Original Article
Multi-institution, Prospective, Randomized Trial to Compare the Success Rates of Single-port Versus Multiport Laparoscopic Hysterectomy for the Treatment of Uterine Myoma or Adenomyosis Tae-Joong Kim, MD1, So-Jin Shin, MD, PhD1, Tae-Hyun Kim, MD, Chi-Heum Cho, MD, PhD*, Sang-Hoon Kwon, MD, PhD, SeokJu Sung, MD, PhD, Taejong Song, MD, Sooyoung Hur, MD, PhD, Yong-Man Kim, MD, PhD, Shin-Wha Lee, MD, PhD, Young Tae Kim, MD, PhD, Eun Ji Nam, MD, PhD, Yong Beom Kim, MD, PhD, Jung Ryeol Lee, MD, PhD, Hyun-Jin Roh, MD, PhD, and Hyewon Chung, MD From the Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine (Drs. T.-J. Kim, T.-H. Kim), Seoul, Korea, Keimyung University School of Medicine (Drs. Cho, Kwon, Shin, and Chung), Daegu, Korea, CHA Gangnam Medical Center, CHA University (Drs. Sung and Song), Seoul, Korea, The Catholic University of Korea, Seoul St. Mary’s Hospital (Dr. Hur), Seoul, Korea, University of Ulsan College of Medicine, Asan Medical Center (Drs. Y.-M. Kim and S.-W. Lee), Seoul, Korea, Yonsei University College of Medicine, Severance Medical Center (Drs. Y. T. Kim and Nam), Seoul, Korea, Seoul National University Bundang Hospital (Drs. Y. B. Kim and J. R. Lee), Seongnam, Korea, and College of Medicine, University of Ulsan, Ulsan University Hospital (Dr. Roh), Ulsan, Korea.
ABSTRACT Study Objective: To compare the operative outcomes of patients undergoing either single-port or multiport laparoscopic hysterectomy (LH). Methods: Two hundred fifty-six women scheduled for LH for symptomatic myoma and/or adenomyosis from 8 tertiary teaching hospitals were randomized to single-port or multiport groups. Primary outcome was conversion and/or complication proportion of the planned procedure to determine whether the success proportion of the single-port approach was not inferior to that of the multiport approach. Secondary outcomes were postoperative pain and operative scar. Results: Demographic parameters including age, body mass index, parity, and history of vaginal and cesarean delivery were comparable between the 2 groups. The primary outcome of a combined conversion and/or complication rate was similar between the single-port and multiport groups at 8% and 10.3%, respectively. Conversions were similar between the groups with 4% of single-port cases and .8% of multiport cases. Transfusions were the most frequent complication required in 4.0% of single-port cases and 7.9% of multiport cases, with no difference between the groups. Concerning secondary outcomes, postoperative pain score and patient and observer scar assessment were not different between the 2 groups. Although not a specific outcome measure, there was no difference between the groups in blood loss, operative time, and postoperative hospital stay. Conclusion: Single-port LH is not inferior to multiport LH in terms of conversion and/or complications rates, including transfusion. However, the single-port approach did not have any advantage over multiport LH with regard to pain or cosmetic outcomes. These findings were demonstrated by multi-institutional surgeons in Korea. Journal of Minimally Invasive Gynecology (2015) -, -–- Ó 2015 AAGL. All rights reserved.
This independent research was supported by a funding contribution from Covidien. The authors declare no competing interests. 1
Both authors contributed equally to this article.
Corresponding author: Chi-Heum Cho, MD, PhD, Department of Obstetrics and Gynecology, Keimyung University, School of Medicine, 56 Dalseong– ro, Jung-gu, Daegu 700-712, Republic of Korea. 1553-4650/$ - see front matter Ó 2015 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2015.02.022
E-mail: [email protected] Submitted January 14, 2015. Accepted for publication February 28, 2015. Available at www.sciencedirect.com and www.jmig.org
Journal of Minimally Invasive Gynecology, Vol -, No -, -/- 2015
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Keywords:
DISCUSS
Laparoendoscopic single-site surgery; Laparoscopic hysterectomy; Single-port; Randomized clinical trial
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Laparoscopic hysterectomy (LH) has been shown to have many advantages over open hysterectomy, such as less pain, faster recovery, shorter hospital stay, and better cosmesis [1]. Recently, single-incision laparoscopic surgery (SILS) or laparoendoscopic single-site surgery was introduced to maximize these advantages by reducing the number of incisions to 1 umbilical incision. Three randomized controlled trials of LH have been performed to compare the surgical outcomes of patients who underwent conventional multiport LH or single-port LH [2–4]. These studies reported that the operative outcomes of single-port LH are comparable with those of multiport LH. However, less pain, which is a potential benefit of a single-port approach, was not proved consistently in these trials. In addition, better cosmetic outcome was not validated in all trials. These studies had limitations of being conducted at a single institution with small sample sizes. Although single-port LH is technically feasible, with comparable outcomes, and shows some benefits compared with the multiport approach in the literature [2–7], many gynecologic laparoscopists have yet to adopt the singleport approach for LH. Therefore, we designed a multiinstitutional, prospective randomized trial involving novices and experts in SILS to compare the operative outcomes when using these 2 approaches to treat symptomatic uterine myoma or adenomyosis. Primary outcome was conversion and/or complication proportion of the planned procedure to determine whether the success rate of single-port LH was not inferior to that of the conventional multiport LH approach. Secondary outcomes were postoperative pain measured by numeric rating score (NRS) on postoperative day 1 and week 1 and operative scar measured by patient and observer scar assessment scale (POSAS) at postoperative week 1 and at 2 months. Methods This randomized trial was performed from December 2011 to April 2013 in 8 Korean university hospitals that serve as teaching centers. Inclusion criteria were elective patients between ages 20 and 60 years with symptomatic myomas or adenomyosis such as dysmenorrhea, pelvic pain or discomfort, urinary symptoms, and a palpable mass of increasing size or menorrhagia for a duration of at least 2 months. Exclusion criteria included a uterine size . 18 gestational weeks by pelvic examination and those at risk of surgical complications due to an underlying medical
disease such as heart failure, renal insufficiency, liver cirrhosis, pancreatitis, or uncontrolled diabetes. Patients were included after giving informed consent to a protocol approved by the Institutional Review Board (clinicaltrials. gov; NCT01483417). Patients were randomized in a 1:1 ratio to either the single-port or multiport LH treatment groups. Treatment allocation was determined by a computer-generated randomization schedule with random block sizes (2–6) and was stratified by institution. Treatment assignments were placed in sequentially numbered, opaque, sealed envelopes that had been prepared earlier by a third party. Envelopes were opened on the morning of surgery. Randomization could not be blinded for either patients or surgeons because the same surgeons conducted the postoperative evaluations. Fourteen surgeons with experience in more than 100 multiport LH procedures each, and considered experts, participated in this study. Only 5 surgeons among these 14 had experience in greater than 50 single-port LH at the time of the study. Assisting surgeons were obstetrics and gynecology residents. On an individual surgeon level, SILS was performed using a similar technique to that used for multiport LH, except that a single umbilical incision was used. A SILSÔ port (Covidien, New Haven, CT) was used with a 2- to 2.5-cm transumbilical incision. Multiport was defined in this study as using 3 or 4 trocars ranging from 5 to 12 mm in size (Covidien). The 14 participating surgeons did not standardize their LH technique but followed the American Association of Gynecologic Laparoscopists (AAGL) classification system based on their preferred approach (Table 1) [8]. Postoperative care was also not standardized and was prescribed according to each institution’s policies. The primary outcome measure was conversion and/or complication proportion of the planned procedure. The definition of conversion was either the placement of any additional port(s) to what was originally planned or conversion to open hysterectomy. Complications included injury to adjacent organs, fever (.38 C) lasting . 24 hours, port site problem, vault problem, need for transfusion, and other adverse events up to 2 months postoperatively. Secondary outcomes were postoperative pain and cosmetic scar satisfaction. Postoperative pain was assessed using the pain intensity score and the amount of analgesics taken. Patients rated postoperative pain intensity using an NRS on postoperative day 1 and week 1. The scale was presented as a 10-cm line with verbal descriptors ranging from
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Table 1
Fig. 1
AAGL classification system for LH
Patient allocation and follow-up.
Type
Laparoscopic component of hysterectomy
0
Laparoscopic-directed preparation for vaginal hysterectomy, including adhesiolysis and/or excision of endometriosis. Occlusion and division of at least 1 ovarian pedicle, utero-ovarian ligament, or infudinbulopelvic ligament, but not the uterine artery. Type I plus occlusion and division of 1 or both uterine arteries. Type II plus a portion, but not all, of the cardinaluterosacral ligament complex, unilateral or bilateral. Complete detachment of the cardinal-uterosacral complex, unilateral or bilateral, with or without entry into the vagina. Includes TLH.
I
II III IV
‘‘no pain’’ to ‘‘pain as bad as it could be.’’ According to the postoperative pain management protocol at each institution, intravenous patient-controlled analgesia (PCA) could be used. For cosmetic scar satisfaction, we used the POSAS as a measurement tool [9], which is composed of 6 questions for patients and 5 questions for the observer. The sum of patient and observer points was compared on postoperative week 1 and at 2 months. The higher the combined patient and observer score, the less satisfactory the cosmetic scar result, with a worse combined score of 110. Statistics Baseline characteristics of the patients, intraoperative and postoperative outcomes, postoperative pain, and scar stratification were analyzed. Continuous variables were compared using the Mann-Whitney U test or 2-sample t test. The Fisher’s exact test or the c2 test was used for categorical variables, according to the size of the expected frequency. Significance was determined at p , .05. Primary and secondary outcomes were analyzed according to the original treatment assignment (intent to treat). The hypothesis in the present study was that the rate of conversion and/or complications with single-port LH was not inferior to that of multiport LH. Complication rates including conversions were assumed to be 15% in conventional multiport LH and similar in the single-port LH group. We conducted the noninferiority comparison test using a 90% confidence interval (CI) for the difference in conversion and/or complication rate between the 2 groups. We defined a prespecified noninferiority margin of .2; thus, if the upper boundary of the 90% CI for the difference in conversion and/or complication rate was no more than 20%, we would regard the SILS approach to be noninferior to the multiport approach. This study planned to include 128 participants in each group with the assumption of a 10% dropout rate. Analysis was based on SAS version 9.3 (SAS Institute, Cary, NC).
Results Of the 256 patients randomized for the study, 251 received either single-port LH or multiport LH (Fig. 1). All patients received their intended treatment. Table 2 shows a breakdown by institution concerning the number of patients enrolled in the study, the type of LH performed by single-port or multiport approach based on the AAGL classification system, and the number and size of multiports used. Three patients in the single-port group and 2 in the multiport group withdrew from the study before surgery but after randomization. The 2 groups were similar with respect to age, body mass index, parity, mode of previous delivery, and history of previous abdominal surgery. Operating times, uterine weight, estimated blood loss, and postoperative hospital stay were not different between the 2 groups (Table 3). Two patients (1.6%) with severe adhesions in the posterior cul de sac undergoing a SILS approach were converted to open laparotomy. In addition, 3 patients (2.4%) in the SILS group had an additional 5-mm port placed in the lower abdomen to improve visualization and facilitate dissection. One patient (.8%) undergoing a multiport approach required 1 additional port because of the discovery of dense and diffuse adhesion. There was no difference between the 2 groups in conversion rates (Table 4). There were a total of 6 complications (4.9%) in the intraoperative and postoperative period after single-port LH, compared with 13 (10.3%) in the multiport LH group, with no differences between groups (Table 4). The breakdown of complications included 5 (4.0%) in the SILS group and 10 (7.9%) in the multiport group requiring transfusions during the intraoperative and/or postoperative period. Wound disruption of the umbilical single-port site occurred after postoperative day 10 in 1 patient (.8%). The umbilical
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Table 2 Participating institutions with enrolled patients and their techniques for LH as classified by the AAGL system Institution
n
Single-port
Multiport (ports used)
Asan Medical Center CHA Gangnam Medical Center Keimyung University Samsung Medical Center Seoul National University Bundang Hospital Seoul St. Mary’s Hospital Severance Medical Center Ulsan University Hospital
30 40 86 30 10 (6)y 5 (4)y 40 15
I I, IV* III IV IV IV IV I
I (two 5 mm, one 12 mm) I, III (one 5 mm, two 12 mm)* III (two 5 mm, two 12 mm) IV (three 5 mm) IV (three 5 mm) IV (two 5 mm, two 12 mm) IV (four 5 mm) I (two 5 mm, one 12 mm)
* Two participating surgeons’ techniques were different. y Four patients at Seoul National University and 1 at Seoul St. Mary’s Hospital dropped out of the study before surgery but after enrollment.
wound was disrupted for a length of approximately 5 mm but did not show swelling, redness, bleeding, or pus-like discharge; the wound was conservatively managed with betadine dressing and oral antibiotics. In the multiport LH group, 1 patient (.8%) experienced ureter injury during the operation. A double J catheter was inserted after repairing the ureter, and the patient stayed in the hospital until postoperative day 13 for observation. The double J catheter was removed 8 weeks after hospital discharge without any sequelae. One multiport LH patient (.8%) developed fever . 38 C on the day of operation. The fever was normalized after administration of intramuscular diclofenac 75 mg and application of an icepack. Another multiport LH patient (.8%) was readmitted at postoperative day 10 because of abdominal pain. She was diagnosed as having peritonitis by computed tomography
scan and physical examination in the emergency room and treated with intravenous antibiotics after readmission. Another patient in the multiport LH group (.8%) developed vulvar ecchymosis on postoperative day 2 and was transfused with packed red blood cells because of a hemoglobin level of 6.3 g/dL. Her hospital stay was prolonged to 9 days for observation with medication for pain control. A final multiport LH patient (.8%) developed a hematoma at a lower abdominal port site on postoperative day 2. Although an ultrasonogram did not show any intra-abominal hematoma, the patient was transfused with packed red blood cells because of a hemoglobin level of 8.3 g/dL. She remained in the hospital until postoperative day 4. The first primary endpoint was the proportion of conversion and/or complication. Ten patients (8.0%) in the singleport group and 13 (10.3%) in the multiport group underwent
Table 3 Demographic data and operative variables of the study population (n 5 251)
Median age, yr (range) Median body mass index, kg/m2 (range) Median parity (range) Vaginal delivery Previous cesarean section Previous abdominal surgery Diagnosis on pathology Adenomyosis Leiomyoma Adenomyosis and leiomyoma Endometrial polyp* Median operative time, min (range) Median uterine weight, g (range) Median estimated blood loss, mL (range) Median postoperative hospital stay, days (range)
Single-port (n 5 125)
Multiport (n 5 126)
p value
47 (28–60) 23.4 (17.1–35.8) 2 (0–4) 89 (71.2) 37 (29.6) 26 (20.8)
47 (35–54) 23.4 (18.0–33.3) 2 (0–4) 85 (67.5) 42 (33.3) 24 (19.0)
.68 .88 .46 .59 .59 .75 .11
32 (25.6) 65 (52.0) 27 (21.6) 1 (.8) 80 (30–250) 280 (65–1380) 100 (10–1200) 3 (2–7)
Values are total number of cases, with percents in parentheses, unless otherwise specified. * One patient presumed to have a submucosal myoma was revealed to have an endometrial polyp on final pathology.
34 (27.0) 77 (61.1) 15 (11.9) 0 69.5 (25–240) 298 (60–750) 150 (10–700) 3 (2–13)
.22 .23 .98 .45
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Table 4
Table 5
Conversion and complication(s) between groups (n 5 251)
Comparison of postoperative pain and scar cosmesis evaluation
Single-port (n 5 125) Conversion Additional port(s) Open laparotomy Presence of complications Transfusion (intraoperative/ immediately postoperative) Ureter injury Fevery Port site problem Wound disruption Hematoma Vulvar ecchymosis Peritonitis
5 (4.0) 3 (2.4) 2 (1.6) 6 (4.9) 5 (4.0)
Multiport (n 5 126) 1 (.8) 1 (.8) 0 13* (10.3) 10 (7.9)
0 0 1 (.8) 0 0 0
1 (.8) 1 (.8) 0 1 (.8) 1 (.8) 1 (.8)
Values in parentheses are percents. * Two patients with port site hematoma or vulvar ecchymosis, respectively, also underwent transfusion. The total number of patients with complications in the multiport group was 13. y Fever over 38 C lasting over 24 hours.
between groups (n 5 249)
Use of additional pain killer (n) NSAIDs Opioids PCA use on operation day, n (%) Pain score after 24 hours PCA use after 24 hours, n (%) Pain score at first OPD visit POSAS score at first OPD visit Patient’s score Observer’s score POSAS score at second OPD visit* Patient’s score Observer’s score
Single-port (n 5 123)
Multiport (n 5 126)
p value
1 (0–6) 0 (0–2) 97 (78)
1 (0–6) 0 (0–2) 100 (79)
.48 .14 .73
3 (0–9) 76 (62) 1 (0–5) 14 (11–62) 8 (5–28) 6 (5–45) 11 (11–35)
3 (0–9) 84 (67) 1 (0–6) 14 (11–57) 8 (5–27) 6 (5–37) 11 (11–57)
.76 .43 .41 .93 .90 .67 .65
6 (6–21) 5 (5–15)
6 (6–20) 5 (5–37)
.81 .39
NSAIDs 5 nonsteroidal anti-inflammatory drugs; OPD 5 outpatient department. Values are medians with ranges in parentheses unless otherwise specified. * At the 2-month evaluation, 1 patient in the SILS-port group and 5 patients in the multiport group were lost to follow-up. POSAS score and complication rate at the second OPD visit were therefore evaluated in 122 and 121 patients, respectively.
conversion and/or experienced complications with no difference between groups. As described in Table 4, procedure conversion was required in 5 patients in the single-port group and complications occurred in 6 single-port LH patients, with 1 patient requiring a conversion and also experiencing a complication, for a total of 10 patients (8.0%). Two of the 5 converted single-port patients refused participation in the postoperative pain and POSAS assessment. In the multiport LH group, of the 13 patients who developed a complication, 1 patient also required a procedure conversion, for a total of 13 patients (10.3%). The difference in total conversion and/or complication proportion between the 2 groups was .0232 (90% CI, 2.0367 to .083). The upper limit of the 90% CI (.083) was less than the noninferiority margin (.2). Therefore, we inferred that LH performed using a single-port technique is noninferior to a multiport LH. The intensity of postoperative pain did not differ significantly between the groups (Table 5), either at 24 hours after the operation or at postoperative week 1. Median pain score measured by NRS was 3 points at postoperative 24 hours and 1 point at postoperative week 1 in both groups. The use of intravenous PCA was also not different between the 2 groups, with almost 80% of patients in both groups consenting to PCA administration and with no difference in the number of additional parenteral analgesic drugs used for pain relief during the postoperative period. Analysis of scar satisfaction after surgery revealed no difference between the 2 groups (Table 5). In both groups, the scar satisfaction measured by POSAS improved slightly over time. At 1 week after surgery, POSAS scored 14 for each group, representing only 12.7% of the highest worst
combined patient and observer score of 110. At 2 months after surgery, POSAS scored 11 for each group, representing only 10% of the highest worst combined score. Overall scar satisfaction was excellent, with no difference between the groups during follow-up.
Discussion The present study was a large, multi-institutional, prospective randomized trial involving novices as well as experts in SILS as primary surgeons in the field of gynecology. To our knowledge, this is the first multi-institutional randomized trial of LH in which 14 surgeons at 8 hospitals participated. We therefore expect the results from this trial to confirm or update the findings of previous studies [2–4]. The results showed single-port LH is not inferior to multiport LH in terms of conversion and/or complications. However, the single-port approach did not have any advantages in terms of pain or cosmetic outcomes. These findings are consistent with a meta-analysis of randomized controlled trials in gynecology conducted by Song et al in 2013 [10]. Before this study, multiple institutions in Korea were evaluated, and 8 Korean university hospitals that serve as teaching centers were selected. There was no significant difference of demographic data and operative variables between institutions in our preliminary study. Several LH techniques with variations in the extent of the laparoscopic contribution to the procedure have been
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described. Generally, LH can be subcategorized into laparoscopically assisted vaginal hysterectomy (LAVH), or total LH (TLH), depending on the extent of the surgery performed either laparoscopically or vaginally [11]. LH techniques can also be described using the AAGL classification system [8]. LH techniques were not standardized in this study (Table 2) for the following reasons. First, standardization of surgical techniques at multi-institutions is not easy in practice. Second, we sought to compare the operative outcomes of patients undergoing either SILS or multiport LH in a practice setting, regardless of LH techniques. Third, previous randomized trials have shown inconsistent results in terms of the potential advantages of SILS regardless of surgical technique. Chen et al [3] reported less pain associated with single-port LAVH than with multiport LAVH, whereas Song et al [4] did not show any pain score advantage with single-port LAVH. Jung et al [2] compared single-port versus multiport TLH and did not show any difference in pain scores. We included both TLH and LAVH in our study to evaluate types I to IV LHs on the AAGL classification system. The study was not powered to conduct a subgroup analysis by AAGL LH classification; however, it was run for LAVH and TLH cosmesis, and there was no difference between single-port LH and multiport LH. The demographic profile of participants included in this study was similar to that of patients included in previous randomized trials (Table 3) [2–4]. For example, 31% of participants had a history of cesarean delivery, which is very similar to previous trials. Although the uterine size calculated by uterine weight in this study was larger than that reported in the studies by Jung et al [2] and Chen et al [3], operative time appears to be shorter. We assumed that because SILS has increased in popularity in Korea, novices in SILS are able to adopt single-port LH more easily than in the past because of the availability of expert mentoring. Two patients in the SILS group were converted to open laparotomy in the same institution because of severe cul de sac obliteration. Surgeons decided to perform laparotomy promptly after seeing the adhesions without trying to use additional port(s). These conversions therefore do not necessarily indicate that SILS is inferior to the multiport approach. Less postoperative pain has been suggested to be a benefit of SILS compared with the multiport approach [3,5,12,13]. However, we did not find a difference in NRS pain score or analgesic usage between the SILS group and multiport group in our study, which may be due to the following reasons. First, because the multiport approach is also a minimally invasive technique, the difference in pain between 2 minimally invasive approaches is more likely to be negligible and may not be detected by the measurement tools. Second, pain after laparoscopic surgery can be classified into visceral pain, abdominal wound pain, and shoulder pain. Theoretically, the difference between the 2 approaches should manifest only as a variation in abdominal wound pain, although the major pain after LAVH was reported to be visceral pain, not abdominal wound pain [14]. Third, the level of pain can vary according to the port’s size
Journal of Minimally Invasive Gynecology, Vol -, No -, -/- 2015
and location. Three institutions (Samsung Medical Center, Seoul National University Bundang Hospital, and Severance Medical Center) did not use a 12-mm trocar when performing multiport LH, which could lessen abdominal wound pain. Finally, pain itself is a very subjective measure. We selected the POSAS to measure cosmetic outcome because scar satisfaction is a subjective patient index and we wanted to add an observer’s assessment into the evaluation to assist in revealing if any differences exist. Whereas Song et al [4] revealed better cosmesis after SILS than after multiport LAVH using a body image scale and cosmetics scar scale, we found no difference in cosmetic outcome between the 2 approaches. One potential explanation is that because POSAS does not consider the number of scars, 1 relatively large umbilical scar in SILS may not be assessed better than multiple small abdominal scars. There were several limitations of the present study. First, the LH technique was not standardized, although this was intentional because we wanted to evaluate SILS versus multiport LH in a practice setting. Second, we also could not blind the surgeons or patients. In conclusion, this multi-institutional, prospective randomized trial involving novices as well as experts in SILS revealed that single-port LH is not inferior to multiport LH in terms of conversion and/or complications. However, the single-port approach also did not have any pain or cosmetic advantages compared with the multiport approach. Acknowledgments The final draft of the manuscript was reviewed by a native English speaker, John Hauschild, at Covidien to provide English editing assistance. References 1. Johnson N, Barlow D, Lethaby A, Tavender E, Curr L, Garry R. Methods of hysterectomy: systematic review and meta-analysis of randomised controlled trials. BMJ. 2005;330:1478. 2. Jung YW, Lee M, Yim GW, et al. A randomized prospective study of single-port and four-port approaches for hysterectomy in terms of postoperative pain. Surg Endosc. 2005;25:2462–2469. 3. Chen YJ, Wang PH, Ocampo EJ, Twu NF, Yen MS, Chao KC. Single-port compared with conventional laparoscopic-assisted vaginal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2011;117:906–912. 4. Song T, Cho J, Kim TJ, et al. Cosmetic outcomes of laparoendoscopic single-site hysterectomy compared with multi-port surgery: randomized controlled trial. J Minim Invasive Gynecol. 2013;20:460–467. 5. Kim TJ, Lee YY, Cha HH, et al. Single-port-access laparoscopicassisted vaginal hysterectomy versus conventional laparoscopicassisted vaginal hysterectomy: a comparison of perioperative outcomes. Surg Endosc. 2010;24:2248–2252. 6. Fagotti A, Boruta DM 2nd, Scambia G, Fanfani F, Paglia A, Escobar PF. First 100 early endometrial cancer cases treated with laparoendoscopic single-site surgery: a multicentric retrospective study. Am J Obstet Gynecol. 2012;206:353. e1-6. 7. Fanfani F, Fagotti A, Rossitto C, et al. Laparoscopic, minilaparoscopic and single-port hysterectomy: perioperative outcomes. Surg Endosc. 2012;26:3592–3596.
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8. Olive DL, Parker WH, Cooper JM, Levine RL. The AAGL classification system for laparoscopic hysterectomy. Classification committee of the American Association of Gynecologic Laparoscopists. J Am Assoc Gynecol Laparosc. 2000;7:9–15. 9. Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010; 203:36. e1-8. 10. Song T, Kim ML, Jung YW, Yoon BS, Joo WD, Seong SJ. Laparoendoscopic single-site versus conventional laparoscopic gynecologic surgery: a metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2013;209:317. e1-9.
7 11. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;CD003677. 12. Romanelli JR, Earle DB. Single-port laparoscopic surgery: an overview. Surg Endosc. 2009;23:1419–1427. 13. Ramirez PT. Single-port laparoscopic surgery: is a single incision the next frontier in minimally invasive gynecologic surgery? Gynecol Oncol. 2009;114:143–144. 14. Kim JH, Lee YS, Shin HW, Chang MS, Park YC, Kim WY. Effect of administration of ketorolac and local anaesthetic infiltration for pain relief after laparoscopic-assisted vaginal hysterectomy. J Int Med Res. 2005;33:372–378.
Multi-institution, Prospective, Randomized Trial to Compare the Success Rates of Single-port Versus Multiport Laparoscopic Hysterectomy for the Treatment of Uterine Myoma or Adenomyosis Tae-Joong Kim, MD1, So-Jin Shin, MD, PhD1, Tae-Hyun Kim, MD, Chi-Heum Cho, MD, PhD*, Sang-Hoon Kwon, MD, PhD, SeokJu Sung, MD, PhD, Taejong Song, MD, Sooyoung Hur, MD, PhD, Yong-Man Kim, MD, PhD, Shin-Wha Lee, MD, PhD, Young Tae Kim, MD, PhD, Eun Ji Nam, MD, PhD, Yong Beom Kim, MD, PhD, Jung Ryeol Lee, MD, PhD, Hyun-Jin Roh, MD, PhD, and Hyewon Chung, MD From the Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine (Drs. T.-J. Kim, T.-H. Kim), Seoul, Korea, Keimyung University School of Medicine (Drs. Cho, Kwon, Shin, and Chung), Daegu, Korea, CHA Gangnam Medical Center, CHA University (Drs. Sung and Song), Seoul, Korea, The Catholic University of Korea, Seoul St. Mary’s Hospital (Dr. Hur), Seoul, Korea, University of Ulsan College of Medicine, Asan Medical Center (Drs. Y.-M. Kim and S.-W. Lee), Seoul, Korea, Yonsei University College of Medicine, Severance Medical Center (Drs. Y. T. Kim and Nam), Seoul, Korea, Seoul National University Bundang Hospital (Drs. Y. B. Kim and J. R. Lee), Seongnam, Korea, and College of Medicine, University of Ulsan, Ulsan University Hospital (Dr. Roh), Ulsan, Korea.
ABSTRACT Study Objective: To compare the operative outcomes of patients undergoing either single-port or multiport laparoscopic hysterectomy (LH). Methods: Two hundred fifty-six women scheduled for LH for symptomatic myoma and/or adenomyosis from 8 tertiary teaching hospitals were randomized to single-port or multiport groups. Primary outcome was conversion and/or complication proportion of the planned procedure to determine whether the success proportion of the single-port approach was not inferior to that of the multiport approach. Secondary outcomes were postoperative pain and operative scar. Results: Demographic parameters including age, body mass index, parity, and history of vaginal and cesarean delivery were comparable between the 2 groups. The primary outcome of a combined conversion and/or complication rate was similar between the single-port and multiport groups at 8% and 10.3%, respectively. Conversions were similar between the groups with 4% of single-port cases and .8% of multiport cases. Transfusions were the most frequent complication required in 4.0% of single-port cases and 7.9% of multiport cases, with no difference between the groups. Concerning secondary outcomes, postoperative pain score and patient and observer scar assessment were not different between the 2 groups. Although not a specific outcome measure, there was no difference between the groups in blood loss, operative time, and postoperative hospital stay. Conclusion: Single-port LH is not inferior to multiport LH in terms of conversion and/or complications rates, including transfusion. However, the single-port approach did not have any advantage over multiport LH with regard to pain or cosmetic outcomes. These findings were demonstrated by multi-institutional surgeons in Korea. Journal of Minimally Invasive Gynecology (2015) -, -–- Ó 2015 AAGL. All rights reserved.
This independent research was supported by a funding contribution from Covidien. The authors declare no competing interests. 1
Both authors contributed equally to this article.
Corresponding author: Chi-Heum Cho, MD, PhD, Department of Obstetrics and Gynecology, Keimyung University, School of Medicine, 56 Dalseong– ro, Jung-gu, Daegu 700-712, Republic of Korea. 1553-4650/$ - see front matter Ó 2015 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2015.02.022
E-mail: [email protected] Submitted January 14, 2015. Accepted for publication February 28, 2015. Available at www.sciencedirect.com and www.jmig.org
Journal of Minimally Invasive Gynecology, Vol -, No -, -/- 2015
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Keywords:
DISCUSS
Laparoendoscopic single-site surgery; Laparoscopic hysterectomy; Single-port; Randomized clinical trial
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Laparoscopic hysterectomy (LH) has been shown to have many advantages over open hysterectomy, such as less pain, faster recovery, shorter hospital stay, and better cosmesis [1]. Recently, single-incision laparoscopic surgery (SILS) or laparoendoscopic single-site surgery was introduced to maximize these advantages by reducing the number of incisions to 1 umbilical incision. Three randomized controlled trials of LH have been performed to compare the surgical outcomes of patients who underwent conventional multiport LH or single-port LH [2–4]. These studies reported that the operative outcomes of single-port LH are comparable with those of multiport LH. However, less pain, which is a potential benefit of a single-port approach, was not proved consistently in these trials. In addition, better cosmetic outcome was not validated in all trials. These studies had limitations of being conducted at a single institution with small sample sizes. Although single-port LH is technically feasible, with comparable outcomes, and shows some benefits compared with the multiport approach in the literature [2–7], many gynecologic laparoscopists have yet to adopt the singleport approach for LH. Therefore, we designed a multiinstitutional, prospective randomized trial involving novices and experts in SILS to compare the operative outcomes when using these 2 approaches to treat symptomatic uterine myoma or adenomyosis. Primary outcome was conversion and/or complication proportion of the planned procedure to determine whether the success rate of single-port LH was not inferior to that of the conventional multiport LH approach. Secondary outcomes were postoperative pain measured by numeric rating score (NRS) on postoperative day 1 and week 1 and operative scar measured by patient and observer scar assessment scale (POSAS) at postoperative week 1 and at 2 months. Methods This randomized trial was performed from December 2011 to April 2013 in 8 Korean university hospitals that serve as teaching centers. Inclusion criteria were elective patients between ages 20 and 60 years with symptomatic myomas or adenomyosis such as dysmenorrhea, pelvic pain or discomfort, urinary symptoms, and a palpable mass of increasing size or menorrhagia for a duration of at least 2 months. Exclusion criteria included a uterine size . 18 gestational weeks by pelvic examination and those at risk of surgical complications due to an underlying medical
disease such as heart failure, renal insufficiency, liver cirrhosis, pancreatitis, or uncontrolled diabetes. Patients were included after giving informed consent to a protocol approved by the Institutional Review Board (clinicaltrials. gov; NCT01483417). Patients were randomized in a 1:1 ratio to either the single-port or multiport LH treatment groups. Treatment allocation was determined by a computer-generated randomization schedule with random block sizes (2–6) and was stratified by institution. Treatment assignments were placed in sequentially numbered, opaque, sealed envelopes that had been prepared earlier by a third party. Envelopes were opened on the morning of surgery. Randomization could not be blinded for either patients or surgeons because the same surgeons conducted the postoperative evaluations. Fourteen surgeons with experience in more than 100 multiport LH procedures each, and considered experts, participated in this study. Only 5 surgeons among these 14 had experience in greater than 50 single-port LH at the time of the study. Assisting surgeons were obstetrics and gynecology residents. On an individual surgeon level, SILS was performed using a similar technique to that used for multiport LH, except that a single umbilical incision was used. A SILSÔ port (Covidien, New Haven, CT) was used with a 2- to 2.5-cm transumbilical incision. Multiport was defined in this study as using 3 or 4 trocars ranging from 5 to 12 mm in size (Covidien). The 14 participating surgeons did not standardize their LH technique but followed the American Association of Gynecologic Laparoscopists (AAGL) classification system based on their preferred approach (Table 1) [8]. Postoperative care was also not standardized and was prescribed according to each institution’s policies. The primary outcome measure was conversion and/or complication proportion of the planned procedure. The definition of conversion was either the placement of any additional port(s) to what was originally planned or conversion to open hysterectomy. Complications included injury to adjacent organs, fever (.38 C) lasting . 24 hours, port site problem, vault problem, need for transfusion, and other adverse events up to 2 months postoperatively. Secondary outcomes were postoperative pain and cosmetic scar satisfaction. Postoperative pain was assessed using the pain intensity score and the amount of analgesics taken. Patients rated postoperative pain intensity using an NRS on postoperative day 1 and week 1. The scale was presented as a 10-cm line with verbal descriptors ranging from
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Table 1
Fig. 1
AAGL classification system for LH
Patient allocation and follow-up.
Type
Laparoscopic component of hysterectomy
0
Laparoscopic-directed preparation for vaginal hysterectomy, including adhesiolysis and/or excision of endometriosis. Occlusion and division of at least 1 ovarian pedicle, utero-ovarian ligament, or infudinbulopelvic ligament, but not the uterine artery. Type I plus occlusion and division of 1 or both uterine arteries. Type II plus a portion, but not all, of the cardinaluterosacral ligament complex, unilateral or bilateral. Complete detachment of the cardinal-uterosacral complex, unilateral or bilateral, with or without entry into the vagina. Includes TLH.
I
II III IV
‘‘no pain’’ to ‘‘pain as bad as it could be.’’ According to the postoperative pain management protocol at each institution, intravenous patient-controlled analgesia (PCA) could be used. For cosmetic scar satisfaction, we used the POSAS as a measurement tool [9], which is composed of 6 questions for patients and 5 questions for the observer. The sum of patient and observer points was compared on postoperative week 1 and at 2 months. The higher the combined patient and observer score, the less satisfactory the cosmetic scar result, with a worse combined score of 110. Statistics Baseline characteristics of the patients, intraoperative and postoperative outcomes, postoperative pain, and scar stratification were analyzed. Continuous variables were compared using the Mann-Whitney U test or 2-sample t test. The Fisher’s exact test or the c2 test was used for categorical variables, according to the size of the expected frequency. Significance was determined at p , .05. Primary and secondary outcomes were analyzed according to the original treatment assignment (intent to treat). The hypothesis in the present study was that the rate of conversion and/or complications with single-port LH was not inferior to that of multiport LH. Complication rates including conversions were assumed to be 15% in conventional multiport LH and similar in the single-port LH group. We conducted the noninferiority comparison test using a 90% confidence interval (CI) for the difference in conversion and/or complication rate between the 2 groups. We defined a prespecified noninferiority margin of .2; thus, if the upper boundary of the 90% CI for the difference in conversion and/or complication rate was no more than 20%, we would regard the SILS approach to be noninferior to the multiport approach. This study planned to include 128 participants in each group with the assumption of a 10% dropout rate. Analysis was based on SAS version 9.3 (SAS Institute, Cary, NC).
Results Of the 256 patients randomized for the study, 251 received either single-port LH or multiport LH (Fig. 1). All patients received their intended treatment. Table 2 shows a breakdown by institution concerning the number of patients enrolled in the study, the type of LH performed by single-port or multiport approach based on the AAGL classification system, and the number and size of multiports used. Three patients in the single-port group and 2 in the multiport group withdrew from the study before surgery but after randomization. The 2 groups were similar with respect to age, body mass index, parity, mode of previous delivery, and history of previous abdominal surgery. Operating times, uterine weight, estimated blood loss, and postoperative hospital stay were not different between the 2 groups (Table 3). Two patients (1.6%) with severe adhesions in the posterior cul de sac undergoing a SILS approach were converted to open laparotomy. In addition, 3 patients (2.4%) in the SILS group had an additional 5-mm port placed in the lower abdomen to improve visualization and facilitate dissection. One patient (.8%) undergoing a multiport approach required 1 additional port because of the discovery of dense and diffuse adhesion. There was no difference between the 2 groups in conversion rates (Table 4). There were a total of 6 complications (4.9%) in the intraoperative and postoperative period after single-port LH, compared with 13 (10.3%) in the multiport LH group, with no differences between groups (Table 4). The breakdown of complications included 5 (4.0%) in the SILS group and 10 (7.9%) in the multiport group requiring transfusions during the intraoperative and/or postoperative period. Wound disruption of the umbilical single-port site occurred after postoperative day 10 in 1 patient (.8%). The umbilical
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Table 2 Participating institutions with enrolled patients and their techniques for LH as classified by the AAGL system Institution
n
Single-port
Multiport (ports used)
Asan Medical Center CHA Gangnam Medical Center Keimyung University Samsung Medical Center Seoul National University Bundang Hospital Seoul St. Mary’s Hospital Severance Medical Center Ulsan University Hospital
30 40 86 30 10 (6)y 5 (4)y 40 15
I I, IV* III IV IV IV IV I
I (two 5 mm, one 12 mm) I, III (one 5 mm, two 12 mm)* III (two 5 mm, two 12 mm) IV (three 5 mm) IV (three 5 mm) IV (two 5 mm, two 12 mm) IV (four 5 mm) I (two 5 mm, one 12 mm)
* Two participating surgeons’ techniques were different. y Four patients at Seoul National University and 1 at Seoul St. Mary’s Hospital dropped out of the study before surgery but after enrollment.
wound was disrupted for a length of approximately 5 mm but did not show swelling, redness, bleeding, or pus-like discharge; the wound was conservatively managed with betadine dressing and oral antibiotics. In the multiport LH group, 1 patient (.8%) experienced ureter injury during the operation. A double J catheter was inserted after repairing the ureter, and the patient stayed in the hospital until postoperative day 13 for observation. The double J catheter was removed 8 weeks after hospital discharge without any sequelae. One multiport LH patient (.8%) developed fever . 38 C on the day of operation. The fever was normalized after administration of intramuscular diclofenac 75 mg and application of an icepack. Another multiport LH patient (.8%) was readmitted at postoperative day 10 because of abdominal pain. She was diagnosed as having peritonitis by computed tomography
scan and physical examination in the emergency room and treated with intravenous antibiotics after readmission. Another patient in the multiport LH group (.8%) developed vulvar ecchymosis on postoperative day 2 and was transfused with packed red blood cells because of a hemoglobin level of 6.3 g/dL. Her hospital stay was prolonged to 9 days for observation with medication for pain control. A final multiport LH patient (.8%) developed a hematoma at a lower abdominal port site on postoperative day 2. Although an ultrasonogram did not show any intra-abominal hematoma, the patient was transfused with packed red blood cells because of a hemoglobin level of 8.3 g/dL. She remained in the hospital until postoperative day 4. The first primary endpoint was the proportion of conversion and/or complication. Ten patients (8.0%) in the singleport group and 13 (10.3%) in the multiport group underwent
Table 3 Demographic data and operative variables of the study population (n 5 251)
Median age, yr (range) Median body mass index, kg/m2 (range) Median parity (range) Vaginal delivery Previous cesarean section Previous abdominal surgery Diagnosis on pathology Adenomyosis Leiomyoma Adenomyosis and leiomyoma Endometrial polyp* Median operative time, min (range) Median uterine weight, g (range) Median estimated blood loss, mL (range) Median postoperative hospital stay, days (range)
Single-port (n 5 125)
Multiport (n 5 126)
p value
47 (28–60) 23.4 (17.1–35.8) 2 (0–4) 89 (71.2) 37 (29.6) 26 (20.8)
47 (35–54) 23.4 (18.0–33.3) 2 (0–4) 85 (67.5) 42 (33.3) 24 (19.0)
.68 .88 .46 .59 .59 .75 .11
32 (25.6) 65 (52.0) 27 (21.6) 1 (.8) 80 (30–250) 280 (65–1380) 100 (10–1200) 3 (2–7)
Values are total number of cases, with percents in parentheses, unless otherwise specified. * One patient presumed to have a submucosal myoma was revealed to have an endometrial polyp on final pathology.
34 (27.0) 77 (61.1) 15 (11.9) 0 69.5 (25–240) 298 (60–750) 150 (10–700) 3 (2–13)
.22 .23 .98 .45
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Table 4
Table 5
Conversion and complication(s) between groups (n 5 251)
Comparison of postoperative pain and scar cosmesis evaluation
Single-port (n 5 125) Conversion Additional port(s) Open laparotomy Presence of complications Transfusion (intraoperative/ immediately postoperative) Ureter injury Fevery Port site problem Wound disruption Hematoma Vulvar ecchymosis Peritonitis
5 (4.0) 3 (2.4) 2 (1.6) 6 (4.9) 5 (4.0)
Multiport (n 5 126) 1 (.8) 1 (.8) 0 13* (10.3) 10 (7.9)
0 0 1 (.8) 0 0 0
1 (.8) 1 (.8) 0 1 (.8) 1 (.8) 1 (.8)
Values in parentheses are percents. * Two patients with port site hematoma or vulvar ecchymosis, respectively, also underwent transfusion. The total number of patients with complications in the multiport group was 13. y Fever over 38 C lasting over 24 hours.
between groups (n 5 249)
Use of additional pain killer (n) NSAIDs Opioids PCA use on operation day, n (%) Pain score after 24 hours PCA use after 24 hours, n (%) Pain score at first OPD visit POSAS score at first OPD visit Patient’s score Observer’s score POSAS score at second OPD visit* Patient’s score Observer’s score
Single-port (n 5 123)
Multiport (n 5 126)
p value
1 (0–6) 0 (0–2) 97 (78)
1 (0–6) 0 (0–2) 100 (79)
.48 .14 .73
3 (0–9) 76 (62) 1 (0–5) 14 (11–62) 8 (5–28) 6 (5–45) 11 (11–35)
3 (0–9) 84 (67) 1 (0–6) 14 (11–57) 8 (5–27) 6 (5–37) 11 (11–57)
.76 .43 .41 .93 .90 .67 .65
6 (6–21) 5 (5–15)
6 (6–20) 5 (5–37)
.81 .39
NSAIDs 5 nonsteroidal anti-inflammatory drugs; OPD 5 outpatient department. Values are medians with ranges in parentheses unless otherwise specified. * At the 2-month evaluation, 1 patient in the SILS-port group and 5 patients in the multiport group were lost to follow-up. POSAS score and complication rate at the second OPD visit were therefore evaluated in 122 and 121 patients, respectively.
conversion and/or experienced complications with no difference between groups. As described in Table 4, procedure conversion was required in 5 patients in the single-port group and complications occurred in 6 single-port LH patients, with 1 patient requiring a conversion and also experiencing a complication, for a total of 10 patients (8.0%). Two of the 5 converted single-port patients refused participation in the postoperative pain and POSAS assessment. In the multiport LH group, of the 13 patients who developed a complication, 1 patient also required a procedure conversion, for a total of 13 patients (10.3%). The difference in total conversion and/or complication proportion between the 2 groups was .0232 (90% CI, 2.0367 to .083). The upper limit of the 90% CI (.083) was less than the noninferiority margin (.2). Therefore, we inferred that LH performed using a single-port technique is noninferior to a multiport LH. The intensity of postoperative pain did not differ significantly between the groups (Table 5), either at 24 hours after the operation or at postoperative week 1. Median pain score measured by NRS was 3 points at postoperative 24 hours and 1 point at postoperative week 1 in both groups. The use of intravenous PCA was also not different between the 2 groups, with almost 80% of patients in both groups consenting to PCA administration and with no difference in the number of additional parenteral analgesic drugs used for pain relief during the postoperative period. Analysis of scar satisfaction after surgery revealed no difference between the 2 groups (Table 5). In both groups, the scar satisfaction measured by POSAS improved slightly over time. At 1 week after surgery, POSAS scored 14 for each group, representing only 12.7% of the highest worst
combined patient and observer score of 110. At 2 months after surgery, POSAS scored 11 for each group, representing only 10% of the highest worst combined score. Overall scar satisfaction was excellent, with no difference between the groups during follow-up.
Discussion The present study was a large, multi-institutional, prospective randomized trial involving novices as well as experts in SILS as primary surgeons in the field of gynecology. To our knowledge, this is the first multi-institutional randomized trial of LH in which 14 surgeons at 8 hospitals participated. We therefore expect the results from this trial to confirm or update the findings of previous studies [2–4]. The results showed single-port LH is not inferior to multiport LH in terms of conversion and/or complications. However, the single-port approach did not have any advantages in terms of pain or cosmetic outcomes. These findings are consistent with a meta-analysis of randomized controlled trials in gynecology conducted by Song et al in 2013 [10]. Before this study, multiple institutions in Korea were evaluated, and 8 Korean university hospitals that serve as teaching centers were selected. There was no significant difference of demographic data and operative variables between institutions in our preliminary study. Several LH techniques with variations in the extent of the laparoscopic contribution to the procedure have been
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described. Generally, LH can be subcategorized into laparoscopically assisted vaginal hysterectomy (LAVH), or total LH (TLH), depending on the extent of the surgery performed either laparoscopically or vaginally [11]. LH techniques can also be described using the AAGL classification system [8]. LH techniques were not standardized in this study (Table 2) for the following reasons. First, standardization of surgical techniques at multi-institutions is not easy in practice. Second, we sought to compare the operative outcomes of patients undergoing either SILS or multiport LH in a practice setting, regardless of LH techniques. Third, previous randomized trials have shown inconsistent results in terms of the potential advantages of SILS regardless of surgical technique. Chen et al [3] reported less pain associated with single-port LAVH than with multiport LAVH, whereas Song et al [4] did not show any pain score advantage with single-port LAVH. Jung et al [2] compared single-port versus multiport TLH and did not show any difference in pain scores. We included both TLH and LAVH in our study to evaluate types I to IV LHs on the AAGL classification system. The study was not powered to conduct a subgroup analysis by AAGL LH classification; however, it was run for LAVH and TLH cosmesis, and there was no difference between single-port LH and multiport LH. The demographic profile of participants included in this study was similar to that of patients included in previous randomized trials (Table 3) [2–4]. For example, 31% of participants had a history of cesarean delivery, which is very similar to previous trials. Although the uterine size calculated by uterine weight in this study was larger than that reported in the studies by Jung et al [2] and Chen et al [3], operative time appears to be shorter. We assumed that because SILS has increased in popularity in Korea, novices in SILS are able to adopt single-port LH more easily than in the past because of the availability of expert mentoring. Two patients in the SILS group were converted to open laparotomy in the same institution because of severe cul de sac obliteration. Surgeons decided to perform laparotomy promptly after seeing the adhesions without trying to use additional port(s). These conversions therefore do not necessarily indicate that SILS is inferior to the multiport approach. Less postoperative pain has been suggested to be a benefit of SILS compared with the multiport approach [3,5,12,13]. However, we did not find a difference in NRS pain score or analgesic usage between the SILS group and multiport group in our study, which may be due to the following reasons. First, because the multiport approach is also a minimally invasive technique, the difference in pain between 2 minimally invasive approaches is more likely to be negligible and may not be detected by the measurement tools. Second, pain after laparoscopic surgery can be classified into visceral pain, abdominal wound pain, and shoulder pain. Theoretically, the difference between the 2 approaches should manifest only as a variation in abdominal wound pain, although the major pain after LAVH was reported to be visceral pain, not abdominal wound pain [14]. Third, the level of pain can vary according to the port’s size
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and location. Three institutions (Samsung Medical Center, Seoul National University Bundang Hospital, and Severance Medical Center) did not use a 12-mm trocar when performing multiport LH, which could lessen abdominal wound pain. Finally, pain itself is a very subjective measure. We selected the POSAS to measure cosmetic outcome because scar satisfaction is a subjective patient index and we wanted to add an observer’s assessment into the evaluation to assist in revealing if any differences exist. Whereas Song et al [4] revealed better cosmesis after SILS than after multiport LAVH using a body image scale and cosmetics scar scale, we found no difference in cosmetic outcome between the 2 approaches. One potential explanation is that because POSAS does not consider the number of scars, 1 relatively large umbilical scar in SILS may not be assessed better than multiple small abdominal scars. There were several limitations of the present study. First, the LH technique was not standardized, although this was intentional because we wanted to evaluate SILS versus multiport LH in a practice setting. Second, we also could not blind the surgeons or patients. In conclusion, this multi-institutional, prospective randomized trial involving novices as well as experts in SILS revealed that single-port LH is not inferior to multiport LH in terms of conversion and/or complications. However, the single-port approach also did not have any pain or cosmetic advantages compared with the multiport approach. Acknowledgments The final draft of the manuscript was reviewed by a native English speaker, John Hauschild, at Covidien to provide English editing assistance. References 1. Johnson N, Barlow D, Lethaby A, Tavender E, Curr L, Garry R. Methods of hysterectomy: systematic review and meta-analysis of randomised controlled trials. BMJ. 2005;330:1478. 2. Jung YW, Lee M, Yim GW, et al. A randomized prospective study of single-port and four-port approaches for hysterectomy in terms of postoperative pain. Surg Endosc. 2005;25:2462–2469. 3. Chen YJ, Wang PH, Ocampo EJ, Twu NF, Yen MS, Chao KC. Single-port compared with conventional laparoscopic-assisted vaginal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2011;117:906–912. 4. Song T, Cho J, Kim TJ, et al. Cosmetic outcomes of laparoendoscopic single-site hysterectomy compared with multi-port surgery: randomized controlled trial. J Minim Invasive Gynecol. 2013;20:460–467. 5. Kim TJ, Lee YY, Cha HH, et al. Single-port-access laparoscopicassisted vaginal hysterectomy versus conventional laparoscopicassisted vaginal hysterectomy: a comparison of perioperative outcomes. Surg Endosc. 2010;24:2248–2252. 6. Fagotti A, Boruta DM 2nd, Scambia G, Fanfani F, Paglia A, Escobar PF. First 100 early endometrial cancer cases treated with laparoendoscopic single-site surgery: a multicentric retrospective study. Am J Obstet Gynecol. 2012;206:353. e1-6. 7. Fanfani F, Fagotti A, Rossitto C, et al. Laparoscopic, minilaparoscopic and single-port hysterectomy: perioperative outcomes. Surg Endosc. 2012;26:3592–3596.
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8. Olive DL, Parker WH, Cooper JM, Levine RL. The AAGL classification system for laparoscopic hysterectomy. Classification committee of the American Association of Gynecologic Laparoscopists. J Am Assoc Gynecol Laparosc. 2000;7:9–15. 9. Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010; 203:36. e1-8. 10. Song T, Kim ML, Jung YW, Yoon BS, Joo WD, Seong SJ. Laparoendoscopic single-site versus conventional laparoscopic gynecologic surgery: a metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2013;209:317. e1-9.
7 11. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;CD003677. 12. Romanelli JR, Earle DB. Single-port laparoscopic surgery: an overview. Surg Endosc. 2009;23:1419–1427. 13. Ramirez PT. Single-port laparoscopic surgery: is a single incision the next frontier in minimally invasive gynecologic surgery? Gynecol Oncol. 2009;114:143–144. 14. Kim JH, Lee YS, Shin HW, Chang MS, Park YC, Kim WY. Effect of administration of ketorolac and local anaesthetic infiltration for pain relief after laparoscopic-assisted vaginal hysterectomy. J Int Med Res. 2005;33:372–378.
