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Original Article Outcomes of Total Laparoscopic Hysterectomy Using a 5-mm Versus 10-mm Laparoscope: A Randomized Control Trial Jade N. Acton, MBBS, MRANZCOG*, Stuart G. Salfinger, MBBS, FRANZCOG, CGO, Jason Tan, MBBS, FRANZCOG, CGO, and Paul A. Cohen, BM BCh, MA, FRANZCOG, MD From the Department of Endoscopy, King Edward Memorial Hospital, Perth, Western Australia, Australia (Dr. Acton), and Department of Gynaecologic Oncology, St. John of God Hospital Subiaco, University of Western Australia, Perth, Western Australia, Australia (Drs. Salfinger, Tan, and Cohen). ABSTRACT Study Objective: To determine if the use of a 5-mm umbilical incision and laparoscope would result in a higher likelihood of earlier discharge from hospital after total laparoscopic hysterectomy (TLH) compared with a 10-mm umbilical incision and laparoscope. Secondary objectives of the study were to determine if the use of a 5-mm laparoscope would lead to a reduction in postoperative pain scores and a shorter operating time without an increase in complication rates. Design: Prospective, randomized, double-blinded, clinical trial (Canadian Task Force classification I). Setting: A tertiary care setting. Patients: Seventy-eight patients scheduled for TLH were prospectively recruited. Interventions: Women undergoing TLH were assigned to either a 5-mm umbilical port and laparoscope (5LH) or a 10-mm umbilical port and laparoscope (10LH). All patients underwent a standardized operative technique and anesthetic protocol. Patients and research assistants responsible for postoperative pain assessment were blinded to group. Analysis was by intention-to-treat. Measurements and Main Results: The primary outcome measure was length of hospital stay. Secondary outcome measures were operating time, pain scores on postoperative days 1 and 7, and complication rates. There was no difference in length of hospital stay between the 2 arms. Compared with the 10LH group, the 5LH group had shorter operative times (32.6 vs 40 minutes; p 5 .01) and less postoperative pain on day 1 (2.5 vs 3.3; p 5 .03 for ‘‘pain with movement’’) and on day 7 (.92 vs 1.8; p 5 .002). Complication rates were similar between the 2 groups. Conclusion: TLH with a 5-mm laparoscope resulted in shorter operative times and less pain on postoperative days 1 and 7, compared with a 10-mm laparoscope, with similar length of stay and complications. Journal of Minimally Invasive Gynecology (2016) 23, 101–106 Crown Copyright Ó 2016 Published by Elsevier Inc. All rights reserved. Keywords: DISCUSS Laparoscopic hysterectomy; Laparoscopy/methods; Mini-laparoscopy; Pain; Port size You can discuss this article with its authors and with other AAGL members at http:// www.AAGL.org/jmig-22-6-JMIG-D-15-00344. Use your Smartphone to scan this QR code and connect to the discussion forum for this article now* * Download a free QR Code scanner by searching for ‘‘QR scanner’’ in your smartphone’s app store or app marketplace. Hysterectomy is the most common gynecologic surgical procedure performed in reproductive-aged women. Every year more than 500 000 hysterectomies are performed in There was no funding for this research. Drs. Salfinger and Tan are paid consultants for teaching purposes by Covidien Health Care. Drs. Acton and Cohen report no conflicts of interest. Corresponding author: Dr. Jade N. Acton, MBBS, MRANZCOG, King Edward Memorial Hospital, PO Box 1617, Subiaco, WA, Australia, 6904. E-mail: [email protected] Submitted June 5, 2015. Accepted for publication September 1, 2015. Available at www.sciencedirect.com and www.jmig.org the United States [1] and approximately 30 000 in Australia [2]. Compared with abdominal hysterectomy, the advantages of a laparoscopic approach include decreased postoperative intravenous analgesia requirements, shorter length of hospital stay, enhanced time to recovery, and faster return to work and daily activities [1]. Longer operating times have been shown to be offset by shorter hospital stays, with similar hospital costs overall [1]. As minimally invasive surgical techniques have evolved, there has been considerable interest in further minimizing the ‘‘invasiveness’’ of procedures. By decreasing the number and/or size of the operating ports and surgical instruments, 1553-4650/$ - see front matter Crown Copyright Ó 2016 Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2015.09.001 102 it is hoped that patient outcomes will improve further. Advances in the manufacture of surgical equipment and fiberoptic technology have led to the development of smaller caliber instruments and improved optics and light sources and the emergence of the concept of ‘‘mini-laparoscopy’’ [3]. Although internationally there has been a trend toward smaller incisions and surgical instruments, research has tended to focus on a reduction in size of the ancillary ports but not the primary port. Several studies in the gynecologic and general surgical literature have shown that minilaparoscopic instruments offer safe alternatives to conventional laparoscopy but have thus far failed to demonstrate a significant decrease in postoperative pain scores [3,4]. We hypothesize that this failure to show improvements in postoperative pain scores after mini-laparoscopy may be attributable to the larger diameter of the primary port used for the laparoscope. The use of a 10-mm transumbilical laparoscope for minimally invasive hysterectomy has been standard practice among laparoscopic gynecologic surgeons in Western Australia. Despite their widespread availability, 5-mm laparoscopes are not routinely used because of a perception that the image quality and definition are inferior compared with 10-mm laparoscopes. We have previously demonstrated that the use of a 5-mm umbilical port resulted in a higher proportion of patients being discharged home after total laparoscopic hysterectomy (TLH) on the first postoperative day compared with patients whose procedure was performed using a 10-mm umbilical port [5]. This was, however, a retrospective analysis and hence subject to potential sources of bias. Our hypothesis was that the use of a 5-mm umbilical incision and laparoscope would result in a higher likelihood of earlier discharge from hospital after TLH compared with a 10-mm umbilical incision and laparoscope. We also hypothesized that the use of a 5-mm laparoscope would lead to a reduction in postoperative pain scores and a shorter operating time without an increase in complication rates. Methods In this prospective randomized trial, patients were recruited between July 1, 2013 and February 28, 2014. There were no changes to the study methodology after trial commencement. Women who were scheduled to undergo a TLH were eligible to participate in the study and were enrolled by one of the authors (S.S. or J.T.). Indications for hysterectomy were early-stage endometrial cancer, microinvasive cervical cancer requiring simple extrafascial hysterectomy, prophylactic risk reduction surgery, complex adnexal masses not deemed to be high risk for malignancy, and dysfunctional uterine bleeding. Exclusion criteria were the need for comprehensive surgical staging of malignant disease, a previous midline laparotomy, and suspected or known severe endometriosis. The trial was conducted in Journal of Minimally Invasive Gynecology, Vol 23, No 1, January 2016 the Department of Gynecologic Oncology at St. John of God Hospital, Subiaco, Western Australia. Our primary outcome measure was length of hospital stay. Secondary outcome measures included pain scores on postoperative days 1 and day 7, operating time, and complication rates. The study sample size was based on detecting a clinically significant reduction in length of hospital stay when the 5mm umbilical port technique was used. Previously published institutional data showed a reduction in length of hospital stay for 5-mm umbilical incisions (38% discharged on day 1; mean length of stay, 1.9 days) when compared with 10mm umbilical incisions (3% discharged day 1; mean length of stay, 3.05 days) [5]. A priori calculations showed a required sample size of 32 patients per trial arm to demonstrate a 30% increase in the discharge rate on day 1 at alpha 5 .05 for 80% power. Patients were randomly assigned to undergo TLH using either a 1-0 mm umbilical incision and laparoscope (10-mm laparoscopic hysterectomy [10LH]) or a 5-mm umbilical incision and laparoscope (5-mm laparoscopic hysterectomy [5LH]). The ancillary ports in both treatment groups were 5 mm in diameter. Randomization was performed on the basis of a block-randomization computer-generated list, with a block size of 6. The surgeon was notified of the allocation in the operating theatre on the morning of the procedure. Patients were blinded to their randomization. The study protocol was approved by the Human Research Ethics Committee at St. John of God Hospital, Subiaco (reference no. 607) and registered with the Australian and New Zealand Clinical Trial Registry (clinical trial no. ACTRN12613000696796). Patients underwent a standardized anesthesia protocol, including induction with propofol (2–3 mg/kg) and fentanyl (1.5 mg/kg), neuromuscular blockade with rocuronium (.5 mg/kg), and maintenance with sevoflurane (.7–2.0% endotracheal concentration) and fentanyl. Increases in blood pressure or heart rate were treated by additional doses of fentanyl (50–100 mg) as required and at discretion of the anesthetist. Dexamethasone 4 mg was given for prophylaxis of postoperative nausea and vomiting. Postoperatively, patients were initially managed with a fentanyl protocol in recovery (20-mg boluses, every 5 minutes as required until discharge from recovery) and regular paracetamol and celocoxib with oxycodone and tramadol as required. Surgery was performed by 1 of 2 gynecologic oncologists (S.S. or J.T.), who had both undertaken laparoscopic fellowships before gynecologic oncology subspecialty training. The same surgical technique was used for both 10LH and 5LH. Instrumentation included graspers, scissors, monopolar electrocautery, and a suction-washing system. Tissue dissection and coagulation was performed with a Ligasure 5-mm device (Covidien, Mansfield, MA). The surgical technique is described in Appendix A. The rectus sheath in patients randomized to the 10LH arm was closed using an interrupted 1.0 synthetic absorbable Acton et al. Outcomes of TLH Using 5-mm vs 10-mm Laparoscope suture (Polysorb; Covidien, Mansfield, MA). The rectus sheath in patients randomized to the 5LH arm was not closed. All skin incisions were closed subcutaneously with a 3.0 synthetic absorbable suture (Caprosyn; Covidien, Mansfield, MA). Patients, research assistants, and nursing staff responsible for pain assessment and recording pain scores were blinded to which group randomization had occurred, and the patients’ wounds were concealed by standard-size nontransparent dressings. The blinded research assistants assessed patients each day for discharge, and the discharge time was recorded. Postoperative pain was rated on day 1, at rest, on movement, and at the umbilicus and on day 7 using a 100-mm visual analogue scale with anchors of no pain and worst possible pain. Quality of life was measured at 6 weeks using an EQ-5D-5L quality of life instrument (Appendix B). Intraoperative complications were defined as any event that required additional surgical procedures to be performed, including repair of iatrogenic visceral injury and hemorrhage requiring blood transfusion. Postoperative complications included febrile episode, urinary voiding difficulties or urinary tract infection, wound infection, vault hematoma, venous thrombosis, sepsis, return to the operating room, and hospital readmission after discharge. Fig. 1 Flow of participants through the randomized clinical trial. 103 Statistical analysis of outcomes data was performed with GraphPad (GraphPad Software, San Diego, CA). A 2-sided paired t test was used to compare continuous variables. Fisher’s exact test was used to analyze proportions. Results were analyzed by intention-to-treat. Results Seventy-eight patients were enrolled in the study. Forty women were randomly assigned to the 10LH group and 38 to the 5LH group. Two patients were excluded from the 5LH group because of breaches in the anesthetic protocol. Flow of participants through the randomized clinical trial is displayed in Figure1. No patients were lost to follow-up. The demographics and baseline characteristics of the participants were comparable between groups (Table 1). The procedures in both groups were distributed evenly between both operating physicians. Perioperative outcomes are summarized in Table 2. The 2 groups had comparable uterine size, adhesions, and estimated blood loss. There were no intraoperative complications or conversions to laparotomy in either group. The operating time (taken as the time from the first skin incision to closure of the final skin incision) in the 5LH group was nearly 8 minutes shorter than in the 104 Journal of Minimally Invasive Gynecology, Vol 23, No 1, January 2016 Table 1 Table 3 Baseline characteristics Discharge time 5LH group (n 5 36) 10LH group (n 5 40) Median age, yr (range) 51.5 (32–83) 54 (35–77) 26.9 (19–40) 27.0 (20–39) BMI, kg/m2 Obese (BMI . 30) 13 (36%) 10 (25%) Menopause 19 (52%) 23 (58%) Parity (range) 2 (0–4) 2 (0–4) Previous abdominal surgery 17 (47%) 12 (30%) Previous cesarean section 9 (25%) 6 (15%) Indication for surgery DUB 8 (22%) 5 (12.5%) Early endometrial cancer 8 (22%) 8 (20%) High-grade cervical dysplasia 4 (11%) 4 (10%) Adnexal disease 4 (11%) 8 (20%) Risk reduction 12 (33%) 15 (37.5%) p .92 .51 .39 .68 .31 .12 .28 .40 5LH 5 5-mm laparoscopic hysterectomy; 10LH 5 10-mm laparoscopic hysterectomy; BMI 5 body mass index; DUB 5 dysfunctional uterine bleeding. 10LH group (32.6 vs 40 minutes; p 5 .01). No patients in the 5LH group required conversion of their 5-mm umbilical port to a larger port to facilitate completion of the procedure. There were no intraoperative complications in either group and no statistical difference in postoperative complications. Length of hospital stay is shown in Table 3. There was no significant difference between the 2 groups in the proportion 10LH group (n 5 40) p 24 (67%) 1.36 6 .53 24 (60%) 1.425 6 .54 .55 .61 34 (22–48) 34.6 (20–70) .81 5LH 5 5-mm laparoscopic hysterectomy; 10LH 5 10-mm laparoscopic hysterectomy. of patients discharged on the first postoperative day or in the length of hospital stay. Pain scores recorded in each group are shown in Table 4. There was a significant reduction in postoperative pain on movement on day 1 (2.5 vs 3.3; p 5 .03) in the 5LH group but no difference in pain at rest or pain localized at the umbilicus. There was a significantly lower pain score on day 7 in patients in the 5LH group (.92 vs 1.8; p 5 .002) compared with patients in the 10LH group. There was no difference between the 2 groups in the overall quality of life score or the individual components of the quality of life instrument at 6 weeks. Discussion Main Findings In this double-blind, randomized, controlled trial of the use of a 5-mm versus 10-mm laparoscope for TLH, there Table 2 Perioperative outcomes Operative time, min Procedure performed TLH TLH 1 USO TLH 1 BSO Uterine weight, g (range) Adhesiolysis/uterine debulking required Intraoperative complications Estimated blood loss, mL (range) Postoperative complications No. discharged by 24 hr Mean discharge day average 6 standard deviation Median discharge hours postoperative (range) 5LH group (n 5 36) Table 4 Pain scores and quality of life 5LH group (n 5 36) 10LH group (n 5 40) 32.6 6 10.2 40 6 13.54 11 1 24 117.5 (57–680) 8 (22%) 11 0 29 118 (70–487) 8 (20%) .76 .86 0 42 (0–100) 0 50 (25–100) .13 3 (8%)* 4 (10%)y .88 p .01 .98 Day 1 pain score Rest Movement Umbilicus Day 7 pain score Quality of life (/100) Mobility* Personal care* Usual activities* Pain/discomforty Anxiety/depressiony 5LH group (n 5 36) 10LH group (n 5 40) p 1.77 6 1.77 2.5 6 1.62 .92 6 1.72 .92 6 1.72 85.1 6 11.2 1.06 6 .32 160 1.08 6 .27 1.17 6 .37 1.11 6 .46 1.95 6 1.93 3.33 6 1.67 .625 6 .86 1.8 6 1.32 85.2 6 9.52 1.03 6 .15 160 160 1.1 6 .3 1.05 6 .22 .68 .03 .35 .002 .97 .61 1 .06 .40 .45 5LH 5 5-mm laparoscopic hysterectomy; 10LH 5 10-mm laparoscopic hysterectomy; TLH 5 total laparoscopic hysterectomy; USO 5 unilateral salpingo-oopherectomy; BSO 5 bilateral salpingo-oopherectomy. 5LH 5 5-mm laparoscopic hysterectomy; 10LH 5 10-mm laparoscopic hysterectomy. Values are means 6 standard deviations, medians with ranges in parentheses, or number of cases with percents in parentheses. * Two vault hematomas, 1 wound infection. y Four vault hematomas. Values are means 6 standard deviations. * Scale: 1 5 no problems, 2 5 slight problems, 3 5 moderate problems, 4 5 severe problems, 5 5 unable to perform. y Scale: 1 5 nil, 2 5 slight, 3 5 moderate, 4 5 severe, 5 5 extreme. Acton et al. Outcomes of TLH Using 5-mm vs 10-mm Laparoscope was no difference in length hospital of stay or complication rates between the 2 groups. Patients in the 5LH group had shorter operative times and less pain on postoperative days 1 and 7. Our findings differ from an earlier retrospective study conducted at our institution that showed a significantly longer length of hospital stay in patients whose TLH was performed using a 10-mm laparoscope (3.05 days for 10mm umbilical incision in the earlier study vs 1.43 days for the 10-mm port in this trial) [5]. It is conceivable that selection bias inherent in retrospective observational studies may account for the observed difference in outcomes compared with the current trial. Strengths and Limitations The strengths of our study are its prospective, randomized participant and research assistant blinded design. Discharge times are difficult to accurately capture, and it has been shown that these are influenced by multiple factors, including availability of an escort, nursing shortages, and delays in supplying discharge medications [6]. It is conceivable that some of these factors may have confounded our results. Our study has several limitations. Capturing the return of postoperative patients to their normal activities as well as measuring the postoperative use of analgesia may have added important clinical information, and it is a weakness of our study that these were not included. Participants’ comorbidities, including preoperative chronic pain, substance abuse, or potentially pain-modifying diseases such as diabetes mellitus with microvascular complications or peripheral neuropathy, were not recorded, and this may have confounded our results. Our study is also limited by its relatively small sample size. Interpretation (in Light of Other Evidence) Previous studies have examined the effects on pain scores of using smaller size ancillary ports, but the results of these studies have been conflicting [3,4,7–9]. Only 1 other randomized trial has compared mini-laparoscopic total hysterectomy with conventional TLH [3]. In this study by Ghezzi et al [3], 76 women were randomized to either mini-laparoscopic hysterectomy or to conventional laparoscopic hysterectomy for the treatment of presumed benign pathology at a single tertiary hospital. The primary outcomes were postoperative pain at 1, 3, 8, and 24 hours, and there was no significant difference in outcomes between the 2 treatment groups. Secondary outcomes included length of hospital stay, estimated blood loss, and decrease in hemoglobin concentration, all of which did not differ between the 2 treatment arms. However, the authors were comparing the use of 5-mm umbilical and ancillary ports (conventional laparoscopic hysterectomy) with 3-mm umbilical and ancillary ports (mini-laparoscopic hysterectomy), which may 105 account for the observed similarities in postoperative pain scores between the 2 treatment arms and for the difference in outcomes observed in our study. In the general surgical literature, results of randomized trials comparing the use of 3-mm or 5-mm ports and instruments with standard laparoscopic procedures have been conflicting. Although some have shown decreased postoperative pain [7–9], others have failed to show any significant differences in postoperative pain, length of hospital stay, or recovery time [10,11]. Other studies have demonstrated that reducing the size or even number of ports in a laparoscopic cholecystectomy significantly reduced postoperative pain [7,8]. It is difficult to compare results from general surgical trials to gynecologic laparoscopy studies for 2 reasons. First, many of these studies used at least one 10-mm or 12-mm port with smaller ancillary ports, and the larger incision may have influenced the postoperative pain scores. Second, in laparoscopic cholecystectomies or appendectomies the specimens are removed through 1 of the abdominal port sites, which may exacerbate postoperative pain at that site. Although we have demonstrated a significant reduction in postoperative pain with the use of a 5-mm umbilical port, it is uncertain whether this difference is clinically meaningful because the pain scores in both treatment groups were low and there was no difference in length of hospital stay between the 2 study arms. The increased pain score on movement in the 10LH group may be attributable to the rectus sheath suture, although pain at the umbilicus did not differ between the 2 groups. It is also conceivable that confounding factors such as differences in postoperative analgesia or pre-existing comorbidities between the study arms may have accounted for these findings. This rectus sheath suture is clinically important to reduce the risk of hernia formation [12]. A survey by the American Association of Gynecologic Laparoscopists demonstrated that 86.3% of all trocar site hernias occurred in sites where the ports were at least 10 mm [12]. Studies have shown that the closure of a fascial defect because of a 12-mm trocar significantly decreased the rate of developing a hernia at the site (.22%), when compared with leaving it open (8%) [13]. The incidence of herniation through a 5-mm port is much lower, comprising only 2.7% of all trocar site hernias, and thus closure is not routinely recommended [13,14]. Our study was not powered to detect a decrease in umbilical hernias between the 2 treatment groups, and this is an important area for future research. We have also demonstrated a significant difference in the operating time, with procedures in the 5LH group being an average of 7.4 minutes faster than those in the 10LH group. This may be due to the additional time required to close the umbilical port in the 10LH group. However, it is possible that other patient-specific or operating room factors may have accounted for part of the observed difference 106 Journal of Minimally Invasive Gynecology, Vol 23, No 1, January 2016 in operating times. The reduced operating time in the 5LH group may have significant benefits for operating theatre utility, especially when several TLHs are scheduled on the same operating list and may have significant cost benefits. Conclusion In summary, in this blinded, randomized, controlled trial comparing the use of a 5-mm versus 10-mm umbilical port and scope for laparoscopic hysterectomy, we found that the 5LH group had shorter operative times and a decrease in pain on postoperative days 1 and 7, with similar length of stay and complications. It is not clear if the observed difference in pain scores is clinically meaningful because the pain scores in both treatment groups were low and there was no difference in length of hospital stay between the 2 study arms. Our findings suggest that concerns about poor visualization with a 5-mm endoscope may be unfounded and that laparoscopic hysterectomy with a 5-mm scope is feasible with equivalent outcomes. Supplementary Data Supplementary data related to this article can be found at 10.1016/j.jmig.2015.09.001. References 1. Paraiso MFR, Ridgeway B, Park AJ, et al. A randomized trial comparing conventional and robotically assisted total laparoscopic hysterectomy. Am J Obstet Gynecol. 2013;208:368. 2. Hill EL, Graham ML, Shelley JM. Hysterectomy trends in Australiadbetween 2000/01 and 2004/05. Austral N Z J Obstet Gynaecol. 2010;50:153–158. 3. Ghezzi F, Cromi A, Siesto G, et al. Minilaparoscopic versus conventional laparoscopic hysterectomy: results of a randomized trial. J Minim Invasive Gynecol. 2011;18:455–461. 4. Nomura H, Okuda K, Saito N, et al. Mini-laparoscopic surgery versus conventional laparoscopic surgery for patients with endometriosis. Gynecol Minim Invasive Ther. 2013;2:85–88. 5. Acton J, Salfinger S. Effect of umbilical port and endoscope size on discharge times and postoperative recovery after total laparoscopic hysterectomy: a retrospective review. J Gynecol Surg. 2014;30.5:273–275. 6. Pavlin DJ, Rapp SE, Polissar NL, et al. Factors affecting discharge time in adult outpatients. Anesth Analg. 1998;87:816–826. 7. Leggett P, Churchman-Winn R, Miller G. Minimizing ports to improve laparoscopic cholecystectomy. Surg Endosc. 2000;14:32–36. 8. Bisgaard T, Klarskov B, Trap R, et al. Microlaparoscopic vs conventional laparoscopic cholecystectomy. Surg Endosc Other Intervent Techn. 2002;16:458–464. 9. Novitsky YW, Kercher KW, Czerniach DR, et al. Advantages of minilaparoscopic vs conventional laparoscopic cholecystectomy: results of a prospective randomized trial. Arch Surg. 2005;140:1178–1183. 10. Cheah W, Lenzi J, So J, et al. Randomized trial of needlescopic versus laparoscopic cholecystectomy. Br J Surg. 2001;88:45–47. 11. Lau DH, Yau KK, Chung CC, et al. 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