European Journal of Obstetrics & Gynecology and Reproductive Biology 188 (2015) 83–87
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Single-port laparoscopically assisted-transumbilical ultraminilaparotomic myomectomy (SPLA-TUM) versus single port laparoscopic myomectomy: a randomized controlled trial Jin-Sung Yuk a, Hyun Young Ji a, Kye Hyun Kim b, Jung Hun Lee a,* a b
The Department of Obstetrics and Gynecology, MizMedi Hospital, Eulji University School of Medicine, Seoul, Republic of Korea The Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
A R T I C L E I N F O
A B S T R A C T
Article history: Received 10 September 2014 Received in revised form 15 February 2015 Accepted 2 March 2015
Objective: To evaluate whether single-port laparoscopically assisted-transumbilical ultraminilaparotomic myomectomy (SPLA-TUM) has a shorter operating time than single port laparoscopic myomectomy (SP-LM), without negatively affecting postoperative pain and cosmesis. Study design: We performed a randomized controlled trial at a University teaching hospital. A total of 92 premenopausal women with symptomatic, superficial intramural or subserosal fibroids were randomized to receive either SPLA-TUM or SP-LM. The primary outcome measured was the operating time. The secondary outcome measures included postoperative pain, as measured by a visual analog scale (VAS) at 2, 6, 12, 24, and 48 h after the operation, and cosmetic outcomes, as measured by the Vancouver scar scale (VSS) and patient satisfaction with the scars, using a VAS at 3 postoperative months. Results: There were no differences in the patient demographics or in the clinical characteristics of the resected fibroids between the two groups. The operation results showed no differences in the hemoglobin changes, return of bowel activity, hospital stay, and complication rate between the groups. The mean operating time in the SPLA-TUM group was shorter than that in the SP-LM group (87.0 32.7 min compared with 102.3 32.9 min, P = 0.026). The patients in each group demonstrated no differences in their postoperative pain levels, VSS scores, and satisfaction with the scars, but the SPLA-TUM group had a longer umbilical wound compared with the SP-LM group. Two (4.3%) patients in the SPLA-TUM group received SP-LM. One (2.2%) patient in the SP-LM group and two (4.3%) patients in the SPLA-TUM group were converted to two or three port laparoscopic myomectomy. Conclusions: SPLA-TUM has a shorter operating time than SP-LM due to convenient suturing and knotting; the two procedures have comparable postoperative pain levels and cosmetic outcomes. However, further study is needed to evaluate the long-term outcomes of SPLA-TUM. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Gynecology Laparoscopy Myomectomy Single-port surgery
Introduction Since single-port laparoscopic myomectomy (SP-LM) was first introduced [1,2], various studies of this procedure have been published [3–7]. However, compared with the extensive research on single port laparoscopic surgeries in other gynecologic fields, studies of SP-LM are sparse. This discrepancy might be because of the distinct characteristics of myomectomy, which has excision and suturing unlike those in other (mainly destructive) surgeries.
* Corresponding author. Tel.: +82 10 6316 7470; fax: +82 2 2007 1466. E-mail address: [email protected] (J.H. Lee). http://dx.doi.org/10.1016/j.ejogrb.2015.03.004 0301-2115/ß 2015 Elsevier Ireland Ltd. All rights reserved.
Furthermore, single-port laparoscopic surgery (SP-LS) is difficult to apply in myomectomy because it is inevitably accompanied by technical difficulties, particularly in laparoscopic suturing and knotting. To overcome the technical disadvantages of SP-LM, the authors developed a new surgical technique called ‘Single-port Laparoscopically Assisted-transumbilical Ultraminilaparotomic Myomectomy (SPLA-TUM)’ by integrating the advantages of both single-port laparoscopy and minilaparotomy [8]. The authors hypothesized that SPLA-TUM might shorten the operating time while maintaining the feasibility, safety, and advantages of singleport laparoscopy. In this study, we evaluated whether SPLA-TUM has a shorter operating time than SP-LM.
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J.-S. Yuk et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 188 (2015) 83–87
Materials and methods Study design This prospective, randomized, controlled trial was performed at a university teaching hospital from July 2012 to November 2013. The study protocol was approved by the institutional review board at our hospital.
with a submucosal or deep intramural fibroid on ultrasonographic examination, or (3) women with psychiatric disorders, an American Society of Anesthesiologist classification grade >3, malignant disease, tattoos and piercing in the umbilicus, a history of keloids, a previous umbilicus scar, or medical conditions that could affect wound healing, such as diabetes mellitus, severe malnutrition, and disease requiring chronic corticosteroids. Each patient was enrolled prior to undergoing surgery and provided written informed consent.
Participants Operative technique All premenopausal women (older than 18 years old) scheduled for SP-LM were enrolled. The indications of SP-LM are women with symptomatic, superficial intramural or subserosal type of fibroid on ultrasonographic examination and with a uterus 16 weeks gestational size on pelvic examination [2,5,8]. A fibroid is defined as a superficial intramural fibroid when the distance between it and the endometrium is >5 mm on an ultrasonographic examination. The following exclusion criteria were applied: (1) women younger than 18 years old or postmenopausal women, (2) women
SPLA-TUM and SP-LM were performed in the same manner as our previous studies [2,5,8]. Common in both methods, the GelPoint access (Alexis, Applied Medical, Rancho Santa Margarita, CA, USA) was established through a 15–20 mm trans-umbilical incision under general anesthesia (Fig. 1A). After injecting a dilute solution of vasopressin (10 IU/100 mL normal saline) into the tissue around the base and capsule of fibroids, the fibroids were resected using conventional and articulating laparoscopic instruments
Fig. 1. The actual image of single port laparoscopic myomectomy (SP-LM) and single port laparoscopically assisted—transumbilical ultraminilaparotomic myomectomy (SPLA-TUM) (A) The GelPoint platform establishment, (B) Injections of a dilute solution of vasopressin into the tissue around the fibroid, (C) Resection of a fibroid using conventional and articulating laparoscopic instruments, intraperitoneal view (D) and extraperitoneal view (E) of extracorporeal knots that were seated using a knot pusher phase in SP-LM, and (F) the closure of uterine defect in SPLA-TUM.
J.-S. Yuk et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 188 (2015) 83–87
(Fig. 1B and C). The morcellation and extraction of the resected fibroid was performed with a scalpel through the umbilical incision. The technical difference between the methods was as follows. In SPLM, the defect in the myometrial and serosal layers was closed in one layer using interrupted sutures of 1–0 polyglactin 910 (Vicryl1, Ethicon Inc., Somerville, NJ, USA), with extracorporeal knots that were seated using a knot pusher (Fig. 1D and E). In SPLA-TUM, the GelPort was detached from the wound retractor, and the umbilical incision was pulled caudally with an Army-Navy retractor. Then, the uterine incision was grasped with Allis clamps and pulled toward the transumbilical incision. The myometrial and serosal layers were approximated in one layer with figure-of-8 sutures of 1–0 polyglactin 910 just above or below the wound retractor in the same manner as a minilaparotomic myomectomy (Fig. 1F). Outcomes measured The primary endpoint was to compare the operating time and short-term outcomes of SPLA-TUM and SP-LM. The secondary endpoint was to compare the postoperative pain and cosmetic outcomes of both procedures. Preoperative magnetic resonance imaging (MRI) was performed in all patients, and the size of the removed fibroids was determined based on the MRI. All fibroids that were found on MRI were removed. The operating time was defined as the period elapsed from the skin incision to the skin closure. The hemoglobin change was calculated by the difference between the preoperative hemoglobin level and the hemoglobin level on the first postoperative day. The return of bowel activity was defined as the period from the end of anesthesia to the first occurrence of bowel gas passage; and postoperative fever was defined as a body temperature 38 8C on two consecutive occasions at least 6 h apart, except during the first 24 h.
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every 12 h) was administered by patient request and was recorded. Postoperative pain was assessed using visual analogue scale (VAS) scores and postoperative analgesic use. The VAS (0 mm, no pain and 100 mm, maximal pain) scores were measured postoperatively at 2, 6, 12, 24, and 48 h. Scar and satisfaction assessment The length of the scar was measured with the scale in the supine position. Scar assessment was performed at 3 postoperative months using the Vancouver scar scale (VSS) [9]. The VSS rated the following four physical characteristics of the scar: vascularity, pigmentation, pliability, and height. Each variable contained ranked subscales that may be summed to obtain a total score ranging from 0 to 13, wherein 0 represents normal skin. All patients were asked to rate their overall satisfaction with the scars using a 10 cm VAS [10]. Sample size and randomization Based on our preliminary study of SPLA-TUM [8], the sample size was estimated with an equation appropriate for comparing two independent group means and was based on a two-sided a level of 0.05 having 90% power to detect a 10% difference in the operating time. A minimum sample size was 42 patients for each arm and at least 92 subjects needed to be randomized, assuming a 10% attrition rate. The patients were randomly assigned using a computer-generated list of random numbers. The randomization sequence was generated with a single block size of four. The randomization was performed in the operating room. A flow diagram of the participants is presented in Fig. 2. Statistical analysis
The patients were followed-up postoperatively at 10 days, 1 month and 3 months. At each visit, we performed a pelvic examination and transvaginal ultrasonography and evaluated the umbilical wounds and any surgical complications. At 3 postoperative months, we assessed the scars and the patients’ satisfaction with them.
The data are expressed as the mean standard deviation. Normality testing was conducted using the Shapiro–Wilk test for normality on each variable. An unpaired t-test was used to compare parametric variables, and Pearson’s x2 test or Fisher’s exact test was used to compare the categorical variables. P < 0.05 indicates a significant difference. All analyses were performed using the Statistical Package for Social Sciences (SPSS), version 17.0 for Windows (SPSS Inc., Chicago, IL, USA).
Postoperative pain assessment
Results
For postoperative pain control, tramadol (25 mg, intravenous injection every 6 h) or diclofenac (90 mg, intramuscular injection
During the study period, 116 women were assessed for eligibility; 92 of these women fulfilled both the inclusion and
Monitoring
Fig. 2. Flow diagram of the participants. SP-LM Single port laparoscopic myomectomy; SPLA-TUM Single port laparoscopically assisted—transumbilical ultraminilaparotomic myomectomy.
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exclusion criteria and were randomly assigned to SPLA-TUM or SPLM group (46 women in each group) (Fig. 1). There were no statistically significant between-group differences in the demographics of the participants or in the clinical characteristics of the resected fibroids (Tables 1 and 2). In terms of operative results, there were no significant differences in the hemoglobin changes, return of bowel activity, hospital stay, or complication rate between the groups (Table 3). The mean operating time in the SPLA-TUM group was shorter than that in the SP-LM group (P = 0.026). In two (4.3%) women in the SPLA-TUM group, SPLA-TUM was converted to SP-LM because SPLA-TUM did not provide a satisfactory surgical field. In one (2.2%) case in the SP-LM group and two (4.3%) cases in the SPLATUM group, two- or three-port laparoscopic myomectomy was performed because the SP-LM failed to repair the uterine defect or to properly dissect the tissue surrounding the fibroid that was located on the lower posterior wall of the uterus or lateral pelvic wall. Women with postoperative fever or transient ileus were treated conservatively. There were no between-group differences in the postoperative pain levels, VSS scores, and overall satisfaction with the scars, but the SPLA-TUM group had a longer umbilical wound than the SP-LM group (Table 4). Comment In our previous report on the surgical technique and initial experience of SPLA-TUM, we proposed that SPLA-TUM theoretically has several advantages provided by single-port laparoscopy and ultraminilaparotomy [8]. In aspect of single-port laparoscopy, the advantages are (1) favorable cosmetic outcomes and (2) greater applicability, as well as minimizing surgical injuries to the tubes or uterus by better understanding of the anatomical relationship compared with minilaparotomy. On the other hand, the advantages that the nature of ultraminilaparotomy offers are (1) shortening the surgical time by convenient suturing and knotting, as well as by quickly removing the resected fibroids, (2) retaining a tactile sense, and (3) shortening the learning curve. The authors proposed that shortening the surgical time is the most valuable clinical advantage, and performed the current study to confirm this hypothesis. In this study, there were no differences between the Table 1 Demographics of the participants. SP-LM group
SPLA-TUM group
P-value
Mean SD/number (%) Number of patients Age (years) Parity Nulliparous Multiparous BMI (kg/m2) Number of patients with previous abdominal surgeries Number of surgeries = 1 Number of surgeries = 2 Indication for myomectomy Dysfunctional uterine bleeding Dysmenorrhea Menorrhagia Pelvic pain Infertility Palpable pelvic mass Urinary symptom
46 36.9 6.8
46 37.3 6.3
32 (69.6) 14 (30.4) 22.9 3.3 9 (19.6)
33 (71.7) 13 (28.2) 21.7 2.8 9 (19.6)
7 (15.2) 2 (4.3)
4 (8.7) 5 (10.9)
(6.5) (21.7) (19.6) (19.6) (8.7) (21.7) (2.2)
6 8 6 11 2 10 3
SP-LM group
114
(13.0) (17.4) (13.0) (23.9) (4.3) (21.7) (6.5)
SP-LM group = women who underwent single-port laparoscopic myomectomy; SPLA-TUM group = women who underwent single-port laparoscopically assistedtransumbilical ultraminilaparotomic myomectomy. a Using an unpaired t test. b Using Pearson’s x2 test.
P-value
0.972a
113
2.5 1.8
2.5 1.8
0.954a
3.5 2.7
3.7 2.6
0.587a
6.1 2.3
6.2 2.0
0.846a 0.241b
51 38 20 5
(44.7) (33.3) (17.5) (4.4)
53 34 14 12
(46.9) (30.1) (12.4) (10.6) 0.526b
45 (39.5) 69 (60.5)
40 (35.4) 73 (64.6)
SP-LM group = women who underwent single-port laparoscopic myomectomy; SPLA-TUM group = women who underwent single-port laparoscopically assistedtransumbilical ultraminilaparotomic myomectomy. a Using an unpaired t test. b Using Pearson’s x2 test.
SPLA-TUM and SP-LM groups regarding the clinical characteristics of the patients and resected fibroids, which can affect the surgical results. No differences were noted between the groups for the operative outcomes, including changes in the hemoglobin, return of bowel activity, hospital stay, complication rate, and the rate of using an additional trocar. However, the operating time in the SPLA-TUM group was approximately 15% less than that in the SPLM group (87.0 32.7 min compared with 102.3 32.9 min, P = 0.026). These findings showed that SPLA-TUM is feasible and safe and can reduce the operating time in selected women with symptomatic fibroid compared with SP-LM. One or two additional trocars were utilized in one (2.2%) woman in the SP-LM group and two (4.3%) women in the SPLATUM group. In these cases, we could not complete the repair of the hysterotomy site or the proper dissection of the tissue surrounding the fibroid because the fibroid was located on the lower posterior wall of the uterus or lateral pelvic wall. Although various instruments and surgical techniques for single-port laparoscopy have been developed, single-port laparoscopy is accompanied inevitably by increased technical difficulty and restricted surgical Table 3 Operation outcomes. SP-LM group
0.059a 0.349b
SPLA-TUM group
Mean SD/number (%) Total number of removed fibroids Mean number of removed fibroids in each patient Mean diameter of the removed fibroid (cm) Maximal diameter of the largest fibroid in a patient (cm) Location of myoma Anterior Posterior Fundal Lateral Type of myoma Subserosal Intramural
0.753a 0.891b
0.719b 3 10 9 9 4 10 1
Table 2 Clinical characteristics of the resected fibroids.
SPLA-TUM group
P-value
Mean SD/number (%) Operating time (min) Hemoglobin change (g/dL) Return of bowel activity (h) Hospital stay (days) Conversion to SP-LM, multiport laparoscopy, or laparotomy Conversion to SP-LM Conversion to multiport laparoscopy Conversion to laparotomy Operative complication Postoperative fever Transient ileus Transfusion
102.3 32.9 1.4 0.8 39.4 8.8 4.3 0.5
87.0 32.7 1.6 0.8 38.3 10.6 4.2 0.4
1 (2.2)
2 (4.3) 2 (4.3)
0 (0)
0 (0)
1 (2.2) 2 (4.3) 4 (8.7)
1 (2.2) 0 (0) 3 (6.5)
0.026a 0.361a 0.607a 0.364a 0.203b
0.521c
SP-LM group = women who underwent single-port laparoscopic myomectomy; SPLA-TUM group = women who underwent single-port laparoscopically assistedtransumbilical ultraminilaparotomic myomectomy. a Using the unpaired t test. b Using Fisher’s exact test. c Using Pearson’s x2 test.
J.-S. Yuk et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 188 (2015) 83–87 Table 4 Postoperative pain and cosmetic outcomes. SP-LM group SPLA-TUM group P-value Mean SD/number (%) Postoperative pain (VAS score) At 2 postoperative hours 6.3 2.3 6.5 2.2 At 6 postoperative hours 3.8 2.3 3.9 1.9 At 12 postoperative hours 2.8 1.7 3.0 1.6 At 24 postoperative hours 2.0 1.2 2.1 1.6 At 48 postoperative hours 1.9 1.7 2.3 1.9 Cumulative number of patients given additional analgesics At 2 postoperative hours 6 (13.0) 11 (23.9) At 6 postoperative hours 7 (15.2) 13 (28.2) At 12 postoperative hours 8 (17.4) 14 (30.4) At 24 postoperative hours 11 (23.9) 15 (32.6) At 48 postoperative hours 11 (23.9) 15 (32.6) Cosmetic outcomes Length of umbilical wound (mm) 17.7 4.1 19.5 3.6 Vancouver scar scale score 4.2 2.2 4.3 2.2 VAS for scar cosmesis 8.1 1.9 8.1 2.4
0.695a 0.641a 0.642a 0.643a 0.644a 0.179b 0.129b 0.143b 0.354b 0.354b 0.029a 0.851a 0.964a
SP-LM group = women who underwent single-port laparoscopic myomectomy; SPLA-TUM group = women who underwent single-port laparoscopically assistedtransumbilical ultraminilaparotomic myomectomy; VAS for scar cosmesis = visual analog scale represents the patients’ overall satisfaction with the scar. a Using an unpaired t test. b Using Pearson’s x2 test.
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be identical to the obstetrical results after laparotomic myomectomy because suturing and knotting in SPLA-TUM are performed in the same manner as those in laparotomic myomectomy. Laparoscopic myomectomy reportedly reduces postoperative adhesion, which might influence postoperative fertility [13]. Although the fibroid is laparoscopically removed, and there is great distance between the hysterotomy scar and the abdominal incision in SPLA-TUM, further study is needed to determine whether SPLA-TUM reduces postoperative adhesion formation, as with laparoscopic myomectomy. Our study has several limitations. First, although BMI is thought to be an important factor that affects accessibility in SPLA-TUM, this study included only Korean women, who have lower BMIs compared with the Western population [14]. Second, a comparison with minilaparotomic myomectomy, which is another alternative to SP-LM, was not performed. Third, because reasonable indications for SP-LM have not yet been established, our arbitrary inclusion and exclusion criteria were used. In conclusions, SPLA-TUM has a shorter surgical time than SPLM because of the convenient suturing and knotting used, and the two procedures have comparable postoperative pain and cosmetic outcomes. However, further studies are needed to evaluate the long-term outcomes of SPLA-TUM. Conflict of interest statement
space; SP-LS instruments that could overcome these problems are unavailable [2]. Therefore, the authors believe that it is inevitable that some of the SP-LS operations are converted to multiport laparoscopy, and the surgeon should not hesitate to place additional trocars if needed. Two (4.3%) cases in the SPLA-TUM group were converted to SP-LM because the hysterotomy site could not be exposed for suturing through the umbilical incision. These cases involved nulliparous women, with relatively high body mass indices (BMIs) (26.26 and 27.78 kg/m2). As mentioned in our previous report [8], the patients’ tissue pliability, parity, BMIs, and height affected the accessibility of SPLA-TUM. The authors discount the preoperative prediction of the SPLA-TUM accessibility on a specific person because general anesthesia can highly impact the tissue pliability. Nevertheless, based on our experience, SPLA-TUM seems to be unlikely to be offered in obese, tall, nulliparous women. In designing SPLA-TUM, we identified two problems that can arise from this procedure. One is whether SPLA-TUM increases postoperative pain by retracting an umbilical incision, and the other is whether SPLA-TUM elongates the length of the incision by pulling the umbilicus caudally. In this study, there was no significant difference in the pain score and analgesics consumption within 48 h after the operation between the two groups. This result showed that SPLA-TUM did not increase the postoperative pain level. These findings are thought to be caused by how the umbilical traction in SPLA-TUM affects the postoperative pain level, which is negligible, or by the anatomical characteristics of the umbilicus, which lacks muscle [11]. However, although the difference between the groups was statistically insignificant, there was a trend for increase in the number of patients who needed analgesics for the insignificant difference between the VAS scores of the groups for postoperative pain. Regarding the cosmetic outcomes, the umbilical scar length in the SP-LM group was approximately 2 mm longer than that in the SPLA-TUM group (17.7 4.1 compared with 19.5 3.6, P = 0.029). However, the VSS score and overall satisfaction with the scars was not different between the two groups. The results were similar to those of our previous report on the postoperative pain after single port laparoscopic surgery [12]. Therefore, although SPLA-TUM slightly extends the umbilical incision, it does not appear to have a clinically significant effect on cosmesis. Regarding the obstetrical outcomes after SPLA-TUM, the strength of the hysterotomy site after SPLA-TUM is believed to
This article was not supported by any financial funds and not affiliated with the instrumental company referred to in the text. Condensation Compared with single port laparoscopic myomectomy, singleport laparoscopically assisted-transumbilical ultraminilaparotomic myomectomy (SPLA-TUM) can shorten surgical times, with comparable postoperative pain and cosmetic outcomes. References [1] Kim YW, Park BJ, Ro DY, Kim TE. Single-port laparoscopic myomectomy using a new single-port transumbilical morcellation system: initial clinical study. J Minim Invasive Gynecol 2010;17:587–92. [2] Lee JH, Choi JS, Jeon SW, Son CE, Lee SJ, Lee YS. Single-port laparoscopic myomectomy using transumbilical GelPort access. Eur J Obstet Gynecol Reprod Biol 2010;153:81–4. [3] Choi CH, Kim TH, Kim SH, et al. Surgical outcomes of a new approach of laparoscopic myomectomy: single port and modified suture technique. J Minim Invasive Gynecol 2014;21:580–5. [4] Han CM, Lee CL, Su H, Wu PJ, Wang CJ, Yen CF. Single-port laparoscopic myomectomy: initial operative experience and comparative outcome. Arch Gynecol Obstet 2013;287:295–300. [5] Kim JY, Kim KH, Choi JS, Lee JH. A prospective matched case-control study of laparoendoscopic single site versus conventional laparoscopic myomectomy. J Minim Invasive Gynecol 2014;21:1036–40. [6] Kim SK, Lee JH, Lee JR, Suh CS, Kim SH. Laparoendoscopic single-site myomectomy versus conventional laparoscopic myomectomy: a comparison of surgical outcomes. J Minim Invasive Gynecol 2014;21:775–81. [7] Yoshiki N, Okawa T, Kubota T. Single-incision laparoscopic myomectomy with intracorporeal suturing. Fertil Steril 2011;95:2426–8. [8] Kang JH, Lee DH, Lee JH. Single-port laparoscopically assisted transumbilical ultraminilaparotomic myomectomy. J Minim Invasive Gynecol 2014;21: 945–50. [9] Baryza MJ, Baryza GA. The Vancouver scar scale: an administration tool and its interrater reliability. J Burn Care Rehabil 1995;16:535–8. [10] Duncan JA, Bond JS, Mason T, et al. Visual analogue scale scoring and ranking: a suitable and sensitive method for assessing scar quality. Plast Reconstr Surg 2006;118:909–18. [11] Ghezzi F, Cromi A, Colombo G, et al. Minimizing ancillary ports size in gynecologic laparoscopy: a randomized trial. J Minim Invasive Gynecol 2005;12:480–5. [12] Eom JM, Ko JH, Choi JS, Hong JH, Lee JH. A comparative cross-sectional study on cosmetic outcomes after single port or conventional laparoscopic surgery. Eur J Obstet Gynecol Reprod Biol 2013;167:104–9. [13] Bulletti C, Polli V, Negrini V, Giacomucci E, Flamigni C. Adhesion formation after laparoscopic myomectomy. J Am Assoc Gynecol Laparosc 1996;3:533–6. [14] Kim DM, Ahn CW, Nam SY. Prevalence of obesity in Korea. Obes Rev 2005;6:117–21.
Contents lists available at ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Single-port laparoscopically assisted-transumbilical ultraminilaparotomic myomectomy (SPLA-TUM) versus single port laparoscopic myomectomy: a randomized controlled trial Jin-Sung Yuk a, Hyun Young Ji a, Kye Hyun Kim b, Jung Hun Lee a,* a b
The Department of Obstetrics and Gynecology, MizMedi Hospital, Eulji University School of Medicine, Seoul, Republic of Korea The Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
A R T I C L E I N F O
A B S T R A C T
Article history: Received 10 September 2014 Received in revised form 15 February 2015 Accepted 2 March 2015
Objective: To evaluate whether single-port laparoscopically assisted-transumbilical ultraminilaparotomic myomectomy (SPLA-TUM) has a shorter operating time than single port laparoscopic myomectomy (SP-LM), without negatively affecting postoperative pain and cosmesis. Study design: We performed a randomized controlled trial at a University teaching hospital. A total of 92 premenopausal women with symptomatic, superficial intramural or subserosal fibroids were randomized to receive either SPLA-TUM or SP-LM. The primary outcome measured was the operating time. The secondary outcome measures included postoperative pain, as measured by a visual analog scale (VAS) at 2, 6, 12, 24, and 48 h after the operation, and cosmetic outcomes, as measured by the Vancouver scar scale (VSS) and patient satisfaction with the scars, using a VAS at 3 postoperative months. Results: There were no differences in the patient demographics or in the clinical characteristics of the resected fibroids between the two groups. The operation results showed no differences in the hemoglobin changes, return of bowel activity, hospital stay, and complication rate between the groups. The mean operating time in the SPLA-TUM group was shorter than that in the SP-LM group (87.0 32.7 min compared with 102.3 32.9 min, P = 0.026). The patients in each group demonstrated no differences in their postoperative pain levels, VSS scores, and satisfaction with the scars, but the SPLA-TUM group had a longer umbilical wound compared with the SP-LM group. Two (4.3%) patients in the SPLA-TUM group received SP-LM. One (2.2%) patient in the SP-LM group and two (4.3%) patients in the SPLA-TUM group were converted to two or three port laparoscopic myomectomy. Conclusions: SPLA-TUM has a shorter operating time than SP-LM due to convenient suturing and knotting; the two procedures have comparable postoperative pain levels and cosmetic outcomes. However, further study is needed to evaluate the long-term outcomes of SPLA-TUM. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Gynecology Laparoscopy Myomectomy Single-port surgery
Introduction Since single-port laparoscopic myomectomy (SP-LM) was first introduced [1,2], various studies of this procedure have been published [3–7]. However, compared with the extensive research on single port laparoscopic surgeries in other gynecologic fields, studies of SP-LM are sparse. This discrepancy might be because of the distinct characteristics of myomectomy, which has excision and suturing unlike those in other (mainly destructive) surgeries.
* Corresponding author. Tel.: +82 10 6316 7470; fax: +82 2 2007 1466. E-mail address: [email protected] (J.H. Lee). http://dx.doi.org/10.1016/j.ejogrb.2015.03.004 0301-2115/ß 2015 Elsevier Ireland Ltd. All rights reserved.
Furthermore, single-port laparoscopic surgery (SP-LS) is difficult to apply in myomectomy because it is inevitably accompanied by technical difficulties, particularly in laparoscopic suturing and knotting. To overcome the technical disadvantages of SP-LM, the authors developed a new surgical technique called ‘Single-port Laparoscopically Assisted-transumbilical Ultraminilaparotomic Myomectomy (SPLA-TUM)’ by integrating the advantages of both single-port laparoscopy and minilaparotomy [8]. The authors hypothesized that SPLA-TUM might shorten the operating time while maintaining the feasibility, safety, and advantages of singleport laparoscopy. In this study, we evaluated whether SPLA-TUM has a shorter operating time than SP-LM.
84
J.-S. Yuk et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 188 (2015) 83–87
Materials and methods Study design This prospective, randomized, controlled trial was performed at a university teaching hospital from July 2012 to November 2013. The study protocol was approved by the institutional review board at our hospital.
with a submucosal or deep intramural fibroid on ultrasonographic examination, or (3) women with psychiatric disorders, an American Society of Anesthesiologist classification grade >3, malignant disease, tattoos and piercing in the umbilicus, a history of keloids, a previous umbilicus scar, or medical conditions that could affect wound healing, such as diabetes mellitus, severe malnutrition, and disease requiring chronic corticosteroids. Each patient was enrolled prior to undergoing surgery and provided written informed consent.
Participants Operative technique All premenopausal women (older than 18 years old) scheduled for SP-LM were enrolled. The indications of SP-LM are women with symptomatic, superficial intramural or subserosal type of fibroid on ultrasonographic examination and with a uterus 16 weeks gestational size on pelvic examination [2,5,8]. A fibroid is defined as a superficial intramural fibroid when the distance between it and the endometrium is >5 mm on an ultrasonographic examination. The following exclusion criteria were applied: (1) women younger than 18 years old or postmenopausal women, (2) women
SPLA-TUM and SP-LM were performed in the same manner as our previous studies [2,5,8]. Common in both methods, the GelPoint access (Alexis, Applied Medical, Rancho Santa Margarita, CA, USA) was established through a 15–20 mm trans-umbilical incision under general anesthesia (Fig. 1A). After injecting a dilute solution of vasopressin (10 IU/100 mL normal saline) into the tissue around the base and capsule of fibroids, the fibroids were resected using conventional and articulating laparoscopic instruments
Fig. 1. The actual image of single port laparoscopic myomectomy (SP-LM) and single port laparoscopically assisted—transumbilical ultraminilaparotomic myomectomy (SPLA-TUM) (A) The GelPoint platform establishment, (B) Injections of a dilute solution of vasopressin into the tissue around the fibroid, (C) Resection of a fibroid using conventional and articulating laparoscopic instruments, intraperitoneal view (D) and extraperitoneal view (E) of extracorporeal knots that were seated using a knot pusher phase in SP-LM, and (F) the closure of uterine defect in SPLA-TUM.
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(Fig. 1B and C). The morcellation and extraction of the resected fibroid was performed with a scalpel through the umbilical incision. The technical difference between the methods was as follows. In SPLM, the defect in the myometrial and serosal layers was closed in one layer using interrupted sutures of 1–0 polyglactin 910 (Vicryl1, Ethicon Inc., Somerville, NJ, USA), with extracorporeal knots that were seated using a knot pusher (Fig. 1D and E). In SPLA-TUM, the GelPort was detached from the wound retractor, and the umbilical incision was pulled caudally with an Army-Navy retractor. Then, the uterine incision was grasped with Allis clamps and pulled toward the transumbilical incision. The myometrial and serosal layers were approximated in one layer with figure-of-8 sutures of 1–0 polyglactin 910 just above or below the wound retractor in the same manner as a minilaparotomic myomectomy (Fig. 1F). Outcomes measured The primary endpoint was to compare the operating time and short-term outcomes of SPLA-TUM and SP-LM. The secondary endpoint was to compare the postoperative pain and cosmetic outcomes of both procedures. Preoperative magnetic resonance imaging (MRI) was performed in all patients, and the size of the removed fibroids was determined based on the MRI. All fibroids that were found on MRI were removed. The operating time was defined as the period elapsed from the skin incision to the skin closure. The hemoglobin change was calculated by the difference between the preoperative hemoglobin level and the hemoglobin level on the first postoperative day. The return of bowel activity was defined as the period from the end of anesthesia to the first occurrence of bowel gas passage; and postoperative fever was defined as a body temperature 38 8C on two consecutive occasions at least 6 h apart, except during the first 24 h.
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every 12 h) was administered by patient request and was recorded. Postoperative pain was assessed using visual analogue scale (VAS) scores and postoperative analgesic use. The VAS (0 mm, no pain and 100 mm, maximal pain) scores were measured postoperatively at 2, 6, 12, 24, and 48 h. Scar and satisfaction assessment The length of the scar was measured with the scale in the supine position. Scar assessment was performed at 3 postoperative months using the Vancouver scar scale (VSS) [9]. The VSS rated the following four physical characteristics of the scar: vascularity, pigmentation, pliability, and height. Each variable contained ranked subscales that may be summed to obtain a total score ranging from 0 to 13, wherein 0 represents normal skin. All patients were asked to rate their overall satisfaction with the scars using a 10 cm VAS [10]. Sample size and randomization Based on our preliminary study of SPLA-TUM [8], the sample size was estimated with an equation appropriate for comparing two independent group means and was based on a two-sided a level of 0.05 having 90% power to detect a 10% difference in the operating time. A minimum sample size was 42 patients for each arm and at least 92 subjects needed to be randomized, assuming a 10% attrition rate. The patients were randomly assigned using a computer-generated list of random numbers. The randomization sequence was generated with a single block size of four. The randomization was performed in the operating room. A flow diagram of the participants is presented in Fig. 2. Statistical analysis
The patients were followed-up postoperatively at 10 days, 1 month and 3 months. At each visit, we performed a pelvic examination and transvaginal ultrasonography and evaluated the umbilical wounds and any surgical complications. At 3 postoperative months, we assessed the scars and the patients’ satisfaction with them.
The data are expressed as the mean standard deviation. Normality testing was conducted using the Shapiro–Wilk test for normality on each variable. An unpaired t-test was used to compare parametric variables, and Pearson’s x2 test or Fisher’s exact test was used to compare the categorical variables. P < 0.05 indicates a significant difference. All analyses were performed using the Statistical Package for Social Sciences (SPSS), version 17.0 for Windows (SPSS Inc., Chicago, IL, USA).
Postoperative pain assessment
Results
For postoperative pain control, tramadol (25 mg, intravenous injection every 6 h) or diclofenac (90 mg, intramuscular injection
During the study period, 116 women were assessed for eligibility; 92 of these women fulfilled both the inclusion and
Monitoring
Fig. 2. Flow diagram of the participants. SP-LM Single port laparoscopic myomectomy; SPLA-TUM Single port laparoscopically assisted—transumbilical ultraminilaparotomic myomectomy.
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exclusion criteria and were randomly assigned to SPLA-TUM or SPLM group (46 women in each group) (Fig. 1). There were no statistically significant between-group differences in the demographics of the participants or in the clinical characteristics of the resected fibroids (Tables 1 and 2). In terms of operative results, there were no significant differences in the hemoglobin changes, return of bowel activity, hospital stay, or complication rate between the groups (Table 3). The mean operating time in the SPLA-TUM group was shorter than that in the SP-LM group (P = 0.026). In two (4.3%) women in the SPLA-TUM group, SPLA-TUM was converted to SP-LM because SPLA-TUM did not provide a satisfactory surgical field. In one (2.2%) case in the SP-LM group and two (4.3%) cases in the SPLATUM group, two- or three-port laparoscopic myomectomy was performed because the SP-LM failed to repair the uterine defect or to properly dissect the tissue surrounding the fibroid that was located on the lower posterior wall of the uterus or lateral pelvic wall. Women with postoperative fever or transient ileus were treated conservatively. There were no between-group differences in the postoperative pain levels, VSS scores, and overall satisfaction with the scars, but the SPLA-TUM group had a longer umbilical wound than the SP-LM group (Table 4). Comment In our previous report on the surgical technique and initial experience of SPLA-TUM, we proposed that SPLA-TUM theoretically has several advantages provided by single-port laparoscopy and ultraminilaparotomy [8]. In aspect of single-port laparoscopy, the advantages are (1) favorable cosmetic outcomes and (2) greater applicability, as well as minimizing surgical injuries to the tubes or uterus by better understanding of the anatomical relationship compared with minilaparotomy. On the other hand, the advantages that the nature of ultraminilaparotomy offers are (1) shortening the surgical time by convenient suturing and knotting, as well as by quickly removing the resected fibroids, (2) retaining a tactile sense, and (3) shortening the learning curve. The authors proposed that shortening the surgical time is the most valuable clinical advantage, and performed the current study to confirm this hypothesis. In this study, there were no differences between the Table 1 Demographics of the participants. SP-LM group
SPLA-TUM group
P-value
Mean SD/number (%) Number of patients Age (years) Parity Nulliparous Multiparous BMI (kg/m2) Number of patients with previous abdominal surgeries Number of surgeries = 1 Number of surgeries = 2 Indication for myomectomy Dysfunctional uterine bleeding Dysmenorrhea Menorrhagia Pelvic pain Infertility Palpable pelvic mass Urinary symptom
46 36.9 6.8
46 37.3 6.3
32 (69.6) 14 (30.4) 22.9 3.3 9 (19.6)
33 (71.7) 13 (28.2) 21.7 2.8 9 (19.6)
7 (15.2) 2 (4.3)
4 (8.7) 5 (10.9)
(6.5) (21.7) (19.6) (19.6) (8.7) (21.7) (2.2)
6 8 6 11 2 10 3
SP-LM group
114
(13.0) (17.4) (13.0) (23.9) (4.3) (21.7) (6.5)
SP-LM group = women who underwent single-port laparoscopic myomectomy; SPLA-TUM group = women who underwent single-port laparoscopically assistedtransumbilical ultraminilaparotomic myomectomy. a Using an unpaired t test. b Using Pearson’s x2 test.
P-value
0.972a
113
2.5 1.8
2.5 1.8
0.954a
3.5 2.7
3.7 2.6
0.587a
6.1 2.3
6.2 2.0
0.846a 0.241b
51 38 20 5
(44.7) (33.3) (17.5) (4.4)
53 34 14 12
(46.9) (30.1) (12.4) (10.6) 0.526b
45 (39.5) 69 (60.5)
40 (35.4) 73 (64.6)
SP-LM group = women who underwent single-port laparoscopic myomectomy; SPLA-TUM group = women who underwent single-port laparoscopically assistedtransumbilical ultraminilaparotomic myomectomy. a Using an unpaired t test. b Using Pearson’s x2 test.
SPLA-TUM and SP-LM groups regarding the clinical characteristics of the patients and resected fibroids, which can affect the surgical results. No differences were noted between the groups for the operative outcomes, including changes in the hemoglobin, return of bowel activity, hospital stay, complication rate, and the rate of using an additional trocar. However, the operating time in the SPLA-TUM group was approximately 15% less than that in the SPLM group (87.0 32.7 min compared with 102.3 32.9 min, P = 0.026). These findings showed that SPLA-TUM is feasible and safe and can reduce the operating time in selected women with symptomatic fibroid compared with SP-LM. One or two additional trocars were utilized in one (2.2%) woman in the SP-LM group and two (4.3%) women in the SPLATUM group. In these cases, we could not complete the repair of the hysterotomy site or the proper dissection of the tissue surrounding the fibroid because the fibroid was located on the lower posterior wall of the uterus or lateral pelvic wall. Although various instruments and surgical techniques for single-port laparoscopy have been developed, single-port laparoscopy is accompanied inevitably by increased technical difficulty and restricted surgical Table 3 Operation outcomes. SP-LM group
0.059a 0.349b
SPLA-TUM group
Mean SD/number (%) Total number of removed fibroids Mean number of removed fibroids in each patient Mean diameter of the removed fibroid (cm) Maximal diameter of the largest fibroid in a patient (cm) Location of myoma Anterior Posterior Fundal Lateral Type of myoma Subserosal Intramural
0.753a 0.891b
0.719b 3 10 9 9 4 10 1
Table 2 Clinical characteristics of the resected fibroids.
SPLA-TUM group
P-value
Mean SD/number (%) Operating time (min) Hemoglobin change (g/dL) Return of bowel activity (h) Hospital stay (days) Conversion to SP-LM, multiport laparoscopy, or laparotomy Conversion to SP-LM Conversion to multiport laparoscopy Conversion to laparotomy Operative complication Postoperative fever Transient ileus Transfusion
102.3 32.9 1.4 0.8 39.4 8.8 4.3 0.5
87.0 32.7 1.6 0.8 38.3 10.6 4.2 0.4
1 (2.2)
2 (4.3) 2 (4.3)
0 (0)
0 (0)
1 (2.2) 2 (4.3) 4 (8.7)
1 (2.2) 0 (0) 3 (6.5)
0.026a 0.361a 0.607a 0.364a 0.203b
0.521c
SP-LM group = women who underwent single-port laparoscopic myomectomy; SPLA-TUM group = women who underwent single-port laparoscopically assistedtransumbilical ultraminilaparotomic myomectomy. a Using the unpaired t test. b Using Fisher’s exact test. c Using Pearson’s x2 test.
J.-S. Yuk et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 188 (2015) 83–87 Table 4 Postoperative pain and cosmetic outcomes. SP-LM group SPLA-TUM group P-value Mean SD/number (%) Postoperative pain (VAS score) At 2 postoperative hours 6.3 2.3 6.5 2.2 At 6 postoperative hours 3.8 2.3 3.9 1.9 At 12 postoperative hours 2.8 1.7 3.0 1.6 At 24 postoperative hours 2.0 1.2 2.1 1.6 At 48 postoperative hours 1.9 1.7 2.3 1.9 Cumulative number of patients given additional analgesics At 2 postoperative hours 6 (13.0) 11 (23.9) At 6 postoperative hours 7 (15.2) 13 (28.2) At 12 postoperative hours 8 (17.4) 14 (30.4) At 24 postoperative hours 11 (23.9) 15 (32.6) At 48 postoperative hours 11 (23.9) 15 (32.6) Cosmetic outcomes Length of umbilical wound (mm) 17.7 4.1 19.5 3.6 Vancouver scar scale score 4.2 2.2 4.3 2.2 VAS for scar cosmesis 8.1 1.9 8.1 2.4
0.695a 0.641a 0.642a 0.643a 0.644a 0.179b 0.129b 0.143b 0.354b 0.354b 0.029a 0.851a 0.964a
SP-LM group = women who underwent single-port laparoscopic myomectomy; SPLA-TUM group = women who underwent single-port laparoscopically assistedtransumbilical ultraminilaparotomic myomectomy; VAS for scar cosmesis = visual analog scale represents the patients’ overall satisfaction with the scar. a Using an unpaired t test. b Using Pearson’s x2 test.
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be identical to the obstetrical results after laparotomic myomectomy because suturing and knotting in SPLA-TUM are performed in the same manner as those in laparotomic myomectomy. Laparoscopic myomectomy reportedly reduces postoperative adhesion, which might influence postoperative fertility [13]. Although the fibroid is laparoscopically removed, and there is great distance between the hysterotomy scar and the abdominal incision in SPLA-TUM, further study is needed to determine whether SPLA-TUM reduces postoperative adhesion formation, as with laparoscopic myomectomy. Our study has several limitations. First, although BMI is thought to be an important factor that affects accessibility in SPLA-TUM, this study included only Korean women, who have lower BMIs compared with the Western population [14]. Second, a comparison with minilaparotomic myomectomy, which is another alternative to SP-LM, was not performed. Third, because reasonable indications for SP-LM have not yet been established, our arbitrary inclusion and exclusion criteria were used. In conclusions, SPLA-TUM has a shorter surgical time than SPLM because of the convenient suturing and knotting used, and the two procedures have comparable postoperative pain and cosmetic outcomes. However, further studies are needed to evaluate the long-term outcomes of SPLA-TUM. Conflict of interest statement
space; SP-LS instruments that could overcome these problems are unavailable [2]. Therefore, the authors believe that it is inevitable that some of the SP-LS operations are converted to multiport laparoscopy, and the surgeon should not hesitate to place additional trocars if needed. Two (4.3%) cases in the SPLA-TUM group were converted to SP-LM because the hysterotomy site could not be exposed for suturing through the umbilical incision. These cases involved nulliparous women, with relatively high body mass indices (BMIs) (26.26 and 27.78 kg/m2). As mentioned in our previous report [8], the patients’ tissue pliability, parity, BMIs, and height affected the accessibility of SPLA-TUM. The authors discount the preoperative prediction of the SPLA-TUM accessibility on a specific person because general anesthesia can highly impact the tissue pliability. Nevertheless, based on our experience, SPLA-TUM seems to be unlikely to be offered in obese, tall, nulliparous women. In designing SPLA-TUM, we identified two problems that can arise from this procedure. One is whether SPLA-TUM increases postoperative pain by retracting an umbilical incision, and the other is whether SPLA-TUM elongates the length of the incision by pulling the umbilicus caudally. In this study, there was no significant difference in the pain score and analgesics consumption within 48 h after the operation between the two groups. This result showed that SPLA-TUM did not increase the postoperative pain level. These findings are thought to be caused by how the umbilical traction in SPLA-TUM affects the postoperative pain level, which is negligible, or by the anatomical characteristics of the umbilicus, which lacks muscle [11]. However, although the difference between the groups was statistically insignificant, there was a trend for increase in the number of patients who needed analgesics for the insignificant difference between the VAS scores of the groups for postoperative pain. Regarding the cosmetic outcomes, the umbilical scar length in the SP-LM group was approximately 2 mm longer than that in the SPLA-TUM group (17.7 4.1 compared with 19.5 3.6, P = 0.029). However, the VSS score and overall satisfaction with the scars was not different between the two groups. The results were similar to those of our previous report on the postoperative pain after single port laparoscopic surgery [12]. Therefore, although SPLA-TUM slightly extends the umbilical incision, it does not appear to have a clinically significant effect on cosmesis. Regarding the obstetrical outcomes after SPLA-TUM, the strength of the hysterotomy site after SPLA-TUM is believed to
This article was not supported by any financial funds and not affiliated with the instrumental company referred to in the text. Condensation Compared with single port laparoscopic myomectomy, singleport laparoscopically assisted-transumbilical ultraminilaparotomic myomectomy (SPLA-TUM) can shorten surgical times, with comparable postoperative pain and cosmetic outcomes. References [1] Kim YW, Park BJ, Ro DY, Kim TE. Single-port laparoscopic myomectomy using a new single-port transumbilical morcellation system: initial clinical study. J Minim Invasive Gynecol 2010;17:587–92. [2] Lee JH, Choi JS, Jeon SW, Son CE, Lee SJ, Lee YS. Single-port laparoscopic myomectomy using transumbilical GelPort access. Eur J Obstet Gynecol Reprod Biol 2010;153:81–4. [3] Choi CH, Kim TH, Kim SH, et al. Surgical outcomes of a new approach of laparoscopic myomectomy: single port and modified suture technique. J Minim Invasive Gynecol 2014;21:580–5. [4] Han CM, Lee CL, Su H, Wu PJ, Wang CJ, Yen CF. Single-port laparoscopic myomectomy: initial operative experience and comparative outcome. Arch Gynecol Obstet 2013;287:295–300. [5] Kim JY, Kim KH, Choi JS, Lee JH. A prospective matched case-control study of laparoendoscopic single site versus conventional laparoscopic myomectomy. J Minim Invasive Gynecol 2014;21:1036–40. [6] Kim SK, Lee JH, Lee JR, Suh CS, Kim SH. Laparoendoscopic single-site myomectomy versus conventional laparoscopic myomectomy: a comparison of surgical outcomes. J Minim Invasive Gynecol 2014;21:775–81. [7] Yoshiki N, Okawa T, Kubota T. Single-incision laparoscopic myomectomy with intracorporeal suturing. Fertil Steril 2011;95:2426–8. [8] Kang JH, Lee DH, Lee JH. Single-port laparoscopically assisted transumbilical ultraminilaparotomic myomectomy. J Minim Invasive Gynecol 2014;21: 945–50. [9] Baryza MJ, Baryza GA. The Vancouver scar scale: an administration tool and its interrater reliability. J Burn Care Rehabil 1995;16:535–8. [10] Duncan JA, Bond JS, Mason T, et al. Visual analogue scale scoring and ranking: a suitable and sensitive method for assessing scar quality. Plast Reconstr Surg 2006;118:909–18. [11] Ghezzi F, Cromi A, Colombo G, et al. Minimizing ancillary ports size in gynecologic laparoscopy: a randomized trial. J Minim Invasive Gynecol 2005;12:480–5. [12] Eom JM, Ko JH, Choi JS, Hong JH, Lee JH. A comparative cross-sectional study on cosmetic outcomes after single port or conventional laparoscopic surgery. Eur J Obstet Gynecol Reprod Biol 2013;167:104–9. [13] Bulletti C, Polli V, Negrini V, Giacomucci E, Flamigni C. Adhesion formation after laparoscopic myomectomy. J Am Assoc Gynecol Laparosc 1996;3:533–6. [14] Kim DM, Ahn CW, Nam SY. Prevalence of obesity in Korea. Obes Rev 2005;6:117–21.
