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CE ONLINE Minimally Invasive Procedures: Today and the Future (An Online Continuing Education Activity) A Continuing Education Activity Sponsored By Sponsored By Welcome to Minimally Invasive Procedures: Today and the Future (An Online Continuing Education Activity) CONTINUING EDUCATION INSTRUCTIONS This educational activity is being offered online and may be completed at any time. Steps for Successful Course Completion To earn continuing education credit, the participant must complete the following steps: 1. Read the overview and objectives to ensure consistency with your own learning needs and objectives. At the end of the activity, you will be assessed on the attainment of each objective. 2. Review the content of the activity, paying particular attention to those areas that reflect the objectives. 3. Complete the Test Questions. Missed questions will offer the opportunity to re-read the question and answer choices. You may also revisit relevant content. 4. For additional information on an issue or topic, consult the references. 5. To receive credit for this activity complete the evaluation and registration form. 6. A certificate of completion will be available for you to print at the conclusion. Pfiedler Enterprises will maintain a record of your continuing education credits and provide verification, if necessary, for 7 years. Requests for certificates must be submitted in writing by the learner. If you have any questions, please call: 720-748-6144. CONTACT INFORMATION: © 2013 All rights reserved Pfiedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado 80014 www.pfiedlerenterprises.com Phone: 720-748-6144 Fax: 720-748-6196 DSL #13-0181 OVERVIEW This continuing education activity will provide an overview of the clinical considerations related to current techniques in Minimally Invasive Procedures (MIPs). The historical evolution of MIPs, including the overall patient benefits, will be reviewed. The most current MIPs being implemented across multiple surgical specialties today will be explored. Emerging technologies that support MIPs – single site laparoscopy, natural orifice transluminal endoscopic surgery (NOTES), and robotics – will also be discussed. Objectives Upon completion of this continuing nursing education activity, the participant should be able to: 1. Discuss the history and continuing evolution of minimally invasive procedures. 2. Compare the risks and benefits of MIPs versus open surgical approaches for all procedures. 3. Outline the rationale for the slow adoption of minimally invasive procedures by surgeons. 4. Explain where the MIP field may be expanding beyond traditional laparoscopic approaches. 5. Identify which procedures, and what clinical and economic evidence exists to support the use of robotics in MIPs. INTENDED AUDIENCE This continuing education activity is intended for nurses, certified surgical technologists, and other health care personnel who are interested in learning more about the evolution of and latest techniques in minimally invasive procedure techniques across multiple surgical specialties. CREDIT/CREDIT INFORMATION State Board Approval for Nurses Pfiedler Enterprises is a provider approved by the California Board of Registered Nursing, Provider Number CEP14944, for 2.0 contact hour(s). Obtaining full credit for this offering depends upon completion, regardless of circumstances, from beginning to end. Licensees must provide their license numbers for record keeping purposes. The certificate of course completion issued at the conclusion of this course must be retained in the participant’s records for at least four (4) years as proof of attendance. 3 AST Credit This continuing education activity is approved for 7.75 CE credits by the Association of Surgical Technologists, Inc. for continuing education for the Certified Surgical Technologist and Certified Surgical First Assistant. This recognition does not imply that AST approves or endorses and product or products that are discussed or mentioned in enduring material. IACET Credit for Allied Health Professionals Pfiedler Enterprises has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102. CEU STATEMENT As an IACET Authorized Provider, Pfiedler Enterprises offers CEUs for its programs that qualify under ANSI/ IACET Standard. Pfiedler Enterprises is authorized by IACET to offer 0.2 CEUs (2.0 contact hours) for this program. RELEASE AND EXPIRATION DATE This continuing education activity was planned and provided in accordance with accreditation criteria. This material was originally produced in April 2013 and can no longer be used after April 2015 without being updated; therefore, this continuing education activity expires in April 2015. DISCLAIMER Accredited status as a provider refers only to continuing nursing education activities and does not imply endorsement of any products. SUPPORT Grant funds for the development of this activity were provided by Ethicon. AUTHORS/PLANNING COMMITTEE/REVIEWERS Anthony Adams, CST Certified Surgical Technologist University of Colorado Hospital Aurora, CO Julia A. Kneedler, RN, MS, EdD Director of Education Pfiedler Enterprises Aurora, CO Judith I. Pfister, RN, BSN, MBA Program Manager Pfiedler Enterprises Aurora, CO 4 Elizabeth Deroian, RN, BA Program Manager Pfiedler Enterprises Aurora, CO Rose Moss, RN, MN, CNOR Nurse Consultant Elizabeth, CO DISCLOSURE OF RELATIONSHIPS WITH COMMERCIAL ENTITIES FOR THOSE IN A POSITION TO CONTROL CONTENT FOR THIS ACTIVITY Pfiedler Enterprises has a policy in place for identifying and resolving conflicts of interest for individuals who control content for an educational activity. Information listed below is provided to the learner, so that a determination can be made if identified external interests or influences pose a potential bias of content, recommendations or conclusions. The intent is full disclosure of those in a position to control content, with a goal of objectivity, balance and scientific rigor in the activity. Disclosure includes relevant financial relationships with commercial interests related to the subject matter that may be presented in this educational activity. “Relevant financial relationships” are those in any amount, occurring within the past 12 months that create a conflict of interest. A “commercial interest” is any entity producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients. Activity Planning Committee/Authors/Reviewers: Anthony Adams, CST No conflicts of interest Julia A. Kneedler, RN, MS, EdD Co-owner of company that receives grant funds from commercial entities Judith I. Pfister, RN, BSN, MBA Co-owner of company that receives grant funds from commercial entities Elizabeth Deroian, RN, BA No conflicts of interest Rose Moss, RN, MN, CNOR No conflicts of interest 5 PRIVACY AND CONFIDENTIALITY POLICY Pfiedler Enterprises is committed to protecting your privacy and following industry best practices and regulations regarding continuing education. The information we collect is never shared for commercial purposes with any other organization. Our privacy and confidentiality policy is covered at our website, www.pfiedlerenterprises.com, and is effective on March 27, 2008. To directly access more information on our Privacy and Confidentiality Policy, type the following URL address into your browser: http://www.pfiedlerenterprises.com/privacypolicy In addition to this privacy statement, this Website is compliant with the guidelines for internet-based continuing education programs. The privacy policy of this website is strictly enforced. CONTACT INFORMATION If site users have any questions or suggestions regarding our privacy policy, please contact us at: Phone: 720-748-6144 Email: [email protected] Postal Address: 2101 S. Blackhawk Street, Suite 220 Aurora, Colorado 80014 Website URL: http://www.pfiedlerenterprises.com 6 OvERVIEW OF MIPs: CLINICAL BENEFITS AND HISTORICAL EVOLUTION Overview & Clinical Benefits Minimally invasive procedures (MIPs) are defined as surgical procedures performed through small incisions or the natural orifice using video cameras and specialized instrumentation; this approach is often referred to as “laparoscopic”. MIP techniques have been shown to be as effective as open surgery, with demonstrated benefits including1: • • • • Shorter length of stay (LOS) in the hospital; Less overall complications and postoperative pain; Quicker recovery and thus a quicker return to work and normal activities; and Lower rates of surgical site infections. Table 1 outlines the advantages of MIPs over traditional open procedures. Table 1 – Advantages of MIP over Open Procedures2 MIP Open Ambulatory or short hospital stay. Hospital admission. Short postoperative recuperation. Four to six week recuperation. Decreased postoperative pain; reduced need for postoperative pain medications. Postoperative pain related to the surgical site; more analgesics required. Quicker return to normal activities/lifestyle. Return to normal activities/lifestyle varies with recuperation period. Lower rates of surgical site infection. Higher risk for surgical site infections and subsequent readmission. In a meta-analysis of 112 articles on MIPs versus open surgical procedures, the evaluated measures included length of stay in the hospital; return to work; and return to normal activities (return to preoperative work level) – all of these measures were improved in patients undergoing MIPs. These results are depicted in Figures 1, 2, and 3.3 7 Figure 1 – Weighted Average: Length of Stay: MIP versus Open Surgical Procedures Lap Ventral Hernia Repair 2.01 9 studies Open Vag Hysterectomy 8 studies 2.91 3.88 Abd Lap Hysterectomy 19 studies Length of Stay for MIP is shorter than for Open procedures. 3.95 2.70 Abd 3.89 Lap 2.70 Vag 2.91 Hysterectomy 10 studies Lap Fundoplication 3.56 7 studies 37 studies Open 7.69 2.28 Lap Appendectomy Open 2.92 Lap Colectomy 5.82 16 studies Lap Cholecystectomy 3.23 0 2 8.17 Open 14 studies 4 9.24 Open 6 8 10 12 14 16 18 20 22 DAYS Figure 2 – Weighted Average: Return to Work: MIP versus Open Surgical Procedures Return to work for MIP is shorter than for Open procedures. Ve ntral He rnia Re pair 1 s tudy Hys te re ctom y 1 s tudy Lap Open Vag Lap Hys te re ctom y 25.95 35.00 Abd Abd Lap 1 s tudy Lap Appe nde ctom y 26.60 Vag 39.93 35.00 11.32 Open 10 s tudie s 14.54 Lap Cole ctom y 23.06 Open 2 s tudie s Lap Chole cys te ctom y 13.91 5 10 15 20 25 30 DAYS 8 41.98 35.08 Open 8 s tudie s 0 41.51 22.77 4 s tudie s Hys te re ctom y 47.80 35 40 45 50 55 60 Figure 3 – Weighted Average: Return to Normal Activities: MIP versus Open Surgical Procedures Lap Ventral Hernia Repair 1 study 21.10 Open Vag Hysterectom y 36.75 39.90 Abd 1 study Lap Hysterectom y 22.19 Abd 1 study Lap Hysterectom y 36.75 Vag 11.69 Lap Open 14 studies 39.90 22.19 1 study Appendectom y Return to Normal Activities for MIP is shorter than for Open procedures. 33.75 17.78 Lap Colectom y 31.11 Open 2 studies Lap Cholecystectom y 2 studies 0 5 10 13.06 Open 15 20 71.51 24.45 25 30 35 40 45 50 55 60 65 70 75 DAYS Another important advantage of MIPs is that these techniques may reduce the odds of acquiring a hospital-acquired infection (HAI), or nosocomial infection, in comparison to open surgery in certain procedures. In an analysis based on 399 nosocomial infection markers (NIM) in 337 patients, laparoscopic cholecystectomy and hysterectomy each reduced the overall odds of acquiring nosocomial infections by more than 50%; these procedures also resulted in statistically significantly fewer readmissions with nosocomial infections.4 Excluding appendectomy, the odds ratio for laparoscopic versus open NIMassociated readmission was 0.346. Laparoscopic appendectomy did not significantly change the odds of acquiring nosocomial infections. Further, minimally invasive approaches significantly reduce the rate of each type of nosocomial infection, specifically: • • • • • Respiratory tract: Bloodstream: Wound: Urinary tract: Others: 80% reduction 69% reduction 59% reduction 39% reduction 8% reduction Laparoscopic cholecystectomy and hysterectomy resulted in an overall 65% reduction in associated readmission for nosocomial infections. These clinical advantages also have an impact on both direct and indirect costs. The shorter LOS, the shift to an outpatient setting, and reduced postoperative pain contribute to less follow-up care and treatment, thereby decreasing direct costs of care. Because patients can resume their normal activities, including return to work, there is reduced 9 80 absenteeism and improved presenteeism, thereby reducing indirect costs. As a result, MIPs have immediate cost savings potential. As we will discuss, while MIP techniques have come a long way, their development and evolution continue to go further. There is a clear trend demonstrating a decrease in invasiveness as medical devices and skills develop. Historical Evolution of MIPs5,6,7 Despite physicians’ desire to visualize the interior of the body organs, the development of endoscopy and minimally invasive surgery was relatively slow. Early scopes were used as specula for inspection of natural body orifices. The first recorded minimally invasive procedure was performed around 400 BC when Hippocrates described the use of a primitive speculum and resectoscope to evaluate hemorrhoids; his contemporaries were using vaginal specula. Since Hippocrates, several surgeons have experimented with MIS techniques. Archigenes from Syria developed a vaginal speculum and also wrote instructions about patient positioning for optimal use of the instrument. This idea was later embellished when Abul Kasim (AD 936-1013), an Arabian physician, used a series of mirrors to enhance illumination for inspection of the vagina and cervix. With each generation of surgeons, surgical techniques and devices were continually advanced and refined. Technology was limited and surgeons typically practiced new techniques on animals, while developing new equipment, particularly light sources used to illuminate dark body cavities. In the early 1800s, endoscopic surgery began to take on new meaning when Philip Bonzzini (1773-1809) developed the Lichtleiter, which was a modified light conductor made from mirrors, tin, and leather; illumination was provided by a candle. This device was the forerunner of the modern endoscope. A French surgeon, Antonin Jean Desormeaux (1815-1881), introduced a cystoscope that burned alcohol and turpentine for illumination around 1853; he considered using electricity for the device, but thought that the fuel-burning model was more portable. Desormeaux has been referred to as the “Father of Endoscopy”. A few years later, a dentist, Julius Bruck, developed the first internal light source composed of looped platinum wire heated to glowing brightness by electricity. The inherent risks were obvious, because surrounding structures were frequently burned by the intense heat. Bruck subsequently developed a series of water-cooling covers, but these increased the size of the device, making it awkward to handle. It was not until the early nineteenth century when Maximilian Nitze (1848-1906), an Austrian urologist, developed a urologic instrument that became the basis of modern endoscopy. Nitze used the light source developed by Bruck and, assisted by an optician, created a tri-lensed endoscope that allowed a greater field of vision with an internal illumination source. By 1880, his cystoscope was featured in medical catalogs. Next, the entire concept of internal illumination for endoscopy was revolutionized by Thomas Edison’s invention of the incandescent light bulb. By 1886, miniature light bulbs were placed in the cystoscopes for internal examination of the bladder. In the early 1900s, Dr. Chevalier Jackson of Philadelphia further improved endoscopy by the development of a laryngoscope and bronchoscope. Introduced in 1902, endoscopic 10 inspection of the human abdominal cavity was enhanced in 1910 by, Swedish surgeon, Hans Christian Jacobaeus (1879-1937) when he first introduced the concept of creating a working space by insufflating air into the peritoneum and viewing the abdominal contents with the Nitze cystoscope. The first use of carbon dioxide (CO2) as a means of creating a working space in the abdomen was described by Richard Zollikofer of Switzerland around 1924. Zollikofer demonstrated that CO2 was not explosive within the abdomen and also that it was readily absorbed without event. Later, this was supported in the literature by a German surgeon, Roger Korbsh. Korbsh found that the intra-abdominal pressure should be maintained at 15 cm H2O or lower in order to avoid the physiologic complications associated with pressure on the diaphragm. Initially, the delivery of CO2 into the peritoneal cavity was done through the sheath for the cystoscope. Then, around 1938, a spring-loaded needle that had been developed by a Hungarian surgeon, Janos Veress, for the purpose of draining ascites, was used for insufflation. This needle, which is referred to as the Veress needle, is still the preferred method of insufflation. Because CO2 is nonflammable, tubal ligation using electrocoagulation was possible in the 1950s and then popularized by gynecologic surgeons Raoul Palmer from France and Frangenheim from Germany. In England in the late 1960s, Professor Harold Hopkins developed the rodless system of rigid endoscopes that improved clarity and brightness. Hopkins traveled to Germany to work with Karl Storz on his prototype; thus, the fiberoptic system for illumination was born, allowing color photography of the body’s internal surface to be performed clearly. By the late 1970s, gynecologic surgeons embraced laparoscopy and thoroughly incorporated these techniques into their practice. In the late 1970s to early 1980s, endoscopic surgery moved from the category of diagnostic to operative. Semm termed his pioneering work pelviscopy; his work led to many technological advances in instrumentation, equipment, and practices. Flexible and rigid endoscopic procedures were also increasing for other surgical specialties. In the 1970s, orthopedic surgeons began to develop the art or arthroscopy. The first laparoscopic-assisted appendectomy was performed in 1977; the first recorded liver biopsy was performed in 1982. In France, surgeons reported the first surgical laparoscopic cholecystectomy in 1987. Surgeons in both the United States and United Kingdom, began performing these procedures laparoscopically in 1988. Thus, the “laparoscopy revolution” began in earnest in the United States in the late 1980s. Surgeons developed and refined techniques to perform procedures using the laparoscope, thereby eliminating the need for a large incision. Since the 1990s, equipment, instrumentation, surgical skills, and perioperative nursing knowledge have markedly expanded as MIS has become a safe approach for a multitude of surgical interventions. Since the widespread introduction of MIS techniques in the late 1980s, current trends in surgery are increasingly moving toward minimal access approaches, including reducing both the size as well as the number of access sites (see Figure 4). The reduction of the number of trocars, and therefore port site incisions, is one way to minimize 11 the invasiveness of the surgical intervention. Two emerging techniques: single site laparoscopy (SSL) and natural orifice transluminal endoscopic surgery (NOTES) offer patients the least invasive surgical approach. These techniques will be described in greater detail later in this study guide. Figure 4 – Evolution of MIP Clinical Benefits of MIPs The early advances in MIPs occurred long before the modern concerns of decreasing surgical costs and reducing the patient lengths of stay. There are several factors that contribute to the initial and ongoing success of minimally invasive surgery.8, 9, 10 Technology is often blamed for increasing health care costs; however, some medical advances such as minimally invasive surgery, have demonstrated effectiveness in improving the efficiency of health care, enhancing the quality of care provided, and reducing overall expenses. The clinical advantages of MIS – smaller incisions, reduced bleeding, decreased postoperative pain, shorter lengths of hospital stays, lower rates of surgical site infections, and faster recuperation – are well documented. Additionally, patients report higher quality of life scores after minimally invasive surgery when compared to traditional, open procedures; the need for overnight stay is eliminated; and patients are able to return to work sooner. These are benefits not only to the patients, health care facilities, insurers, surgeons, and health care plans, but to the overall health care economy as well (see Table 2). 12 Table 2 – Benefits of MIPs Patient Less scarring Reduction in postoperative pain Shorter recovery Quicker return to activities of daily living and work Decreased risk of nosocomial infection Employers Lower total cost of care Employees recover and return to work faster Improved productivity Lower replacement and overtime costs Surgeon Better clinical outcomes Improved quality of care Differentiate and appeal to patients Health Care Facility Reduced costs through reduced lengths of stay Improved clinical outcomes Leverage for improved reimbursement Differentiation Growth potential Health Care Plans Lower medical costs Lower disability costs Improved clinical outcomes Reduced total health care costs to employees Improved clinical care Competitive differentiation Measurable quality improvements Member satisfaction The remainder of this study guide will discuss MIPs across multiple surgical specialties, as these techniques are becoming increasingly adopted (see Table 3); this discussion will include the various types of procedures, the rationale for their use, patient selection criteria, and clinical results. 13 Table 3 – MIP Adoption Rates11 Procedure Rate of MIP Adoption Hemorrhoidectomy 9% Colectomy 28 % Hysterectomy 30 % Appendectomy 82 % Reflux Surgery 90 % Bariatric Surgery 90 % Cholecystectomy 95 % Video-Assisted Thoracic Surgery (VATS) - Pulmonary Wedge Resection - Lobectomy - Partial or Complete Pneumonectomy 35 % 27 % 43 % Inguinal Herniorrhaphy 19 % Ventral Herniorrhaphy 35 % Support for MIPs: Medical Society Statements Today, as MIPs continue to evolve, they are the standard of care and preferred treatment option for many indications across multiple surgical specialties. This is evidenced by statements from several medical societies supporting the use of MIPs, as outlined below. • American Society of Breast Surgeons “A major goal of modern breast medicine is to minimize the number of patients with benign lesions who undergo open surgical breast biopsies for diagnosis. Image guided percutaneous needle biopsy is the diagnostic procedure of choice for image-detected breast abnormalities.”12 • American Society of Colon and Rectal Surgeons “Laparoscopic colectomy for curable cancer results in equivalent cancer related survival to open colectomy when performed by experienced surgeons.”13 • National Comprehensive Cancer Network (NCCN) “The NCCN guidelines recommend laparoscopic colectomy as an option because clinical trials have shown that laparoscopic colectomy is as good a procedure as abdominal colectomy.”14 14 GENERAL SURGERY This section will discuss minimally invasive approaches for appendectomy; cholecystectomy; colorectal procedures; procedures on the pancreas (resections and pseudocysts), spleen, thyroid, and tonsils; bariatric surgery; and gynecological procedures (hysterectomy, bilateral salpingo-oophorectomy, and colposuspension). Appendectomy Appendicitis is considered in the differential diagnosis of almost every patient who presents with acute abdominal pain; furthermore, acute appendicitis is the most common cause of an acute surgical abdomen in the United States. Therefore, appendectomy is the most common emergency surgical procedure of the abdomen and is performed in cases of acute appendicitis; four appendectomies are performed for every 1,000 children annually in the United States.15, 16 The patient typically presents with periumbilical pain followed by anorexia and nausea. The pain then localizes to the right lower quadrant as the inflammatory process progresses to involve the parietal peritoneum overlying the appendix. This classic pattern of migratory pain is the most reliable symptom of acute appendicitis. Fever then ensues, followed by the development of leukocytosis. Laparoscopic appendectomy (LA) was first described by Semm in 1983, but its potential has not yet been fully realized.17, 18 This is partially because open appendectomy is not considerably more traumatic than LA and also that LA is not driven by patient requests because it is usually an emergency procedure and thus the surgeon determines the surgical approach. While several prospective randomized studies have compared both open and laparoscopic appendectomy, the overall differences in outcomes remain small. However, the percentage of appendectomies performed laparoscopically continues to increase (see Table 4).19 15 Table 4 – Laparoscopic Appendectomy Procedure Data, as a % of Total, U.S., 2006-2012*20 Year Total Procedures % Laparoscopic Laparoscopic Procedures 2006 353,000 35.7% 126,000 2007 356,000 36.2& 129,000 2008 359,000 36.7% 132,000 2009 362,000 37.2% 135,000 2010 366,000 37.7% 138,000 2011 369,000 38.2% 141,000 2012 372,000 38.7% 144,000 *Note: Numbers may not add to totals due to rounding. While LA is being performed with increased frequency, it continues to be used selectively. The laparoscopic approach is at least as safe as the corresponding open procedure and offers benefits in terms of lower wound infection rates and shorter hospital stay and recovery period. Clinically, obese patients have reported having less pain and shorter lengths of hospital stays after laparoscopic versus open appendectomy.21 Also, patients with perforated appendicitis have reported having lower rates of wound infection following laparoscopic removal of the appendix.22, 23 In addition, patients treated laparoscopically have also been shown to have improved quality-of-life scores two weeks postoperatively and lower readmission rates.24, 25 However, in comparison with open appendectomy, the laparoscopic approach involves higher operating room costs, but these have been counterbalanced in some series by the shorter lengths of stay.26 There are certain contraindications for LA; these include extensive adhesions, radiation or immunosuppressive therapy, and severe portal hypertension coagulopathies.27 Laparoscopic appendectomy is also contraindicated in the first trimester of pregnancy. Cholecystectomy Open cholecystectomy has been performed for over a century, but the first laparoscopic cholecystectomy (LC) on a human was reported in 1985.28 By 1994, LC accounted for approximately 90% of elective procedures and has been recognized as the standard of care since then.29 By 2005, 86% of all cholecystectomies in the U.S. were performed laparoscopically; as noted above, projections indicate that this has 16 increased to over 95%.30 Tables 5 and 6 present procedure history and forecasts for open and laparoscopic cholecystectomy.31 Table 5 – Cholecystectomy Surgical Procedure Volumes* Year OC % Annual Change LC % Annual Change Total 2005 108.0 - 669.5 2.2 777.5 - 2006 105.5 -2.3 684.0 2.2 789.5 1.5 2007 103.3 -2.4 699.0 2.0 802.0 1.6 2008 100.5 -2.4 713.2 2.0 813.7 1.5 2009 98.0 -2.5 727.8 2.0 825.8 1.5 2010 96.0 -2.0 742.8 2.0 838.2 1.5 2011 94.0 -2.1 757.4 2.0 851.4 1.6 2012 92.0 -2.1 772.3 2.0 864.3 1.5 2013 90.0 -2.2 789.0 2.2 879.0 1.7 2014 88.0 -2.2 805.0 2.0 893.0 1.6 Compound Annual Growth Rate (CAGR) (2005-2014) -2.3% - 2.1% - 1.6% _ * Procedure volume in thousands. 17 % Annual Change Table 6 – Laparoscopic Cholecystectomy Procedure Data, as a % of Total, U.S., 2006-2012* Year Total Procedures % Laparoscopic Laparoscopic Procedures 2006 1,032,000 93.7% 967,000 2007 1,048,000 94.0% 985,000 2008 1,063,000 94.3% 1,003,000 2009 1,092,000 94.6% 1,020,000 2010 1,106,000 94.9% 1,037,000 2011 1,118,000 95.2% 1,053,000 95.5% 1,068,000 2012 CAGR (2008-2012) 1.6% *Note: Numbers may not add to totals due to rounding. Gallstone disease is the most common gastrointestinal reason for hospitalization in the U.S.32 Cholecystectomy is performed primarily to ameliorate the morbidity associated with gallstones in the gallbladder and/or biliary tree. A gallstone can cause symptoms by one of two mechanisms: either it obstructs the cystic duct or common bile duct, or more rarely, erodes through the gallbladder wall.33 However, most patients remain asymptomatic from their gallstones.34 Although the mechanism is unclear, some patients develop symptomatic gallstones with biliary colic due to a stone obstructing the cystic duct. There are contraindications for laparoscopic cholecystectomy. Absolute contraindications include the inability to tolerate general anesthesia, refractory coagulopathy, and suspicion of gallbladder carcinoma. Relative contraindications are primarily dictated by a surgeon’s management approach and experience, and include previous upper abdominal surgery, cholangitis, diffuse peritonitis, cirrhosis or portal hypertension, chronic obstructive pulmonary disease, cholecystoenteric fistula, morbid obesity, and pregnancy.35 In a Cochrane review of randomized controlled trials comparing LC to OC published in 2006, no difference was found in operative mortality, the rate of intraoperative complications, or the overall rate of minor complications.36 Intraoperative complications were reported in 30 trials and affected 0.9% of laparoscopic and 0.1% of open patients. Approximately 2% of patients treated by laparoscopy experienced minor complications, 18 compared to 3% of patients in the open group; however, the overall risk of experiencing any complication at all was modestly lower. Notably, the risk of bile duct injury did not differ between the two procedures. In regard to clinical outcomes, there was no statistically significant difference in operating time between the two procedures; however, patients treated with LC were discharged from the hospital three days sooner and returned to work 22.5 days sooner than the patients treated with OC. For these reasons, LC is now the preferred surgical approach. Colectomy Over 500,000 surgical procedures are performed each year to treat colon diseases; the most common procedures include partial or total colectomy, hemorrhoidectomy, and sigmoidectomy.37 Laparoscopic and other minimally invasive procedures have been slow to be adopted because of the relative complexity of colorectal procedures; however, while open colectomy remains the gold standard, laparoscopy is being used more frequently. Table 7 summarizes the near future forecast of colon procedure volumes in the U.S. 19 Table 7 – Surgical Procedure Volume Forecast in U.S., by Type of Procedure (20052014)* Year Partial Colectomy % Annual Change Total Colectomy % Annual Change Sigmoidectomy % Annual Change Total % Annual Change 2005 141.6 - 11.7 - 89.0 - 242.3 - 2006 144.5 2.1 11.9 1.7 90.1 1.2 246.5 1.7 2007 147.5 2.1 12.1 1.7 91.4 1.4 251.0 1.8 2008 150.5 2.0 12.4 2.5 92.7 1.4 255.6 1.8 2009 153.7 2.1 12.7 2.4 94.0 1.4 260.4 1.9 2010 157.0 2.1 13.0 2.4 95.4 1.5 265.4 1.9 2011 160.5 2.1 13.3 2.3 96.8 1.5 270.6 2.0 2012 164.0 2.2 13.6 2.3 98.1 1.3 275.7 1.9 2013 167.5 2.1 13.9 2.2 99.5 .4 280.9 1.9 2014 170.8 2.1 14.2 2.2 101.1 1.5 286.0 1.8 CAGR (20052014) 2.1% - 2.2% - 1.4% - 1.9% - * Procedure volume in thousands. 20 The leading indications for colectomy include malignant conditions such as colon and rectal cancer, as well as benign conditions such as polyps, inflammatory bowel disease, diverticulitis, hemorrhage, ischemia, trauma, and redundancy, for example volvulus, constipation, or rectal prolapse. In 2006, there were an estimated 148,600 new cases and 58,000 deaths related to colorectal cancer in the U.S.38 Colorectal cancer is the second leading cause of cancer death in the U.S. and the fourth most common newly diagnosed internal cancer overall. Surgical resection is the treatment option of choice for most patients with colorectal cancer. The goals of surgery are wide resection of the involved segment of the bowel and removal of its lymphatic drainage. Colon resections should include radical en bloc removal of the draining lymphovascular complex, with bowel margins wide enough to limit intraluminal and pericolic (lymphatic) recurrence. In most cases, intramural spreading of cancer should not exceed 2 cm, but an oncologic resection of the abdominal colon should aim at achieving proximal and distal margins of at least 5-10 cm to ensure adequate procurement of the epicolic and pericolic lymph nodes.39 The approach toward rectal cancers depends on the location of the lesion. For lesions of the rectosigmoid and upper rectum, low anterior resection can be performed through an abdominal incision, followed by primary anastomosis. Surgical treatment of rectal cancer should employ total mesorectal excision. Even for low rectal lesions, a sphincter-saving resection can be performed safely if a distal margin of at least 2 cm of normal bowel can be resected below the lesion, a goal that is now facilitated by end-to-end stapling devices.40 There is increasing evidence that suggests the quality of the procedure performed to treat colorectal carcinoma is directly correlated with the quality of the oncologic outcome; while the majority of this evidence comes from the rectal carcinoma studies, the correlation appears to hold true for colon cancer.41 In a study conducted by the German Colon Cancer Study Group, the treating surgeon and the treating institution were found to be independent variables that affected both survival and locoregional recurrence after colon cancer resections.42 Furthermore, there is controversy regarding the routine use of no-touch isolation for curative treatment of colon cancer because this practice is not evidence-based; however, some sources recommend the following practices to minimize the risk of locoregional recurrences43: • Wide mesenteric clearance, including high ligation of all draining mesenteric vessels; • Minimization of trauma to the tumor during mobilization; • Adequate proximal and distal bowel margins; • Wide clearance of tumor in cases of contiguous organ invasion; and • Complete and accurate intraoperative exploration. Laparoscopic colectomy is also a surgical approach for certain inflammatory conditions such as Crohn’s disease and diverticulitis. These inflammatory processes may result in such severe pericolic inflammation and thickening that dissection of the mesentery close to the bowel wall may not be possible. For these patients, it is often necessary 21 to perform a more radical mesenteric dissection in an area where the mesentery is softer. In addition, severe inflammatory adhesions can cause the bowel to be stuck to the retroperitoneum, thus making the usual lateral mobilization of the colon almost impossible. In these cases, early division of the mesentery (ie, medial-to-lateral mobilization of the colon) may provide easier access to the proper plane of dissection, where the tissues are soft. This approach is undertaken to help minimize the risk of injury to retroperitoneal organs. The differences between segmental colon resections for benign disease and those for malignancies are fundamentally important and may have a substantial effect on outcome.44 For patients with benign colon disease, removal of the diseased portion of the bowel in a manner that leaves uninvolved, healthy, and well-vascularized margins should be sufficient treatment. Electrosurgical devices can reliably seal mesenteric vessels as large as 7 mm in diameter without the traditional clamping and tying; they can also reduce operating times during more extensive colon resections for both minimally invasive and open approaches. Minimally invasive colorectal surgery involves the use of several small incisions through which a specialized camera and several laparoscopic instruments are inserted. An insufflator is used to inflate the peritoneal cavity with carbon dioxide (CO2), thereby creating a pneumoperitoneum that provides a working space to perform the operation. Tilting of the operating room table in various positions during the procedure utilizes gravity to allow the intra-abdominal organs to fall away from the area of dissection, providing the requisite exposure that would normally be achieved through the use of retractors in an open procedure. Intestinal resection requires laparoscopic ligation of large vessels, mobilization and removal of a long floppy segment of colon, and restoration of intestinal continuity. Once the colon segment has been completely mobilized and its blood supply divided, a small skin incision is made to exteriorize the colon, a resection and anastomosis are performed extracorporeally, and the rejoined colon is placed back into the abdomen.45 Though the benefits are clear, they have not been as compelling when compared to the clear advantages associated with other laparoscopic procedures. The primary reason is that a colectomy, whether open or laparoscopic, results in a delayed return of bowel function; although this return of bowel function occurs sooner after laparoscopic surgery, the difference is approximately one or two days, resulting in a similar reduction in the length of hospital stay. Additionally, the laparoscopic approach is associated with longer operating times. Although the long-term benefits of open and laparoscopic techniques are equivalent, the short-term benefits are distinct advantages for the patient. In practical terms, the laparoscopic approach is associated with less pain, a faster recovery, earlier return of bowel function, a shorter hospital stay, possible immune benefits, and smaller scars, thereby making it the preferred method for intestinal resection.46 Most patients are suitable candidates for a laparoscopic approach; with an experienced surgeon, even patients with a history of prior abdominal surgery are candidates. The laparoscopic colectomy technique has a somewhat long learning curve because of the advanced laparoscopic skills it involves. Unlike other laparoscopic procedures, 22 for example, Nissen fundoplication or cholecystectomy, colorectal procedures entail dissection and mobilization of intra-abdominal organs in multiple quadrants. The lack of tactile feedback during laparoscopic surgery can make tumor localization difficult, especially if the lesion location has not been tattooed on the colon wall prior to the procedure. It is imperative that the exact location of the tumor is known prior to proceeding with a colectomy. Even when the lesion location has been tattooed onto the colon, the mark can often be difficult to see, or there may be confusion regarding the location of the tattoo in relation to the tumor (either proximal or distal), which can affect surgical margins.47 Other factors that increase the difficulty of laparoscopic-assisted colectomy include48: • Operative exposure is difficult to obtain. • It requires the control of numerous vessels encased in a fatty mesentery. • The 2-dimensional view and loss of tactile sensation increases the risk for injury to vital structures. • In the presence of inflammation, mobilization of the colon becomes more difficult and the identification of vital structures becomes less obvious. The laparoscopic-assisted approach continues to gain popularity and has evolved to include not only “pure” laparoscopic techniques, but also hand-assist devices. Therefore, HALS (hand-assist laparoscopic surgery) for colorectal cancer is an important variant of the laparoscopic approach that also merits discussion. It is considered a minimally invasive procedure and is similar to the laparoscopic approach, but includes the intraprocedural insertion of the hand into the abdominal cavity. However, the size of the incision is smaller than that used in the open approach. Hand-assisted laparoscopic surgery can be used as a bridge for surgeons who are not completely familiar with laparoscopic techniques; even for the most experienced laparoscopic surgeons, it is often the preferred technique for surgery involving left-sided pathology (that is, the descending or sigmoid colon and the rectum).49 The use of a handassist device has several advantages, including50: • A decrease in the learning curve associated with laparoscopy; • The provision of tactile feedback for the surgeon; and • Reduction of operating time, while still preserving many of the advantages of laparoscopic surgery. By combining laparoscopic surgery with the tactile feedback of a hand-assist device, surgeons can not only reduce operating time, but also have a lower procedure conversion rate. The technique involves making an incision the width of a hand and placing a simple, ring-like hand-assist device to facilitate laparoscopic dissection (see Figure 5). New hand port devices facilitate this technique without the loss of pneumoperitoneum, which is essential for performing laparoscopic procedures. Because an incision (usually 4-5 cm) is necessary to remove the colon specimen at the end of a laparoscopic operation, the difference between a pure laparoscopic procedure and the hand-assisted technique is generally a few additional centimeters (usually 3-4 cm) of incision length. Several clinical trials have demonstrated that there is no difference 23 in patient recovery or discharge for laparoscopic versus hand-assisted techniques.51, This technique has particular advantages with overweight or obese patients, since larger incisions are often needed and also because of the increased risk of both wound infection and pulmonary complications.53 52 Figure 5 – Hand-Assist Device The latest generation of hand-assist devices allows the surgeon to insert the device at the beginning of the procedures and then use it as either a hand port or laparoscopic instrument port throughout the remainder of the procedure. The insertion site of the handassist device also provides a useful location for performing extracorporeal anastomosis and removal of a bulky specimen without contamination and a separate, larger incision, as noted above.54 At this time, there is no indication that the laparoscopic approach is associated with poorer long-term outcomes than open colectomy, so there are very few true contraindications; however, some conditions make the laparoscopic approach more difficult, such as55: • • • • Intra-abdominal adhesions from prior surgical intervention; Bleeding disorders; Obesity; and Pregnancy. Other factors that may preclude the laparoscopic approach include56: • Patients with severe restrictive pulmonary disease – these patients cannot tolerate the acidosis generated by the carbon dioxide pneumoperitoneum. In addition, the restrictive pulmonary disease limits the rate of ventilation that can be provided by the anesthesia provider. • Patients with large, bulky lesions – in these patients, larger incisions are required in order to obtain the specimen; therefore, it makes little sense to attempt a laparoscopic approach. • Gender – men may be more difficult to operate on than women due to a greater prevalence of fat in the mesentery, regardless of overall body weight. 24 A Cochrane systematic analysis of randomized controlled trials comparing laparoscopic and conventional colorectal resection was published in 2005.57 In terms of surgeryrelated complications, laparoscopic colorectal resection is associated with a lower rate of total morbidity. Seventeen studies reported the incidence of wound infection; the relative risk was also lower in laparoscopic patients. However, the incidence of intra-abdominal abscesses was not significantly different between the two procedures. Postoperative ileus was less frequent among patient undergoing laparoscopy. Postoperative bleeding and mortality, though, were infrequent events under both surgical approaches, and were reported in 16 to 17 studies respectively. In regard to other outcomes, a total of 22 trials reported operating time with laparoscopic colorectal resection was a longer procedure by approximately 42 minutes. Blood loss was 72 mL less in laparoscopic patients, although the variability in this outcome was high. Pain perception on the first postoperative day was assessed in six trials; laparoscopy was associated with a nine point lower reporting on a 100 point visual analog scale for pain. Length of hospital say was also one and onehalf days shorter for laparoscopic patients. In the past, concerns regarding port-site recurrences initially kept laparoscopy from being widely accepted in the treatment of colorectal carcinoma.58 However, several randomized, controlled studies have reported that the wound recurrence rates with laparoscopic resections are no different from those with open resections.59, 60 Particularly significant were the long-awaited results of the randomized, prospective trial carried out by the Clinical Outcomes of Surgical Therapy (COST) Study Group, which found the oncologic outcomes of open and laparoscopic surgery to be similar after a median follow-up period of 4.4 years.61 Also noteworthy was a randomized, prospective trial from Barcelona, which reported that cancer-related survival was actually better after laparoscopic surgery for colon cancer than after open surgery.62 Further randomized trials are under way in Europe and Australia. These studies have helped to lift the virtual moratorium on laparoscopic treatment of colorectal cancer, but surgeons must be reminded that they must first gain adequate laparoscopic experience with benign conditions of the colon before attempting laparoscopy for malignant disease. In regard to oncological outcomes, a recent report summarized the results of a systematic review of randomized controlled trials by comparing the overall complication, mortality, and recurrence rate between laparoscopic resection and open surgery for colorectal cancer.63 Fifteen trials with 4,207 patients who reported long-term outcomes of the overall complication, mortality, and recurrence rate were included. The combined results of the individual trials showed no statistically significant difference in the odds ratio for overall recurrence, local recurrence, distant metastasis, wound-site recurrence, colorectal cancer-related mortality, colon cancer-related mortality, rectal cancer-related mortality, and overall mortality between the laparoscopic surgery and open surgery groups. The overall complications in the laparoscopic surgery group were much lower than that in the open surgery group. This meta-analysis showed that the successful laparoscopic colorectal resection for colorectal cancer was as effective as open surgery in terms of the oncological outcomes, thereby suggesting that laparoscopic surgery can be continued in patients with colorectal cancer. 25 Laparoscopic surgical treatment of colorectal disease has been slow to gain acceptance, largely because the techniques are difficult to master, the procedures are longer, and the ileus response is still not eliminated after the procedure. However, controlled studies performed by experienced surgeons have found laparoscopy to have advantages over open resection in terms of resolution of ileus, duration of hospitalization, level of postoperative pain, recovery of pulmonary function, and complication rates. Studies also suggest that there appears to be a lower incidence of surgical site complications after laparoscopy than after open surgery, as well as a lower incidence of postoperative adhesions. Pancreas The principles of traditional pancreatic surgery have always been wide exposure, gentle tissue manipulation, preservation of blood supply, and accurate reconstruction of the pancreatic duct.64 While minimally invasive surgery is now the preferred method of surgical management for a variety of diseases of the gastrointestinal tract, those of the pancreas remain some of the most challenging surgical situations encountered by the general surgeon. However, minimally invasive techniques are now being applied to diseases of the pancreas. With less than a decade of experience, this class of techniques has permanently altered the surgical approach to most surgically treated diseases. Once a patient is through the acute phase of pancreatitis, one of the later complications is a pancreatic pseudocyst.65 In the past, surgeons operated on pseudocysts that were 6 cm or larger that persisted longer than six weeks after the episode of acute pancreatitis.66 Current data indicate that asymptomatic pseudocysts can be safely observed and many of them will resolve spontaneously. If the patient complains of persistent pain, early satiety, or has weight loss due to the cyst, a minimally invasive approach to drainage is indicated; today, a minimally invasive approach is standard. Pseudocysts that do not have a large component of solid debris can be addressed with endoscopic transgastric drainage. Using endoscopic ultrasound, an incision is made through the posterior wall of the stomach into the anterior aspect of the pseudocyst; this allows stents to be placed (typically, multiple stents are used). Another minimally invasive technique is to place a transpapillary pancreatic duct stent; this stent can be placed into the cyst or it can bridge the defect in the pancreatic duct to facilitate drainage into the duodenum. In patients whom these techniques fail, or when the cyst has a large amount of solid debris, a minimally invasive approach can still be undertaken with a laparoscopic cystgastrostomy. This technique simulates the open surgical approach and can be accomplished using endoscopic stapling devices. However, not all pancreatic cysts are pseudocysts; identification of cystic neoplasms of the pancreas are becoming increasingly common, due to the prevalence of computerized tomography (CT) imaging.67 In the past, most surgeons were aggressive about recommending pancreatic resection for all cystic lesions of the pancreas, except pseudocysts; however, this strategy has recently been under consideration. Observation is now the recommended treatment, especially for pancreatic cystic neoplasms smaller than 2-3 cm in diameter and in the absence of atypical cells or other markers. When resection is performed, a minimally invasive approach is gaining in popularity. As 26 discussed, it is now routine to approach many abdominal operations using laparoscopic techniques including more complex operations such as colon resection as well as gastric and esophageal resection. Pancreas resection is one of the most difficult types of abdominal surgery and is complicated by several factors, including its retroperitoneal location; intimate relationship to other organs such as the spleen, stomach, duodenum, and bile duct; and relationship to major vascular structures, eg, the superior mesenteric vein, splenic vein, portal vein, branches of the celiac axis, and superior mesenteric artery. The issue of the transected pancreatic parenchyma and potential for a pancreatic leak also complicate this procedure. However, despite these challenges, an increasing number of reports in the literature describing laparoscopic pancreatic surgery are beginning to appear. Laparoscopic distal pancreatectomy was approached first. Endoscopic stapling devices have proven an effective way to control not only the splenic artery and vein, but also the transected pancreatic margin. In addition, small series of laparoscopic Whipple procedures are also emerging. As seen in many other types of MIPs, reduced blood loss, less pain, and decreased length of hospital stay seem to be emerging as potential advantages. Splenectomy68 Splenectomy – either the total or partial removal of the spleen – is performed for various reasons and with different degrees of urgency. Most splenectomies are done after a patient has been diagnosed with hypersplenism, which is not a specific disease but a syndrome. However, there are two diseases for which a splenectomy is the only treatment – primary cancers of the spleen and the blood disorder hereditary spherocytosis (HS). In HS, the absence of a specific protein in the red blood cell membrane leads to the formation of relatively fragile cells that are easily damaged when they pass through the spleen. This cell destruction does not occur anywhere in the body and ends when the spleen is removed. HS can appear at any age, including newborns, although doctors prefer to delay splenectomy until the child is about five to six years of age. Splenectomy is also indicated for the following disorders: • Idiopathic thrombocytopenic purpura (ITP). This is a disease in which platelets are destroyed by antibodies in the body’s immune system. A splenectomy is the definitive treatment for this disease and is effective in about 70% of cases of chronic ITP. • Trauma. The spleen can be ruptured by blunt as well as penetrating injuries to the chest or abdomen. Motor vehicle accidents are the most common cause of blunt traumatic injury to the spleen. • Abscesses. Abscesses of the spleen are relatively uncommon, but have a high mortality rate. • Rupture of the splenic artery. This artery sometimes ruptures as a complication of pregnancy. As of 2003, there are no medical alternatives to splenectomy. In patients who are poor candidates for surgery, splenic embolization is one alternative. Embolization involves occluding the splenic artery with synthetic substances (eg, polyvinyl alcohol foam, polystyrene, and silicone), in order to shrink the size of the spleen. The primary risk 27 associated with splenectomy is postsplenectomy sepsis. Mortality from postsplenectomy sepsis is highest in children, especially in the first two years after surgery; however, this risk can be reduced by vaccinating the child preoperatively. In some cases, a twoyear course of penicillin postoperatively, or long-term treatment with ampicillin, may be recommended. Other risks associated with the procedure include pancreatitis and atelectasis. For some patients, a splenectomy does not address the underlying causes of splenomegaly or other conditions. Another potential complication is excessive bleeding postoperatively, especially for patients with ITP. Infection of the incision immediately after surgery may also occur. Results of the procedure depend on the indication. In blood disorders, removing the spleen removes the cause of the blood cell destruction. Normal results for patients with an enlarged spleen are relief of pain and the complications of splenomegaly. However, it is not always possible to predict which patients will respond well or to what degree. Morbidity and mortality associated with splenectomy vary with the underlying disease or the extent of other injuries. Rates of complete recovery from the surgery itself are excellent, in the absence of other severe injuries or comorbidities. In recent years, as with other surgical specialties, minimally invasive techniques for splenectomy have been used with more frequency. However, as of 2003, a laparoscopic procedure is contraindicated if the patient’s spleen is greatly enlarged. Most surgeons will not remove a spleen longer than 20 cm (as measured by a CT scan) by this method. The laparoscopic approach for splenectomy has been shown to have several benefits over conventional open splenectomy.69 A quicker return to function, earlier discharge from the hospital, less postoperative pain, and better cosmesis due to the smaller incisions have been reported by multiple authors. Decreased intraoperative blood loss and transfusion requirements have also been described. Thyroidectomy Traditional thyroid surgery is not a severely deforming operation but does leave a scar in an area that, unlike chest or abdominal procedures, is visible on a daily basis.70 While minimally invasive thyroid surgery has no formal definition, it is primarily defined by the smaller length of the incision. As with other minimally invasive approaches, the goals of endoscopic thyroid surgery include reduction in the length of the scar; decreased pain; earlier discharge; and shorter recovery time. Thyroidectomy evolved since the turn of the last century when Kocher took a dangerous procedure and improved its safety; prior to Kocher, 40% of thyroid surgery patients died; after Kocher less than 1% died. However, at that time, incision length was not a major concern. As the last century progressed, thyroid goiter became less prevalent due to the addition of iodine to salt; as a result, thyroid nodules were detected when they were smaller in sizes. As surgical techniques were also being refined during this period, thyroidectomy incisions could therefore start to decrease in size. In general, incisions for thyroid surgery currently vary in size based on the: • Size of the gland (goiters need larger incisions); • Presence of thyroiditis (inflammation increases the difficulty of the procedure); and • Patient’s body (obesity or a short neck also increases the difficulty). 28 Minimally invasive thyroidectomy is indicated for thyroid cancers less than 2 cm; thyroid nodules less than 3.5 cm; small goiters; and glands that are free of thyroiditis. Contraindications (ie, conditions that require a standard incision) include: • • • • Large thyroid goiters; Large thyroid cancers (greater than 2 cm); Thyroiditis; and Thyroid cancer that has metastasized to the lymph nodes. The first case of endoscopic thyroid surgery was described in 1997.71 In 2000, the cosmetic results of endoscopic thyroid surgery were further improved by performing an endoscopic thyroidectomy via an axillary and anterior breast approach.72, 73 This scarless (ie, in the neck) endoscopic thyroidectomy (SET) attracted widespread attention due to its very good cosmesis. The primary disadvantage of SET is the much larger plane of tissue dissection.74, 75 In one study comparing the conventional surgical approach to SET, the total length of the incisions and volume of blood loss in SET were significantly lower; in addition to the superior cosmetic result, postoperative pain was significantly less severe and rates of paresthesia and discomfort with swallowing were also markedly lower in the patients in the endoscopic group.76 An endoscopic transaxillary approach to total thyroidectomy has also been reported, as endoscopic neck surgery for the thyroid and parathyroid continues to be explored as an alternative to open thyroidectomy. A recent study of 22 patients was conducted to determine the safety and feasibility of endoscopic transaxillary total thyroidectomy (ETTT).77 In this study of 20 females and 2 males, average age 49.3 ± 12.9 years, no conversions to an open procedure were necessary. Mean operating time was 238 ± 72.7 minutes; average blood loss was 40 mL ± 28.3 mL; mean weight of the gland was 137.05 g ± 129.21g. The recurrent laryngeal nerve was identified with no permanent injury. Six patients developed hoarseness of the voice for an average of 15.1 ± 8.01 days. None of the patients developed tetany or hypocalcemia requiring treatment. Six patients experienced transient numbness in the anterior chest wall lasting two weeks in five patients and two months in one. All patients were discharged within 24 hours of admission. The authors concluded that while ETTT requires additional operating time compared with the open approach, visualization of the nerve and parathyroid is improved and it is cosmetically favorable. Although the learning curve is steep, with experience the operative time will decrease. ETTT is a different approach, but one that is safe and feasible. Tonsillectomy78, 79 A minimally invasive approach to tonsillectomy – powered intracapsular tonsillectomy (PIT) in which the tonsils are partially removed with a microdebrider – is also gaining popularity today. Traditional tonsillectomy procedures remove the tonsil tissue completely, thereby exposing the underlying throat muscles to bacteria and endotoxins, thermal injury, and inflammation. These factors are believed to contribute to the severe pain, slower recovery, and higher rate of complications associated with these traditional approaches. However, in many cases, a near-complete removal of tonsil tissue provides 29 a safe and effective treatment, but with considerably less pain and a faster recovery. With this technique, the surgeon can precisely remove 90-95% of the tonsils, using the microdebrider; essentially, the tonsil is removed from the outside in, as the resection is performed distal to the branching of the primary tonsillar vessels, thereby exposing only the smaller branched arterioles. The thin layer of tonsil tissue that is intentionally left intact acts as a protective shield for the delicate throat muscles, thus reducing the amount of postoperative pain and recovery time. The advantages of a powered intracapsular tonsillectomy include: • Reduced postoperative pain – Because PIT protects the delicate throat muscles from exposure by leaving a thin layer of tonsil tissue intact, the amount of pain most patients experience postoperatively is greatly reduced. • Faster recovery and return to normal activity – Because the throat muscles are protected and the pain is greatly reduced, the recovery is typically twice as fast. Children who undergo the PIT technique can expect to return to normal activity in 2.5 days; this also means parents can go back to work sooner.80 • Fewer hospital readmissions for complications – Dehydration and bleeding are the two primary complications associated with traditional tonsillectomy procedures. In a study comparing 150 children who underwent PIT with 162 children who had standard tonsillectomy, only one patient in the PIT group, but five in the standard procedure group were readmitted due to dehydration; in all, 11 readmissions were needed in the standard tonsillectomy group, whereas only two were required in the PIT group.81 One disadvantage of PIT is that because the tonsils are not completely removed, the potential exists that the tonsils may regrow and thus need to be removed or that they may become infected; however, the risk of regrowth does not appear to be significant. Another disadvantage is that it may take longer to perform than total tonsillectomy; because larger tonsils have more volume, tissue removal often takes longer to perform. The PIT technique may be contraindicated for patients with chronic or recurrent tonsillar infection because it obviates the risk that a patient will require additional surgery in the future. Bariatric Surgery Today, an estimated 200 million adults in the U.S. (68% of the adult population) are categorized as being overweight or obese. Obesity is the second-leading cause of preventable death in the U.S., resulting in nearly 112,000 deaths every year; in addition, the condition is a leading cause of type 2 diabetes, disability, and heart disease, and is a significant contributor to the rising costs of health care. Despite the critical need for weight loss in the majority of the adult population, research has found that diet and exercise alone is unsuccessful in 80-85% of patients at one year; furthermore, only approximately 1% of eligible obese people currently undergo bariatric surgery due to its high cost and high risk of complications.82 Bariatric surgery, also called weight reduction or weight loss surgery, is the surgical treatment of obesity; up until the 1990s, open procedures were the norm for virtually 30 all bariatric procedures; however, minimally invasive laparoscopic surgery has become the technique of choice for bariatric procedures and some procedures have moved to ambulatory surgery units (the historical development of bariatric surgery is briefly summarized in Table 8).83 Table 8 – Historical Development of Bariatric Surgery Decade Procedural Development 1950s Jejunoileal bypass 1960s Jejunocolic bypass Gastric bypass 1970s Gastroplasty Biliopancreatic diversion 1980s Gastric banding Adjustable gastric banding 1990s Laparoscopic access becomes approach of choice 2000s Laparoscopic-adjustable gastric band (LAGB) approved by the U.S. Food & Drug Administration Gastric and vagal pacing developed Endoscopically accessed interventions evolve with implanted balloon and stapling delivery devices Today, the rate of MIP for bariatric surgery is 88%.84 However, while the current economic conditions continue to restrain market growth, the U.S. market for minimally invasive bariatric surgical devices is expected to exhibit relatively strong growth over the next five years; the U.S. minimally invasive bariatric surgical products market is expected to increase at a compound annual rate of 6.6%. Benefits are expected from increased utilization of LAGB systems, the growing use of single-incision procedures, as well as emerging incisionless technologies, such as intragastric balloons and other transorally inserted weight loss devices, in addition to gastric stimulators or vagal blocking systems. Minimally invasive robotic surgery is also expected to continue to significantly improve bariatric surgical outcomes.85 There are three categories of bariatric surgical procedures:86, 87 • Restrictive – with restrictive procedures (eg, vertical gastric banding, adjustable gastric banding, and sleeve gastrectomy), the size of the stomach is reduced, ie, the basic anatomical structure and capacity of the stomach is altered, without affecting the normal digestive processes; therefore, caloric and nutrient absorption are not affected. After having this type of procedure, when the patient eats, the food is digested and absorbed normally, but the patient feels fuller sooner due to the smaller capacity of the stomach; therefore, he/she eats less. 31 • Malabsorptive – malabsorptive procedures (eg, biliopancreatic diversion) are more technically complex; these procedures reduce the absorptive capacity of the small intestine with a bypass of a segment or segments of the proximal small bowel. As a result, the digestion process is incomplete, thereby diminishing the amount of calories and nutrients the body can effectively absorb. • Combination – the Roux-en-Y gastric bypass – is largely restrictive and mildly malabsorptive. This procedure reroutes the passage of ingested food and fluid from a small pouch created in the proximal stomach to a segment of the proximal small bowel. Thus, the amount of food a patient can comfortably eat is reduced (ie, restriction), and the amount of calories that can be digested in the small intestine (ie, malabsorption) is also reduced. This combination of bariatric methods leads to greater weight loss; therefore, the Roux-en-y procedure is seen as one of the best ways to treat clinically severe obesity. Obese patients typically present with serious co-existing health conditions, such as cardiopulmonary disease, type 2 diabetes, and obstructive sleep apnea; therefore, any patient seeking bariatric surgery must meet the following eligibility criteria in order to be a suitable candidate88: • • • • • • Is morbidly obese, complicated by medical conditions secondary to obesity; Has a history of failed diet therapy; Is motivated; Is psychologically stable; Has acceptable operative risks; and Is well-informed regarding the procedure, recovery, and postoperative lifestyle modifications. Contraindications are not easily generalized, because morbidly obese patients are usually at greater risk for any surgical procedure; however, patients at highest risk include those89: • • • • • With end-stage heart and lung function; Who are unable to ambulate; Who weigh more than 600 pounds (272 kg); Who are younger than late teens or older than 65 years; and With Prader-Willi syndrome. Hysterectomy In women of childbearing age, hysterectomy is the second most frequently performed surgical procedure, after cesarean section.90 The prevalence of hysterectomy procedures in the U.S. is approximately 5.6 per 1,000 women. In 2005 alone, over 533,300 hysterectomies were performed in the U.S. In general, the surgery is considered an elective procedure and done when less-invasive options have failed. Table 9 presents procedure history and forecasts for abdominal, vaginal, and laparoscopically assisted vaginal hysterectomies (LAVH).91 32 Table 9 – Hysterectomy, U.S. Procedure Volumes Forecast by Type, 2005-2014* Year Abdominal Procedures % Annual Change Vaginal Procedures % Annual Change LAVH Procedures % Annual Change Total % Annual Change 2005 404.0 - 229.5 - 101.3 - 734.8 - 2006 405.5 0.4 223.5 -2.6 110.9 9.5 739.9 0.7 2007 406.8 0.3 217.5 -2.7 120.3 8.5 744.6 0.6 2008 408.0 0.3 211.5 -2.8 130.8 8.7 750.3 0.8 2009 409.2 0.3 205.8 -2.7 141.5 8.2 756.5 0.8 2010 410.4 0.3 200.0 -2.8 152.3 7.6 762.7 0.8 2011 411.8 0.3 194.0 -3.0 162.6 6.7 768.4 0.7 2012 413.0 0.3 189.0 -2.6 174.8 7.5 776.8 1.1 2013 414.2 0.3 184. -2.6 187.1 7.0 785.3 1.1 2014 415.5 0.3 178.0 -3.3 198.7 6.2 792.2 0.9 (CAGR) (20052014) 0.3% - -2.8% - 7.8% - 0.8% - * Procedure volume in thousands. The leading indications for hysterectomy include abnormal uterine bleeding (AUB), fibroids or leiomyomas, endometriosis, uterine prolapse, and gynecological cancer. In regard to gynecological cancer, malignant etiologies include cervical intraepithelial neoplasia, endometrial adenocarcinoma, uterine sarcoma, leiomyosarcoma, and ovarian carcinoma. Hysterectomy is performed either via an open abdominal procedure or vaginally, using a laparoscope.92 There are four major types of hysterectomy: total (removal of both the uterus and cervix); total with bilateral salpingo-oophorectomy (a total hysterectomy with removal of the ovaries and fallopian tubes); subtotal (known as partial or supracervical because the cervix is left intact); and radical (usually performed for cancer and includes removal of the upper portion of the vagina and pelvic lymph nodes). There are also four categories of minimally invasive approaches: vaginal hysterectomy; laparoscopically assisted vaginal hysterectomy; laparoscopic hysterectomy; and total laparoscopic hysterectomy.93 Overall, hysterectomy rates vary widely in different parts of the U.S.; about 55% of hysterectomies are still performed abdominally.94 The common factor in determining the surgical approach to hysterectomy has been found to be the comfort level of the surgeon with a specific procedure; this, both nation-wide and world-wide, results in a predominance of abdominal hysterectomies.95 MIPs have been promoted as being advantageous due to shorter hospitalization and recovery time compared to abdominal hysterectomy. However, the surgeon must be 33 experienced in the procedure before these benefits can be realized. The disadvantages include potentially longer operating times (directly related to how much of the procedure is performed laparoscopically), higher costs, and an increased risk of damage to the urinary tract. In examining outcomes between abdominal and laparoscopic hysterectomy, when complications were compared, the evidence supported a lower risk of wound and abdominal infections with the laparoscopic approach, along with a lower risk of an infection of any type.96 There was also a lower risk of an operative or early postoperative complication of any type as well as a lower risk of a major complication (eg, bleeding and ureter injury). Laparoscopic hysterectomy patients also reported returning to work about 13.6 days sooner. In one study, the median length of stay was three days for laparoscopic hysterectomy patients versus four days for abdominal hysterectomy; patients returned to work 11.1 weeks after their laparoscopic procedure, compared to 13.6 weeks after abdominal hysterectomy.97 Compared to abdominal hysterectomy, laparoscopic hysterectomy procedures are typically longer by an average of 10.6 minutes. Laparoscopically assisted vaginal hysterectomy is shorter by an average of 7.6 minutes.98 Within MIP subtypes, vaginal hysterectomy is a significantly shorter procedure than laparoscopic hysterectomy (41.5 minutes shorter on average); laparoscopically assisted vaginal hysterectomy is significantly shorter than laparoscopic hysterectomy with uterine artery ligation (average of 25.3 minutes). BLADDER SUSPENSION Despite the growing body of medical knowledge on stress urinary incontinence (SUI), controversies over its management remain.99 SUI is the most common type of incontinence and occurs almost exclusively in females. SUI affects approximately 16.5 million women in the United States; nearly two-thirds of these women are under 50 years of age. Risk factors for developing SUI include: • • • • • • • Age > 60 years; History of prior incontinence surgery; History of pelvic radiation; Positive standing stress test without hypermobility; Positive standing stress test with an empty bladder; Leakage much greater than stress load; and Decreased tactile resistance when placing a cotton swab transurethrally. Various treatment options have been developed to rectify the negative impact of SUI on an individual’s quality of life, including both medical therapy and surgical procedures.100 Surgical treatment offers the highest cure rate (85-90%) when compared to medical options; the Burch colposuspension procedure in which the bladder and urethra are suspended, has been the gold standard for surgical treatment. This same procedure can be done using minimally invasive techniques; however, this procedure has a significant 34 learning curve so it has not been done by the majority of gynecological laparoscopists.101 It is often done along with a paravaginal repair, where the sides of the vagina have become disconnected from the pelvic side wall and need to be reattached to better support the bladder. In 1991, the Burch procedure by laparoscopic approach was described and performed with a technique similar to conventional surgery.102 In recent years, laparoscopic Burch colposuspension has become increasingly popular and also offers the best surgical treatment option for genuine stress incontinence. The use of the laparoscopic technique allows the suprapubic approach to the bladder neck without the need for laparotomy, thus providing postoperative benefits associated with MIPs. Advantages of the laparoscopic approach include elimination of the abdominal incision and better visual access and exposure of the anatomic structures. The visual clarity and magnification of tissues facilitates more precise dissection and better hemostasis. As with other MIPs, the patient usually experiences much less discomfort and pain postoperatively, has a quicker recovery, and shorter length of hospital stay. Postoperative complications including wound infection, retropubic hematoma, and detrusor instability may also be reduced. A Cochrane systematic analysis of 22 randomized and quasi-randomized controlled trials in women with symptomatic or urodynamic diagnosis of stress or mixed incontinence that included laparoscopic colposuspension as the intervention was reported in 2006.103 Ten of the 22 studies involved comparison of laparoscopic with open colposuspension. While the women’s subjective impression of cure was similar for both procedures, with short- and medium-term follow-up, there was some evidence of poorer results with colposuspension on objective outcomes. Trends shown indicated fewer perioperative complications, less postoperative pain, and shorter hospital stay for laparoscopic procedures as compared to open colposuspension; however, laparoscopic colposuspension was more costly. Eight studies compared laparoscopic colposuspension with newer “self-fixing” vaginal slings. While there were no significant differences in the reported short- and long-term subjective cure rates, the objective cure rates at 18 months favored the slings. No significant differences were observed for postoperative voiding dysfunction and perioperative complications; however, laparoscopic colposuspension had a significantly longer operating time and hospital stay. Significantly higher subjective and objective one-year cure rates were found for women randomized to two paravaginal sutures when compared to one suture in a single trial; three studies compared sutures with mesh and staples for laparoscopic colposuspension and demonstrated a trend towards favoring the use of sutures. The current available evidence suggests that laparoscopic colposuspension may be as good as open colposuspension at two years postoperatively. However, the newer vaginal sling procedures appear to offer even greater benefits, better objective outcomes in the short term, and similar subjective outcomes in the longer term. If laparoscopic colposuspension is performed, the use of two paravaginal sutures appears to be the most effective method. 35 VIDEO-ASSISTED THORACIC SURGERY (VATS) Indications and Contraindications for Thoracic MIPs104 Today, thoracic MIPs is effective as both a diagnostic and therapeutic tool for a variety of thoracic diseases, including complex problems. General indications and contraindications are outlined below; additional indications and contraindications identified for specific thoracic MIS procedures also are presented. Indications Diagnostic indications for thoracic MIS include: • • • • • • • • • Undiagnosed pleural effusion; Indeterminate pulmonary nodule; Undiagnosed interstitial lung disease; Pulmonary infection in an immunosuppressed patient; To define the cell type in known thoracic malignancy; To define the extent of a primary thoracic tumor; Nodal staging of a primary thoracic tumor; Diagnosis of intrathoracic pathology to stage a primary extrathoracic tumor; and Evaluation of intrapleural infection. Therapeutic indications for minimally invasive thoracic procedures include: • Lung ◦◦ ◦◦ ◦◦ ◦◦ ◦◦ ◦◦ ◦◦ Spontaneous pneumothorax; Bullous disease; Lung volume reduction; Persistent parenchymal air leak; Benign pulmonary nodule; Resection of a primary lung tumor (in highly selected cases); and Resection of pulmonary metastasis (in highly selected cases). • Mediastinum ◦◦ Drainage of pericardial effusion; ◦◦ Excision of bronchogenic or pericardial cyst; ◦◦ Resection of selected primary mediastinal tumors; ◦◦ Esophageal myotomy; ◦◦ Facilitation of transhiatal esophagectomy; ◦◦ Resection of primary esophageal tumors; ◦◦ Thymic resection; and ◦◦ Ligation of thoracic duct. • Pleura ◦◦ Drainage of an early empyema; ◦◦ Drainage of a multiloculated effusion; and ◦◦ Pleurodesis. 36 Contraindications Minimally invasive thoracic surgery is contraindicated in the following situations: • • • • • Extensive intrapleural adhesions; The inability to sustain single-lung ventilation; Extensive involvement of hilar structures; Preoperative induction of chemotherapy or chemoradiation; and Severe coagulopathy. Thoracic MIPs Available Today As both the numbers and types of thoracic MIPs continue to evolve, the procedures available today are briefly described below.105 • Wedge resection – excision of a wedge of the lung that contains the malignant tissue along with a margin of the surrounding healthy tissue. MIS wedge resections are performed for non-small cell lung cancer or pulmonary metastasis; for small (less than 3 cm) peripheral masses; and patients who are not appropriate candidates for lobectomy (eg, those with pulmonary hypertension and severe medical illnesses). It is contraindicated in patients with prior ipsilateral thoracic surgery or radiation and in pregnant patients. • Lobectomy – removal of an entire lobe of a cancerous lung. Most lobectomies can be performed by VATS. A lobectomy performed by VATS should be a standard, anatomic resection, just as the procedure performed through a thoracotomy. The indications for VATS lobectomy include Stage 1 lung cancer; a tumor less than 6 cm in diameter; and benign disease (eg, bronchiectasis). Relative contraindications include a tumor 5-8 cm in diameter; preoperative irradiation or chemotherapy; sleeve resections; and chest wall invasions. Contraindications are tumors greater than 8 cm in diameter; mediastinal invasion; and surgeon discomfort. • Pneumonectomy – removal of an entire lung in order to treat the cancer. A pneumonectomy can be performed by VATS, and the specimen usually fits through the same size of incision that is used for a VATS-type lobectomy, depending on the size and location of the lesion. In general, a large central tumor is not appropriate for VATS due to involvement of the mediastinal structures. The surgeon must ensure that the tumor is not amenable to a sleeve resection, which may be difficult to determine by the VATS approach. Therefore, rarely is pneumonectomy best handled by VATS. • Sleeve lobectomy – a lung resection in which a section of bronchus or trachea is removed along with diseased lung tissue after which the proximal and distal ends are anastomosed. Surgeons with excellent video skills can perform a standard sleeve lobectomy by VATS. • Segmentectomy – removal of a segment that contains malignant tissues from a lobe of the lung. Segmentectomy is an option for small, anatomically well-situated lung cancer. The creation of a segmental fissure and dissecting out the segmental vessels can be done using a thoracoscopic technique. 37 • Mediastinal and esophageal procedures: ◦◦ Mediastinoscopy. This is an important procedure for staging lung cancer. Video-assisted mediastinoscopy has greatly improved the quality and safety of the procedure. Node dissection can be performed with the standard video mediastinoscope. ◦◦ Mediastinal lymph node dissection (right- and left-sided). This is a critical part of any lung cancer procedure. Lymph node dissection should be performed for all types of cancer resections (eg, wedge, segmentectomy, lobectomy, pneumonectomy) to ensure proper staging and for possible therapeutic benefit. No additional incisions are made for mediastinal lymph node dissection; the procedure uses the existing incisions for the video-assisted lobectomy, which usually precedes node dissection. ◦◦ Esophageal mobilization. Mobilization of the esophagus by VATS provides the advantage of a complete cancer operation performed by minimally invasive technique. Although most VATS procedures are performed with the patient in the lateral decubitus position, the prone position offers several advantages for surgery on structures in the posterior mediastinum. For example, in the prone position, lung retraction is not needed because gravity causes the lung to fall out of the way. ◦◦ Thymectomy. Using the VATS approach for this procedure is an excellent technique for patients with myasthenia gravis and small (less than 4 cm) thymomas that do not appear to invade other structures. • Lung volume reduction surgery (LVRS) – a procedure in which nonfunctional lung tissue in emphysema patients is removed, thereby allowing more room in the thoracic cavity for good, relatively healthy tissue, thus improving lung function. In comparison with medical management, LVRS can improve quality of life, pulmonary function, exercise tolerance, and survival for selected patients. Although LVRS can be performed by VATS or a median sternotomy with the same morbidity, mortality, and benefits, the VATS approach costs less and provides faster recovery. Patients who are candidates for LRVS as symptomatic, despite maximal medical management, including oxygen supplementation, inhalers, and pulmonary rehabilitation. Patients with severe emphysema are deconditioned; rehabilitation reconditions the leg muscles and decreases dyspnea. Patients who are better conditioned are better prepared to cooperate with their postoperative care regimen, such as immediate ambulation and use of incentive spirometer, to reduce respiratory complications. Patients who do not cooperate well or fail at rehabilitation are poor candidates for LVRS. The most important patient selection factor is a heterogeneous pattern of emphysema identified on CT and lung perfusion scanning. • Resection of pulmonary blebs and bullae. One of the earliest and most widespread uses for VATS was in the treatment of patients with spontaneous blebs. Bleb resection by VATS has become a standard procedure; however, this method for pleurodesis remains controversial. Studies of treatment of spontaneous pneumothorax have not shown that one method of pleurodesis is more successful 38 • • • • • than another. Video-assisted resection of bullae is part of LVRS for the treatment of end-stage emphysema. Thoracic sympathectomy. Thoracic sympathectomy has been used for the treatment of sympathetic dysfunction since it was first described in the 1940s; with the advent of VATS, the procedure has become more widely applied. VATS provides excellent visual acuity and the potential for doing the procedure more quickly and with fewer complications. Thoracic sympathectomy is indicated for various sympathetic disorders, but it is most commonly performed for hyperhidrosis. Less common indications include reflex sympathetic dystrophy, upper extremity ischemia, Raynaud’s disease, debilitating facial blushing, and splanchnicectomy for pancreatic pain. First rib resection for thoracic outlet syndrome (TOS). TOS refers to compression of the subclavian vessels or the brachia plexus, or both by the first rib and adjacent structures at the superior aperture of the chest; therefore, treatment of TOS requires resection of the first rib. The most common symptoms are neurologic and are related to compression of the brachial plexus in the distribution of the ulnar nerve. While there are several approaches for TOS, the VATS approach has several advantages. For example, the shoulder does not need to be lifted or held for an extended period of time; the exposure is good; and the cutaneous nerves in the axilla are not disturbed. MIS for atrial fibrillation. Due to the technological advances in MIS instrumentation and the increase in surgeons’ experience with VATS approaches, surgical ablation for atrial fibrillation can now be successfully performed using minimally invasive techniques. Thoracoscopic approach to spinal deformities. The conventional approaches to the spine have been posterolateral, costotransverse, and anterior; to reach the anterior spine, anterior thoracotomy has traditionally been used. There are several problems associated with thoracotomy, such as the long incision, rib resection, significant rib spreading, tissue desiccation, alteration of pulmonary and shoulder girdle function, pain, associated morbidity, and poor cosmesis. The VATS approach presents the spinal surgeon with a minimally invasive option for approaching the anterior vertebral column. The goals of VATS in spine surgery are the same as for thoracotomy in reducing the surgical morbidity associated with open procedures. In addition, the VATS approach has led to many exciting new techniques for the treatment of disc space. Surgical instruments guided through an endoscope, are able to gain access to the chest through 15-20 mm ports rather than through an 8-10 inch long incision required for thoracotomy. Diaphragmatic plication. Plication of a paralyzed diaphragm can relieve dyspnea and substantially improve pulmonary function. The procedure is considered to be underused and may be performed by VATS techniques. The diaphragm absorbs the pleural fluid created daily in the pleural space; when the diaphragm is plicated well, there is much less absorptive surface. Postoperatively, the patient may drain a remarkably large amount of fluid through the chest tube. 39 Table 10 shows the volumes forecast for VATS procedures for 2005 through 2014. Approximately 26,000 thoracoscopies were performed in the U.S. in 2005. The number of these procedures is expected to increase over the forecast period at a compound annual rate of 5.6% to reach an estimated 43, 000 in the year 2014. MIPs are expected to be utilized in more lung procedures due to improved instrumentation and broader acceptance of thoracoscopy by chest surgeons.106 Table 10 – Thoracoscopy (VATS), U.S. Procedure Volumes, 2005-2014107 Year Thoracoscopy % Annual Change 2005 26,000 - 2006 27,000 3.9 2007 28,100 4.1 2008 29,300 4.3 2009 30,700 4.8 2010 32,500 5.9 2011 34,500 6.2 2012 36,800 6.7 2013 39,500 7.3 2014 43,000 8.9 (CAGR) (2005-2014) 5.6% - Patient Benefits of Thoracic MIPs As with other minimally invasive techniques, VATS offers patients a number of important clinical benefits when compared to open surgical procedures, such as108, 109: • VATS is associated with a significantly lower risk (70%) of overall postoperative complications. • VATS only requires a number of small incisions and causes less physical injury to the patient’s body while allowing the surgeon to perform a highly effective procedure. • Compared with open surgery, which typically requires four to six weeks of recovery time, VATS patients can often return to work and resume other activities as soon as one week after surgery.110 40 • VATS may significantly reduce postoperative pain and need for additional treatment. Research has demonstrated that postoperative pain measured after more than one year was reduced by 61% with VATS versus open surgery. In addition, VATS procedures may significantly reduce the total dosage, duration, and total administration of analgesia. • Delivery of planned adjuvant chemotherapy may be more feasible after VATS compared to open surgery. CARDIAC SURGERY111, 112 Minimally invasive cardiac surgery is defined as cardiac surgery without the use of cardiopulmonary bypass or without the use of a sternotomy for patients with coronary artery disease; some patients can have this procedure without either one. The primary rationale for minimally invasive cardiac surgery is to reduce the morbidity of cardiac operations. The traditional approach to coronary artery bypass graft (CABG) surgery, as well as aortic and mitral valve replacements, requires a sternotomy and subsequent opening of the chest cavity. This causes a great deal of trauma to the patient, increasing the recovery time as well as the level of pain the patient experiences. Unlike the traditional approach, which involves a 10-12 inch incision and placing the patient on the cardiopulmonary bypass machine, new minimally invasive approaches may avoid placing the patient on this machine and can be performed through a smaller 3-5 inch incision, made between the ribs, or may be done with several small incisions. Endoscopic bypass procedures, which are still in development, are performed through small incisions, approximately 1-2 inches long. The potential benefits of minimally invasive coronary artery bypass surgery include: • Decreased length of hospital stay – because patients experiences less pain and therefore are able to cough and breathe deeply postoperatively, they are often discharged from the hospital in two to three days, as compared to the typical five to ten days for conventional CABG surgery. • Quicker recovery – avoidance of the cardiopulmonary bypass machine and the use of smaller incisions may reduce the risks of complications such as stroke and renal failure; as a result, patients can return to their normal activities in two weeks rather than the typical six to eight weeks with conventional surgery. • Reduced bleeding and blood trauma – avoidance of cardiopulmonary bypass eliminates the need for systemic anticoagulation and administration of blood products and also reduces hemolysis. All of these factors may adversely affect the blood’s ability to clot after surgery. • Reduced rate of infection – a smaller incision results in less exposure and handling of tissue, which may reduce the risk of infection. • Increased patient indications – some patients are poor candidates for traditional bypass surgery because their illness is too advanced, their heart is too weak, they have multiple comorbidities, or because they will not accept blood products. 41 Therefore, some patients are able to receive this life-saving surgery through minimally invasive techniques. • Decreased costs – the cost of minimally invasive cardiac surgery may be approximately 25% less than the cost of traditional bypass surgery. As with minimally invasive CABG, minimally invasive heart valve procedures also result in less pain for the patient, a shorter hospital stay, and a quicker recovery time; there is also less bleeding and potential for infection. ORTHOPEDIC SURGERY (rotator cuff, knees, & hips) Orthopedic surgery is a dynamic, ever-changing specialty; technological advances in the multitude of instrumentation, hardware, and systems have resulted in the improved treatment of orthopedic disorders.113 This section will focus on MIPs in rotator cuff repair and total knee and hip arthroplasty. Rotator Cuff Repair The majority of rotator cuff tears occur through the insertion of the tendinous fibers of the supraspinatus muscle that attaches onto the greater tuberosity of the proximal humerus.114 Supraspinatus syndrome, also known as impingement syndrome, can involve several pathologic conditions, including calcium deposits, bicipital tendonitis, subacromial bursitis, tenosynovitis, and other nonarticular lesions along with a cuff tear. Partial rotator cuff tears and impingement syndrome typically affect people in the middle decades of life or later; these conditions are often attributable to aging and the degenerative process. Complete rotator cuff tears are the result of accidental injuries in younger patients, typically those who engage in sports, eg, quarterbacks and pitchers. The method of treatment depends upon the size and shape of the tear; many can be treated conservatively with physical therapy and non-steroidal anti-inflammatory drugs. Surgery may be performed when conservative treatment is unsuccessful. The goals of any treatment option are the restoration of joint stability, pain relief, and return to normal activities of daily living. Traditionally, surgical repair of a torn rotator cuff has been performed through an open or mini-open approach that requires a 1.5-4 cm incision, with a slow recovery period and significant postoperative pain.115 Today, surgical techniques for rotator cuff repair have progressed to more minimally invasive procedures, facilitated by improved instrumentation. As a result, repair with a minimally invasive technique is making a dramatic difference in postoperative pain and comfort, while providing excellent results. With each advance in technique, surgeons experience a learning curve to master the new technique.116 Initially, some tears were considered too large to be treated with minimally invasive techniques. As surgeons become more experienced in using less invasive techniques, they are better able to treat most tears with a less invasive approach. The most recent development is the all-arthroscopic technique. Each step toward less invasive surgery has benefited the patient by reducing: • Surgical blood loss; • Postoperative pain; 42 • Postoperative stiffness; and • Length of hospital stay. As noted, some people with rotator cuff disease do not require surgical treatment, but when surgery is indicated most patients are candidates for arthroscopic repair of rotator cuff tendon tears.117 While arthroscopic surgery does represent a viable option for many patients with rotator cuff injury, some patient considerations are contraindications; these include a long-standing tear accompanied by arthritic changes, previous infection, and nerve or muscle damage. Therefore, the decision on how to treat rotator cuff tears is based on the patient’s severity of symptoms, functional requirements, and presence of other illnesses that may complicate treatment.118 Total Knee Arthroplasty Total knee arthroplasty is performed for individuals with a painful, disabling, degenerative joint that is no longer responsive to conservative therapy in order to restore motion of the joint and function to the muscles and ligaments.119 Over 542,000 people undergo this procedure annually.120 The goal of knee replacement is to provide a pain-free knee that allows relatively normal activities and lasts for a long time. To achieve these goals, it is important that the knee implants be inserted with proper positioning. The bones and ligaments are prepared very carefully to allow the knee to be functional and durable. Using the current techniques, 90% to 95% of knee replacements last 15 years or longer. Minimally invasive total knee replacement involves the use of a smaller incision than the one used in traditional knee replacement, which typically averages 8-10 inches in length. In minimally invasive knee surgery, the incision is only 4-6 inches long.121 Because there is less damage to the tissue around the knee, patients who undergo this procedure may expect a shorter hospital stay, a shorter recovery, and improved cosmesis. While there is no doubt that an artificial knee can be implanted through a smaller incision, controversy still exists among surgeons as to whether it can be done as well as with the traditional approach. Today, however, new techniques for opening the knee may be more important than the length of the incision. For example, some techniques are “quadriceps-sparing” because they protect the quadriceps tendon and muscle in the front of the thigh. Other techniques, ie, “mid-vastus” and “sub-vastus” still create small incisions in the muscle but are also less invasive. Several early studies of minimally invasive knee replacement surgery have shown some benefits compared with traditional knee replacement, such as less blood loss, shorter hospital stay, and better motion. However, other studies have shown a higher rate of complications with minimally invasive knee surgery, including poorer positioning of the knee implants.122 Total Hip Arthroplasty123, 124 Total hip arthroplasty is also a common orthopedic procedure, performed on patients with hip pain due to degenerative joint disease, rheumatoid arthritis, or avascular necrosis. Furthermore, as the population ages, it is expected to become even more common to relieve pain and improve mobility. 43 Minimally invasive hip arthroplasty procedures allow the surgeon to replace the hip through one or two small incisions. Candidates for MIPs are typically thinner, younger, healthier, and more motivated to have a quick recovery compared with patients who undergo the traditional surgery. Minimally invasive hip arthroplasty procedures, similar to open procedures, are technically demanding; therefore, they require that the surgeon and operating team have considerable experience. The implants used for minimally invasive hip arthroplasty are the same as those used for traditional hip replacement; however, specially designed instruments are needed to prepare the socket and femur and in order to properly place the implants. The surgical procedure is similar, but there is less soft-tissue dissection. A single minimally invasive hip incision may measure only 3-6 inches, but is dependent upon the size of the patient and the difficulty of the procedure. The incision is usually made over the outside of the hip. The muscles and tendons are dissected, but to a lesser extent than in the traditional hip replacement procedure; these muscles and tendons are routinely repaired after the implants are in place to promote healing and help prevent dislocation of the hip. Two-incision hip arthroplasty involves making a 2-3 inch incision over the groin for placement of the acetabular cup and a 1-2 inch incision over the buttock for placement of the femoral stem. To perform the two-incision procedure, the surgeon may need fluoroscopic guidance; operative time may be longer for this procedure than for traditional hip arthroplasty. The reported benefits of less invasive hip replacement include: • Reduced postoperative pain; • More cosmetic incisions; • Less muscle damage; • Shorter lengths of hospital stay; and • Faster rehabilitation. For traditional hip replacement, the hospital stay averages four to five days. Many patients need extensive rehabilitation afterward. With less-invasive procedures, the hospital stay may be as short as one or two days; some patients may be discharged the day of surgery. EMERGING TECHNIQUES THAT ENHANCE MIPs Technological advancements that support and enhance MIPs have the potential to further revolutionize the practice of surgery in almost every specialty. Since the widespread introduction of minimally invasive techniques in the late 1980s, current trends in surgery are increasingly moving toward minimal access approaches, including reducing both the size as well as the number of access sites. The reduction of the number of trocars, and therefore port site incisions, is one way to minimize the invasiveness of the surgical intervention. Three developing techniques that support MIPs: single site laparoscopy (SSL), natural orifice transluminal endoscopic surgery (NOTES), and robotics are described in greater detail below. 44 Single Site Laparoscopy Single site laparoscopy (SSL) is an innovative approach to MIPs. SSL may also be referred to as laparoendoscopic single site surgery (LESS) and single-port-access (SPA) surgery. Traditional laparoscopic surgery enables surgeons to perform minimally invasive procedures through three to five small incisions in a patient’s abdomen, through which the endoscope and instrumentation are inserted. Single site laparoscopy involves making one small incision (about 2 cm) in the umbilicus area and inserting multiple instruments through a single deployment device. SSL is currently being used in various general surgery (eg, gall bladder, hernia, spleen, colorectal), gynecologic, and urologic procedures.125 While the multidisciplinary applications of SSL are expanding, the potential significance of the technique is yet to be recognized. Safety and efficacy studies of SSL are currently underway in many institutions. The technique has potential incremental advantages over traditional MIS for cosmesis, wound infection, postoperative pain (especially in upper abdominal surgery), and recuperation. Specialized disposable and reusable instruments are being produced to facilitate SSL; however, no major capital expenditures are required. Many advanced laparoscopic procedures are being performed via SSL using traditional laparoscopic instruments, thus keeping costs competitive with those for traditional MIS. Traditional laparoscopic two-handed dissection, ablation, and suturing techniques are also utilized, so surgeon training in SSL should be a much easier transition than that which occurred from open surgery to traditional laparoscopic surgery in the early 1990s. Most procedures are currently being performed using a 5 mm camera trocar and two 5 mm working trocars, all introduced through a single access device in one periumbilical incision. Specialized equipment for SPA surgery falls into two broad categories: access ports and hand instruments. A typical SSL access port consists of two 5 mm seals and a larger 15 mm seal in a low profile design that allows surgeons to use a wide variety of instrumentation (eg, straight, angled, curved) across several different procedures. Some of these devices are available with 360 degree rotation of the seal cap, which enables quick re-orientation of instruments during procedures and reduces the need for instrument exchanges. Standard hand instruments are rigid in design and were developed over the last 30 years for use in laparoscopy. Articulation is designed to overcome one of the challenges inherit in SSL, decreased triangulation of instruments. A number of factors influence a surgeon’s decision to use standard or articulating hand instruments including which access port they use, their own surgical skills, and cost as articulating instruments are significantly more expensive than standard instruments. NOTES126, 127 Another advanced minimally invasive technique is NOTES: natural orifice transluminal endoscopic surgery, in which the surgeon operates almost exclusively through a single entry point, for example, the mouth, vagina, or rectum. This technique, which is presently experimental and being studied at research hospitals and facilities around the world, has the potential for more significant improvements in cosmesis, skin infections, hernias, postoperative pain, and recuperation. NOTES must, however, be distinguished from fully endoluminal, natural orifice surgery (NOS), such as cystoscopic, colonoscopic, 45 transanal, and endoscopic procedures performed within a hollow structure. The NOTES technique, by contrast, is designed to produce an opening in an unrelated organ which must be safely and reliably repaired at the conclusion of the procedure. In NOTES, a highly specialized, sophisticated instrument is passed through an incision in the stomach, vagina, bladder, or colon to access the peritoneal cavity, thus increasing the potential severity of complications as a result of this entry method. Animal studies are underway in many institutions to evaluate the risks of this type of transluminal entry and develop the optimal endoscopic closure technique along with the ideal endoscopic vehicle and instrumentation. It is widely recognized that substantial technological development and years of experience in dedicated centers will be needed to evaluate and perfect the NOTES technique. As the instrumentation evolves, safety and efficacy studies will be needed, followed by extensive outcome studies comparing NOTES results with those for traditional MIS. It is apparent to see why the NOTES technique has the potential to reduce or even eliminate some of the complications associated with surgical and/or invasive procedures. Patients would realize the benefits of less invasive surgery by decreased recovery time; less physical discomfort associated with traditional procedures; and have virtually no visible scarring postoperatively.128 Surgical site infection is always a risk for the surgical patient. The skin is the most common source for bacterial surgical site infections; therefore, clinicians hypothesize that the absence of transabdominal incisions with a NOTES approach may decrease postoperative infections.129 An early NOTES trial following an incompletely closed gastrotomy found an intra-abdominal abscess and suppurative peritonitis, though not involving a skin infection; this highlights the critical significance of the viscerotomy closure.130 Most early animal (swine) NOTES studies do not show a high rate of postoperative intra-abdominal infections; however, the rate of intra-abdominal infection has not been studied in large trials. While abdominal wall infections should not be seen with NOTES procedures, it is not clear whether the overall postoperative infection rate will be decreased. 46 Robotics131, 132 Robotic technology has also transformed MIPs. Robotic systems enhance the surgeon’s dexterity – the use of specialized instruments with increased degrees of freedom greatly improves the surgeon’s ability to manipulate instruments and tissues. Other important advantages include the restoration of proper hand-eye coordination and an ergonomic position. Essentially, a robotic system eliminates the fulcrum effect, thus making instrument manipulation more intuitive. With the surgeon sitting at a remote, ergonomically designed workstation, the systems currently available eliminate the need for him/her to twist and turn in awkward positions in order to manipulate the instruments and/or visualize the monitor. The enhanced vision provided by a robotic system is also noteworthy. The 3-dimensional view with depth perception is a significant improvement over the conventional laparoscopic camera views. Another advantage is the surgeon’s ability to directly control a stable visual field with increased magnification and maneuverability. All of this creates images with increased resolution that, combined with the increased degrees of freedom and enhanced dexterity, greatly enhances the surgeon’s ability to identify and dissect anatomic structures and also to perform microanastomoses. Robotic systems do, however, have some disadvantages, including: • Cost. For many institutions, the startup and ongoing costs of a system may be prohibitive. In addition, the costs associated with system upgrades, depending on how much needs to be updated and how often, may also be significant. For many facilities, in order to justify the purchase of a robotic system, they must gain widespread multidisciplinary use. • Size. A robotic system requires adequate space for the additional equipment and personnel; most systems are relatively large and have somewhat cumbersome robotic arms. This is an important disadvantage in today’s already crowdedoperating rooms. Miniaturizing the robotic arms and instrumentation will address the issues related to their current size. In many cases, larger operating suites with multiple ceiling-mounted booms and wall mountings will be needed to consolidate the equipment and accommodate the additional space requirements of robotic surgical systems. • Lack of compatible instruments. Lack of certain instruments increases the reliance on assistants to perform part of the procedure; however, this is a temporary disadvantage because new technologies continue to be developed to address these shortcomings. • Procedural revisions. Many standardized procedures will need to be revised in order to be adapted to robotic technology. • Learning curve and time required for training. In regard to outcomes, the results of analyses of both cost and safety outcomes associated with robot-assisted laparoscopic hysterectomy were recently reported. In one study, the clinical and economic outcomes (ie, hospital costs) for women over 18 years of age undergoing laparoscopic hysterectomy performed with and without robotic assistance in inpatient and outpatient settings were compared; the association between 47 robot-assisted hysterectomy and adverse events, hospital costs, surgery time, and length of stay were examined.133 Of the 36,188 patient records analyzed from 358 hospitals, 95% (n = 34,527) of laparoscopic hysterectomies were performed without robotic assistance. Inpatient and outpatient settings did not differ substantively in frequency of adverse events. For cardiac, neurologic, wound, and vascular complications, frequencies were less than1% for robot and non-robot procedures. In both inpatient and outpatient settings, use of robotic assistance was consistently associated with statistically significant, higher per-patient average hospital costs: inpatient procedures with and without robotic assistance cost $9,640 versus $6,973, respectively; outpatient procedures with and without robotic assistance cost $7,920 versus $5,949, respectively. Inpatient surgery times were significantly longer for robot-assisted procedures, 3.22 hours compared with non-robot procedures at 2.82 hours. Similarly, outpatient surgery times with robot averaged 2.99 hours versus 2.46 hours for non-robot procedures. These findings reveal little clinical difference in terms of perioperative and postoperative events. This, combined with the increased per-case hospital costs of the robot, suggests that further investigation is warranted when considering this technology for routine laparoscopic hysterectomies. In another prospective matched case-control study at one institution, perioperative data from the initial 40 consecutive total robot-assisted hysterectomies for benign indications were recorded and matched 1:1 with total laparoscopic hysterectomies according to age, body mass index (BMI), and uterus weight.134 Surgical costs were calculated for both procedures. Surgeons’ subjective impressions of robotics were evaluated with a self-developed questionnaire. The results indicated that no conversions to laparotomy or severe perioperative complications occurred. Mean operating time was 109 minutes for the robotic group and 83 minutes for the conventional laparoscopic group. Mean postoperative hospitalization for robotic surgery was 3.3 days versus 3.9 days for the conventional laparoscopic group. The average surgical cost of a robot-assisted laparoscopic hysterectomy was 4067 euros compared to 2151 euros for the conventional laparoscopic procedure at this institution. For the robotic group, wider range of motion of the instruments and better ergonomics were considered to be an advantage, and lack of direct access to the patient was stated as a disadvantage. This study concluded that robot-assisted hysterectomy is a feasible and interesting new technique with comparable outcomes to those of total laparoscopic hysterectomy. Operating times of total laparoscopic hysterectomy seem to be achieved quickly, especially for experienced laparoscopic surgeons. However, the costs of robotic surgery are still higher than for conventional laparoscopy. Therefore, randomized clinical trials need to be conducted to further evaluate benefits of this new technology for patients and surgeons and also analyze its cost-effectiveness in gynecological surgery. 48 SUMMARY Historically, surgery was performed through traditional, open incisions. As a result of the ingenuity and efforts of many pioneering surgeons, minimally invasive surgical techniques were born. Over the past several decades, numerous technological advances have dramatically expanded these approaches since the early, rudimentary endeavors. With the advent of minimally invasive techniques, many procedures in almost every surgical specialty are performed through small incisions and are more effective treatment options for the patient. Today, emerging techniques such as SSL and NOTES offer exciting new treatment options for many patients. Compared to open surgical procedures, MIPs offer distinct benefits for the patient including decreased postoperative pain, less trauma to the tissues, a shorter recovery period and length of hospital stay, and potentially lower risk of infection. Perioperative personnel must continually work to acquire and update the requisite knowledge and skills in order to safely integrate the latest techniques for MIPs into their daily practice. Through the enhancement of technical expertise, the surgical team can assist in the evolution of minimally invasive surgery and maximize the benefits of the latest MIPs to ultimately promote optimal patient outcomes. 49 Glossary Laparoscopy Endoscopic examination of the peritoneal body cavity through a percutaneous access portal, placement of expansion medium to create a working space, and manipulation of intraabdominal organs. Minimally Invasive Procedures (MIPs) Surgical procedures performed through small incisions or the natural orifice using video cameras and specialized instrumentation; often referred to as the laparoscopic approach. Natural Orifice Transluminal Endoscopic Surgery (NOTES) An advanced minimally invasive surgery technique in which the surgeon operates almost exclusively through a single entry point, typically the patient’s umbilicus, mouth, or vagina. Pneumoperitoneum The state of the peritoneal cavity being filled with gas, often induced for diagnostic or therapeutic purposes. Single Site Laparoscopy (SSL) The use of one incision, rather than several incisions, to insert laparoscopic instrumentation. Also referred to as LESS: laparoendoscopic singlesite surgery and SPA: single port access. Trocar A surgical instrument that consists of a sheath with a sharp (or blunt) obturator used to puncture or penetrate multiple layers of tissue. The sheath remains in place as the obturator is removed. Additional instruments are passed through the sheath. 50 References 1. Roumm AR, Pizzi L, Goldfarb NI, Cohn H. Minimally invasive: minimally reimbursed? An examination of six laparoscopic surgical procedures. Surgical Innovation. 2005; 12(3):261-287. 2. Ball KA. Surgical modalities. Alexander’s Care of the Patient in Surgery, 14th ed. St. Louis, MO: Elsevier Mosby; 2011; 205. 3. Roumm AR, Pizzi L, Goldfarb NI, Cohn H. 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