA (Dr. Chekan, Moore). S2 Statistical Solutions, Inc., Cincinnati, OH, USA (Drs. Hunter, Gunnarsson). Dr. Chekan is an employee of Ethicon Endo-Surgery, Inc. Mr. Moore was an employee of Ethicon Endo-Surgery at the time of the research. Dr. Gunnarsson is President and Dr. Hunter is an employee of S2 Statistical Solutions, Inc. which is a paid consultant to Ethicon Endo-Surgery, Inc. This research was funded by Ethicon Endo-Surgery, Inc. which is a manufacturer of minimally invasive surgical equipment and manufactures and sells products that are used in the procedures analyzed in this study. Address correspondence to: Candace L. Gunnarsson, EdD, S2 Statistical Solutions, 11176 Main St, Cincinnati, OH 45241, USA. Telephone: (513) 247-0561, Fax: (866) 247-0524, E-mail: [email protected] DOI: 10.4293/108680812X13517013317635 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 30 verse events were significantly higher (P ⬍ .0001) for single-port surgery compared with mini-laparoscopic surgery (95% confidence interval for odds ratio, 1.38 –2.68) and single-port surgery versus conventional surgery (95% confidence interval for odds ratio, 1.37–2.35). Mini-laparoscopic surgery hospital costs were significantly (P ⬍ .0001) lower than the costs for conventional surgery by $211, and there were no significant differences in adverse events. Conclusions: These findings should inform practice patterns, treatment guidelines, and payor policy in managing cholecystectomy patients. Key Words: Abdominal, Cholecystectomy, Laparoscopic. INTRODUCTION Cholecystectomy is one of the most frequently performed abdominal surgery procedures in the United States, with ⬎750,000 cholecystectomies performed laparoscopically each year.1,2 Laparoscopic cholecystectomy evolved from surgical attempts to improve patient outcomes, including postoperative morbidity, cosmetic results, hospital length of stay, and duration of convalescence.3–5 Continued attempts to improve these outcomes have led to the development of alternatives to conventional laparoscopic cholecystectomy (CLC), including micro- or mini-laparoscopic cholecystectomy (MLC) and, more recently, single-port cholecystectomy surgery (SPS).6 However, understanding the effect of these emerging techniques on clinical and economic outcomes is critical to guiding practice patterns, clinical guidelines, and payor decisions. SPS is a technical departure from CLC in that it uses a single, transabdominal incision rather than multiple incisions for trocar insertion.7,8 This procedure is typically performed with several trocars spaced closely together or with a multi-instrument port.7–9 MLC is performed by use of percutaneous instrumentation or trocars that are significantly smaller in size than those used in conventional laparoscopic procedures. The procedure was primarily developed to reduce incisional pain. JSLS (2013)17:30 – 45 Studies have reported improvements in cosmetic outcome, pulmonary function, and overall satisfaction.10 –14 One small study did report that up to 38% of patients (5 of 13) required conversion from MLC to CLC.10 The purpose of this article is a cost comparison of cholecystectomy approaches including conventional, singleport, and mini-laparoscopic surgeries. We performed our analysis using the Premier Hospital Database as a source of cost from the hospital perspective. METHODS A protocol describing the analysis objectives, criteria for patient selection, data elements of interest, and statistical methods was submitted to the New England Institutional Review Board, and exemption was obtained (No. 11–240). Data Source The Premier Hospital Database, which contains clinical and utilization information on patients receiving care in 442 hospitals and ambulatory surgery centers across the United States during the period of interest, was used. Specifically, this database contains complete patient billing, hospital cost, and coding histories from more than 25 million inpatient discharges and 175 million hospital outpatient visits.15 Data for 2009 through the second quarter of 2010 were used and anonymized with regard to patient identifiers. Patients and Procedures Eligible patients were those aged ⱖ18 years undergoing an outpatient laparoscopic cholecystectomy. International Classification of Diseases, Ninth Revision and Current Procedural Terminology codes for identifying the laparoscopic cholecystectomy, diagnosis codes for identifying patient comorbid conditions, and all adverse events are listed in Appendices A, B, and C, respectively. Eligible patients with procedure codes identifying a laparoscopic cholecystectomy were then subdivided into 3 mutually exclusive groups: CLC, SPS, or MLC. Hospital charge descriptions for the surgical tools used were text mined to identify SPS procedures. The distinction between MLC and CLC was based on the size of the surgical instrument. MLC was defined by records of no SPS products identified in the charge master descriptions, record of at least 1 product ⬍5 mm used; not more than 1 product ⬎5 mm used, and any other products identified equaled 5 mm. Procedures that were not identified as SPS or MLC were considered CLC procedures. Statistical Analyses Initial counts, percentages, means, and standard deviations for demographics, comorbid conditions, hospital characteristics, safety, and cost outcomes were summarized for CLC, SPS, and MLC by use of descriptive statistics for patients in the outpatient setting. Safety outcomes of interest were selected from adverse events occurring during or up to 30 days after surgery. Cost outcomes were total hospital costs per patient, both fixed and variable. Because the sample size for the SPS group was very limited in the inpatient setting, univariate and multivariable analyses were performed on outpatient procedures only. Furthermore, by examining patients in the outpatient setting only, it was possible to analyze a more homogeneous patient population. Multivariable logistic regression analyses were run for binary outcomes, such as adverse events. Ordinary least squares regressions were used for the continuous outcome of hospital costs. For all models, the following explanatory variables were included: age, sex, race, marital status, insurance type, comorbid conditions (e.g., diabetes), census region of the hospital, rural versus urban hospitals, teaching versus nonteaching hospitals, and number of hospital beds. By use of these explanatory variables, multivariable models were estimated to isolate the effects of SPS versus CLC, SPS versus MLC, and MLC versus CLC on hospital costs. To eliminate cost outliers, both the upper 0.5% and lower 0.5% of costs were set to missing values. In addition to the trimming of outliers, a natural-log transformation of the costs was used as the dependent variable in multivariate models. Smearing estimates were then used to avoid the introduction of bias when we converted back to the untransformed dollar scale.16 All analyses were performed with SAS software, version 9.2 (SAS Institute, Cary, NC, USA). RESULTS There were a total of 193,014 eligible laparoscopic cholecystectomy procedures identified in the database from the period from the first quarter of 2009 through the second quarter of 2010. A patient attrition diagram is shown in Figure 1. The majority of all procedures (59%, 116,823 of 196,628) were performed in the outpatient setting, with 98% (114,356) of these patients undergoing a CLC. For the remaining 2% of outpatient procedures (2,467), 527 SPS procedures and 1,940 MLC procedures were identified. As summarized in Table 1, characteristics of eligible outpatient procedures show that there were substantially more JSLS (2013)17:30 – 45 31 Costs and Clinical Outcomes of Conventional Single Port and Micro Laparoscopic Cholecystectomy, Chekan E et al. Table 1. Patient Characteristics SPS (n ⫽ 527) (%) MLC (n ⫽ 1,940) (%) CLC (n ⫽ 114,356) (%) 18–40 yr 282 (53.5) 751 (38.7) 43,452 (38.0) 41–50 yr 113 (21.4) 411 (21.2) 23,364 (20.4) 51–60 yr 76 (14.4) 361 (18.6) 21,703 (19.0) 61–70 yr 35 (6.6) 258 (13.3) 15,413 (13.5) 71–80 yr 17 (3.2) 124 (6.4) 8,068 (7.1) ⬎80 yr 4 (0.8) 35 (1.8) 2,356 (2.1) Female 445 (84.4) 1,443 (74.4) 86,757 (75.9) Male 82 (15.6) 497 (25.6) 27,599 (24.1) 108 (20.5) 582 (30.0) 35,410 (31.0) Age Gender Insurance Government Managed care 331 (62.8) 1,090 (56.2) 56,228 (49.2) Other 88 (16.7) 268 (13.8) 22,718 (19.9) 418 (79.3) 1,318 (67.9) 81,096 (70.9) Race White Figure 1. Patient attrition is shown from all data from the first quarter (Q1) of 2009 to the second quarter (Q2) of 2010 to the subset used in our analysis. The analysis included patients with International Classification of Diseases, Ninth Revision (ICD-9) code 51.23 or Current Procedural Terminology (CPT) code 47562, 47563, or 47564 whose gender was known, who were aged ⱖ18 years, and who underwent outpatient visits. women than men, with rates for both dropping off after age 50 years. Regarding insurance, more patients had managed care than government or other sources of insurance. In the outpatient setting, the 3 procedure groups (SPS, MLC, and CLC) appear to be very well balanced overall in terms of patient demographics. The distribution of patient comorbidities is shown in Table 2 and suggests a lower percentage of comorbidities overall in the SPS population, with the rates of many of the 32 African American 22 (4.2) 109 (5.6) 8,358 (7.3) Hispanic 27 (5.1) 172 (8.9) 7,509 (6.6) Other 60 (11.4) 341 (17.6) 17,307 (15.1) Invalid code 0 (0.0) 0 (0.0) 86 (0.1) conditions as low as half of the rates in the other cohorts. Hypertension was the most common comorbid condition across all 3 groups. Unadjusted Analysis The cholecystectomies studied were performed in 428 hospitals. Most procedures, as well as most patients, derived from urban, nonteaching, moderate- to largesized hospitals in the South.15 As noted earlier for the overall patient population, hospital characteristics were well balanced across all 3 surgical cohorts (CLC, MLC, and SPS). All adverse events are reported in Table 3. Events are subdivided into 5 categories: procedure related, systemic, other events, death, and bleeding. The most common complications were in the category of other events and included abdominal rigidity/tenderness, digestive system complications, gastroparesis paralytic ileus, nausea and vomiting, operative complications, and JSLS (2013)17:30 – 45 Table 2. Comorbid Conditions SPS (n ⫽ 527) (%) MLC (n ⫽ 1,940) (%) CLC (n ⫽ 114,356) (%) Cardiomyopathy 2 (0.4) 15 (0.8) 778 (0.7) Cerebrovascular accident 1 (0.2) 11 (0.6) 548 (0.5) Chronic obstructive pulmonary disease 14 (2.7) 73 (3.8) 4,232 (3.7) Diabetes 23 (4.4) 170 (8.8) 9,904 (8.7) Ischemic heart disease, including myocardial infarction 17 (3.2) 131 (6.8) 7,108 (6.2) Hypertensive heart disease without heart failure 2 (0.4) 8 (0.4) 566 (0.5) Heart failure 8 (1.5) 40 (2.1) 2,145 (1.9) Hypertension 86 (16.3) 414 (21.3) 24,664 (21.6) Chronic liver disease/disorders 14 (2.7) 75 (3.9) 6,425 (5.6) Transient ischemic attack 1 (0.2) 16 (0.8) 754 (0.7) Table 3. Adverse Events SPS (n ⫽ 527) (%) MLC (n ⫽ 1,940) (%) CLC (n ⫽ 114,356) (%) Bile duct fistula 0 (0.0) 0 (0.0) 7 (0.0) Bile duct obstruction 2 (0.4) 2 (0.1) 195 (0.2) Bile duct perforation 0 (0.0) 0 (0.0) 6 (0.0) Cerebrovascular accident 0 (0.0) 1 (0.1) 43 (0.0) Acute myocardial infarction 0 (0.0) 2 (0.1) 37 (0.0) Procedure related Systemic adverse events Transient ischemic attack 0 (0.0) 2 (0.1) 46 (0.0) Other embolism 0 (0.0) 3 (0.2) 120 (0.1) Pneumothorax 0 (0.0) 0 (0.0) 16 (0.0) Pulmonary embolism 1 (0.2) 3 (0.2) 95 (0.1) Abdominal rigidity/tenderness 0 (0.0) 0 (0.0) 114 (0.1) Digestive system complications 8 (1.5) 15 (0.8) 735 (0.6) Gastroparesis paralytic ileus 4 (0.8) 7 (0.4) 438 (0.4) Other adverse events Nausea and vomiting 45 (8.5) 86 (4.4) 4,874 (4.3) Operative complication 19 (3.6) 30 (1.6) 2,006 (1.8) Peritonitis (not specified) 1 (0.2) 3 (0.2) 103 (0.1) Death during procedure 0 (0.0) 0 (0.0) 2 (0.0) Death after procedure 0 (0.0) 2 (0.1) 35 (0.0) 0 (0.0) 0 (0.0) 9 (0.0) Death Hemorrhage/bleeding Minor bleeding Major bleeding Any one or more adverse event 0 (0.0) 0 (0.0) 20 (0.0) 62 (11.8) 123 (6.3) 7,307 (6.4) JSLS (2013)17:30 – 45 33 Costs and Clinical Outcomes of Conventional Single Port and Micro Laparoscopic Cholecystectomy, Chekan E et al. peritonitis. The overall adverse event rate was higher for SPS (12%) than for MLC (6%) and CLC (6%), with most of the events in all 3 groups falling into the “other events” category. The procedure-related systemic events, death and bleeding, were very infrequent (⬍0.5%) for all 3 groups. Table 4 shows the unadjusted means and medians for hospital costs, as well as median surgery time, for each group. In the outpatient setting, CLC (median, $3,600.37) costs slightly more than MLC (median, $3,357.01) but less than SPS (median, $4,367.93). It is essential to adjust for a number of potential confounders in multivariable regression analyses, including patient demographics, comorbid conditions, and hospital characteristics. Adjusted Analysis The results of adjusted analyses of costs and complication rates are shown in Table 5. After we adjusted for the aforementioned variables, adjusted mean hospital costs remained significantly higher (P ⬍ .0001) for SPS versus MLC ($4,680.40 vs $3,846.19) and SPS versus CLC ($5,313.96 vs $4,350.29). When we compared MLC versus CLC, cost differences were lower but still significant (P ⬍ .0001), with MLC at $4,137.23 versus CLC at $4,349.06. Results of the multivariable logistic regressions for the likelihood of patients having an adverse event showed significant (P ⬍ .0001) odds ratios of 1.92 (95% confidence interval, 1.38 –2.68) for SPS compared with MLC and 1.80 (95% confidence interval, 1.37–2.35) for SPS compared with CLC. However, when MLC was compared with CLC, the difference was not significant. DISCUSSION This retrospective analysis of a large, nationally representative database of hospitals and procedures found that patients undergoing SPS had higher adverse event rates than those undergoing MLC or CLC. The analysis also showed that SPS was associated with higher adjusted hospital outpatient costs than CLC but that MLC, when performed in this setting, was the least expensive. These findings are somewhat consistent with a recent review of SPS, which also raised concerns about the safety of the procedure, and a recent meta-analysis of primarily MLC procedures, which found similar rates of adverse events compared with patients undergoing CLC.17,18 Clinical Implications Innovations in the surgical approach to performing cholecystectomy represent an important potential pathway to improving patient outcomes. The development and diffusion of laparoscopic cholecystectomy to the United States that began more than 20 years ago heralded a reduction in postoperative mortality rates and days of convalescence for patients who would have otherwise been treated with open cholecystectomy.2 This pattern of innovation continues with both SPS and MLC. However, continued improvements in patient outcomes can only be ensured with careful attention to the comparative effectiveness of these procedures relative to CLC, which constitutes most cholecystectomies currently performed in developed countries.19 Adverse event rates in patients undergoing cholecystectomy in outpatient hospital centers were highest in patients treated with SPS compared with MLC and CLC and were comparable between patients treated with MLC and those treated with CLC. This difference appears to be driven by higher rates of bile duct obstruction, digestive system complications, gastroparesis, paralytic ileus, postoperative nausea and vomiting, and operative complications in the SPS population. The incidence of serious adverse events, including bile duct injury, thromboembolic events (including stroke and myocardial infarction), and hemorrhage, was low across all proce- Table 4. Unadjusted Utilization and Cost Outcomes SPS (n ⫽ 527) MLC (n ⫽ 1,940) CLC (n ⫽ 114,356) Surgery time (median, h) 1.60 1.26 1.35 Anesthesia time (median, h) 1.57 1.50 1.47 No. of readmissions (30 days after surgery) (%) 20 (3.8) 71 (3.7) 3,200 (2.8) Median 4,367.93 3,357.01 3,600.37 Mean 4,573.74 3,814.35 3,964.67 SD 1,664.17 1,992.26 1,967.81 Total hospital costs ($) 34 JSLS (2013)17:30 – 45 Table 5. Multivariable Cost and Adverse Event Findingsa LSb Mean 95% CIb for LS Mean SPS $4,680.40 $4,480.96–$4,888.73 MLC $3,846.19 $3,722.38–$3,974.11 ORb 95% CI for OR P Value SPS/MLC outpatients (n ⫽ 2,535) Total hospital costs ($) ⬍ .0001 Adverse events (any adverse event/none) SPS vs MLC 1.92 1.38–2.68 .0001 SPS/CLC outpatients (n ⫽ 114,883) Total hospital costs ($) SPS $5,313.96 $5,119.09–$5,516.25 CLC $4,350.29 $4,276.75–$4,425.09 ⬍ .0001 Adverse events (any adverse event/none) SPS vs CLC 1.80 1.37–2.35 ⬍ .0001 MLC/CLC outpatients (n ⫽ 116,296) Total hospital costs ($) MLC $4,137.23 $4,037.97–$4,238.93 CLC $4,349.06 $4,275.54–$4,423.85 ⬍ .0001 Adverse events (any adverse event/none) MLC vs CLC 1.01 0.84–1.21 .9333 a All models are adjusted for patient demographics, comorbid conditions, patient severity, and hospital characteristics. CI⫽confidence interval; LS⫽least square; OR⫽odds ratio. b dures and did not appear to be substantially different in patients undergoing SPS. Economic Implications Adjusted hospital outpatient costs were highest in patients undergoing SPS: SPS cost 18% more than MLC and 18% more than CLC, with a difference of $834 and $964, respectively (Table 5). The analyses also showed that MLC was associated with the lowest hospital costs. It is likely that the differences in adverse event rates detailed earlier contributed to the cost differences. Because otherwise healthy patients with reliable home support can leave the hospital within 6 hours of undergoing cholecystectomy, outpatient models of cholecystectomy are increasingly used.20 The sources of variation in costs of cholecystectomy procedures performed in an outpatient setting should be explored further in future studies, but these findings of statistically significant differences between the cost of SPS and the cost of MLC or CLC may have important implications with regard to the cost of the procedure to the hospital or outpatient facility. With approximately 750,000 laparoscopic cholecystectomies performed in the United States each year, any differences in procedure-related costs or savings could be significant and realizable.1,2 Limitations This analysis was limited by the lack of more detailed information about patients and procedures. For instance, it would have been of interest to examine the influence of additional patient characteristics, such as weight or body mass index, and more procedure-related details. In the future, this may be possible as clinically rich datasets become available from greater use of electronic medical records in hospital settings, thereby facilitating analyses in these directions. The analyses of adverse event rates and the specific types of complications constituting these rates in patients undergoing SPS were also limited by a small sample size, particularly compared with the number of patients in the database who underwent MLC or CLC. Surgeon experience is a well-established predictor of the overall inci- JSLS (2013)17:30 – 45 35 Costs and Clinical Outcomes of Conventional Single Port and Micro Laparoscopic Cholecystectomy, Chekan E et al. dence of laparoscopic complications, and we were unable to adjust for this important variable.21,22 The available data will likely become more robust over time as procedure volume increases. Even without access to the additional clinical detail available in electronic medical records, the Premier Hospital Database provides a strong basis for this analysis, given the very large numbers of patients and procedures that it provides, as well as the nationwide scope it represents.15 Thus the cost of each procedure was based on costs across the Premier network. This analysis found MLC to have a statistically lower cost to the hospital in comparison with CLC. The reasons for these differences were not ascertained, and further study to understand these differences would be of interest. CONCLUSION The analysis of a large, nationally representative hospital claims database provides evidence that, in the outpatient setting, SPS costs approximately 18% more than MLC and CLC. Mini-laparoscopic surgery costs approximately 5% less than traditional laparoscopy. Although additional studies may be useful, these findings could help shape practice patterns, treatment guidelines, and payor policy in the management of patients requiring cholecystectomy. References: 1. Khan MH, Howard TJ, Fogel EL, et al. Frequency of biliary complications after laparoscopic cholecystectomy detected by ERCP: experience at a large tertiary referral center. Gastrointest Endosc. 2007;65:247–252. 2. Vollmer CM Jr, Callery MP. Biliary injury following laparoscopic cholecystectomy: why still a problem? Gastroenterology. 2007;133:1039 –1041. 3. Schirmer BD, Edge SB, Dix J, Hyser MJ, Hanks JB, Jones RS. Laparoscopic cholecystectomy. Treatment of choice for symptomatic cholelithiasis. Ann Surg. 1991;213:665– 676; discussion 677. 7. Hodgett SE, Hernandez JM, Morton CA, Ross SB, Albrink M, Rosemurgy AS. Laparoendoscopic single site (LESS) cholecystectomy. J Gastrointest Surg. 2009;13:188 –192. 8. Philipp SR, Miedema BW, Thaler K. Single-incision laparoscopic cholecystectomy using conventional instruments: early experience in comparison with the gold standard. J Am Coll Surg. 2009;209:632– 637. 9. Ponsky TA. Single port laparoscopic cholecystectomy in adults and children: tools and techniques. J Am Coll Surg. 2009;209:e1–e6. 10. Bisgaard T, Klarskov B, Trap R, Kehlet H, Rosenberg J. Pain after microlaparoscopic cholecystectomy. A randomized doubleblind controlled study. Surg Endosc. 2000;14:340 –344. 11. Bisgaard T, Klarskov B, Trap R, Kehlet H, Rosenberg J. Microlaparoscopic vs conventional laparoscopic cholecystectomy: a prospective randomized double-blind trial. Surg Endosc. 2002;16:458 – 464. 12. Hosono S, Osaka H. Minilaparoscopic versus conventional laparoscopic cholecystectomy: a meta-analysis of randomized controlled trials. J Laparoendosc Adv Surg Tech A. 2007;17:191– 199. 13. Novitsky YW, Kercher KW, Czerniach DR, et al. Advantages of mini-laparoscopic vs conventional laparoscopic cholecystectomy: results of a prospective randomized trial. Arch Surg. 2005; 140:1178 –1183. 14. Schwenk W, Neudecker J, Mall J, Bohm B, Muller JM. Prospective randomized blinded trial of pulmonary function, pain, and cosmetic results after laparoscopic vs. microlaparoscopic cholecystectomy. Surg Endosc. 2000;14:345–348. 15. Premier Research Services—Premier I. Available at: http:// www.premier-inc.com/prs. Accessed September 3, 2011. 16. Duan N. Smearing estimate: a nonparametric retransformation method. J Am Stat Assoc. 1983;78:605– 610. 17. Allemann P, Schafer M, Demartines N. Critical appraisal of single port access cholecystectomy. Br J Surg. 2010;97:1476 –1480. 18. Thakur V, Schlachta CM, Jayaraman S. Minilaparoscopic versus conventional laparoscopic cholecystectomy a systematic review and meta-analysis. Ann Surg. 2011;253:244 –258. 4. Wiesen SM, Unger SW, Barkin JS, Edelman DS, Scott JS, Unger HM. Laparoscopic cholecystectomy: the procedure of choice for acute cholecystitis. Am J Gastroenterol. 1993;88:334 – 337. 19. Visser BC, Parks RW, Garden OJ. Open cholecystectomy in the laparoendoscopic era. Am J Surg. 2008;195:108 –114. 5. Wilson RG, Macintyre IM, Nixon SJ, Saunders JH, Varma JS, King PM. Laparoscopic cholecystectomy as a safe and effective treatment for severe acute cholecystitis. BMJ. 1992;305:394 –396. 21. Csikesz NG, Singla A, Murphy MM, Tseng JF, Shah SA. Surgeon volume metrics in laparoscopic cholecystectomy. Dig Dis Sci. 2010;55:2398 –2405. 6. McCormack D, Saldinger P, Cocieru A, House S, Zuccala K. Micro-laparoscopic cholecystectomy: an alternative to singleport surgery. J Gastrointest Surg. 2011;15:758 –761. 22. Moore MJ, Bennett CL. The learning curve for laparoscopic cholecystectomy. The Southern Surgeons Club. Am J Surg. 1995; 170:55–59. 36 20. Curet MJ, Contreras M, Weber DM, Albrecht R. Laparoscopic cholecystectomy. Surg Endosc. 2002;16:453– 457. JSLS (2013)17:30 – 45 Appendix A. Procedure Codes for Laparoscopic Cholecystectomy Description ICD-9a code 51.23 Laparoscopic cholecystectomy 51.24 Laparoscopic partial cholecystectomy CPTa code 47562 Laparoscopic cholecystectomy 47563 Laparoscopic cholecystectomy with cholangiography 47564 Laparoscopic cholecystectomy with exploration of common duct a CPT⫽Current Procedural Terminology; ICD-9⫽International Classification of Diseases, Ninth Revision. Appendix B. Diagnosis Codes for Comorbid Conditions Event Transient ischemic attack Cerebrovascular accident Diabetes ICD-9a Code Description 435.8 Other specified transient cerebral ischemia 435.9 Unspecified transient cerebral ischemia 430 Subarachnoid hemorrhage 431 Intracerebral hemorrhage 432 Nontraumatic extradural hemorrhage 432.1 Subdural hemorrhage 432.9 Unspecified intracranial hemorrhage 433.01 Occlusion and stenosis, basilar artery, with cerebral infarction 433.11 Occlusion and stenosis, carotid artery, with cerebral infarction 433.21 Occlusion and stenosis, vertebral artery, with cerebral infarction 433.31 Occlusion and stenosis, multiple and bilateral precerebral arteries, with cerebral infarction 433.81 Occlusion and stenosis, other specified precerebral artery, with cerebral infarction 433.91 Occlusion and stenosis, unspecified precerebral artery, with cerebral infarction 434.01 Cerebral thrombosis, with cerebral infarction 434.11 Cerebral embolism, with cerebral infarction 434.91 Cerebral artery occlusion, unspecified, with cerebral infarction 997.02 Iatrogenic cerebrovascular infarction or hemorrhage 249 Secondary diabetes mellitus 249.01 Secondary diabetes mellitus without mention of complication, uncontrolled 249.1 Secondary diabetes mellitus with ketoacidosis 249.11 Secondary diabetes mellitus with ketoacidosis, uncontrolled 249.2 Secondary diabetes mellitus with hyperosmolarity 249.21 Secondary diabetes mellitus with hyperosmolarity, uncontrolled 249.3 Secondary diabetes mellitus with other coma 249.31 Secondary diabetes mellitus with other coma, uncontrolled 249.4 Secondary diabetes mellitus with renal manifestations JSLS (2013)17:30 – 45 37 Costs and Clinical Outcomes of Conventional Single Port and Micro Laparoscopic Cholecystectomy, Chekan E et al. Appendix B. (continued) Diagnosis Codes for Comorbid Conditions Event 38 ICD-9a Code Description 249.41 Secondary diabetes mellitus with renal manifestations, uncontrolled 249.5 Secondary diabetes mellitus with ophthalmic manifestations 249.51 Secondary diabetes mellitus with ophthalmic manifestations, uncontrolled 249.6 Secondary diabetes mellitus with neurological manifestations 249.61 Secondary diabetes mellitus with neurological manifestations, uncontrolled 249.7 Secondary diabetes mellitus with peripheral circulatory disorders 249.71 Secondary diabetes mellitus with peripheral circulatory disorders, uncontrolled 249.8 Secondary diabetes mellitus with other specified manifestations 249.81 Secondary diabetes mellitus with other specified manifestations, uncontrolled 249.9 Secondary diabetes mellitus with unspecified complication 249.91 Secondary diabetes mellitus with unspecified complication, uncontrolled 250 Diabetes mellitus 250.01 Diabetes mellitus without mention of complication, type I (juvenile type), not stated as uncontrolled 250.02 Diabetes mellitus without mention of complication, type II or unspecified type, uncontrolled 250.03 Diabetes mellitus without mention of complication, type I (juvenile type), uncontrolled 250.1 Diabetes with ketoacidosis, type II or unspecified type, not stated as uncontrolled 250.11 Diabetes with ketoacidosis, type I (juvenile type), not stated as uncontrolled 250.12 Diabetes with ketoacidosis, type II or unspecified type, uncontrolled 250.13 Diabetes with ketoacidosis, type I (juvenile type), uncontrolled 250.2 Diabetes with hyperosmolarity 250.21 Diabetes with hyperosmolarity, type I (juvenile type), not stated as uncontrolled 250.22 Diabetes with hyperosmolarity, type II or unspecified type, uncontrolled 250.23 Diabetes with hyperosmolarity, type I (juvenile type), uncontrolled 250.3 Diabetes with other coma 250.31 Diabetes with other coma, type I (juvenile type), not stated as uncontrolled 250.32 Diabetes with other coma, type II or unspecified type, uncontrolled 250.33 Diabetes with other coma, type I (juvenile type), uncontrolled 250.4 Diabetes with renal manifestations 250.41 Diabetes with renal manifestations, type I (juvenile type), not stated as uncontrolled 250.42 Diabetes with renal manifestations, type II or unspecified type, uncontrolled 250.43 Diabetes with renal manifestations, type I (juvenile type), uncontrolled 250.5 Diabetes with ophthalmic manifestations 250.51 Diabetes with ophthalmic manifestations, type I (juvenile type), not stated as uncontrolled 250.52 Diabetes with ophthalmic manifestations, type II or unspecified type, uncontrolled JSLS (2013)17:30 – 45 Appendix B. (continued) Diagnosis Codes for Comorbid Conditions Event Chronic obstructive pulmonary disease ICD-9a Code Description 250.53 Diabetes with ophthalmic manifestations, type I (juvenile type), uncontrolled 250.6 Diabetes with neurological manifestations, type II or unspecified type, not stated as uncontrolled 250.61 Diabetes with neurological manifestations, type I (juvenile type), not stated as uncontrolled 250.62 Diabetes with neurological manifestations, type II or unspecified type, uncontrolled 250.63 Diabetes with neurological manifestations, type I (juvenile type), uncontrolled 250.7 Diabetes with peripheral circulatory disorders 250.71 Diabetes with peripheral circulatory disorders, type I (juvenile type), not stated as uncontrolled 250.72 Diabetes with peripheral circulatory disorders, type II or unspecified type, uncontrolled 250.73 Diabetes with peripheral circulatory disorders, type I (juvenile type), uncontrolled 250.8 Diabetes with other specified manifestations 250.81 Diabetes with other specified manifestations, type I (juvenile type), not stated as uncontrolled 250.82 Diabetes with other specified manifestations, type II or unspecified type, uncontrolled 250.83 Diabetes with other specified manifestations, type I (juvenile type), uncontrolled 250.9 Diabetes with unspecified complication 250.91 Diabetes with unspecified complication, type I (juvenile type), not stated as uncontrolled 250.92 Diabetes with unspecified complication, type II or unspecified type, uncontrolled 250.93 Diabetes with unspecified complication, type I (juvenile type), uncontrolled 491.1 Mucopurulent chronic bronchitis 491.2 Obstructive chronic bronchitis 491.21 Obstructive chronic bronchitis with (acute) exacerbation 491.22 Obstructive chronic bronchitis with acute bronchitis 491.8 Other chronic bronchitis 491.9 Unspecified chronic bronchitis 492 Emphysema 492.0 Emphysematous bleb 492.8 Other emphysema 493.2 Chronic obstructive asthma 493.20 Chronic obstructive asthma, unspecified 493.21 Chronic obstructive asthma with status asthmaticus 493.22 Chronic obstructive asthma with (acute) exacerbation 494 Bronchiectasis 494.0 Bronchiectasis without acute exacerbation JSLS (2013)17:30 – 45 39 Costs and Clinical Outcomes of Conventional Single Port and Micro Laparoscopic Cholecystectomy, Chekan E et al. Appendix B. (continued) Diagnosis Codes for Comorbid Conditions Event Chronic liver disease/disorders Hypertension Ischemic heart disease, including myocardial infarction 40 ICD-9a Code Description 494.1 Bronchiectasis with acute exacerbation 496 Chronic airway obstruction, not elsewhere classified 571.x Chronic liver disease and cirrhosis 571.4x Chronic hepatitis 572.x Liver abscess and sequelae of chronic liver disease 573.x Other disorders of liver 401 Essential hypertension 401.0 Malignant essential hypertension 401.1 Benign essential hypertension 401.9 Unspecified essential hypertension 405 Secondary hypertension 405.0 Malignant secondary hypertension 405.01 Malignant renovascular hypertension 405.09 Other malignant secondary hypertension 405.1 Benign secondary hypertension 405.11 Benign renovascular hypertension 405.19 Other benign secondary hypertension 405.9 Unspecified secondary hypertension 405.91 Unspecified renovascular hypertension 405.99 Other unspecified secondary hypertension 410 Acute myocardial infarction 410.0 Acute myocardial infarction of anterolateral wall 410.01 Acute myocardial infarction of anterolateral wall, initial episode of care 410.02 Acute myocardial infarction of anterolateral wall, subsequent episode of care 410.1 Acute myocardial infarction of other anterior wall 410.10 Acute myocardial infarction of other anterior wall, episode of care unspecified 410.11 Acute myocardial infarction of other anterior wall, initial episode of care 410.12 Acute myocardial infarction of other anterior wall, subsequent episode of care 410.2 Acute myocardial infarction of inferolateral wall 410.20 Acute myocardial infarction of inferolateral wall, episode of care unspecified 410.21 Acute myocardial infarction of inferolateral wall, initial episode of care 410.22 Acute myocardial infarction of inferolateral wall, subsequent episode of care 410.3 Acute myocardial infarction of inferoposterior wall 410.30 Acute myocardial infarction of inferoposterior wall, episode of care unspecified 410.31 Acute myocardial infarction of inferoposterior wall, initial episode of care 410.32 Acute myocardial infarction of inferoposterior wall, subsequent episode of care 410.4 Acute myocardial infarction of other inferior wall 410.40 Acute myocardial infarction of other inferior wall, episode of care unspecified JSLS (2013)17:30 – 45 Appendix B. (continued) Diagnosis Codes for Comorbid Conditions Event ICD-9a Code Description 410.41 Acute myocardial infarction of other inferior wall, initial episode of care 410.42 Acute myocardial infarction of other inferior wall, subsequent episode of care 410.5 Acute myocardial infarction of other lateral wall 410.50 Acute myocardial infarction of other lateral wall, episode of care unspecified 410.51 Acute myocardial infarction of other lateral wall, initial episode of care 410.52 Acute myocardial infarction of other lateral wall, subsequent episode of care 410.6 Acute myocardial infarction of posterior wall infarction 410.61 Acute posterior wall infarction, initial episode of care 410.62 Acute posterior wall infarction, subsequent episode of care 410.7 Subendocardial infarction 410.70 Subendocardial infarction, episode of care unspecified 410.71 Subendocardial infarction, initial episode of care 410.72 Subendocardial infarction, subsequent episode of care 410.8 Acute myocardial infarction of other specified sites 410.80 Acute myocardial infarction of other specified sites, episode of care unspecified 410.81 Acute myocardial infarction of other specified sites, initial episode of care 410.82 Acute myocardial infarction of other specified sites, subsequent episode of care 410.9 Acute myocardial infarction of unspecified site 410.90 Acute myocardial infarction of unspecified site, episode of care unspecified 410.91 Acute myocardial infarction of unspecified site, initial episode of care 410.92 Acute myocardial infarction of unspecified site, subsequent episode of care 411 Other acute and subacute forms of ischemic heart disease 411.0 Postmyocardial infarction syndrome 411.1 Intermediate coronary syndrome 411.8 Other acute and subacute forms of ischemic heart disease 411.81 Acute coronary occlusion without myocardial infarction 411.89 Other acute and subacute forms of ischemic heart disease, other 412 Old myocardial infarction 413 Angina pectoris 413.0 Angina decubitus 413.1 Prinzmetal angina 413.9 Other and unspecified angina pectoris 414 Other forms of chronic ischemic heart disease 414.0 Coronary atherosclerosis 414.00 Coronary atherosclerosis of unspecified type of vessel, native or graft 414.01 Coronary atherosclerosis of native coronary artery 414.02 Coronary atherosclerosis of autologous vein bypass graft 414.03 Coronary atherosclerosis of nonautologous biological bypass graft JSLS (2013)17:30 – 45 41 Costs and Clinical Outcomes of Conventional Single Port and Micro Laparoscopic Cholecystectomy, Chekan E et al. Appendix B. (continued) Diagnosis Codes for Comorbid Conditions Event Heart failure 42 ICD-9a Code Description 414.04 Coronary atherosclerosis of artery bypass graft 414.05 Coronary atherosclerosis of unspecified bypass graft 414.06 Coronary atherosclerosis of native coronary artery of transplanted heart 414.07 Coronary atherosclerosis of bypass graft transplanted heart 414.1 Aneurysm and dissection of heart 414.10 Aneurysm of heart (wall) 414.11 Aneurysm of coronary vessels 414.12 Dissection of coronary artery 414.19 Other aneurysm of heart 414.2 Chronic total occlusion of coronary artery 414.3 Coronary atherosclerosis due to lipid rich plaque 414.8 Other specified forms of chronic ischemic heart disease 414.9 Chronic ischemic heart disease, unspecified 398.91 Rheumatic heart failure (congestive) 402.01 Benign hypertensive heart disease without heart failure 402.11 Benign hypertensive heart disease with heart failure 402.91 Unspecified hypertensive heart disease with heart failure 404.01 Hypertensive heart and chronic kidney disease, malignant, with heart failure and with chronic kidney disease stage I through stage IV, or unspecified 404.03 Hypertensive heart and chronic kidney disease, malignant, with heart failure and with chronic kidney disease stage V or end stage renal disease 404.11 Hypertensive heart and chronic kidney disease, benign, with heart failure and with chronic kidney disease stage I through stage IV, or unspecified 404.13 Hypertensive heart and chronic kidney disease, benign, with heart failure and chronic kidney disease stage V or end stage renal disease 404.91 Hypertensive heart and chronic kidney disease, unspecified, with heart failure and with chronic kidney disease stage I through stage IV, or unspecified 404.93 Hypertensive heart and chronic kidney disease, unspecified, with heart failure and chronic kidney disease stage V or end stage renal disease 428 Heart failure 428.0 Congestive heart failure, unspecified 428.1 Left heart failure 428.2 Systolic heart failure 428.21 Acute systolic heart failure 428.22 Chronic systolic heart failure 428.23 Acute on chronic systolic heart failure 428.3 Diastolic heart failure 428.31 Acute diastolic heart failure 428.32 Chronic diastolic heart failure 428.33 Acute on chronic diastolic heart failure 428.4 Combined systolic and diastolic heart failure 428.41 Acute combined systolic and diastolic heart failure JSLS (2013)17:30 – 45 Appendix B. (continued) Diagnosis Codes for Comorbid Conditions Event Cardiomyopathy Hypertensive heart disease without heart failure ICD-9a Code Description 428.42 Chronic combined systolic and diastolic heart failure 428.43 Acute on chronic combined systolic and diastolic heart failure 428.9 Heart failure, unspecified 425 Cardiomyopathy 425.0 Endomyocardial fibrosis 425.1 Hypertrophic cardiomyopathy 425.2 Obscure cardiomyopathy of Africa 425.3 Endocardial fibroelastosis 425.4 Other primary cardiomyopathies 425.5 Alcoholic cardiomyopathy 425.7 Nutritional and metabolic cardiomyopathy 425.8 Cardiomyopathy in other diseases classified elsewhere 425.9 Secondary cardiomyopathy, unspecified 402 Hypertensive heart disease 402.0 Malignant hypertensive heart disease 402.1 Benign hypertensive heart disease 402.10 Benign hypertensive heart disease without heart failure 402.9 Unspecified hypertensive heart disease 404 Hypertensive heart and chronic kidney disease 404.02 Hypertensive heart and chronic kidney disease, malignant, without heart failure and with chronic kidney disease stage V or end stage renal disease 404.1 Benign hypertensive heart and renal disease 404.12 Hypertensive heart and chronic kidney disease, benign, without heart failure and with chronic kidney disease stage V or end stage renal disease 404.9 Unspecified hypertensive heart and renal disease 404.90 Hypertensive heart and chronic kidney disease, unspecified, without heart failure and with chronic kidney disease stage I through stage IV, or unspecified 404.92 Hypertensive heart and chronic kidney disease, unspecified, without heart failure and with chronic kidney disease stage V or end stage renal disease a ICD-9⫽International Classification of Diseases, Ninth Revision. JSLS (2013)17:30 – 45 43 Costs and Clinical Outcomes of Conventional Single Port and Micro Laparoscopic Cholecystectomy, Chekan E et al. Appendix C. Diagnosis Codes for Adverse Events Event Transient ischemic attack Cerebrovascular accident Acute myocardial infarction Pneumothorax Pulmonary embolism Other embolism 44 ICD-9a Code Description 435.8 Other specified transient cerebral ischemia 435.9 Unspecified transient cerebral ischemia 430 Subarachnoid hemorrhage 431 Intracerebral hemorrhage 432.0 Nontraumatic extradural hemorrhage 432.1 Subdural hemorrhage 432.9 Unspecified intracranial hemorrhage 433.01 Occlusion and stenosis, basilar artery, with cerebral infarction 433.11 Occlusion and stenosis, carotid artery, with cerebral infarction 433.21 Occlusion and stenosis, vertebral artery, with cerebral infarction 433.31 Occlusion and stenosis, multiple and bilateral precerebral arteries, with cerebral infarction 433.81 Occlusion and stenosis, other specified precerebral artery, with cerebral infarction 433.91 Occlusion and stenosis, unspecified precerebral artery, with cerebral infarction 434.01 Cerebral thrombosis, with cerebral infarction 434.11 Cerebral embolism, with cerebral infarction 434.91 Cerebral artery occlusion, unspecified, with cerebral infarction 997.02 Iatrogenic cerebrovascular infarction or hemorrhage 410.01 Acute myocardial infarction, anterolateral wall 410.11 Acute myocardial infarction, other anterior wall 410.21 Acute myocardial infarction, inferolateral wall 410.31 Acute myocardial infarction, inferoposterior wall 410.41 Acute myocardial infarction, other inferior wall 410.51 Acute myocardial infarction, other lateral wall 410.61 Acute myocardial infarction, true posterior wall 410.71 Acute myocardial infarction, subendocardial (NSTEMIa) 410.81 Acute myocardial infarction, other sites 410.91 Acute myocardial infarction, unspecified site 512.0 Spontaneous tension pneumothorax 512.1 Iatrogenic pneumothorax 512.8 Other spontaneous pneumothorax 415.1 Pulmonary embolism and infarction 415.11 Iatrogenic pulmonary embolism and infarction 415.12 Septic pulmonary embolism 415.19 Other pulmonary embolism and infarction 453.4 Acute venous embolism and thrombosis of deep vessels of lower extremity 453.41 Acute venous embolism and thrombosis of deep vessels of proximal lower extremity 453.42 Acute venous embolism and thrombosis of deep vessels of distal lower extremity JSLS (2013)17:30 – 45 Appendix C. (continued) Diagnosis Codes for Adverse Events Event Operative complication Other adverse events ICD-9a Code Description 453.8 Acute venous embolism and thrombosis of other specified veins 453.9 Other venous embolism and thrombosis of unspecified site 997.1 Cardiac complications 997.2 Peripheral vascular complications 997.3 Respiratory complications 997.31 Ventilator associated pneumonia 997.39 Other respiratory complications 997.4 Digestive system 997.5 Urinary tract 997.7 Vascular complications of other vessels 998 Other complications of procedures 998.x Other complications of procedures 998.xx Other complications of procedures 997.4 Digestive system complications 789.4x Abdominal rigidity/tenderness 789.6x Abdominal rigidity/tenderness 536.2 Nausea and vomiting nausea 564.3 Nausea and vomiting nausea 787.0x Nausea and vomiting nausea 536.3 Gastroparesis paralytic ileus 560.1 Gastroparesis paralytic ileus 567.9 Peritonitis not specified 567.8x Peritonitis not specified 576.2 Bile duct obstruction 576.3 Bile duct perforation 576.4 Bile duct fistula a ICD-9⫽International Classification of Diseases, Ninth Revision; NSTEMI⫽non–ST-segment elevation myocardial infarction. JSLS (2013)17:30 – 45 45 SCIENTIFIC PAPER Complications of Liver Resection: Laparoscopic Versus Open Procedures Douglas P. Slakey, MD, MPH, Eric Simms, MD, Barbara Drew, MD, Farshid Yazdi, MD, Brett Roberts, MD ABSTRACT INTRODUCTION Background and Objective: Minimally invasive surgery for liver resection remains controversial. This study was designed to compare open versus laparoscopic surgical approaches to liver resection. Laparoscopic approaches to liver resection have found acceptance among institutions where surgeons have the requisite experience. Improved techniques and technologic advances have permitted better control of intrahepatic blood vessels and bile ducts, improving the safety and feasibility of laparoscopic liver resection.1–5 Several studies have described laparoscopic liver resections as safe and have shown some advantages over open liver resections, especially in terms of decreased postoperative pain, less intraoperative blood loss, reduced recovery time, and shorter hospital stay.6 Methods: We performed a single-center retrospective chart review. Results: We compared 45 laparoscopic liver resections with 17 open cases having equivalent resections based on anatomy and diagnosis. The overall complication rate was 25.8%. More open resection patients had complications (52.9% vs 15.5%, P ⬍ .008). The conversion rate was 11.1%. The mean blood loss was 667.1 ⫾ 1450 mL in open cases versus 47.8 ⫾ 89 mL in laparoscopic cases (P ⬍ .0001). Measures of intravenous narcotic use, intensive care unit length of stay, and hospital length of stay all favored the laparoscopic group. Patients were more likely to have complications or morbidity in the open resection group than in the laparoscopic group for both the anterolateral (P ⬍ .085) and posterosuperior (P ⬍ .002) resection subgroups. Conclusion: In this series comparing laparoscopic and open liver resections, there were fewer complications, more rapid recovery, and lower morbidity in the laparoscopic group, even for those resections involving the posterosuperior segments of the liver. Key Words: Liver resection, Laparoscopic, LigaSure. Department of Surgery, Tulane University School of Medicine, New Orleans, LA, USA (all authors). Address correspondence to: Douglas P. Slakey, MD, MPH, Department of Surgery, Tulane University School of Medicine, 1430 Tulane Ave, SL-22, New Orleans, LA 70112-2699, USA. Telephone: (504) 988-2317, Fax: (504)988-1874 E-mail: [email protected] DOI: 10.4293/108680812X13517013317716 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 46 When one is evaluating the safety of surgical methods, the intraoperative and postoperative morbidity and mortality rates are considered the primary metrics of efficacy and safety.7 Measures of outcome, such as blood loss, duration of hospital stay, and duration of postoperative ileus, are also important when one is determining the efficacy and cost-effectiveness of procedures. Postoperative morbidity for liver resection is predominantly associated with hemorrhage from the cut edge, ascites (especially in cirrhotic patients or patients with cysts), and intra-abdominal fluid collection or abscess, with reported rates of 11% to 34%.8 Morbidity and mortality rates are increased with major resections and the presence of cirrhosis.9 Most published studies and reviews describing the safety and efficacy of laparoscopic liver resection are narrowly focused on a homogeneous type of procedure (e.g., left lobectomy) or specific diagnosis (e.g., hepatocellular carcinoma). To date, few studies have compared all-indication open and laparoscopic liver resections with respect to complications, morbidity, and outcome. The goal of this study was to assess the safety and efficacy of laparoscopic liver resection by comparing the outcomes of laparoscopic liver resections versus open procedures with equivalent resections based on anatomy and indication. METHODS The study design was a single-center retrospective chart review, and institutional review board approval was obtained. We compared 45 consecutive laparoscopic liver resections with 17 open resections with similar indications JSLS (2013)17:46 –55 and anatomy of resection. The 17 open cases were chosen because they closely matched the parameters recorded for the laparoscopic cases; all cases were performed within the same period, and no matched open cases were excluded. All resections were performed by 1 of 2 senior hepatobiliary staff surgeons, each of whom performed both laparoscopic and open resections, using similar techniques. Cases in which biopsy was the only procedure were not included in this study. Demographic information, operative details, and postoperative outcome data were analyzed. Results are expressed as mean ⫾ standard deviation. Statistical analyses included the odds ratio and relative risk with 95% confidence intervals, and results were verified by use of an online statistics calculator from the Centre for Evidence Based Medicine.10 Cases converted from laparoscopic to open were included in the laparoscopic group for intent-to-treat analysis. Surgical Technique In patients receiving laparoscopic liver resection, both pure laparoscopic and hand-assisted techniques were grouped together. Only 2 of the 45 laparoscopic cases involved a hand-assisted technique, 1 for a large symptomatic cyst in the right lobe of the liver and the other for a large hemangioma in the left lobe. Ultrasonography with duplex was used in all cases, with the Aloka 7.5-MHz flexible linear laparoscopic transducer (Hitachi Aloka Medical, Ltd., Willingford, CT, USA) for laparoscopic cases and the Philips 15– 6L intraoperative linear array transducer (Andover, MA, USA) for the open cases. For laparoscopic resections, supraumbilical trocars were placed first by use of the Hasson technique, and additional trocars were placed as needed based on individual anatomy. Laparoscopic resections used either three or four 10-mm to 1-mm trocars so that ultrasonography probes and staplers could be inserted through any trocar. For the 2 resections that used hand-assisted techniques, the Applied Medical GelPort (Rancho Santa Margarita, CA, USA) was placed in an incision in the right upper quadrant, with some variation based on anatomy and position of the masses. For right or left hemihepatectomy or left lateral lobectomy, the portal pedicles were most often divided within the liver parenchyma by use of a linear stapler. Similarly, hepatic veins were identified as the parenchymal dissection progressed cephalad, with dissection only as much as necessary to allow a linear stapler to be safely positioned and fired. Parenchymal dissection was primarily completed with the LigaSure Atlas 10-mm vessel sealing device during laparoscopic cases and the LigaSure Max (Covidien, Mansfield, MA, USA) device during open procedures. Cholecystectomy and cholangiography were performed when indicated. The Pringle maneuver was only rarely used to aid in bleeding control and was never performed for ⬎20 minutes. In laparoscopic cases, once a transected surgical specimen was detached, it was inserted into an Endobag (Cardinal Health, Dublin, Ott, USA) and extracted through either an enlarged epigastric port incision or a hand-port incision if present. Hemostasis was achieved by use of an argon beam coagulator and sometimes titanium clips and/or fibrin glue sealant. After irrigation of the surgical field, pneumoperitoneum was evacuated for 5 minutes in laparoscopic cases and then reinsufflated to inspect for hemostasis. Blake-type closed suction drains were used in ⬍20% of cases (not different for open or laparoscopic). The nomenclature of Strasberg11 was used to describe the types of resections. Anterolateral procedures were defined as resections involving liver segments II, III, IVa (the anterior part of segment IV), V, and VI. Posterosuperior procedures were defined as resections involving segments IVb (the posterior part of segment IV), VII, and VIII. No caudate resections were performed. RESULTS A total of 62 liver resections are included in this cohort (45 laparoscopic and 17 open). Patient demographics, indications for resection, and tumor characteristics are summarized in Table 1. No significant differences were noted between the open and laparoscopic resection groups with respect to patient age, sex, severity of underlying liver disease, preoperative diagnosis, or indication for resection. The size, number, and location of the resected lesions were also similar. There were no significant differences between the open and laparoscopic groups with respect to operative procedures (Table 2). Conversion to an open approach was required in 5 of 45 laparoscopic cases (11.1%) because of inadequate visualization of the liver (n ⫽ 3) or an insufficient resection margin (n ⫽ 2). No conversion was performed for bleeding. The indication for resection was hepatocellular carcinoma in 17 patients (27.0%), metastatic colon cancer in 8 (12.9%), symptomatic hepatic cyst in 8 (12.9%), hemangioma in 6 (9.6%), focal nodular hyperplasia in 14 (22.6%), hepatic adenoma in 3 (4.8%), other malignant lesion in 4 (6.5%), and other nonmalignant lesion in 2 (3.2%). Table 1 shows the number of laparoscopic and open cases for each indication. The “other” malignant lesions were carcinoid tumor (n ⫽ 1), sclerosing malignant epithelial neoplasm (n ⫽ 1), and cholangiocarcinoma (n ⫽ 2). The JSLS (2013)17:46 –55 47 Complications of Liver Resection: Laparoscopic Versus Open Procedures, Slakey DP et al. Table 1. Characteristics of Patients Who Underwent Laparoscopic and Open Resection of Hepatic Lesions Total (N ⫽ 62) Laparoscopic Group (n ⫽ 45) Open Group (n ⫽ 17) 53.1 ⫾ 13.4 53.5 ⫾ 13.9 52.4 ⫾ 12.5 Demographic factors Age, yr Sex (male/female) 28/29 (45.2%/46.8%) 19/26 (42.2%/57.8%) 12/5 (70.6%/29.4%) Liver disease (normal/CLDa/Ca) 31/17/20 22/16/16 7/5/6 17 12 5 Indications for liver resection, n Hepatocellular carcinoma Colorectal metastasis to liver 8 5 3 Symptomatic cyst 8 7 1 Hemangioma 6 4 2 Focal nodular hyperplasia 14 10 4 Hepatic adenoma 3 3 0 Malignant lesion—other 4 3 1 Nonmalignant lesion—other 2 1 1 Size (cm) 7.3 ⫾ 3.6 6.4 ⫾ 3.6 10.5 ⫾ 3.8 Number (single/multiple) 35/27 26/19 6/11 20/5/28/9 16/3/20/6 4/2/8/3 Tumor characteristics Location (ALa/PSa/both/indeterminate) a AL⫽anterolateral segments; C⫽cirrhosis; CLD⫽chronic liver disease; PS⫽posterosuperior segments. Table 2. Liver Resection Types No. of Resections/Procedures Total No. Laparoscopic Group Open Group Right hemihepatectomy (segments V, VI, VII, VIII) 2 0 2 Left hemihepatectomy (segments II, III, IV) 4 3 1 Right posterior sectionectomy (segments VII, VIII, IVb) 0 0 0 2 1 1 Major resections Minor resections Left lateral sectionectomy (segments II, III) Right trisegmentectomy (segments V, VI, VII) 1 0 1 Bisegmentectomy (segments VII, VIII) 1 1 0 Segment 3 1 1 0 Segment 4a 1 1 0 Segment 6 1 1 0 49 37 12 Segmentectomy Nonanatomic 48 JSLS (2013)17:46 –55 “other” nonmalignant lesions were a focus of mucinous epithelial metaplasia (n ⫽ 1) and fibrosis suspicious for schistosomiasis (n ⫽ 1). The open resection group showed a significantly increased risk of having at least 1 complication (P ⫽ .007) (Table 3). In addition, the open resection group showed significantly increased lengths of both intensive care unit stay and hospital stay (P ⫽ .05 and P ⫽ .01, respectively). There was no significant difference in the need for intravenous narcotic pain medication, the length of postoperative ileus (expressed as time to initiation of oral intake), and 30-day or 1-year mortality rate between the open and laparoscopic resection groups. The amount of blood loss was greater in the open group than in the laparoscopic group (median, 988 mL vs 95 mL; P ⫽ .0001). Overall, intraoperative bleeding was limited except in 3 open resection patients who required intraoperative blood transfusion. Postoperative transfusion was required in 6 patients (5 from the open group and 1 from the laparoscopic group). The overall complication rate was 25.8%, and complications included pleural effusion (2 patients), wound infection (2 patients), incisional hernia (4 patients), hematoma requiring drainage (1 patient), abscess requiring drainage (1 patient), upper gastrointestinal bleed (2 patients), bile duct stricture (1 patient), common bile duct obstruction (1 patient), bile leak (1 patient), ascites requiring drainage (5 patients), and retained drain requiring a procedure (1 patient). The complication rate in the laparoscopic group was 15.5%. The complication rate in open cases was 52.9%. Twenty patients (32.2%) underwent resections of the anterolateral segments of the liver, and 33 patients (53.2%) underwent resections of the posterosuperior segments of the liver or resections of both the anterolateral and posterosuperior segments. Nine patients (14.5%) had resections that could not be categorized as anterolateral or posterosuperior. Laparoscopic and open complications and outcomes in each liver resection group are shown in Table 4. The open posterosuperior resection group had significantly more complications than the laparoscopic posterosuperior resection group (P ⫽ .002). DISCUSSION The indications and techniques for laparoscopic liver surgery have expanded during the past decade and today include major resections such as right and left hemihepatectomy. However, laparoscopic liver resection has remained limited for nonanatomic resections of the anterolateral and posterosuperior segments. This is because of concerns regarding the risks of bleeding and of jeopardizing oncologic principles by not achieving adequate margins, as well as difficulty in replicating the basic maneuvers of open liver resection (i.e., mobilization of the liver and maintaining vascular control) laparoscopically.8 Starting in the late 1990s, published series showed that laparoscopic resection of select hepatic lesions not only is safe but also often has a better postoperative outcome than similar open procedures.1,3,5,9 Biertho et al.12 confirmed the safety of the laparoscopic approach for resection of minor hepatic lesions in a review of 186 laparoscopic liver resections between 1991 and 2001, showing a morbidity rate of 16%. More recent series have shown increasing rates of laparoscopy for resection of nonmalignant lesions, especially in the noncirrhotic liver.5,13–16 Most series report that the laparoscopic approach to malignant hepatic lesions has been more narrow if these lesions often occur in patients with less hepatic reserve, such as patients with chronic liver disease, cirrhosis, or chemotherapy.13 Despite this, the suitability and safety of benign and malignant lesion laparoscopic liver resection have been shown in a 2007 meta-analysis of 8 studies, which showed lower operative blood loss, fewer complications, and a shorter duration of hospital stay in the laparoscopic groups.17 There are no randomized clinical trials comparing laparoscopic with open hepatic resection.18 The overall complication rate in our study was 25.8%, which corresponds to rates described in the literature.1 Interestingly, the complication rate in the laparoscopic group was only 15.5%, significantly lower than that in the open cases. The incidences of pleural effusion and incisional infection were higher in the open group. Intraoperative bleeding was limited except in 3 open resection patients in whom a transfusion was required (4.8%). The incidence of significant bleeding in patients included in this study was lower than that for recent series in the literature.13,19 –21 Lesions adjacent to or invading large hepatic veins are recognized to be at increased risk of bleeding.22 The major risk factors for significant or uncontrolled bleeding are the size and location of the lesion. Though difficult to quantify, expertise and available technology are recognized as major factors in maintaining vascular control.20,23 The role of pneumoperitoneum in homeostasis and meticulous dissection enabled by laparoscopic magnification are also considered important factors contributing to decreased blood loss in laparoscopic procedures. Magnification may render laparoscopic dissection of large hepatic veins safer than in open laparotomy.13,15 The use of vascular staples (with endoscopic linear staplers) for homeostasis and the use of the LigaSure device JSLS (2013)17:46 –55 49 Complications of Liver Resection: Laparoscopic Versus Open Procedures, Slakey DP et al. Table 3. Complications Total Laparoscopic Group Open Group ORa Relative 95% CIa Risk Cases with complications, n (male, female) 16 (11, 5) 7 (4, 3) 9 (7, 2) 6.11 .007 Mortality at 30 d, n (male, female) 1 (1, 0) 0 1 (1, 0) 5.63 .86 Mortality at 12 m, n (male, female) 3 (2, 1) 0 3 (2, 1) 19.29 .06 Blood loss, mean (male, female); range (mL) 427.4 (676.3, 240.8); 0–5000 95.0 (115.0, 88.4); 0–350 988.0 (1050.4, 850.0); 10–5000 (SD, 969.09) (SD, 88.75) (SD, 1450.5) IV pain medications ⬎5 d 10 (7, 3) 5 (3, 2) 5 (4, 1) 3.33 .17 ICUa stay ⬎5 d 8 (5, 3) 3 (2, 1) 5 (3, 2) 5.83 .05 P Value .0001 Measures of outcome, n (male, female) a Hospital stay ⬎10 d 9 (8, 1) 3 (2, 1) 6 (6, 0) 7.64 .01 Postoperative ileus ⬎4 d 4 (3, 1) 1 (0, 1) 3 (3, 0) 9.43 .10 Pleural effusion 2 (1, 1) 0 2 (1, 1) 12.0 .23 Incisional infection 2 (2, 0) 0 2 (2, 0) 12.0 .23 Incisional hernia 4 (1, 3) 1 (0, 1) 3 (1, 2) 9.43 .10 Hematoma requiring drainage 1 (1, 0) 0 1 (1, 0) 5.63 .86 Abscess requiring drainage 1 (1, 0) 0 1 (1, 0) 5.63 .86 Upper GIa bleed requiring EGD/epia 2 (2, 0) 1 (1, 0) 1 (1, 0) 2.75 .94 Bile duct stricture requiring ERCPa 1 (1, 0) 0 1 (1, 0) 5.63 .86 CBDa obstruction 1 (1, 0) 0 1 (1, 0) 5.63 .86 Bile leak 1 (0, 1) 1 (0, 1) 0 0 .61 Ascites requiring drainage 5 (4, 1) 3 (2, 1) 2 (2, 0) 1.86 .89 Retained drain requiring procedure 1 (1, 0) 1 (1, 0) 0 0 .61 Total No. of specific complications (male, female) Having a complication in open group vs laparoscopic group 5.29 1.83–15.34 .003 Having [me]1 measure of poor outcome in open group vs laparoscopic group 3.67 1.48–9.07 .008 a CBD⫽common bile duct; CI⫽confidence interval; EGD/epi⫽esophagogastroduodenoscopy/episode; ERCP⫽endoscopic retrograde cholangiopancreatography; GI⫽gastrointestinal; ICU⫽ intensive care unit; IV⫽intravenous; OR⫽odds ratio. 50 JSLS (2013)17:46 –55 Table 4. Intraoperative and Postoperative Results by Location of Resection Anterolateral Group Posterosuperior (PS and AL⫹PS)a Other Resection Cases Lapa Lap Open Lap Open Open a Conversion, n 3 NA 2 NA 0 NA Blood loss requiring transfusion 4 U, n (male, female) 0 0 0 0 0 1 (1, 0) Mortality within 30 d after operation, n (male, female) 0 0 0 1 (1, 0) 0 0 Mortality within 12 m, n (male, female) IVa pain medication 5 d, n (male, female) ICUa stay 5 d, n (male, female) Hospital stay 10 d, n (male, female) 0 2 (1, 1) 0 1 (1, 0) 0 0 4 (2, 2) 2 (2, 0) 1 (1, 0) 2 (1, 1) 0 1 (1, 0) 2 (1, 1) 1 (1, 0) 1 (1, 0) 4 (2, 2) 0 0 2 (1, 1) 2 (2, 0) 1 (1, 0) 2 (2, 0) 1 (1, 0) 1 (1, 0) 1 (0, 1) 2 (2, 0) 0 1 (1, 0) 0 0 Pleural effusion 0 0 0 2 (1, 1) 0 0 Incisional infection 0 0 0 1 (1, 0) 0 1 (1, 0) Incisional hernia 0 1 (0, 1) 1 (0, 1) 1 (0, 1) 0 1 (1, 0) Hematoma requiring drainage 0 0 0 1 (1, 0) 0 0 Postoperative ileus 4 d, n (male, female) Complications, n (male, female) Abscess requiring drainage 0 0 0 1 (1, 0) 0 0 Upper GIa bleed requiring EGD/epia 1 (1, 0) 1 (1, 0) 0 0 0 0 Bile duct stricture requiring ERCPa 0 0 0 1 (1, 0) 0 0 CBDa obstruction 0 0 0 1 (1, 0) 0 0 Bile leak requiring drainage 1 (0, 1) 0 0 0 0 0 Ascites requiring drainage 1 (1, 0) 1 (1, 0) 2 (1, 1) 1 (1, 0) 0 0 Retained drain requiring procedure Total complications (n ⫽ 21) 0 0 0 1 (1, 0) 0 0 3 (2, 1) 3 (2, 1) 3 (1, 2) 10 (8, 2) 0 2 (2, 1) a AL⫽anterolateral segments; CBD⫽common bile duct; ERCP⫽endoscopic retrograde cholangiopancreatography; EGD/ epi⫽esophagogastroduodenoscopy/episode; GI⫽gastrointestinal; ICU⫽ intensive care unit; IV⫽intravenous; Lap⫽laparoscopic; NA⫽not applicable; PS⫽posterosuperior segments. to advance toward large vascular structures in the deeper parenchyma may also decrease the risk of bleeding.13,22,23 As hepatobiliary surgical teams gain experience with laparoscopic techniques, a significant percentage of liver resections may be accomplished laparoscopically. At our center, greater than two-thirds of the liver resections are performed by a laparoscopic approach. In this study only 11.1% of cases in the laparoscopic group required conversion to open resection. The reasons for conversion were unsatisfactory visualization and an inadequate mar- gin of resection. The latter is likely because of the inability of the surgeon to palpate lesions with a laparoscopic approach, resulting in difficulty identifying an optimal margin.18,24,25 The conversion rate in this study was low relative to that reported in the literature.15,20,26,27 One relative contraindication to the laparoscopic approach in our experience has been previous upper abdominal surgery and the resultant adhesions. Despite the increasing use of laparoscopy for hepatic procedures, the surgical techniques have been largely limited to patients who have lesions confined to the an- JSLS (2013)17:46 –55 51 Complications of Liver Resection: Laparoscopic Versus Open Procedures, Slakey DP et al. terolateral segments of the liver.18 This is primarily because laparoscopic liver resection of the posterosuperior segments is associated with poorer access and visualization compared with open resection.18,28 To a large degree, lesions located in the posterosuperior segments of the liver are still considered relative contraindications to laparoscopy.13,15,18,29 Of note, the posterosuperior group in our study had a greater number of tumors that involved ⬎1 segment, as well as a greater proportion of deepseated tumors requiring longer and more complicated procedures, than anterolateral cases. This may contribute to the greater number of complications and poor measures of outcome in the posterosuperior groups relative to the anterolateral groups. Interestingly, our study shows a significantly greater proportion of complications and poor measures of outcome in the open posterosuperior resection group than in the laparoscopic group. This observation may be tempered by the fact that most of the open posterosuperior resection recipients had a greater number of lesions overall (9 of 10 open posterosuperior resection patients had ⱖ2 lesions). Another potential limitation of the study is the smaller number of open cases. This indicates the value of developing a multicenter outcomes database as opposed to relying on single-center studies. Although the demographic differences between the groups in this study were not statistically significant, a greater proportion of women underwent laparoscopic liver resections (57.8%) and a greater number of men underwent open resections (70.6%). Sex was not considered an indication or contraindication for either surgical approach. It is not clear from this analysis why more male patients had open resections, although it is possible that body habitus played a role. In larger male patients, some resections may not be amenable to resection given current limitations of laparoscopic instruments. Studies have noted that male sex is an independent risk factor for liver failure after hepatectomy, although other hepatic resection complications associated with sex have not been elucidated.30 In our study, when the open and laparoscopic resection groups are stratified by sex, some of the differences in complications and measures of poor outcome between the open and laparoscopic resections do show statistical significance. Nonetheless, male patients undergoing open hepatic resection in this study show a significantly greater proportion of poor measures of outcome (most notably longer hospital stay) than those undergoing laparoscopic resection. Laparoscopic and open complications and outcomes stratified by sex are shown in Table 5. 52 For patients in whom hepatic reserve was a consideration, such as patients with chronic liver disease or cirrhosis, nonanatomic resections or tumorectomies are preferred as opposed to anatomic lobectomies. Nonanatomic resections in these segments can be considered major liver resections because of challenges with exposure, as well as the transection line, which is often curved.13,20 One series by Dagher et al.13 noted that nonanatomic resections in the posterosuperior segments are more difficult than other major resections (right hemihepatectomy, left hemihepatectomy, left lateral segmentectomy). They noted that nonanatomic resections in these segments resulted in more profuse bleeding, greater transfusion requirements, and more frequent conversion. Other series have recommended the hand-assisted laparoscopic technique for resection in these segments to improve exposure and assist in transection.18,31 The hand-assisted technique allows for digital palpation that is usually not possible in laparoscopy, as well as manual control of bleeding. The hand-assisted technique does have several drawbacks including being generally more invasive, having a greater risk of air leakage, and causing operator fatigue.32 Laparoscopic liver surgery is being used with increasing frequency by abdominal surgery programs worldwide.1 In the past 3 years, an increasing percentage of left lateral segmentectomies have been performed by laparoscopy.13 A greater number of left and right hemihepatectomies are also being performed laparoscopically in select centers.13 In our study 1 of the 2 left lateral sectionectomies and 3 of the 4 left hemihepatectomies were performed laparoscopically. Our analysis shows that laparoscopic liver resection can be considered as safe as open liver resection for most patients with lesions located in both the anterolateral and posterosuperior segments of the liver if performed by surgeons with the requisite expertise and experience in laparoscopy. Because laparoscopic liver resection is still in its nascency, further technologic innovations will be required before the laparoscopic approach can be considered the standard for the surgical resection of hepatic lesions.32 The expansion of the use of laparoscopy for liver resection is limited by the necessity of specialized surgical training, as well as fear of loss of vascular control, but the scope of the laparoscopic approach will continue to expand to be considered suitable for any resection of hepatic tumors.33 The lower operative and postoperative blood loss, shortened intensive care unit stay and overall hospital stay, shortened duration of postoperative ileus, and smaller incidence of complications and postoperative morbidities have significant ramifications in terms of reducing overall morbidity and health care costs. JSLS (2013)17:46 –55 Table 5. Complications by Sex Cases with complications, male, n Total Lapa Group Open Group ORa 11 4 7 5.25 Relative Risk 95% CIa P Value .08 Cases with complications, female, n 5 3 2 5.11 .36 Mortality at 30 d, male, n 1 0 1 3.46 .90 Mortality at 30 d, female, n 0 0 0 5.20 .64 Mortality at 12 m, male, n 2 0 2 7.60 .46 Mortality at 12 m, female, n 1 0 1 13.0 .55 IVa pain medications 5 d, male 7 3 4 2.67 .49 IV pain medications 5 d, female 3 2 1 3.0 .98 ICU stay 5 d, male 5 2 3 2.83 .57 ICU stay 5 d, female 3 1 2 16.67 .09 Measures of outcome, n a Hospital stay 10 d, male 8 2 6 8.5 .04 Hospital stay 10 d, female 1 1 0 2.5 .56 Postoperative ileus 4 d, male 3 0 3 12.67 .17 Postoperative ileus 4 d, female 1 1 0 2.5 .56 Pleural effusion, male 1 0 1 3.45 .90 Pleural effusion, female 1 0 1 13.0 .55 Incisional infection, male 2 0 2 7.6 .46 Total No. of specific complications Incisional infection, female 0 0 0 5.2 .64 Incisional hernia, male 1 0 1 3.46 .90 Incisional hernia, female 3 1 2 16.67 .09 Hematoma requiring drainage, male 1 0 1 3.46 .90 Hematoma requiring drainage, female 0 0 0 5.2 .64 Abscess requiring drainage, male 1 0 1 3.46 .90 Abscess requiring drainage, female 0 0 0 5.2 .64 Upper GIa bleed requiring EGD/epia, male 2 1 1 1.64 .68 Upper GI bleed requiring EGD/epi, female 0 0 0 5.2 .64 Bile duct stricture requiring ERCPa, male 1 0 1 3.46 .90 Bile duct stricture requiring ERCP, female 0 0 0 5.2 .64 CBDa obstruction, male 1 0 1 3.46 .90 CBD obstruction, female 0 0 0 5.2 .64 Bile leak, male 0 0 0 1.58 .42 Bile leak, female 1 1 0 2.5 .56 Ascites requiring drainage, male 4 2 2 1.7 .96 Ascites requiring drainage, female 1 1 0 2.5 .56 Retained drain requiring procedure, male 1 1 0 0.75 .49 Retained drain requiring procedure, female 0 0 0 5.2 .64 JSLS (2013)17:46 –55 53 Complications of Liver Resection: Laparoscopic Versus Open Procedures, Slakey DP et al. Table 5. (continued) Complications by Sex Relative Risk 95% CIa P Value Having a complication in open group vs lap group, male 2.77 0.66–11.52 .28 Having a complication in open group vs lap group, female 3.47 0.46–26.37 .52 Having [me]1 measure of poor outcome in open group vs lap group, male 3.62 1.15–11.37 .05 Having [me]1 measure of poor outcome in open group vs lap group, female 3.12 0.56–17.46 .40 Total Lapa Group Open Group ORa a CBD⫽common bile duct; CI⫽confidence interval; EGD/epi⫽esophagogastroduodenoscopy/episode; ERCP⫽endoscopic retrograde cholangiopancreatography; GI⫽gastrointestinal; ICU⫽ intensive care unit; IV⫽intravenous; Lap⫽laparoscopic; OR⫽odds ratio. References: 1. Troisi R, Montalti R, Smeets P, et al. The value of laparoscopic liver surgery for benign hepatic tumors. Surg Endosc. 2008;22:38 – 44. 2. Samama G, Chiche L, Brefort JL, Le Roux Y. Laparoscopic anatomical hepatic resection. Report of four left lobectomies for solid tumors. Surg Endosc. 1998;12(1):76 –78. 11. Strasberg SM. Nomenclature of hepatic anatomy and resections: a review of the Brisbane 2000 system. J Hepatobiliary Pancreat Surg. 1998;12:351–355. 12. Biertho L, Waage A, Gagner M. Laparoscopic hepatectomy. Ann Chir. 2002;127(3):164 –170. 13. Dagher I, Proske JM, Carloni A, Richa H, Tranchart H, Franco D. Laparoscopic liver resection: results for 70 patients. Surg Endosc. 2007;21:619 – 624. 3. Rau HG, Buttler E, Meyer G, Schardey HM, Schildberg FW. Laparoscopic liver resection compared with conventional partial hepatectomy-a prospective analysis. Hepatogastroenterology. 1998;45:2333–2338. 14. Borzellino G, Ruzzenente A, Minicozzi AM, Giovinazzo F, Pedrazzani C, Guglielmi A. Laparoscopic hepatic resection. Surg Endosc. 2006;20:787–790. 4. Katkhouda N, Hurwitz M, Gugenheim J, et al. Laparoscopic management of benign solid and cystic lesions of the liver. Ann Surg. 1999;229(4):460 – 466. 15. Cherqui D, Husson E, Hammoud R, et al. Laparoscopic liver resections: a feasibility study in 30 patients. Ann Surg. 2000;232: 753–762. 5. Descottes B, Glineur D, Lachachi F, et al. Laparoscopic liver resection of benign liver tumors. Surg Endosc. 2003;17(1):23–30. 16. Rogula T, Gagner M. Current status of the laparoscopic approach to liver resection. J Long Term Eff Med Implants. 2004;14:23–31. 6. Gagner M, Rheault M, Dubuc J. Laparoscopic partial hepatectomy for liver tumor. Surg Endosc. 1992;6:97–98. 7. Azagra JS, Goergen M, Gilbart E, Jacobs D. Laparoscopic anatomical (hepatic) left lateral segmentectomy: technical aspects. Surg Endosc. 1996;10:758 –761. 8. Cherqui D, Chouillard E, Laurent A, Tayar C. Hépatectomies par abord coelioscopique. EMC Tech Med Chir. 2006; 3(40 –768):1– 8. 9. Morino M, Morra I, Rosso E, Miglietta C, Garrone C. Laparoscopic vs open hepatic resection: a comparative study. Surg Endosc. 2003;17(12):1914 –1918. 10. KT Clearinghouse, Centre for Evidence-Based Medicine (2000 –2012). Stats calculator. Available at: http://ktclearinghouse.ca/cebm/practise/ca/calculators/statscalc. Accessed May 29, 2012. 54 17. Simillis C, Constantinides VA, Tekkis PP, et al. Laparoscopic versus open hepatic resections for benign and malignant neoplasms-a meta-analysis. Surgery. 2007;141:203– 211. 18. Cho JY, Han HS, Yoon YS, Shin SH. Feasibility of laparoscopic liver resection for tumors located in the posterosuperior segments of the liver, with a special reference to overcoming current limitations on tumor location. Surgery. 2008; 144:32–38. 19. Takayama T, Makuuchi M, Kubota K, et al. Randomized comparison of ultrasonic vs clamp transection of the liver. Arch Surg. 2001;136:922–928. 20. Vibert E, Perniceni T, Levard H, Denet C, Shahri NK, Gayet B. Laparoscopic liver resection. Br J Surg. 2006;93:67–72. JSLS (2013)17:46 –55 21. Wu CC, Ho WM, Cheng SB, et al. Perioperative parenteral tranexamic acid in liver tumor resection: a prospective randomized trial toward a “blood transfusion”–free hepatectomy. Ann Surg. 2006;243:173–180. 28. Kaneko H, Takagi S, Otsuka Y, et al. Laparoscopic liver resection of hepatocellular carcinoma. Am J Surg. 2005;189:190 – 194. 22. Chang S, Laurent A, Tayar C, Karoui M, Cherqui D. Laparoscopic as routine approach for left lateral sectionectomy. Br J Surg. 2007;94:58 – 63. 29. Laurent A, Cherqui D, Lesurtel M, Brunetti F, Tayar C, Fagniez PL. Laparoscopic liver resection for subcapsular hepatocellular carcinoma complicating chronic liver disease. Arch Surg. 2003;138:763–769. 23. Farges O, Jagot P, Kirstetter P, Marty J, Belghiti J. Prospective assessment of the safety and benefit of laparoscopic liver resections. J Hepatobiliary Pancreat Surg. 2002;9:242–248. 30. Bachellier P, Rosso E, Pessaux P, et al. Risk factors for liver failure and mortality after hepatectomy associated with portal vein resection. Ann Surg. 2011;253:173–179. 24. John TG, Greig JD, Crosbie JL, Miles WF, Garden OJ. Superior staging of liver tumors with laparoscopy and laparoscopic ultrasound. Ann Surg. 1994;220:711–719. 31. Huang MT, Lee WJ, Wang W, Wei PL, Chen RJ. Handassisted laparoscopic hepatectomy for solid tumor in the posterior portion of the right lobe: initial experience. Ann Surg. 2003;238:674 – 679. 25. Rahusen FD, Cuesta MA, Borgstein PJ, et al. Selection of patients for resection of colorectal metastases to the liver using diagnostic laparoscopy and laparoscopic ultrasonography. Ann Surg. 1999;230:31–37. 26. Cherqui D, Laurent A, Tayar C, et al. Laparoscopic liver resection for peripheral hepatocellular carcinoma in patients with chronic liver disease: midterm results and perspectives. Ann Surg. 2006;243:499 –506. 32. Dulucq JL, Wintringer P, Stabilini C, Berticelli J, Mahajna A. Laparoscopic liver resections: a single center experience. Surg Endosc. 2005;19:886 – 891. 33. Koffron A, Geller D, Gamblin TC, Abecassis M. Laparoscopic liver surgery: shifting the management of liver tumors. Hepatology. 2006;44:1694 –1700. 27. Gigot JF, Glineur D, Santiago Azagra J, et al. Laparoscopic liver resection for malignant liver tumors: preliminary results of a multicenter European study. Ann Surg. 2002;236:90 –97. JSLS (2013)17:46 –55 55 SCIENTIFIC PAPER Robotic Liver Resection: Initial Experience With Three-Arm Robotic and Single-Port Robotic Technique Emad Kandil, MD, Salem I. Noureldine, MD, Bob Saggi, MD, Joseph F. Buell, MD ABSTRACT INTRODUCTION Background and Objective: Robotic-assisted surgery offers a solution to fundamental limitations of conventional laparoscopic surgery, and its use is gaining wide popularity. However, the application of this technology has yet to be established in hepatic surgery. Over the past decade, minimally invasive liver surgery has gained acceptance with proliferation worldwide. This was a slow process, evolving from small peripheral resections to formal hepatic lobectomies. Significant skepticism and often vocal resistance were observed during this evolution. Not until several large series and a consensus statement were published did laparoscopic hepatic surgery achieve a routine place in hepatic surgery.1– 4 Several subsequent studies have confirmed the oncologic equivalence of laparoscopic liver resection with open liver resection. In this setting, laparoscopic liver resection has become the standard of care for left lateral sectionectomy. Recent studies have confirmed the benefits of laparoscopic liver resection in patients undergoing repeat hepatectomy or as a bridge to subsequent liver transplantation.3,5 The benefits of laparoscopic liver resection, which include shorter operative and recovery times, less blood loss, and a lower incidence of postoperative adhesions, make this technique highly desirable.2,4 –7 Methods: A retrospective analysis of our prospectively collected liver surgery database was performed. Over a 6-month period, all consecutive patients who underwent robotic-assisted hepatic resection for a liver neoplasm were included. Demographics, operative time, and morbidity encountered were evaluated. Results: A total of 7 robotic-assisted liver resections were performed, including 2 robotic-assisted single-port access liver resections with the da Vinci-Si Surgical System (Intuitive Surgical Sunnyvalle, Calif.) USA. The mean age was 44.6 years (range, 21– 68 years); there were 5 male and 2 female patients. The mean operative time (⫾ SD) was 61.4 ⫾ 26.7 minutes; the mean operative console time (⫾ SD) was 38.2 ⫾ 23 minutes. No conversions were required. The mean blood loss was 100.7 mL (range, 10 –200 mL). The mean hospital stay (⫾ SD) was 2 ⫾ 0.4 days. No postoperative morbidity related to the procedure or death was encountered. Conclusion: Our initial experience with robotic liver resection confirms that this technique is both feasible and safe. Robotic-assisted technology appears to improve the precision and ergonomics of single-access surgery while preserving the known benefits of laparoscopic surgery, including cosmesis, minimal morbidity, and faster recovery. Key Words: Robotic liver resection, Minimally invasive liver surgery, Robotic hepatectomy, SILS, Single port, Single access. Division of Endocrine and Oncological Surgery, Tulane Transplant Institute, Department of Surgery, Tulane University School of Medicine, New Orleans, LA, USA (all authors). This research and work was fully supported by Tulane University Medical Center. Dr Buell is a consultant for both Ethicon and Coviden. Address correspondence to: Joseph F. Buell, MD, Department of Surgery, Tulane University School of Medicine, 1415 Tulane Ave, TW 35, New Orleans, LA, 70112 USA. Telephone: 504 988 0783, Fax: 504 988 7510, E-mail: [email protected] DOI: 10.4293/108680812X13517013317671 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 56 Despite the numerous benefits of laparoscopic liver resections, there are several inherent limitations to this technique. These include restricted instrument motion, 2-dimensional imaging, complex ergonomics, and unstable operative exposure.8,9 Robotic-assisted technology appears to offer key solutions to these same fundamental limitations of conventional laparoscopic surgery.10 –17 Unfortunately, as was witnessed with initial laparoscopic liver resections, the application of robotic technology in liver surgery has been controversial. To date, few large series of robotic liver resection have been reported. This study examines our group’s preliminary experience with robotic-assisted liver resections. METHODS A retrospective review of our prospectively collected liver surgery database was conducted to include all robotic-assisted liver resections performed between February and August 2011 at a tertiary care center. Demographics, operative time, intraoperative blood loss, pathology, and postoperative outcome were evaluated. Liver resections were defined according to the International Hepato-Pancreato-Biliary Asso- JSLS (2013)17:56 – 62 ciation’s Couinaud classification.18 Resection for benign tumors was considered only for symptomatic lesions or for the presence of uncertainty at preoperative biopsy or radiologic evaluation. Resection of colorectal liver metastases was considered only in the absence of peritoneal carcinomatosis or unresectable extrahepatic disease. In patients with hepatocellular cancers, only those with well-compensated cirrhosis (Child-Pugh class A/B, low grade) with no signs of severe portal hypertension (esophageal varices ⬎F2) were eligible for robotic liver resections. Surgical Technique Patient and trocar positioning for robotic-assisted laparoscopic liver resection. While under general anesthesia, the patient was placed in a supine position, and 4 trocars were inserted. A 12-mm trocar port for the robotic camera was placed above the umbilicus by the Hassan technique. Two 8-mm robotic ports were placed at the left upper quadrant and right upper quadrant, and a 12-mm trocar port was placed at the midclavicular line lateral to the umbilicus for the assistant. Intraoperative ultrasonography was performed with a 7.5MHz, 10-mm SSD-1700 linear transducer (BK Medical, Peabody, MA, USA) to examine the remaining liver for undetectable lesions and obtain adequate surgical resection margins. The da Vinci-Si Surgical System (Intuitive Surgical, Sunnyvalle, CA, USA) robot was brought into position over the right shoulder of the patient and docked after placement of the ports. The operator moved to the robot console to control the robotic arms. The assisting surgeon remained at the patient’s side to change robotic instruments and performed clipping, stapling, and mobilization through the assistant 12-mm trocar. Figure 1 depicts the position of the trocars. A vascular reticulating endoscopic stapler (Coviden, Norwalk, CT, USA) was used to divide the ligamentum teres hepatis and to control the main branches of the portal veins (Figure 2A). The endoscopic articulating stapler allowed safe control of the major vessels from the hepatic parenchyma (Figure 2B). A Harmonic scalpel (Ethicon Endo-Surgery, Cincinnati, OH, USA) was used to incise the capsule, to divide the parenchyma, and to perform dissection (Figure 2C). A grasper was used to retract the liver. An endoscopic suction device was used to aid in the dissection of the blood vessels. Bile leaks and hemostasis were completed with argon plasma coagulation (Figure 2D). Patient and trocar positioning for robotic-assisted single-port access liver resection. While under gen- Figure 1. Image of abdomen showing positioning of trocars. eral anesthesia, the patient was placed in a supine position. An incision measuring approximately 3 cm was made above the umbilicus. Dissection was performed down through the fascia to the peritoneum. A single-port device (Applied Medical, Rancho Santa Margarita, CA, USA) was then placed once the abdomen was entered. The single port included 3 small ports that were used for the placement of the robotic arms. The robotic arms were equipped with a Harmonic scalpel, a Prograsper (Intuitive Surgical, Sunnyvale, CA, USA), and a 12-mm camera. In addition, a 12-mm port was placed in the lower left quadrant for the assistant. The abdomen was then insufflated with 4 L of carbon dioxide. Intraoperative ultrasonography was performed to examine the remaining liver to search for undetectable lesions and obtain adequate surgical resection margins. The da Vinci-Si Surgical System robot was brought into position and docked over the patient’s right shoulder after port placements. The operator moved to the console to control the robotic arms. The assisting surgeon remained at the patient’s side to change robotic instruments and perform clipping, stapling, and mobilization through the assistant 12-mm trocar. Figure 3A depicts the position of the trocars. Intraoperative ultrasonography was performed to examine the remaining liver to search for undetectable lesions and obtain adequate surgical resection margins. The Harmonic scalpel was used to incise the capsule and to perform dissection. The grasper was used to retract the liver. The main branches of the portal veins were controlled with the application of the endoscopic articulating stapler by use of a white cartridge. The hepatic surfaces were inspected for any evidence of bile leaks, JSLS (2013)17:56 – 62 57 Robotic Liver Resection: Initial Experience With Three-Arm Robotic and Single-Port Robotic Technique, Kandil E et al. Figure 2. A. The transected falciform ligament was used to expose the underside of the liver, with dissection of the inferior surface. B. The endoscopic articulating stapler allowed safe control of the major vessels. C. The capsule was incised with the Harmonic scalpel. D. Argon plasma coagulation. and hemostasis was completed with argon plasma coagulation as needed. Figure 3B shows the surgical incision used for the single-port device. RESULTS Seven of 29 liver resections (24%) were performed with the da Vinci Si-Surgical System during the 6-month study period. Table 1 depicts demographic information, indications for surgery, and characteristics of the lesions. The mean age was 44.6 years (range, 21– 68 years), and 71.4% of patients were men. The mean total operative time (⫾ SD) was 61.4 ⫾ 26.7 minutes; the mean operative console time (⫾ SD) was 38.2 ⫾ 23 minutes. The mean blood loss was 100.7 mL (range, 10 –200 mL). The mean hospital stay (⫾ SD) was 2 ⫾ 0.4 days (Table 2). No postoperative morbidity related to the procedure or death was encountered. Successful resection was established in all patients 58 without requiring a conversion to the traditional open approach. No patients required a blood transfusion. The latter 2 cases were performed by a robotic-assisted single-port access technique. The mean estimated blood loss (⫾ SD) was 22.5 ⫾ 10.6 mL. The mean robot docking time (⫾ SD) was 7 ⫾ 1.7 minutes, the mean operative console time (⫾ SD) was 33.5 ⫾ 12.0 minutes, and the mean total operative time (⫾ SD) was 60.5 ⫾ 13.4 minutes. DISCUSSION Over the past decade, laparoscopic liver resection has become an acceptable technique for the management of benign tumors, colorectal metastases, and hepatocellular cancers. Multiple studies have confirmed that laparoscopic liver resection results in a shorter operative time, less blood loss, and a shorter length of hospital stay. Despite consider- JSLS (2013)17:56 – 62 control hemorrhage through the use of temporary digital control or direct application of pressure.3,21,22 However, the use of hand-assisted devices or hybrid incisions leads to a greater interruption of the abdominal wall, diluting the potential benefits of minimally invasive surgery. Robotic-assisted surgery is a new tool that provides a novel way of controlling hemorrhage through stabilized suture repair. Robotic surgery uniquely allows free articulation of the suturing arms, subsequently minimizing the difficulties faced when one is performing conventional laparoscopic liver surgery.10 –17 The da Vinci-Si Surgical System provides surgeons with intuitive translation of the instrument handle to the tip movement, eliminating the mirror-image effect. In addition, a remotely controlled camera provides improved visualization with high-quality 3-dimensional images and a stable camera platform with scaling, tremor filtering, and coaxial alignment of the eyes and EndoWrist, with a 360° range of motion, allowing more precise operating techniques (Asheville, NC, USA).5,23–26 Robotic-assisted laparoscopic liver resection is a procedure in evolution. This operative platform potentially increases the diversity of laparoscopic liver resections able to be performed by a surgeon. The ease of robotic suturing opens the surgeon’s ability to access the biliary system and repair potential vascular injuries. Figure 3. A. Positioning of single-access port. B. Abdomen postoperatively. able controversy, no increases in operative complications or inferior oncologic outcomes were observed. These clinical findings suggest that laparoscopic resection could be expanded to most hepatic resections, including cirrhotic patients and all malignancies.19,20 Unfortunately, conventional laparoscopic liver surgery has several inherent limitations.15 These include challenging exposure, suboptimal visualization, and the complexity of vascular control during major hepatic hemorrhage. Control of major vascular hemorrhage is one of the most important issues in hepatic surgery. These challenges made the use of hand-assisted devices and laparoscopicassisted open resection (hybrid) attractive options. These devices and techniques afford several benefits, including the ability to use the surgeon’s hand to stabilize, mobilize, and However, significant criticism exists over the use of robotic-assisted surgery for liver resection. As was experienced in the early application of laparoscopic liver surgery, significant concerns over safety and efficacy exist. Robotic surgery does in fact separate the surgeon from having direct contact with the patient. This results in significant fear regarding hemorrhage and, in particular, concern about delays in conversion inherent with the use of the robot. Currently, robotic instrumentation has evolved and has become diversified but still lacks a stapling platform or a robotic argon coagulator, necessitating the addition of a qualified surgical assistant. In robotic liver surgery, an experienced assistant surgeon is required to suction, retract, and introduce the vascular stapler. As was seen with the evolution of conventional laparoscopic liver resection, a significant learning curve exists. Robotic liver surgery requires significant experience with the robot both as an assistant and on the console. Competency in robotic liver surgery will require experience in robotic surgery and open hepatic surgery, as well as advanced laparoscopic liver resection. Despite all of these concerns, several small series of robotic-assisted liver resections have been reported with limited conversion rates, reasonable blood loss, and minimal postoperative morbidity, even for major hepatectomy.14,27,28 However, when compared with con- JSLS (2013)17:56 – 62 59 Robotic Liver Resection: Initial Experience With Three-Arm Robotic and Single-Port Robotic Technique, Kandil E et al. Table 1. Demographic Information, Indications for Surgery, and Characteristics of Lesions for 7 Patients in Cohort Case Sequence Sex Age, yr Body Mass Index Diagnosis Tumor Size, cm Resection Complications Length of Stay, d 1 Male 45 36.5 Hepatic adenoma 6 Left lobe None 2 2 Male 58 32.1 Hepatoma 1.5 Bisegment 7 and 8 None 2 3 Male 21 26.4 Focal nodular hyperplasia 8 Left lateral sectionectomy None 1 4 Male 28 26.4 Hodgkin lymphoma 1 Dx wedge segment 2 Atelectasis 1 5 Male 28 26.4 Hodgkin lymphoma 1 Dx wedge segment 3 None 1 6 Female 64 28.1 Adenoma (procedure performed for suspected metastases) 1.5 Single port: left lateral segmentectomy Delirium and tremors 5 7 Female 68 40.4 Metastatic adenocarcinoma (colorectal mass) 1.4 Single port: left lateral segmentectomy None 2 Table 2. Intraoperative Data for Patients in Cohort Case Sequence Estimated Blood Loss, mL Console Time, min Docking Time, min ORa Time, min 1 200 10 60 90 2 200 6 65 86 3 200 7 55 79 4 10 6 10 26 5 50 6 11 28 6 (single-port access) 15 9 25 51 7 (single-port access) 30 11 42 70 a OR⫽operating room. ventional laparoscopic liver resection, the robotic approach appears to provide similar outcomes.29 An additional potential advantage of robotic-assisted technology is the ability to perform a hepatic resection through the single-port access approach. There are significant data to support the use of single-port laparoscopy because it has gained momentum in multiple disciplines, including laparoscopic cholecystectomy, colectomy, and nephrectomy.30 –33 The advantages of single-port laparoscopy have been reported as decreased morbidity, postoperative pain, shorter hospital stay, and faster recovery, in addition to a cosmetic advantage.33 However, to date, there have only been a few case reports using single-port laparoscopic surgery for liver resections because of the complexity of such procedures and the significant and 60 often cumbersome crisscrossing “sword fighting” of instruments during triangulation inside the abdominal cavity. These significant prerequisites restrain the enthusiasm of many surgeons, making single-port laparoscopic liver resections a rather limited field.31 The use of the robotic control through the single-access port appears to limit the occurrence of crisscrossing, improving the ability to use this instrumentation, and allows for a more meaningful use of 3 arms without the frustration or added difficulty with this approach. A recent study from Japan confirmed that robotic single-port liver resection was feasible in a porcine model.34 This study subsequently concluded that single-port laparoscopic liver resection was technically feasible and safe. In our study we elected to use the single-access approach in the last 2 JSLS (2013)17:56 – 62 procedures to minimize trauma and port-related complications, such as organ damage, adhesions, bleedings, wound infections, and hernias.33,35 The potential benefits of robotic-assisted single-port access surgery remain to be proven; however, potential therapeutic benefits might include less postoperative pain, a shorter hospital stay, and faster recovery, in addition to the cosmetic advantage. The decrease in abdominal wall trauma could be specifically useful for cirrhotic patients, provided that the incision is made in the supraumbilical location to avoid bleeding from large umbilical veins and to allow a secure closure. The use of the GelPort (Ranchos Margarita, CA, USA) device makes it possible to use large instruments, such as standard laparoscopic ultrasonography probes, LigaSure (Boulder, CO, USA) devices, and staplers. This facilitates the procedure and helps minimize blood loss. 6. 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CONCLUSION Our group has shown that robotic-assisted laparoscopic liver resection is both feasible and safe. We also have reported the first 2 cases of robotic-assisted single-port access liver resection. Our initial experience confirms that robotic liver resection can be practical in select cases. We found no higher incidence of conversion, morbidity, or even death. Robotic liver surgery allows potential advantages not otherwise inherent in conventional laparoscopic liver resection. A robotic approach to single-port access appears technically feasible and safe. Nevertheless, this remains a challenging procedure, requiring both hepatobiliary and laparoscopic experience. Additional experiences are mandatory to assess and examine the safety of this emerging technique. References: 1. Nguyen KT, Gamblin TC, Geller DA. World review of laparoscopic liver resection—2,804 patients. Ann Surg. 2009;250(5):831–841. 2. Buell JF, Thomas MT, Rudich S, et al. 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Vibert E, Perniceni T, Levard H, Denet C, Shahri NK, Gayet B. Laparoscopic liver resection. Br J Surg. 2006;93(1):67–72. 21. Cuschieri A. Laparoscopic hand-assisted hepatic surgery. Semin Laparosc Surg. 2001;8:104 –113. JSLS (2013)17:56 – 62 61 Robotic Liver Resection: Initial Experience With Three-Arm Robotic and Single-Port Robotic Technique, Kandil E et al. 22. Koffron AJ, Auffenberg G, Kung R, Abecassis M. Evaluation of 300 minimally invasive liver resections at a single institution: less is more. Ann Surg. 2007;246:385–392; discussion 92–94. 23. Vidovszky TJ, Smith W, Ghosh J, Ali MR. Robotic cholecystectomy: learning curve, advantages, and limitations. J Surg Res. 2006;136:172–178. 24. D’Annibale A, Morpurgo E, Fiscon V, et al. Robotic and laparoscopic surgery for treatment of colorectal diseases. Dis Colon Rectum. 2004;47(12):2162–2168. 25. Camarillo DB, Krummel TM, Salisbury JK Jr. Robotic technology in surgery: past, present, and future. Am J Surg. 2004; 188:2S–15S. 26. Hashizume M, Tsugawa K. Robotic surgery and cancer: the present state, problems and future vision. Jpn J Clin Oncol. 2004;34(5):227–237. 27. Choi GH, Choi SH, Kim SH, et al. Robotic liver resection: technique and results of 30 consecutive procedures. Surg Endosc. 2012;26(8):2247–2258. 28. Lai EC, Tang CN, Li MK. Robot-assisted laparoscopic hemihepatectomy: technique and surgical outcomes. Int J Surg. 2012; 10(1):11–15. 29. Berber E, Akyildiz HY, Aucejo F, Gunasekaran G, Chalikonda S, Fung J. Robotic versus laparoscopic resection of liver tumours. HPB (Oxford). 2010;12(8):583–586. 62 30. Rosok BI, Edwin B. Single-incision laparoscopic liver resection for colorectal metastasis through stoma site at time of reversal of diversion ileostomy: a case report. Minim Invasive Surg. 2011;502176, 2011. 31. Shetty GS, You YK, Choi HJ, Na GH, Hong TH, Kim DG. Extending the limitations of liver surgery: outcomes of initial human experience in a high-volume center performing singleport laparoscopic liver resection for hepatocellular carcinoma. Surg Endosc. 2011;26(6):1602–1608. 32. Aikawa M, Miyazawa M, Okamoto K, et al. Single-port laparoscopic hepatectomy: technique, safety, and feasibility in a clinical case series. Surg Endosc. 2011;26(6):1696 –1701. 33. Gaujoux S, Kingham TP, Jarnagin WR, D’Angelica MI, Allen PJ, Fong Y. Single-incision laparoscopic liver resection. Surg Endosc. 2011;25(5):1489 –1494. 34. Sugimoto M, Tanaka K, Matsuoka Y, et al. da Vinci robotic single-incision cholecystectomy and hepatectomy using singlechannel GelPort access. J Hepatobiliary Pancreat Sci. 2011; 18(4):493– 498. 35. Back M, Nimmesgern T, Langwieler TE. Single port access laparoscopy: a review of the most recent development in minimally invasive surgery [in German]. Zentralbl Chir. 2010;135(2): 183–187. JSLS (2013)17:56 – 62 SCIENTIFIC PAPER Sleeve Gastrectomy as a Stand-alone Bariatric Operation for Severe, Morbid, and Super Obesity Dan Eisenberg, MD, MS, Anna Bellatorre, MA, Nina Bellatorre, RN, MS ABSTRACT Background: The laparoscopic sleeve gastrectomy (LSG) is emerging as an effective bariatric operation and is especially attractive in high-risk populations. In this study we examine the efficacy of LSG as a stand-alone operation in the veteran population. Methods: This is a retrospective review of consecutive patients who underwent LSG as a stand-alone procedure at the Palo Alto Veterans Affairs medical center with a minimum 12-month follow-up. Results: Of 205 patients undergoing bariatric surgery, 71 patients had a sleeve gastrectomy, 40 of whom had the operation performed at least 12 months previously. Thirtysix (90%) were available for 1-year follow-up, with a mean follow-up duration of 22 months (range: 12– 42), a mean body mass index of 48.3 kg/m2, and an 83% male population. Mean percent excess weight loss was 61% at an average of 22 months, with no significant difference between severely obese, morbidly obese, and super obese cohorts. Diabetes remission was seen in 56% of patients, hypertension remission in 51.6%, and obstructive sleep apnea remission in 46.4%, and gastroesophageal reflux disease improved or did not change in 83%. Medication use significantly decreased after surgery. Conclusion: LSG is safe and effective as a stand-alone bariatric operation in the high-risk veteran population. It is effective in severely obese, morbidly obese, and super obese patients. LSG induces remission or improvement in comorbidities of nearly all patients, translating to a decrease in medication use. Department of Surgery, Stanford School of Medicine, Stanford, CA, USA (Dr. Eisenberg). Department of Surgery, Palo Alto VA Health Care System, Palo Alto, CA, USA (Drs. Eisenberg, N. Bellatorre). Department of Sociology, Univeristy of Nebraska-Lincoln, Lincoln, NE, USA (Dr. A. Bellatorre). Address correspondence to: Dan Eisenberg, MD, MS, Department of Surgery, Stanford School of Medicine, Palo Alto VA HCS, 3801 Miranda Avenue, Palo Alto, CA 94304. Telephone: 650-852-3461. E-mail: [email protected] DOI: 10.4293/108680812X13517013317077 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. Key Words: Obesity, Sleeve gastrectomy, Bariatric surgery, Veterans, Diabetes, Hypertension, Obstructive sleep apnea, Gastroesphageal reflux. INTRODUCTION The problem of obesity in the United States has reached epidemic proportions. It has increased over the past few decades, and it is now estimated that ⬎30% of American adults are obese, and nearly two-thirds are either overweight or obese.1,2 The prevalence of severe and morbid obesity (corresponding to a body mass index [BMI] ⬎35 kg/m2 and 40 kg/m2, respectively) has increased as well. Bariatric surgery, meanwhile, has emerged as the only effective and durable treatment of morbid obesity. Bariatric surgery consistently induces durable weight loss and reliably causes improvement or remission of comorbid diseases, such as diabetes mellitus and hypertension (HTN).3–10 The prevalence of obesity is especially high in the veteran population, and veterans are an especially high-risk bariatric surgical group.11–13 Laparoscopic sleeve gastrectomy (LSG), first described as a modification of the biliopancreatic diversion-duodenal switch (BPD-DS), is emerging as a popular operation for the treatment of morbid obesity, with acceptable morbidity and long-term weight loss compared with the laparoscopic Roux-en-Y gastric bypass (LRYGB) and adjustable gastric band (AGB).14 –16 The advantages of this procedure include lack of an intestinal bypass, thus avoiding gastrointestinal anastomoses, metabolic derangements, and internal hernias, shorter operating times, and no implantation of a foreign body.17 LSG has a favorable complication profile,17–19 making it an especially attractive procedure for higher-risk patients. It has been shown that male gender, advanced age, higher BMI, and the presence of multiple comorbidities are associated with higher risk of morbidity and mortality after bariatric surgery.20,23 The bariatric patient presenting to our Veterans Medical Center is typically male, older, heavier, and has more comorbidities than the bariatric cohort in the general population, representing a higher-risk bariatric surgical group.12 In this study, we examined the efficacy of LSG as a single stand- JSLS (2013)17:63– 67 63 Sleeve Gastrectomy as a Stand-Alone Bariatric Operation for Severe, Morbid, and Super Obesity, Eisenberg D et al. alone bariatric operation in the veteran population, and compared outcomes among severely obese, morbidly obese, and super obese patients. METHODS After obtaining institutional review board approval, we reviewed the medical records of consecutive patients who underwent bariatric surgery at the Palo Alto Veterans Affairs (VA) Health Care System. All patients were followed before and after surgery by a dedicated multidisciplinary bariatric team including a bariatrician, bariatric surgeon, dietitian, psychologist, and exercise physiologist. Data for patients who had an LSG and a minimum of 12 months of follow-up were collected. These included patient demographic characteristics, weight, height, and comorbid conditions. After surgery, patients were followed after 2 weeks, 2 months, 6 months, 12 months, and at least annually thereafter. Surgical Procedure All operations were performed laparoscopically under general anesthesia, with the patient in the supine position. We used a 5-port technique with the bed in the reverseTrendelenburg position. The division of the vascular supply to the greater curvature of the stomach was begun 6 cm proximal to the pylorus and continued to the angle of His, using the LigaSure device (Covidien, Norwalk, CT). The gastrectomy was performed using an Echelon Flex stapler (Ethicon, Somerville, NJ). The sleeve volume was calibrated to an intralumenal 36-Fr endoscope. The green staple load (4.1/60 mm) was used for the first 3 staple firings, followed by gold staple loads (3.8/60 mm) to complete the sleeve. SeamGuard (W.L. Gore, Flagstaff, AZ) buttressing strips were used to reinforce the staple line. The proximal resection line was performed 1 cm to the left of the angle of His. An endoscopic air-leak test was routinely performed at the conclusion of the operation, and an upper gastrointestinal contrast study was performed on the first postoperative day before introduction of oral liquid nutrition. All patients were discharged on a standard liquid diet. RESULTS Of the 205 patients who underwent bariatric surgery, 71 patients had an LSG, of whom 40 had the operation performed at least 12 months previously. Thirty-six (90%) were available for 1-year follow-up, with a mean follow-up duration of 22 months (range: 12– 42). Thirty of the patients (83%) were male and had a mean age of 53 years at the time of surgery. Patients with type 2 diabetes represented 50% of the cohort, 84% had HTN, 78% had obstructive sleep apnea, and 67.5% carried a diagnosis of gastroesophageal reflux disease (GERD) (Table 1). Overall, patients had a mean of 5.2 preoperative comorbid conditions, a mean calculated age-modified, Charlson comorbidity index score of 3, and were taking an average of 6.2 medications. The mean BMI was 48.3 kg/m2: 25% were severely obese (BMI 35–39 kg/m2), 31% were morbidly obese (BMI 40 – 49 kg/m2), and 44% were super obese (BMI ⬎50 kg/m2). Early postoperative complications included urinary tract infection (2.8%), urinary retention (8.4%), prolonged nausea (8.4%), and refractory HTN in 2.8%. There was 1 postoperative staple-line leak (2.8%) identified 8 months after surgery in the distal sleeve and treated with partial gastrectomy. One patient had intraoperative bleeding from a splenic capsular tear that required conversion to Table 1. Patient Characteristics Total BMI 35–39 kg/m2 BMI 40–49 kg/m2 BMI 50⫹ kg/m2 N 36 9 (25%) 11 (31%) 16 (44%) M/F (%) 83/17 88/12 55/45 94/6 Age (y) 53 57 51 52 Preoperative BMI (kg/m2) 48.3 38.0 43.7 56.3 No. comorbidities 5.2 5.0 5.7 5.0 DM (%) 18 (50) 5 6 7 HTN (%) 31 (84) 8 11 12 Statistical Analysis OSA (%) 28 (78) 6 11 14 Group comparisons were performed using multiple regression and linear regression analyses, using Stata 11.0 software (StataCorp, College Station, TX); portions of the means were compared using the 2 test. GERD (%) 24 (67.5) 5 9 10 64 M ⫽ male; F ⫽ female; BMI ⫽ body mass index; DM ⫽ diabetes mellitus; HTN ⫽ hypertension; OSA ⫽ obstructive sleep apnea; GERD ⫽ gastroesophageal reflux disease. JSLS (2013)17:63– 67 open for control. All other operations were completed laparoscopically. There was no perioperative mortality. GERD, GERD symptoms worsened in 17% after LSG, improved in 25%, and did not change in the majority (58%). The mean percent excess weight loss (%EWL) for the entire group was 61% at a mean follow-up of 22 months (Table 2). Although the mean %EWL was highest for the cohort with a BMI of 35 to 39 kg/m2 (71%), this was not statistically significant (morbidly obese cohort 60% EWL, super obese cohort 56% EWL; P⫽.113). DISCUSSION Total medication usage decreased from a mean of 6.2 to 3.8 (P⫽.002). Reduction of medication usage postoperatively correlated strongly with a preoperative diagnosis of diabetes. In addition, a negative relationship between percentage of excess weight loss and a previous diagnosis of diabetes was identified. The presence of a previous diagnosis of diabetes was the strongest single negative predictor of %EWL. This finding is associated with a predicted 17.1-point reduction in the percentage of EWL for patients with a previous diagnosis of diabetes relative to patients without diabetes (95% CI⫽2.16 –32. 03%; P⫽.026). Of the diabetic patients undergoing LSG, 56% had complete remission of diabetes (100% of patients had improvement or remission) (Table 3). The super obese cohort had the largest percentage of diabetes remission (71.4%). HTN resolved in 51.6% of the patients, whereas 46.4% of the patients with obstructive sleep apnea had complete resolution. Of the 24 patients with a diagnosis of Table 2. Percent Excess Weight Loss for Each Weight Classification %EWL Total BMI 35–39 kg/m2 BMI 40–49 kg/m2 BMI 50⫹ kg/m2 P Value 61% 71% 60% 56% .113 %EWL ⫽ percent excess weight loss. Table 3. Postoperative Remission of Comorbidities Remission (%) Improvement or Remission (%) DM 56.0 100 HTN 51.6 87 OSA 46.4 100 DM ⫽ diabetes mellitus; HTN ⫽ hypertension; OSA ⫽ obstructive sleep apnea. LSG is increasing in popularity, and, despite limited longterm data, it is accepted as a safe and effective bariatric operation and is especially attractive for the higher-risk patient.21 The higher-risk patient is characterized by male gender, increased age, and the presence of comorbidities such as diabetes and HTN.22,23 We found the use of LSG as a stand-alone bariatric procedure to be highly effective in the US veteran population. This is especially significant because the prevalence of obesity among American veterans is especially high. Three in 4 male veterans are overweight or obese, and the prevalence of overweight and obesity among veterans who use VA outpatient facilities is higher than in the general population.32 This veteran population is often a challenging bariatric surgical group, representing a mostly male older cohort, with multiple comorbidities, compared with the general bariatric population.13 Older age and male gender— both characteristics of the veteran bariatric surgical patient—are associated with adverse outcomes after bariatric surgery.23 In addition, the bariatric patients at the Palo Alto VA center described in this study were referred to our surgical center from great distances, averaging more than 300 miles, posing specific challenges for postoperative follow-up and treatment of late complications. Nonetheless, with a mean follow-up of 22 months in this study, we have shown %EWL that compares favorably with multiple published results in the nonveteran population undergoing LSG.16,17,24 Residing a large distance from the medical and surgical center is typical of VA patients but less common in the general population. For this reason, it is valuable to identify a durable and effective operation that has low early and late morbidity for veteran patients who may not be able to easily access their bariatric surgical team because of geographic limitations. This makes the LSF as a stand-alone operation especially attractive in this patient population. Unlike the patients described in this study, large series of LSG as a stand-alone procedure in the literature typically describe a population that is mostly female and younger with a lower BMI than the average veteran bariatric population.33 To our knowledge, this is the first study to describe LSG as a stand-alone operation in veterans. Our reported mean EWL compares favorably with published results but is slightly less than the %EWL documented in the general population. This may be a result of the demographic characteristics of the veteran patients, as described previously. JSLS (2013)17:63– 67 65 Sleeve Gastrectomy as a Stand-Alone Bariatric Operation for Severe, Morbid, and Super Obesity, Eisenberg D et al. We found that the preoperative obesity classification, patient gender, patient age, and presence of other preoperative comorbidities, other than diabetes, had no statistically significant effect on %EWL. The efficacy of LSG as a stand-alone weight loss operation in the veteran population was seen in all BMI ranges. In comparing the results in patients with severe obesity, morbid obesity, and super obesity, we found that LSG as a stand-alone procedure was most effective in the cohort with a BMI of 35 to 39 kg/m2, but this was not statistically significant. However, we did note that more patients in this group were able to achieve a normal BMI after LSG than patients in other groups. This suggests that in addition to the morbidly and super obese groups, the LSG is a very effective standalone operation for the severely obese population. All but one of the patients with BMI ⬎50 kg/m2 were satisfied with total weight loss after a minimum of 1 year. Despite a high satisfaction rate overall, it appears that it may be difficult for the super obese population to reach a BMI ⬍30 kg/m2 with LSG alone. Chopra et al25 found similar results 24 months after surgery, with a greater %EWL in the cohort of patients with a BMI ⬍50 kg/m2 compared with those with BMI ⬎50 kg/m2, although their results were not statistically significant. In this study, we also showed that there is no significant difference between the morbidly obese and the severely obese. We found that LSG alone also resulted in significant improvement in obesity-related comorbid conditions, in a manner similar to that seen with the general population undergoing LSG, and compares favorably with patients undergoing LRYGB.26 Nearly all patients with diabetes, HTN, or obstructive sleep apnea saw improvement in their comorbidities, and a large proportion had complete remission. This was seen in all weight categories. Casella et al27 demonstrated that duration of diabetes for ⬎10 years before surgery predicts lower rates of complete remission postoperatively. It is possible that we saw this effect in our study population because only 56% had complete remission of type 2 diabetes. Interestingly, 50% of the diabetic patients in this study were taking injectable insulin preoperatively, but in this relatively small cohort it did not correlate with lack of remission postoperatively. There is disagreement in the literature with respect to the effect of LSG on GERD symptoms.25,28,29 In the present study, we found that a minority of patients had exacerbation of GERD symptoms, whereas most of the patients had no change in GERD symptoms. Overall improvement in comorbidities translated to a significant decrease in total medication requirements after 66 surgery in all weight groups. LSG has previously been shown to decrease diabetes and HTN medication requirements after surgery.30 In this study, we demonstrated a decrease in all medications, although we excluded vitamin supplements. There were no mortalities, and there was a favorable complication profile. We had a single leak in the postoperative period, also comparing favorably with published results.24 Interestingly, our leak presented several months after surgery and was identified in the distal portion of the gastric sleeve. This is in contrast to most reported leaks that are identified in the proximal stomach and often take a long time to heal.31 Because of the location in this specific case, we treated the leak by partial gastrectomy and drainage. Other complications appeared in the immediate postoperative period and were easily treated with nonoperative measures. CONCLUSION LSG is safe and effective as a stand-alone bariatric treatment in members of the high-risk veteran population group who are severely, morbidly, and super obese. In addition, LSG induces remission or improvement in comorbidities of nearly all patients and in all obesity categories, translating to a decrease in medication use. References: 1. Mokdad AH, Ford ES, Bowman BA, et al. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. J Am Med Assoc. 2003;289:76 –79. 2. Flegal KM, Carroll MD, et al. Prevalence and trends in obesity among US adults, 1999 –2008. J Am Med Assoc. 2010;303: 235–241. 3. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. J Am Med Assoc. 2004; 292:1724 –1737. 4. Sugerman HJ, Wolfe LG, Sica DA, et al. Diabetes and hypertension in severe obesity and effects of gastric bypass-induced weight loss. Ann Surg. 2003;237:751–758. 5. Pories WJ, Swanson MS, MacDonald KG, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995;222: 339 –350. 6. MacDonald KG Jr, Long SD, Swanson MS, et al. The gastric bypass operation reduces the progression and mortality of noninsulin-dependent diabetes mellitus. J Gastrointest Surg. 1997;1: 213–220. JSLS (2013)17:63– 67 7. Ahmed AR, Rickards G, Coniglio D, et al. Laparoscopic Roux-en-Y gastric bypass and its early effect on blood pressure. Obes Surg. 2009;19:845– 849. 8. Carson JL, Ruddy ME, Duff AE, et al. The effect of gastric bypass surgery on hypertension in morbidly obese patients. Arch Intern Med. 1994;154:193–200. 9. Hinojosa MW, Varela JE, Smith BR, et al. Resolution of systemic hypertension after laparoscopic gastric bypass. J Gastrointest Surg. 2009;13:793–797. 10. Sjöström CD, Lissner L, Wedel H, et al. Reduction in incidence of diabetes, hypertension, and lipid disturbances after intentional weight loss induced by bariatric surgery: the SOS intervention study. Obes Res. 1999;7:477– 484. 11. Safadi BY, Kieran JA, Hall RG, et al. Introducing laparoscopic Roux-en-Y gastric bypass at a Veterans Affairs medical facility. Am J Surg. 2004;188:606 – 610. 12. Maciejewski ML, Livingston EH, Smith VA, et al. Survival among high-risk patients after bariatric surgery. J Am Med Assoc. 2011;305:2419 –2426. 13. Alami RS, Morton JM, Sanchez BR, et al. Laparoscopic Rouxen-Y gastric bypass at a Veterans Affairs and high-volume academic facilities: a comparison of institutional outcomes. Am J Surg. 2005;190:821– 825. 14. Gumbs AA, Gagner M, Dakin G, et al. Sleeve gastrectomy for morbid obesity. Obes Surg. 2007;17:962–969. 15. Rubin M, Yehoshua RT, Stein M, et al. Laparoscopic sleeve gastrectomy with minimal morbidity. Early results in 120 morbidly obese patients. Obes Surg. 2008;18:1567–1570. 16. Bohdjalian A, Langer FB, Shakeri-Leidenmuhler S, et al. Sleeve gastrectomy as sole and definitive bariatric procedure: 5-year results for weight loss and ghrelin. Obes Surg. 2010;20: 535–540. 21. Updated position statement on sleeve gastrectomy as a bariatric procedure. Surg Obes Relat Dis. 2010;6:1–5. 22. Livingston EH, Ko CY. Assessing the relative contributions of individual risk factors on surgical outcome for gastric bypass surgery; a baseline probability analysis. J Surg Res. 2002;105:48 –52. 23. Livingston EH, Huerta S, Arthur D, et al. Male gender is a predictor of morbidity and age a predictor of mortality for patients undergoing gastric bypass surgery. Ann Surg. 2002;125: 576 –582. 24. Deitel M, Gagner M, Erickson AL, et al. Third international summit: current status of sleeve gastrectomy. Surg Obes Relat Dis. 2011;7:749 –759. 25. Chopra A, Chao E, Etkin Y, et al. Laparoscopic sleeve gastrectomy for obesity: can it be considered a definitive procedure? Surg Endosc. 2011 [Epub ahead of print]. 26. Todkar JS, Shah SS, Shah PS, et al. Long-term effects of laparoscopic sleeve gastrectomy in morbidly obese subjects with type 2 diabetes mellitus. Surg Obes Relat Dis. 2010;6:142–145. 27. Casella G, Abbatini F, Cali B, et al. Ten-year duration of type 2 diabetes as prognostic factor for remission after sleeve gastrectomy. Surg Obes Relat Dis. 2011;7:697–702. 28. Howard DD, Caban AM, Cendan JC, et al. Gastroesophageal reflux after sleeve gastrectomy in morbidly obese patients. Surg Obes Relat Dis. 2011;7:709 –713. 29. Carter PR, LeBlanc KA, Hausmann MG, et al. Association between gastroesophageal reflux disease and laparoscopic sleeve gastrectomy. Surg Obes Relat Dis. 2011;7:569 –572. 30. Slater BJ, Bellatorre N, Eisenberg D. Early postoperative outcomes and medication cost savings after laparoscopic sleeve gastrectomy in morbidly obese patients with type 2 diabetes. J Obes. 2011;2011:350523. 17. Shi X, Karmali S, Sharma A, et al. A review of laparoscopic sleeve gastrectomy for morbid obesity. Obes Surg. 2010;20:1171–1177. 31. Casella G, Soricelli E, Rizzello M, et al. Nonsurgical treatment of staple line leaks after laparoscopic sleeve gastrectomy. Obes Surg. 2009;19:821– 826. 18. Aggarwal S, Kini SU, Herron DM. Laparoscopic sleeve gastrectomy for morbid obesity: a review. Surg Obes Relat Dis. 2007;3:189 –194. 32. Das SR, Kinsinger LS, Yancy Jr WS, et al. Obesity prevalence among veterans at veterans affairs medical facilities. Am J Prev Med. 2005;28:291–294. 19. Lalor PF, Tucker ON, Szomstein S, et al. Complications after laparoscopic sleeve gastrectomy. Surg Obes Relat Dis. 2008;4:33–38. 33. Boza C, Salinas J, Salgado N, et al. Laparoscopic sleeve gastrectomy as a stand-alone procedure for morbid obesity: report of 1,000 cases and 3-year follow-up. Obes Surg. 2012;8: 133–137. 20. Buchwald H, Estok R, Fahrbach K, et al. Trends in mortality in bariatric surgery: a systematic review and meta-analysis. Surgery. 2007;142:621– 632. JSLS (2013)17:63– 67 67 SCIENTIFIC PAPER Pancreaticojejunostomy Sleeve Reconstruction After Pancreaticoduodenectomy in Laparoscopic and Open Surgery Zhao Lei, MS, Wang Zhifei, MD, Xu Jun, MD, Liu Chang, MD, Xu Lishan, MD, Guan Yinghui, MD, Zhai Bo, MS ABSTRACT Introduction: Laparoscopic procedures for pancreatic surgery have been significantly improved recently; however, only a limited number of successful laparoscopic or laparoscopy-assisted pancreaticoduodenectomy (PD) have been reported. The limitations could be attributed to the complexity of the reconstruction procedures under laparoscopic observation and the high incidence of complications. Postoperative pancreatic fistula (POPF) has been regarded traditionally as the most frequent major complication and is a potentially serious and life-threatening event. It remains the single most important cause of morbidity after PD and contributes significantly to prolonged mortality. Several modified methods of pancreas anastomosis were introduced to prevent POPF. However, few methods with a satisfactory leakage rate have yet to be seen. Collating principle of theoretical mechanics, we introduce a new method of reconstruction by performing an asymmetric sleeving-joint pancreaticojejunostomy (SJPJ). The aim of this study is to summarize the results of a new technique that is designed to decrease the POPF. Methods: From January 2004 to December 2010, SJPJ was performed on 86 patients undergoing PD by 1 surgeon: a laparoscopic reconstruction was completed in 9 cases, a hand-assisted laparoscopic reconstruction in 2 cases, and an open SJPJ reconstruction in 75 cases. Discussion: We used SJPJ, an asymmetric pancreaticojejunostomy (PJ). The time of operation ranged from 300 minutes to 640 minutes. Postoperatively there were no major morbidities and no deaths. Although POPF was Department of General Surgery, Fourth Affiliated Hospital of Harbin Medical University, Harbin City, Heilongjiang Province, China (all authors). Drs. Lei and Zhifei contributed equally to this work and should be considered co–first authors. This work was supported by a grant from the Ministry of Education of China [Grant No. W2012RQ06]. Address correspondence to: Jun Xu, Department of General Surgery, Fourth Affiliated Hospital of Harbin Medical University, No. 37, Yiyuan Street, NanGang District, Harbin City, Heilongjiang Prov, 150001, China. Telephone: 008613796001434. E-mail: [email protected] DOI: 10.4293/10860812X13517013318238 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 68 observed in the laparoscopic SJPJ group with pancreatic adenocarcinoma, 3 patients developed POPF in the open SJPJ group with ampullary adenocarcinoma (n⫽1) and pancreatic adenocarcinoma (n⫽2). The POPF rate was 9.30% in the open SJPJ group and 9.10% in the laparoscopic SJPJ group. The SJPJ procedure facilitates PJ, both laparoscopically and in open surgery. It is safe, effective, and feasible in experience hands. Key Words: Laparoscopic, Pancreaticojejunostomy, Pancreaticoduodenectomy, Asymmetry. INTRODUCTION Pancreaticoduodenectomy (PD) is one of the most commonly performed procedures for the management of periampullary adenocarcinoma and cancer of the head of the pancreas. Recently, laparoscopic surgery has evolved to such an extent that even laparoscopic PD has been performed.1,2 Postoperative pancreatic fistula (POPF) has been regarded traditionally as the most frequent major complication and is a potentially serious life-threatening event. It remains the single most important cause of morbidity after PD and also contributes significantly to prolonged mortality.3 Previous publications reported that the incidence of pancreatic leakage ranged between 9.9% and 28.5%, and different definitions of PF were applied with high statistical differences between them.4 To prevent POPF, many methods have been attempted; pancreaticojejunostomy (PJ) is the most common technique used for pancreatic reconstruction5 and also the most concerning. Many modified methods of PJ were introduced in the literature such as Blumgart’s anastomosis for PJ,6 PJ with application of patch,7 and PengI.II-type binding PJ.8 However, few methods5 with a satisfactory leakage rate have yet to be seen. The best technique in pancreatic anastomosis, especially under laparoscope, is still debated.5,8 We introduce a new method of pancreatic reconstruction by performing a sleeving-joint pancreaticojejunostomy (SJPJ) during PD, which was applied both in laparoscopic and open surgery. JSLS (2013)17:68 –73 MATERIALS AND METHODS Materials From January 2004 to December 2010, data of 158 cases undergoing PD (11 cases of laparoscopic PD, 147 cases of open PD) by the same surgeon were retrospectively studied and were divided into 3 groups according to the different reconstruction patterns for PJ: laparoscopic SJPJ in 11 cases (group A), open SJPJ in 75 cases (group B), and conventional end-to-end PJ in 72 cases (group C). The primary indications for surgery were severe to moderate unremitting abdominal pain, unrelieved or partially relieved with analgesics; severe unremitting icterus; and significant weight loss. In group A, a totally laparoscopic reconstruction was completed in 9 cases and a handassisted laparoscopic reconstruction in 2 cases. A stent was placed in the pancreatic duct in some of the patients (Table 1). All patients underwent routine hematological and biochemical investigations and abdominal radiograph, ultrasonography computed tomography scan, and magnetic resonance cholangiopancreatography. All patients were predicted to be fully resectable. PD was performed by the surgeon with experience of ⬎80 conventional open PD and ⬎100 complicated hepatobiliary and pancreatic surgery operations. Boulder, CO), respectively. An ancillary 5-mm trocar was inserted 1.0 cm under the intersection of the right anterior axillary line (AAL) and CM for laparoscopic grasping forceps. All of the positions of trocars were inserted as illustrated in Figure 1. For open PD, the patients were placed in the supine position. Resecting Specimen After a thorough exploration of the abdomen viscera and systematic examination of any suspicious serosal lesion, especially in the liver and stomach, the gastrocolic ligament was dissected and divided. The right half of the great omentum was opened; a Kocher incision was made and extended to 15.0 cm distal to the Treitz ligament for completely mobilizing the duodenum. The superior mesenteric vein (SMV) was identified and dissected following the middle colic vein below the pancreatic inferior margin toward the junction of the SMV and portal vein. The dorsal aspect of the pancreatic neck was then directly dissected from the SMV and portal vein. The hepatoduodenal ligament was dissected, and the eighth and twelfth group lymph nodes together with the surrounding soft tissue were removed for a complete skeletonization. Distal gastrectomy was completed using Endo GIA (Covidien) after dividing the right gastric gastroepiploic arteries and gastroduodenal artery with LigaSure. The common hepatic General Considerations The operation was performed under general anesthesia with preoperative and intraoperative antibiotic cover. For laparoscopic PD, the patient was placed in a supine position with both lower limbs abducted. The first 10-mm trocar was inserted 1.0 cm under the umbilicus to allow the laparoscope (Olympus, Tokyo, Japan), and a pneumoperitoneum was established with the pressure at 13 mm Hg. A 5-mm trocar and a 15-mm trocar were inserted 1.0 cm under the junction of the left and right medio clavicular line (MCL) and costal margin (CM) for laparoscopic harmonic scalpel (UHS) and LigaSure (Covidien, Table 1. Data of Patients With and Without Stent in the Pancreatic Duct Laparoscopic SJPJ (n⫽11) Open SJPJ (n⫽75) Open PJ (n⫽72) With stent (n) 10 47 45 POPF (n) (%) 1 (10.00) 0 (0) 5 (11.11) Without stent (n) 1 28 27 POPF (n) (%) 0 (0) 3 (10.71) 10 (37.04) Figure 1. Trocar placement and site of surgical incision for the specimen delivery. JSLS (2013)17:68 –73 69 Pancreaticojejunostomy Sleeve Reconstruction After Pancreaticoduodenectomy in Laparoscopic and Open Surgery, Lei Z et al. duct was transected after cholecystectomy. The neck of the pancreas was carefully divided using a laparoscopic harmonic scalpel. The uncinate process of the pancreas was separated and dissected along the SMV. The upper portion of the jejunum was transected with Endo GIA. The resection margins were tumor-free in all patients and confirmed by frozen section and histopathology. Reconstruction A modified reconstruction procedure was performed with Child’s reconstruction. Laparoscopic SJPJ was performed first. The remnant of the pancreas was dissected for a distance of 2.0 cm from the cut edge. First, the anastomosis was constructed in an end-to-end fashion. The posterior wall consisted of interrupted 2 sutures with 5-0 absorbable monofilament incorporating the pancreatic capsule 2.0 cm distant to the pancreatic stump and seromuscular bites of the jejunum. Tension should be maintained on the jejunum specifically between sutures, for a tight connection between the anastomosis part (Figure 2A). Second, the anterior jejunum wall was drawn to wrap over the pancreatic stump with a 3.0-cm distance to the pancreatic stump; then the seromuscular layer of the jejunum was sutured to the pancreatic capsule. Thus, an asymmetry of 1.0 cm between 2 sides at the PJ site was made to form an additional appropriate tension. One or 2 sutures were added to keep a 0.3- to 0.5-cm distance between sutures (Figure 2B, C), depending on the size of the pancreatic stump. Finally, a binding technique was routinely added: a 4-0 nonabsorbable ligature was circled around the jejunum loop with the pancreatic stump inside, 1.0 cm distant to the anastomosis, after 2 string sutures were placed, connecting it to the jejunum serosa to prevent sliding. Then the circled ligature was tied to form an appropriate tension until the wall where the jejunum was bound appeared a little wrinkled (Figure 2D). Cholangiojejunostomy (CHJ) and gastrojejunostomy (GJ) were done on the same jejunal loop distal to the PJ. CHJ was completed 10 cm distal to the stoma of pancreaticojejunostomosis with a 1-layer suture with 3.0 absorbable ligatures. GJ was completed 50.0 cm away from the CHJ site with staples. Two drainage tubes were Figure 2. The main steps of laparoscopic sleeving-joint pancreaticojejunostomy (SJPJ); (B) top view of laparoscopic SJPJ; (C) side view of laparoscopic SJPJ. Figure 3. (A) Sleeving-joint pancreaticojejunostomy (SJPJ) in total laparoscopic reconstruction; (B) SJPJ in hand-assisted laparoscopic reconstruction. 70 JSLS (2013)17:68 –73 placed near the anastomosis site of PJ and CHJ, respectively. RESULTS The volume and the amylase level of the drain fluid were measured daily postoperatively. The draining tube was removed when the drain output was ⬍10 mL/day. POPF was definite according to the definition of the International Study Group of Pancreatic Fistula in 20054: Output via an operatively placed drain (or a subsequently placed percutaneous drain) of any measurable volume of drain fluid on or after postoperative day 3, with an amylase content ⬎3 times the upper normal serum value. The demographic data and the pathological findings of the 3 groups are shown in Table 2. The final pathology of the resected specimens was reviewed by 2 independent pathologists. There were no significant differences in the data between the 3 groups. The intraoperative data and postoperative courses and complications of the 3 groups of patients are presented in Table 3. The mean operative time of laparoscopic SJPJ was 473.8 minutes (range: 300 – 640), which was significantly longer than that of both open SJPJ and open PJ (P⬍.05). For all of the patients in the 3 groups, 35 cases were found to have complications: the total complication rate was 22.15% (35/158). Among them, POPF was observed in 19 cases, with the rate of 12.03% (19/158), bile leakage was found in 3 cases, delayed gastic emptying occurred in 4 cases, and lung infection occurred in 2 cases. Among the cases with the complication of POPF, 4 were found in the laparoscopic and open SJPJ groups, with a rate of 4.65% (4/86), whereas 15 were found in the open PJ group, with a rate of 20.83% (15/72). In groups B and C, the incidence rate of pancreatic leakage was significantly higher in the cases without the placement of stent versus with stent placement (P⬍.05). For those with the stent placement, POPF rate in the laparoscopic and open SJPJ groups was both lower than that in the open PJ group (P⬍.05), whereas there was no significant difference between the laparoscopic and open SJPJ groups. For those without stent placement, the POPF rate was the lowest in the open SJPJ group (P⬍.05), whereas in the laparoscopic SJPJ group, the POPF rate was not taken into account because there was only 1 case. All of the cases with POPF were treated and cured with reliable irrigation and drainage. The mean duration of the postoperative hospital stay for laparoscopic SJPJ was 18.14 days, significantly shorter compared with 22.29 days for open SJPJ and 25.11 days for open PJ. The difference between the 2 groups was significant (P⬍.05). Table 2. Demographic Data and Pathological Findingsa Laparoscopic SJPJ (n⫽11) Open SJPJb (n⫽75) Open PJb (n⫽72) 58.55⫾13.31 54.81⫾10.63 54.68⫾9.96 25.66⫾2.04 26.03⫾1.80 26.92⫾3.23 Male 6 (54.55) 33 (44.00) 35 (48.61) Female 5 (45.45) 42 (56.00) 37 (51.39) 5 (45.45) 25 (33.33) 22 (30.56) Age (y) c Body mass index Gender [n (%)] Final pathology [n (%)] Pancreatic adenocarcinoma Duodenal adenocarcinoma 3 (27.27) 23 (30.67) 16 (22.22) Ampullary adenocarcinoma 1 (9.10) 18 (24.00) 17 (23.61) Chronic pancreatitis and pancreatic lithiasis 1 (9.10) — — Duodenal ulcer attack on the pancreatic papillae 1 (9.10) 6 (8.00) 2 (2.78) Distal bile duct adenocarcinoma — 3 (4.00) 6 (8.33) Pancreatic pseudocyst — — 9 (12.50) Data are presented as mean ⫾ SD. SJPJ⫽sleeving-joint pancreaticojejunostomy; PJ⫽pancreaticojejunostomy. c Calculated as weight in kilograms divided by height in meters squared. a b JSLS (2013)17:68 –73 71 Pancreaticojejunostomy Sleeve Reconstruction After Pancreaticoduodenectomy in Laparoscopic and Open Surgery, Lei Z et al. Table 3. Intraoperative and Postoperative Course and Complicationsa Laparoscopic SJPJb (n⫽11) Open SJPJb (n⫽75) Open PJb (n⫽72) Blood loss (mL) 1106⫾52.67 1103⫾56.14 1143⫾285.61 Operative time (min) 473.75⫾88.27 250.88⫾46.75 288.56⫾53.15 Pancreatic anastomotic leakage 1 (9.10) 3 (4.00) 15 (20.83) Biliary leakage 0 0 0 Delayed gastric emptying 1 (9.10) 2 (2.67) 1 (1.39) Lung infection 0 1 (1.33) 1 (1.39) Intraperitoneal abscess 0 0 0 Postoperative hospital stay (days) 18.14⫾5.99 22.29⫾3.10 25.11⫾4.20 In-hospital mortality [n (%)] 0 0 0 Abdominal complications [n (%)] Data are presented as mean ⫾ SD. SJPJ⫽sleeving-joint pancreaticojejunostomy; PJ⫽pancreaticojejunostomy. a b The follow-up ranged from 1 to 6 months. Icterus relief was complete in 158 patients. Pain relief was complete in 155 patients (98.10%). In 3 patients (1.90%) with initial pain relief, pain recurred after approximately 3 to 6 months but was milder in intensity, was occasional, and could be relieved with oral analgesics. Exocrine function of the pancreas was normal in all patients. No deaths were reported in all cases within 6 months. DISCUSSION POPF is one of the most common and serious complications of PD, and various attempts at PJ have been attempted to reduce its incidence.9 Our study showed a lower rate of POPF with the novel SJPJ pattern than with conventional PJ, taking the stent placement in the pancreatic duct as an independent factor. The incidence of POPF is generally considered to be related to several factors: placement of the stent inside the pancreatic duct, the texture of the pancreatic stump, and the pattern for anastomosis. PJ is a commonly used pattern. Still, various modified attempts have been tried,5–7,9 and some were reported to be effective and have been applied. However, the length for connecting the pancreas and jejunum is no doubt an important factor, and an appropriate longer length for the pancreatic stump plugged into the jejunum should be an effective modification. Yet, little attention is paid to its modification. This is understandable given the fact that a longer freeing of the dorsal side for pancreatic stump is somehow hard to achieve. However, the anterior side of the pancreatic 72 stump can be easily and safely for dissection to a longer distance, which will result in the longer connection for PJ anteriorly. In addition, the different length of jejunum connecting the pancreatic stump will produce an asymmetry for the anastomosis part; as a result, the anterior jejunum wall connecting the pancreatic stump will retract slightly to form a tension that makes the connection between the posterior wall of the jejunum and the pancreatic stump tighter. In addition, we also applied a binding around the jejunum loop with the pancreatic stump inside similar to binding PJ by Peng’s procedure without destroying the mucosa of the segment of jejunum contacting with the pancreatic stump. The advantages of this binding procedure have already been introduced.5 We merely combined the binding with our asymmetry anastomosis as SJPJ. The binding technique may also have contributed to the lower POPF rate of laparoscopic and open SJPJ, so there should have been a comparative study taking the binding technique as a single factor to rule out its influences. Before laparoscopic PD, we completed 58 cases of open PD from January 2004 to November 2005. During that time, 40 PJs and 18 SJPJs were performed. After the initial experience, we performed more SJPJs than PJs. Specifically, since December 2005, SJPJs have been the only procedure for laparoscopic PD at our center. In this retrospective study, we take the placement of the pancreatic stent as a single factor to rule out the influence of pancreatic duct drainage. In all of the cases in the 3 groups, we abandoned the placement of the pancreatic JSLS (2013)17:68 –73 duct stent only in the cases whose pancreatic ducts could not be found and also with nearly normal pancreatic texture. For those with a stent in open PD, the POPF rate of open SJPJ was lower than that in open PJ (P⬍.05), whereas for those without stent placement, the POPF rate of open SJPJ was lower than that in open PJ (P⬍.05) too, which shows that SJPJ reduces the POPF rate in open PD. CONCLUSION Laparoscopic PJ after PD was rarely reported because it is technically demanding and there is a high risk of PF complication. The rates of POPF in laparoscopy were still unsatisfactory.10–12 On the basis of the data in our study, laparoscopic SJPJ reduces the POPF rate. In addition, to our experience, it does not add much to the technique’s difficulties. Our study suggests that SJPJ is a safe and feasible new technique for PJ, but more cases are needed to verify this validity. References: 1. Tantia O, Jindal MK, Khanna S, Sen B. Laparoscopic lateral pancreaticojejunostomy: our experience of 17 cases. Surg Endosc. 2004;18:1054 –1057. 2. Zureikat AH, Breaux JA, Steel JL, Hughes SJ. Can laparoscopic pancreaticoduodenectomy be safely implemented? J Gastrointest Surg. 2011;15:1151–1157. 3. Poon RT, Lo SH, Fong D, Fan ST, Wong J. Prevention of pancreatic anastomotic leakage after pancreaticoduodenectomy. Am J Surg. 2002;183:42–52. 5. Peng SY, Wang JW, Lau WY, et al. Conventional versus binding pancreaticojejunostomy after pancreaticoduodenectomy: a prospective randomized trial. Ann Surg. 2007;245:692– 698. 6. Kleespies A, Rentsch M, Seeliger H, Albertsmeier M, Jauch KW, Bruns CJ. Blumgart anastomosis for pancreaticojejunostomy minimizes severe complications after pancreatic head resection. Br J Surg. 2009;96:741–750. 7. Chirletti P, Caronna R, Fanello G, et al. Pancreaticojejunostomy with application of fibrinogen/thrombin-coated collagen patch (TachoSil) in Roux-en-Y reconstruction after pancreaticoduodenectomy. J Gastrointest Surg. 2009;13:1396 –1398; author reply 1399 –1400. 8. Peng S, Mou Y, Cai X, Peng C. Binding pancreaticojejunostomy is a new technique to minimize leakage. Am J Surg. 2002;183:283–285. 9. Chen XP, Qiu FZ, Zhang ZW, Chen YF, Huang ZY, Zhang WG. A new simple and safe technique of end-to-end invaginated pancreaticojejunostomy with transpancreatic U-sutures— early postoperative outcomes in consecutive 88 cases. Langenbecks Arch Surg. 2009;394:739 –744. 10. Palanivelu C, Jani K, Senthilnathan P, Parthasarathi R, Rajapandian S, Madhankumar MV. Laparoscopic pancreaticoduodenectomy: technique and outcomes. J Am Coll Surg. 2007;205: 222–230. 11. Dulucq JL, Wintringer P, Mahajna A. Laparoscopic pancreaticoduodenectomy for benign and malignant diseases. Surg Endosc. 2006;20:1045–1050. 12. Kendrick ML, Cusati D. Total laparoscopic pancreaticoduodenectomy: feasibility and outcome in an early experience. Arch Surg. 2010;145:19 –23. 4. Bassi C, Dervenis C, Butturini G, et al. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005;138:8 –13. JSLS (2013)17:68 –73 73 SCIENTIFIC PAPER Laparoscopic Inguinal Exploration and Mesh Placement for Chronic Pelvic Pain Paul J. Yong, MD, PhD, Christina Williams, MD, Catherine Allaire, MD ABSTRACT Background and Objective: Chronic pelvic pain affects 15% of women. Our objective was to evaluate empiric laparoscopic inguinal exploration and mesh placement in this population. Methods: Retrospective cohort with follow-up questionnaire of women with lateralizing chronic pelvic pain (right or left), ipsilateral inguinal tenderness on pelvic examination, no clinical hernia on abdominal examination, and ipsilateral empiric laparoscopic inguinal exploration with mesh placement (2003–2009). Primary outcome was pain level at the last postoperative visit. Secondary outcomes were pain level and SF-36 scores from the follow-up questionnaire. Results: Forty-eight cases met the study criteria. Surgery was done empirically for all patients, with only 7 patients (15%) found to have an ipsilateral patent processus vaginalis (shallow peritoneal dimple or a deeper defect (occult hernia)). Of 43 cases informative for the primary outcome, there was pain improvement in 15 patients (35%); pain improvement then return of the pain in 18 patients (42%); and pain unchanged in 9 patients (21%) and worse in 1 patient (2%). Improvement in pain was associated with a positive Carnett’s test in the ipsilateral abdominal lower quadrant (P ⫽ .024). Thirteen patients returned the questionnaire (27%), and the pain was now described as improved in 9 patients (69%), unchanged in 4 patients (31%), and worse in none. Three SF-36 subscales showed improvement (physical functioning, social functioning, and pain). Department of Obstetrics and Gynecology, University of British Columbia, Vancouver, BC, Canada (all authors).; Division of Reproductive Endocrinology and Infertility, University of British Columbia, Vancouver, BC, Canada (Drs. Williams, Allaire).; BC Women’s Center for Reproductive Health, Vancouver, BC, Canada (all authors). In memory of Rachael Bagnall, medical student and research assistant on this project, who passed away before the study could be completed. Address correspondence to: Dr. Paul Yong, BC Women’s Center for Reproductive Health, D600 – 4500 Oak Street, Vancouver, BC, V6H 3N1, Canada. Telephone: (604) 875-2445, Fax: (604) 875-2569, E-mail: [email protected] DOI: 10.4293/108680812X13517013317310 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 74 Conclusion: In select women with chronic pelvic pain, empiric laparoscopic inguinal exploration and mesh placement results in moderate improvement in outcome. A positive Carnett’s test in the ipsilateral abdominal lower quadrant is a predictor of better outcome. Key Words: Chronic pelvic pain, Laparoscopy, Inguinal, Mesh. INTRODUCTION Chronic pelvic pain (at least 6 mo duration) affects up to 15% women, can have a devastating impact on quality-oflife, and can be of musculoskeletal, neuropathic, gastrointestinal, urologic, or gynecologic origin.1 One musculoskeletal cause of chronic pelvic pain is a hernia, which may be inguinal, obturator, femoral, sciatic, ventral, Spigelian, or incisional.2 If an inguinal (indirect) hernia is present, surgical repair of such hernias is effective for treatment of chronic pelvic pain.3 One method of repair is transabdominal preperitoneal (TAPP), involving laparoscopic exploration and placement of mesh at the inguinal canal.4 However, most women with chronic pelvic pain will not have a clinical hernia. Two abstracts have described empiric laparoscopic inguinal exploration and mesh placement in women with chronic pelvic pain but without a clinical hernia.5,6 It is important to determine whether this empiric treatment is indeed evidence-based, in particular whether it is safe and effective in women with chronic pelvic pain. In this retrospective study with follow-up questionnaire, we review our experience with empiric laparoscopic exploration and mesh placement in women with lateralizing chronic pelvic pain (right or left), no evidence of clinical hernia on abdominal examination, and ipsilateral inguinal tenderness on pelvic examination. MATERIALS AND METHODS The BC Women’s Center for Reproductive Health is an academic tertiary referral center affiliated with the University of British Columbia, which specializes in chronic pelvic pain and endometriosis and in reproductive endocri- JSLS (2013)17:74 – 81 nology and infertility. Patients referred for chronic pelvic pain or endometriosis, or both, are given an initial preoperative questionnaire that includes the 36-Item Short Form Health Survey (SF-36) for quality-of-life.7 In addition to an abdominal examination and ultrasound-guided pelvic examination, patients who exhibit lateralizing chronic pelvic pain (right- or left-sided) are examined for inguinal tenderness. On pelvic examination, a single digit is placed above the cervix, ventrally towards the pubic bone, then laterally towards the inguinal canal and the internal ring. During laparoscopy under low pressures, the examining digit can be seen approaching the insertion of the round ligament into the pelvic sidewall where it then dives caudally into the internal ring and inguinal canal. If inguinal tenderness on pelvic examination is demonstrated ipsilateral to the patient’s lateralizing chronic pelvic pain, then the patient is offered ipsilateral laparoscopic inguinal exploration and mesh placement in addition to other indicated procedures (e.g., excision of endometriosis). Surgical technique (Figure 1): After laparoscopic entry, use of 3 or 4 ports, and inspection for inguinal abnormalities, an incision is made ventral to where the round ligament enters the pelvic sidewall, with attention to avoid the inferior epigastric. The extraperitoneal space is explored until the round ligament is seen diving into the Figure 1. Laparoscopic inguinal exploration and mesh. (A) Example of a patent processus vaginalis [arrow] lateral to insertion of the round ligament into the pelvic sidewall. (B) Opening of extraperitoneal space near the round ligament insertion into the pelvic sidewall where it dives into the internal ring [arrow], with accompanying fat [asterisk], which is removed prior to mesh placement. (C) Mesh placement over the round ligament and internal ring. (D) Extraperitonealization of the mesh. JSLS (2013)17:74 – 81 75 Laparoscopic Inguinal Exploration and Mesh Placement for Chronic Pelvic Pain, Yong PJ et al. inguinal internal ring to the inguinal canal. Fat is removed from around the ligament at its entry into the internal ring, and then an approximately 3-cm x 4-cm piece of polypropylene mesh is placed over the round ligament and the internal ring. The peritoneum is then sutured to extraperitonealize the mesh, usually incorporating a piece of mesh in the suture to avoid mesh migration. We performed a retrospective review of empiric laparoscopic inguinal exploration and mesh placement done by 2 surgeons (CW and CA) at the BC Women’s Center for Reproductive Health. Inclusion criteria were lateralizing chronic pelvic pain, ipsilateral inguinal tenderness on pelvic examination, and ipsilateral empiric laparoscopic inguinal exploration and mesh placement (2003–2009). Exclusion criterion was the presence of a clinical hernia on abdominal examination. Medical records were reviewed (preoperative to postoperative), including the preoperative SF-36 and the level of pain at the last postoperative visit. For the follow-up questionnaire component of the study, patients were sent a package by mail that included a consent form for the study and a postoperative questionnaire containing another copy of the SF-36 and a question about the current level of pain. The study was approved by the research ethics boards of the University of British Columbia and BC Women’s and Children’s Hospitals (H09 – 00025). The primary (short-term) outcome was the level of pain at the last postoperative visit, which was coded as follows: 1) Improvement (complete or partial resolution); 2) Improvement then return of the pain; 3) No change; or 4) Worse. The primary outcome was tested for an association with the following predictor variables: age; BMI; nulliparity; side of the pain (right or left); duration of pain; pain characteristics (cyclical or noncyclical); previous laparoscopy; other chronic pelvic pain diagnosis (endometriosis, interstitial cystitis, irritable bowel syndrome, vulvodynia, or psychiatric comorbidity); ipsilateral abdominal lower quadrant tenderness; positive Carnett’s test in the ipsilateral abdominal lower quadrant indicative of abdominal wall pain (positive Carnett test⫽worsening or no change in tenderness with abdominal wall flexion/contraction); laparoscopic diagnosis of a patent processus vaginalis at the round ligament insertion into the sidewall, either a shallow peritoneal dimple or a larger defect (occult hernia) (Figure 1)8; laparoscopic findings after exploration of the ipsilateral inguinal internal ring; laparoscopic abnormality of the contralateral inguinal region; concurrent excision of endometriosis classified as symptomatic, defined as ipsilateral to the pain and tender on physical examination (i.e., tender in the ipsilateral cul-desac, uterosacral ligament, sidewall, or adnexa); concurrent excision 76 of endometriosis classified as incidental, defined as contralateral or nontender on physical examination; and other concurrent procedures. Endometriosis was confirmed on histology in all cases. In addition, we reviewed the intraoperative and postoperative complications, and the number of patients requiring reoperation for pelvic pain. Secondary (long-term) outcomes were from the mailed follow-up postoperative questionnaire containing the SF-36 and a question about the current level of pain. The questionnaire asked whether the pain was currently improved, unchanged, or worse. The SF-36 from the follow-up questionnaire (postoperative) was compared to the SF-36 from the initial questionnaire (preoperative). The SF-36 was scored as per the RAND SF-36 1.0 protocol, which derives 8 subscales based on 35 questions with 1 additional question about health change over the last year (http://www.rand. org/health/surveys_tools/mos/mos_core_36item.html) (Table 1). Each subscale and the health change question are scored from 0 –100, with a higher score indicating better quality-of-life.7 Statistical analyses were carried out using SPSS 19.0. For descriptive statistics, means are described as ⫾-1 standard deviation. For tests of association between the primary outcome and the predictor variables, the nonparametric 2-tailed Mann-Whitney and Spearman rank correlation tests were utilized because of nonnormality and nondirectional hypotheses; for the change in SF-36 scores, the parametric 1-tailed paired-sample t test was utilized. Linear regression modeling was performed using likelihood ratio model building. ␣⫽0.05. RESULTS Forty-eight patients met the inclusion criteria. No patients were excluded (i.e., none had a clinical hernia on abdominal examination). Characteristics of the 48 patients are summarized in Table 1. Of note, 38 patients (79%) had had a previous laparoscopy, and of these, almost all (n ⫽ 35) had had a previous laparoscopy for the same pain. The procedures performed at the previous laparoscopy are also summarized in Table 1. At the time of empiric laparoscopic inguinal exploration and mesh placement, there was a laparoscopic diagnosis of an ipsilateral patent processus vaginalis in 7 patients (15%) (Table 1; Figure 1); in an additional 5 patients (10%), there were laparoscopic findings after exploration of the ipsilateral inguinal internal ring (Table 1). Empiric JSLS (2013)17:74 – 81 Table 1. Predictor Variables Predictor Variable Table 1. (Continued) Predictor Variables Study Sample (n ⫽ 48)a Predictor Variable History Study Sample (n ⫽ 48)a Surgical Age 31.4 ⫾ 9.2 BMI 24.4 ⫾ 3.9 Nulliparity (%) 24 (51) Side of Pain (%) R⫽27 (56) After Exploration: Ipsilateral Findings at 5 (10) the Inguinal Internal Ringg (%) L⫽18 (38) Contralateral Inguinal Abnormalityh (%) 4 (8) Bilateral ⫽3 (6) Concurrent Excision of Symptomatic i Endometriosis (%) 4 (8) Concurrent Excision of Incidental j Endometriosis (%) 13 (27) Other Concurrent Laparoscopic k Procedure (%) 8 (17) Duration of Pain (%) Before Exploration: Ipsilateral Patent Processus Vaginalis at the Inguinal Internal Ringf (%) ⬍1 year⫽8 (18) 1–5 years⫽16 (36) ⬎5 years⫽21 (47) Pain Characteristicsb (%) Cyclical⫽24 (57) Previous Laparoscopyc (%) 38 (79) Non-cyclical⫽18 (43) At Least One Other Chronic Pelvic Pain 35 (73) Diagnosisd (%) Endometriosis 22 (46) Interstitial cystitis 3 (6) Irritable bowel syndrome 6 (13) Vulvodynia 3 (6) Psychiatric comorbidity 10 (21) Othere 3 (6) Initial SF-36 Score (from the Preoperative Questionnaire) Physical functioning 68.2 ⫾ 27.0 Role functioning (physical) 33.1 ⫾ 36.1 Role functioning (emotional) 59.5 ⫾ 42.6 Energy/Fatigue 38.6 ⫾ 23.1 Emotional well-being 64.5 ⫾ 18.6 Social functioning 59.7 ⫾ 25.0 Pain 42.7 ⫾ 22.5 General health 58.2 ⫾ 20.7 Health change 35.8 ⫾ 28.7 Examination Ipsilateral Abdominal Lower Quadrant Tenderness (%) 38 (79) Positive Carnett’s Test in the Ipsilateral Abdominal Lower Quadrant (%) 13 (27) 7 (15) a Denominator depends on the number of informative cases for each predictor variable. b Six patients had a previous hysterectomy. c Of the 38 patients with previous laparoscopy, 35 had the previous laparoscopy for the same pain involving the following procedures: treatment of endometriosis (n⫽16), diagnostic procedure only (n⫽11), ovarian cystectomy (n⫽2), treatment of endometriosis and ovarian cystectomy (n⫽1), empiric appendectomy (n⫽1), empiric appendectomy and paratubal cystectomy (n⫽1), salpingectomy (n⫽1), lysis of adhesions (n⫽1), and hysterectomy (n⫽1). d Some patients had more than one other diagnosis. e History of pelvic fractures, previous PID requiring hysterectomy, and inflammatory bowel disease. f Before exploration, there was a patent processus vaginalis, which appeared as a shallow dimple or larger defect (occult hernia) at the peritoneum near the round ligament insertion into the pelvic sidewall (where it later enters the ipsilateral inguinal internal ring)f (Figure 1). g After exploration, there was evidence of an “inguinal hernia,” a “small defect,” or “large amount of fat” at the ipsilateral inguinal ring. h Findings at the contralateral (nonpainful, nontender side) inguinal region: 3 patients with a patent processus vaginalish; and 1 patient with a direct inguinal hernia. i Excision of endometriosis that was ipsilateral and tender on physical exam (ie, tender in the ipsilateral cul-de-sac, uterosacral ligament, sidewall, or adnexa). Endometriosis was confirmed on histology. j Exicision of endometriosis that was either contralateral or nontender on physical examination. Endometriosis confirmed on histology. k Included an ipsilateral ovarian suspension, ipsilateral salpingooophorectomy, ipsilateral lysis of adhesions, and empiric appendectomy, as well as procedures that were done for other indications (contralateral ovarian cystectomy, contralateral salpingo-oophorectomy, contralateral salpingectomy of accessory fallopian tube, and tubal ligation). JSLS (2013)17:74 – 81 77 Laparoscopic Inguinal Exploration and Mesh Placement for Chronic Pelvic Pain, Yong PJ et al. ipsilateral inguinal exploration and mesh placement was done for all patients, regardless of whether these findings were present or not. In addition, 4 patients (8%) had a laparoscopic abnormality of the contralateral inguinal region (the side with no pain or tenderness; Table 1), which was not explored or repaired. Four patients (8%) had a concurrent excision of endometriosis classified as symptomatic, while 13 patients (27%) had concurrent excision of endometriosis classified as incidental (Table 1). Five patients did not return for a postoperative visit, and therefore 43 patients were informative for the primary outcome (pain level at the last postoperative visit). The average time to the last postoperative visit was 12.6 ⫾ 14.2 mo (range ⱕ 1 to 58) from the date of surgery. For the primary (short-term) outcome, there was pain improvement in 15 patients (35%) (complete resolution in 3 and partial resolution in 12 patients), pain improvement then return of the pain in 18 patients (42%), and pain unchanged in 9 patients (21%) and worse in 1 patient (2%). The average time to return of the pain was 8.7⫾-9.8 mo (range ⱕ 1 to 34) from the date of surgery, and triggers were trauma (n ⫽ 3), sports (n ⫽ 2), pregnancy (n ⫽ 2), bikini wax (n ⫽ 1), and unknown (n ⫽ 10). The predictor variables are listed in Table 1. Neither a concurrent surgical procedure (such as excision of endometriosis, whether classified as symptomatic or incidental), nor the presence of an ipsilateral patent processus vaginalis, was associated with the primary outcome (Table 1). The only predictor variable significantly associated with the primary outcome was a positive Carnett’s test in the ipsilateral abdominal lower quadrant, with a positive Carnett’s test associated with improvement of the pain at the last postoperative visit (Spearman’s rho ⫽ 0.34, P ⫽ .024). Of the 11 patients with a positive Carnett’s test informative for the primary outcome, improvement occurred in 8 patients (73%) (complete resolution in 2 and partial resolution in 6 patients), improvement then return of the pain in 2 patients, no change in 1 patient, and worsening in no patients. Of the 32 patients with a negative Carnett’s test, improvement occurred in 7 patients (22%) (complete resolution in 1 and partial resolution in 6 patients), improvement then return of the pain in 16 patients, no change in 8 patients, and worsening in 1 patient. None of the other predictor variables in Table 1 had an association with the primary outcome. In addition, there was possible evidence of selection bias, as patients who had a longer time to the last postoperative visit had a trend towards more pain for the primary outcome (Spearman’s rho⫽-.31, P ⫽ .045). However, when a linear 78 regression model was constructed with a positive Carnett’s test and time to last postoperative visit as predictor variables for the primary outcome, the time to last postoperative visit fell out of the model (P ⫽ .14) with only the positive Carnett’s test remaining significant (P ⫽ .024). There were no intraoperative complications, and the postoperative complications were mild and uncommon (10%): hospitalization for postoperative pain (n ⫽ 2), bladder infection (n ⫽ 1), endometritis (n ⫽ 1), and “slow recovery” (n ⫽ 1). Eight patients required reoperation for pain (17%), which included repeat laparoscopy for mesh removal (n ⫽ 3), open groin exploration by a general surgeon (n ⫽ 2), hysterectomy (n ⫽ 1), hysterectomy and ipsilateral salpingo-oophorectomy (n ⫽ 1), and unknown (n ⫽ 1). One patient requested mesh removal after a motor vehicle accident resulted in return of the pain, and no inguinal abnormality was noted during repeat laparoscopy. A second patient requested mesh removal after return of the pain secondary to trauma, and again no inguinal abnormality was noted. A third patient requested mesh removal after the pain returned (unknown cause), and the inguinal canal looked slightly inflamed and thickened with pathology showing mild chronic and foreign body inflammation. None of these patients had significant improvements in their pain after mesh removal (and one patient requested repeat inguinal exploration and mesh placement), although follow-up was limited. An additional 2 patients were referred to a general surgeon and underwent open groin exploration. One of these patients had experienced no improvement after laparoscopic inguinal exploration and mesh placement, while the other patient had experienced improvement then return of the pain. After open groin exploration, both patients had an initial improvement, then return of the same pain within 3 mo. For the secondary (long-term) outcomes, 13 patients (27%) returned the questionnaire. The time between the surgery and the date of the questionnaire was 73.2 ⫾ 30.6 mo (range ⫽ 23 to 102). There was no evidence of selection bias, as these 13 patients had a similar distribution for the primary outcome (improvement in 4, improvement then return of the pain in 5, no change in 3, and worse in 0) compared to the rest of the sample (P ⫽ .54), and similar initial (preoperative) SF-36 subscale scores compared to the rest of the sample (P ⫽ .39 to 0.98). In these 13 patients who returned the follow-up questionnaire, pain was now described as being improved in 9 patients (69%), unchanged in 4 patients (31%), and worse in 0 patients. Three SF-36 subscales improved from the initial questionnaire (preoperative) to the follow-up questionnaire (postoperative): physical functioning (P ⫽ .032), social func- JSLS (2013)17:74 – 81 tioning (P ⫽ .036), and pain (P ⫽ .035) (Table 2). The SF-36 question about health change also improved (P ⫽ .003) (Table 2). DISCUSSION In this retrospective study with follow-up questionnaire, we found that empiric laparoscopic inguinal exploration and mesh placement in women with lateralizing chronic pelvic pain (right or left), no clinical hernia on abdominal examination, and ipsilateral inguinal tenderness on pelvic examination, resulted in improvement in 35% and improvement with return of the pain in 42% at the time of the last postoperative visit. Of the 27% of patients who returned a questionnaire for long-term follow-up, 69% reported their pain was improved, and several SF-36 subscales showed improvement (physical functioning, social functioning, pain) in addition to an improvement in health change over the last year. Complications were uncommon and mild. Three patients with return of pain requested mesh removal, without significant improvement in symptoms. The primary outcome was not found to be associated with the presence or absence of an ipsilateral patent processus vaginalis. It should be emphasized that the surgery was done empirically in all patients, regardless of whether the ipsilateral inguinal region looked normal or whether there was an ipsilateral patent processus vaginalis. The incidence of patent processus vaginalis in this study (15%) is consistent with previous reports.8 In this study population, it is thought that the chronic pelvic pain and inguinal tenderness may arise from incarcerated fat in the inguinal canal.5 The goal of the surgery is to decompress the ilioinguinal nerve by removing the fat and placing a mesh at the internal ring. There have only been 2 reports of empiric laparoscopic inguinal exploration and mesh placement in women with chronic pelvic pain, some of whom with inguinal tenderness on pelvic examination. A review cited an abstract stating that 80% to 85% of women with chronic pelvic pain obtain “significant”: or complete resolution of their pain with laparoscopic inguinal exploration and mesh placement, although sample size was not provided.5 In another abstract, Janicki et al.6 reported on 21 women with chronic pelvic pain who underwent laparoscopic inguinal exploration and mesh placement, and found that 74% to 78% had “great” improvement or complete resolution of their pain at 6 mo to 12 mo. Hussain et al.9 also reported a high cure rate (70%) for the same surgery for chronic groin pain (n ⫽ 43), although their study sample was 93% male and the majority had a dilated external ring on examination. Our study had a more modest improvement rate, which may be because three-fourths of our study sample had a comorbid chronic pelvic pain diagnosis and half had pain lasting more than 5 y (Table 1), suggesting many women with chronic pain syndrome, central sensitization, and hyperalgesia. In addition, we found 42% of patients had an initial improvement then the pain returned after an average of 8.7 mo. These patients may have experienced a true recurrence due to failure of the procedure, or else have had a temporary placebo effect of the laparoscopy. In a randomized trial for laparoscopic excision of endometriosis, Abbott et al.10 found that about one-third of patients will have pain improvement at 6 mo from a placebo diagnostic laparoscopy. Table 2. Comparison of SF-36 Subscale Scores SF-36 Initial Questionnaire Follow-up Questionnaire Paired Sample (Preoperative) (Postoperative) t test Physical functioning 66.0 ⫾ 33.0 84.2 ⫾ 16.6 2.06 .032 Role functioning (physical) 31.3 ⫾ 37.1 56.3 ⫾ 44.1 1.59 .07 Role functioning (emotional) 69.4 ⫾ 43.7 58.3 ⫾ 42.9 0.60 .28 Energy/Fatigue 39.7 ⫾ 28.1 47.1 ⫾ 23.2 0.92 .19 Emotional well-being 67.3 ⫾ 17.5 72.8 ⫾ 16.4 0.76 .23 Social functioning 58.3 ⫾ 29.4 76.0 ⫾ 17.2 1.99 .036 Pain 43.5 ⫾ 22.4 59.6 ⫾ 19.9 2.02 .035 General health 59.2 ⫾ 24.4 70.0 ⫾ 20.0 1.50 .08 Health change 29.2 ⫾ 20.9 58.3 ⫾ 19.5 3.39 .003 JSLS (2013)17:74 – 81 P-Value 79 Laparoscopic Inguinal Exploration and Mesh Placement for Chronic Pelvic Pain, Yong PJ et al. Weaknesses of our study include a low response rate for the follow-up questionnaire (27%) and the lack of a separate control group. However, the patients who returned the follow-up questionnaire had a similar distribution for the primary outcome and the initial (preoperative) SF-36 subscale scores compared to the patients who did not return the questionnaire (see Results), suggesting a lack of selection bias. In addition, it is not possible to formally rule out a placebo effect of the surgery without a separate placebo control group, which would be difficult for this study (i.e., it would require a group assigned to diagnostic laparoscopy only). Finally, a proportion of patients had concurrent surgical procedures including excision of endometriosis (Table 1): 8% had a concurrent excision of endometriosis classified as symptomatic and 27% had concurrent excision of endometriosis classified as incidental. Although we believe there to be a rational basis for this subdivision of endometriosis (as defined in the Methods), we acknowledge that we cannot be certain that incidental endometriosis was truly incidental and unrelated to the patient’s pain. In addition, although concurrent excision of endometriosis, whether symptomatic or incidental, was not associated with the primary outcome (see Results), we acknowledge that concurrent excision of endometriosis should still be considered a confounder in this study. Strengths of the study include a larger sample size than previous studies, long follow-up for the group who returned the questionnaire (73 mo) compared to previous studies, and the incorporation of a quality-of-life measure (SF-36). In particular, the improvement in SF-36 scores for physical functioning, social functioning, pain, and the health change question were not only statistically significant but also clinically significant, being much larger than the minimally clinically important difference of 3 to 5 points.7 The only predictor variable associated with improvement of the pain at the last postoperative visit (i.e., the primary outcome) was the presence of a positive Carnett’s test in the ipsilateral abdominal lower quadrant. A positive Carnett’s test is a manifestation of abdominal wall pain, of which one cause is neuropathic such as iatrogenic or spontaneous ilioinguinal injury.11,12 The ilioinguinal nerve may provide sensation to an area above the inguinal ligament in the abdominal lower quadrant.12,13 Therefore, it is possible that our patients with a positive Carnett’s test in the ipsilateral abdominal lower quadrant may have some sort of ilioinguinal neuropathy contributing to their pain. Laparoscopic exploration and mesh placement could decompress the 80 ilioinguinal nerve in the inguinal canal, and therefore may improve this ilioinguinal pain. None of our patients had a diagnostic ilioinguinal nerve block, which has been used for diagnosis of entrapment prior to ilioinguinal neurolysis or nerve resection through an abdominal incision.12,14 In the future, a diagnostic ilioinguinal block may also be useful to identify which women may respond to empiric laparoscopic inguinal exploration and mesh. CONCLUSION Our study found moderate improvement in pain and quality-of-life after empiric laparoscopic inguinal exploration and mesh placement in women with lateralizing chronic pelvic pain, no clinical hernia on abdominal examination, and ipsilateral inguinal tenderness on pelvic examination. Patients with a positive Carnett’s test in the ipsilateral abdominal lower quadrant had the best response. Future research should include a prospective study, ideally with randomization. For example, patients could be randomized to laparoscopic inguinal exploration and mesh placement, or to medical management with neuromodulator medications and/or hormonal suppression. We consider such a prospective randomized study to be an important step before empiric laparoscopic exploration and mesh placement can be widely accepted as a treatment modality for women with chronic pelvic pain. In the meantime, empiric laparoscopic inguinal exploration and mesh placement appears to be, at a minimum, a safe treatment option that may result in moderate improvement in select women with lateralizing chronic pelvic pain, most notably those with ipsilateral inguinal tenderness on pelvic examination and a positive Carnett’s test in the ipsilateral abdominal lower quadrant. References: 1. Gomel V. Chronic pelvic pain: a challenge. J Minim Invasive Gynecol. 2007;14:521–526. 2. Carter JE. Surgical treatment for chronic pelvic pain. JSLS. 1998;2:129 –139. 3. Perry CP, Echeverri JD. Hernias as a cause of chronic pelvic pain in women. JSLS. 2006;10:212–215. 4. Reuben B, Neumayer L. Surgical management of inguinal hernia. Adv Surg. 2006;40:299 –317. 5. Metzger DA. Hernias in women: uncommon or unrecognized? Laparoscopy Today. 2004;3(1):8 –10. JSLS (2013)17:74 – 81 6. Janicki TI, Onders R, Bloom BJ, Green AE. Occult inguinal hernias in women with chronic pelvic pain. J Am Assoc Gynecol Laparosc. 2001;8(3Suppl):S28. 11. Suleiman S, Johnston DE. The abdominal wall: an overlooked source of pain. Am Fam Physician. 2001;64:431– 438. 7. Hays RD, Morales LS. The RAND-36 measure of healthrelated quality of life. Ann Med. 2001;33:350 –357. 12. Hahn L. Treatment of ilioinguinal nerve entrapment – a randomized controlled trial. Acta Obstet Gynecol Scand. 2011; 90(9):955–960. 8. van Wessem KJ, Simons MP, Plaisier PW, Lange JF. The etiology of indirect inguinal hernias: congenital and/or acquired? Hernia. 2003;7:76 –79. 13. Knockhaert DC, D’Heygere FG, Bobbaers HJ. Ilioinguinal nerve entrapment: a little-known cause of iliac fossa pain. Postgrad Med J. 1989;65:632– 635. 9. Hussain A, Mahmood H, Singhal T, et al. Laparoscopic surgery for chronic groin pain in the general population: a prospective study. J Laparoendosc Adv Surg Tech A. 2008;18(6):809 – 813. 14. Lee CH, Dellon AL. Surgical management of groin pain of neural origin. J Am Coll Surg. 2000;191:137–142. 10. Abbott J, Hawe J, Hunter D, Holmes M, Finn P, Garry R. Laparoscopic excision of endometriosis: a randomized, placebocontrolled trial. Fertil Steril. 2004;82(4):878 – 884. JSLS (2013)17:74 – 81 81 SCIENTIFIC PAPER Laparoscopic Appendectomy in Women Without Identifiable Pathology Undergoing Laparoscopy for Chronic Pelvic Pain Ann K. Lal, MD, Amy L. Weaver, MS, Matthew R. Hopkins, MD, Abimbola O. Famuyide, MBBS ABSTRACT INTRODUCTION Objectives: To assess the effectiveness of appendectomy in women undergoing laparoscopy for chronic pelvic pain without identifiable pathology. Chronic pelvic pain is generally defined as pelvic pain that persists for at least 6 months. It causes considerable functional impairment to patients and represents a clinical challenge for gynecologists. Although chronic pelvic pain is a common presentation in clinical gynecologic practice, its prevalence is difficult to determine because its definition is ambiguous. Of randomly selected women aged 18 to 50 years, 15% have been reported to visit a gynecologist because of pelvic pain,1,2 and approximately 10% of all visits to a gynecologist are related to pelvic pain.3 The pathophysiology underlying chronic pelvic pain is complex and may involve many organ systems, including the gynecologic, gastrointestinal, genitourinary, musculoskeletal, neurologic, and psychiatric systems. Laparoscopic surgery can reveal certain diagnoses, such as endometriosis, adhesions, uterine anomalies, or adnexal pathology. However, a cause for pelvic pain may not be found in as many as 61% of patients who undergo laparoscopy.1 Furthermore, the presence of visible pathology does not necessarily correlate with the severity of the patient’s pain or the histology.4 Methods: This retrospective cohort study included women aged 15 to 50 years who underwent laparoscopic surgery for chronic pelvic pain without identifiable pathology. The cohort was divided into 2 groups: women who underwent appendectomy and women who had not undergone appendectomy at laparoscopic surgery. Postoperative pain was assessed at 6-week follow-up and by subsequent mailed questionnaire. Results: Women who underwent appendectomy (n ⫽ 19) were significantly more likely to report improvement in pain at 6-week follow-up than women who did not undergo appendectomy (n ⫽ 76) (93% vs 16%; P ⬍ .001). Thirty-six patients (38%) responded to the questionnaire at a median of 4.2 years after surgery, when the median change (improvement) in reported pain was greater in the appendectomy group than in the nonappendectomy group. Conclusion: Appendectomy is effective therapy for patients with chronic pelvic pain of unknown etiology who are undergoing laparoscopy. Key Words: Appendectomy, Laparoscopy, Pelvic pain, Chronic. Department of Obstetrics and Gynecology, University of Illinois, Chicago, IL, USA (Dr. Lal). Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA (Ms. Weaver). Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, MN, USA (Drs. Hopkins and Famuyide). Presented at the 58th Annual Conference of the American College of Obstetricians and Gynecologists, May 15–19, 2010, San Francisco, CA. Address correspondence to: Abimbola O. Famuyide, MBBS, Department of Obstetrics and Gynecology, Mayo Clinic, 200 First St. SW, Rochester, MN 55905. E-mail: [email protected], [email protected]. DOI: 10.4293/108680812X13517013317031 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 82 Incidental appendectomy at the time of laparoscopic surgery has been reported as a good treatment option for women with chronic pelvic pain, with improvement in pain in as many as 97% of patients.5 This is not surprising because histologic examination has revealed pathologies in as many as 66% of grossly normal appendices.6 Although several studies have shown a beneficial effect of laparoscopic appendectomy in the absence of gross pelvic disease, these studies had major flaws in their design or methodology.5–7 These flaws include the use of singlearm, uncontrolled studies5–7; inconsistent definitions of chronic pelvic pain5–7; inclusion of children and men6; lack of adjustment for confounders such as concomitant surgery for endometriosis or other pelvic pathology5–7; and inconsistent use of a validated pain scale.5–7 Thus, questions remain about the internal and external validity of these studies. The objective of this study was to assess the effectiveness of laparoscopic appendectomy in women undergoing laparoscopy for chronic pelvic pain for which no identifiable pathology was encountered. JSLS (2013)17:82– 87 MATERIALS AND METHODS This study was approved by the Mayo Clinic Institutional Review Board. Study subjects were identified through retrospective medical record review for all women aged 15 to 50 years who underwent diagnostic laparoscopic surgery from January 1, 2001 to April 30, 2009 with a surgical indication of chronic pelvic pain or pelvic pain lasting 6 months or longer before surgery. Specific exclusion criteria were prior hysterectomy or bilateral oophorectomy, prior appendectomy, lack of documentation of the presence or absence of the appendix during surgery, grossly visible pathology (eg, endometriosis, adnexal masses, uterine leiomyomas), and abnormal histology. The remaining patients composed the laparoscopy cohort of patients who had no visible or histologic evidence of pelvic pathology. From this cohort, 2 groups were identified: women who underwent appendectomy and women who did not undergo appendectomy or any additional surgical procedures beyond visual inspection. In the first phase of this study, baseline demographic information, including age, parity, location of pain, and history of endometriosis, was abstracted from the preoperative visit notes in each patient’s medical record. The operative note and pathology report from the surgery were reviewed. The preoperative pain assessment was accessed through surgical consultation notes, as documented in the electronic medical record. The patient’s postoperative pain assessment was taken from the first postoperative visit at 6 weeks or at the last episode of care that also included a documented pelvic pain rating. letter detailing the study, a Health Insurance Portability and Accountability Act (HIPAA) form, and the questionnaire. Questionnaires were mailed with the expectation of a response within 6 weeks. Nonresponders were sent a second mailing after those 6 weeks, and nonresponders after the second mailing were then contacted by telephone. Comparisons between 2 groups (ie, appendectomy vs nonappendectomy, responders vs nonresponders) were evaluated using the 2-sample t test or Wilcoxon rank sum test for continuous or ordinal variables and the 2 test or Fisher exact test, as appropriate, for categorical variables. Comparisons of preoperative versus postoperative pain ratings within a group were evaluated using the Wilcoxon signed rank test. All statistical analyses were 2-sided, and P values ⬍ .05 were considered statistically significant. Statistical analyses were performed using SAS version 9.2 software (SAS Institute Inc, Cary, NC). Previous outcome studies have suggested that pelvic pain improved in 80% to 97% of patients who underwent appendectomy at the time of laparoscopy.5–7 Using a 2-tailed 2 test with 2 groups of patients—16 in the appendectomy group and 110 in the nonappendectomy group—to detect improved pelvic pain from 90% in the appendectomy group to 30% in the laparoscopy group, gives a power 90%. Logistic regression modeling was used to adjust for age, body mass index, and other known confounders. RESULTS Medical Record Review In the second phase of the study, a questionnaire was mailed to all patients in the cohort during January 2010. The questionnaire asked patients to recall their pain both preoperatively and postoperatively using a validated 11-point numeric scale and the Pain Disability Index.8,9 They were asked to rate their pain on a scale of 0 to 10, with 0 being “no pain” and 10 being “the worst pain imaginable.” The Pain Disability Index asked patients to rate their preoperative and postoperative disability in 5 categories—family/home responsibilities, recreation, social activity, occupation, and sexual behavior— on a scale of 0 (meaning no disability) to 10 (meaning the worst disability). In addition, the survey included questions regarding any additional procedures they had undergone for chronic pelvic pain or any new medications they had been prescribed for chronic pelvic pain since their initial laparoscopic surgery. We identified 200 patients who underwent laparoscopy for chronic pelvic pain during the study period. After extensive review of the medical records, we found that 95 patients met the inclusion criteria and included them in the analyses—76 in the nonappendectomy group and 19 in the appendectomy group. There was no statistical difference between the 2 groups in age, parity, and history of endometriosis. There was, however, a statistically significant difference in the preoperative location of the pain, with women in the appendectomy group more likely to report right-sided pain than women in the nonappendectomy group (58% [11/19] vs 22% [17/76]; P ⫽ .002). Review of surgical pathology revealed abnormal pathology in 2 (11%) of the 19 patients in the appendectomy group (ie, mild acute appendicitis and chronic appendicitis). The Survey Research Center at the Mayo Clinic administered the questionnaires. The initial contact included a The 6-week postoperative follow-up assessment was available for 14 of 19 patients (74%) in the appendectomy JSLS (2013)17:82– 87 83 Laparoscopic Appendectomy in Women Without Identifiable Pathology Undergoing Laparoscopy for Chronic Pelvic Pain, Lal AK et al. group and 51 of 76 patients (67%) in the nonappendectomy group. Improvement in pain was reported in 13 of 14 patients (93%) in the appendectomy group and 8 of 51 patients (16%) in the nonappendectomy group (P ⬍ .001) (Table 1). Women who underwent appendectomy were 70 times more likely to report improvement in pain compared with women who did not have appendectomy (odds ratio, 69.9; 95% confidence interval, 8.0 – 611.6; P ⬍ .001). median (and mean) change was greater in the appendectomy group than in the nonappendectomy group, the difference was not statistically significant. Finally, the survey data did not show any significant differences in the need for narcotic pain medications, surgical procedures for pain, and chiropractic or physical therapy services after the initial laparoscopic procedure (Table 4). Survey Results DISCUSSION In the second phase of the study, a questionnaire was mailed to all 95 patients. Of these, 36 (38%) completed both the questionnaire and the HIPAA form, and their responses were included in the data analysis. The median duration from the initial laparoscopic surgery to the questionnaire response was 4.2 years (range, 0.9 –9.3). An additional 10 patients who completed the questionnaire but did not return the HIPAA form were categorized as nonresponders and were excluded from the analysis. In the appendectomy group, 8 of 19 patients (42%) responded, and in the nonappendectomy group, 28 of 76 (37%) responded. There were no significant differences in baseline demographics between responders and nonresponders (data not shown). This retrospective cohort study was performed to assess the effectiveness of laparoscopic appendectomy on pelvic pain improvement in patients with no identifiable pelvic pathology. At a 6-week postoperative follow-up visit, 93% of patients who underwent appendectomy had an improvement in pain. In addition, in a survey completed after surgery, the patients in the appendectomy group reported a greater mean decrease in pain than did the nonappendectomy group. The pain improvements that we found were similar to those of other studies assessing the effectiveness of appendectomy, including a prospective study by AlSalilli and Vilos,5 who found a 97% improvement in pain after appendectomy. These numbers are consistent with the results of previous studies and show promise in the treatment of pelvic pain. For all 6 pain and disability measures, preoperative pain and disability data were not significantly different between the 2 groups. In the nonappendectomy group, the range in median values for the 6 measures was 4.5 to 8.0 before surgery and 1.5 to 3.0 after surgery, with a range in the median change of 1.0 to 4.0 (Table 2). In the appendectomy group, the range in median values was 6.0 to 8.0 before surgery and 0 to 2.0 after surgery, with a range in the median change of 4.0 to 5.0 (Table 3). Although the Previous studies have assessed appendectomy as a possible treatment for patients with chronic pelvic pain and have shown improvement in pain, with rates from 89% to 97%.5,6,10 Despite undergoing extensive medical and radiologic evaluation, 97% of patients with recurrent right lower quadrant pain reported immediate relief of pain and Table 1. Results from the First Phase of the Study: Pain Improvement at 6 Weeks after Laparoscopic Surgerya Characteristic Appendectomy Group (N ⫽ 19) Nonappendectomy Group (N ⫽ 76) P Value Comparing the 2 Groups with Follow-up Follow-up (n ⫽ 14) No Follow-up (n ⫽ 5) Follow-up (n ⫽ 51) No Follow-up (n ⫽ 25) Age (y), mean (SD) 26.3 (8.3) 23 (4.1) 29.6 (8.5) 27.3 (7.8) .21 Parity ⱖ1 3 (21) 2 (40) 24 (47) 9 (36) .08 History of endometriosis 5 (36) 0 13 (25) 4 (16) .45 Right-sided pain (documented locations) 10/12 (83) 1/4 (25) 11/29 (38) 6/13 (46) .008 Improvement in pain at 6-week follow-up assessment 13 (93) — 8 (16) — ⬍ .001 a Values are expressed as number (%) unless indicated otherwise. 84 JSLS (2013)17:82– 87 Table 2. Results from Survey Data: Pain Disability Index Scores Before and After Surgery for Patients in the Nonappendectomy Groupa Life Activity and Pain Categories Patients Without Concurrent Appendectomy (n ⫽ 28) Before Surgery Mean (SD) Median Family/home responsibilities Recreation Social activity Occupation Sexual behavior Pain After Surgery Mean (SD) Median Before–After Difference Mean (SD) Median 5.1 (2.8) 2.8 (2.9) 2.3 (2.8) 5 2 1.5 5.8 (3) 3 (2.9) 2.8 (3.4) 5.5 3 1.5 5.1 (3.2) 2.9 (3.2) 2.2 (2.7) 5.5 1.5 1 5 (3.5) 2.8 (3.3) 2.2 (3) 4.5 2 1 6.2 (2.9) 3.1 (3.2) 3.2 (3.4) 6.0 2.5 2.5 7.2 (2) 3.6 (3) 3.6 (3.2) 8 3 4 a Mean changes were 1.0 to 4.0 for all categories assessed. Table 3. Results from Survey Data: Pain Disability Index Scores Before and After Surgery for Patients in the Appendectomy Group Life Activity and Pain Categories Family/home responsibilities Recreation Social activity Occupation Sexual behavior Pain Patients with Concurrent Appendectomy (n⫽8) Before Surgery Mean (SD) Median After Surgery Mean (SD) Median Before–After Difference Mean (SD) Median 5.5 (3.7) 1.1 (1.4) 4.4 (3.3) 6.5 0.5 4.5 6 (4.1) 1.4 (1.8) 4.6 (3.5) 7 0.5 4.5 4.9 (3.5) 1 (1.4) 3.9 (2.8) 6 0 4.5 5.1 (3.6) 1 (1.1) 4.1 (3.5) 6 1 4 6.6 (3.1) 2.3 (2.6) 4.4 (3.3) 7 1.5 5 7.3 (2.5) 2.5 (2.2) 4.8 (3.2) 8 2 5 89% reported no recurrence, with a median follow-up of 19 months.6 In 1 study, with an appendectomy rate of 60% in patients with right-sided chronic pelvic pain, the pain was relieved in 97%.5 Studies have evaluated the operative complication rate and mortality rate and have found no increase in groups of patients in whom appendectomy was performed.11,12 In one study assessing laparoscopic appendectomy for sus- JSLS (2013)17:82– 87 85 Laparoscopic Appendectomy in Women Without Identifiable Pathology Undergoing Laparoscopy for Chronic Pelvic Pain, Lal AK et al. Table 4. Results from Survey Data: Secondary Outcomesa Outcome Nonappendectomy Group (n ⫽ 28) Appendectomy Group (n ⫽ 8) 25 (89) 6 (75) 3 (11) 2 (25) Additional surgeryc P Valueb .30 No Yes d Additional procedures .56 Missing 0 (0) 1 (13) No 23 (82) 7 (100) Yes 5 (18) 0 (0) ⬎ .99 Narcotic pain medications No 25 (89) 8 (100) Yes 3 (11) 0 (0) a Values are expressed as number (%) unless indicated otherwise. Fisher exact test. c Additional surgical procedures for pelvic pain. d Chiropractic or physical therapy services for pelvic pain. b pected acute appendicitis, the overall mortality rate was 0% and the general morbidity rate was 1%.13 In a study of 100 patients undergoing incidental appendectomy at the time of pelvic laparoscopic surgery, no increase in morbidity associated with the additional procedure was found.14 Similarly, our study found no complications in the negative laparoscopy cohort. Because total complications with laparoscopy are low, a larger sample size is needed to better assess whether appendectomy performed at the time of laparoscopic surgery contributes to an increase in complications of gynecologic laparoscopic surgery. In our study, 2 of 19 patients had abnormal appendix at the time of surgery (ie, mild acute appendicitis and chronic appendicitis). Similarly, Drozgyik et al15 found chronic appendicitis in 3.8% of their patients. Other studies have shown a higher percentage of abnormal histologic or gross appendices. One study of 356 patients undergoing laparoscopic surgery found that 30.2% of the appendix specimens had abnormal histology, including lymphoid hyperplasia, endometriosis, and chronic and acute appendicitis.11 Wie et al16 reported similar findings in 34.9% of histologic abnormalities. In a study of 231 women with endometriosis, 115 women had pathologic abnormalities in their appendix when it was removed at the time of their surgery for chronic pelvic pain.17 These abnormal histologic findings may contribute to chronic pelvic pain, specifically right lower quadrant pain. Other 86 studies have shown long-term improvement of pain in patients who underwent appendectomy, regardless of whether abnormal pathology was present at the time the appendix was removed.12 Our study serves to better elucidate the relationship between appendectomy and improvement of chronic pelvic pain. Compared with prior studies, our study has several strengths. First, it is a cohort study with specifically defined exclusion criteria. It is also a single-institution study, providing a more consistent definition of chronic pelvic pain and more standardized surgical practices and postoperative follow-up. We also used a validated assessment of pain, with the 11-point numeric pain scale and the Pain Disability Index. One of the main limitations of our study is its retrospective nature. In addition, we had a poor response rate in the second phase of the study. Only 38% of the cohort responded to the survey, although there were no demographic or clinical differences between responders and nonresponders. The inadequate response undermined efforts to quantify any differences between the groups in the need for additional analgesic use and surgical interventions. Also, recall bias may have been a factor because the survey was sent during a defined period, regardless of when the patient’s surgery was performed. Although we believe a well-designed, randomized controlled trial can JSLS (2013)17:82– 87 address the design limitations of this study, enrollment could be challenging. This study has demonstrated in the short term the effectiveness of appendectomy in patients with chronic pelvic pain, especially right-sided pelvic pain that has no obvious pelvic pathology. Long-term outcomes data from randomized clinical trials are needed to validate these findings. References: 1. Mathias SD, Kuppermann M, Liberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996;87(3):321– 327. 2. McVeigh E. The surgical management of pelvic pain. Curr Obstet Gynaecol. 2005;15(5):291–297. 8. Fauconnier A, Dallongeville E, Huchon C, Ville Y, Falissard B. Measurement of acute pelvic pain intensity in gynecology: a comparison of five methods. Obstet Gynecol. 2009;113(2 Pt 1): 260 –269. 9. Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984;59(3):974. 10. Fayez JA, Toy NJ, Flanagan TM. The appendix as the cause of chronic lower abdominal pain. Am J Obstet Gynecol. 1995; 172(1 Pt 1):122–123. 11. Lee JH, Choi JS, Jeon SW, et al. Laparoscopic incidental appendectomy during laparoscopic surgery for ovarian endometrioma. Am J Obstet Gynecol. 2011;204(1):28.e1– e5. 12. Popovic D, Kovjanic J, Milostic D, et al. Long-term benefits of laparoscopic appendectomy for chronic abdominal pain in fertile women. Croat Med J. 2004;45(2):171–175. 3. Reiter RC. A profile of women with chronic pelvic pain. Clin Obstet Gynecol. 1990;33(1):130 –136. 13. Nana AM, Ouandji CN, Simoens C, Smets D, Mendes da Costa P. Laparoscopic appendectomies: results of a monocentric prospective and non-randomized study. Hepatogastroenterology. 2007;54(76):1146 –1152. 4. El Bishry G, Tselos V, Pathi A. Correlation between laparoscopic and histological diagnosis in patients with endometriosis. J Obstet Gynaecol. 2008;28(5):511–515. 14. Nezhat C, Nezhat F. Incidental appendectomy during videolaseroscopy. Am J Obstet Gynecol. 1991;165(3):559 –564. 5. AlSalilli M, Vilos GA. Prospective evaluation of laparoscopic appendectomy in women with chronic right lower quadrant pain. J Am Assoc Gynecol Laparosc. 1995;2(2):139 –142. 15. Drozgyik I, Vizer M, Szabo I. Significance of laparoscopy in the management of chronic pelvic pain. Eur J Obstet Gynecol Reprod Biol. 2007;133(2):223–226. 6. DeCou JM, Gauderer MW, Boyle JT, Green JA, Abrams RS. Diagnostic laparoscopy with planned appendectomy: an integral step in the evaluation of unexplained right lower quadrant pain. Pediatr Surg Int. 2004;20(2):123–126.. 16. Wie HJ, Lee JH, Kyung MS, Jung US, Choi JS. Is incidental appendectomy necessary in women with ovarian endometrioma? Aust N Z J Obstet Gynaecol. 2008;48(1):107–111. 7. Agarwala N, Liu CY. Laparoscopic appendectomy. J Am Assoc Gynecol Laparosc. 2003;10(2):166 –168. 17. Berker B, Lashay N, Davarpanah R, Marziali M, Nezhat CH, Nezhat C. Laparoscopic appendectomy in patients with endometriosis. J Minim Invasive Gynecol. 2005;12(3):206 –209. JSLS (2013)17:82– 87 87 SCIENTIFIC PAPER A Pilot Feasibility Multicenter Study of Patients After Excision of Endometriosis Patrick Yeung Jr, MD, Frank Tu, MD, MPH, Krisztina Bajzak, MD, MPH, Georgine Lamvu, MD, Olga Guzovsky, Rob Agnelli, MStats, Mary Peavey, MD, Wendy Winer, RN, Robert Albee Jr, MD, Ken Sinervo, MD ABSTRACT Objective: To serve as a pilot feasibility study for a randomized study of excision versus ablation in the treatment of endometriosis by (1) estimating the magnitude of change in symptoms after excision only at multiple referral centers and (2) determining the proportion of women willing to participate in a randomized trial. Methods: We performed a multicenter prospective study of women undergoing excision for endometriosis (Canadian Task Force class II-3) at Duke University Center for Endometriosis Research & Treatment (currently the Saint Louis University Center for Endometriosis), Center for Endometriosis Care, Northshore University Health System, Memorial University (Canada), and Florida Hospital. The study comprised 100 female patients, aged 18 to 55 years, with endometriosis-suspected pelvic pain. The intervention was laparoscopic excision only of the abnormal peritoneum suspicious for endometriosis. The main outcome measures were quality of life, pelvic pain, dysmenorrhea, dyspareunia, and bowel and bladder symptoms. Results: The mean follow-up period was 8.5 months. Excision of endometriosis showed a significant reduction in all pain scores except bowel symptoms, as well as significant improvement in quality of life. Of the patients, 84% were willing to participate in a randomized study. Department of Obstetrics, Gynecology & Women’s Health, Saint Louis University, and Saint Louis University Center for Endometriosis, St. Louis, MO, USA (Dr. Yeung). Northshore University Health System, Evanston, IL, USA (Dr. Tu). Memorial University, St. John’s, Newfoundland, Canada (Dr. Bajzak). Florida Hospital, Orlando, FL, USA (Dr. Lamvu). School of Medicine, Saint Louis University, St. Louis, MO, USA (Guzovsky). SAS Institute, Cary, NC, USA (Mr. Agnelli). Department of Obstetrics & Gynecology, Duke University, Durham, NC, USA (Dr. Peavey). Center for Endometriosis Care, Atlanta, GA, USA (Ms. Winer; Drs. Sinervo, Albee). DOI: 10.4293/108680812X13517013317833 Address correspondence to: Paul Yeung, Jr, MD, Director, Center for Endometriosis, Minimally Invasive Gynecologic Surgery, 1031 Bellevue Ave, Ste 400, St. Louis, MO 63117, E-mail: [email protected] © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 88 Conclusions: Quality of life is a needed primary outcome for any randomized study comparing excision versus ablation. A multicenter comparative trial is feasible, although quality assurance would have to be addressed. Patients were willing to be randomized even at surgical referral centers. Key Words: Endometriosis, Excision, Ablation, Randomized study, Quality of life. INTRODUCTION The optimal technique for the surgical management of peritoneal endometriosis is not clear. Two main categories of surgical management exist and are referred to as ablation (where endometrial implants are destroyed with energy, which will include vaporization, without a specimen being taken out of the body) and excision (where the implant is completely removed from the body and sent to the pathology department). There is little evidence from randomized controlled trials (RCTs) to guide surgical management of endometriosis-associated pelvic pain. In the classic RCT by Sutton et al.1 published in 1994, the combination of laparoscopic ablation and laser uterosacral nerve ablation was compared with no surgical treatment. There was a statistically significant improvement in the treatment group compared with no treatment at 6 months (62.5% vs 22.6%), and this benefit was continued in more than 90% of patients for up to 1 year.2 In an RCT by Abbott et al.3 published in 2004, immediate laparoscopic excision was compared with delayed excision at 6 months, and patients were followed up for up to 12 months after the initial surgery. Statistically, more patients had improvement of pain after excision versus placebo (80% vs 32%) per the protocol. Both these trials compared a surgical technique (or combination of techniques) with no treatment (or delayed treatment), and the results of the techniques cannot be compared against each other. There have only been 2 RCTs that directly compared ablation and excision in the laparoscopic management of endometriosis. A small trial of 24 women performed by JSLS (2013)17:88 –94 Wright et al.4 in 2005 compared excision of endometriosis versus ablation and found that both treatments reduced overall symptom scores by roughly 30% at 6 months. However, given the small numbers, the study was underpowered, and no conclusions can be drawn from this trial. A second, more recent RCT performed by Healey et al.5 in 2010 was powered to compare laparoscopic excision versus ablation of endometriosis for the primary outcome of pelvic pain. There was no statistically significant difference in improvement of pelvic pain using the visual analog scale (VAS) at 12 months when comparing excision versus ablation (56.4% vs 48.4%). However, there were trends in improvement for dyschezia and dyspareunia. An overall assessment of pain symptoms, such as quality of life (QOL), was not performed. The authors advised that these results are only applicable to results achievable by a generalist gynecologist and are not necessarily applicable to a specialist. In practice, there is a tendency for gynecologic surgeons to want to perform ablation because it is considered easier. Theoretically, excision is advantageous because it ensures that the entire lesion or pathologic tissue is removed, especially for deeply infiltrating endometriosis or disease found over a vital organ or structure. The purpose of this study was to collect data from several referral sites, both academic and private, with experience and expertise in treating endometriosis by excision. There were 2 specific aims for the study, meant to be used as a pilot feasibility study for a subsequent comparative RCT that might give new information on whether excision or ablation is the better technique for treating symptomatic endometriosis. First, we aimed to obtain an estimate of the proportion of symptomatic women being treated for endometriosis at surgical referral sites who would be willing to participate in a randomized trial of laparoscopic excision versus ablation of endometriosis. Second, we aimed to estimate the magnitude of change in pain symptoms and global QOL in symptomatic women at least 6 months after undergoing laparoscopic excision only of endometriosis at several different referral centers. METHODS Informed consent was obtained and documented for patients seen at 5 referral centers in North America (formerly Duke University Center for Endometriosis Research & Treatment in Durham, North Carolina [currently Saint Louis University Center for Endometriosis in St. Louis, Missouri]; Center for Endometriosis Care in Atlanta, Georgia; Northshore University Health System in Evanston, Illinois; Florida Hospital in Orlando, Florida; and Memorial University in St. John’s, Newfoundland, Canada) that specialize in the management of pelvic pain or endometriosis. A 2-page (front and back) questionnaire was then administered by the site investigator and/or the nursing staff. The study was approved by the institutional review board at each of the institutions. Questions from the survey included information on baseline demographics, severity and type of pain, previous medical and surgical history, and openness to participating in a randomized trial comparing excision versus ablation on the surgical management of endometriosis. The goal was to obtain information from approximately 20 consecutive patients per site, for a total of 100 patients. Data on the number of patients per site, as well as operative data, were collected. A follow-up 2-page questionnaire, sent by mail or administered by a phone consultation, was completed starting at 6 months after the surgery. Inclusion criteria were female patients, aged 18 to 55 years, with endometriosis-associated persistent pelvic pain defined as all of the following: 3 months of chronic pelvic pain (defined as average pain intensity ⬎5 of 10 for ⬎50% of that time), which must have been predominantly localized to the pelvic region, bounded by the umbilicus superiorly and the inguinal ligament and symphysis pubis inferiorly, and could not be solely from the lumbar back or the skin (thus excluding isolated lumbago and vulvodynia); pain despite 1 class of medical treatments (eg, over-the-counter anti-inflammatories or hormonal suppression with oral contraceptives) for their endometriosis-associated pain; and at least 1 pelvic visceral pain component (dysmenorrhea, dyspareunia, dyschezia, or dysuria). Exclusion criteria included prior bilateral salpingo-oophorectomy or post–natural menopause status, as well as significant mental or chronic systemic illness that might confound pain assessment or the ability to complete the study. The primary symptom outcomes measured were QOL and pain—pelvic pain, dysmenorrhea, dyspareunia, and bowel and bladder symptoms. Analysis of variance and Fisher exact tests were used to compare the baseline demographic data between the centers as appropriate. VAS scores are a validated way to measure pain and were used to measure overall pelvic pain, as well as the different types of visceral pain.6 Patients were asked on the preoperative and postoperative questionnaire to rate their pain by placing a mark on a 10-cm line, and the measured distance to the mark (in millimeters) gave the VAS score. JSLS (2013)17:88 –94 89 A Feasibility Multicenter Study of Patients After Excision of Endometriosis, Yeung P et al. QOL was also assessed simply as an overall assessment of symptoms, before and after surgery, by asking the patient to rate it on a scale from 0 to 100. This way of measuring QOL has been validated in previous studies.7 Paired t tests were used to compare VAS scores and QOL scores when a close-to-normal distribution could be assumed. When the numbers were smaller or a normal distribution could not be assumed, nonparametric tests were used as appropriate (eg, signed rank test or sign test). Analysis of variance and Kruskal-Wallis (nonparametric) tests were used to compare the change in VAS scores and in QOL scores between the centers as appropriate. Fisher exact tests were used to compare the rate of histologically proven endometriosis by preoperative symptom between centers. The other important outcome measured was the percentage of participants who would be willing to be randomized in a controlled study of excision versus ablation. This was reported simply as a percentage of those surveyed who responded yes to this question. RESULTS Consecutive patients seen at any of the 5 participating centers and who met the inclusion criteria were invited to be included in the study. There were a total of 100 patients (Figure 1) who enrolled in the study and completed the informed consent form, 90% (90 of 100) of whom underwent excision surgery. Of the 90 patients who underwent surgery, 72.2% (65 of 90) had histologically confirmed endometriosis and 61.1% (55 of 90) completed a postoperative questionnaire. The mean time after which the follow-up questionnaire was completed was 8.5 months (range, 6 –14 months). Of particular interest, 84.0% (84 of 100) of the patients who completed the initial questionnaire indicated that they would be willing to participate in a randomized trial of laparoscopic excision versus ablation of endometriosis. There was no difference in the baseline demographics of the patients seen at the 5 centers (Table 1), except for previous medical therapy. Overall, more than 80% of patients presenting to the 5 centers had previous surgical interventions and more than 90% of patients had previous hormonal therapy. Of the patients in whom histologically proven endometriosis was found, 55 of 65 (84.6%) overall had received previous hormonal therapy or surgery. When we compared VAS scores after surgery with those before surgery in the patients who had confirmed endo- Figure 1. Flowchart of recruited subjects at all centers. *The 90 patients who underwent surgery were distributed across the 5 centers as follows: 50 from Center for Endometriosis Research & Treatment, Duke University, Durham, North Carolina; 20 from Center for Endometriosis Care, Atlanta, Georgia; 11 from Northshore University Health System, Evanston, Illinois; 5 from Florida Hospital, Orlando, Florida; and 4 from Memorial University, St. John’s, Newfoundland, Canada. 90 JSLS (2013)17:88 –94 Table 1. Baseline Demographics Overall and by Center Overall (100) DUa (59) CEa (20) NSa (13) MUa (4) FHa (4) P Value Age at presentation (y) 31.6 31.1 32 32.3 34.3 32.8 .91 Age at menstruation (y) 12.3 12.4 12.2 12.6 11.8 11.8 .78 Duration of pelvic pain (y) 9.3 9 11.6 8.2 9 7.2 .64 White 85/100 (85%) 50/57 (88%) 17/20 (85%) 10/13 (77%) 3/4 (75%) 5/5 (100%) .31 History of infertility 31/95 (32.6%) 17/58 (29.3%) 4/20 (20%) 6/13 (46.2%) 2/4 (50%) 2/5 (40%) .44 Previous medical treatment 87/95 (91.6%) 53/58 (91.4%) 14/20 (70%) 13/13 (100%) 3/4 (75%) 4/5 (80%) .04 Previous surgery 78/95 (82.1%) 45/58 (77.6%) 18/20 (90%) 11/13 (84.6%) 1/4 (25%) 3/5 (60%) .05 CE ⫽ Center for Endometriosis Care, Atlanta, GA; DU ⫽ Center for Endometriosis Research & Treatment, Duke University, Durham, NC; FH ⫽ Florida Hospital, Orlando, FL; MU ⫽ Memorial University, St. John’s, Newfoundland, Canada; NS ⫽ Northshore University Health System, Evanston, IL. a metriosis, there was a significant reduction in pain scores for all symptoms except bowel symptoms (Table 2). Of the symptoms that had significant reductions in pain by VAS score, bladder pain showed the least (1.8 reduction) and dyspareunia showed the most (2.9 reduction). Also of note, the QOL scores were significantly improved after excision surgery, with a mean improvement of 19.5 points (P ⬍ .001). Comparisons were also made for the change in symptoms and QOL scores with hormonal suppression versus without hormonal suppression, and there were no significant changes found for any of these comparisons (Table 2). In addition, the change in VAS scores and the change in QOL scores were compared between the centers, and no significant differences were found. When looking at the patients who underwent surgery and who did not have histologically confirmed endometriosis, we found no improvement in QOL scores, although there was improvement in pelvic pain (P ⬍ .01) and dyspareunia (P ⫽ .03). Pain symptoms (chronic pelvic pain, dysmenorrhea, dyspareunia, bowel symptoms, bladder symptoms) when present had a rate of histologically proven endometriosis ranging from 71.6% to 74%, with chronic pelvic pain being the least predictive and deep dyspareunia being the most predictive (Table 3). These results were compared between centers, and no significant differences were found. DISCUSSION A particular strength of this study is that it describes outcomes after excision for endometriosis from multiple referral centers; as such, it is the first study known to include data from multiple centers after excision. This shows that a multicenter trial is feasible, even among surgical referral sites. Most studies that have been pub- lished on excision for the surgical management of endometriosis have been from a single surgeon or center.5,8,9 Patients were suspected to have endometriosis based on the overall assessment of the surgeon from the clinical history and examination findings. One of the benefits of excision is the histologic confirmation of disease, and more than 7 of 10 patients who underwent surgery in this study for the suspicion of endometriosis had histologically proven disease. Even more noteworthy is that of the patients in whom histologically proven endometriosis was found, a high percentage (84.6%) had received either previous hormonal therapy or surgery by ablation as “treatment” for presumed endometriosis, indicating that these interventions are ineffective at suppressing or preventing disease. The data from this study further indicate that the addition of hormonal suppression after excision did not further reduce VAS scores for pain or benefit QOL scores, when compared with patients without postoperative hormonal suppression. In the RCT of excision versus ablation for endometriosis by Healey et al.5 (2010), differences in pelvic pain were not statistically significant, but there were trends for a difference in bowel-related symptoms and dyspareunia. In addition, as mentioned earlier, the results of their study came from a single center and are likely only applicable to generalist gynecologists. In our prospective multicenter study on excision for endometriosis, there were significant reductions in pelvic pain, dysmenorrhea, dyspareunia, and bladder symptoms but not bowel symptoms. In contrast to the study by Healey et al.,5 where fewer than one-third of patients who underwent surgery previously JSLS (2013)17:88 –94 91 A Feasibility Multicenter Study of Patients After Excision of Endometriosis, Yeung P et al. Table 2. VAS and QOL Scores Before and After Surgery in Patients Who Had Confirmed Endometriosis Preoperative Postoperative Change in Score P Value 5.2 (n ⫽ 65) 2.4 (n ⫽ 43) –2.6 ⬍ .001a,b Postoperative suppression 5.3 (n ⫽ 23) 2.8 (n ⫽ 24) –2.5 .19c,d No suppression 4.6 (n ⫽ 39) 2.5 (n ⫽ 37) –2.1 7.5 (n ⫽ 65) 4.0 (n ⫽ 36) –2.6 .002a,e Postoperative suppression 7.5 (n ⫽ 23) 4.7 (n ⫽ 19) –2.8 .32b,c No suppression 7.1 (n ⫽ 38) 3.3 (n ⫽ 16) –3.8 5.1 (n ⫽ 61) 2.0 (n ⫽ 41) –3.0 ⬍ .001a,f Postoperative suppression 5.1 (n ⫽ 21) 3.0 (n ⫽ 22) –2.1 .20c,e No suppression 4.9 (n ⫽ 38) 1.0 (n ⫽ 18) –3.9 Bowel symptoms 3.4 (n ⫽ 65) 2.0 (n ⫽ 42) –0.3 .6a,b Postoperative suppression 3.8 (n ⫽ 23) 2.5 (n ⫽ 23) –1.3 .22c,e No suppression 3.1 (n ⫽ 37) 1.5 (n ⫽ 18) –1.6 2.6 (n ⫽ 65) 0.6 (n ⫽ 41) –1.8 ⬍ .001a,e Postoperative suppression 2.5 (n ⫽ 23) 0.8 (n ⫽ 22) –1.7 .11c,g No suppression 2.5 (n ⫽ 37) 0.4 (n ⫽ 18) –2.1 63.3 (n ⫽ 65) 83.3 (n ⫽ 43) 20.0 ⬍ .001a,e Postoperative suppression 60.8 (n ⫽ 23) 78.5 (n ⫽ 24) 17.7 .15b,c No suppression 67.7 (n ⫽ 37) 89.3 (n ⫽ 18) 21.6 Pelvic pain Dysmenorrhea Dyspareunia Bladder symptoms QOL a Comparison of preoperative and postoperative scores for symptom. t Test. c Comparison of changes in system with and without hormonal suppression. d Wilcoxon 2-sample test. e Sign test. f Signed rank test. g t Test with Satterwaite correction for unequal variances. b Table 3. The Rate of Histologically-Confirmed Endometriosis by Preoperative Symptom Symptom Overall DUa CEa NSa MUa FHa Pelvic pain 58/81 (71.6%) 35/45 (77.8%) 14/19 (73.9%) 6/9 (66.7%) 2/3 (66.7%) (0/5) 0% Menstrual cramps 61/83 (73.5%) 37/46 (80.4%) 14/17 (82.4%) 7/11 (63.6%) 3/4 (75%) (0/5) 0% Pain with intercourse 57/77 (74.0%) 37/44 (84.1%) 12/17 (70.6%) 6/9 (66.7%) 2/3 (66.7%) (0/4) 0% Pain with bowel movements 39/54 (72.2%) 21/25 (84%) 11/15 (73.3%) 6/10 (60.0%) 1/1 (100%) (0/3) 0% Pain with full bladder 32/44 (72.7%) 18/25 (72%) 9/14 (64.3%) 3/6 (50.0%) 2/2 (100%) (0/2) 0% CE ⫽ Center for Endometriosis Care, Atlanta, GA; DU ⫽ Center for Endometriosis Research & Treatment, Duke University, Durham, NC; FH ⫽ Florida Hospital, Orlando, FL; MU ⫽ Memorial University, St. John’s, Newfoundland, Canada; NS ⫽ Northshore University Health System, Evanston, IL. a 92 JSLS (2013)17:88 –94 received either hormonal or surgical treatment, patients in our study received either hormonal or surgical treatment in the vast majority of cases (⬎80%). One might predict that patients having previous treatment might respond with less benefit from another surgical intervention, yet the rates of improvement in VAS scores were comparable in both studies. Also of note is the finding that patients did not have symptom improvement in QOL scores when no endometriosis was found histologically. A strength of this study is the inclusion of a single validated measure of QOL before and after excision surgery. A scale of 0 to 100 for the QOL score is easy to use and has been validated as an assessment tool.7 Most studies on the surgical management of endometriosis use pelvic pain as the primary outcome as measured by VAS scores.1,3,5 A potential problem with using pelvic pain as the primary outcome of a study on endometriosis is that some components of pain may improve after surgically treating endometriosis whereas others may not, at least to the same extent. A QOL assessment may be a better overall measure of the clinical benefit of surgery for treating endometriosis by translating multiple pain symptoms to a single measure of their effect on daily functioning. In fact, published reviews have recommended the inclusion of a QOL assessment in trials that look at pain as an outcome.10,11 Our study showed a statistically significant improvement in QOL scores after excision at multiple centers. It is our recommendation that a QOL measure be used as the primary symptom outcome measure for future comparative trials on excision versus ablation in the surgical management of endometriosis. This study has produced an estimate of the benefit on QOL after excision to be an increase of 20 points. There are no known studies that have evaluated QOL after ablation. Weaknesses of this study include the skewed actual numbers of recruitment, with more than 58 of 100 patients coming from a single center and 78 of 100 from 2 centers. Perhaps more important is the lack of quality assurance or some objective way to determine whether adequate or complete excision of all areas of abnormal peritoneum was achieved at each of the centers. In any subsequent randomized comparative trial comparing excision and ablation, objective or third-party quality assurance will need to be included for both techniques, especially if a particular referral center favors a particular approach over the other. As reported in a recent study on complete excision of endometriosis in teenagers, one of the most important benefits of excision may not be symptom relief but may be eradication of disease.12 Potential eradication of disease by excision might benefit future fertility, and this benefit might need to be evaluated also in a comparative trial of excision versus ablation in the treatment of endometriosis. One of the aims of this study was to obtain an estimate of the rate of patients presenting to referral centers for pelvic pain or endometriosis (in particular, centers that specialize in the excision of endometriosis) who would be willing to be randomized to either excision or ablation of endometriosis at the time of surgery. The vast majority of patients (84.0%) were willing to be randomized when asked this question. This bodes well for the feasibility of a randomized comparative trial even at referral centers that specialize in a particular surgical approach to the treatment of endometriosis. The results of this study indicate that patients were overwhelmingly willing to be randomized to either excision or ablation for endometriosis even at referral centers, that QOL may be a better overall measure as a primary outcome when one is looking at the benefit of surgery for endometriosis, and that a comparative RCT is feasible, as well as needed, among multiple centers that specialize in surgically treating endometriosis. CONCLUSION A multicenter prospective study evaluating surgical treatment for endometriosis is feasible. Another comparative trial comparing excision versus ablation in the surgical management of endometriosis is needed at multiple centers but also with primary outcomes other than simply pelvic pain. Patients are willing to be randomized even at referral centers that treat endometriosis. References: 1. Sutton CJ, Ewen SP, Whitelaw N, Haines P. Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis [see comment]. Fertil Steril. 1994; 62(4):696 –700. 2. Sutton CJ, Pooley AS, Ewen SP, Haines P. Follow-up report on a randomized controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal to moderate endometriosis. Fertil Steril. 1997;68(6):1070 –1074. 3. Abbott J, Hawe J, Hunter D, Holmes M, Finn P, Garry R. Laparoscopic excision of endometriosis: a randomized, placebo-controlled trial [see comment]. Fertil Steril. 2004;82(4): 878 – 884. JSLS (2013)17:88 –94 93 A Feasibility Multicenter Study of Patients After Excision of Endometriosis, Yeung P et al. 4. Wright J, Lotfallah H, Jones K, Lovell D. A randomized trial of excision versus ablation for mild endometriosis. Fertil Steril. 2005;83(6):1830 –1836. 5. Healey M, Ang WC, Cheng C. Surgical treatment of endometriosis: a prospective randomized double-blinded trial comparing excision and ablation. Fertil Steril. 2010;94(7):2536 –2540. 6. Fauconnier A, Dallongeville E, Huchon C, Ville Y, Falissard B. Measurement of acute pelvic pain intensity in gynecology: a comparison of five methods. Obstet Gynecol. 2009;113(2, pt 1):260–269. 7. de Boer AG, van Lanschot JJ, Stalmeier PF, et al. Is a singleitem visual analogue scale as valid, reliable and responsive as multi-item scales in measuring quality of life? Qual Life Res. 2004;13(2):311–320. 8. Albee RB Jr, Sinervo K, Fisher DT. Laparoscopic excision of lesions suggestive of endometriosis or otherwise atypical in appearance: relationship between visual findings and final histologic diagnosis. J Minim Invasive Gynecol. 2008;15(1):32–37. 94 9. Redwine DB. Conservative laparoscopic excision of endometriosis by sharp dissection: life table analysis of reoperation and persistent or recurrent disease. Fertil Steril. 1991;56(4):628 – 634. 10. Neelakantan D, Omojole F, Clark TJ, Gupta JK, Khan KS. Quality of life instruments in studies of chronic pelvic pain: a systematic review. J Obstet Gynaecol. 2004;24(8):851– 858. 11. Turk DC, Dworkin RH, Revicki D, et al. Identifying important outcome domains for chronic pain clinical trials: an IMMPACT survey of people with pain. Pain. 2008;137(2):276–285. 12. Yeung P Jr, Sinervo K, Winer W, Albee RB Jr. Complete laparoscopic excision of endometriosis in teenagers: is postoperative hormonal suppression necessary? Fertil Steril. 2011;95(6):1909–1912, 1912.e1. JSLS (2013)17:88 –94 SCIENTIFIC PAPER Robotic-Assisted Hysterectomy for the Management of Severe Endometriosis: A Retrospective Review of Short-Term Surgical Outcomes Mohamed A. Bedaiwy, MD, PhD, Mohamed Y. Abdel Rahman, MD, Mark Chapman, MD, Heidi Frasure, MS, Sangeeta Mahajan, MD, Vivian E. von Gruenigen, MD, William Hurd, MD, Kristine Zanotti, MD ABSTRACT Key Words: Robotics, Endometriosis, Surgery. Objectives: The primary objective was to examine the safety and feasibility of robotic-assisted laparoscopy in a cohort of women treated surgically for stage III and IV endometriosis. The secondary objective was to explore whether the stage of endometriosis affected surgical outcome. INTRODUCTION Methods: In this cohort study, 43 women with severe endometriosis were treated with robot-assisted laparoscopic hysterectomy with unilateral or bilateral salpingooophorectomy for stage III (n ⫽ 19) or stage IV (n ⫽ 24) disease. Results: Histopathologic evaluation confirmed endometriosis in all patients, and fibroids were also shown in 12 patients. The median actual operative time was 145 min (range, 67–325 min), and the median blood loss was 100 mL (range, 20 – 400 mL). All but one of the procedures were completed successfully robotically. The length of hospital stay was 1 d for 95% of patients (41 of 43), and 2 patients had prolonged stays of 4 d and 5 d, respectively. One patient was readmitted for a vaginal cuff abscess; this represented the only complication identified in this series. Conclusions: Robot-assisted laparoscopic surgery appears to be a reasonably safe and feasible method for the definitive surgical management of women with severe endometriosis. Department of Obstetrics and Gynecology, University Hospitals, Case Western Reserve University, Cleveland, OH, USA (Drs. Bedaiwy, Abdel Rahman, Chapman, Frasure, Mahajan, Hurd, Zanotti). Summa Akron City Hospital, Akron, OH, USA (Dr. von Gruenigen). Presented in part at the annual meeting of the Society of Gynecologic Surgeons, San Antonio, TX, USA, April 10 –13, 2011. Address correspondence to: Kristine Zanotti, MD, Director, University Hospitals Center for Robotic Surgery, Gynecologic Oncology, University Hospitals Case Medical Center and The Seidman Cancer Center, 11100 Euclid Ave, Cleveland, OH 44106, USA, Telephone: 216 844 5011. Fax: 216 844 7631, E-mail: kristine. [email protected] DOI: 10.4293/108680812X13517013317275 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. Endometriosis is estimated to occur in 6% to 10% of women of reproductive age,1 with a prevalence of 38% (range, 20%–50%) in infertile women,2 and in 71% to 87% of women with chronic pelvic pain.3 In the past, symptomatic moderate to severe endometriosis was most commonly treated by laparotomy with the removal of affected tissue, with or without hysterectomy and bilateral salpingo-oophorectomy. More recently, many women with advanced endometriosis have been treated with a laparoscopic approach because it results in a shorter hospital stay and recovery period compared with laparotomy. However, conventional laparoscopy has inherent limitations for the treatment of advanced endometriosis because of the adhesive nature of the disease, obliteration of the surgical plans, variability of surgical skill levels, and normal mechanics of the human hand. The use of a robotic system to assist with laparoscopy has been shown to overcome some of the technical limitations of laparoscopy while maintaining its minimally invasive nature. The most widely used system for robotically assisted laparoscopy is the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA). Advantages of this system include a steady 3-dimensional (3D) image and articulating instrumentation that allow for 7 degrees of movement, mimicking the human wrist. It also filters the surgeon’s hand tremors at the console and eliminates the fulcrum effect encountered in conventional laparoscopy. Moreover, it allows movement downscaling, increasing accuracy and precision. To date, only a small study has been published that examines the feasibility of robotically assisted laparoscopy for the management of advanced endometriosis.4 The primary objective of this study is to report our experience with the safety and feasibility of robotic surgical treatment of advanced pelvic endometriosis. The secondary objective was to explore whether the stage of endometriosis affected surgical outcome. JSLS (2013)17:95–99 95 Robotic-Assisted Hysterectomy for the Management of Severe Endometriosis, Bedaiwy MA et al. MATERIALS AND METHODS The institutional review board of the University Hospitals Case Medical Center, Cleveland, Ohio, approved this retrospective chart review study. Our series consists of 43 patients who underwent robotically assisted laparoscopic surgery for the treatment of advanced endometriosis between April 2008 and March 2010. All data were collected directly from the patients’ charts by use of a standardized data collection sheet. The electronic records of 422 patients who underwent robotic surgery during the study period for gynecologic indications were evaluated. Patients with histologically confirmed endometriosis were identified. Operative reports of this cohort were reviewed. The extent of disease as dictated by the primary surgeon was matched against the American Society for Reproductive Medicine (ASRM) classification of endometriosis for staging.5 Patients with stage I and II endometriosis were excluded (n ⫽ 11). Patients who underwent conservative surgical management with uterine preservation were also excluded (n ⫽ 7). There were no selection criteria to use the robotic platform. This was based solely on surgeon preference, scheduling, and availability. Demographic and clinical characteristics were recorded, and the patients were divided into 2 groups according to the ASRM classification by endometriosis stage III or IV.5 Outcome variables included total operating room, actual operative time, and postanesthesia care unit (PACU) time (in minutes); estimated blood loss (in milliliters); and uterine weight (in grams). Complications were determined by examination of the hospital chart and the postoperative visit notes within 6 mo after surgery. Operative Technique After induction of general anesthesia, the patient was positioned in the dorsal lithotomy position with both arms tucked by the patient’s side. A beanbag was adjusted to keep the arms and the shoulders in place. Pneumoperitoneum was usually induced with a Veress needle. A 12-mm trocar was placed 2 to 5 cm supraumbilically. Two 8-mm robotic trocars were placed bilaterally, 10 cm lateral to and at the level of the umbilicus. An accessory 10-mm trocar was placed in the left lower quadrant. Monopolar scissors were inserted through the right robotic trocar, and a plasma kinetic dissecting forceps was inserted through the left robotic trocar. Oophorectomy was started by entering the retroperitoneal space of the lateral pelvic sidewall with unipolar electrosurgery. The infundibulopelvic (IP) ligament was then 96 skeletonized. The ureter was identified. Subsequently, unipolar electrosurgery was used to create a window below the IP ligament and above the ureter. The IP was then coagulated 3 times and divided. Alternatively, the IP was coagulated and cut if the ureter could be visualized easily. This process was repeated on the contralateral side when both ovaries were removed. Lysis of adhesions was then performed to restore normal anatomy in patients with extensive adhesions. Unilateral lateral pelvic sidewall dissection and ureterolysis were performed in a total of 8 patients (3 with stage III and 5 with stage IV disease) to resect deep infiltrating lesions. Partial obliteration of the cul-de-sac was treated with sharp dissection in only 3 patients with stage IV disease. Careful dissection with and without the use of electrocautery was used to preserve the integrity of the ureter, pelvic vessels, and rectum. The hysterectomy portion of the procedure was then completed by a standard approach according to the surgeon’s preference. The Foley catheter was removed at the end of the procedure. A regular diet was started on the same day of the operation, and patients were allowed to ambulate as soon as possible. The patient was routinely discharged the morning after surgery, unless the patient’s clinical condition required continued hospitalization. A routine postoperative visit was made 4 to 6 wk after the surgery and as needed thereafter. Total operative time was defined as the time elapsed from intubation to extubation in minutes. Actual operative time was defined as the time elapsed from skin incision to skin closure. The PACU time was defined as the time from arriving to the PACU until discharge of the patient to the floor. Statistical Analysis Patient characteristics and surgical parameters for the entire cohort of patients were described. A secondary goal was to compare these parameters among patients with stage III and stage IV endometriosis. Patient demographic and clinical characteristics were compared between stage III and IV endometriosis patients by use of the MannWhitney U test for continuous variables and 2 tests for categorical variables. The median total operating room, actual operative, and PACU times were compared for women with stage III and IV endometriosis by use of the Mann-Whitney U test. P ⬍ .05 was considered statistically significant. Data were analyzed with SPSS software, version 17.0 (SPSS, Chicago, IL, USA). JSLS (2013)17:95–99 RESULTS Patient Characteristics Forty-three women underwent a robotic procedure for advanced endometriosis (Table 1). Of these, 19 (44.2%) had stage III and 24 (55.8%) had stage IV endometriosis. The median patient age was 46 y (range, 32– 68 y), and the mean body mass index was 28 kg/m2 (range, 20.2–50.2 kg/m2). Baseline characteristics were similar in both groups. Nine patients (20.9%) had previously undergone laparotomy for various indications. Along with the hysterectomy, both ovaries were removed in 29 of 43 patients (67.5%). In 14 patients (32.5%), only 1 ovary was removed and the contralateral ovary was preserved. Intraoperative Outcomes The median total operative time was 190 min (range, 97–368 min), including patient positioning, robot docking, performing surgery, and performing closure of the port sites. The median actual operative time was 145 min (range, 67–325 min), and both total operating room time and actual operative time were comparable between the 2 groups (Table 1). There was no difference between the 2 groups regarding estimated blood loss and uterine weight. Pathologic evaluation confirmed the endometriosis diagnosis in all patients. There was 1 conversion to laparotomy because of the size and location of multiple fibroids in a woman with a 14 wk–sized uterus. One patient also required vaginal assistance to expedite completion of her hysterectomy. Postoperative Outcomes There was no significant difference between groups in PACU times, with a median of 80 min (range, 32–165 min) for all patients. Narcotics were given postoperatively as needed. All patients were sent home with oral oxycodone/ acetaminophene, 5/325 mg. Histopathologic confirmation of the disease was established postoperatively. Concomitant fibroids were confirmed in 12 patients (27.9%). Almost all patients were discharged the day after surgery (41 of 43 [95%]); 1 patient who was converted to laparotomy was discharged after 5 d, and another patient stayed for 3 d because of postoperative ileus that resolved spontaneously. One patient was readmitted on postoperative day 11 with fever, chills, and lower abdominal pain. Computed tomography showed a vaginal cuff abscess. She was treated with antibiotics, the abscess was drained vaginally under general anesthesia, and a Foley catheter was Table 1. Baseline Characteristics and Intraoperative Outcome Measures of Study Population Patient/Clinical Demographics Age [median (range)] (y) 2 BMIb [mean (SD)] (kg/m ) Overall (N ⫽ 43) Stage III Endometriosis (n ⫽ 19) Stage IV Endometriosis (n ⫽ 24) P Valuea 46 (32–68) 49 (34–68) 43.5 (32–61) .339 28 (20.2–50.2) 26.8 (21.3–45.4) 30.4 (20.2–50.2) .695 Previous surgery 9 (20.9%) 3 (15.8%) 6 (25%) .708 Total ORb time [median (range)] (min) 190 (97–368) 190 (97–290) 183 (138–368) .934 Actual operative time [median (range)] (min) 145 (67–325) 145 (67–234) 146.5 (102–325) .882 Uterine weight [median (range)] (g) 121.3 (48–570) 105 (52–376) 125.1 (48–570) .839 EBLb [median (range)] (mL) 100 (20–400) 100 (25–325) 100 (20–400) .503 Complications intraoperatively 2 (4%) 1 (5.2%) 1 (4.2%) .999 PACU time [median (range)] (min) 80 (32–165) 87.5 (32–135) 80.0 (32–165) .752 1d 41 (95.3%) 19 (100%) 22 (91.7%) .495 ⬎1 d 2 (4.7%) 0 2 (8.3%) 1 (2%) 0 Hospital stay Complications postoperatively 1 (4.2%) .999 Comparison of stage III and stage IV endometriosis with Mann-Whitney U or test. BMI ⫽ body mass index; EBL ⫽ estimated blood loss; OR ⫽ operating room. a 2 b JSLS (2013)17:95–99 97 Robotic-Assisted Hysterectomy for the Management of Severe Endometriosis, Bedaiwy MA et al. placed into the abscess cavity. She remained afebrile and was discharged after 4 d. The Foley catheter was removed after 7 d. DISCUSSION Our study represents the largest cohort of patients with advanced endometriosis managed with definitive surgery by robotic laparoscopy reported in the literature. In this study of 43 patients with stage III and IV endometriosis, intraoperative complication rates were low and only 1 patient required conversion to laparotomy. Moreover, only 1 minor and 1 major postoperative complication occurred, manifesting as a self-limited ileus and a vaginal cuff abscess, respectively. Together these data suggest both the feasibility and safety of this surgical modality for the definitive treatment of severe endometriosis. There are very few randomized trials evaluating the different surgical approaches to pelvic endometriosis. Whereas Nezhat et al.4 observed no benefit of robotic over conventional laparoscopy for the surgical treatment of stage I or II endometriosis, we speculate that such comparisons are unlikely to be equivocal for more severe manifestations of endometriosis. A 10% rate of conversion to laparotomy has been reported in patients with severe endometriosis managed with conventional laparoscopy when performed by high-volume, experienced laparoscopic surgeons.6 In our series there were no conversions to laparotomy because of an intraoperative complication; moreover, a 2% overall conversion rate (1 of 50) compares favorably with that reported with conventional laparoscopy. Furthermore, as the complexity of pelvic dissection necessary for the surgical management of severe pelvic endometriosis increases, the advantages provided by the robotic platform become more indispensible. Isolated reports have documented its use in patients with severe endometriosis involving the urinary and gastrointestinal systems.7,8 These reports encourage further exploration of robotic surgery in this population of patients. Among its inherent characteristics, the 3D technology of robotic surgery is of particular importance in the surgical management of severe endometriosis. The robotic platform improves the depth of perception and facilitates the resection of deep infiltrating lesions. In addition, the robotic system improves dexterity, filters the surgeon’s tremor, and improves intuitive movements.9,10 These features enable the surgeon to execute complicated surgical steps such as re-creation of an obliterated cul-de-sac, lateral pelvic wall dissection and resection of densely adherent endometriomas, ureterolysis, and enterolysis. 98 Moreover, the 7 df and 3D visual image permit easier handling of the tissue.10,11 Robotic surgery has several disadvantages compared with traditional laparotomy. These include increased cost; the lack of tactile feedback to the surgeon; the presence of bulky robotic arms, as well as long and thick cords; the inability to move the surgical table once the robot arms are attached; and a limited range of motion with respect to operating in different quadrants in the same case.4 A major potential limitation of robotic surgery is the absence of tactile (also called “haptic”) feedback. This is of particular importance when the dissection is close to delicate structures, such as the ureter, blood vessels, and rectum. This could lead to an inability to determine the strength needed for suturing without breaking the suture or possible injury to adjacent structures. It is especially true in early cases performed by inexperienced surgeons, and its effect will decrease but not disappear with experience. In addition, visual cues from the 3D image may dampen this limitation.12 This study has several limitations. First, it is a retrospective study and, as such, has inherent weaknesses. Ideally, a prospective randomized trial with laparotomy or laparoscopy without robotic assistance as a control group will be of interest when analyzing the perioperative outcomes. The study is also limited by the lack of a control group. In addition, it is limited by the lack of long-term outcomes including recurrence of endometriosis. Given the fact that the long-term objective of most patients with pelvic pain due to endometriosis is pain relief, a study with the longterm goal of pain relief is needed. However, most our patients were followed up for up to 1 y after surgery without recurrence of symptoms. The ASRM scoring system did not correlate well with either perioperative or postoperative outcome measures in our cohort of patients. Although the ASRM system’s limitations in predicting clinically relevant outcomes in patients with endometriosis, such as pelvic pain and fertility, are well described, the scoring system was developed to describe the extent and location of anatomic distortion in patients with endometriosis. Anatomic findings, such as cul-de-sac obliteration, adhesions to the broad ligament and pelvic sidewall, and deep peritoneal implants, are anticipated to add to the complexity of definitive surgery for endometriosis. We regard our finding that the operative time was not significantly correlated with ASRM stage as a significant negative finding. Although these data may suggest limitations in either the functionality or the reproducibility of the ASRM system (or JSLS (2013)17:95–99 both), one may also surmise that these findings further attest to the ability of the robotic technique to manage distorted pelvic anatomy with greater ease. Because of these questions, long-term prospective studies on the definitive surgical management of severe endometriosis are of great interest. However, investigators will also be challenged to prospectively define meaningful and reproducible inclusion criteria for these studies. CONCLUSION In this retrospective cohort of 43 patients with stage III and IV endometriosis, we found robotic-assisted laparoscopy to be both safe and feasible. Moreover, we speculate that the unique features of the robotic platform may offer advantages over conventional laparoscopy in patients with more severe forms of endometriosis and allow more women with this condition the opportunity for surgical management by a minimally invasive approach. A prospective study is essential to more fully evaluate the relative merits of the robotic platform in the surgical treatment of severe endometriosis. 4. Nezhat C, Lewis M, Kotikela S, et al. Robotic versus standard laparoscopy for the treatment of endometriosis. Fertil Steril. 2010;94:2758 –2760. 5. Revised American Society for Reproductive Medicine classification of endometriosis: 1996. Fertil Steril. 1997;67(5):817– 821. 6. Marchal F, Rauch P, Vandromme J, et al. Telerobotic-assisted laparoscopic hysterectomy for benign and oncologic pathologies: initial clinical experience with 30 patients. Surg Endosc. 2005;19(6):826 – 831. 7. Frick AC, Barakat EE, Stein RJ, Mora M, Falcone T. Roboticassisted laparoscopic management of ureteral endometriosis. JSLS. 2011;15(3):396 –399. 8. Averbach M, Popoutchi P, Marques OW Jr, Abdalla RZ, Podgaec S, Abrao MS. Robotic rectosigmoidectomy—pioneer case report in Brazil. Current scene in colorectal robotic surgery. Arq Gastroenterol. 2010;47(1):116 –118. 9. Falcone T, Goldberg JM. Robotic surgery. Clin Obstet Gynecol. 2003;46(1):37– 43. 10. Bedaiwy MA, Barakat EM, Falcone T. Robotic tubal anastomosis: technical aspects. JSLS. 2011;15(1):10 –15. 11. Frick AC, Falcone T. Robotics in gynecologic surgery. Minerva Ginecol. 2009;61(3):187–199. References: 1. Giudice LC, Kao LC. Endometriosis. Lancet. 2004;364(9447): 1789 –1799. 2. Balasch J, Creus M, Fábregues F, et al. Visible and nonvisible endometriosis at laparoscopy in fertile and infertile women and in patients with chronic pelvic pain: a prospective study. Hum Reprod. 1996;11(2):387–391. 12. Barakat EE, Bedaiwy MA, Zimberg S, Nutter B, Nosseir M, Falcone T. Robotic-assisted, laparoscopic, and abdominal myomectomy: a comparison of surgical outcomes. Obstet Gynecol. 2011;117(2 Pt 1):256 –265. 3. Leibson CL, Good AE, Hass SL, et al. Incidence and characterization of diagnosed endometriosis in a geographically defined population. Fertil Steril. 2004;82(2):314 –321. JSLS (2013)17:95–99 99 SCIENTIFIC PAPER Perioperative Outcomes of Robotic Versus Laparoscopic Hysterectomy for Benign Disease Kristin E. Patzkowsky, MD†, Sawsan As-Sanie, MD, MPH, Noam Smorgick, MD, MSc, Arleen H. Song, MD, MPH‡, Arnold P. Advincula, MD ABSTRACT Key Words: Hysterectomy, Laparoscopy, Robotic surgery. Background and Objectives: We compared the perioperative outcomes of hysterectomy performed by robotic (RH) versus laparoscopic (LH) routes for benign indications using the Dindo-Clavien scale for classification of the surgical complications. Methods: Retrospective chart review of all patients who underwent robotic (n⫽288) and laparoscopic (n⫽257) hysterectomies by minimally invasive surgeons at the University of Michigan from March 2001 until June 2010. Results: Age, body mass index, operative time, and estimated blood loss were not statistically different between groups. The RH subgroup had a larger uterine weight (LH 186.4⫾130.6 g vs RH 234.9⫾193.9 g, P⫽.001), higher prevalence of severe adhesions (13.2% vs 23.3%, respectively, P⫽.003), and stage III–IV endometriosis (4.7% vs 15.3%, respectively, P⬍.05). There were no differences in the rates of Dindo-Clavien grade I, grade II, and grade III surgical complications between the RH and LH groups (9.7%, 13.2%, and 3.1%, respectively, in the RH group vs 6.2%, 9.3%, and 5.8%, respectively, in the LH group, P⬎.05). However, the rates of urinary tract infection were higher in the RH group (LH 2.7% vs RH 6.9%, P⫽.02), whereas the conversion to laparotomy rate was higher in the LH group (LH 6.2% vs RH 1.7%, P⫽.007). Conclusions: Perioperative outcomes for laparoscopic and robotic hysterectomy for benign indications appear to be equivalent. University of Michigan Health Center, Ann Arbor, MI, USA (Drs. As-Sanie, Smorgick, Advincula). Montefiore Medical Center, Centennial Women’s Center, Bronx, NY, USA (Dr. Patzkowsky) Celebration Hospital, Celebration, FL, USA (Dr. Song). Dr. Advincula is a consultant for Intuitive Surgical, Cooper Surgical, and Ethicon Women’s Health & Urology. Presented at the 39th Annual Meeting of the American Association of Gynecologic Laparoscopists, Las Vegas, Nevada, November 2010. Recipient of “Robotic Technology Award” for the best abstract on robotic technology at this meeting. Address correspondence to: Kristin Patzkowsky, MD, Montefiore Medical Center, Centennial Women’s Center, 3332 Rochambeau Ave, Bronx, NY 10467. Telephone: 718-920-6311. Email: [email protected] DOI: 10.4293/108680812X13517013317914 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 100 INTRODUCTION Interest in minimally invasive gynecological surgery has grown tremendously over the past 20 years. Numerous studies have demonstrated the benefits of laparoscopy over laparotomy, including decreased blood loss, shorter length of hospital stay, decreased pain, earlier return to routine activities, and improved cosmesis.1,2 Despite these advantages, the percentage of gynecological hysterectomies performed laparoscopically has remained relatively stagnant at 12% to 14% nationally.3–5 Some of the proposed reasons for its lack of widespread implementation are the need for specialized training, its steep learning curve, longer operative time, 2-D view, limited degrees of instrument motion, and tremor amplification. The da Vinci surgical system (Intuitive Surgical, Sunnyvale, CA) has improved on these shortcomings intrinsic to laparoscopy and has been rapidly incorporated into clinical practice. Feasibility studies have shown success in performing robotic hysterectomy, myomectomy, sacrocolpopexy, gynecologic cancer staging, and tubal reanastomsis.6 –10 Similar to those about laparoscopy, studies have shown improved surgical outcomes (decreased blood loss, shorter length of stay, decreased pain, and earlier return to activities) with robotic surgery when compared with an abdominal route.11–14 Although there are clear benefits of both robotic and laparoscopic surgery over laparotomy, few studies have directly compared perioperative outcomes of robotic and laparoscopic hysterectomy for benign indications. In a recent review of the literature, Sarlos and Kots15 concluded that most clinical outcomes such as blood loss, complications, and hospital stay were comparable for the robotic and the laparoscopic hysterectomy. However, despite the paucity of supportive data, robotic surgery has been rapidly adopted into gynecological practice and has grown at a rate that has far exceeded that seen with laparoscopy. The purpose of this study is to compare perioperative outcomes in all consecutive patients undergoing laparoscopic and robotic hysterectomy for benign indication at one academic center. JSLS (2013)17:100 –106 MATERIALS AND METHODS After institutional review board approval, consecutive cases of laparoscopic and robotic hysterectomy for benign indications were collected by search of billing codes and retrospectively reviewed by electronic medical record. Included were all laparoscopic and robotic hysterectomies performed from March 1, 2001 until June 30, 2010, by the faculty of the Minimally Invasive Gynecology Division at the University of Michigan Health System. All 3 surgeons were fellowship trained in minimally invasive gynecological surgery and were proficient in laparoscopic hysterectomy but had newly incorporated robotic surgery during the study period. The University of Michigan is a teaching hospital, and residents and/or fellows participated in all procedures at various levels as deemed appropriate by the faculty surgeon. Data regarding the extent of trainee involvement were not collected and are not part of this study. The surgical approach was determined preoperatively according to the surgeon’s and patient’s preferences, based on the specific patient’s characteristics. Women with a preoperative diagnosis of malignancy and those who underwent concomitant procedures for treatment of urinary incontinence and/or pelvic organ prolapse were excluded from the study. Only patients with American Association of Gynecologic Laparoscopists (AAGL) type IVE total hysterectomy and type III laparoscopic supracervical hysterectomy were included.16 A systematic chart review using standardized case report forms was conducted. Demographic and patient variables collected were age, parity, body mass index, race, medical and surgical history, preoperative symptoms, previous treatment(s), and primary indication for surgery. Recorded surgical variables were surgical route, surgical procedure, operating time (intubation to exit from the operating room), revised American Fertility Society endometriosis score,17 Diamond adhesion index score,18 culdotomy technique, estimated blood loss, final pathological diagnosis, specimen weight, and length of hospital stay. No charts were excluded because ⬍1% of all charts were missing data for uterine weight and operative time only. All patients were scheduled for postoperative follow-up within 4 to 8 weeks from surgery. Patients’ attendance at this visit and duration of postoperative follow-up were obtained from the medical records. The medical records were reviewed for intraoperative and postoperative complications occurring for 12 weeks after hysterectomy. However, complications clearly related to surgery such as cuff dehiscence were included regardless of the time of occurrence. The postoperative complications were classified into severity grades according to the Dindo-Clavien scale.19 This classification is based on the type of therapy needed to correct the complication and was found to be reproducible and applicable to various surgical fields, including gynecology.20 Grade I complication includes any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II complications include blood transfusions or total parenteral nutrition or other intervention that requires pharmacological treatment with drugs other than such allowed for grade I complications. Grade III complications require surgical, endoscopic, or radiological intervention. Surgical Procedures Total hysterectomy was performed according to the AAGL type IVE, laparoscopically directed removal of the entire uterus, and supracervical hysterectomy was performed according to AAGL laparoscopic supracervical hysterectomy type III; occlusion and division of uterine arteries were performed laparoscopically.16 All patients were given prophylactic antibiotics at the start of surgery. The ZUMI or the RUMI uterine manipulators backloaded with a KOH colpotomy ring (all by Cooper Surgical, Trumbull, CT) were used. The uterine arteries were controlled with the use of electrosurgical instruments. The da Vinci robotic surgical platform was used in all cases of robotic hysterectomy. The monopolar shears and the Gyrus PK dissecting forceps (Gyrus ACMI, Norwalk, OH) were placed in the right and left robotic arms, respectively, for the hysterectomy procedure, and the tenaculum or Prograsp forceps were sometimes used in the fourth robotic arm (all by Intuitive Surgical, Sunnyvale, CA). Culdotomy or amputation of the uterine corpus was performed using the monopolar scissors at 30 W coagulation current. The vaginal cuff was closed with a series of figure-eight stitches using a 0-Vicryl suture (Ethicon, Cincinnati, OH) with intracorporeal knot-tying. The laparoscopic hysterectomy was performed using the Gyrus PK cutting forceps. Culdotomy or amputation of the uterine corpus was performed using the monopolar J-hook (range: 30 –50 W cut current), bipolar spatula (Gyrus ACMI), or Harmonic scalpel (Ethicon). The Endostich device (Covidien, Mansfield, MA) was used for vaginal cuff closure using a series of 0-Vicryl interrupted or figureeight sutures and extracorporeal knot-tying. The uterosa- JSLS (2013)17:100 –106 101 Perioperative Outcomes of Robotic Versus Laparoscopic Hysterectomy for Benign Disease, Patzkowsky KE et al. cral ligaments were incorporated in the angle closures of both surgical approaches. Statistical analyses were performed using the SPSS software, version 17.0 (IBM, Armonk, NY). Two-tailed statistical significance was set at .05. A normal distribution of the data was determined using the Kolmogorov-Smirnov test. The Student t test was used for comparison of means for normally distributed data, whereas the Mann-Whitney U test was used for comparison of non-normally distributed data. The 2 and the Fisher exact test were used when appropriate for comparison of proportions. RESULTS A total of 545 patients underwent hysterectomy for benign disease during the study period; 257 were performed laparoscopically (LH) and 288 were performed robotically (RH). Among all patients, 98% had documented follow-up after surgery, with 83% of patients followed for ⱖ4 weeks and 60% followed for ⱖ6 weeks. Patients’ demographics are compared in Table 1. There were no statistically significant differences in mean age, body mass index, and prevalence of diabetes or hypertension between the 2 groups. There was a higher prev- Table 1. Comparison of Patient Demographics Between the Laparoscopic (LH) and Robotic (RH) Cohorts a Age (y) b LH (n⫽257) RH (n⫽288) P Value 42.3⫾6.9 43.2⫾7.1 .1 Parity 2 (0–5) 2 (0–6) .8 BMIa,c (kg/m2) 29.1⫾6.7 30.3⫾8.6 .08 White 212 (82.5) 213 (74.0) Black 32 (12.5) 37 (12.8) Asian 5 (1.9) 8 (2.8) Other Race (%) 8 (3.1) 30 (10.4) 15 (5.8) 16 (5.6) Hypertension (%) 38 (14.8) 47 (16.3) Previous laparotomy (%) 90 (35.0) 151 (52.4) ⱖ2 38 (14.8) 75 (26.0) Expressed as mean ⫾ standard deviation. Expressed as median (range). c BMI ⫽ body mass index. 102 The surgical complications classified according to the Dindo-Clavien scale in the 2 groups are compared in Table 3. Although grade I and grade II complications were seemingly more prevalent in the robotic group (grade I, LH 6.2% vs RH 9.7% and grade II, LH 9.3% vs 13.2%), whereas grade III complications were more prevalent in the laparoscopic group (LH 5.8% vs RH 3.1%), these differences did not reach statistical significance (P⬎.1). There were no cases of grade IV or grade IV complications in either group. The various perioperative complications in the 2 groups are compared in Table 4. The incidence of viscus injury .6 .5 .002 ⱖ1 b Operative characteristics for each group are summarized in Table 2. The rates of total hysterectomy and concomitant adnexectomy were similar in both groups, as were the estimated blood loss and operative time. Intraoperatively confirmed stage III–IV endometriosis and the incidence of severe adhesions (defined as a Diamond adhesion score ⬎11) were more common in women undergoing robotic hysterectomy. The mean uterine weight was also greater in the robotic cohort (LH 186.4⫾130.6 g, 95% confidence interval 170.0 –202.8 g vs RH 234.9⫾193.9 g, 95% confidence interval 212.3–257.7 g, P⫽.001). The conversion to laparotomy rates were significantly higher in the laparoscopic cohort (LH 6.2% vs RH 1.7%, P⫽.007). .03 Diabetes (%) a alence of higher-order (ⱖ2) laparotomies in the robotic cohort (LH 14.8% vs RH 26.0%, P⬍.05). In both cohorts, the most common indications for surgery were chronic pelvic pain and symptomatic uterine fibroids, followed by abnormal uterine bleeding (P⬎.05) (Figure 1). Figure 1. Primary indications for hysterectomy in the laparoscopic (LH) and robotic (RH) cohorts. CPP ⫽ chronic pelvic pain. “Others” refers to adnexal masses, endometrial hyperplasia, and cervical dysplasia. JSLS (2013)17:100 –106 Table 2. Comparison of Intraoperative Surgical Characteristics Between the Laparoscopic (LH) and Robotic (RH) Cohorts LH (n⫽257) RH (n⫽288) P Value Total hysterectomy (%) 185 (72.0) 213 (74.0) .6 Concomitant USO/BSOa (%) 102 (39.7) 109 (37.8) .3 Stage III/IV endometriosis (%) 12 (4.7) 44 (15.3) .001 Severe adhesionsb (%) 34 (13.2) 67 (23.3) .003 Table 4. Comparison of Perioperative Complications Between the Laparoscopic (LH) and Robotic (RH) Cohorts LH (n⫽244) RH (n⫽255) P Value Viscus injurya (%) 3 (1.2) 5 (1.7) .4 Blood transfusion (%) 3 (1.2) 1 (0.3) .3 Vesicovaginal fistula (%) 1 (0.4) 0 .9 Vaginal cuff complicationsb (%) 6 (2.3) 14 (4.9) .09 Vaginal cuff dehiscence (%) 5 (1.9) 1 (0.3) .08 Thrombotic event (%) 2 (0.8) 0 .2 Pneumonia (%) 0 2 (0.7) .3 Urinary tract infection (%) 7 (2.7) 20 (6.9) .02 Uterine weightc (g) 186.4⫾130.6 234.9⫾193.9 .001 Estimated blood lossc (mL) 100.9⫾136.4 99.4⫾166.5 .9 228.1⫾60.1 231.0⫾64.2 .9 Urinary retention (%) 11 (4.3) 31 (10.8) .003 .007 Ileus (%) 0 2 (0.7) .3 Wound complicationsc (%) 5 (1.9) 9 (3.1) .3 Reoperation (%) 13 (5.1) 5 (1.7) .03 c Operative time (min) Conversion to laparotomy (%) 16 (6.2) 5 (1.7) USO ⫽ unilateral salpingo-oophorectomy; BSO ⫽ bilateral salpingo-oophorectomy. b Defined as Diamond adhesion score ⱖ11. c Expressed as mean ⫾ standard deviation. a Table 3. Comparison of Postoperative Surgical Complications Between the Laparoscopic (LH) and Robotic (RH) Cohorts According to the Dindo-Clavien Scale Gradea LH (n⫽257) RH (n⫽288) P Value I (%) 16 (6.2) 28 (9.7) .2 II (%) 24 (9.3) 38 (13.2) .2 III (%) .1 15 (5.8) 9 (3.1) IIIa (%) 1 (0.4) 4 (1.4) IIIb (%) 14 (5.4) 5 (1.7) a There were no cases of grade IV or grade V complications in either group. (bowel, bladder, ureter) was low in both groups (LH 1.2% vs RH 1.7%, P⫽.4). Overall, there were 4 bladder injuries, 3 of which were recognized and repaired intraoperatively, and 2 bowel injuries, 1 of which was recognized and repaired intraoperatively. One patient who underwent robotic hysterectomy sustained a combined bladder and bowel injury diagnosed 14 days postoperatively after presenting with fever and pelvic abscess. There were 2 ureteral injuries in the LH group and 1 in the RH group. All 3 cases were managed conservatively with either temporary ureteral stenting or percutaneous nephrostomy. a Bowel, bladder, and ureteral injury. Vaginal cuff abscess, cuff cellulitis, and cuff hematoma. c Wound infection and wound hematoma. b There were fewer patients with vaginal cuff dehiscence in the RH cohort (0.5%) than in the LH cohort (2.7%), but this difference did not reach statistical significance (P⫽.07) (Table 4). All patients reported coitus immediately preceding cuff dehiscence. However, not all episodes were associated with the first coitus after the hysterectomy. Five of the 6 patients with cuff dehiscence presented within 3 months after their surgery, and the sixth patient presented on the 29th postoperative day. There was no significant relationship between vaginal cuff dehiscence and age, body mass index, menopausal status, diabetes, tobacco use, estimated blood loss, or type of energy used for culdotomy (data not shown). The rates of other vaginal cuff complications (ie, cellulitis, abscess, and hematoma) were similar in the 2 groups (LH 2.3% vs RH 4.9%, P⫽.09) (Table 4). Vaginal cuff abscess occurred in 1.2% of LH patients versus 2.4% of RH patients (P⫽.2). The incidence of cuff abscess increased with the severity of endometriosis, with a 1.1% incidence in patients without endometriosis, 2.6% incidence in patients with stage I–II endometriosis, and 9.3% incidence in patients with stage III–IV endometriosis (P⫽.01). There was no association between vaginal cuff abscess and body mass index, diabetes, tobacco use, operative time, estimated blood loss, or the need for morcellation (data not shown). JSLS (2013)17:100 –106 103 Perioperative Outcomes of Robotic Versus Laparoscopic Hysterectomy for Benign Disease, Patzkowsky KE et al. There was a significantly higher rate of urinary tract infection and urinary retention in the RH cohort than in the LH cohort (Table 4). Urinary retention was not associated with age, body mass index, presence of diabetes, smoking status, previous cesarean sections, previous abdominal surgeries, uterine weight, intra-abdominal adhesions, or estimated blood loss (data not shown). Overall, the need for reoperation was statistically greater in the LH cohort (Table 4). The indications for reoperation in the laparoscopic cohort included vaginal cuff dehiscence (n⫽5), significant vaginal cuff bleeding (n⫽2), vaginal cuff abscess (n⫽2), cystoscopic repair of ureteral injury (n⫽1), vesicovaginal fistula (n⫽1), prolapsed fallopian tube through the vaginal cuff (n⫽1), and trocar site hematoma (n⫽1). In the RH cohort, 5 patients underwent reoperation for vaginal cuff abscess (n⫽2), vaginal cuff bleeding (n⫽1), cuff dehiscence (n⫽1), and repair of bladder and bowel injury (n⫽1). DISCUSSION This series directly compares perioperative outcomes of LH with RH for benign indications. Our data suggest that more complex surgeries are being performed robotically, as indicated by the higher prevalence of stage III–IV endometriosis, high-order (ⱖ2) previous laparotomies, severe adhesions, and a larger mean uterine weight. Despite the greater complexity of surgery, surgical outcomes including surgical complications, estimated blood loss, and operative time are similar between RH and LH groups, and the overall complication rate is acceptably low. Because this is a retrospective study, the difference in complexity of cases between the 2 groups reflects the surgeons’ preference to perform complex hysterectomies via the robotic route. A randomized study would be better designed to compare the outcome of the 2 surgical approaches for cases of similar complexity. Another drawback of our study is the different distribution of the LH and RH cases over the ⬃10-year study period, with more LH cases performed in the earlier years and more RH cases performed in later years. This may introduce a bias in the occurrence of surgical complication in the laparoscopic groups because it could be assumed that the surgeons gained additional surgical experience during the 10 years of the study. However, this bias may be offset by the surgeons being novice robotic surgeons when this technique was introduced. 104 Previous studies reporting surgical complications of laparoscopic and robotic hysterectomy classified these complications into major and minor categories. In these studies, the rate of major complications varied widely, from ⬍1% to 20%. This wide range is probably because of the absence of a standard definition of a major or minor complication as well as extreme variability in the follow-up time for reporting of complications, ranging from 1 day to ⬎6 weeks.11–15 In the current study, the DindoClavien scale was used to classify the surgical complications. This system grades surgical complications according to the treatments required19 and has been shown to be reproducible and fairly easy to use.20 Using the DindoClavien scale, there were no statistically significant differences in surgical complications between the 2 groups, and the rates of grade III complications were low in both groups, indicating that both surgeries can be performed safely. Nevertheless, our study may still be underpowered to detect differences in rare postoperative complications such as viscus injury. Further studies and meta-analyses could provide additional data on the occurrence of these rare complications. Postoperative vaginal cuff abscess was an infrequent complication in both the LH and RH groups and was directly related to the presence and severity of endometriosis. We postulate that this relationship is a consequence of greater tissue dissection, greater use of electrosurgery, more tissue necrosis, and possibly a less hemostatic surgical bed associated with both the laparoscopic and the robotic approach to an obliterated cul-de-sac. Previous studies have consistently shown the incidence of cuff dehiscence complicating total LH and RH to be higher than the vaginal and abdominal routes.21–23 The incidence of cuff dehiscence after total laparoscopic hysterectomy was found to be as high as 4.9% in a large retrospective study from 2007.24 However, the data from this large study were recently reanalyzed and showed the 10-year cumulative incidence of dehiscence after total LH to be 1.35%.25 In the current study, the incidence of cuff dehiscence after total laparoscopic hysterectomy was higher when compared with RH. This difference approached, but did not reach, statistical significance (P⫽.07), possibly because the sample size was underpowered to detect this relatively rare complication. Operative cost is another important consideration when comparing LH with RH. Two previous studies26,27 estimated that the added cost of robotic hysterectomy over laparoscopic hysterectomy is in the range of $2600. This factor needs to be considered when determining the ap- JSLS (2013)17:100 –106 propriate route of surgery, especially because operative outcomes for these 2 routes appear to be similar. Our study is limited by its retrospective and nonrandomized design, leading to possible inaccurate or incomplete data collection, which may result in an underestimation of surgical complications. The nonrandomized retrospective design is also known to be associated with possible selection case bias, where more difficult cases may have been chosen for a robotic approach according to surgeon preference. Another limitation of our study is the long duration of the study period, during which some surgical and postoperative management practices may have changed. Conversely, collecting data over a long period enabled us to include a relatively large number of patients. CONCLUSION Perioperative outcomes for LH and RH for benign indications are equivalent. These findings are similar to a recent Cochrane Review that concluded limited evidence showed that robotic surgery did not benefit women with benign gynecological disease as far as effectiveness or safety.28 Our study suggested that some outcomes trend toward improvement with a robotic route, including a lower incidence of vaginal cuff dehiscence and a lower rate of conversion to laparotomy. Future studies using a randomized study design may further investigate the operative outcomes of the robotic and laparoscopic routes. References: 1. Johnson N, Barlow D, Lethaby A, Tavender E, Curr L, Garry R. Methods of hysterectomy: systematic review and meta-analysis of randomized controlled trials. BMJ. 2005;330:1478 –1486. 2. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cohcrane Database Syst Rev. 2009;8:CD003677. 3. Farquhar CM, Steiner CA. Hysterectomy rates in the United States 1990 –1997. Obstet Gynecol. 2002;99:229 –234. 4. Jacoby VL, Autry A, Jacobson G, Domush R, Nkagawa A, Jacoby A. Nationwide use of laparoscopic hysterectomy compared with abdominal and vaginal approaches. Obstet Gynecol. 2009;114:1041–1048. 7. Daneshgari F, Kefer JC, Moore C, Kaouk J. Robotic abdominal sacrocolpopexy/sacrouteropexy repair of advanced female pelvic organ prolapse (POP): utilizing POP-quantification based staging and outcomes. BJU Int. 2007;100:875– 879. 8. Degueldre M, Vandromme J, Huong PT, Cadiere GB. Robotically assisted laparoscopic microsurgical tubal reanastomosis: a feasibility study. Fertil Steril. 2000;74:1020 –1023. 9. Marchal F, Rauch P, VAndromme J, et al. Telerobotic-assisted laparoscopic hysterectomy for benign and oncologic pathologies: initial clinical experience with 30 patients. Surg Endosc. 2005;19: 826 – 831. 10. Reynolds RK, Advincula AP. Robot-assisted laparoscopic hysterectomy: technique and initial experience. Am J Surg. 2006; 191:555–560. 11. Boggess JF. A comparative study of three surgical methods for hysterectomy with staging for endometrial cancer; robotic assistance, laparoscopy, laparotomy. Am J Obstet Gynecol. 2008; 199:360.e1–9. 12. Boggess JF, Gehrig PA, Cantrell L, et al. A case-control study of robotic assisted type III radical hysterectomy with pelvic lymph-node dissection compared with open radical hysterectomy. Am J Obstet Gynecol. 2008;199:357.e1–7. 13. Magrina JF, Kho RM, Weaver AL, Motero RP, Magtibay PM. Robotic radical hysterectomy: comparison with laparoscopy and laparotomy. Gynecol Oncol. 2008;109:86 –91. 14. Shashoua AR, Gill D, Locher SR. Robotic-assisted total laparoscopic hysterectomy versus conventional total laparoscopic hysterectomy. JSLS. 2009;13(3):364 –369. 15. Sarlos D, Kots LA. Robotic versus laparoscopic hysterectomy: a review of recent comparative studies. Curr Opin Obstet Gynecol. 2011;23:283–288. 16. Olive DL, Parker WH, Cooper JM, Levine RL. The AAGL classification system for laparoscopic hysterectomy. J Am Assoc Gynecol Laparosc. 2000;7:9 –15. 17. The American Fertility Society. Revised American Fertility Society classification of endometriosis: 1985. Fertil Steril. 1985; 43:351–352. 18. Diamond MP, Daniell JF, Johns DA, et al. Postoperative adhesion development after operative laparoscopy: evaluation at early second-look procedures. Operative Laparoscopy Study Group Fertil Steril. 1991;55:700 –704. 5. Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007;110:1091–1095. 19. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205– 213. 6. Advincula AP, Song AH, Burke W, Reynolds RK. Preliminary experience with robot-assisted laparoscopic myomectomy. J Am Assoc Gynecol Laparosc. 2004;11:511–518. 20. Clavien PA, Barkun J, de Oliveira ML, et al. The ClavienDindo classification of surgical complications: five-year experience. Ann Surg. 2009;250:187–196. JSLS (2013)17:100 –106 105 Perioperative Outcomes of Robotic Versus Laparoscopic Hysterectomy for Benign Disease, Patzkowsky KE et al. 21. Donnez O, Jadoul P, Squifflet J, Donnez J. A series of 3190 laparoscopic hysterectomies for benign disease from 1990 to 2006: evaluation of complications compared with vaginal and abdominal procedures. BJOG. 2009;116:492–500. 22. Garry R, Fountain J, Mason S, et al. The eVALuate study: two parallel randomized trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. BMJ. 2004;328:129. 23. Makinen J, Johansson J, Tomas C, et al. Morbidity of 10,110 hysterectomies by type of approach. Hum Reprod. 2001;16: 1473–1478. 24. Hur HC, Guido RS, Mansuria SM, Hacker MR, Sanfilippo JS, Lee TT. Incidence and patient characteristics of vaginal cuff dehiscence after different modes of hysterectomies. J Minim Invasive Gynecol. 2007;14:311–317. 106 25. Hur HC, Donnellan N, Mansuria S, Barber RE, Guido R, Lee T. Vaginal cuff dehiscence after different modes of hysterectomy. Obstet Gynecol. 2011;118:794 – 801. 26. Sarlos D, Kots L, Stevanovic N, Schaer G. Robotic hysterectomy versus conventional laparoscopic hysterectomy: outcome and cost analyses of a matched case-control study. Eur J Obstet Gynecol Reprod Biol. 2010;150:92–96. 27. Pasic RP, Rizzo JA, Fang H, et al. Comparing robot-assisted with conventional laparoscopic hysterectomy: impact on cost and clinical outcomes. J Minim Invasive Gynecol. 2010;17:730 – 738. 28. Liu H, Lu D, Wang L, Shi G, Clarke J. Robotic surgery for benign gynaecolgical disease. Cochrane Database Syst Rev. 2012;15;2:CD008978. JSLS (2013)17:100 –106 SCIENTIFIC PAPER Postoperative Patient Satisfaction After Laparoscopic Supracervical Hysterectomy Garri Tchartchian, MD, Konstantinos Gardanis, MD, Bernd Bojahr, Rudy Leon de Wilde ABSTRACT INTRODUCTION Background and Objectives: The aim of this study was to evaluate postoperative patient satisfaction in women after laparoscopic supracervical hysterectomy (LASH). Hysterectomy is one of the most commonly performed surgical procedures in gynecology. Supracervical hysterectomy has been rediscovered as a minimally invasive alternative to all methods of total hysterectomy. In the 1940s, supracervical hysterectomy, which was then performed by laparotomy, was largely replaced by total hysterectomy. This was the result of advances in medical technology and the emerging use of antibiotics, and to prevent the occurrence of cervical stump carcinoma and the development of prolapse as adverse events after supracervical hysterectomy. The major changes in technique introduced were extrafascial removal of the entire uterus with anchoring of the anterior and posterior vaginal cuff at the corners to the uterosacral ligaments.1 In this prelaparoscopic era, total hysterectomy dominated with its 2 approaches: vaginal (VH) and abdominal (AH). Reich2 first performed laparoscopic hysterectomy in 1989. During the past 2 decades, the laparoscopic approach to hysterectomy has evolved. Currently, 3 types of laparoscopic hysterectomy (LH) are practiced: laparoscopically assisted vaginal hysterectomy (LAVH), where VH is preceded by laparoscopy; total LH (TLH), where the vaginal vault is sutured laparoscopically; and laparoscopic supracervical hysterectomy (LASH). Methods: A retrospective study by a mailed questionnaire among 2334 women who underwent hysterectomy via LASH at the MIC-Klinik, Berlin, between 1998 and 2004 was conducted. Indications for LASH were uterus myomatosus, adenomyosis uteri, disorders of bleeding, and genital descensus. The LASH operation technique was standardized and remained consistent throughout the observation period. Pearson’s test for metric variables, Spearman’s rank correlation test for ordinal data, Mann-Whitney U test, and Kruskal-Wallis test were used. Results: Of the 2334 questionnaires mailed, 1553 were returned and 1431 (61.3%) of those could be analyzed. Almost 94% (93.9%) of the women were highly satisfied with the outcome, 5.6% reported medium satisfaction, and 0.5% were not satisfied. There was no significant difference in patient satisfaction with regard to the different indication for LASH. Conclusion: This study demonstrates high postoperative patient satisfaction after LASH. The rate of highly satisfied women might be increased by carefully choosing the right indications for LASH and improving operation techniques. This is important for widening acceptance of this innovative new operation standard. Key Words: LASH, Hysterectomy, Satisfaction. Klinik für Minimal Invasive Chirurgie, Berlin-Zehlendorf, Germany (Dr. Tchartchian, Dr. Bojahr) Universitätsfrauenklinik Tübingen, Tübingen, Germany (Dr. Gardanis) Pius-Hospital, Klinik für Frauenheilkunde, Geburtshilfe und Gynäkologische Onkologie, Oldenburg, Germany (Dr. de Wilde) Address correspondence to: Garri Tchartchian, Klinik für Minimal Invasive Chirurgie, Kurstraße 11, 14129 Berlin-Zehlendorf, Germany. Telephone: 0049-30-80988155, Fax: 0049-30-80988188, E-mail: [email protected] © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. Advantages of LASH are less morbidity, faster reconvalescence, shorter hospital stay, and subsequent reduced economic burden. Further, supracervical hysterectomy preserves the anatomy of the cervix and surrounding structures. Numerous authors note that the cervix should not be removed without indication because this might result in genital descensus, bladder and bowel alterations, or sexual disorders.3– 6 The leading argument against supracervical hysterectomy is the possibility of cervical stump carcinoma development. Although the risk of cervical stump carcinoma is low (0.11 to 1.9%),7,8 postoperative preventive cancer screening is obligatory, and women with conspicuous Papanicolaou test results should be excluded from LASH. Beyond medical and economical reasons, patient satisfaction plays an important role with regard to the acceptance and widening of a new operation technique. The aim of JSLS (2013)17:107–110 107 Postoperative Patient Satisfaction After Laparoscopic Supracervical Hysterectomy, Tchartchian G et al. this study was to evaluate postoperative patient satisfaction in women after LASH. To our knowledge, this issue has been evaluated only in small cohorts. MATERIALS AND METHODS Patient satisfaction of women who underwent hysterectomy via LASH at the MIC-Klinik, Berlin, between 1998 and 2004 was evaluated in a retrospective study by mailed questionnaire. Indications for LASH were uterus myomatosus, adenomyosis uteri, disorders of bleeding, and genital descensus. In the case of genital descensus, LASH was performed in combination with cervicosacropexy or with suspension with modified McCall suture. Benignity was clarified by colposcopy and cytology. No woman had endometriosis. In the case of abnormal bleeding and suspect sonographic findings, dilation and curettage was performed. Preoperative counseling emphasized the need for continued cervical screening and a possibility of cyclical bleeding in the future. The LASH operation technique standardized and remained consistent throughout the observation period.9 Patients are placed in the dorsal lithotomy position with the bladder drained before operation. A uterine manipulator is not used. With sufficient pulling of the forceps to the other side, it is not necessary for safety reasons to use a manipulator. With this method, our intraoperative complication rate remains as low as with use of a manipulator. Pneumoperitoneum is established via the Veress needle through the umbilicus, and a 5-mm port is inserted followed by two 5-mm lower quadrant ports, lateral to the inferior epigastric arteries. The round ligaments and the uterine tubes are coagulated and transected bilaterally. After creation of a bladder flap, the parametria are dissected and the uterine arteries secured with a bipolar device. The uterus is amputated using a monopolar hook. Hemostasis is performed by bipolar coagulation of the cervical stump, including the epithelium lining the endocervical canal. The cervical stump is covered with peritoneum using a purse-string suture. Uterine morcellation is carried out with a 10-, 15-, or 20-mm electric morcellator through the dilated left lower quadrant port. During the observation period from June 1998 to October 2004, 2334 LASH operations were performed at MICKlinik, Berlin. In the same period, 14 AHs, 1 TLH, and 77 LAVHs were performed. A questionnaire was sent at a minimum of 6 months after the operation to all 2334 women. We used Pearson’s test for metric variables, Spearman’s rank correlation test for ordinal data, as well as the Mann-Whitney U test and Kruskal-Wallis test. A P value ⬍ .05 was considered statistically significant. Data were analyzed using SPSS version 13.0 (SPSS Inc./IBM, Armonk, NY). RESULTS Of all 2334 questionnaires sent out, 1553 were returned and 1431 (61.3%) of those could be analyzed. As shown in Table 1, 1344 patients (93.9%) were highly satisfied with their outcome after LASH. Eighty patients (5.6%) reported medium satisfaction and 7 patients (0.5%) were not satisfied. There was no significant difference in patient satisfaction with regard to the different indication for LASH. When the period between the date of LASH and the date of questioning was classified into 6 subgroups (5 to 6 years, 4 to 5 years, 3 to 4 years, 2 to 3 years, 1 to 2 years, and 6 to 12 months), no significant difference in patient satisfaction could be found within the different subgroups (Table 2). Patients were asked about the occurrence of postoperative vaginal bleeding. There was no significant difference in the percentages of postoperative bleeding with regard to the indication for LASH (Table 3). As shown in Table 4, 288 of the 1344 patients (21.4%) who were highly satisfied with LASH had postoperative vaginal bleeding. Of the 80 women reporting medium satisfaction, 41 (51.3%) had vaginal bleeding, whereas in the group of 7 poorly satisfied women, 5 (71.4%) had postoperative bleeding. Table 1. Postoperative Patient Satisfaction After LASH Patient Satisfaction Uterus Myomatosus High, n (%) 1116 (94.6) 72 (90.0) 149 (92.5) 7 (70.0) 1344 (93.9) Medium, n (%) 58 (4.9) 8 (10.0) 12 (7.5) 2 (20.0) 80 (5.6) Poor, n (%) 6 (0.5) 0 (0.0) 0 (0.0) 1 (10.0) 7 (0.5) 108 Adenomyosis Uteri Bleeding Disorders JSLS (2013)17:107–110 Genital Descensus All Indications Table 2. Postoperative Patient Satisfaction at Different Time Points of Follow-up After LASH Patient Satisfaction 6 mo to 1 y 1 to 2 y 2 to 3 y 3 to 4 y 4 to 5 y 5 to 6 y High, n (%) 362 (92.8) 453 (93.4) 212 (94.6) 191 (95.5) 97 (97.0) 29 (90.6) Medium, n (%) 26 (6.7) 29 (6.0) 12 (5.4) 7 (3.5) 3 (3.0) 3 (9.4) Poor, n (%) 2 (0.5) 3 (0.6) 0 (0.0) 2 (1.0) 0 (0.0) 0 (0.0) Table 3. Postoperative Bleeding After LASH Patient Satisfaction Table 5. Influence of Postoperative Bleeding on Quality of Life Postoperative Bleeding No Yes Negative Influence of Postoperative Bleeding on Quality of Life Uterus myomatosus, n (%) 901 (76.4) 279 (23.6) No Yes Adenomyosis uteri, n (%) 61 (76.2) 19 (23.8) Bleeding disorders, n (%) 126 (78.3) 35 (21.7) Uterus myomatosus,n (%) 227 (79.4) 59 (20.6) Genital descensus, n (%) 9 (90.0) 1 (10.0) Adenomyosis uteri, n (%) 8 (53.3) 7 (46.7) All indications, n (%) 1097 (76.7) 334 (23.3) Bleeding disorders, n (%) 18 (54.5) 15 (45.5) Table 4. Postoperative Bleeding and Patient Satisfaction Patient Satisfaction Postoperative Bleeding No Yes High, n (%) 1056 (78.6) 288 (21.4) Medium, n (%) 39 (48.8) 41 (51.2) Poor, n (%) 2 (28.6) 5 (71.4) A significant correlation between patient satisfaction and postoperative vaginal bleeding could be observed (P ⬍ .05). Another question evaluated whether postoperative vaginal bleeding had a negative influence on quality of life. Differences in patient satisfaction between women having answered this question with “yes” or with “no” are highly significant (P ⬍ .0004). Table 5 shows the influence of postoperative vaginal bleeding on quality of life with regard to the indication for LASH. Of the 286 women with postoperative vaginal bleeding when LASH was indicated because of uterus myomatosus, 59 patients (20.6%) claimed that the bleeding had a negative influence on their quality of life. This was also reported by 7 of the 15 women with adenomyosis uteri (46.7%). When LASH was indicated because of bleeding disorders, 33 women still had postoperative bleeding. Here, the bleeding negatively Indication for LASH influenced quality of life in 15 women (45.5%). The percentages of women in whom postoperative bleeding negatively influenced quality of life significantly differed with regard to the respective indication for LASH (P ⬍ .0004). DISCUSSION This retrospective analysis of patient satisfaction in women after LASH shows that most patients are highly satisfied with their postoperative outcome, which is in line with smaller studies.10 –12 Postoperative satisfaction was constantly high after the different indications for LASH and did not depend on the duration of the observation period and the date of LASH, respectively. The latter fact might be of particular interest for gynecologists deciding to establish laparoscopic operation techniques in their departments because early LASH operations performed 6 years ago were also considered. Approximately one-quarter of the women had postoperative bleeding. This is not a result of too-high amputation rates. As the cervical mucus recovers after surgery, it may react to hormonal changes in the area of the ovaries. In the future, we will try to resolve this problem by sufficient duration of coagulation. The rate of postoperative bleeding published is between 1% and 25%, whereby this discrepancy might be explained by different case numbers, operation techniques, or observation periods.11,13–16 Patient satisfaction correlated with these postoperative vaginal bleeding occurrences. This was even more pronounced when quality of life JSLS (2013)17:107–110 109 Postoperative Patient Satisfaction After Laparoscopic Supracervical Hysterectomy, Tchartchian G et al. was decreased by postoperative bleeding. With regard to the different indications for LASH, postoperative bleeding was found to have a mostly negative influence on quality of life in women who had LASH for adenomyosis uteri or for preoperative bleeding disorders. This underlines the importance of choosing the right indication for LASH. In particular, women with bleeding disorders or dysmenorrhea should be carefully counseled that postoperative (cyclic) bleeding might persist. An influence of the operation technique on postoperative bleeding was demonstrated by others, and the height of uterus amputation, as well as coagulation of the endocervical canal, is considered to play an important role.17,18 Future prospective trials should be conducted to evaluate patient satisfaction with regard to different operation techniques or modifications. CONCLUSION This study demonstrates high postoperative patient satisfaction in women after LASH. The rate of highly satisfied women might be increased by carefully choosing the right indications for LASH and improving operation techniques. This is important for widening acceptance of this innovative new operation standard. References: 1. Richardson EH. A simplified technique for abdominal panhysterectomy. Surg Obstet Gynecol. 1929;48:248 –251. 2. Reich H. New techniques in advanced laparoscopic surgery. Baillieres Clin Obstet Gynaecol. 1989;3(3):655– 681. 3. Pelosi MA, Pelosi MA 3rd. Laparoscopic supracervical hysterectomy using a single-umbilical puncture (mini-laparoscopy). J Reprod Med. 1992;37(9):777–784. 4. Hasson HM. Cervical removal at hysterectomy for benign disease. Risks and benefits. J Reprod Med. 1993;38(10):781–790. 5. Lyons TL. Laparoscopic supracervical hysterectomy. A comparison of morbidity and mortality results with laparoscopically assisted vaginal hysterectomy. J Reprod Med. 1993;38(10):763– 767. 110 6. Mettler L, Semm K. Subtotal versus total laparoscopic hysterectomy. Acta Obstet Gynecol Scand Suppl. 1997;164:88 –93. 7. Kilkku P, Gronroos M. Peroperative electrocoagulation of endocervical mucosa and later carcinoma of the cervical stump. Acta Obstet Gynecol Scand. 1982;61(3):265–267. 8. Kilkku P, Grönroos M, Taina E, Söderström O. Colposcopic, cytological and histological evaluation of the cervical stump 3 years after supravaginal uterine amputation. Acta Obstet Gynecol Scand. 1985;64(3):235–236. 9. Bojahr B, Raatz D, Schonleber G, Abri C, Ohlinger R. Perioperative complication rate in 1706 patients after a standardized laparoscopic supracervical hysterectomy technique. J Minim Invasive Gynecol. 2006;13(3):183–189. 10. Kilkku P, Lehtinen V, Hirvonen T, Grönroos M. Abdominal hysterectomy versus supravaginal uterine amputation: psychic factors. Ann Chir Gynaecol Suppl. 1987;202:62– 67. 11. van der Stege JG, van Beek JJ. Problems related to the cervical stump at follow-up in laparoscopic supracervical hysterectomy. JSLS. 1999;3(1):5–7. 12. Okaro EO, Jones KD, Sutton C. Long term outcome following laparoscopic supracervical hysterectomy. BJOG. 2001; 108(10):1017–1020. 13. Schwartz RO. Laparoscopic hysterectomy. Supracervical vs. assisted vaginal. J Reprod Med. 1994;39(8):625– 630. 14. Lyons TL. Laparoscopic supracervical hysterectomy. Baillieres Clin Obstet Gynaecol. 1997;11(1):167–179. 15. Learman LA, Summitt RL Jr, Varner RE, et al. A randomized comparison of total or supracervical hysterectomy: Surgical complications and clinical outcomes. Obstet Gynecol. 2003;102(3): 453– 462. 16. Hasson HM, Rotman C, Rana N, Asakura H. Experience with laparoscopic hysterectomy. J Am Assoc Gynecol Laparosc. 1993; 1(1):1–11. 17. Donnez J, Nisolle M. Laparoscopic supracervical (subtotal) hysterectomy (LASH). J Gynecol Surg. 1993;9(2):91–94. 18. Ghomi A, Hantes J, Lotze EC. Incidence of cyclical bleeding after laparoscopic supracervical hysterectomy. J Minim Invasive Gynecol. 2005;12(3):201–205. JSLS (2013)17:107–110 SCIENTIFIC PAPER Total Microlaparoscopic Radical Hysterectomy in Early Cervical Cancer Francesco Fanfani, MD, Valerio Gallotta, MD, Anna Fagotti, PhD, Cristiano Rossitto, MD, Elisa Piovano, MD, Giovanni Scambia, MD ABSTRACT INTRODUCTION Background and Objective: In less than 2 decades, laparoscopy has contributed to modification in the management of early cervical cancer patients, and all comparisons between open and laparoscopic-based radical operations showed an identical oncological outcome. The aim of this study is to describe surgical instrumentations and technique to perform total microlaparoscopy radical hysterectomy in early cervical cancer patients and report our preliminary results in terms of operative time and perioperative outcomes. In less than 2 decades, laparoscopy has definitely contributed to modification in the management of cervical cancer patients. After laparoscopy’s introduction in 1990,1 several studies have documented the safety and feasibility of laparoscopic radical hysterectomy in early-stage cervical cancer patients (ECC).1–10 In the first period, laparoscopy was considered assistance to a radical vaginal approach (LARVH), whereas more recently there is general agreement about the achievability to perform all of the procedures by laparoscopy (TLRH).2,3 All comparisons between open and laparoscopic-based radical operations for the treatment of women with ECC show an identical oncological outcome.2,4,6,8 Methods: Between January 1, 2012, and March 25, 2012, 4 consecutive early cervical cancer patients were enrolled in this study. Results: We performed 3 type B2 and 1 type C1-B2 total microlaparoscopy radical hysterectomy, and in all cases concomitant bilateral salpingo-oophorectomy and pelvic lymphadenectomy were carried out. Median operative time was 165 minutes (range: 155 to 215) (mean: 186), and median estimated blood loss was 30 mL (range: 20 to 50). Median number of pelvic lymph nodes removed was 12 (range: 11 to 15). All procedures were completed without 5-mm port insertion and without conversion. No intraoperative or early postoperative complications were reported. Conclusions: This report suggests a role of microlaparoscopy in the surgical management of early cervical cancer with adequate oncological results, superimposable operative time, and perioperative outcomes with respect to standard laparoscopy. Key Words: Microlaparoscopy, Radical hysterectomy, Cervical cancer. Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome, Italy Address correspondence to: Francesco Fanfani, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Largo Agostino Gemelli 8, 00168 Rome, Italy. Telephone and fax: ⫹39 – 0630156332, E-mail: [email protected] DOI: 10.4293/108680812X13517013318319 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. In recent years, many efforts have been made by laparoscopic surgeons to further reduce the surgical invasiveness of minimally invasive approaches by reducing the trauma of access ports by reducing their diameter to 3 mm or performing single-port surgery. The evolution of even more minimally invasive surgery toward microlaparoscopy (M-LPS) and single-port laparoscopy (LESS) has been supported by different goals: (1) To extend to even more minimally invasive techniques the benefits already realized for laparoscopy versus laparotomy in terms of postoperative pain, recovery time, and cosmetic results; and (2) to perform laparoscopic procedures with the leastinvasive approach with the assumption of minimizing the risk of incisional complications. Recently, different studies showed an early postoperative benefit in terms of pain for patients who underwent hysterectomy by LESS with respect to patients treated using standard laparoscopy (S-LPS).11,12 Regarding M-LPS hysterectomy, Ghezzi et al13,14 recently found that ports can be safely reduced in size without a negative impact on the surgeon’s ability to perform total hysterectomy and that M-LPS appears to have no advantage over S-LPS in terms of postoperative pain. We have recently shown that both M-LPS and LESS hysterectomy can be performed safely and seem to be associated with halving of early postoperative pain, with a lower request of analgesia compared with standard laparoscopy.15 JSLS (2013)17:111–115 111 Total Microlaparoscopic Radical Hysterectomy in Early Cervical Cancer, Fanfani F et al. To our knowledge, there are no reports about total M-LPS radical hysterectomy. The following are our preliminary results and surgical technique obtained with total M-LPS radical hysterectomy in ECC patients. MATERIALS AND METHODS Between January 1, 2012 and March 25, 2012, 19 cervical cancer patients were referred to the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart in Rome, Italy. All of these patients were prospectively evaluated for M-LPS treatment. Inclusion criteria were FIGO stage IA2-IB1 cervical cancer with no evidence of lymph node and/or adnexal and/or corpus uteri involvement at computed tomography/magnetic resonance imaging; uterine size ⬍12 weeks’ gestation; no history of previous xifo-pubic abdominal major laparotomic surgery (laparotomy for peritonitis, bowel resection, etc); body mass index (BMI) ⬍35; and American Society of Anesthesiologists score ⬍II. Our institutional review board approved the study, and patients were informed about the M-LPS technique and signed a written informed consent acknowledging the risk of standard laparoscopic and/or laparotomic conversion. The same surgical team (1 experienced surgeon, 1 fellow, and 1 resident) performed all of the interventions. Patient demographic (age, race), surgical (type of hysterectomy, operative time, blood loss), and postoperative (complications, discharge, bladder voiding function, ileus) data were prospectively collected. Clinical (BMI, previous neoplasms) and diagnostic information regarding actual disease (stage, grade, histotype, lymph nodes, residual disease) were also noted from paper patient charts and electronic medical records. Operative time (OT) was defined as the interval between incision start and closure. Operative complications were defined as bowel, bladder, ureteral, or vascular injuries, and an estimated blood loss (EBL) ⱖ500 mL. Anemia was considered when hemoglobin level was ⬍8 g/dL, and fever was considered when body temperature was at least 38 °C in 2 consecutive measurements at least 6 hours apart, excluding the first day after surgery. Patients were discharged home when they were fully mobile, apyrexial, and could pass urine satisfactorily. Early postoperative complications were defined as any adverse event that occurred within 30 days after surgery, and they were considered severe if they resulted in unplanned readmission, blood transfusion, or a secondary surgical procedure. 112 Surgical Instruments and Technique Surgical procedures were performed with one disposable optic-view transumbilical 10-mm port (Endopath Xcel 10-mm optic-view; Ethicon Endo-Surgery, Cincinnati, OH). A 10-mm 0 ° HD-videolaparoscope (Endoeye; Olympus Winter & Ibe GmbH, Hamburg, Germany) was inserted in the umbilical port. Patients under general anesthesia were positioned in the dorsal lithotomic position with both legs supported in Allen stirrups with a Trendelenburg tilt. A reusable intrauterine manipulator (Karl Storz, Tuttlingen, Germany) was used to move the uterus. Once pneumoperitoneum (12 mm Hg) was achieved, 3 additional 3.5-mm reusable ports with conical tip were inserted, and 3-mm operative instruments (Karl Storz) were used (Figure 1) from choices of dissecting and grasping forceps, monopolar scissors or spatula, suction and irrigation tube (Karl Storz), and 2 types of bipolar coagulator (Take-Apart bipolar coagulating forceps [Karl Storz] and PK Molly forceps [Gyrus ACMI, Hamburg, Germany]. Monopolar scissors/hook/spatula were inserted into the suprapubic port; bipolar forceps were inserted into the left port; and the right port was used for grasping or as a suction/irrigation device. The disposition of the instruments did not change during the intervention. After pelvic and abdominal exploration and washing, the operations started with opening of the pelvic retroperitoneal spaces. Paravesical and pararectal spaces were developed with blunt dissection. Systematic removal of external iliac and obturator nodes was performed by a combination of bipolar forceps and monopolar scissors/spatula (Figure 2). A free endo-bag was inserted through the umbilical port Figure 1. External vision of the surgical field: one 10/12-mm umbilical port and three 3-mm ancillary ports. JSLS (2013)17:111–115 Figure 2. Right pelvic lymphadenectomy. EIA ⫽ external iliac artery; EIV ⫽ external iliac vein; GN ⫽ genitofemoral nerve; ON ⫽ obturator nerve, OUA ⫽ obliterated umbilical artery, PM ⫽ psoas muscle. Figure 4. Dissection of the right paracervix after uterine artery section and ureteral tunnel development. P ⫽ paracervix; U ⫽ ureter; UVL ⫽ uterovesical ligament. nopolar and bipolar devices with the “vessel by vessel” technique. Dissection of the ureteral tunnel and vesicovaginal spaces was accomplished with monopolar and blunt technique and with the aid of bipolar coagulation (Figure 4). At that point, the vaginal wall was identified and transected with a monopolar hook using pure section energy to avoid postoperative ureteral and bladder complications. The specimens were removed vaginally. The vaginal cuff was then closed by laparoscopy with 0 polyglactin running sutures using a 3-mm needle holder (Karl Storz). A hydropneumatic test for bladder integrity was performed at the end of the procedure. The laparoscopic access point was not sutured but was closed only with steri-strips. Radical hysterectomy was classified according to Querleu and Morrow classification.16 Figure 3. Dissection of the posterior paracervix. HN ⫽ hypogastric nerve; R ⫽ rectum; U ⫽ ureter; US ⫽ uterosacral ligament; V ⫽ vagina. after removing the camera; then after replacing the camera, lymph nodal specimens were put into the endo-bag, removed throughout the umbilical port after removing the camera again, and sent for frozen section analysis. The uterine artery was identified, coagulated, and sectioned at the origin from the umbilical artery with bipolar forceps. The uterosacral ligament was transected after separation of the hypogastric nerve after Okabayashi’s pararectal space development with combination of mono- and bipolar instruments (Figure 3). The paracervical tissue and the uterosacral ligaments were transected combining mo- RESULTS During the study period, 4 of 19 consecutive cervical cancer patients (20.1%) met all the inclusion criteria and were enrolled in this trial. None of the candidate patients refused to be enrolled in the study. Table 1 shows the clinicopathological and procedural characteristics of the study population. All patients were Caucasian. The median/mean age was 46/52 years (range: 45 to 70), and the median/mean BMI was 22.2/23.4 kg/m2 (range: 20 to 28.5). Three patients were staged as FIGO 1A2 (2 of these had positive margins after cone biopsy), and the remaining patient was staged as FIGO 1B1. Three women had squamous histology, and 1 had an adenocarcinoma. Two patients had a moderate (G2) differentiated JSLS (2013)17:111–115 113 Total Microlaparoscopic Radical Hysterectomy in Early Cervical Cancer, Fanfani F et al. Table 1. Patients and Procedural Characteristics of the Study Population Characteristics Results patient with FIGO stage IIA endometrial cancer underwent adjuvant radiotherapy. At this time (median follow-up time 7 months [range: 6 to 9]), no recurrences were registered. Age (y), median/mean (range) 46/52 (45–70) BMIa (kg/m2), median/mean (range) 22.2/23.4 (20–28.5) DISCUSSION Operative time (min), median/mean (range) 165/186 (155–215) Estimated blood loss (mL), median/ mean (range) 30/32 (20–50) Intraoperative complications 0 In the recent years, more attention has focused on the role of new endoscopic techniques aimed to further minimize the invasiveness of surgical treatment and minimize possible morbidity. In this context, M-LPS and LESS could represent an upgrade of standard laparoscopy in terms of surgical trauma, postoperative pain, and less damage to women’s body image with visible scars.11–14 Postoperative complications 0 Conversion to LPS/LPTa during hysterectomy 0 Ileus (days), median/mean (range) 1/1 (1–1) Time to discharge (days), median/ mean (range) 2/2.2 (1–3) BMI ⫽ body mass index; LPS ⫽ laparoscopy; LPT ⫽ laparotomy. a cervical cancer. In the other 2 patients, these data were not available before surgery, and definitive pathology found only intraepithelial neoplasia or carcinoma in situ. We performed 3 type B2 and 1 type C1 on the left and B2 on the right paracervix total M-LPS radical hysterectomy, and in all cases concomitant bilateral salpingo-oophorectomy and systematic removal of external iliac and superficial obturator nodes were performed. The median/mean EBL and OT were 30/32 mL (range: 20 to 50) and 165/186 minutes (range: 155 to 215), respectively. No minor or major intraoperative complications were registered. All of the procedures were completed without 5-mm port insertion and without conversion. Foley catheter was removed 24 to 32 hours after surgery, and postmintional residual was ⬍100 mL in all cases. Postoperative ileus was 1 day in all patients. The median time to discharge was 2 days from surgery (range: 1 to 3). No postoperative complications and readmissions were registered in the early (within 30 days after surgery) postoperative period, nor during the first follow-up visit (3 months after surgery). Definitive pathology confirmed clinical stage in 3 cases, and in one case, diagnosed endometrioid endometrial adenocarcinoma extended to the endocervix. The median number of pelvic lymph nodes removed was 12 (range: 11 to 15). Definitive histology confirmed frozen section analysis on pelvic nodes as all negative. The median/mean length of vaginal margin was 1.5/1.6 cm (range: 1.3 to 1.9). Resection margins were free of disease in all cases, and only the 114 In this preliminary study, we describe surgical instrumentations and technique to perform total M-LPS radical hysterectomy in ECC patients. As previously reported by Ghezzi et al,14 for total hysterectomy, our study suggests that ports can be safely reduced in size without a negative impact on the surgeon’s ability to perform radical hysterectomy. Also, considering that this is a very preliminary experience, we observed no longer OT for M-LPS with respect to standard laparoscopic radical hysterectomy and superimposable perioperative outcomes.2,6,8 The similar OT between M-LPS and standard laparoscopy could be justified by the fact that the reduction of port and instrument size from 5 to 3 mm does not influence the surgical technique. These peculiarities of M-LPS could offer some advantages of this approach with respect to single-port surgery when performing advanced surgery as radical hysterectomy and pelvic lymphadenectomy—in particular (1) different from single-port, the surgical field is the same of standard laparoscopy, maintaining the triangularization between the instruments; and (2) the third operative instrument, managed by the second surgeon, can reduce the loss of time in some specific surgical steps. It is conceivable that, different from single-port surgery, the M-LPS technique does not require a specific learning curve. Moreover, the smaller trocars require less force to penetrate the abdominal wall, and this allows a more controlled entry and consequently the reduction of the risk of port-related injury to both the abdominal wall and the intraabdominal organs. Nevertheless, the scar-free procedure could potentially have a significant impact on patients’ body image, which is not only a cosmetic result, but is also an aid to cope with a past cancer diagnosis. Other remarkable considerations have to be taken from the oncological point of view: this preliminary experience suggests that M-LPS appears to have an adequate onco- JSLS (2013)17:111–115 logical performance in terms of type of hysterectomy and number of pelvic lymph nodes removed. As far as technical limits are concerned, we can hypothesize that the smaller (3 mm vs 5 mm) bipolar grasp dimension could be insufficient to control severe hemorrhage during paracervical vessel dissection. In our previous retrospective study comparing M-LPS, single-port, and laparoscopic hysterectomy, we reported 2 cases of additional 5-mm port insertion to control a severe hemorrhage; one of these was in the M-LPS group and the other was in the single-port group.15 Thus, waiting for more effective 3-mm new generation devices, preventive hemostasis (ie, uterine artery closure at the beginning of the procedure), and gentle surgical technique should be recommended. Moreover, the high flexibility of such little instruments could limit the capability to perform an adequate retroperitoneal dissection in the presence of fibrosis. In this study, patients’ average BMI was low, and it is possible that in the surgical management of obese patients, the reduced strength of the instruments could be a limit compared with standard laparoscopy, especially for large and small bowel traction. In this preliminary experience, we found that in wellselected cases, M-LPS radical hysterectomy seems safe and may offer a new tool in minimally invasive surgery for ECC patients. Further large and prospective, randomized trials are needed to confirm these results and to compare this technique with standard laparoscopy to identify potential advantages for the patients. CONCLUSION lymphadenectomy in patients with stage I cervical cancer: Surgical morbidity and intermediate follow-up. Am J Obstet Gynecol. 2002;187:340 –348. 5. Ramirez PT, Slomovitz BM, Soliman PT, Coleman RL, Levenback C. Total laparoscopic radical hysterectomy and lymphadenectomy: The M.D. Anderson Cancer Center experience. Gynecol Oncol. 2006;102:252–255. 6. Frumovitz M, dos Reis R, Sun CC, et al. Comparison of total laparoscopic and abdominal radical hysterectomy for patients with early- stage cervical cancer. Obstet Gynecol. 2007;110:96–102. 7. Nam JH, Park JY, Kim DY, Kim JH, Kim YM, Kim YT. Laparoscopic versus open radical hysterectomy in early-stage cervical cancer: Long-term survival outcomes in a matched cohort study. Ann Oncol. 2012;23(4):903–911. 8. Pellegrino A, Vizza E, Fruscio R, et al. Total laparoscopic radical hysterectomy and pelvic lymphadenectomy in patients with Ib1 stage cervical cancer: Analysis of surgical and oncological outcome. Eur J Surg Oncol. 2009;35(1):98 –103. 9. Malzoni M, Tinelli R, Cosentino F, Fusco A, Malzoni C. Total laparoscopic radical hysterectomy versus abdominal radical hysterectomy with lymphadenectomy in patients with early cervical cancer: Our experience. Ann Surg Oncol. 2009;16(5):1316 –1323. 10. Naik R, Jackson KS, Lopes A, Cross P, Henry JA. Laparoscopic assisted radical vaginal hysterectomy versus radical abdominal hysterectomy—a randomised phase II trial: Perioperative outcomes and surgicopathological measurements. BJOG. 2010;117(6):746 –751. 11. Fanfani F, Rossitto C, Gagliardi ML, et al. Total laparoendoscopic single-site surgery (LESS) hysterectomy in low-risk early endometrial cancer: A pilot study. Surg Endosc. 2012;26(1):41–46. This report suggests a role of M-LPS in the surgical management of ECC with adequate oncological results and specific advantages of a further less invasive surgery than standard laparoscopy. 12. Fagotti A, Boruta DM 2nd, Scambia G, Fanfani F, Paglia A, Escobar PF. First 100 early endometrial cancer cases treated with laparoendoscopic single-site surgery: A multicentric retrospective study. Am J Obstet Gynecol. 2012;206(4):353.e1– e6. References: 13. Ghezzi F, Cromi A, Siesto G, Zefiro F, Franchi M, Bolis P. Microlaparoscopy: A further development of minimally invasive surgery for endometrial cancer staging—initial experience. Gynecol Oncol. 2009;113(2):170 –175. 1. Canis M, Mage M, Wattiez A, Pouly JL, Manhes H, Bruhat MA. Does endoscopic surgery have a role in radical surgery of cancer of the cervix uteri? J Gynecol Obstet Biol Reprod (Paris). 1990;19:921. 2. Koehler C, Gottschalk E, Chiantera V, Marnitz S, Hasenbein K, Schneider A. From laparoscopic assisted radical vaginal hysterectomy to vaginal assisted laparoscopic radical hysterectomy. BJOG. 2012;119(2):254 –262. 3. Nezhat CR, Burrell MO, Nezhat FR, Benigno BB, Welander CE. Laparoscopic radical hysterectomy with para-aortic and pelvic node dissection. Am J Obstet Gynecol. 1992;166:864 – 865. 14. Ghezzi F, Cromi A, Siesto G, et al. Minilaparoscopic versus conventional laparoscopic hysterectomy: Results of a randomized trial. J Minim Invasive Gynecol. 2011;18(4):455– 461. 15. Fanfani F, Fagotti A, Rossitto C, et al. Laparoscopic, minilaparoscopic and single-port hysterectomy: Perioperative outcomes. Surg Endosc. 2012 Jun 8. [Epub ahead of print]. 16. Querleu D, Morrow CP. Classification of radical hysterectomy. Lancet Oncol. 2008;9(3):297–303. 4. Spirtos NM, Eisenkop SM, Schlaerth JB, Ballon SC. Laparoscopic radical hysterectomy (type III) with aortic and pelvic JSLS (2013)17:111–115 115 SCIENTIFIC PAPER Comparison of Robotic, Laparoscopic, and Abdominal Myomectomy in a Community Hospital Joseph M. Gobern, MD, C. J. Rosemeyer, DO, James F. Barter, MD, Albert J. Steren, MD ABSTRACT Background and Objectives: To evaluate the operative outcomes between robotic, laparoscopic, and abdominal myomectomies performed by a private gynecologic oncology practice in a suburban community hospital. Methods: The medical records of 322 consecutive robotic, laparoscopic, and abdominal myomectomies performed from January 2007 through December 2009 were reviewed. The outcomes were collected from a retrospective review of patient medical records. Results: Records for 14/322 (4.3%) patients were incomplete. Complete data were available for 308 patients, including 169 (54.9%) abdominal, 73 (23.7%) laparoscopic, and 66 (21.4%) robotic-assisted laparoscopic myomectomies. Patients were similar in age, body mass index, parity, and previous abdominopelvic surgery. Median operative time for robotic surgery (140 min) was significantly longer (P⬍.005) compared to laparoscopic (70 min) and abdominal (72 min) myomectomies. Robotic and laparoscopic myomectomies had significantly less estimated blood loss and hospital stay compared to abdominal myomectomies. There was no significant difference in complications or in the median size of the largest myoma removed between the different modalities. However, the median aggregate weight of myomas removed abdominally (200g; range, 1.4 to 2682) was significantly larger than that seen laparoscopically (115g; range, 1 to 602) and robotically (129g; range 9.4 to 935). Postoperative transfusion was significantly less frequent in robotic myomecDepartment of Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, MD, USA (Drs Gobern, Rosemeyer); Women’s Health Specialist, Holy Cross Hospital, Silver Spring, MD, USA (Drs Barter, Steren). The opinion or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense. The authors thank Robin S. Howard, MA, for her assistance in data analysis and manuscript review. Address correspondence to: COL Joseph M. Gobern, Department of Obstetrics and Gynecology, Walter Reed National Military Medical Center, 8901 Wisconsin Ave, Bethesda, MD 20889, USA. Phone: (301) 295-4394, Fax: (301) 295-0764, E-mail: [email protected] DOI: 10.4293/108680812X13517013317473 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 116 tomies compared to laparoscopic and abdominal myomectomies. Conclusion: While robotic-assisted laparoscopic myomectomies had longer operative times, laparoscopic and roboticassisted laparoscopic myomectomies demonstrated shorter hospital stays, less blood loss, and fewer transfusions than abdominal myomectomies. Robotic myomectomy offers a minimally invasive alternative for management of symptomatic myoma in a community hospital setting. Key Words: Myomectomy, Robotic surgery, Laparoscopic, Laparoscopy, Fibroids. INTRODUCTION Fibroids are the most common benign tumor of the uterus and are present in up to 80% of women. Although only 25% of women are affected by symptoms like pelvic pain, pressure, heavy menses, recurrent pregnancy loss, and infertility, it remains the leading indication for hysterectomy and a common women’s health concern.1,2 Treatment alternatives include medical management with oral contraceptives, nonsteroidal anti-inflammatory medications, or GnRH agonists. Additionally, evolving technology continues to expand the conservative options available for women desiring uterine preservation to include uterine artery embolization, MRI-guided high frequency ultrasound, and radio frequency ablation. Myomectomy, however, remains the gold-standard for women affected by symptoms of a fibroid uterus who desire uterine preservation.3 Myomectomy has traditionally been managed by laparotomy and has demonstrated effective clinical outcomes for symptoms as well as fertility.4,5 Comparison of outcomes for laparoscopic and robotic-assisted laparoscopic myomectomy (RALM) has demonstrated comparable clinical outcomes for blood loss, hospital stay, and complications despite longer robotic operative times.6,7 The feasibility of the adoption of robotic-assisted surgery by the community gynecologist has been discussed by Payne et al.8 The authors concluded that the length of stay and decrease in blood loss seen with robotic-assisted surgery “hold true not only for academic centers but also in community settings involving JSLS (2013)17:116 –120 the general gynecologist.” However, the data regarding myomectomies have primarily been reported from university teaching hospitals and regional medical centers. Considering the limited adoption of these techniques in the community hospital setting, this study sought to evaluate operative outcomes of abdominal, laparoscopic, and RALM performed in a community hospital. METHODS All myomectomies performed consecutively in a single gynecology practice from January 2007 through December 2009 were identified. All procedures were performed by 1 of 2 gynecologic oncologists in a single community hospital. Both surgeons were experienced advanced laparoscopists. The same providers performed the preoperative evaluation and counseling for each patient to determine the indication and route of surgery. The hospital electronic medical record was used to review and collect data from each patient’s chart including scanned outpatient encounters and imaging reports presented as part of the preoperative admission documentation. All patients with documented removal of at least 1 myoma were included. Patients were excluded if no record was available or no documentation of myoma removal was evident in the record. Demographic data, including age, race, body mass index (BMI), and parity were collected. Additionally, baseline clinical data including indication for surgery, symptomatology, number of myoma, size of largest myoma, American Society of Anesthesiologists (ASA) physical status classification, and history of prior abdominal or pelvic surgery was recorded. Perioperative outcomes, which included operative time, length of hospital stay, estimated blood loss, packed red blood cell (PRBC) transfusion, and intraoperative and postoperative complications, as well as aggregate myoma weight, were collected for comparison among operative groups. Surgical indications were categorized into symptoms of bleeding, pain or pressure, fertility, and other. The largest myoma was documented as the greatest diameter of the single largest myoma reported on preoperative imaging by ultrasound or magnetic resonance imaging (MRI). The myoma weight was determined as the aggregate weight of tissue reported from the pathology report. Operative time and estimated blood loss was extracted from the anesthesia record. Length of hospital stay was documented as date of discharge less date of admission, whereas 0 d indicates same day surgery. The primary outcomes were identified as length of hospital stay, estimated blood loss, and operative time. Finally, intraoperative or postopera- tive complications, transfusions, and myoma characteristics were secondarily compared among groups. Symmetrically distributed numerical variables were summarized with means and standard deviations while other variables were summarized with medians and ranges. Appropriate parametric tests were utilized where data demonstrated normal distribution, and nonparametric tests were used for alternative parameters. For numerical variables, univariable comparisons were conducted with either analysis of variance or Kruskal-Wallis analysis of ranks (for non-normal data). 2 and Fisher exact test were used for categorical data. Statistical analysis was performed using SPSS for Windows Inc. version 16 (Nov 2007). Differences were considered significant at P⬍.05. This protocol was granted exempt status by the Holy Cross Hospital Institutional Review Board. RESULTS A total of 322 records were analyzed with 14/322 (4.3%) records excluded for incomplete or absent data. Complete data were available for 308/322 (95.7%) patients including 169 (54.9%) abdominal, 73 (23.7%) laparoscopic, and 66 (21.4%) robotic-assisted myomectomies. Patients in each category were similar in age, BMI, parity, and previous abdominopelvic surgery (Table 1). Patients who reported their race as black, however, more often underwent abdominal myomectomy (Table 2). Additionally, evaluation of baseline clinical characteristics revealed no statistically significant difference in patients with prior myomectomy, ASA classification, or presenting symptoms of pain, pressure, and bleeding (Tables 1 and 2). Patients with a fertility indication more frequently had an abdominal myomectomy (Table 2). Operative time for robotic surgery (140 min; range, 55 to 328) was longer compared to laparoscopic (70 min; range, 17 to 218) and abdominal myomectomy (17 min; range, 13 to 185; P⬍.005). Laparoscopic and robotic myomectomy had significantly (P⬍.005) less estimated blood loss as well as shorter hospital stay compared to abdominal myomectomy (Table 3). Among secondary outcomes, there was no significant difference between all modalities of surgery for postoperative complication or between laparoscopic and robotic surgery for conversion to laparotomy. However, postoperative transfusion was significantly (P⬍.005) less frequent in robotic myomectomy compared to laparoscopic and abdominal myomectomy (Table 3). The characteristics of myomas between the operative groups were compared. There was no significant differ- JSLS (2013)17:116 –120 117 118 108 (70%) 47 (71%) 1 (60%) 33 (21%) 18 (27%) 13 (31%) 13 (8%) 37 (2%) 6 (10%) ASA 2 [n (%); p⫽0.13] ASA 1 [n (%); p⫽0.13] 20 (12%) 2 (3%) 5 (8%) 70 (42%) 30 (41%) 24 (36%) 26 (15%) 16 (22%) 18 (27%) 12 (7%) 7 (10%) 9 (14%) 169 73 66 Abdominal Laparoscopic Robotic 39 (27–50) 39 (23–56) 40 (26–51) 27 (18–46) 25 (19–52) 27 (19–53) 103 (61%) 23 (32%) 28 (42%) 38 (22%) 31 (42%) 22 (33%) 16 (10%) 12 (16%) 7 (11%) Prior Myomectomy [n (%); p⫽0.063] Prior Surgery [n (%); p⫽0.74] Prior Parity [n (%); p⫽0.053] Other Race [n (%); p⫽0.001] Asian [n (%); p⫽0.001] White [n (%); p⫽0.001] Black [n (%); p⫽0.001] BMI (p⫽0.067) n Age [(yrs) Median (range)] p⫽0.69 ence in the median size of the largest myoma removed robotically (6.1 cm; range, 1.8 to 18.4), laparoscopically (6.4 cm; range, 1 to 14), or abdominally (6.1 cm; range, 2.2 to 15; P⫽.13), although most myomas ⬎10 cm were removed abdominally (Figure 1). The median aggregate weight of myoma removed abdominally (200g; range, 1.4 to 2682), however, was significantly (P⬍.005) larger than that of myomas removed laparoscopically (115g; range, 1 to 602) and robotically (129g; range, 9.4 to 935). DISCUSSION Type of Myomectomy Table 1. Operative Outcomes of Abdominal, Laparoscopic, and Robotic Assisted-Laparoscopic Myomectomy in a Community Hospital Comparison of Demographic Data ASA 3 [n (%); p⫽0.13] Comparison of Robotic, Laparoscopic, and Abdominal Myomectomy in a Community Hospital, Gobern JM et al. Myomectomy is performed commonly for women with symptomatic fibroid uterus desiring uterine preservation and future fertility. Laparoscopic myomectomy was first reported in 1979.9 This technique has been performed safely and has consistently demonstrated advantages, such as decreased blood loss, shorter hospital stay, less postoperative disability, and comparable complications compared to abdominal myomectomy.10 –17 Clinical outcomes for fertility and obstetrical outcomes are also comparable to abdominal myomectomy.18 Comparison of outcomes for laparoscopic and roboticassisted laparoscopic myomectomy has demonstrated comparable clinical outcomes for blood loss, hospital stay, and complications despite longer robotic operative times in university hospitals and medical centers.6,7 The American College of Obstetricians and Gynecologist and the American Association of Gynecologic Laparoscopist have confirmed the advantages of laparoscopy over laparotomy. Despite advances in laparoscopic technique, as well as the advantages of laparoscopic myomectomy reported over 30 y, most gynecologic procedures are still performed through abdominal incisions.8,19 The technical skill required for excision of myoma and lack of surgeon experience are considered significant limiting factors to the wide acceptance of this technique.18,20 Technical advantages of robotic-assisted laparoscopic surgery may help overcome these challenges and perhaps improve the adoption of the laparoscopic technique.8,11 These advantages include 3-dimensional visualization, instrument articulation, improved dexterity, and the elimination of tremor and counterintuitive movements.21,22 Specifically, these advantages offer the community-based gynecologist greater facility with which to suture and surgically dissect laparoscopically. Specifically, this study demonstrated primary surgical outcomes of operative time, decreased hospital stay, and decreased estimated blood loss with robotic-assisted laparoscopic myomectomy that were consistent with published reports in university-based teaching hospitals and regional medical centers. These findings, coupled with the demonstrated advantages of robotic-assisted laparoscopic surgery, JSLS (2013)17:116 –120 Table 2. Comparison of Preoperative Symptoms/Indications Type of Myomectomy n Pain/Pressure [n (%); p⫽0.072] Bleeding [n (%); p⫽0.64] Fertility [n (%); p⫽0.0005] Other [n (%); p⫽0.003] Abdominal 169 55 (33%) 66 (39%) 92 (54%) 5 (3%) Laparoscopic 73 35 (48%) 24 (33%) 19 (26%) 10 (14%) Robotic 66 23 (35%) 23 (35%) 23 (35%) 7 (11%) Table 3. Comparison of Perioperative Outcomes Type of Myomectomy n Procedure Time [(min) Median (range) p⬍0.0005] Hospital Stay [(days) Median (range) p⬍0.0005] EBL [(mL) Median (range) p⬍0.0005] Post-op Complications [n (%) p⫽0.58] Transfusion [n (%) p⬍0.0005] Conversions to Laparotomy [n (%) p⫽0.5] Abdominal 169 72 (13–185) 2 (0–12) 200 (10–2500) 17 (10%) 43 (26%) N/A Laparoscopic 73 70 (17–218) 0 (0–6) 100 (10–1800) 5 (7%) 9 (12%) 6 (8%) Robotic 66 140 (55–328) 1 (0–17) 100 (10–1000) 8 (12%) 4 (6%) 3 (5%) Largest Myoma Maximum Myoma Size Robotic-assisted laparoscopy has been proposed as a way to overcome many of the technical challenges to traditional laparoscopy through improved imaging as well as enhanced dexterity of surgical instruments.8,11 While these characteristics have been demonstrated in university-based teaching hospitals and medical centers, this is the first comparison of abdominal, laparoscopic and RALM in a community hospital.10 This study demonstrated reduced blood loss and shorter hospital stay consistent with previously published reports. Additionally, the differences in operative times and comparable rates of complications in our community hospital were similar to those of university-based teaching hospitals and medical centers with experienced surgeons. Figure 1. Largest myoma on preoperative imaging, which was removed by abdominal, laparoscopic, or robotically assisted laparoscopic myomectomy. Strengths of this study include the large, continuous case series with a high rate of complete patient data sets in a single community hospital with access to all routes of surgery. Limitations of this study include all those inherent to the retrospective design. A statistical difference was demonstrated in clinical outcomes although the descriptive nature of the study results may reflect some differences from the preselection process and individual patient characteristics. P values were reported, nonetheless, as a direct comparison to studies reported from medical centers and university-based hospitals. may improve the adaptation of this technique by general gynecologists desiring to offer a more minimally invasive approach to their patients in a community-based practice. Concerns over increased costs, operating times, and number of laparoscopic ports associated with robotic surgery continue to be addressed. New evidence suggests comparable costs and operating times for robotic-assisted laparoscopy Type of Surgery JSLS (2013)17:116 –120 119 Comparison of Robotic, Laparoscopic, and Abdominal Myomectomy in a Community Hospital, Gobern JM et al. compared with conventional laparoscopy, especially when performed by experienced robotic surgeons.6,23–25 CONCLUSION Laparoscopic and robotic-assisted myomectomies performed in this community hospital demonstrated clinical outcomes consistent with those published from universitybased teaching hospitals and medical centers in the hands of experienced laparoscopist. Further prospective randomized studies evaluating whether the same outcomes are observed with general gynecologists trained in robotic surgery are warranted. This is especially true in the community hospital setting. Regardless, robotic-assisted laparoscopic myomectomy offers a minimally invasive alternative for management of symptomatic myoma and may expand the adoption of the laparoscopic technique in the community hospital setting. References: 1. Laughlin SK, Stewart EA. Uterine Leiomyomas: Individualizing the Approach to a Heterogenous Condition. Obstet Gynecol. 2011;117(2):396 – 403. 2. Agdi M, Tulandi T. Minimally invasive approach for myomectomy. Semin Reprod Med. 2010;28(3):228 –234. 3. Bonney V. The techniques and results of myomectomy. Lancet. 1931;220:171–177. 4. Babaknia A, Rock JA, Jones HW Jr. Pregnancy success following abdominal myomectomy for infertility. Fertil Steril. 1978; 30(6):644 – 647. 5. Parker WH. Uterine myomas: management. Fertil Steril. 2007;88(2):255–271. 6. Bedient CE, Magrina JF, Noble BN, Kho RM. Comparison of robotic and laparoscopic myomectomy. Am J Obstet Gynecol. 2009;201(6):566.e1–5. 7. Nezhat C, Lavie O, Hsu S, Watson J, Barnett O, Lemyre M. Robotic-assisted laparoscopic myomectomy compared with standard laparoscopic myomectomy–a retrospective matched control study. Fertil Steril. 2009;91(2):556 –559. 8. Payne TN, Pitter MC. Robotic-assisted surgery for the community gynecologist: can it be adopted? Clin Obstet Gynecol. 2011;54(3):391– 411. 9. Semm K. New methods of pelviscopy (gynecologic laparoscopy) for myomectomy, ovariectomy, tubectomy and adnectomy. Endoscopy. 1979;11(2):85–93. 11. Barakat EE, Bedaiwy MA, Zimberg S, Nutter B, Nosseir M, Falcone T. Robotic-assisted, laparoscopic, and abdominal myomectomy: a comparison of surgical outcomes. Obstet Gynecol. 2011;117(2):256 –265. 12. Falcone T, Bedaiwy MA. Minimally invasive management of uterine fibroids. Curr Opin Obstet Gynecol. 2002;14(4):401– 407. 13. Nezhat C, Nezhat F, Silfen SL, Schaffer N, Evans D. Laparoscopic myomectomy. Int J Fertil. 1991;36(5):275–280. 14. Miller CE, Johnston M. Laparoscopic myomectomy using ultrasonic dissection. Surg Technol Int. 1995;(4):227–233. 15. Mais V, Ajossa S, Guerriero S, Mascia M, Solla E, Melis GB. Laparoscopic versus abdominal myomectomy: a prospective, randomized trial to evaluate benefits in early outcome. Am J Obstet Gynecol. 1996;174(2):654 – 658. 16. Ascher-Walsh CJ, Capes TL. Robot-assisted laparoscopic myomectomy is an improvement over laparotomy in women with a limited number of myomas. J Minim Invasive Gynecol. 2010;17(3):306 –310. 17. Nash K, Feinglass J, Zei C, Lu G, Mengesha B, LewickyGaupp C, Lin A. Robotic-assisted laparoscopic myomectomy versus abdominal myomectomy: a comparative analysis of surgical outcomes and costs. Arch Gynecol Obstet. 2012;285(2):435– 440. 18. Sami WM, Heaton RL. The role of laparoscopic myomectomy in the management of uterine fibroids. Curr Opin Obstet Gynecol. 2011;23(4):273–277. 19. Matthews CA. Applications of robotic surgery in gynecology. J Womens Health (Larchmt). 2010;19(5):863– 867. 20. Lee CL, Wang CJ. Laparoscopic myomectomy. Taiwan J Obstet Gynecol. 2009;48(4):335–341. 21. Visco AG, Advincula AP. Robotic gynecologic surgery. Obstet Gynecol. 2008;112:1369 –1384. 22. Robotic-assisted surgery. ACOG Technology Assessment in Obstetrics and Gynecology No. 6. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2009;114:1153–1155. 23. Shashoua AR, Gill D, Locher SR. Robotic-assisted total laparoscopic hysterectomy versus conventional total laparoscopic hysterectomy. JSLS. 2009;13(3):364 –369. 24. Jonsdottir GM, Jorgensen S, Cohen SL, et al. Increasing minimally invasive hysterectomy: effect on cost and complications. Obstet Gynecol. 2011;117(5):1142–1149. 25. Bush A, Morris SN, Millham FH, Isaacson KB. Women’s preferences for minimally invasive incisions. J Minim Invasive Gynecol. 2011;18(5)L:640 – 643. 10. Advincula AP, Xu X, Goudeau S 4th, Ransom SB. Robotassisted laproscopic myomectomy versus abdominal myomectomy: a comparison of short-term surgical outcomes and immediate costs. J Minim Invasive Gynecol. 2007;14(6):698 –705. 120 JSLS (2013)17:116 –120 SCIENTIFIC PAPER Laparoscopic Ureteroneocystostomy for Ureteral Injuries After Hysterectomy Alexandre Pompeo, MD, Wilson R. Molina, MD, David Sehrt, BS, Marcos Tobias-Machado, MD, Renato M. Mariano Costa Jr, MD, Antonio Carlos Lima Pompeo, MD, Fernando J. Kim, MD ABSTRACT Objectives: To examine the feasibility of early laparoscopic ureteroneocystostomy for ureteral obstruction due to hysterectomy injury. Methods: We retrospectively reviewed a 10-y experience from 2 institutions in patients who underwent early (⬍30 d) or late (⬎30 d) laparoscopic ureteroneocystostomy for ureteral injury after hysterectomy. Evaluation of the surgery included the cause of the stricture and intraoperative and postoperative outcomes. Results: A total of 9 patients with distal ureteral injury after hysterectomy were identified. All injuries were identified and treated as early as 21 d after hysterectomy. Seven of 9 patients underwent open hysterectomy, and the remaining patients had vaginal and laparoscopic radical hysterectomy. All ureteroneocystostomy cases were managed laparoscopically without conversion to open surgery and without any intraoperative complications. The Lich-Gregoir reimplantation technique was applied in all patients, and 2 patients required a psoas hitch. The mean operative time was 206.6 min (range, 120 –280 min), the mean estimated blood loss was 122.2 cc (range, 25–350 cc), and the mean admission time was 3.3 d (range, 1–7 d). Cystography showed no urine leak when the ureteral stent was removed at 4 to 6 wk after the procedure. Ureteroneocystostomy patency was followed up with cystography at 6 mo and at least 10 y after ureteroneocystostomy. Division of Urology, Department of Surgery, Denver Health Medical Center and University of Colorado Health Sciences Center, Denver, CO, USA (Drs. A. Pompeo, Molina, Sehrt, Kim). Tony Grampsas Cancer Institute, Denver, CO, USA (Dr. Kim). Division of Urology, ABC Medical School, São Paulo, Brazil (Drs. A. Pompeo, Tobias-Machado, Mariano Costa, A.C.L. Pompeo). Wilson R. Molina has a Fellowship Grant with Boston Scientific. Fernando J. Kim is a Principal Investigator for Olympus, Covidien, Healthtronics, Amgem, and Cubist. Alexandre Pompeo, David Sehrt, Marcos Tobias-Machado, Renato M. Mariano Costa Jr, and Antonio Carlos Lima Pompeo have no conflicts of interest or financial ties to disclose. Address correspondence to: Fernando Kim, MD, Division of Urology, Denver Health Medical Center, 777 Bannock St, MC 0206, Denver, CO 80204, USA. Telephone: (303) 436-6558, Fax: (303) 436-6572, E-mail: [email protected] DOI: 10.4293/108680812X13517013317437 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. Conclusion: Early laparoscopic ureteral reimplantation may offer an alternative surgical approach to open surgery for the management of distal ureteral injuries, with favorable cosmetic results and recovery time from ureteral obstruction due to hysterectomy injury. Key Words: Laparoscopy, Ureteroneocystostomy, Ureteral reimplantation, Hysterectomy. INTRODUCTION Hysterectomy is the most frequent gynecologic procedure for benign uterine disease.1 Unfortunately, because of the close proximity of the ureter to the cervix and uterine artery, unintended injury to the ureter may occur during this procedure. Ureteral injury may occur because of suture, clip, or staple ligation; crush injury; or electrocautery thermal spread, which can lead to the development of hydronephrosis, loss of renal function, fistula formation, and possible sepsis if not detected intraoperatively.2 Optimal management of distal ureteral stricture includes resection of the stenosis, spatulation of the healthy ureter, and tension-free ureteroureteral anastomosis with optimal ureterovesical mucosa apposition. Traditionally, these procedures have been performed by an open approach after the acute phase has passed (⬎6 wk), but laparoscopy has emerged as a minimally invasive option.3–5 In 1992 Nezhat and Nezhat6 reported the first laparoscopic ureteroureterostomy for the repair of a ureteral injury during a laparoscopic gynecologic procedure. Since then, laparoscopic ureteroneocystostomy has been reported, but the reconstructive steps may be challenging to surgeons. We evaluated a 10-y multi-institutional experience with early and late laparoscopic ureteral reimplantation in patients who were treated for distal ureteral injury after hysterectomy performed by surgeons (F.J.K. and M.T.-M.) at 2 institutions. MATERIALS AND METHODS We retrospectively reviewed the charts of patients who underwent laparoscopic ureteroneocystostomy after hysterectomy from 2002 to 2011 at Denver Health Medical Center (Denver, CO, USA) and the ABC Medical School (São Paulo, JSLS (2013)17:121–125 121 Laparoscopic Ureteroneocystostomy for Ureteral Injuries After Hysterectomy, Pompeo A et al. Figure 1. Left distal hydronephrosis of left ureter at 2 y after hysterectomy (CT scan and ascendant pyelogram). (Arrow) stenosis of the ureter. Brazil). Data collection included demographics, cause of the stricture, and intraoperative and postoperative outcomes. Surgical Technique Identification of the ureteral stricture was made preoperatively with computed tomography (CT)–intravenous pyelography and then intraoperatively with retrograde ureteropyelography (Figure 1). A council-tip Foley catheter (Bard, Covington, GA) was then placed, followed by a 5-mm ureteral catheter, and then a Superstiff guidewire (Boston Scientific, Natick, MA) catheter was inserted. Laparoscopic ureteroneocystostomy was performed in a transperitoneal manner with the Lich-Gregoir technique. The Kocher maneuver was performed after incision of the line of Toldt, and the ureter was released, dissected above the stenotic area, clipped distally, and sectioned (Figure 2A). The bladder was mobilized to achieve a good length up to the incised ureter without requiring insufflation of the bladder. By use of laparoscopic scissors, the bladder was incised and dissected with good mucosa exposure (Figure 2B). Mucosa-mucosa anastomosis was performed with absorbable No. 3.0 Polysorb suture (Johnson & Johnson, New Brunswhick, NJ) starting at the 6-o’clock position after spatulation of the distal ureter (Figure 2C). Before the ureterovesical anastomosis was finalized, a ureteral stent was placed with assistance from the Superstiff guidewire, and the bladder anastomotic site was tested for watertightness with irrigation and filling up the bladder with 250 cc of sterile saline solution (Figure 2D). 122 A Foley catheter was removed 1 wk postoperatively. Cystography was performed at 4 to 6 wk at the time the double-J ureteral stent was removed if no extravasation was identified. CT intravenous urography was performed and serum creatinine levels were obtained at 3 mo to reassess the ureteroneocystostomy. Renal nuclear (Mercaptoacetyltriglycine) scans were ordered for patients who had questionable decreased renal function postoperatively. RESULTS A total of 9 patients with ureteral stricture due to iatrogenic injury from hysterectomy were identified. A percutaneous nephrostomy tube was placed in 4 patients (44.4%) before the ureteroneocystostomy. Interestingly, in 1 of these patients, the ureter was medially deviated because of previous procedures (Figure 3). In the 5 patients who did not have urinary diversion, hydronephrosis and ureteral obstruction with ipsilateral flank pain developed at 7 d and 1, 2, 3, and 13 y after hysterectomy. Ureterovaginal fistula developed in 2 patients with long-term obstruction. Preoperative creatinine levels were normal in all patients, ranging from 0.5 mg/dL to 0.9 mg/mL. The mean patient age was 48.5 y (range, 30–76 y). Table 1 shows patient demographics and preoperative data. Seven patients (77.8%) underwent open hysterectomy: The procedure was performed in 5 patients (71.4%) because of myoma and in 1 patient (14.3%) because of cervical cancer; moreover, 1 patient (14.3%) underwent JSLS (2013)17:121–125 Figure 2. (A) Resection of stenotic area. (B) Mucosal exposure of the detrusor muscle of the bladder. (C) Ureterovesical anastomosis after ureteral spatulation. (D) Suture of muscular layer of the bladder wall (detrusor). Table 1. Patient Demographics and Stricture Etiology Patient Age BMIa ASA No. (y) (kg/m2) Side Ureteral Etiology Position 1 58 28.2 2 Left distal 2 46 32.8 2 Right distal OH, myoma 3 50 31.2 2 Left distal OH, myoma 4 43 21.5 3 Right distal OH, myoma 5 42 35.1 3 Right distal ORHa, cervical cancer 6 76 20.7 3 Left distal VHa, myoma 7 30 25.3 1 Right distal OH, myoma 8 55 18.9 1 Left distal LRHa, cervical cancer 9 40 20.5 1 Left distal OH, uterine atony OHa, myoma ASA ⫽ American Society of Anesthesiologists class; BMI ⫽ body mass index; LRH ⫽ laparoscopic radical hysterectomy; OH ⫽ open hysterectomy; ORH ⫽ open radical hysterectomy; VH ⫽ vaginal hysterectomy. a Figure 3. Intraoperative pyelogram of ureter deviated past midsagittal plane. emergent laparotomy and hysterectomy for bleeding due to uterine hemorrhage and failure to coagulate after vaginal delivery. Vaginal hysterectomy was performed in 1 patient (11.1%), whereas 1 patient (11.1%) underwent laparoscopic radical hysterectomy. JSLS (2013)17:121–125 123 Laparoscopic Ureteroneocystostomy for Ureteral Injuries After Hysterectomy, Pompeo A et al. Table 2. Surgical Outcomes Patient No. ORTa (min) EBLa (mL) Procedure Hospital Stay (d) Complications 1 250 250 Ureteroneocystostomy 3 No 2 240 150 Ureteroneocystostomy 7 Transfusion reaction 3 200 25 Ureteroneocystostomy 2 No 4 280 25 Ureteroneocystostomy 3 No 5 220 100 Ureteroneocystostomy and psoas hitch 3 No 6 130 50 Ureteroneocystostomy 2 No 7 120 50 Ureteroneocystostomy 1 No 8 240 350 Ureteroneocystostomy and psoas hitch 7 Urinary tract infection 9 180 100 Ureteroneocystostomy 2 No EBL ⫽ estimated blood loss; ORT ⫽ operative time. a All ureteroneocystostomies were successfully performed by a laparoscopic approach without conversion to open surgery. Surgical outcomes are summarized in Table 2. The mean operative time was 206.6 min (range, 120–280 min), and the mean estimated blood loss was 122.2 cc (range, 25–350 cc). The increased operating room time was because of intraperitoneal adhesions from previous surgery including hysterectomy. The mean hospital stay was 3.3 d (range, 1–7 d). Two patients were hospitalized for 1 wk: 1 patient because of a blood transfusion reaction (the patient who underwent emergent hysterectomy and was repaired 7 d thereafter) and another as a result of a complicated urinary tract infection. CT cystography or voiding cystography showed no urine leak and a patent ureteroneocystostomy in all patients. In 2 cases the bladder received a psoas hitch to allow for a tension-free ureterovesical anastomosis. Postoperative creatinine levels were normal for all patients (range, 0.7–1.1 mg/dL). In 1 patient with a psoas hitch, lowergrade ureterovesical reflux was observed without clinical repercussion on renal function (Figure 4). DISCUSSION Iatrogenic ureteral injury is a grave complication that can occur during abdominal or pelvic surgeries. Ureteral injuries have a documented incidence of 0.3% to 1.5%.7 Fortunately, ureteral injuries from open hysterectomy are also rare and occur in 0.2% to 0.4% of these procedures.8,9 Leonard et al.1 published a series of 1300 laparoscopic hysterectomies, with a ureteral injury rate of 0.3%, comparable with that in the published open series. Unfortunately, our patients were diagnosed after the hysterectomy. Five patients had the repair within 30 d of injury, showing that early repair is feasible and efficient 124 Figure 4. Postoperative aspect of CT cystogram after psoas hitch with low-grade reflux. contrary to the dogma that one should wait 3 to 6 mo after injury for repair. Pathology reports from the injury sites confirmed fibrotic tissue and complete obliteration of the ureteral lumen. Open surgical procedures have good long-term results with reported success rates ⬎80%.2 However, open surgical procedures are associated with a longer hospital stay, extra blood loss, and the need for additional pain medication.4 Nevertheless, minimally invasive techniques have gained in popularity in recent years.10 –20 Since the first report of a laparoscopic ureteroneocystostomy was published by Nezhat and Nezhat6 in 1992, only a few JSLS (2013)17:121–125 reports with small sample sizes have been recorded in the literature. Moreover, these reports were not limited only to post-hysterectomy ureteral injuries and did not address the optimal timing of the ureteral reimplantation. Our series focused on patients who required ureteroneocystostomy after hysterectomy only. In addition, even more extensive ureteric defects were successfully repaired with the psoas-hitch technique and Boari flap laparoscopically. 5. Modi P, Goel R, Dodiya S. Laparoscopic ureteroneocystostomy for distal ureteral injuries. Urology. 2005;66(4):751–753. Recently, robot-assisted techniques have been described for ureteral reimplantation. However, robot-assisted ureteral reimplantation in adult patients is not a universal reality because of the cost and inexperience of surgeons in countries outside of the United States and a few Asian and European countries. The laparoscopic approach certainly can be performed in most practices where a robot is not available. 8. Harkki-Siren P, Sjoberg J, Mäkinen J, et al. Finnish national register of laparoscopic hysterectomies. A review and complications of 1165 operations. Am J Obstet Gynecol. 1997;176(1 Pt 1):118–122. This study has several limitations. It is retrospective and limited by the small sample of patients. However, the feasibility of performing the procedure early may offer benefits to the patients who often may have a percutaneous nephrostomy tube placed and may decrease the anxiety level of the surgeon who caused the injury. CONCLUSION The laparoscopic technique of early ureteral reimplantation for the repair of ureteral obstruction due to hysterectomy injury may be challenging, but it is feasible. Our 10-y experience showed that early laparoscopic ureteroneocystostomy offers similar success rates compared with open procedures, decreasing issues associated with delayed repair of injuries. References: 1. Leonard F, Fotso A, Borguese B, Chopin N, Foulot H, Chapron C. Ureteral complications from laparoscopic hysterectomy indicated for benign uterine pathologies: a 13-year experience in a continuous series of 1300 patients. Hum Reprod. 2007;22(7):2006 –2011. 2. Sakellariou P, Protopapas AG, Voulgaris Z, et al. Management of ureteric injuries during gynecological operations: 10 years experience. Eur J Obstet Gynecol Reprod Biol. 2002;101(2):179–184. 3. Simmons MN, Gill IS, Fergany AF, Kaouk JH, Desai MM. Laparoscopic ureteral reconstruction for benign stricture disease. Urology. 2007;69(2):280 –284. 4. Rassweiler JJ, Gözen AS, Erdogru T, Sugiono M, Teber D. Ureteral reimplantation for management of ureteral strictures: a retrospective comparison of laparoscopic and open techniques. Eur Urol. 2007;51(2):512–522. 6. Nezhat C, Nezhat F. Laparoscopic repair of ureter resected during operative laparoscopy. Obstet Gynecol. 1992;80(3 Pt 2):543–544. 7. Parpala-Sparman T, Paananen I, Santala M, Ohtonen P, Hellstrom P. Increasing numbers of ureteric injuries after the introduction of laparoscopic surgery. Scand J Urol Nephrol. 2008; 42(5):422– 427. 9. Mäkinen J, Johansson J, Tomas C, et al. Morbidity of 10110 hysterectomy by type of approach. Hum Reprod. 2001;16(7): 1473–1478. 10. Phipps JH, Tyrrell NJ. Transilluminating ureteric stents for preventing operative ureteric damage. Br J Obstet Gynaecol. 1992;99(1):81. 11. Paulson JD. Laparoscopically assisted vaginal hysterectomy. A protocol for reducing urinary tract complications. J Reprod Med. 1996;41(9):623– 628. 12. Ostrzenski A, Radolinski B, Oatrzenska KM. A review of laparoscopic ureteral injury in pelvic surgery. Obstet Gynecol Surv. 2008;58(12):794 –799. 13. Ehrlich RM, Gershman A, Fuchs G. Laparoscopic vesicoureteroplasty in children: initial case reports. Urology. 1994;43(2):255–261. 14. Reddy PK, Evans RM. Laparoscopic ureteroneocystostomy. J Urol. 1994;152(6 Pt 1):2057–2059. 15. Nezhat CH, Malik S, Nezhat F, Nezhat C. Laparoscopic ureteroneocystostomy and vesicopsoas hitch for infiltrative endometriosis. JSLS. 2004;8(1):3–7. 16. Modi P, Gupta R, Rizvi SJ. Laparoscopic ureteroneocystostomy and psoas hitch for post hysterectomy ureterovaginal fistula. J Urol. 2008;180(2):615– 617. 17. Fugita OE, Dinlenc C, Kavoussi L. The laparoscopic Boari flap. J Urol. 2001;166(1):51–53. 18. Smith RP, Oliver JL, Peters CA. Pediatric robotic extravesical ureteral reimplantation: comparison with open surgery. J Urol. 2011;185(5):1876 –1881. 19. Marchini GS, Hong YK, Minnillo BJ, et al. Robotic assisted laparoscopic ureteral reimplantation in children: case matched comparative study with open surgical approach. J Urol. 2011; 185(5):1870 –1875. 20. Kasturi S, Sehgal SS, Christman MS, Lambert SM, Casale P. Prospective long-term analysis of nerve sparing extravesical robotic assisted laparoscopic ureteral reimplantation. Urology. 2012;79(3):680 – 683. JSLS (2013)17:121–125 125 SCIENTIFIC PAPER Laparoscopic Surgery for Kidney Orthotopic Transplant in the Pig Model Bulang He, Gabby C. Musk, Lingjun Mou, Gerald L. Waneck, Luc Delriviere ABSTRACT Background and Objectives: Laparoscopic surgery has rapidly expanded in surgical practice with well-accepted benefits of minimal incision, less analgesia, better cosmetics, and quick recovery. The surgical technique for kidney transplantation has remained unchanged since the first successful kidney transplant in the 1950s. Over the past decade, there were only a few case reports of kidney transplantation by laparoscopic or robotic surgery. Therefore, the aim of this study is to develop a laparoscopic technique for kidney transplantation at the region of the native kidney. Methods: After initial development of the laparoscopic technique for kidney transplant in cadaveric pigs, 5 live pigs (Sus scrofa, weighing 45–50 kg) underwent laparoscopic kidney transplant under general anesthesia. First, laparoscopic donor nephrectomy was performed, and then the kidney was perfused and preserved with cold Ross solution. The orthotopic auto-transplant was subsequently performed using the laparoscopic technique. The blood flow of the kidney graft was assessed using Doppler ultrasonography, and urine output was monitored. Results: The laparoscopic kidney transplant was successful in 4 live pigs. Immediate urine output was observed in 3 pigs. The blood flow in the kidney was adequate, as determined using Doppler ultrasonography. Conclusion: It has been shown that laparoscopic kidney orthotopic transplant is feasible and safe in the pig model. Immediate kidney graft function can be achieved. A further study will be considered to identify the potential Liver and Kidney Transplant Unit, Sir Charles Gairdner Hospital, Nedlands, Australia (Messrs He, Mou, Delriviere). surgical morbidity and mortality after recovery in a pig model before translating the technique to clinical human kidney transplantation. Key Words: Laparoscopic surgery, Orthotopic kidney transplant, Pig model. INTRODUCTION The use of laparoscopic surgery has been widely expanded in clinical surgical practice. In the kidney transplant field, it is well accepted that laparoscopic donor nephrectomy has equal kidney graft function with minimal incision, less analgesia, better cosmetic appearance, and quick recovery.1–5 The surgical technique for kidney transplantation has remained unchanged since the first successful kidney transplant in the 1950s.6 The kidney is routinely placed in the iliac fossa with the renal artery being anastomosed to the iliac artery and the renal vein end being anastomosed to the side of the external iliac vein. The disadvantage of this technique is that the kidney graft is vulnerable to injury or trauma because it is exposed to the front of the pelvis. It also becomes very challenging when a third or fourth subsequent kidney transplant is required because of adhesions around the iliac vessels from previous transplant surgery. Therefore, the aim of this study is to develop a laparoscopic technique for orthotopic kidney transplant. We predict that laparoscopic kidney transplant will have the advantages of equal graft function, a smaller incision, less pain, a better cosmetic appearance, a quicker recovery, and a shorter hospital stay compared with conventional open surgery. Animal Care Service, The University of Western Australia, Perth, Australia (Musk). Transplant Immunology Laboratory, The University of Western Australia, Perth, Australia (Mr. Waneck). Research funding was received from Western Australian Transplant Service. Address correspondence to: Bulang He, MBBS, MS, FRACS, Telephone: 0061-893464055, Fax: 0061-8-93467442, E-mail: [email protected] DOI: 10.4293/108680812X13517013318021 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 126 METHODS The study was approved by the animal ethics committee of the university. The study consists of 2 parts. In part 1 the laparoscopic technique for kidney transplant was developed on 10 cadaveric pigs that were used for other studies. The technique development included the justification of port position and vessel anastomosis. In part 2 JSLS (2013)17:126 –131 the laparoscopic kidney transplant was performed in live pigs. geal temperature, and electrocardiogram. The parameters were recorded every 5 minutes. Animals Surgical Procedure Ten cadaveric pigs were used after a study conducted by the department of respiratory medicine. The lungs of the pigs were removed by the respiratory medicine team for histopathology. Approval was obtained from the animal ethics committee of the university for this secondary study. Five live pigs (Sus scrofa, 2 male and 3 female pigs), weighing 45 to 50 kg, were transported to the Large Animal Facility of the university 2 weeks before surgery for acclimatization. The pigs were housed in a pen above the floor. They were fed a maintenance diet (Grower; Westfeeds Pty Ltd, Bentley, Australia) and allowed free access to tap water. Daily care was provided by the staff of the Large Animal Facility. The pigs were euthanized by intravenous injection of pentobarbital (160 mg/kg) at the end of the study. After general anesthesia, the pig was placed in the right decubitus position. The camera port was inserted via a small open incision (1.5 cm) at a site to the left of midline and above the umbilicus. The other ports were placed under vision; the sites of the ports are shown in Figure 1. The left kidney was identified and the bowel dissected medially. The renal artery and vein and ureter were exposed and dissected. The renal artery was dissected to the origin of the aorta and the renal vein to the origin of the vena cava to obtain the best possible vessel exposure. This facilitated the subsequent auto-transplant. The left kidney was mobilized free from its attachments. The ureter was divided first at the level of the lower pole. At this point, 1,500 IU of heparin was given intravenously. A small low midline incision (6 cm) in the abdomen was created by longitudinally cutting the skin and fascia at the midline. Then, the muscular layer was opened through the left para-midline (Figure 2). The peritoneal layer remained intact at this stage. The renal artery and vein were clamped with an endoscopic Bulldog device (B. Braun Melsungen AG, Melsungen, Germany) and divided. The kidney was then delivered by opening the peritoneum via the incision and perfused on the back table immediately with cold (4°C) Ross perfusion fluid (Orion Laboratories, Balcatta, Australia) (1 L of Ross solution plus 10,000 IU of heparin). The kidney graft was prepared on the back table. No. 6-0 Prolene stitches (Ethicon, Somerville, New Jersey) were placed at the upper and lower Anesthesia Food was withheld for 12 hours before anesthesia and surgery, but the pigs were allowed free access to water. Anesthesia was induced with a combination of Zoletil (4.4 mg/kg) and xylazine (2.2 mg/kg) by intramuscular injection in the neck. An auricular vein was cannulated, and propofol (1 mg/kg) was administered intravenously to achieve an adequate depth of anesthesia for tracheal intubation. The trachea was intubated with a cuffed endotracheal tube (Portex Soft Seal Cuff, 8.0-mm inner diameter; SIMS Portex Ltd, Hythe, United Kingdom). Anesthesia was maintained with isoflurane delivered in 100% oxygen. Mechanical ventilation was commenced immediately after oral intubation of the trachea with a tidal volume of 10 to 15 mL/kg and peak inspiratory pressure ⬍25 cm of water. The respiratory rate was adjusted to achieve normocapnia (end-tidal carbon dioxide level, 35– 45 mm Hg). The depth of anesthesia was assessed subjectively by a veterinary anesthetist throughout the procedure and altered accordingly. The auricular artery was also cannulated for direct blood pressure measurement. In addition, a central line catheter was inserted into the left jugular vein (7-French, 2-lumen catheter; Arrow International, Reading, Pennsylvania) for measurement of central venous pressure and delivery of intravenous fluid therapy (Hartmann solution and Gelofusin). Pancuronium was administered (0.1 mg/kg intravenously) for neuromuscular blockade. The observations were continuous including oxyhemoglobin saturation, end-tidal carbon dioxide level, invasive blood pressure, central venous pressure, pharyn- Figure 1. Positions of ports. JSLS (2013)17:126 –131 127 Laparoscopic Kidney Orthotopic Transplant, He B et al. Figure 2. Small midline incision for delivery of kidney graft. Figure 4. Renal vein end-to-end anastomosis. RV anastomosis RA anastomosis Figure 5. Renal graft reperfused rapidly and uniformly. The arrows show renal artery (RA) and renal vein (RV) anastomosis by running suture. Figure 3. Renal artery end-to-end anastomosis. corners of the renal vein as marking stitches, thus facilitating the manipulation of the vessel during the anastomosis. The kidney was preserved in the cold perfusion fluid until implantation. The kidney was then implanted at the orthotopic location by a laparoscopic technique. The kidney graft was continuously flushed with cold (4°C) normal saline solution via an extra 5-mm port during the period of vessel anastomosis. The renal artery was anastomosed end to end to the renal artery stump and the renal vein was anastomosed end to end to the renal vein stump by No. 6-0 Prolene running sutures (Figures 3, 4, and 5) in the first 4 pigs and by interrupted stitches in the fifth pig (Figure 6). The venous running suture was tied with a growth factor margin allowing distension of the venous anastomosis 128 after reperfusion. The kidney graft was reperfused by removing the venous Bulldog device, followed by the arterial Bulldog device. Forty milligrams of furosemide was given intravenously after kidney reperfusion. The ureteral catheter that was inserted into the ureter was brought out via the laparoscopic port for observation of urine output. Postoperative Course The pig remained under anesthesia during the period of observation. The vital signs were recorded every 5 minutes. The urine output was monitored. Doppler ultrasonography was performed to check the blood flow in the kidney graft. Graft nephrectomy was performed by a laparoscopic technique at the end of the observation period. The pig was then euthanized according to the study pro- JSLS (2013)17:126 –131 RV Figure 6. Renal graft reperfused rapidly and uniformly. The arrow shows renal vein (RV) interrupted stitches. tocol. The vessel anastomoses were examined on the bench table. Figure 7. Removed kidney graft after transplantation. The renal artery and vein anastomoses are patent. RESULTS technique for kidney transplant has remained unchanged since the first successful kidney transplant in the 1950s.6 Basically, an open incision is needed at the lower abdomen and the kidney graft is placed at the iliac fossa in a heterotopic position. In this open surgery, the incision is approximately 15 to 20 cm long and cutting of the muscular layers is unavoidable. Recently, there have been few reports of heterotopic kidney transplant by laparoscopic/ robotic surgery, which could minimize the incision for placement of the kidney graft.9 –14 However, the disadvantage of these techniques is that the kidney graft is located at the pelvis, where it is relatively superficial and susceptible to injury during contact sports or trauma. Moreover, a third or fourth kidney transplant can also be very difficult because of the formation of adhesions surrounding the iliac vessels from previous transplant surgery. Open surgery for orthotopic kidney transplant has been reported in the literature as an effective alternative for those recipients in whom a heterotopic transplant was inappropriate, such as patients with a retained iliac fossa from a former graft, thrombosis of the iliac vein, or severe arthromatosis on the iliac artery.15–18 The long-term patient and graft survival rates are comparable with those for conventional heterotopic kidney transplant.18 However, open orthotopic kidney transplant has not been the favored approach because it is more difficult when compared with conventional heterotopic kidney transplant. It usually requires a longer midline incision or use of a posterolateral lumbotomy, in which massive muscles will be cut.17,18 As a result, more analgesia is required and the recovery takes longer. This study has shown that orthotopic kidney transplant can be performed safely by a laparoscopic ap- The vital signs of all pigs were stable during the surgery and postoperative observation period. The blood pressure was stable from 100 mm Hg/60 mm Hg to 140 mm Hg/80 mm Hg. There were no intraoperative complications and no conversion to open surgery. There was minimum blood loss in 4 pigs, and 1 pig had more blood oozing during the anastomosis. The operative time for laparoscopic donor nephrectomy ranged from 1 hour 20 minutes to 1 hour 50 minutes (mean, 1 hour 30 minutes). The time for renal artery anastomosis ranged from 30 to 40 minutes, whereas the time for renal vein anastomosis ranged from 25 to 35 minutes. The graft warm ischemic time ranged from 3 to 5 minutes. The graft cold ischemic time ranged from 1 hour 50 minutes to 2 hours 20 minutes. Four of five grafts were reperfused rapidly and uniformly (Figures 5 and 6). Urine output was immediately seen in 3 pigs. The blood flow in the kidney grafts was satisfactory on Doppler ultrasonography; the arterial waveforms in the kidney parenchyma were normal, as was venous flow. On postmortem examination, the vessel anastomosis was shown to be widely patent in 3 pigs (Figure 7), whereas there was narrowing at the anastomoses of the renal artery and vein in the other 2 pigs. DISCUSSION The use of laparoscopic surgery has expanded rapidly in clinical surgical practice, replacing conventional open surgery. A laparoscopic technique has also been successfully used for vessel anastomosis with satisfactory results and significant benefits to patients.7,8 However, the surgical JSLS (2013)17:126 –131 129 Laparoscopic Kidney Orthotopic Transplant, He B et al. proach, in which only a small midline (6-cm) incision is needed. The application of the laparoscopic technique for human orthotopic kidney transplant could facilitate the consideration in selected recipients. In particular, it could be useful for younger recipients who wish to enjoy active sports and those who have an unsuitable pelvic condition for heterotopic kidney transplant. To our knowledge, this is the first report of laparoscopic kidney orthotopic transplant in a pig model. Obviously, in this experiment, laparoscopic kidney transplant only requires a small incision (6 cm) in the lower midline for delivery of the kidney graft in and out. The incision was created by opening the skin and fascia at the midline and opening the muscular layer in the para-midline, which makes the incision function like a valve to effectively reduce gas leak. This incision is time and cost saving because it does not need to be closed or sealed to prevent gas leak, and it thus minimizes the warm ischemic time of the graft. In this study, we have learned that the laparoscopic vessel anastomosis for kidney transplant is safe and feasible. The quality of vessel anastomosis by the laparoscopic technique is reliable on postmortem examination. Nevertheless, the anastomotic stenosis tends to occur in the fashion of a continuous anastomosis because the renal vein wall is very thin and the renal artery is very small in caliber. This phenomenon was also reported in open kidney orthotopic transplant in a pig model.19 The interrupted stitch for vessel anastomosis could be considered in a future study when the laparoscopic suture technique is improved (Figure 6). This could prevent the possibility of anastomotic stenosis in this model. Alternatively, the sutures can be tied after the Bulldog device has been repositioned, allowing the blood flow through the anastomosis in the renal artery and the growth factor created at the renal vein anastomosis to prevent the anastomotic stenosis. It was noticed that the vessel anastomotic time was longer by the laparoscopic technique. However, this is a fairly new technique. The laparoscopic instruments used in this experiment were not fine enough because the renal artery was usually smaller in caliber (⬃2–3 mm in diameter) than those in the human kidney. We believe the laparoscopic vessel anastomotic time will be reduced dramatically with further practice over time and modification of the laparoscopic instruments. Robotic surgery may have advantages in vessel anastomosis because of its 3-D view of the system compared with laparoscopic surgery.11,13,14 It may shorten the vessel anastomotic time, improve the quality of vessel anastomosis, and minimize the ischemic-reperfusion injury to the graft. Further stud130 ies will also be of value in determining the technique for endoscopic vessel anastomosis. Regarding animal welfare concerns, this model of laparoscopic kidney transplant could be applied to other research projects in which the kidney transplant model is involved, such as ischemic-reperfusion injury with benefits of smaller incision and less requirement for analgesia. This model could also provide an opportunity for surgeons who wish to perform human laparoscopic kidney transplant to obtain the skill. A limitation of this study is that the observation of graft function was performed for only up to 4 hours after kidney transplant. Further studies have been approved by our animal ethics committee to investigate the impact of laparoscopic kidney transplant on morbidity and mortality in a survival pig model. The pigs and kidney graft function will be observed for 4 weeks after transplant using the laparoscopic technique. The graft function will be monitored by regular testing of the serum creatinine level after laparoscopic kidney transplant. Further information on safety and feasibility will be provided before application to human clinical kidney transplant with the laparoscopic technique. Nevertheless, our initial experience suggests that the use of the laparoscopic technique could facilitate orthotopic kidney transplant in selected recipients. References: 1. Tooher R, Boult M, Maddern GJ, Rao MM. Final report from the ASERNIP-S audit of laparoscopic live-donor nephrectomy. ANZ J Surg. 2004;74(11):961–963. 2. Merlin TL, Scott DF, Rao MM, et al. The safety and efficacy of laparoscopic live donor nephrectomy: a systematic review. Transplantation. 2000;70(12):1659 –1666. 3. Melcher ML, Carter JT, Posselt A, et al. More than 500 consecutive laparoscopic donor nephrectomies without conversion or repeated surgery. Arch Surg. 2005;140(9):835– 839; discussion 839 – 840. 4. Hadjianastassiou VG, Johnson RJ, Rudge CJ, Mamode N. 2509 living donor nephrectomies, morbidity and mortality, including the UK introduction of laparoscopic donor surgery. Am J Transplant. 2007;7(11):2532–2537. 5. He B, Mitchell A, Delriviere L, et al. Laparoscopic donor nephrectomy. ANZ J Surg. 2011;81(3):159 –163. 6. Murray JE, Merrill JP, Harrison JH. Kidney transplantation between seven pairs of identical twins. Ann Surg. 1958;148(3): 343–359. 7. Chung BI, Gill IS. Laparoscopic splenorenal venous bypass for nutcracker syndrome. J Vasc Surg. 2009;49(5):1319 –1323. JSLS (2013)17:126 –131 8. Bruls S, Quaniers J, Tromme P, Lavigne JP, Van Damme H, Defraigne JO. Comparison of laparoscopic and open aortobifemoral bypass in the treatment of aortoiliac disease. Results of a contemporary series (2003–2009). Acta Chir Belg. 2012;112(1):51–58. 9. Hoznek A, Zaki SK, Samadi DB, et al. Robotic assisted kidney transplantation: an initial experience. J Urol. 2002;167(4):1604–1606. 10. Rosales A, Salvador JT, Urdaneta G, et al. Laparoscopic kidney transplantation. Eur Urol. 2010;57(1):164 –167. 11. Giulianotti P, Gorodner V, Sbrana F, et al. Robotic transabdominal kidney transplantation in a morbidly obese patient. Am J Transplant. 2010;10(6):1478 –1482. 12. Modi P, Rizvi J, Pal B, et al. Laparoscopic kidney transplantation: an initial experience. Am J Transplant. 2011;11(6):1320 –1324. 13. Boggi U, Vistoli F, Signori S, et al. Robotic renal transplantation: first European case. Transpl Int. 2011;24(2):213–218. 14. Benedetti E. Robotic intra-peritoneal kidney transplant in obese recipients. Presented at: American Transplant Congress; April 30-May 4, 2011; Philadelphia, PA. 15. Ferri M, Russell JD, Whelan JP. Orthotopic renal transplantation in a patient with a massive pelvic arteriovenous malformation. J Urol. 2000;163(3):899. 16. Rodrigues P, D’Imperio M, Campagnari M, Azevedo LA, Campagnari JC, van Bellen B. Alternative grafting technique for patients unsuited to heterotopic transplantation due to diseased pelvic conditions. Urol Int. 2004;73(4):316 –319. 17. Paduch DA, Barry JM, Arsanjani A, Lemmers MJ. Indication, surgical technique and outcome of orthotopic renal transplantation. J Urol. 2001;166(5):1647–1650. 18. Musquera M, Peri LL, Alvarez-Vijande R, Oppenheimer F, Gil-Vernet JM, Alcaraz A. Orthotopic kidney transplantation: an alternative surgical technique in selected patients. Eur Urol. 2010;58(6):927–933. 19. Jochmans I, Lerut E, Heedfeld V, Wylin T, Pirenne J, Monbaliu D. Reproducible model for kidney autotransplantation in pigs. Transplant Proc. 2009;41(8):3417–3421. JSLS (2013)17:126 –131 131 CASE REPORT Laparoscopic Excision of Splenic Artery Aneurysm Youngjin Kim, MD, Samir Johna, MD ABSTRACT INTRODUCTION Introduction: Splenic artery aneurysm is more frequently diagnosed today with the advancement and liberal use of imaging modalities. A symptomatic aneurysm, an aneurysm of any diameter in a pregnant woman or a woman of childbearing age, and an aneurysm ⬎2 cm are all strong indications for surgery because of a significantly increased risk for splenic artery rupture. Splenic artery aneurysm (SAA) is the most common splanchnic arterial aneurysm, accounting for approximately 60% of all visceral aneurysms, and is the third most common abdominal aneurysm, after aortic and iliac artery aneurysms.1,2 The incidence of SAA has been reported to be between 0.02% and 10.4% in the general population, with a prominent occurrence in multiparous women.1 The increase in the incidence of SAA in the past decade can be attributed to the technical advancement and more frequent use of imaging modalities. Most patients with SAAs are asymptomatic. However, a symptomatic aneurysm, an aneurysm of any diameter in a pregnant woman or a woman of childbearing age, and an aneurysm ⬎2 cm are all strong indications for surgery because of a significantly increased risk for splenic artery rupture.1 Various treatment options for SAA include endovascular management, laparoscopic surgery, and open surgery.3 We report the successful laparoscopic surgical treatment of a 2.5-cm SAA near the splenic hilum by en bloc resection of the SAA and the spleen. Case Description: A 35-year-old, morbidly obese, African American woman presented with constant left flank pain for 4 weeks. Angiography confirmed a 2.5-cm splenic artery aneurysm near the splenic hilum. Because angioembolization was unlikely to succeed because of extensive collaterals and the aneurysm’s proximity to the splenic hilum, laparoscopic excision of the aneurysm with splenectomy was performed. Discussion: We report the successful laparoscopic surgical treatment of a 2.5-cm splenic artery aneurysm. Any splenic artery aneurysm with a significantly increased risk of rupture requires a prompt intervention. Although percutaneous embolization of the splenic artery is the most frequently applied therapy today, surgical repair is preferred for all symptomatic aneurysms because of the greater likelihood of success. Key Words: Aneurysm, Laparoscopy, Splenic artery, Rupture. Department of General Surgery, Arrowhead Regional Medical Center/Kaiser Permanente Fontana Medical Center, Fontana, CA, USA (Drs. Kim, Johna). Address correspondence to: Youngjin Kim, MD, Department of General Surgery, Kaiser Permanente Fontana Medical Center, 9985 Sierra Ave, Fontana, CA 92335, USA. Telephone: (909) 427-5626, Fax: (909) 427-4065, E-mail: [email protected] DOI: 10.4293/108680812X13517013317392 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 132 CASE REPORT A 35-year-old, morbidly obese, African American woman presented with constant left flank pain, which she had had for 4 weeks. She had no significant medical history and no family history of aneurysm or connective tissue disorder. Physical examination was benign. Computed tomography showed no obvious disease processes except a questionable aneurysm of the splenic artery, and subsequent computed tomography angiography confirmed a 2.5-cm SAA near the splenic hilum (Figure 1). A multidisciplinary discussion among the primary admitting team, the vascular surgeon, the general surgeon, and the interventional radiologist resulted in a recommendation of angioembolization as the treatment of choice. However, after visceral angiography, the interventional radiologist believed that angioembolization was unlikely to succeed in this case because of extensive collaterals. Surgical options, including open aneurysm excision or laparoscopic en bloc resection with the spleen because of the hilar location of the aneurysm, were discussed with the patient. The laparoscopic approach was offered based on reports of success- JSLS (2013)17:132–134 Figure 1. Coronal computed tomography image showing large aneurysm of splenic artery. ful treatment of SAA with the risk of rupture, which is difficult to treat with interventional radiology therapy.4 On laparoscopy, the aneurysm was found to be partly embedded in the tail of the pancreas and the hilum of the spleen. The spleen appeared to be normal in size and texture. The aneurysm was excised en bloc with the spleen because the aneurysm was too close and tethered to the hilum, where isolation of the aneurysm would be dangerous and ultimately unnecessary. The SAA was identified and dissected ex vivo to confirm the removal of the aneurysm (Figure 2). The surgery was complicated by the patient’s shortness of breath due to pulmonary atelectasis. She eventually recovered and was discharged home on postoperative day 5. DISCUSSION SAA is the most frequently encountered type of splanchnic artery aneurysm and is the third most common abdominal aneurysm, after aortic and iliac artery aneurysms.1 Female patients are 4 times more likely to have SAAs than male patients. An increased incidence of SAAs has been associated with several conditions, including pregnancy, degenerative atherosclerosis, portal hypertension, medial fibrodysplasia, arteritis, collagen vascular disease, ␣1-antitrypsin deficiency, and pancreatitis. Less common causes include idiopathic dissection, septic emboli, essential hypertension, polyarteritis nodosa, systemic lupus erythematosus, Ehlers-Danlos syndrome, and neurofibromatosis. Pseudoaneurysms of the splenic artery are most often caused by chronic pancreatitis or by trauma.5 More than two-thirds of aneurysms of the splenic artery are true aneurysms. They are usually saccular and occur at a bifurcation in the splenic hilum.6 The true cause of SAA formation is unclear. However, an increase in splenic Figure 2. Isolated SAA after en bloc resection of aneurysm and spleen. blood flow may play a role in the development of SAA in patients with portal hypertension due to liver cirrhosis or transplantation. In addition, the increased prevalence in multiparous women may be related to increased splenic blood flow and the effects of estrogen on the elastic tissue of the tunica media.7 SAA rupture has been associated with aneurysm size ⬎2 cm, pregnancy, history of liver cirrhosis or transplantation, and ␣1-antitrypsin deficiency. The overall risk for rupture is 5%. Evidence in the literature indicates that pregnant patients are at high risk for rupture of SAAs, with a maternal mortality rate near 70% and an even more devastating fetal mortality rate of 90% to 95%.8 SAA, once mostly found incidentally at autopsy, is more frequently diagnosed with the technical advancement of diagnostic imaging, prompting an earlier intervention for those at an increased risk for SAA rupture. Traditionally, open laparotomy with either aneurysm ligation alone or splenectomy with ligation was the gold standard for the management of SAA. Today, various therapeutic options are available for SAA, including noninvasive endovascular management and laparoscopic or open surgery with or without splenectomy.9 Percutaneous embolization of the splenic artery is the most frequently applied therapy. It may be performed for all SAAs except those located at the splenic hilum.10 Aneurysm of the proximal splenic artery can be treated with simple ligation JSLS (2013)17:132–134 133 Laparoscopic Excision of Splenic Artery Aneurysm, Youngjin K et al. or aneurysmectomy, but those involving the hilum require splenectomy.3 Most recently, stent grafts and covered stents have been used with success, especially in the presence of portal hypertension, because the extensive collateral circulation that develops with portal hypertension makes surgery more difficult.11 Surgical repair is preferred for all symptomatic aneurysms because of the greater likelihood of success.5 Rarely, aneurysmectomy with end-to-end anastomosis may be used when the SAA is not intrasplenic or in the hilum. Since the first successful laparoscopic-assisted SAA resection performed in 1993 by Saw et al.,12 simple laparoscopic ligation of the artery proximal to the SAA and SAA resection with or without splenectomy have been conducted with increasing frequency. In experienced hands, laparoscopic surgery is a simple, safe, minimally invasive technique, with rapid recovery, decreased postoperative pain, and shorter hospital stay compared with the open technique.13 Some authors have advocated a tangential stapler resection of sacciform aneurysms to preserve splenic flow, but others worry that this type of laparoscopic treatment leaves behind part of the aneurysmal artery and therefore might contribute to recurrence.14,15 Ligation of the proximal and distal segment is considered safer in lesions of the medial third, because these are often adherent to the pancreas. However, the risk of pancreatic injury during the laparoscopic dissection of an SAA is more theoretical than real because the splenic artery runs separate from the pancreatic parenchyma and a plane can always be found between the two. Ligation is feasible in a mid-SAA by stapling or clipping the inflow and outflow. Preservation of the spleen should be attempted unless the SAA is located deep within the splenic hilum.16 Most recent reviews of laparoscopic surgery for SAAs show successful laparoscopic treatment of hilar SAAs with splenectomy and some even with distal pancreatectomy for SAAs too difficult to treat with interventional radiology therapy.4 In case of splenic artery pseudoaneurysm, most often caused by chronic pancreatitis or trauma, SAA resection with splenectomy with or without distal pancreatectomy is recommended because of the higher risk of recurrence and complications.17 1. Abbas MA, Stone WM, Fowl RJ, et al. Splenic artery aneurysms: two decades experience at Mayo Clinic. Ann Vasc Surg. 2002;16(4):442– 449. 2. Trastek VF, Pairolero PC, Joyce JW, Hollier LH, Bematz PE. Splenic artery aneurysms. Surgery. 1982;91(6):694 – 699. 3. Hashizume M, Ohta M, Ueno K, Okadome K, Sugimachi K. Laparoscopic ligation of splenic artery aneurysm. Surgery. 1993; 113(3):352–354. 4. Obuchi T, Sasaki A, Nakajima J, Nitta H, Otsuka K, Wakabayashi G. Laparoscopic surgery for splenic artery aneurysm. Surg Laparosc Endosc Percutan Tech. 2009;19(4):338 –340. 5. Pasha SF, Gloviczki P, Stanson AW, Kamath PS. Splenic artery aneurysm. Mayo Clin Proc. 2007;82(4):472– 479. 6. Carr SC, Pearce WH, Vogelzang RL, McCarthy WJ, Nemcek AA Jr, Yao JS. Current management of visceral artery aneurysms. Surgery. 1996;120(4):627– 633. 7. Hallett JW Jr. Splenic artery aneurysms. Semin Vasc Surg. 1995;8(4):321–326. 8. Cailouette JC, Merchant EB. Ruptured splenic artery aneurysm in pregnancy: twelfth reported case with maternal and fetal survival. Am J Obstet Gynecol. 1993;168(6 Pt 1):1810 –1813. 9. Kokkalera U, Bhende S, Ghellai A. Laparoscopic management of splenic artery aneurysms. J Laparoendosc Adv Surg Tech A. 2006;16(6):604 – 608. 10. Reidy JF, Rowe PH, Ellis FG. Splenic artery aneurysm embolization—the preferred technique to surgery. Clin Radiol. 1990;41(4):281–282. 11. Arepally A, Dagli M, Hofmann LV, Kim HS, Cooper M, Klein A. Treatment of splenic artery aneurysm with use of a stent-graft. J Vasc Interv Radiol. 2002;13(6):631– 633. 12. Saw EC, Ku W, Ramachandra S. Laparoscopic resection of a splenic artery aneurysm. J Laparoendosc Surg. 1993;3(2):167–171. 13. Ha JF, Sieunarine K. Laparoscopic splenic artery aneurysm resection: review of current trends in management. Surg Laparosc Endosc Percutan Tech. 2009;19(2):e67– e70. 14. Matsumoto K, Ohgami M, Shirasugi N, Nohga K, Kitajima M. A first case report of the successful laparoscopic repair of a splenic artery aneurysm. Surgery. 1997;121(4):462– 464. 15. Lai PB, Leung KL, Lau WY. Laparoscopic repair of a splenic artery aneurysm. Surgery. 1998;123:247–248. CONCLUSION SAA requires prompt attention for patients at increased risk for rupture. Endovascular management is the least invasive and most applied therapy. However, for more complicated cases, laparoscopic surgery should be considered as the next best option. 134 References: 16. Pietrabissa A, Ferrari M, Berchiolli R, et al. Laparoscopic treatment of splenic artery aneurysms. J Vasc Surg. 2009;50(2):275–279. 17. Tessier DJ, Stone WM, Fowl RJ, et al. Clinical features and management of splenic artery pseudoaneurysm: case series and cumulative review of literature. J Vasc Surg. 2003;38(5):969 –974. JSLS (2013)17:132–134 CASE REPORT Transvaginal Liver Surgery Using a Tethered Magnet and a Laparoscopic Rein Daniel Alberto Tsin, MD, Guillermo Dominguez, MD, Fausto Davila, MD, Juan Manuel Alonso-Rivera, MD, Brad Safro, MD, Andrea Tinelli, MD ABSTRACT INTRODUCTION Introduction: A novel technique was used to remove a large liver cyst via culdolaparoscopy. A transvaginal approach with assisted minilaparoscopy in the removal of benign liver lesions has previously been reported in the surgical literature. In one case, culdolaparoscopy with a liver biopsy was an incidental finding1; the other 2 cases reported2 and the case here presented were programmed liver cyst interventions. We used laparoscopy reins and a magnetic grasper in single-port laparoscopy surgery and in transvaginal cholecystectomies.3,4 The transvaginal approach is a safe method with better aesthetic results than prior laparoscopic procedures we had performed, resulting in less patient discomfort and potential risk for abdominal incision site hernias. The initial findings of this approach in the removal of hepatic benign lesions look promising. Case Description: We used laparoscopic instruments, a gastroscope, a laparoscopic rein, and magnets. The magnets consist of an external magnet and a specially modified tethered neodymium internal magnet, safe for use in transvaginal endoscopic surgery. Discussion: These technologies offer some advantages when they are used together: magnets and the rein to aid in exposure, traction–retraction, and triangulation. Previous reports have been published on the removal of benign liver lesions transvaginally, but none to date has involved the use of magnets. This article reports on the role of magnets and reins in an incision reduction approach to the removal of a liver cyst. Key Words: Magnets, Culdolaparoscopy, Liver, Laparoscopy, NOTES. The Mount Sinai Hospital of Queens. Long Island City, NY, USA (Drs. Tsin, Safro).; Fundación Hospitalaria, Buenos Aires, Argentina (Dr. Dominguez).; Sesver Regional Hospital, Poza Rica City, Veracruz, Mexico (Drs. Davila, Alonso-Rivera).; Vito Fazzi General Hospital, Lecce, Italy (Dr. Tinelli). Dr. Guillermo Dominguez, founder of IMANLAP, reports that this financial relationship had no influence on the outcome or content of this paper. Other authors have no financial interests to disclose. Address correspondence to: Daniel Alberto Tsin, MD, The Mount Sinai Hospital of Queens, Long Island City, NY, USA. Telephone: 718-899-7878 Fax: 718-899-0865 E-mail: [email protected] DOI:10.4293/108680812X13517013317239 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. CASE REPORT The surgery was performed in May 2008 at Hospital Regional, Poza Rica, SESVER in Veracruz, Mexico after being approved by the Institutional Review Board for Minilaparoscopy Assisted Natural Orifice Surgery (MANOS) and Natural Orifice Translumenal Endoscopic Surgery (NOTES) using rigid, flexible, and magnetic technologies, with Dr. Fausto Davila as the principal investigator.5 A 32-y-old multiparous female with a body mass index of 35 presented with right upper-quadrant abdominal pain and jaundice. Additional sonogram and computed tomography scan findings showed a simple liver cyst measuring 12.2cm by 12.3cm. Preoperative laboratory results showed a total bilirubin of 9.29 mg/dL (normal, 0.3 to 1.9) a direct bilirubin of 6.86 mg/dL (normal, 0 to 0.3), an alanine transaminase (ALT; serum glutamic pyruvate transaminase [SGPT]) of 116 IU/L (normal, 7 to 56), and an aspartate aminotransferase (AST; serum glutamic oxalacetic transaminase [SGOT]) of 85 IU/L (normal, 5 to 40). The elevated bilirubin was due to pressure from a large simple cyst over the biliary tract. The patient was given a dedicated informed consent for this procedure and was scheduled for surgery after risk and benefits were carefully explained, as was done in previous operations.6 She received intravenous antibiotic prophylaxis with metronidazole and cephalosporins and had undergone bowel preparation starting the night before the procedure. The procedure was done with the patient under general anesthesia with endotracheal intubation. JSLS (2013)17:135–138 135 Transvaginal Liver Surgery Using a Tethered Magnet and a Laparoscopic Rein, Tsin DA et al. The patient was placed in the European position for laparoscopy. In the operating room, one monitor was placed by the patient’s right shoulder, the other by her left foot. The vagina was cleansed with 10% povidone iodine; pelvic examination was done while the patient was anesthetized to assess the pelvis for mobility and potential for obstruction of the posterior cul-desac. After placing a Foley catheter in the urinary bladder, a uterine manipulator (ZUMI-4.5; Circon Cabot, Racine, WI) was inserted, and a weighted vaginal speculum was used to allow proper exposure of the posterior fornix. Pneumoperitoneum was induced with a Verses needle inserted in the umbilical area. The 5-mm umbilical port was placed and a 5-mm laparoscope with camera was inserted. The posterior cul-desac was visualized with the laparoscope. A plastic, 12-mm diameter, 15-cm long armed trocar was placed against the posterior fornix. The weighted speculum was removed and the uterine manipulators together with the trocar were pushed upward and anteriorly. The point of pressure was identified with the laparoscope, and under laparoscopic surveillance, the trocar was inserted into the posterior cul-desac. The armed trocar was removed and the external cannula remained as a vaginal port.7 A set of magnets was used that consisted of a larger external magnet and a smaller intraabdominal magnet, which was an 11 mm in diameter neodymium magnet with an alligator grasper in tandem and an alligator clip applier (IMANLAP, Buenos Aires, Argentina). This intraabdominal magnet was modified with a tether of 0 polypropylene suture, 75cm long. The intraabdominal magnet was introduced via the vaginal port with a Maryland grasper. The free end of the tether remained outside the vaginal port and was held with a Kelly clamp. The external magnet was placed inside a sterilized Ziploc bag. The bagged magnet was introduced into a sterilized tubular stockinet. The stockinet was closed at both ends with knots. The external magnet was used to attract the intraabdominal magnet to the anterior peritoneum in the pelvis. The surgeon then moved the internal magnet by sliding the external magnet along the patient’s abdomen (Figure 1). The magnet was brought to the designated area of the anterior abdominal wall near the cyst and was kept in place.4 A gastroscope (Excera GIF-160 Olympus, Center Valley, PA) was introduced into the abdominal cavity for visualization through the vaginal port with the patient in the Trendelenburg position. The gastroscope was brought to the umbilical line, approximately 10cm away from the liver, and the patient’s position was changed into a reverse Trendelenburg for better visualization. The umbilical port was used to place a 5-mm laparoscope and instruments, e.g., laparoscopic scissors, nee136 Figure 1. The external magnet inside a tubular stockinet. dle holder, and aspiration needle, as well as a rein. The rein consisted of a straight, 6-cm, cutting-edge needle, 2-0 polypropylene (Prolene, Ethicon, Somerville, NJ) 75cm in length with a stoppage at the end made of silastic, measuring 3 ⫻ 2x1mm.7 While viewing the cyst from the vaginal port with a gastroscope, an aspiration needle was placed via the umbilical port for drainage. After the collapse of the cyst wall, an alligator clip applier was used to grasp the back of the alligator clamp attached to the internal neodymium magnet, opening its jaws and grasping the cyst. The internal magnet and the external magnet were then coupled and moved to the desired location by sliding the external magnet along the skin. This technique allowed for retraction of the cyst wall while keeping it under tension (Figure 2). With this exposure, the roof of the cyst was removed using a 5-mm laparoscopy scissor placed in the umbilical port. The rein was introduced into the abdomen via a 5-mm umbilical port. Once the abdomen was accessed, the needle was passed through the cyst wall at the strategic point with relation to the internal magnet to provide better exposure and triangulation. The rein was held as a marionette or at the skin level to anchor the cyst with a Kelly clamp. The rein needle was cut and disposed of safely (Figure 3).7 The removed portion of the cyst was brought to the pelvic area by using the magnets for mobilization. The laparoscopy rein held the specimen as a marionette while allowing traveling from the upper abdomen to the pelvis. A 5-mm laparoscope was placed in the umbilical port. A 10-mm laparoscopic clamp was placed via the vaginal port to grab the specimen. The external magnet was removed. The Kelly JSLS (2013)17:135–138 Figure 2. Tethered magnet holding the cyst wall. Figure 4. Transvaginal magnet and cyst wall extraction. hospital for laparoscopic cholecystectomies. She resumed sexual activities 40 d after surgery without dyspareunia. She was followed for 1 wk and 3 mo after surgery she had no complications. DISCUSSION Figure 3. A magnet, rein exposure. clamps holding the end of the tether and the end of the rein were released and in a coordinated manner, the specimen, the magnet, the rein, and the vaginal port were removed together vaginally (Figure 4). The vaginal port was reintroduced to place a catheter for drainage in the right upper flank. The colpotomy incision was closed with 2-0 chromic sutures placed vaginally. Two hours after surgery the patient was sitting, eating, and with pain of 2cm as measured on her visual analogue scale. Thirty-six hours after surgery, her jaundice began to clear, the total bilirubin was 3.2 mg/dL, the direct bilirubin was 2.1 mg/ dL, the ALT (SGPT) was 59 IU/L, the AST (SGOT) was 24 IU/L and the vaginal drainage was removed. She was discharged 2 d after surgery, which is customary in this Hybrid transvaginal endoscopic surgery can be facilitated with additional instruments, techniques, and a flexible video endoscope. Retraction and exposure are done with magnets and a laparoscopic rein, instead of using additional abdominal ports, which lead to added patient discomfort and unnecessary scaring.7 Magnets have been investigated for their use in the transvaginal approach.3,8,9 The magnets are used through a natural orifice to retract tissues by aligning them with external magnets to avoid additional trocar placement.10 The function of the tether is to localize an out-of-sight or dislodged intraabdominal magnet. The tether should not be used indiscriminately, because pulling may cause injury to adjacent tissues.3 Although the rein can move the target in one direction, the magnet has the option in most cases to move freely via the anterior peritoneum, and the ability to reposition the graspers offers a range of movements beyond the rein. Secured independent tools (SIT) not used in this case are different from the rein; the SIT provides more range of movement without target perforation but has less mobility than the magnets.11 The use of 2 magnets creates a risk of collision of the internal or external magnets; we avoid this event in our approach by combining one set of magnets with a rein. JSLS (2013)17:135–138 137 Transvaginal Liver Surgery Using a Tethered Magnet and a Laparoscopic Rein, Tsin DA et al. CONCLUSION We modified an internal laparoscopic magnet grasper by adding a 75-cm tether. This change was originally recommended for transvaginal cholecystectomies as a way to secure or retrieve the internal magnet in case of misplacement during natural orifice surgery. The tether is left inside the vaginal port, held externally, and removed with the magnet at the end of the procedure. Furthermore, the use of the laparoscopy rein in combination with magnets avoids the risk of collision when more than one internal or external set of magnets is used. The cumulative experience in culdolaparoscopy, a hybrid transvaginal endoscopic surgery, suggests benefits with less pain, fewer hernias, and definitely better cosmetics results. To our knowledge, this is the first report of the use of magnets for the transvaginal treatment of a liver cyst in humans. This concept has the potential to change the way we approach minimally invasive surgery in the abdomen by using different instruments or techniques and combining them with the use of magnets. References: 1. Tsin DA, Bumaschny E, Helman M, et al. Culdolaparoscopic oophorectomy with vaginal hysterectomy: an optional minimalaccess surgical technique. J Laparoendoscope Adv Surg Tech A. 2002;12:269 –271. 2. Castro-Pérez R, Dopico-Reyes E, Acosta-González LR. Minilaparoscopic-assisted transvaginal approach in benign liver lesions. Rev Esp Enferm Dig. 2010;102(6):357–364. sented at: 37th Annual Meeting of the American Association of Gynecologic Laparoscopists; October 28-November 1, 2008; Las Vegas, NV. 4. Padilla BE, Dominguez G, Millan C, Martinez-Ferro M. The use of magnets with single-site umbilical laparoscopic surgery. Semin Pediatr Surg. 2011;20(4):224 –231. 5. Davila FJ, Tsin DA, Gutierrez LS, Lemus J, Jesus R, Davila MR, Torres-Morales J. Transvaginal single port cholecystectomy surgical laparoscopy. Surg Laparosc Endosc Percutan Tech. 2011;21(3):203–206. 6. Tsin DA, Tinelli A, Malvasi A, Davila F, Jesus R, Castro-Perez R. Laparoscopy and natural orifice surgery: first entry safety surveillance step. JSLS. 2011;15(2):133–135. 7. Tsin DA, Davila F, Dominguez G, Tinelli A. Laparoscopy rein and a backward needle entrance. J Laparoendosc Adv Surg Tech A. 2011;21(6):521–523. 8. Park S, Bergs RA, Eberhart R, Baker L, Fernandez R, Cadeddu JA. Trocar-less instrumentation for laparoscopy: magnetic positioning of intra-abdominal camera and retractor. Ann Surg. 2007;245:379 –384. 9. Cho YB, Park CM, Chun HK, et al. Transvaginal endoscopic cholecystectomy using a simple magnetic traction system. Minim Invasive Ther Allied Technol. 2011;20(3):174 –178. 10. Scott DJ, Tang S, Fernandez R, et al. Completely transvaginal NOTES cholecystectomy using magnetically anchored instruments. Surg Endosc. 2007;21:2308 –2316. 11. Tsin DA, Davila F, Dominguez G, Manolas P. Secured independent tools in peritoneoscopy. JSLS. 2010;14:258. 3. Tsin DA, Dominguez G, Jesus R, Aguilar S, Davila F. Transvaginal cholecystectomy using magnetic graspers. Paper pre- 138 JSLS (2013)17:135–138 CASE REPORT Gallstone-Related Abdominal Abscess 8 Years After Laparoscopic Cholecystectomy Andrew Dobradin, MD, PhD, Stephanie Jugmohan, BS, Luis Dabul, BS ABSTRACT INTRODUCTION Background: A common intraoperative complication during laparoscopic cholecystectomy is gallbladder perforation with spillage of gallstones. The undesirable consequence of spilled gallstones is the formation of abscesses months or years after an operation. The beginning of the era of laparoscopic cholecystectomy started on September 12, 1985 in Germany by Prof DrMed Erich Muhe (or since its introduction in France in 1987 by Dubois et al).1 Laparoscopic cholecystectomy is now considered the gold standard of surgical intervention for the treatment of symptomatic cholelithiasis and gallbladder disease.2,3 Case Description: Our clinical report describes an intraabdominal abscess formation in an 82-year-old man that developed 8 years after a laparoscopic cholecystectomy. A computed tomography scan of the abdomen showed an elongated fluid collection in the right abdominal compartment musculature at the level of the internal oblique muscle. Abdominal ultrasonography confirmed a large fluid collection, with 2 echogenic masses in the dependent portion. Incision and drainage of the abscess were performed, and 2 gallstones were found. Conclusion: Any unusual collection of fluid in the perihepatic space and abdominal wall in the area of the surgical incision in a patient with a remote history of cholecystectomy should be evaluated for abscess related to retained gallstone. Early abscess formation is usually diagnosed and treated by the surgeon. However, the late manifestation might be a clinical problem seen in the primary care physician’s office. Therefore, the primary care physician should incorporate diagnosis of gallstonerelated abscess in patients with abdominal abscess formation of unknown etiology. Key Words: Laparoscopic cholecystectomy, Retained gallstones, Abdominal abscess, Gallstones. Winter Park, Florida, USA (all authors). Address correspondence to: Andrew Dobradin, MD, PhD, 320 North Edinburgh Drive, Suite B, Winter Park, FL 32792, USA. Telephone: 407-647-3460, E-mail: [email protected] DOI:10.4293/108680812X13517013317518 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. This commonly performed and well-established minimally invasive surgery is still associated with adverse effects and complications. The most feared complication of laparoscopic cholecystectomy is injury to the common bile duct. The initial high occurrence rate (1.9%) of this type of injury during the early era of laparoscopic surgery has since decreased and stabilized to 0.5%.4,5 Surgeons take precautions to avoid and detect this type of injury by using the “critical view” technique and intraoperative cholangiography.5 Other common complications include retained common bile duct stones, bile leaks, and superficial wound infections. The complications that occur more often with laparoscopic cholecystectomy are perforations of the gallbladder during laparoscopic surgery and spillage of gallstones.6 In their review of the scientific literature, Papasavas et al7 found that in contrast to 127 case reports of complications secondary to dropped gallstones during laparoscopic cholecystectomy, only 2 such events have been described for open cholecystectomies since the year 1963. This is obviously a matter of concern because additional studies reported incidents of gallbladder perforation during laparoscopic surgery varying from 10% to 40%, a 7.3% incidence of gallstone spillage, and an estimated 33% of unretrieved gallstones.8 –13,14 In rare instances, postoperative residual gallstones can contribute to associated abscess formation.14 The formation of abscesses occurs in remote locations to the site of the gallbladder fossa, making diagnosis and causation difficult to establish after the index operation.14 Most of these abscesses have been reported to manifest during the first 4 to 9 months after the initial operation, whereas only a few can be detected as late as 15 years after laparoscopic cholecystectomy.15 In our case, the time between laparoscopic cholecystectomy and abdominal wall abscess formation was 8 years. JSLS (2013)17:139 –142 139 Gallstone-Related Abdominal Abscess 8 Years After Laparoscopic Cholecystectomy, Dobradin A et al. CASE DESCRIPTION An 82-year-old man was admitted to the clinic with complaints of right upper quadrant abdominal pain and soreness in the right subcostal area lasting 2 months. He described the pain as constant and rated it a 5 on a 10-point scale, where 10 represents the worse pain ever. He denied any nausea, vomiting, fever, or chills. His past medical history was significant for hypertension, coronary artery disease, dyslipidemia, Crohn disease, diverticulosis, osteoarthritis, benign prostatic hypertrophy, depression, sleep apnea, and environmental allergies. Eight years prior, he had undergone an uncomplicated laparoscopic cholecystectomy with intraoperative cholangiography. The medical records and operative report were reviewed and there was no description of gallbladder perforation or spillage of stones. Electrocautery and blunt dissection were used to mobilize the gallbladder, and an Endobag was used for gallbladder removal. On physical examination, the patient’s pulse rate was 72 bpm, blood pressure was 110/60 mm Hg, temperature was 97.6°F, and respiratory rate was 16 breaths/minute. On palpation of the abdomen, the patient indicated right subcostal tenderness. The initial laboratory tests revealed a hemoglobin level of 14.3g/dL and white blood cell count of 10.5 ⫻ 1000 cells/L. A computed tomography scan of the abdomen performed both before and after intravenous administration of contrast showed an elongated fluid collection with an enhancing mature wall under the right abdominal musculature compartment (Figure 1). The fluid collection was elongated in the cephalocaudal plane and measured 11 cm in height, 8 cm in maximal depth, and 3 cm in width (Figure 2). Ultrasonography of the right upper quadrant of the abdomen performed in the clinic showed a large volume of fluid collection 6 cm in length and 2 cm in depth, extending from the subdiaphragmatic space toward the iliac wing on the right side. Ultrasonography also revealed 2 echogenic structures on the dependent portion of the cavity with posterior shadowing (Figure 3), one of which measured 9.4 ⫻ 5.3 mm. A diagnosis of abdominal wall abscess was suspected, and ultrasonography-guided aspiration was performed in the clinic. The aspiration returned 70 mL of white purulent material. A Gram stain of the collected fluid showed 1⫹ white blood cells, and the culture did not grow any organisms after 3 days. Two weeks later, incision and drainage of the abdominal wall abscess were performed with the patient under general anesthesia at the hospital. Ultrasonography was used to identify the area of the abscess 140 Figure 1. Gallstone-related abdominal abscess. Computed tomography depicting right flank fluid collection with surrounding inflammatory changes. Figure 2. Gallstone-related abdominal abscess. Computed tomography image of the abdominal abscess. on the right upper abdominal quadrant, which was approximately 2 cm deep, 8 cm wide, and 10 cm long. In the dependent portion of this space, 2 shadowing 5-mm objects were seen. In this area, the incision was made down to the subcuticular tissue, and the muscle of the abdominal wall was split to enter the abscess cavity. A collection of white pus was seen and evacuated with a suction JSLS (2013)17:139 –142 Figure 3. Gallstone-related abdominal abscess. Ultrasonographic study showing a gallstone in the abscess cavity with typical posterior shadowing. device. Two stones were found and one was sent for pathologic examination. The other remained with the suction material. The cavity was irrigated with saline solution, and a 19-Fr Blake drain was placed in the most dependent part of the abscess. The pathology report of the stone described a single, medium, orange/tan irregular calculus, with a 44-mg mass and a size of 5 mm to 9 mm, that was composed primarily of cholesterol. There were no complications from the surgery, and the patient was discharged home on the same day of the operation. On the first clinic follow-up visit, 5 days postoperatively, the drain was removed. One month later, the patient remained in good condition without any complaints. During the same visit, abdominal ultrasonography was performed and revealed a small amount of fluid in the abdominal wall. Abscess formation caused by intraoperative spilled gallstones may occur weeks, months, or even years after cholecystectomy. In a retrospective review, the median and mean times from laparoscopic cholecystectomy until the first onset of symptoms were 3 months and 5.5 months, respectively.14 Brueggemeyer et al6 described a case of the right flank and retroperitoneal abscess after 72 months; however, their extensive review of the literature did not show any such case later than 12 months after laparoscopic cholecystectomy in 23 cases reported from 1992 to 1996. The longest reported abscess formation was 20 years after an open cholecystectomy.15 The longest interval documented between previous laparoscopic cholecystectomy and abscess formation was 15 years.15 In the case presented here, an abdominal wall abscess developed as a result of the 2 retained gallstones after a laparoscopic cholecystectomy performed 8 years earlier. In this particular patient, the late presentation of symptoms of the abscess formation could have been masked by the chronic abdominal pain related to colitis. In laparoscopic cholecystectomies, perforation of the gallbladder may occur during grasping, traction, dissection, and extraction of the gallbladder. The quality of the gallbladder wall is also a contributing factor to gallbladder perforation. Currently, graspers are used to hold the gallbladder wall, and if they are used with too much traction, gallbladder perforation and spillage of stones can result.15 However, traction of the gallbladder during operation is indispensable for proper dissection from its bed. Therefore, the question remains whether it is best to replace graspers with a different gentler instrument with which adequate traction can be addressed for proper exposure.15 If perforation does occur during grasping and traction, the spilled material should be evacuated and the perforation site controlled by clips, by an endoloop, or by placing the grasper in such a way that it closes the perforation.6 DISCUSSION Gallbladder perforations followed by bile leak and gallstone spillage are potential intraoperative events. However, complications caused by gallstone spillage are rare.9 These complications differ in manifestation, location, and onset of symptoms after laparoscopic cholecystectomy. The most frequent complication of residual gallstones after cholecystectomy is abscess formation.16 –18 The abscess location includes the intraperitoneal and extraperitoneal spaces. The most common areas of intraperitoneal abscesses are in the subhepatic and subphrenic spaces.14 Extraperitoneal locations of infections include abdominal wall ports and incision sites.14 During extraction, the gallbladder is squeezed through an abdominal incision, which can cause it to rupture and spill stones. For this reason, surgeons may use a sterile retrieval bag for extraction of the gallbladder. In addition, the retrieval bag facilitates manual breakdown of large gallstones that are often unable to be extracted through the small incisions made during laparoscopic cholecystectomy. The bag prevents spillage of the gallbladder contents into the abdominal cavity and the abdominal wall. If there is spillage of gallstones, it can be addressed during the operation with suitable surgical instruments, application of a suction-irrigation system, stone forceps, a disposable bag, or a combination of these.6 JSLS (2013)17:139 –142 141 Gallstone-Related Abdominal Abscess 8 Years After Laparoscopic Cholecystectomy, Dobradin A et al. An outpatient ultrasonogram of the abdominal wall/cavity was helpful in the initial evaluation of a patient who was suspected of having an abscess related to possible retained gallstones. It is advisable that health care providers include this complication on their list of differential diagnoses when an unusual abdominal wall or cavity abscess develops in a postcholecystectomy patient. CONCLUSION Abdominal cavity abscess formation secondary to retained gallstones after cholecystectomy is a rare condition that can manifest itself many years after an initial operation. Gallbladder perforation and retained or unretrieved gallstones after spillage need to be carefully recorded for later review and for help with diagnosis of the complication in the future. Universal use of a protective bag for gallbladder removal might decrease the chance of a trocar site abscess and superficial site infection. Presence of the highly reflective echoes with posterior shadowing in the abscess cavity can be pathognomic for gallstone abscess in patients with known histories of cholecystectomy, especially those performed with the laparoscopic technique. References: 1. Dubois F, Icard P, Berthelot G, Levard H. Coeliscopic cholecystectomy. Preliminary report of 36 cases. Ann Surg. 1990;211(1):60–62. 2. Litynski GS. Highlights in the History of Laparoscopy. Frankfurt, Germany: Barbara Bernert Verlag; 1996:165–168. 3. Zehetner J, Shamiyeh A, Wayand W. Lost gallstones in laparoscopic cholecystectomy: all possible complications. Am J Surg. 2007;193(1):73–78. 4. Buddingh TK, Weersma R, Savenije RA, van Dam GM, Nieuwenhuijs V. Lower rate of major bile duct injury and increased intraoperative management of common bile duct stones after implementation of routine intraoperative cholangiography. J Am Coll Surg. 2011;213(2):267–274. 5. Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995;180(1):101–125. 6. Brueggemeyer M, Saba A, Thibodeaux L. Abscess formation following spilled gallstones during laparoscopic cholecystectomy. JSLS. 1997;1(2):145–152. 142 7. Papasavas PK, Caushaj PF, Gagné DJ. Spilled gallstones after laparoscopic cholecystectomy. J Laparoendosc Adv Surg Tech A. 2002;12(5):383–386. 8. Schäfer M, Suter C, Klaiber C, Wehrli H, Frei E, Krähenbühl L. Spilled gallstones after laparoscopic cholecystectomy. A relevant problem? A retrospective analysis of 10,174 laparoscopic cholecystectomies. Surg Endosc. 1998;12(4):305–309. 9. Memon MA, Deeik RK, Maffi TR, Fitzgibbons RJ Jr. The outcome of unretrieved gallstones in the peritoneal cavity during laparoscopic cholecystectomy. A prospective analysis. Surg Endosc. 1999;13(9):848 – 857. 10. Rice DC, Memon MA, Jamison RL, et al. Long-term consequences of intraoperative spillage of bile and gallstones during laparoscopic cholecystectomy. J Gastrointest Surg. 1997;1(1): 85–91. 11. Sarli L, Pietra N, Costi R, Grattarola M. Gallbladder perforation during laparoscopic cholecystectomy. World J Surg. 1999; 23(11):1186 –1190. 12. Kimura T, Goto H, Takeuchi Y, et al. Intraabdominal contamination after gallbladder perforation during laparoscopic cholecystectomy and its complications. Surg Endosc. 1996;10(9): 888 – 891. 13. Diez J, Arozamena C, Gutierez L, et al. Lost stones during laparoscopic cholecystectomy. HPB Surg. 1998;11(2):105–108, discussion 108 –109. 14. Woodfield JC, Rodgers M, Windsor JA. Peritoneal gallstones following laparoscopic cholecystectomy. Surg Endosc. 2004; 18(8):1200 –1207. 15. Arishi AR, Rabie ME, Khan MS, et al. Spilled gallstones: the source of an enigma. JSLS. 2008;12(3):321–325. 16. Horton M, Florence MG. Unusual abscess patterns following dropped gallstones during laparoscopic cholecystectomy: etiology and sequelae. Am J Surg. 1998;175(5):375–379. 17. Whiting J, Welch NT, Hallissey MT. Subphrenic abscess caused by gallstones “lost” at laparoscopic cholecystectomy one year previously: management by minimally invasive techniques. Surg Laparosc Endosc. 1997;7(1):77–78. 18. Wilton PB, Andy OJ Jr, Peters JJ, Thomas CF, Patel VS, Scott-Conner CE. Laparoscopic cholecystectomy. Leave no (spilled) stone unturned. Surg Endosc. 1993;7(6):537–538. JSLS (2013)17:139 –142 CASE REPORT Laparoscopic Completion Cholecystectomy and Common Bile Duct Exploration for Retained Gallbladder After Single-Incision Cholecystectomy Matthew Kroh, MD, Sricharan Chalikonda, MD, Bipan Chand, MD, R. Matthew Walsh, MD ABSTRACT Background: Recent enthusiasm in the surgical community for less invasive surgical approaches has resulted in widespread application of single-incision techniques. This has been most commonly applied in laparoscopic cholecystectomy in general surgery. Cosmesis appears to be improved, but other advantages remain to be seen. Feasibility has been demonstrated, but there is little description in the current literature regarding complications. Patient and Methods: We report the case of a patient who previously underwent single-incision laparoscopic cholecystectomy for symptomatic gallstone disease. After a brief symptom-free interval, she developed acute pancreatitis. At evaluation, imaging results of ultrasonography and magnetic resonance cholangiopancreatography demonstrated a retained gallbladder with cholelithiasis. The patient was subsequently referred to our hospital, where she underwent further evaluation and surgical intervention. Results: Our patient underwent 4-port laparoscopic remnant cholecystectomy with transcystic common bile duct exploration. Operative exploration demonstrated a large remnant gallbladder and a partially obstructed cystic duct with many stones. Transcystic exploration with balloon extraction resulted in duct clearance. The procedure took 75 minutes, with minimal blood loss. The patient’s postoperative course was uneventful. Final pathology results demonstrated a remnant gallbladder with cholelithiasis and cholecystitis. Conclusion: This report is the first in the literature to describe successful laparoscopic remnant cholecystectomy and transcystic common bile duct exploration after previous single-port cholecystectomy. Although inadvertent partial cholecystectomy is not unique to this techDepartment of General Surgery, Digestive Disease Institute, Cleveland Clinic, Cleveland, Ohio, USA (all authors). Address correspondence to: Matthew Kroh, MD, Department of General Surgery, Digestive Disease Institute, Cleveland Clinic, Cleveland, OH, USA. Telephone: (216) 445-9966, Fax: (216) 444-2153, E-mail: [email protected] DOI:10.4293/108680812X13517013317356 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. nique, single-port laparoscopic procedures may result in different and significant complications. Key Words: Single-port laparoscopy, Complications, Retained gallbladder. INTRODUCTION New technologies and surgical approaches continue to advance the field of minimally invasive surgery. Laparoscopy has revolutionized approaches to general surgical problems with improved outcomes of decreased postoperative pain and patients’ quicker return to work. In large part because of these successes, natural orifice and singlesite approaches have been adopted. Although enthusiasm for transvisceral approaches has waned, single-site operations have increased significantly. A PubMed search for “single-port laparoscopic surgery” generated 202 peerreviewed articles in the past year, 163 articles in the year prior, and only 8 publications during the intervening 5 years from 5 to 10 years ago. Although many procedures have been described, it appears that the most common application for single-port surgery within general surgery is transumbilical cholecystectomy. Trials are currently underway and certain benefits have been suggested, but the only clear advantage at this time appears to be cosmesis.1 Difficulties with single-port access procedures include external clashing secondary to lack of triangulation and possibly alterations in surgical approaches. As such, complications associated with this technique are now being described and include common bile duct injury, subcapsular hematoma, and incisional hernia.2,3 We describe a case of laparoscopic completion cholecystectomy with transcystic common bile duct exploration for incomplete cholecystectomy after single-port cholecystectomy resulting in retained gallbladder and postoperative gallstone pancreatitis. PATIENTS AND METHODS A 51-year-old woman with symptomatic cholelithiasis underwent a single-port cholecystectomy using a single-port device at an outside hospital. The presence of gallstones JSLS (2013)17:143–147 143 Laparoscopic Completion Cholecystectomy and Common Bile Duct Exploration, Kroh M et al. was confirmed by preoperative ultrasonography, and the patient did not have a prior history of pancreatitis or jaundice. The operative report from the outside hospital was reviewed. The operation was performed with a commercially available single-port trocar with 3 trocars for instruments and camera access. The report described dissection within Calot’s triangle and securing both the cystic duct and cystic artery with clips. There was no specific description of removal of the adventitial tissue from Calot’s triangle to obtain a critical view of safety. There was also no description of difficulties or unusual circumstances during the operation. Cholangiography was not performed during this operation, and the patient was subsequently discharged from the facility on postoperative day 0. On postoperative day 14, she presented to the same hospital emergency department with back and flank pain. She was found to have elevated amylase and lipase levels, so right upper quadrant ultrasonography was performed, which demonstrated an echogenic foci of stones in what appeared to be a cystic structure, or a dilated cystic duct. Ultrasonography also demonstrated a common bile duct dilated to 1.2 cm, but no distal stone was visualized. The patient was admitted and treated for acute pancreatitis with intravenous fluid resuscitation, analgesics, and slow reinstitution of diet. She was discharged after 3 days and was then referred to our facility as an outpatient for a retained remnant or duplicate gallbladder. As part of her workup, magnetic resonance cholangiopancreatography (MRCP) was performed (Figure 1), which demonstrated a large gallbladder remnant with gallstones and normal caliber extrahepatic biliary tree. The patient was advised to undergo completion cholecystectomy with intraoperative cholangiogram. At operation, the patient was placed supine on a radiolucent bed. Entrance into the peritoneal cavity was obtained with a 5-mm optical trocar in the right subcostal region, given her previous intraumbilical incision. After abdominal insufflation, 2 additional 5-mm trocars were placed, one in the epigastrium and one in the right lower quadrant. After a brief sharp adhesiolysis, a 10-mm trocar was placed at the umbilicus. Inferior margin of the liver was carefully elevated, and a large dilated gallbladder remnant was identified (Figure 2). The gallbladder remnant was retracted lateral and cephalad toward the right shoulder. The peritoneum overlying the cystic duct and gallbladder junction was opened, and the cystic artery and cystic duct were dissected out circumferentially. The hepatocystic plate was also partially mobilized, and a critical view of safety with normal hepatic parenchyma behind this structure was obtained (Figure 3). One distal and two proxi144 Figure 1. MRCP. Arrow points to the remnant gallbladder with filling defects and normal extrahepatic biliary tree. Figure 2. Laparoscopic view of remnant gallbladder during adhesiolysis. Black arrows denote the border of the gallbladder. mal clips were placed across the artery, a single clip was placed on the duct, and a small cystic ductotomy was made. The cystic duct was gently compressed, and several stones were removed retrograde through the cystic ductotomy. Cholangiography was performed and showed a normal-caliber common bile duct and common hepatic JSLS (2013)17:143–147 guidance, a balloon extraction catheter was used to successfully remove several small stones retrograde through the dilated ductotomy incision. After several sweeps through the common bile duct, completion cholangiography was performed that showed complete clearance of the stones. The cystic duct was controlled with a suture tie, and both the cystic duct and artery were transected. The remnant gallbladder was dissected off the gallbladder fossa and removed in the standard manner. Examination of the gallbladder was performed immediately after its removal (Figure 5a and 5b). RESULTS Figure 3. Critical view of safety. The cystic duct (white arrow) and the cystic artery (black arrow) seen to be the only 2 structures entering into the remnant gallbladder with normal liver demonstrated behind them. The procedure took 75 minutes, with minimal blood loss. No drain was left. The patient was discharged home on postoperative day 0. Follow-up in the office at 2 weeks Figure 4. Laparoscopic transcystic common bile duct exploration with a balloon extraction catheter in the cystic duct. The white arrow depicts the cannula in the cystic duct; the black arrow shows the remnant gallbladder. duct without filling defects, as well as free contrast flow into the duodenum. There were, however, several filling defects within the cystic duct at its insertion into the common bile duct. A transcystic common bile duct exploration was then performed using a commercially available kit. After dilation of the cystic duct, the access cannula was placed into the duct and a guidewire was inserted through this into the duodenum (Figure 4). Under fluoroscopic Figure 5. A, Gross specimen. The white solid arrow marks clips from the previous operation; the black thin arrow marks the clip on the cystic duct. B, The gross specimen, opened, demonstrating retained stones. JSLS (2013)17:143–147 145 Laparoscopic Completion Cholecystectomy and Common Bile Duct Exploration, Kroh M et al. and by phone at 2 months showed the patient to be symptom free. Final pathologic results were consistent with chronic cholecystitis and cholelithiasis. The presence of the previously placed clips on the gallbladder fundus confirmed the diagnosis of retained gallbladder versus a duplicate or accessory gallbladder. DISCUSSION Minimally invasive surgery and its applications continue to progress. New techniques have been introduced to deliver equal surgical results in a less invasive manner. Single-port laparoscopy is an extension of this phenomenon. Advantages have been suggested and these may include less pain, but until more stringent trials are completed, cosmesis and potential complications from additional trocar sites appear to be the main differences. Drawbacks of this technique, unique from standard multitrocar laparoscopy, have also been identified. This is inherent to the single portal of access and may be related to technical considerations including external clashing of instruments, poor visualization of critical structures, and surgeon fatigue. Complications from single-port cholecystectomy have been described, although whether these are the result of the surgical approach or isolated events is unclear, and large-scale comparative trials against standard laparoscopic approaches have not been performed. In addition, the learning curve for these techniques has not been described. Currently, opportunities for training in single-site surgery are limited but include formal and informal fellowship training, continuing medical education courses sponsored by surgical societies, and industry-sponsored events including laboratory work and proctoring. Planned partial cholecystectomy is a described technique when dissection is inhibited by severe inflammation, and it may prevent biliary injury in the setting of cholecystitis. Incomplete cholecystectomy may also arise inadvertently with incomplete dissection of Calot’s triangle, resulting in transection of the gallbladder fundus instead of the cystic duct. Although inadvertent partial cholecystectomy was initially thought to have increased with the widespread adoption of laparoscopy, increased rates have not been seen in the surgical literature.4 Retained gallbladder after cholecystectomy can manifest with symptoms similar to primary gallstone-related disease. Biliary symptoms after cholecystectomy are evaluated with ultrasonography, and typically in these cases this will demonstrate a cystic lesion containing stones.5 MRCP can further delineate biliary anatomy, and it is considered a definitive test for diagno146 sis. Completion cholecystectomy, by means of laparotomy or laparoscopy, is the definitive treatment.4,6 As with all new technologies, single-port access procedures have inherent limitations. Request for patient consent for single-port techniques should include full disclosure of the risks, benefits, and alternatives to the procedure. Although there are not absolute contraindications to this technique, patient selection should be left to the surgeon’s discretion. With the adoption of multitrocar laparoscopic cholecystectomy, there was a significant increase in common bile duct injuries. Although this rate improved with increased surgeon experience, the overall rate is still higher than with the open technique. Standardized techniques for safe laparoscopic cholecystectomy have been developed and have resulted in decreased rates of major biliary complications. Techniques of routine cholangiography to identify aberrant biliary anatomy and demonstration of the critical view of safety have improved the overall conduct of cholecystectomy. If single-port applications are to become widespread for cholecystectomy, the operation must not deviate from these protocols. Cholangiography can and should be used routinely to demonstrate biliary anatomical variants, strictures or stones, or to identify structures for safe gallbladder removal. Dissection in Calot’s triangle must be complete to achieve a critical view of safety both to prevent major biliary injury and to perform a complete operation. This visualization may be compromised by a single port of access originating from the umbilicus by not allowing cephalad and lateral retraction of the gallbladder. The result may be biliary injury or, as in this case, incomplete cholecystectomy secondary to failure to remove all adventitial tissue in Calot’s triangle. Using different techniques including improved commercial access devices and instruments, as well as robotics, may improve retraction and/or dissection and may represent an improvement in conduct and safety over current manual single-port techniques.7 Surgeons should also have a low threshold to add additional trocars to recreate relationships seen in standard laparoscopy or convert to open procedures as dictated on an individual patient basis. Recreation of a safe cholecystectomy technique, either laparoscopic or open, must be paramount for single-port procedures, especially in light of the relative improvement over standard laparoscopy. In this particular case, incomplete cholecystectomy resulted in acute gallstone pancreatitis requiring hospitalization and then an additional surgical procedure for definitive care. JSLS (2013)17:143–147 CONCLUSION This detailed report is the first in the literature to describe successful laparoscopic remnant cholecystectomy and transcystic common bile duct exploration after previous single-port cholecystectomy. Although inadvertent partial cholecystectomy is not unique to single-port techniques, careful attention to performing the appropriate procedure, regardless of technique, must be achieved in the face of applying new technologies. References: 1. Philips MS, Marks JM, Roberts K, et al. Intermediate results of a prospective randomized controlled trial of traditional fourport laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy. Surg Endosc. 2012;26(5):1296 –1303. 2. Krajinovic K, Ickrath P, Germer CT, Reibetanz J. Trocar-site hernia after single-port cholecystectomy: not an exceptional complication? J Laparoendosc Adv Surg Tech A. 2011;21(10): 919 –921. 3. Hansen AJ, Augenstein J, Ong ES. Large subcapsular liver hematoma following single-incision laparoscopic cholecystectomy. JSLS. 2011;15(1):114 –116. 4. Pernice LM, Andreoli F. Laparoscopic treatment of stone recurrence in a gallbladder remnant: report of an additional case and literature review. J Gastrointest Surg. 2009;13(11):2084 – 2091. 5. Demetriades H, Pramateftakis MG, Kanellos I, Angelopoulos S, Mantzoros I, Betsis D. Retained gallbladder remnant after laparoscopic cholecystectomy. J Laparoendosc Adv Surg Tech A. 2008;18(2):276 –279. 6. Walsh RM, Ponksy JL, Dumot J. Retained gallbladder/cystic duct remnant calculi as a cause of postcholecystectomy pain. Surg Endosc. 2002;16(6):981–984. 7. Kroh M, El-hayek K, Rosenblatt S, et al. First human surgery with a novel single-port robotic system: cholecystectomy using the da Vinci single-site platform. Surg Endosc. 2011;25(11): 3566 –3573. JSLS (2013)17:143–147 147 CASE REPORT Catastrophic Bleeding From a Marginal Ulcer After Gastric Bypass Shafik Sidani, MD, Ehab Akkary, MD, Robert Bell, MD, MA ABSTRACT INTRODUCTION Marginal ulceration at the gastrojejunal anastomosis is a common complication following Roux-Y gastric bypass (RYGB). Hemodynamically significant hemorrhagic marginal ulcers are usually treated either endoscopically or surgically. We describe a unique case of life-threatening hemorrhagic marginal ulcer eroding into the main splenic artery. This condition was initially managed with angiographic embolization, followed by surgical intervention. It is well established that Roux-Y gastric bypass (RYGB) causes significant weight loss and aids resolution of obesity related comorbidities.1 The surgery is also associated with a low incidence of early and late complications, including anastomotic leak, pulmonary embolism, small bowel obstruction, anastomotic stricture, gastrointestinal hemorrhage, and marginal ulceration (MU).2 Although a relatively minor complication, MU commonly occurs during the early or late postoperative period. The reported incidence of MU after RYGB ranges between 0.6% and 16%, and is more frequently diagnosed in smokers than nonsmokers.3,4 The true incidence of MU is difficult to assess, because many patients are asymptomatic. Management of MU varies from medical treatment with proton pump inhibitors, H2-receptor blockers, and sucralfate, to endoscopy or surgery, depending on the cause and complications.5 In the case of hemorrhagic MU, endoscopic control or laparotomy is usually the standard of care.4,6 Bleeding marginal ulcers following gastrojejunostomy are usually supplied by jejunal branches of the superior mesenteric artery or gastric branches of the celiac artery.7 We present a case of life-threatening hemorrhagic MU 18 months after conducting open RYGB. The bypass eroded into the main splenic artery and was managed with angiographic embolization followed by surgery. Key Words: Marginal ulcer, Gastric bypass, Embolization, Morbid obesity. CASE REPORT Department of Surgery, Yale University, New Haven, Connecticut, USA (all authors). Address correspondence to: Robert Bell, MD, Department of Surgery, Yale University School of Medicine, 40 Temple St, New Haven, CT 06510, USA. Telephone: (203) 764-9060, Fax: 203-764-9066, E-mail: [email protected] DOI: 10.4293/10860812X13517013318274 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 148 A 65-year-old male with a history of diabetes and hyperlipidemia underwent an open RYGB at an outside institution 18 months prior to presentation. He was not on chronic acid suppression therapy. At the emergency room, the patient presented with hematemesis and orthostatic hypotension. In the supine position, his blood pressure was 109/66 with a heart rate of 77. Orthostatic measurements were 86/54 and 89, respectively. His hematocrit was 21%. After initial fluid resuscitation and blood transfusion, the patient underwent esophagogastroduodenoscopy (EGD) that revealed large blood clots in the gastric pouch and bright red blood oozing from a marginal ulcer at the gastrojejunal (GJ) anastomosis. The patient received multiple transfusions of packed red blood cells and a pantoprazole infusion. Adequate visualization and endo- JSLS (2013)17:148 –151 Figure 1A. Mesenteric angiography revealing gross extravasation from the mid splenic artery. Figure 1B. The distal splenic artery is not visualized following embolization. scopic hemostasis could not be performed and repeat endoscopy was also unsuccessful. Urgent angiography did not reveal any active bleeding. Subsequently, the hematocrit stabilized, and the patient seemed to recover for the next 5 days. At that point, the patient developed an abrupt onset of severe hematemesis. EGD showed recurrent bleeding from the GJ anastomosis. Mesenteric angiography revealed gross extravasation from the mid splenic artery (Figure 1A), which was successfully embolized. Following embolization, the distal splenic artery could not be visualized, and the splenic parenchyma could not be seen due to poor collateral flow (Figure 1B). Within 8 hours of embolization, the patient developed abdominal pain, distention, and lactic acidosis. An abdominal CT scan revealed pneumoperitoneum with high attenuation ascites representing contrast and hemorrhage (Figure 2). The patient was urgently taken to the operating room for exploratory laparotomy. Approximately 2.5 liters of blood and clots were evacuated from the peritoneal cavity. With the aid of intraoperative endoscopy, a large defect was found in the gastric remnant, the gastric pouch, and the proximal Roux limb of the jejunum. The Roux limb was completely detached from the gastric pouch. Gelfoam and coils were visualized in the lesser sac, and the splenic artery was non-pulsatile. The spleen appeared dusky; hence, splenectomy was performed. The gastric remnant, gastric pouch, and Roux limb of the jejunum (that included the perforations) were resected back to viable tissue. The remaining gastric pouch and the proximal Roux limb of the jejunum were subsequently reanastomosed utilizing a circular stapling technique. Intraoperative endoscopy revealed a patent, leak-free, anastomosis. The patient was discharged on the ninth postoperative day, after a negative Gastrografin swallow Figure 2. Abdominal CT scan revealing pneumoperitoneum with high attenuation ascites representing contrast and hemorrhage. evaluation. At discharge, he tolerated an oral liquid diet. During the postoperative course, he developed a left upper quadrant intraabdominal abscess requiring percutaneous drainage and intravenous antibiotics. DISCUSSION Marginal ulceration at the gastrojejunal anastomosis is the most common cause of early and late upper GI bleeding following RYGB. Although gastrin levels are decreased following gastric bypass, vagal stimulation is preserved, as is the gastric pouch’s ability to produce acid. Unlike the JSLS (2013)17:148 –151 149 Catastrophic Bleeding from a Marginal Ulcer after Gastric Bypass, Sidani et al. duodenum, the jejunum’s ability to buffer acid via bicarbonate secretion is poor, further contributing to the risk of gastrojejunal marginal ulcers.5,8 The risk of postoperative MU is also increased by factors such as H. pylori infection, nonsteroidal anti-inflammatory drugs (NSAID), anticoagulation, and smoking. Technical factors that increase the risk of MU formation include a large gastric pouch, nonabsorbable sutures, and tissue ischemia at the staple line.3,9 –11 Patients suffering from MU following RYGP usually present with epigastric pain and occasional nausea and emesis. Clinically significant upper GI hemorrhage is not usually observed.3,4,12 The diagnosis of MU is performed endoscopically. Uncomplicated MU is generally managed with high-dose proton pump inhibitor (PPI) therapy. Preventive low-dose PPI or H2-blocker therapy is a common practice following RYGB.5,6,11,13 Triple therapy is usually started in case of H. pylori infection. Cessation of smoking is mandatory and NSAIDS should be discontinued, if possible. Hemodynamically significant upper GI bleed secondary to MU is managed endoscopically or surgically, after initiating intravenous formulations of proton pump inhibitor therapy. At our institution, an 80-mg intravenous bolus of pantoprazole followed by an infusion at a rate of 8mg/hr is used. Endoscopic options include heater probe coaptive coagulation, bipolar probe coaptive coagulation, chemical sclerosant, epinephrine injection, laser therapy, and hemostatic clip placement. Surgical management is usually required if endoscopic therapy fails to adequately control the bleeding. Angiographic interventions are generally considered for bleeding secondary to traditional peptic ulcer disease, especially when patients are at high risk for surgery.14 There are no reports in the literature describing angiographic intervention for the control of bleeding marginal ulcers. In a series of 18 patients, Ljungdahl et al15 reported successful management of massive gastric and duodenal bleeding with transcatheter selective arterial embolization in 17 of those patients. All cases involved bleeding from the left gastric or gastroduodenal arteries or their branches. No case involved the splenic artery, nor was marginal ulceration a cause of the bleeding in any of the reported cases. When needed, surgical management can be performed using the open or laparoscopic technique and involves excision of the gastrojejunostomy, including the ulcerated areas and construction of a new gastrojejunostomy.6 During the procedure, the bleeding vessels must be meticulously identified and ligated. The current case, reports a novel approach to the management of clinically significant hemorrhagic MU, involving the splenic artery. Preoperative control of bleeding is a key step given the amount of inflammation present in patients with MU. 150 Attention should be paid to collateral circulation causing hemorrhage following embolization of a visceral artery, requiring trial of different embolic agents for adequate bleeding control or immediate surgery.16,18 CONCLUSION We describe a unique life-threatening complication of marginal ulceration following RYGB. We also propose a novel approach to its management. Massive upper GI bleeding, due to marginal ulcer eroding into the main splenic artery, can be controlled preoperatively with angiographic selective embolization to allow successful surgical repair. This strategy should also be considered in patients with hemodynamic instability. References. 1. Pories WJ. Bariatric surgery: risks and rewards. J Clin Endocrinol Metab. 2008;93(11 Suppl 1):S89 –96. 2. Elder KA, Wolfe BM. Bariatric surgery: a review of procedures and outcomes. Gastroenterology. 2007;132:2253–2271. 3. Jordan JH, Hocking MP, Rout WR, et al. Marginal ulcer following gastric bypass for morbid obesity. Am Surg. 1991;57: 286 –288. 4. Sapala JA, Wood MH, Sapala MA, et al. Marginal ulcer after gastric bypass: a prospective 3-year study of 173 patients. Obes Surg. 1998;8:505–516. 5. Gumbs AA, Duffy AJ, Bell RL. Incidence and management of marginal ulceration after laparoscopic Roux-Y gastric bypass. Surg Obes Relat Dis. 2006;2:460 – 463. 6. Nguyen NT, Hinojosa MW, Gray J, et al. Reoperation for marginal ulceration. Surg Endosc. 2007;21:1919 –1921. 7. Oglevie SB, Smith DC, Mera SS. Bleeding marginal ulcers: angiographic evaluation. Radiology. 1990;174:943–944. 8. Demaria EJ, Sugerman HJ, Kellum JM, et al. Results of 281 consecutive total laparoscopic Roux-en-Y gastric bypasses to treat morbid obesity. Ann Surg. 2002;235:640 – 645. 9. Pope GD, Goodney PP, Burchard KW, et al. Peptic ulcer/ stricture after gastric bypass: a comparison of technique and acid suppression variables. Obes Surg. 2002;12:30 –33. 10. Siilin H, Wanders A, Gustavsson S, et al. The proximal gastric pouch invariably contains acid-producing parietal cells in Rouxen-Y gastric bypass. Obes Surg. 2005;15:771–777. 11. Frezza EE, Herbert H, Ford R, et al. Endoscopic suture removal at gastrojejunal anastomosis after Roux-en-Y gastric bypass to prevent marginal ulceration. Surg Obes Relat Dis. 2007;3:619 – 622. JSLS (2013)17:148 –151 12. Sanyal AJ, Sugerman HJ, Kellum JM, et al. Stomal complications of gastric bypass: incidence and outcome of therapy. Am J Gastroenterol. 1992;87:1165–1169. 16. Goldman ML, Skorapa V, Jr., Galambos JT, et al. Intra-arterial tissue adhesives for medical splenectomy in dogs. Am J Gastroenterol. 1978;70:489 – 495. 13. Schirmer B, Erenoglu C, Miller A. Flexible endoscopy in the management of patients undergoing Roux-en-Y gastric bypass. Obes Surg. 2002;12:634 – 638. 17. Goldman ML, Freeny PC, Tallman JM, et al. Transcatheter vascular occlusion therapy with isobutyl 2-cyanoacrylate (bucrylate) for control of massive upper-gastrointestinal bleeding. Radiology. 1978;129:41– 49. 14. Millward SF. ACR Appropriateness criteria on treatment of acute nonvariceal gastrointestinal tract bleeding. J Am Coll Radiol. 2008;5:550. 15. Ljungdahl M, Eriksson LG, Nyman R, et al. Arterial embolisation in management of massive bleeding from gastric and duodenal ulcers. Eur J Surg. 2002;168:384 –390. 18. Morse SS, Siskind BN, Horowitz NR, et al. Splenic arteriogastric fistula from plication of a gastric ulcer. Therapeutic embolization. J Clin Gastroenterol. 1987;9:480 – 482. JSLS (2013)17:148 –151 151 CASE REPORT Endoclip Closure of a Large Colonic Perforation Following Colonoscopic Leiomyoma Excision Vamsi R. Velchuru, MD, FRCS, Marek Zawadzki, MD, Amy L. Levin, MD, Christine M. Bouchard, MD, Slawomir Marecik, MD, Leela M. Prasad, MD, John J. Park, MD ABSTRACT INTRODUCTION Background and Objective: Endoscopic removal of large colonic submucosal lesions can lead to a higher risk of perforation. Although not as common following diagnostic and therapeutic colonoscopy, it does occur more often following therapeutic colonoscopy. We present a case of a large submucosal mass excised endoscopically, resulting in a large perforation that was closed using endoclips. While endoclips are typically used for smaller perforations, we have found that they can be used safely on a larger defect. Surgical resection has been the mainstay of treatment for large colonic lesions. Unfortunately, even with the introduction of laparoscopy, significant morbidity still exists. Endoscopic removal of large benign colonic submucosal lesions has been successfully performed, although it brings with it an increased risk of bleeding and perforation. In fact, reports show significant operative morbidity (36%) and mortality (7%).1 Traditionally, these complications have been addressed with a laparotomy,1 but recently laparoscopic2 and endoscopic techniques3,4 have been used successfully to close perforations. Methods: A 68-y-old woman presented with a 2.9-cm benign submucosal mass found in the hepatic flexure. It was removed via endoscopic polypectomy, leaving a perforation of 3cm x 3cm. The perforation was closed with endoscopic clips. Results: Histology of the specimen showed clear margins. At 4-wk follow-up, the patient had no complications. A colonoscopy at 6-mo follow-up showed only a scar at the procedure site with no complaints. Conclusions: Large iatrogenic colonic perforations can be managed successfully using endoclips, particularly in a prepped colon. Key Words: Colonic submucosal lesions, Perforation, Therapeutic colonoscopy, Endoclip. Division of Colon and Rectal Surgery, Advocate Lutheran General Hospital, Park Ridge, IL, USA (all authors).; Division of Colon Rectal Surgery, University of Illinois of Chicago, Chicago, IL, USA (Drs. Velchuru, Zawadzki, Prasad). Presented as a poster at SAGES 12th World Congress of Endoscopic Surgery Landover, MD, USA, April 14 –17, 2010. Address correspondence to: Vamsi R. Velchuru, MD, FRCS, Division of Colon and Rectal Surgery, University of Illinois Medical Center at Chicago, 840 S. Wood Street, MC 958 #518, Chicago, IL 60612, USA. Telephone: (312) 996-2061, Fax: (312) 996-1214, E-mail: [email protected] DOI: 10.4293/108680812X13517013317554 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 152 The incidence of colonic perforation following colonoscopy can vary between 0.03% and 2%.4 – 6 Perforation rates increases with therapeutic interventions7 and the size of the polyp.6 We present a case of a large submucosal mass that was excised endoscopically, resulting in a 3-cm x 3-cm perforation that was closed using endoclips. Typically, these clips are used for smaller perforations2; however, we have found that they can be used safely on a larger defect. Endoclips have been used to clip a vessel in a bleeding ulcer or to achieve hemostasis from the base of a polyp after polypectomy. MATERIALS AND METHODS A 68-y-old woman presented with a 3-cm mass at the hepatic flexure (Figure 1), which was found during a routine outpatient colonoscopy. The mass was submucosal and the overlying mucosa was ulcerated. The lesion was firm. Biopsy of the lesion showed colonic mucosa with inflammatory changes. A subsequent CT scan of the abdomen confirmed that it was a 3-cm submucosal mass with benign features. The patient was taken for planned endoscopic resection with primary closure. The operating room was on standby in the event the resulting defect could not be closed endoscopically. A snare polypectomy was successfully performed that resulted in a 3-cm perforation (Figure 2). Seven endoclips (Resolution Clip; Boston Scientific, Natick MA) were placed in order to seal the colotomy (Figure 3). A frozen section of the specimen showed a benign stromal neoplasm. JSLS (2013)17:152–155 Figure 1. Hepatic flexure mass as seen on colonoscopy. Figure 3. Endoclips closing the perforation site. Figure 2. Perforation after Snare Polypectomy. RESULTS A postprocedure abdominal X-ray revealed expected free air (Figure 4), and the patient was admitted for observation. On postprocedure day 1, the patient’s examination was unremarkable. She was started on a clear liquid diet. On postprocedure day 2, she advanced to a soft diet and was discharged home. Final pathology revealed a 2.9-cm submucosal leiomyoma with clear margins. The patient returned to the office 4 wk later without complaints. A colonoscopy at 6 mo showed a scar at the site. DISCUSSION Colonic leiomyomas are rare benign stromal tumors that can cause gastrointestinal bleeding,8 obstruction,9 and, in Figure 4. Postprocedure X-ray showing free air. Note the endoclips in the right upper quadrant. rare instances, progress to a sarcoma.10 Large benign colonic lesions have been removed by colonic resection and anastomosis, although recently they have been managed via an endoscopic mucosal resection11 and endoscopic polypectomy.12 The size, type (pedunculated or sessile), configuration, and site of the lesion all determine the type of procedure to be performed. Pedunculated lesions13 and those over 2cm12 have been dealt with using endoloops or hemoclips. One report12 showed a 3.5-cm lipoma that was excised by endoscopic JSLS (2013)17:152–155 153 Endoclip Closure of a Large Colonic Perforation Following Colonoscopic Leiomyoma Excision, Velchuu VR et al. polypectomy with no complications. Endoloops can also be used to resect large colonic lipomas to prevent bleeding and perforation.14 Perforation risk increases with therapeutic colonoscopy,4,7,15 polyps ⬎ 2cm,16 in the elderly (⬎75yrs),15 and in female patients.17 Full-thickness endoscopic removal should be contemplated only after the lesion is proven benign either by imaging or histopathology, as a malignant lesion can potentially convert an early disease to stage 4 disease leading to bad prognosis. Depending on the size of the perforation and clinical condition, treatment strategies vary. Small perforations can be managed conservatively with a success rate of 33% to 73%.18 Operative intervention can be managed by simple closure of the perforation15 or via a bowel resection with or without anastomosis.1 Colonic perforations have been dealt with laparoscopically leading to shorter hospital stay and decreased postoperative morbidity.19 Endoscopic closure of colonic perforation has been performed using endoclips, particularly when the perforation is ⬍ 1cm.4 Few authors3,20 have used the endoclips for perforations ⬎ 1 cm. Trecca et al.3 reported 2 perforations ⬎ 3cm that were managed using endoclips successfully. In both patients, 3 TriClips (Cook Medical, Bloomington, IN) were used. In our case, the perforation was 3cm in size, and 7 clips were used to close the defect. The patient was discharged on the second day. Of course, the number of clips used can vary, depending on the size of the perforation.3 Endoscopic closure of an iatrogenic colonic perforation at colonoscopy is feasible, because it is a prepped colon and there is minimal contamination. Closure should, however, be undertaken using minimal to no air insufflation.3 This helps with approximation of the edges and prevents fecal spillage. An experienced colonoscopist is the most important factor as the endoclip application can be technically challenging, and also depends on the site (hepatic flexure in our case) and size of the perforation. Reports21,22 have shown clip closure to be successful in 69.2% to 92.6% of cases. Still, 2 of 27 patients who underwent clip application needed surgery, making it vitally important to monitor patients for complications following the procedure.21 We did not perform follow-up examination with X-ray for the clips3 or immediate colonoscopy,23 because the patient was clinically well. A follow-up endoscopy 6 mo postprocedure revealed a scar. Intravenous antibiotics and serial examinations are paramount in the postprocedure period to identify any leaks that can lead to peritonitis. Our patient made a remarkable recovery and was sent home in 2 d. 154 In our practice, therapeutic colonoscopy for large polyps is managed in the operating room with the patient anesthetized. We often perform diagnostic laparoscopy in suspicious cases to confirm that there is no leak at the site. CO2 colonoscopy is often performed to minimize intraabdominal free air, and to minimize distension of the colon, in the event that we need to convert to a laparoscopic procedure. Colonic perforations that are 3cm x 3cm following a benign excision can be closed using endoclips, which is possible in view of the prepped colon, with immediate identification of the perforation and with minimal contamination. Laparoscopic repair of an iatrogenic colon perforation has been shown to be feasible with decreased morbidity and shorter hospital stay compared to the open approach.24 Delayed diagnosis is associated with higher morbidity1 and can be dealt with by laparoscopy or with laparotomy. To date, 3 cases have been reported in the literature with successful outcomes for perforations of 3cm3,20 that have been closed with endoclips. The case reported herein is about the largest perforation managed following a leiomyoma excision from the colon. Immediate identification of the perforation is critical to using the endoscopic technique. Endoclip application can be challenging, and the success rate can depend on the colonoscopist, presence of fecal contamination, and the size and site of the perforation. An experienced colonoscopist with vast experience in therapeutic procedures is the most important factor for a successful outcome. Other factors are clean bowel with minimal contamination, the site of the perforation, and the availability of operating room facility. While endoscopic removal of 1-cm to 2-cm lesions has been reported, we believe this is the first reported case of an endoscopically resected 3-cm leiomyoma leading to perforation that was successfully repaired using endoclips. Immediate thorough evaluation of the polypectomy site for both bleeding and perforation is a good practice, particularly in high-risk cases and this avoids delayed diagnosis. Serial clinical examination following the procedure is very important to help identify any signs of sepsis. As endoscopic technology continues to evolve, and its use increases, we believe this method will become the standard of care. References: 1. Iqbal CW, Cullinane DC, Schiller HJ, Sawyer MD, Zietlow SP, Farley DR. Surgical management and outcomes of 165 colonoscopic perforations from a single institution. Arch Surg. 2008; 143(7):701–707. JSLS (2013)17:152–155 2. Kilic A, Kavic Stephen. Laparoscopic colotomy repair following colonoscopic polypectomy. JSLS. 2008;12(1):93–96. 3. Trecca A, Gaj F, Gagliardi G. Our experience with endoscopic repair of large colonoscopic perforations and review of the literature. Tech Coloproctol. 2008;12:315–322. 4. Jovanovic I, Zimmermann L, Fry LC, Monkemuller K. Feasibility of endoscopic closure of an iatrogenic colon perforation occurring during colonoscopy. Gastrointest Endosc. 2011;73(3)550 –555. 5. Korman LY, Overholt BF, Box T, Winker CK. Perforation during colonoscopy in endoscopic ambulatory surgical centers. Gastrointest Endosc. 2003;58(4):554 –557. 6. Ahlawat S, Gupta N, Benjamin SB, Al-Kawas FH. Large colorectal polyps: endoscopic management and rate of malignancy: does size matter? J Clin Gastroenterol. 2011;45:347–354. 7. Damore LJ 2nd, Rantis PC, Vernava AM 3rd, Longo WE. Colonoscopic perforations. Etiology, diagnosis, and management. Dis Colon Rectum. 1996;39(11):1308 –1314. 8. Moussi A, Nouira R, Bourguiba B, Daldoul S, Zaouche A. Rare cause of a lower gastrointestinal bleeding. Tunis Med. 2010;88(12):961–963. 9. Padberg BC, Emmermann A, Zornig C, Germer M, Schroder S. Leiomyomatosis of the colon: Case report and literature review. Pathologe. 2007;28(2):161–165. 10. Agaimy A, Wunsch PH. True smooth muscle neoplasms of the GIT: morphological spectrum and classification in a series of 85 cases from a single institute. Lagenbecks Arch Surg. 2007; 392(1):75– 81. 11. Repici A, Tricerri R. Endoscopic polypectomy: techniques, complications and follow-up. Tech Coloproctol. 2004 Dec;8 Suppl 2:s283–290. Review. 12. Geraci G, Pisello F, Antonio S, Modica G, Sciumè C. Endoscopic resection of a large colonic lipoma: case report and review of the literature. Case Rep Gastroenterol. 2010 Feb 3;4(1):6 –11. 13. Luigiano C, Ferra F, Ghersi S, et al. Endoclip–assisted resection of large pedunculated colorectal polyps: Technical aspects and outcome. Dig Dis Sci. 2010 Jun;55(6)1726 –1731. 14. Jansen JB, Temmerman A, Tjhie-Wensing JW. Endoscopic removal of a large colonic lipomas. Ned Tijdschr Geneeskd. 2010;154:A2215. Dutch. 15. Lohsiriwat V, Sujarittanakarn S, Akaraviputh T, Lertakyamanee N, Lohsiriwat D, Kachinthorn U. What are the risk factors of colonoscopic perforation? BMC Gastroenterol. 2009;24:9:71. 16. Pèrez Roldán F, González Carro P, Legaz Huidobro ML et al. Endoscopic resection of large colorectal polyps. Rev Esp Enferm Dig. 2004;96:36 – 47. 17. Anderson ML, Pasha TM, Leighton JA. Endoscopic perforation of the colon: lessons from a 10-year study. Am J Gastroenterol. 2000;95(12):3418 –3422. 18. Lohsiriwat V. Colonoscopic perforation: Incidence, risk factors, management and outcome. World J Gastroenterol. 2010; 16(4):425– 430. 19. Bleier JI, Moon V, Feingold D, et al. Initial repair of iatrogenic colon perforation using laparoscopic methods. Surg Endosc. 2008;22:646 – 649. 20. Barbagallo F, Castello G, Latteri S, et al. Successful endoscopic repair of an unusual colonic perforation following polypectomy using an endoclip device. World J Gastroenterol. 2007;13(20):2889 –2891. 21. Magdeburg R, Collet P, Post S, Kaehler G. Endoclipping of iatrogenic colonic perforation to avoid surgery. Surg Endosc. 2008;22:1500 –1504. 22. Taku K, Sano Y, Fu KI, et al. Iatrogenic perforation associated with therapeutic colonoscopy: A multicenter study in Japan. J Gastroenterol Hepatol. 2007;22:1409 –1414. 23. Kirschnaik A, Kratt T, Stüker D et al. A new endoscopic over the scope clip system for the treatment of lesions and bleeding in the GI tract: first clinical experiences. Gastrointest Endosc. 2007; 66(1):162–167. 24. Bleier JI, Moon V, Feingold D, et al. Initial repair of iatrogenic colon perforation using laparoscopic methods. Surg Endosc. 2008;22(3):646 – 649. JSLS (2013)17:152–155 155 CASE REPORT Robotic Repair of Uterine Dehiscence Mauricio Francisco La Rosa, MD, Shirley McCarthy, MD, PhD, Christine Richter, MD, Masoud Azodi, MD ABSTRACT INTRODUCTION Background and Objectives: During the past few decades, there has been a significant increase in the number of cesarean deliveries, and thus an increase in the number of complications. A common complication of multiple cesarean deliveries is symptomatic uterine scar dehiscence, for which there are no treatment guidelines available. We report a case of uterine scar dehiscence—the repair of it by robotic surgery—and review the literature on this defect. During the last few decades, there has been a significant increase in the number of cesarean deliveries, hence, complications including uterine scar dehiscence, whose incidence was previously rare but is now increasing.1 Case: The patient was a 39-year-old woman, gravida 4 para 2022, complaining of persistent vaginal spotting for the prior 5 months with a history of a cesarean delivery 3 months before the onset of the symptoms. Discussion: We report a case of a successful robotic repair of a symptomatic cesarean scar defect. Conclusion: We propose further studies that include more patients so this technique may become the standard for cesarean scar defect. Key Words: Cesarean scar defect, Uterine dehiscence, Robotic repair. Lima, Peru (Dr. La Rosa). Department of Radiology, Yale-New Haven Hospital, New Haven, CT, USA (Dr. McCarthy). Gynecologic Oncology Section, Department of Obstetrics Gynecology and Reproductive Science, Yale University School of Medicine, New Haven, CT, USA (Drs. Richter, Azodi). Address correspondence to: Masoud Azodi, MD, Department of Obstetrics Gynecology and Reproductive Science, Gynecological Oncology Section, Yale University School of Medicine, 333 Cedar St., FMB 332, New Haven, CT 06510, USA. Telephone: (203) 785-4013, Fax: (203) 785-6782, E-mail: [email protected] Robotic surgery is becoming the repair technique of choice for some types of surgery such as myomectomy. Currently, no guidelines are available for the treatment of symptomatic uterine dehiscence at the cesarean scar. We report a case of uterine scar dehiscence repair by robotic surgery, review the literature, and suggest this entire technique as the possible new gold standard for the repair of this defect. CASE REPORT A 39-year-old woman, gravida 4 para 2022, presented to the gynecologic oncology clinic complaining of persistent vaginal spotting for the prior 5 months. She had a cesarean delivery 3 months before the onset of symptoms. Three months before her presentation, the patient resumed normal menses, which was associated with persistent spotting. She denied abdominal or vaginal pain, dyspareunia, fever, nausea, vomiting, or vaginal discharge. During these months, she also complained of progressive fatigue and exercise-induced shortness of breath. Her obstetric history was significant for 2 cesarean deliveries, the first in 2006 and the last 3 months before the onset of her symptoms. The indication for both surgeries was failure to progress. During the last cesarean delivery, the obstetrician reported that the subcutaneous tissue was very thin but densely adherent to the fascia, with significant scarring. Also, the bladder was densely adhered to the uterus. The uterine incision was low transverse, just above the lower uterine segment. Uterine closure was performed in 3 layers. The postoperative period was uncomplicated. The patient had a laparoscopic ovarian cystectomy in 2008. Her last Pap smear, 6 months earlier, had normal findings. Her past medical history was positive for iron deficiency anemia and migraine headaches. She reported being allergic to nabumetone. She was taking 325 mg of ferrous sulfate twice per day. DOI: 10.4293/108680812X13517013317996 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 156 On physical examination, the patient had stable vital signs. Her weight was 63.9 kg, height was 1.7 m, and body JSLS (2013)17:156 –160 mass index was 22.1. The pelvic examination revealed normal external female genitalia and some dark blood in the vagina vault, but no visible cervical or vaginal lesions. The uterus was mobile without any masses or nodularity. As part of the patient’s work-up, a magnetic resonance imaging (MRI) scan and an ultrasonogram were obtained and showed dehiscence at the lower uterine segment, with a collection of blood in the area of the dehiscence and hematocolpos (Figure 1). These findings led to the diagnosis of abnormal uterine bleeding secondary to uterine scar dehiscence. Treatment options with associated risks and benefits were discussed with the patient, and she opted for a da Vinci–assisted laparoscopic repair of the lesion. After general anesthesia, the patient was placed in a low lithotomy position, and an 8-mm skin incision was made in the umbilical area. A pneumoperitoneum was created, and three 5-mm incisions were made—2 pediatric da Vinci ports and 1 assistant port were placed. The uterus was densely adhered to the abdominal wall, so adhesiolysis was performed using sharp dissection and electrocautery. The bladder flap was developed using sharp dissection, mobilizing the bladder from the lower uterine segment. The defect in the lower uterine segment was identified. At this point, hysteroscopy was initiated, and the hysteroscopic view showed an approximately 3-cm defect in the lower uterine segment and a thin scarlike membrane covering it; however, during the hysteroscopy, the laparoscopic view showed a bulging lower uterine segment (Figure 2). The intrauterine cavity appeared to be normal. A uterine incision was made using electrocautery and the blood was removed. The edges of the defect were freshened using unipolar electrocautery. The uterus was closed using 0-Vicryl sutures in 2 layers. The sutures were inspected hysteroscopically. After copious irrigation and evacuating the pneumoperitoneum, the trocars were removed and the skin was closed using 4 – 0 Caprosyn sutures. Blood loss was ⬍50 mL. The patient was discharged home on postoperative day 1. Three months later, she had her first follow-up examination and was asymptomatic. She had spotting for about 2 weeks after surgery but has since had no problems. Menses were adequate with no intermenstrual spotting. DISCUSSION Cesarean delivery is the most common obstetric surgery in the United States, with an increasing incidence of up to 25% of all births.2,3 Figure 1. (A) A sagittal T2-weighted scan demonstrates a large clot (arrow) at the level of the internal os. Note that no overlying myometrium or fibrous stroma is seen. Dense adhesions involving the anterior uterine wall (arrowhead) attach to the abdominal wall on other images (not shown). (B) Fat-suppressed T1weighted scan demonstrates high signal at cesarean delivery scar site consistent with hematoma (short arrow). Long arrows indicate blood in the endocervical canal and vagina. A meta-analysis of birth after a previous cesarean delivery found that the incidence of cesarean scar dehiscence, also JSLS (2013)17:156 –160 157 Robotic Repair of Uterine Dehiscence, La Rosa MF et al. Figure 2. (A and B) Hysteroscopic view of uterine scar dehiscence and (C) the suture post repair of the cesarean scar defect. known as cesarean scar defect (CSD), was 1.9%.4 OfiliYebovi et al found uterine scars in 99.1% of patients with a history of a cesarean delivery, but 19.4% had a defect in their scars; 9.9% of the CSDs were severe, defined as the loss of ⬎50% of myometrial mantle at the scar level.1 Other studies have reported rates of CSD between 0.6% and 3.8%.5,6 Cesarean scar dehiscence is typically defined as discontinuity of the myometrium at the site of a previous cesarean delivery incision or as a subperitoneal separation of the uterine scar in the lower uterine segment, with the chorioamniotic membrane visible through the peritoneum.3,4 Risk factors for CSD are a history of multiple prior cesarean deliveries, a retroflexed uterus, and the inability to visualize the entire cesarean scars by ultrasonography.4 Uterine healing is a complex process that depends on several biochemical variables, such as transforming growth factor– family, tumor necrosis factor–␣, platelet-derived growth factor, fibroblast growth factor, and vascular endothelial growth factor. All of these factors control the production of collagen in the healing area.7,8 Pollio et al9 reported higher collagen content in the areas of CSD compared with the well-healed cesarean scars. This finding was attributed to lower-than-normal transforming growth factor–3 and connective tissue growth factor. These defects showed increased expression of fibroblast growth factor, vascular endothelial growth factor, platelet-derived growth factor, and tumor necrosis factor–␣.9 One of the principal concerns with uterine dehiscences is their possible association with uterine rupture. Several studies have found that no relationship exists between these 2 variables. However, one study reported a positive association between uterine dehiscence and uterine rupture, but it was not statistically significant, probably because of the low power of the study, given the rareness of the condition.10 Thus, there is no consensus about screening nonpregnant women for uterine scar defects. The width and depth of the defect is proportional to the number of previous cesarean deliveries. The width is also 158 greater in patients who have a retroflexed uterus, maybe a result of the reduced vascular perfusion. The width of the defect is greater in patients who present with vaginal spotting, dyspareunia, and chronic pelvic pain.6 Cesarean scar dehiscence is asymptomatic in most patients but can cause symptoms, such as dysmenorrhea11 and intermenstrual bleeding.12,13 In a 3-year study,14 Wang et al found that among the 293 patients diagnosed with CSD by transvaginal sonography, the most common symptom was intermenstrual spotting (64%), followed by dysmenorrhea (53%), chronic pelvic pain (40%), and dyspareunia (18%). Some mechanisms that could explain these symptoms have been proposed; for example, vaginal bleeding could be the result of the presence of congested endometrial folds (61% of the cases) or the presence of a polyp in the scar recess (16% of the cases). A lack of coordinated muscular contractions around the CSD can also contribute to the collection of debris and therefore cause intermenstrual spotting. Chronic pelvic pain and dyspareunia can be caused by a lymphocytic infiltration (65% of the cases) or a distortion of the lower uterine segment (75%). Finally, the presence of dysmenorrhea in these patients could be produced by iatrogenic adenomyosis.1 In addition, the cesarean scar dehiscence can also be the site of implantation in an ectopic pregnancy,15 increasing the prevalence of this disease during the last decade of life.16,17 In an ultrasonography study,18 it was reported that the risk of a defective scar is directly related to the degree of thinning of the lower uterine segment at 37 weeks of pregnancy. The sensitivity and negative predictive value of ultrasonography for the diagnosis of scar dehiscence in pregnant patients was 88.9% and 96.2%, respectively. Retention of blood in the scar dehiscence was also found, likely accounting for intermenstrual spotting. MRI has been shown to be the most definitive modality to evaluate uterine incision healing after cesarean deliveries.19,20 It has the advantage of superior contrast resolution, enabling detailed visualization of tissue planes. Fur- JSLS (2013)17:156 –160 thermore, MRI is not impeded by body habitus or bowel gas. The size of the defect can be better estimated by using MRI. In a case of posterior wall dehiscence from laparoscopic myomectomy, MRI was able to clearly depict the defect, whereas the initial ultrasonographic evaluation did not.21 Hemorrhage or hematomas have a characteristic signal on MRI and therefore can be readily distinguished from other fluid collections or masses. One study suggested that the presence of a bladder flap hematoma ⬎5 cm should prompt a careful search for dehiscence.22 In expectant management of uterine dehiscence during pregnancy, MRI can be used to confirm the diagnosis, and then the lesion can be followed by ultrasonography if it is adequately visualized by the latter modality.23 There are no guidelines for the treatment of intermenstrual bleeding caused by CSD. Nevertheless, multiple techniques had been proposed for the repair of uterine scar dehiscence—for example, hysteroscopic resection of the fibrotic tissue5 or the technique proposed by Donnez et al,24 who reported 3 cases of satisfactory laparoscopic repair of uterine scar dehiscence. Regarding the type of suture used, Greenberg et al25 conducted a small pilot study in ewes and concluded that the absorbable knotless barbed suture was equivalent to knotted smooth sutures for closing of the uterus.19 CONCLUSION To our knowledge, this is the first reported case of a CSD repair using a pediatric robot that uses 5-mm trocars. The surgical result was excellent. Postoperatively, the patient’s symptoms resolved and she is asymptomatic. This technique has been used for treatment of several other diseases, but never previously for CSD. We believe that this technique can become, after further studies, the gold standard surgery for this specific defect. 4. Blanco JD, Collins M. Willis D, Prien S. Prostaglandin E2 gel induction of patients with a prior low transverse cesarean section. Am J Perinatal. 1992;9:80 – 83. 5. Bromley B, Pitcher BL, Klapholz H, Lichter E, Benacerraf BR. Sonographic appearance of uterine scar dehiscence. Int J Gynaecol Obstet. 1995;51:S3–S6. 6. Tahara M, Shimizu T, Shimoura H. Preliminary report of treatment with oral contraceptive pills for intermenstrual vaginal bleeding secondary to a cesarean section scar. Fertil Steril. 2006;86:477–479. 7. Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev. 2003;83:835– 870. 8. Singer AJ, Clark RAF. Cutaneous wound healing. N Engl J Med. 1999;341:738 –746. 9. Pollio F, Staibano S, Mascolo M, et al. Uterine dehiscence in term pregnant patients with one previous cesarean delivery: Growth factor immunoexpression and collagen content in the scarred lower uterine segment. Am J Obstet Gynecol. 2006;194: 527–534. 10. Vikhareva O, Valentin L. Clinical importance of appearance of Cesarean hysterotomy scar at transvaginal ultrasonography in nonpregnant women. Obstet Gynecol. 2011;117:525–532. 11. Morris H. Surgical pathology of the lower uterine segment cesarean section scar: is the scar a source of clinical symptoms? Int J Gynecol Pathol. 1995;14(1):16 –20. 12. Thurmond AS, Harvey WJ, Smith SA. Cesarean section scar as a cause of abnormal vaginal bleeding: diagnosis by sonohysterography. J Ultrasound Med. 1999;18:13–16. 13. Fabres C, Arriagada P, Fernandez C, Mackenna A, Zegers F, Fernandez E. Surgical treatment and follow-up of women with intermenstrual bleeding due to cesarean section scar defect. J Minim Invasive Gynecol. 2005;12(1):25–28. 14. Wang CB, Chiu WW, Lee CY, Sun YL, Lin YH, Tseng CJ. Cesarean scar defect: correlation between Cesarean section number, defect size, clinical symptoms and uterine position. Ultrasound Obstet Gynecol. 2009;34(1):85– 89. References: 15. Ito M, Nawa T, Mikamo H, Tamaya T. Lower segment uterine rupture related to early pregnancy by in vitro fertilization and embryo transfer after previous cesarean delivery. J Med. 29(1–2): 85–91, 1998. 1. Ofili-Yebovi D, Ben Nagi J, Sawyer E, et al. Deficient lowsegment cesarean section scars: prevalence and risk factors. Ultrasound Obstet Gynecol. 2008;31:72–77. 16. Wang CB, Tseng CJ. Primary evacuation therapy for Cesarean scar pregnancy: three new cases and review. Ultrasound Obstet Gynecol. 2006;27:222–226. 2. Seffah JD. Re-laparotomy after cesarean section. Int J Gynaecol Obstet. 2005;88:25:3–7. 17. Rotas MA, Haberman S, Levgur M. Cesarean scar ectopic pregnancies. Obstet Gynecol. 2006;170(6):1373–1381. 3. Betrán AP, Merialdi M, Lauer JA, et al. Rates of caesarean section: analysis of global, regional and national estimates. Paediatr Perinat Epidemiol. 2007;21:98 –113. 18. Rozenberg P, Goffinet F, Philippe HF, Nisand I. Ultrasonographic measurement of lower uterine segment to assess risk of defects of scarred uterus. Lancet. 1996;347(8997):281–284. JSLS (2013)17:156 –160 159 Robotic Repair of Uterine Dehiscence, La Rosa MF et al. 19. Woo GM, Twickler DM, Stettler RW, Erdman WA, Brown CEL. The pelvis after cesarean section and vaginal delivery: normal MR findings. AJR Am J Roentgenol. 1993;161(6):1249 –1252. 20. Dicle O, Kucukler C, Pirnar T, Erata Y, Posaci C. Magnetic resonance imaging evaluation of incision healing after cesarean sections. Eur Radiol. 1997;7(1):31–34. 21. Humar BD, Levine D, Katz NL, Lim KH. Expectant management of uterine dehiscence in the second trimester of pregnancy. Obstet Gynecol. 2003;102(5 Pt 2):1139 –1142. 22. Hasbargen U, Summerer-Moustaki M, Hillemanns P, Scheidler J, Kimmig R, Hepp H. Uterine dehiscence in a nullipara, diagnosed by 160 MRI, following use of unipolar electrocautery during laparoscopic myomectomy: case report. Hum Reprod. 2002;17:2180–2182. 23. Maldjian C, Adam R, Maldjian J, Smith R. MRI appearance of the pelvis in the post cesarean-section patient. Magn Reson Imaging. 1999;17:223–227. 24. Steenfos HH. Growth factors and wound healing. Scand J Plast Reconstr Surg Hand Surg. 1994;28:95–105. 25. Greenberg JA, Walden S, Hammer CM, Grazul-Balska AT, Vonnahme KA. A comparison of barbed and smooth sutures for ovine cesarean delivery. Int J Gynecol Obstet. 2011;113:215–217. JSLS (2013)17:156 –160 CASE REPORT Laparoscopic Removal of Abdominal Cerclage at 19 Weeks’ Gestation James F. Carter, MD, Ashlyn Savage, MD, David E. Soper, MD ABSTRACT INTRODUCTION We discuss laparoscopic removal of an abdominal cerclage in a 39-year-old woman, gravida 4, para 0, abortus 3, who presented at 19 weeks’ gestation with ruptured membranes. This patient had a failed previous vaginal cerclage. An abdominal cerclage was performed at the time of abdominal myomectomy. A subsequent pregnancy was diagnosed, with ruptured membranes at 19 weeks’ gestation, and the patient opted for pregnancy termination. After laparoscopic removal of the cerclage, cervical laminaria were placed, and the patient underwent an uncomplicated dilation and curettage procedure the following day. Abdominal cerclage was originally described by Benson and Durfee1 in 1965. Most patients who have had recurrent second trimester pregnancy loss as a result of an incompetent cervix, now termed cervical insufficiency, can be treated successfully with a transvaginal cerclage. A select group of patients who have recurrent pregnancy loss despite a transvaginal cerclage or who have an anatomically physically disabled cervix, making vaginal cerclage placement impossible, may benefit from the transabdominal approach.2– 4 Key Words: Laparoscopic, Abdominal, Cerclage, Pregnancy, Intrauterine. In the past, the major disadvantage of the transabdominal approach has been the necessity of 2 laparotomies: one associated with placement of the cerclage and the other with cesarean delivery.5 We recently reported our series of successful abdominal cerclage procedures performed laparoscopically.6 Some disorders of pregnancy in the second trimester, before fetal viability, warrant delivery. Previously, these women required either a laparotomy to remove the cerclage to allow vaginal delivery or a hysterotomy for delivery while leaving the cerclage in situ. We describe a successful laparoscopic removal of an abdominal cerclage in a patient with ruptured membranes at 19 weeks’ gestation. To date, removing a cerclage suture laparoscopically at this gestational age has been accomplished only one previous time.7 CASE REPORT Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, SC, USA (all authors). Address correspondence to: James F. Carter, MD, MUSC, Ob/Gyn, 96 Jonathan Lucas Street, Suite 634, Charleston, SC, 29425, USA. Telephone: (843) 792-4500, Fax (843) 792-0053, E-mail: [email protected] DOI: 10.4293/108680812X13517013317194 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. The patient was a 39-year-old woman, gravida 4, para 0, abortus 3, who presented at 19 weeks’ gestation with spontaneous ruptured membranes. She had a poor pregnancy history, including a spontaneous miscarriage at 8 weeks with her first pregnancy and a loss at 16 weeks in her second pregnancy that was attributed to cervical insufficiency. In her third pregnancy, despite a prophylactic McDonald cerclage that was placed early in pregnancy, she had another loss at 16 weeks. The decision was made to place an abdominal cerclage before another pregnancy. The patient was noted to have multiple uterine fibroids, including one 3 ⫻ 3– cm fibroid at the cervical isthmus. At the time of laparotomy, a myomectomy was performed to remove the 2 fibroids, and the abdominal cerclage was placed using a 5-mm Mersilene band. JSLS (2013)17:161–163 161 Laparoscopic Removal of Abdominal Cerclage at 19 Weeks’ Gestation, Carter JF et al. The patient conceived within 3 months of her cerclage placement and had an uneventful early pregnancy. Obstetric ultrasonongraphy at 17 weeks revealed a cervical length of 47 mm and no funneling. At 19 weeks, spontaneous ruptured membranes were confirmed. She was counseled about the options of pregnancy termination versus expectant management. She elected pregnancy termination and preferred dilatation and curettage over induction of labor. To achieve adequate cervical dilation, removal of the abdominal cerclage was necessary. We scheduled the patient for a laparoscopic removal of the cerclage to be followed by placement of a cervical laminaria and a dilation and curettage procedure the following day after sufficient time had elapsed for the laminaria to affect cervical dilation. Figure 1. Dense adhesions in deep pelvis. Operative Procedure While under general anesthesia, the patient was placed in a lithotomy position. The patient’s uterus was 1 cm below the umbilicus. A 10-mm incision was made vertically in the navel, and a Hasson trocar was placed through the umbilicus under direct visualization. We placed two 5-mm trocars bilaterally, slightly above the level of the umbilical incision, and a single accessory port was placed suprapubically. Initial survey of the abdomen revealed moderate adhesions, which were lysed (Figure 1). A 5-mm, 3-blade laparoscopic fan was instrumental for retraction and manipulation of both the bowel and the uterus because this uterus was soft as would be expected in a 19-week gravid uterus. The entire pelvis was filled with the gravid uterus, and we needed all of the ports. The port positions were instrumental in finding the proper angle to dissect and locate the previously placed abdominal cerclage. After displacement of the uterus to the right and somewhat posteriorly and advancing the laparoscope anterior to the uterine fundus, we identified the vesicouterine reflection at the level of the internal cervical os. It required careful dissection with laparoscopic scissors and Maryland forceps along the left lateral vesicouterine reflection, undermining and lifting the bladder off of this portion of the lower uterine segment. Proceeding posteriorly was not an option because of the size of the uterus. This dissection uncovered the Mersilene knot that was positioned just anterolateral to the left uterine artery. We mention this to emphasize that at this gestation age, the lower uterine segment is soft and difficult to manage without incising into either the bladder or the uterine artery laterally. The knot was then grasped with a blunt grasper to elevate the suture. Laparoscopic scissors were gently placed under the single strand of the suture and the suture was transected. 162 Figure 2. Uterus at 19⫹ weeks (our patient). We removed the suture and knot. Blood loss was minimal and we ended her surgery. We then placed 10 laminaria in her cervix in preparation for her dilation and curettage procedure that was scheduled for the following day. DISCUSSION We have previously published a case report11 of a successful laparoscopic removal of an abdominal cerclage in a 17-week-gestation pregnancy. We reconfirm in this case report that in an even larger uterus at 19 weeks, an operative laparoscopy is a viable alternative for removing a cerclage previously placed by laparotomy. An important technical aspect of the case was placement of the trocars.10,11 We placed the lateral trocars at least as high as the navel incision (Figures 2, 3, and 4). This allowed us to achieve the proper angle to address the JSLS (2013)17:161–163 rior area between the uterosacral ligaments. We mention this because at the time of this surgery (10/27/2010), we were reporting the second case of removal of an abdominal cerclage as far as 19 weeks’ gestation.7 This dissection was difficult to perform, and we would not recommend the posterior approach at 19 weeks’ gestation. CONCLUSION An abdominal cerclage can be removed laparoscopically in the second trimester of pregnancy. At 19 weeks’ gestation, this surgery requires a clear operative strategy and superior laparoscopic skills. References: Figure 3. Example of uterus at 16 weeks. 1. Benson RC, Durfee RB. Transabdominal cervicouterine cerclage during pregnancy for treatment of cervical incompetency. Obstet Gynecol. 1965;25:145–155. 2. Novy MJ. Transabdominal cervicoisthmic cerclage: a reappraisal 25 years after its introduction. Am J Obstet Gynecol. 1991;164:1635–1642. 3. Cammarano CL, Herron MA, Parer JT. Validity of indications for transabdominal cerclage for cervical incompetence. Am J Obstet Gynecol. 1995;172:1871–1875. 4. Leiman G, Harrison NA, Rubin A. Pregnancy following conization of the cervix. Complications related to cone size. Am J Obstet Gynecol. 1980;136:14 –18. 5. Lesser KB, Childers JM, Surwit EA. Transabdominal cerclage: a laparoscopic approach. Obstet Gynecol. 1998;91:855– 856. 6. Carter J, Soper D, Goetzl L, Van Dorsten J. Abdominal cerclage for the treatment of recurrent cervical insufficiency: laparoscopy or laparotomy? Am J Obstet Gynecol. 2009;201:111.e1– e4. Figure 4. Example of uterus at 20 weeks. depth and width of the larger uterus, which can block the visualization of the camera and trocars when they are placed through an infraumbilical port. In this case, we were able to displace the uterus posteriorly and lateral enough to develop a bladder flap, accessing the space of Retzius to ensure we had palpated and located the area of the suture and the knot. We were able to grasp the knot and elevate and transect the suture while firmly holding the knot. We then removed the entire knot and suture with good hemostasis. The lateral ports had been placed at a level slightly higher than the umbilicus under direct visualization to gain access to the cervical isthmus and bladder flap. In an earlier article,12 in a pregnancy at 17 weeks, a posterior approach was discussed. In this case, at 19 weeks’ gestation, the uterus was too large to displace anteriorly or laterally enough to gain access to the poste- 7. Agdi M, Tulandi. Placement and removal of abdominal cerclage by laparoscopy. Reprod Biomed Online. 2008 Feb;16(2):308–310. 8. Scarantino SE, Reilly JG, Moretti ML, Pillari VT. Laparoscopic removal of a transabdominal cervical cerclage. Am J Obstet Gynecol. 2000 May;182(5):1086 –1088. 9. McComiskey M, Dornan JC, Hunter D. Removal of transabdominal cerclage. Ulster Med J. 2006;75(3):228. 10. Carter JF, Soper DE. Laparoscopy in pregnancy. JSLS. 2004; 8:57– 60. 11. Carter JF, Soper DE. Laparoscopic abdominal cerclage: a case report. JSLS. 2005;9:491– 493. 12. Carter JF, Soper DE. Laparoscopic removal of abdominal cerclage: a case report. JSLS. 2007;11(3):375–377. JSLS (2013)17:161–163 163 CASE REPORT Single-Incision Laparoscopic Adnexectomy in an Obese Patient with Previous Laparotomies Francesco Sesti, MD, Claudio Boccia, MD, Giuseppe Sorrenti, MD, Alberto Baffa, MD, Emilio Piccione, MD ABSTRACT INTRODUCTION Introduction: No case of single-incision laparoscopic surgery in obese patients who had previously undergone multiple midline vertical laparotomies has been described in the literature to date. Hence we report the first case of single-port laparoscopic salpingo-oophorectomy in an obese patient who was affected by a left adnexal mass and who had previously undergone 3 midline vertical laparotomies. Laparoscopic surgery with a single access site, known as single-incision laparoscopic surgery (SILS), laparoendoscopic single-site surgery, or single-port access surgery, represents a new frontier of minimally invasive surgery. Its feasibility in gynecologic surgery has been shown by various authors who performed salpingo-oophorectomies, uterine myomectomies, hysterectomies, and more recently, radical surgeries with pelvic lymphadenectomy.1–3 Interest in this technique is based on its many benefits over traditional laparoscopy, such as decreased operative time, reduced incidence of intraoperative complications, improvement of cosmetics results, and shorter length of hospital stay.2– 4 Case Description: A postmenopausal 57-year-old woman with a body mass index of 31.2 kg/m2 and a history of 3 midline vertical cesarean deliveries and a right salpingooophorectomy was diagnosed with a left adnexal mass and underwent a single-incision laparoscopic salpingo-oophorectomy. Discussion: The patient was treated successfully. The operative blood loss was minimal. The postoperative hospital stay lasted 18 hours, and postoperative pain was short-lasting. No early or long-term postoperative complications were registered. On histopathologic examination, a diagnosis of ovarian serous cystadenoma was made. Even though this unique case is the first to be reported in the literature, its encouraging results suggest the use of this new surgical technique in similar clinical situations to verify whether the feasibility and safety reported in this article are confirmed. Key Words: Single-incision laparoscopic surgery, Salpingo-oophorectomy, Benign adnexal mass, Midline vertical laparotomies, Obesity. In defining the inclusion and exclusion criteria for SILS in patients, several authors considered obesity, previous abdominal surgeries, and early-stage gynecologic cancer as relative contraindications to this surgical approach whereas patients who had previously undergone ⬎2 midline vertical laparotomies or panniculectomies, who did not possess a native umbilicus, or who had a diagnosis of advanced malignancy were judged unsuitable candidates for SILS.3,5,6 To our knowledge, no case of SILS in obese patients who had previously undergone multiple midline vertical laparotomies has been described in the literature. Hence we report the first case of single-port laparoscopic salpingooophorectomy in an obese patient who was affected by a left adnexal mass and who had been previously undergone 3 midline vertical laparotomies. CASE REPORT Section of Gynecology and Obstetrics, Department of Biomedicine & Prevention, Tor Vergata University Hospital, Rome, Italy (all authors). Address correspondence to: Francesco Sesti, MD, School of Medicine, Department of Biomedicine & Prevention, Tor Vergata University Hospital, Viale Oxford, 81– 00133, Rome, Italy. Telephone: ⫹39 06 20 902 921, Fax: ⫹39 06 20 902 924 E-mail: [email protected] DOI: 10.4293/108680812X13517013317158 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. 164 A postmenopausal 57-year-old woman, gravida III, para III, with a body mass index of 31.2 kg/m2 presented to our institution with a diagnosis of left adnexal mass. In 2004 she had undergone a right quadrantectomy for breast cancer that, at present, was in remission. The patient reported 3 previous cesarean deliveries performed through midline vertical umbilical-pubic incisions. During the last cesarean delivery, she had also undergone right salpingo-oophorectomy because of a benign ovarian cyst. Transabdominal and transvaginal ultrasonography showed a JSLS (2013)17:164 –166 34 ⫻ 27 ⫻ 23–mm left ovarian cyst with no peripheral vascularity, no septa, and no echogenic signs. Ovarian markers were negative. RESULTS The patient received general anesthesia and was placed in a dorsal lithotomic position. After the uterine manipulator was inserted, a 2.5-cm intraumbilical vertical incision was carried out, in part, overlying the old scar. After an open laparoscopy was performed, a SILS multiple-instrument access port device was inserted (Covidien, Mansfield, MA) and pneumoperitoneum was established. We used two 5-mm cannulas for introducing the laparoscopic instruments (Johann forceps [Karl Storz, Tuttlingen, Germany] and 5-mm LigaSure Advance [Covidien]) and a 12-mm cannula for insertion of a 5.5-mm-diameter, 30°, 50-cmlong rigid laparoscope (Storz Hopkins II; Karl Storz). After the entire abdominal cavity had been observed, which appeared normal except for a few tenuous peritoneal adhesions, we visualized the left adnexa that appeared to be of increased size because of the presence of an ovarian cyst with a smooth and even wall (Figure 1). We carried out left salpingo-oophorectomy using a 5-mm LigaSure Advance device (Figure 2). The whole specimen was extracted through the umbilicus by use of an Endobag (Covidien) after partial withdrawal of the port device (Figure 3). The operative time, from the incision of the skin to its complete closure, was 30 minutes (Figure 4). No intraoperative or postoperative complications were observed, and blood loss was minimal. Postoperative pain was assessed at 20 minutes and at 2, 4, and 8 hours by a visual analog scale represented by a line 10 cm long, ranging from 0 (no pain) to 100 (pain as bad as it could be). The score ranged between 6 (20 minutes after surgery) and 0 (8 hours after surgery). The postoperative hospital stay was 18 hours. On histopathologic examination, a diagnosis of ovarian serous cystadenoma was Figure 2. Image after salpingo-oophorectomy was performed with 5-mm LigaSure Advance. Figure 3. Specimen including left ovarian cyst and tube. Figure 4. Incision site at end of skin closure. made. At 3 months after surgery, the scar healing was optimal and no incisional hernia was observed (Figure 5). We acquired institutional review board approval from the local ethics committee and written informed consent from the patient before reporting this case. DISCUSSION Figure 1. Left ovarian cyst with smooth and even wall. SILS is a novel technique that has become progressively more accepted and applied as data supporting its safety and JSLS (2013)17:164 –166 165 Single-Incision Laparoscopic Adnexectomy in an Obese Patient with Previous Laparotomies, Sesti F et al. that this technique was carried out rapidly and without any intraoperative and postoperative complications in an obese woman who had previously undergone ⬎2 midline vertical laparotomies. Even though this unique case is the first to be reported in the literature, its encouraging results suggest the use of this new surgical technique in similar clinical situations to verify whether the feasibility and safety reported in this article are confirmed. References: 1. Fader AN, Escobar PF. Laparoendoscopic single-site surgery (LESS) in gynecologic oncology: technique and initial report. Gynecol Oncol. 2009;114:157–161. Figure 5. Incision site at 3 months after surgery. enhancements in use have accumulated. A few authors emphasize the advantages of this approach over traditional laparoscopy, such as improved cosmetic results, decreased operative time, and reduced postoperative pain.7–9 This case confirms those favorable results. Indeed, postoperative pain analysis shows that at 8 hours after surgery, the patient reported no pain. Probably the minor invasiveness of this approach causes less and rapidly decreasing pain, allowing a faster recovery time and, consequently, a shorter hospitalization. Unlike the conventional laparoscopy, another advantage is the possibility of extracting the whole adnexal specimen into a 12-mm Endobag through the unique umbilical incision after partial withdrawal of the port device. This is of great importance especially in cases of suspected adnexal masses because a whole specimen facilitates the histopathologic diagnosis. However, no case of SILS in an obese patient who had previously undergone multiple midline vertical laparotomies has been described in the literature. Fader et al.6 advised against executing the SILS technique in women with ⬎2 previous midline vertical laparotomies and suggested that patient selection should initially be geared toward simple cases because learning these ergonomically challenging techniques may be less technically demanding in these cases. Moreover, a body mass index ⬎30 kg/m2 was considered an absolute contraindication to SILS.8 CONCLUSION 2. Uppal S, Frumovitz M, Escobar P, Ramirez PT. Laparoendoscopic single-site surgery in gynecology: review of literature and available technology. J Minim Invasive Gynecol. 2011;18:12–23. 3. Fader AN, Rojas-Espaillat L, Ibeanu O, Grumbine FC, Escobar PF. Laparoendoscopic single-site surgery (LESS) in gynecology: a multi-institutional evaluation. Am J Obstet Gynecol. 2010; 203:501.e1–501.e6. 4. Fader AN, Cohen S, Escobar PF, Gunderson C. Laparoendoscopic single-site surgery in gynecology. Curr Opin Obstet Gynecol. 2010;22:331–338. 5. Fagotti A, Fanfani F, Rossitto C, et al. Laparoendoscopic single-site surgery for the treatment of benign adnexal disease: a prospective trial. Diagn Ther Endosc. 2010;2010:108258. 6. Fader AN, Levinson KL, Gunderson CC, Winder AD, Escobar PF. Laparoendoscopic single-site surgery in gynaecology: a new frontier in minimally invasive surgery. J Minim Access Surg. 2011;7:71–77. 7. Yim GW, Jung YW, Paek J, et al. Transumbilical single-port access versus conventional total laparoscopic hysterectomy: surgical outcomes. Am J Obstet Gynecol. 2010;203:26.e1–26.e6. 8. Escobar PF, Bedaiwy MA, Fader AN, Falcone T. Laparoendoscopic single-site (LESS) surgery in patients with benign adnexal disease. Fertil Steril. 2010;93:2074.e7–2074.e10. 9. Fagotti A, Fanfani F, Marocco F, et al. Laparoendoscopic single-site surgery for the treatment of benign adnexal diseases: a pilot study. Surg Endosc. 2011;25:1215–1221. The present case, which was performed by surgeons who had little experience with this procedure, shows 166 JSLS (2013)17:164 –166 CASE REPORT Small Bowel Injury During Laparoendoscopic Single-Site Surgery for Simple Nephrectomy Shreyas S. Joshi, MD, Chandru P. Sundaram, MD ABSTRACT INTRODUCTION Background and Objectives: A 71-year-old man underwent a right simple nephrectomy via the laparoendoscopic single-site surgery (LESS) approach for intractable right flank pain and gross hematuria. A postoperative diagnosis of duodenal injury was suspected by physical findings and confirmed by computed tomography imaging. The use of laparoscopic nephrectomy has blossomed since its initial description by Clayman et al.1 Many advances have made this procedure one of the standards of urologic surgery. Substantial gains have been made in lowering morbidity rates and convalescence time while improving the cosmetic results of these surgeries. In particular, the creation of laparoendoscopic single-site surgery (LESS) has made real the possibility of safe scarless umbilical nephrectomy.2,3 Although much research has been done to elucidate the complication rates of regular and hand-assisted laparoscopic renal surgery,4 the newer single-port approach still requires more clinical data to address efficacy and complication rates. We report the successful completion of a single-port laparoscopic right nephrectomy that was complicated by a duodenal perforation diagnosed postoperatively. Methods: Emergency exploratory laparotomy revealed a ⬍5-mm full-thickness perforation of the duodenum and an accompanying 1-cm seromuscular injury. Results: The subsequent postoperative course was unremarkable except for a right intraabdominal seroma that resolved without intervention. Conclusion: LESS nephrectomy is an effective surgical approach, but more data are needed regarding its surgical outcomes and complications. This case shows that the LESS approach is not without the risk of life-threatening complications, and it must be performed by experienced surgeons in select patients who are notably interested in improved cosmesis, after an informed consent that includes the potential for complications. Key Words: Laparoscopy, Nephrectomy, Single-incision surgery, Intraoperative complications. Department of Urology, Indiana University School of Medicine, Indianapolis, IN, USA (all authors). Address correspondence to: Chandru P. Sundaram, MD, Department of Urology, Indiana University School of Medicine, Indiana Cancer Pavilion, 535 N. Barnhill Dr., Suite 420, Indianapolis, IN 46202, USA. Telephone: (317) 278-3098, Fax: (317) 274-0174, E-mail: [email protected] DOI: 10.4293/108680812X13517013317112 © 2013 by JSLS, Journal of the Society of Laparoendoscopic Surgeons. Published by the Society of Laparoendoscopic Surgeons, Inc. CASE REPORT A 71-year-old white man was observed for several months by urology staff for severe right-sided flank pain and gross hematuria with no definitive diagnosis aside from confirmation of a gross hematuria at the right ureteral orifice. Ureteroscopic examination revealed severe inflammation of the pelvicaliceal urothelium without any evidence of malignancy. After conservative management failed, the patient was scheduled for a laparoscopic right nephrectomy via the LESS approach. The patient was placed in the left lateral position. A 2-cm periumbilical vertical incision was made, in which a Triport (R-Port, Advanced Surgical Concepts, Dublin, UK) single-port trocar was inserted, as has been previously described.5 We performed the remainder of the operation using a flexible tip Olympus 5-mm laparoscope (Olympus, Center Valley, PA), a Cambridge Endo-hook electrode (Cambridge Endoscopic Devices, Framingham, MA), surgical scissors (United States Surgical, Norwalk, CT), an Endo-GIA stapler (United States Surgical), and a Harmonic scalpel (Ethicon Endo-Surgery, Cincinnati, OH). No trocar except for the single-port trocar was used. Two renal arteries were identified posterior and inferior to the renal veins. Both renal arteries were controlled with JSLS (2013)17:167–169 167 Small Bowel Injury During Laparoendoscopic Single-Site Surgery for Simple Nephrectomy, Joshi SS et al. Hem-o-lok polymer clips (Weck-Teleflex, Research Triangle Park, NC). One of the 12-mm port openings was cut open, and a 15-mm EndoCatch retrieval bag (Auto Suture, Norwalk, CT) was inserted through this incision. The entrapment of the mobilized kidney was difficult because of leakage of pneumoperitoneum through the trocar site. A fresh R-port device was placed through this incision, and the laparoscope was reinserted to confirm that there was no bleeding and no visible bowel injury. The R-port was removed and the incision was closed. The patient was stable until 10:00 PM on the same day of surgery, when a sudden onset of severe abdominal pain developed. The patient was treated with intravenous morphine and observed overnight. Physical examination at 7:00 AM on the following day revealed significant abdominal guarding and rebound tenderness. Computed tomography (CT) of the abdomen and pelvis with oral diatrizoic acid suggested a duodenal injury and spillage of oral contrast into the renal fossa (Figure 1). An emergency exploratory laparotomy revealed a ⬍5-mm full-thickness perforation of the duodenum and an accompanying 1-cm seromuscular injury. A primary 2-layered repair of the injury and peritoneal lavage with normal saline solution were performed by the general surgeons. The patient was discharged home on postoperative day 12. At the 2-month follow-up, the patient was noted to be recovering well but admitted to some right flank discomfort and was subsequently found to have an intraabdominal seroma after CT imaging. The seroma was conservatively observed without intervention and it resolved completely by the 4-month follow-up visit. DISCUSSION Laparoscopic nephrectomy provides a profound step forward in reducing patient morbidity associated with surgery when compared with the open approach. As such, research has been conducted to attempt to elucidate the major complications associated with laparoscopic surgery. A meta-analysis of laparoscopic renal surgery series studies between 1995 and 2004 was conducted by Pareek et al,4 showing an overall major complication rate of 9.5%. This included small bowel injury, which ranged between 0.5% and 2.3% of the overall complication rate, depending on the laparoscopic approach that was used. Bowel injury is a well-known potential complication of intraperitoneal surgery. Laparoscopic bowel injury has 168 Figure 1. CT reveals spillage of enteric contrast material (white arrows) into the right renal fossa, suggesting duodenal injury. been characterized for more than a decade, beginning with the seminal evaluation by Bishoff et al,6 who reported a laparoscopic bowel perforation rate of 0.2%, more than half of which occurred in the small bowel. As has been previously suggested for multiport laparoscopic nephrectomy, inadvertent bowel injury during dissection may be averted by the visualization of instruments at all times and by paying particular attention to adjacent structures. It is further recommended that the surgeon remain on the plane between Gerota’s fascia and the bowel mesentery, thus minimizing the risk of bowel injury.7 The presentation of bowel injury after laparoscopy differs from those that present after laparotomy. These symptoms are described as persistent pain at a single trocar site without erythema or purulence, abdominal distention, diarrhea, and leukopenia. There is also a notable lack of ileus, diffuse abdominal pain, nausea, and vomiting.6 The ability to provide a scar-free surgery with decreased pain and postoperative morbidity was examined using the LESS technique by Gill et al,2 who had an excellent surgical outcome in their initial cases. However, little is currently known about the likelihood of encountering various surgical complications as a result of single-port surgery. Apart from improved cosmesis with a single incision in the umbilicus compared with multiple visible incisions during conventional laparoscopy, there is little benefit for the patient.8,9 The learning curve and limitations of LESS, including the lack of triangulation of instruments, inadequate retraction and exposure, and instrument collision, could result in inadvertent injury to neighboring struc- JSLS (2013)17:167–169 tures, as demonstrated in the patient presented here. This complication occurred after we had completed 7 LESS nephrectomies at our institution by a single surgeon who had previously performed more than 1000 laparoscopic renal surgeries. As more institutions and surgeons begin their experience with LESS nephrectomy, the risk of similar complications increases. The LESS nephrectomy is therefore not without the risk of life-threatening complications and must be performed only by highly experienced surgeons in carefully selected patients who are particularly interested in improved cosmesis, after an informed consent that includes the potential for complications. To our knowledge, this is the first published report of a major bowel complication resulting from LESS nephrectomy. Further research and clinical experience will help elucidate the balance between potential benefits and the potential for major complications in single-port nephrectomy. References: 1. Clayman RV, Kavoussi LR, Soper NJ, et al. Laparoscopic nephrectomy: initial case report. J Urol. 1991;146(2):278 –282. 2. Gill IS, Canes D, Aron M, et al. Single port transumbilical (E-NOTES) donor nephrectomy. J Urol. 2008;180(2):637– 641, discussion 641. 3. Raman JD, Bensalah K, Bagrodia A, Stern JM, Cadeddu JA. Laboratory and clinical development of single keyhole umbilical nephrectomy. Urology. 2007;70(6):1039 –1042. 4. Pareek G, Hedican SP, Gee JR, Bruskewitz RC, Nakada SY. Meta-analysis of the complications of laparoscopic renal surgery: comparison of procedures and techniques. J Urol. 2006;175(4): 1208 –1213. 5. Desai MM, Rao PP, Aron M, et al. Scarless single port transumbilical nephrectomy and pyeloplasty: first clinical report. BJU Int. 2008;101(1):83– 88. 6. Bishoff JT, Allaf ME, Kirkels W, Moore RG, Kavoussi LR, Schroder F. Laparoscopic bowel injury: incidence and clinical presentation. J Urol. 1999;161(3):887– 890. 7. Siqueira TM Jr, Kuo RL, Gardner TA, et al. Major complications in 213 laparoscopic nephrectomy cases: the Indianapolis experience. J Urol. 2002;168(4 Pt 1):1361–1365. 8. Raybourn JH 3rd, Rane A, Sundaram CP. Laparoendoscopic single-site surgery for nephrectomy as a feasible alternative to traditional laparoscopy. Urology. 2010;75:100 –103. 9. Raman JD, Bagrodia A, Cadeddu JA. Single-incision, umbilical laparoscopic versus conventional laparoscopic nephrectomy: a comparison of perioperative outcomes and short-term measures of convalescence. Eur Urol. 2009;55(5):1198 –1204. JSLS (2013)17:167–169 169 *Out of 15,000 titles What the laparoscopist next door is reading. Or should be. Are you getting the macro view on minimally invasive? The publications of the Society of Laparoendoscopic Surgeons provide essential multidisciplinary perspective and a far richer cross-reference of experiential knowledge than a single-specialty organization can provide. The peer-reviewed JSLS, Journal of the Society of Laparoendoscopic Surgeons brings important new developments in laparoscopic surgery to SLS members in print and online. The journal’s rapid review process ensures that significant scientific findings are presented with minimal delay. 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