Accepted Manuscript A prospective matched case-control study of laparoendoscopic single site versus conventional laparoscopic myomectomy Ji Ye Kim , MD Kye Hyun Kim , MD, PhD Joong Sub Choi , MD, PhD Jung Hun Lee , MD, PhD PII:
S1553-4650(14)00283-0
DOI:
10.1016/j.jmig.2014.04.017
Reference:
JMIG 2310
To appear in:
The Journal of Minimally Invasive Gynecology
Received Date: 26 March 2014 Revised Date:
27 April 2014
Accepted Date: 29 April 2014
Please cite this article as: Kim JY, Kim KH, Choi JS, Lee JH, A prospective matched case-control study of laparoendoscopic single site versus conventional laparoscopic myomectomy, The Journal of Minimally Invasive Gynecology (2014), doi: 10.1016/j.jmig.2014.04.017. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Running head: Outcomes of laparoendoscopic single site myomectomy
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Title: A prospective matched case-control study of laparoendoscopic single site versus
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conventional laparoscopic myomectomy
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Authors’ names: Ji Ye Kim, MD,1 Kye Hyun Kim, MD, PhD,1 Joong Sub Choi, MD, PhD,2
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and Jung Hun Lee, MD, PhD3
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Authors’ affiliations: 1The Department of Obstetrics and Gynecology, Kangbuk Samsung
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Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea, 2The
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Department of Obstetrics and Gynecology, College of Medicine, Hanyang University
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Hospital, Seoul, Republic of Korea, and 3Department of Obstetrics and Gynecology,
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MizMedi Hospital, Seoul, Republic of Korea
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Corresponding author: Jung Hun Lee, MD, Ph.D., Director of Division of Gynecologic
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Oncology and Gynecologic Minimally Invasive Surgery Center, full time faculty member of
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the Department of Obstetrics and Gynecology, MizMedi Hospital, 295, Gangseo-ro,
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Gangseo-gu, Seoul, 157-723, Republic of Korea
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Tel: 82-10-6316-7470
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Fax: 82-2-2007-1466
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E-mail: [email protected]
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Abstract
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Study Objective: To compare operative and obstetric outcomes of laparoendoscopic single
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site myomectomy (LESS-M) versus conventional laparoscopic myomectomy (conventional-
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LM).
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Design: Prospective matched case-control study.
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Setting: A university hospital and a tertiary care center.
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Patients: Forty-five women underwent LESS-M (LESS-M group) and 90 women received
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conventional LM (conventional LM group)
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Intervention: LESS-M or conventional LM.
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Measurements: Operative and obstetric outcomes.
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Main Results: There were no significant differences in the demographic characteristics,
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operating time (135 vs. 140 minutes), hemoglobin change (1.9 vs. 1.95 g/dL), return of bowel
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activity (35 vs. 28 hours), hospital stay (5 vs. 5 days), or complication rate (11.1 vs. 8.9%)
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between the groups. In terms of obstetric outcomes, no significant differences were observed
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in the duration of follow-up (24.4 vs. 23.2 months), pregnancy rate among patients who
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desired pregnancy (66.7 vs. 50.0%), full-term delivery rate (66.7 vs. 58.3%), and the time to
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first pregnancy after surgery (7.6 vs. 10.1 months) between the two groups.
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Conclusion: LESS-M is feasible and safe and has comparable obstetric outcomes to
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conventional-LM in selected women with symptomatic myomas. However, a large
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prospective randomized study is needed.
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Keywords: Myomectomy, Gynecology, Laparoscopy, Single port surgery
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Introduction
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Uterine myoma is the most common benign tumor of the female genital tract [1]. Since
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Semm introduced laparoscopic myomectomy in the 1970s, it has been an alternative surgical
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treatment for women who wish to preserve their uterus [2]. Recently, with technical
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improvement and the increasing use of minimally invasive surgery, single port laparoscopic
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surgeries have been reported in various surgical fields [3-5]. Despite technical difficulties,
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several articles regarding laparoendoscopic single site myomectomy (LESS-M) reported
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similar operative results and better cosmetic outcomes compared to conventional
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laparoscopic myomectomy (conventional-LM) [1,5].
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To our knowledge, these studies addressed only the surgical technique of LESS-M, and
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there are no studies on its operative or obstetric outcomes [1,6,7]. Therefore, in this study, we
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aimed to compare operative and obstetric outcomes of LESS-M versus conventional-LM.
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Materials and Methods
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This prospective matched case-control study was performed at a university teaching
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hospital from January 2009 to April 2012. Institutional review board approval was obtained
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at the Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine.
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The inclusion criteria were the presence of a symptomatic myoma measuring 8 cm or less
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on ultrasonographic examination and a superficial intramural or subserosal type of myoma. A
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myoma is defined as a superficial intramural myoma when the distance between it and the
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serosa is less than 5 mm on an ultrasonographic examination. Patients whose myomas
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measured > 8 cm or with a submucosal or deep intramural myoma on ultrasonographic
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examination were excluded. LESS-M was preoperatively suggested to all patients fulfilling
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both inclusion and exclusion criteria, and it was performed with the consent of the patients.
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The decision to perform this procedure was not influenced by the patient’s history of
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previous abdominal surgery or body mass index (BMI).
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All data on the clinical characteristics of the patients and the resected myomas were
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prospectively collected. According to the operative findings, the characteristics of the
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myomas were described in terms of the size, number, location, and type. The size of the
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myoma was recorded as follows: each diameter of the resected myoma, the maximal
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diameter of the largest myoma, and the mean diameter of the resected myomas. The
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diagnosis of myoma was histologically confirmed in all cases. The operating time was defined as the period from the incision in the skin to the closure
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of the skin. The hemoglobin change was calculated by the difference between the
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preoperative hemoglobin level and the hemoglobin level on the first postoperative day. The
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return of bowel activity was defined as the period from the end of anesthesia to the first
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occurrence of bowel gas passage. Finally, postoperative fever was defined as a body
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temperature equal to or higher than 38 °C on two consecutive occasions at least six hours
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apart, except during the first 24 hours. Surgical complications were graded according to the
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Dindo–Clavien classification [8].
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LESS-M and conventional-LM were performed in the same manner as our previous report
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[1].
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and articulating laparoscopic instruments after establishing GelPort access (Alexis, Applied
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Medical, Rancho Snata Margarita, CA) through a 15-20mm trans-umbilical incision. The
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defect in the myometrial and serosal layers was closed in one layer by interrupted sutures of
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1-0 polyglactin 910 (Vicryl®, Ethicon Inc., Somerville, NJ) using extracorporeal knots. The
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morcellation and extraction of resected myomas was performed with a scalpel through the
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umbilical incision. In conventional-LM, two 5mm trocars in the umbilicus and left upper
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quadrant and a 12mm trocar in the suprapubic area were used. Laparoscopic myomectomy
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and the closure of uterine defects were carried out in same manner as described above.
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In terms of LESS-M, laparoscopic myomectomy was performed using conventional
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Resected myomas were morcelated and removed via the suprapubic trocar using the
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Gynecare Morcellex tissue morcellator (Ethicon, Inc., Somerville, NJ).
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Statistical Analyses
Each variable was confirmed as not following a normal (Gaussian) distribution via the
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Shapiro–Wilk test. The unpaired t test and a mixed model were used to compare each group’s
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continuous parametric variables. The general estimating equation, Pearson's χ2 test and
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Fisher’s exact test were used to compare the categorical variables. P < 0.05 was taken to
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indicate a significant difference. All analyses were performed using the Statistical Package
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for Social Sciences (SPSS) version 18.0 for Windows (SPSS Inc., Chicago, IL, USA).
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Results
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During the study period, 328 women with symptomatic myomas fulfilled the inclusion
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criteria and exclusion criteria. Among them, 50 patients underwent laparoendoscopic single
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site myomectomy (LESS-M group), and 283 patients underwent conventional laparoscopic
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myomectomy (conventional-LM group). To compare operative outcomes and obstetric
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outcomes, 45 patients of the LESS-M group were matched 1:2 against 90 patients who
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received conventional-LM using the patient’s age and the clinical characteristics (including
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number, type, maximal diameter, and mean diameter) of the resected myomas. The remaining
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patients (n=5) of the LESS-M group could not be matched and were excluded.
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There were no statistically significant differences in clinical characteristics of patients and the resected myomas between the two groups (Tables 1 and 2). In terms of operative results, there were no significant differences between the groups
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(Table 3). One patient in the conventional-LM group underwent fimbrioplasty, and four
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patients in each group with chronic lower abdominal pain and an edematous appendix during
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the operation underwent selective appendectomy.
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Thirteen women had a surgical complication less than grade III, according to the Dindo-
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Clavien classification. These complications included intraoperative bleeding that required
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transfusion, postoperative ileus, voiding difficulty, and supra-pubic wound infection. These
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complications were resolved with conservative treatment. One woman in the conventional-
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LM group underwent reoperation for bleeding of the uterine incision. We converted the
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LESS-M to two-port LM in 3 cases with severe pelvic adhesions.
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The obstetrical outcomes are summarized in Table 4; 8 women in the LESS-M group and
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9 women in the conventional-LM achieved pregnancy. One woman experienced 3
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consecutive pregnancy losses at 23, 26, and 39 months after conventional-LM and was
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diagnosed with recurrent abortion.
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Discussion
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Laparoscopic myomectomy (LM) has become popular since its introduction by Semm in
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the 1970s [2]. Since the 1990s, laparoendoscopic single site surgery (LESS)has been
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performed in various surgical fields, and these procedures include cholecystectomy,
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appendectomy, and hysterectomy [3-5,9]. Unlike LESS, articles regarding the surgical
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technique of LESS-M were published in the late 2010s. This seems to be related to the
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technical difficulty of suturing while performing LESS-M.
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To our knowledge, there are several reports on the surgical technique of LESS-M, but no
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study has proved the feasibility and safety of LESS-M [1,7,10]. In addition, because many of
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the patients who underwent myomectomy were young women who wanted to preserve their
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fertility, obstetric outcomes following LESS-M are an essential issue. However, no studies
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have reported on this issue. Therefore, the authors performed this study to investigate the
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operative and obstetric outcomes of LESS-M.
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Objectively assessing and comparing the operative and obstetric outcome of LESS-M and
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conventional-LM is an extremely complex process. Patient age, the number of resected
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myomas, the type of resected myomas, the diameter of resected myomas, and other issues
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can have considerable influence on these outcomes. Therefore, to minimize the influence of
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those confounding factors, we matched the LESS-M group 1:2 against patients undergoing
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conventional-LM by age and clinical characteristics (including the number, type, maximal
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diameter, and mean diameter) of the resected myomas. This study compared the feasibility and safety of LESS-M and conventional-LM. As
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shown in Table 3, there were no statistically significant differences in operating time,
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hemoglobin change, hospital stay, complication rate, or conversion rate to multiport
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laparoscopy or laparotomy between the two groups. These results show that LESS-M is
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feasible and safe in selected women with symptomatic myomas. However, the LESS-M and
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conventional-LM groups yielded approximately the same results of 135 minutes and 140
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minutes, respectively. The mean operating time for conventional-LM was 97.1 - 155 minutes
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in recent studies, and 25.2% (34 women) of the patients involved in this study underwent
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concomitant surgery [11-13]. Considering this, our result seems to be reasonably acceptable.
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The remarkable point of this study is that while a longer operating time is considered to
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be the disadvantage of LESS, such a longer operating time was not observed the LESS-M
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group. This result seems to be caused by the following factors: 1) rapid morcellation and
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extraction of resected myomas through a relatively large, transumbilical incision using a
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scalpel; 2) proper selection criteria for LESS-M; 3) usage of extracorporeal knotting with a
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conventional knot pusher to minimize technical difficulty of LESS-M; and 4) the surgeon’s
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accumulated experience over approximately 600 cases of LESS since 2009.
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Regarding obstetric outcomes, previous studies reported that pregnancy rate and abortion
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rate after conventional-LM were 40.7-65.4% and 20.4-27.2%, respectively [14-16]. In this
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study, there were no statistically significant differences between the LESS-M group and the
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conventional-LM group in terms of the pregnancy rate (9 women (66.7%) vs. 12 women
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(52.9%), respectively) or abortion rate (1 woman (11.1%) vs. 3 women (25.0%), respectively)
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during the follow-up (24.4 vs. 23.2 months, respectively). There were no cases of premature
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delivery or uterine rupture. All women who became pregnant following ART had been
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transferred to our institution from the infertility clinic after failure of ART. These results are
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acceptable comparison to those obtained in previous studies, and we can conclude that
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obstetric outcomes following LESS-M do not differ from those following conventional-LM.
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However, LESS-M is inevitably accompanied by technical difficulty, especially in terms
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of laparoscopic suturing and knotting. This handicap can negatively influence the
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development of uterine rupture in women who underwent LESS-M, potentially resulting in
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maternal and fetal death [17]. To diminish the risk of uterine rupture, as described in our
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previous report on the surgical technique of LESS-M, we repaired the defect of the
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myometrial and serosal layers in one or two layer with interrupted sutures of 1-0 polyglactin
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910 (Vicryl®, Ethicon Inc., Somerville, NJ) with extracorporeal knots using a conventional
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knot pusher and limited the use of electrocautery. Although there were no cases of uterine
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rupture before or during labor in this study, further studies are needed to confirm this finding
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because the result of this study is limited by either its small sample size or its short duration
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of follow-up. Especially considering LESS-M with three arms and conventional-LM with
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four arms, obstetric outcomes following LESS-M using techniques such as continuous
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suturing or intracorporeal knotting that require expert surgical skills might differ from the
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outcomes of this study.
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The advantages of this study are as follows: 1) recall bias was avoided because this study
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was a prospective design; 2) the effects of the possible confounding factors were minimized
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by matching with various variables such as patient age and clinical characteristics (including
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number, type, maximal diameter, and mean diameter) of the resected myomas; 3) this is a
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first report on the obstetric outcomes following LESS-M; and 4) this study has a relatively
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large number of LESS-M cases and extended follow-up. There are also some limitations of
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our study. First, the study was not able to assess the safety of vaginal delivery after LESS-M
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because all women who delivered after LESS-M underwent elective Cesarean delivery.
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Second, the study was not a large prospective randomized study, although selection bias was
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minimized by a patient’s selection of LESS-M or conventional-LM. Third, the study was not
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able to evaluate a learning curve of LESS-M and the effect of LESS-M on the postoperative
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pain and cosmetic outcome, which are theoretical advantages of LESS.
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In addition, although the result of our study shows the feasibility and safety of LESS-M,
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this may not apply to all surgeons because this study was carried out by expert laparoscopists.
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So, surgeons without the experience of LESS-M need sufficient practice of suturing using
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articulating laparoscopic instruments before performing it. Considering the goal of LESS-M
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is not LESS itself but the myomectomy, if necessary, surgeons should not be afraid of
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conversion from LESS-M to multiport laparoscopic myomectomy for achieving the original
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purpose of a complete myomectomy.
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Conclusions
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In conclusion, LESS-M is feasible and safe and has comparable obstetric outcomes to
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conventional-LM in selected women with symptomatic myomas. However, a large
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prospective randomized study is required to confirm these findings.
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Disclosure Statement
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No competing financial interests exist.
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http://www.AAGL.org/jmig-21-6-JMIG-D-14-00163R1
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Précis
2 Laparoendoscopic single site myomectomy is feasible and safe and has comparable
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obstetric outcomes to conventional laparoscopic myomectomy.
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Table 1. Clinical characteristics of the patients Conventional
-LM group
p- value
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SP-LM group
Median (range) / Number (percent) Number of patients
Age (years) 26-30 31-35
0.301 a
18 (20.0)
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9 (20.0)
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45
11 (24.4)
19 (21.1)
14 (31.1)
27 (30.0)
8 (17.8)
21 (23.3)
3 (6.6)
5 (5.5)
30 (66.7)
54 (60.0)
15 (33.0)
36 (40.0)
22.2 (16.6-28.4)
22.2 (15.4-37.2)
0.259 b
7 (15.5)
27 (30.0)
0.051 a
Number of surgeries = 1
4 (8.9)
19 (21.1)
Number of surgeries = 2
3 (6.7)
7 (7.8)
36-40 41-45
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46-52 Parity
Multiparous
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Nulliparous
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Body mass index (kg/m2)
Number of patients with previous ab-
dominal surgeries
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Number of surgeries = 3
0 (0)
1 (1.1)
Indication for myomectomy
0.591 a 2 (4.4)
14 (15.6)
Dysmenorrhea
7 (15.6)
8 (8.9)
Menorrhagia
8 (17.8)
12 (13.3)
Pelvic pain
8 (17.8)
Infertility
7 (15.6)
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Dysfunctional uterine bleeding
Palpable pelvic mass Urinary symptom
20 (22.2) 3 (3.3)
11 (24.4)
28 (31.1)
2 (4.4)
5 (5.6)
SP-LM group, group underwent single-port laparoscopic myomectomy; Conventional LM
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group, group underwent conventional laparoscopic myomectomy. By the general estimating equation
b
By the mixed model
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Table 2. Characteristics of the removed myomas Conventional LM SP-LM group p- value
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group Median (range) / Number (percent) 73
Mean diameter of myoma in a pa5.0 (2.5-8.0)
Maximal diameter of largest myo-
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tient (cm)
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Total number of removed myomas
5.4 (3.2-8.0)
ma in a patient (cm) Location of myomas
5.9 (2.7-8.0)
0.162 a
30 (41.1)
45 (30.8)
25 (34.2)
61 (41.8)
6 (8.2)
23 (15.8)
12 (16.4)
17 (11.6)
Subserosal
29 (40.0)
58 (39.7)
Intramural
44 (60.0)
88 (60.3)
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Anterior
4.8 (2.0-8.0)
Posterior
Fundal
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Type of myoma
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Lateral
SP-LM group, group underwent single-port laparoscopic myomectomy; Conventional LM group, group underwent conventional laparoscopic myomectomy. a
By the Pearson’s χ2 test
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Table 3. Operative results Conventional LM SP-LM group p- value
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group Median (range) / Number (percent) 135 (65-185)
140 (40-480)
0.319 a
Hemoglobin change (g/dL)
1.9 (0.2-5.8)
1.9 (0.1-5.3)
0.695 a
31.4 (5.2-76.2)
0.641 a
Hospital stay (days)
5 (4-7)
Concomitant surgery Bilateral adnexal surgery
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Unilateral adnexal surgery Incidental appendectomy
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Surgical complications
28.8 (7.5-70.1)
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Return of bowel activity (hours)
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Operating time (minutes)
5 (3-20)
0.146 b
1 (2.2)
4 (4.4)
9 (20.0)
16 (17.8)
2 (4.4)
2 (2.2) 0.737 b
5 (11.1)
7 (7.8)
Dindo-Clavien class ≥3
0
1 (1.1)
3 (6.6)
-
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Dindo-Clavien class < 3
Conversion to multiport laparoscopy or laparotomy
Conversion to multiport laparoscopy
0.663 a
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Conversion to laparotomy
0
-
SP-LM group, group underwent single-port laparoscopic myomectomy; Conventional LM
By the mixed model
b
By the general estimating equation
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group, group underwent conventional laparoscopic myomectomy.
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Table 4. Obstetrical outcomes Conventional LM
p- value
SP-LM group
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group Median (range) / Number (percent) Duration of follow up (months)
24.4 (3.0-41.1)
23.2 (3.9-41.1)
0.501 a
12 (26.7)
26 (20.0)
0.300 b
9 (50.0)
0.380 b
9
12
0.698 c
7 (77.8)
10 (83.3)
2 (22.2)
2 (16.7)
7.6 (3.1-21.7)
10.1 (0.8-26.8)
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Number of pregnancies Spontaneous pregnancy
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Pregnancy following ART Time to first pregnancy (months) Pregnancy outcome
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Ongoing pregnancy
Full-term delivery
8 (66.7)
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Number of patient who conceived
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Number of patients who want to con-
0.442 d 0.380 c
2 (22.2)
2 (16.7)
1 (11.1)
3 (25.0)
6 (66.7)
7 (58.3) 0.192 c
Delivery method
Vaginal delivery
0 (0)
3 (42.9)
Cesarean delivery
6 (100.0)
4 (57.1)
0.400 c
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6 (100.0)
3 (75.0)
Fetal distress
0 (0)
0 (0)
Dynamic dystocia
0 (0)
1 (25.0)
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Elective
SP-LM group, group underwent single-port laparoscopic myomectomy; Conventional LM
group, group underwent conventional laparoscopic myomectomy; ART, assisted reproductive
b
By the mixed model By the Pearson’s χ2 test By the Fisher’s exact test
d
By the unpaired t test
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technique
S1553-4650(14)00283-0
DOI:
10.1016/j.jmig.2014.04.017
Reference:
JMIG 2310
To appear in:
The Journal of Minimally Invasive Gynecology
Received Date: 26 March 2014 Revised Date:
27 April 2014
Accepted Date: 29 April 2014
Please cite this article as: Kim JY, Kim KH, Choi JS, Lee JH, A prospective matched case-control study of laparoendoscopic single site versus conventional laparoscopic myomectomy, The Journal of Minimally Invasive Gynecology (2014), doi: 10.1016/j.jmig.2014.04.017. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Running head: Outcomes of laparoendoscopic single site myomectomy
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Title: A prospective matched case-control study of laparoendoscopic single site versus
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conventional laparoscopic myomectomy
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Authors’ names: Ji Ye Kim, MD,1 Kye Hyun Kim, MD, PhD,1 Joong Sub Choi, MD, PhD,2
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and Jung Hun Lee, MD, PhD3
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Authors’ affiliations: 1The Department of Obstetrics and Gynecology, Kangbuk Samsung
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Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea, 2The
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Department of Obstetrics and Gynecology, College of Medicine, Hanyang University
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Hospital, Seoul, Republic of Korea, and 3Department of Obstetrics and Gynecology,
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MizMedi Hospital, Seoul, Republic of Korea
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Corresponding author: Jung Hun Lee, MD, Ph.D., Director of Division of Gynecologic
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Oncology and Gynecologic Minimally Invasive Surgery Center, full time faculty member of
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the Department of Obstetrics and Gynecology, MizMedi Hospital, 295, Gangseo-ro,
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Gangseo-gu, Seoul, 157-723, Republic of Korea
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Tel: 82-10-6316-7470
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Fax: 82-2-2007-1466
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E-mail: [email protected]
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Abstract
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Study Objective: To compare operative and obstetric outcomes of laparoendoscopic single
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site myomectomy (LESS-M) versus conventional laparoscopic myomectomy (conventional-
5
LM).
6
Design: Prospective matched case-control study.
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Setting: A university hospital and a tertiary care center.
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Patients: Forty-five women underwent LESS-M (LESS-M group) and 90 women received
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conventional LM (conventional LM group)
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Intervention: LESS-M or conventional LM.
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Measurements: Operative and obstetric outcomes.
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Main Results: There were no significant differences in the demographic characteristics,
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operating time (135 vs. 140 minutes), hemoglobin change (1.9 vs. 1.95 g/dL), return of bowel
14
activity (35 vs. 28 hours), hospital stay (5 vs. 5 days), or complication rate (11.1 vs. 8.9%)
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between the groups. In terms of obstetric outcomes, no significant differences were observed
16
in the duration of follow-up (24.4 vs. 23.2 months), pregnancy rate among patients who
17
desired pregnancy (66.7 vs. 50.0%), full-term delivery rate (66.7 vs. 58.3%), and the time to
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first pregnancy after surgery (7.6 vs. 10.1 months) between the two groups.
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Conclusion: LESS-M is feasible and safe and has comparable obstetric outcomes to
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conventional-LM in selected women with symptomatic myomas. However, a large
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prospective randomized study is needed.
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Keywords: Myomectomy, Gynecology, Laparoscopy, Single port surgery
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Introduction
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Uterine myoma is the most common benign tumor of the female genital tract [1]. Since
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Semm introduced laparoscopic myomectomy in the 1970s, it has been an alternative surgical
5
treatment for women who wish to preserve their uterus [2]. Recently, with technical
6
improvement and the increasing use of minimally invasive surgery, single port laparoscopic
7
surgeries have been reported in various surgical fields [3-5]. Despite technical difficulties,
8
several articles regarding laparoendoscopic single site myomectomy (LESS-M) reported
9
similar operative results and better cosmetic outcomes compared to conventional
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laparoscopic myomectomy (conventional-LM) [1,5].
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To our knowledge, these studies addressed only the surgical technique of LESS-M, and
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there are no studies on its operative or obstetric outcomes [1,6,7]. Therefore, in this study, we
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aimed to compare operative and obstetric outcomes of LESS-M versus conventional-LM.
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Materials and Methods
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This prospective matched case-control study was performed at a university teaching
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hospital from January 2009 to April 2012. Institutional review board approval was obtained
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at the Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine.
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The inclusion criteria were the presence of a symptomatic myoma measuring 8 cm or less
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on ultrasonographic examination and a superficial intramural or subserosal type of myoma. A
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myoma is defined as a superficial intramural myoma when the distance between it and the
9
serosa is less than 5 mm on an ultrasonographic examination. Patients whose myomas
10
measured > 8 cm or with a submucosal or deep intramural myoma on ultrasonographic
11
examination were excluded. LESS-M was preoperatively suggested to all patients fulfilling
12
both inclusion and exclusion criteria, and it was performed with the consent of the patients.
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The decision to perform this procedure was not influenced by the patient’s history of
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previous abdominal surgery or body mass index (BMI).
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All data on the clinical characteristics of the patients and the resected myomas were
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prospectively collected. According to the operative findings, the characteristics of the
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myomas were described in terms of the size, number, location, and type. The size of the
18
myoma was recorded as follows: each diameter of the resected myoma, the maximal
19
diameter of the largest myoma, and the mean diameter of the resected myomas. The
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diagnosis of myoma was histologically confirmed in all cases. The operating time was defined as the period from the incision in the skin to the closure
3
of the skin. The hemoglobin change was calculated by the difference between the
4
preoperative hemoglobin level and the hemoglobin level on the first postoperative day. The
5
return of bowel activity was defined as the period from the end of anesthesia to the first
6
occurrence of bowel gas passage. Finally, postoperative fever was defined as a body
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temperature equal to or higher than 38 °C on two consecutive occasions at least six hours
8
apart, except during the first 24 hours. Surgical complications were graded according to the
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Dindo–Clavien classification [8].
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LESS-M and conventional-LM were performed in the same manner as our previous report
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[1].
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and articulating laparoscopic instruments after establishing GelPort access (Alexis, Applied
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Medical, Rancho Snata Margarita, CA) through a 15-20mm trans-umbilical incision. The
14
defect in the myometrial and serosal layers was closed in one layer by interrupted sutures of
15
1-0 polyglactin 910 (Vicryl®, Ethicon Inc., Somerville, NJ) using extracorporeal knots. The
16
morcellation and extraction of resected myomas was performed with a scalpel through the
17
umbilical incision. In conventional-LM, two 5mm trocars in the umbilicus and left upper
18
quadrant and a 12mm trocar in the suprapubic area were used. Laparoscopic myomectomy
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and the closure of uterine defects were carried out in same manner as described above.
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In terms of LESS-M, laparoscopic myomectomy was performed using conventional
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Resected myomas were morcelated and removed via the suprapubic trocar using the
2
Gynecare Morcellex tissue morcellator (Ethicon, Inc., Somerville, NJ).
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Statistical Analyses
Each variable was confirmed as not following a normal (Gaussian) distribution via the
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Shapiro–Wilk test. The unpaired t test and a mixed model were used to compare each group’s
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continuous parametric variables. The general estimating equation, Pearson's χ2 test and
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Fisher’s exact test were used to compare the categorical variables. P < 0.05 was taken to
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indicate a significant difference. All analyses were performed using the Statistical Package
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Results
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During the study period, 328 women with symptomatic myomas fulfilled the inclusion
4
criteria and exclusion criteria. Among them, 50 patients underwent laparoendoscopic single
5
site myomectomy (LESS-M group), and 283 patients underwent conventional laparoscopic
6
myomectomy (conventional-LM group). To compare operative outcomes and obstetric
7
outcomes, 45 patients of the LESS-M group were matched 1:2 against 90 patients who
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received conventional-LM using the patient’s age and the clinical characteristics (including
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number, type, maximal diameter, and mean diameter) of the resected myomas. The remaining
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patients (n=5) of the LESS-M group could not be matched and were excluded.
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There were no statistically significant differences in clinical characteristics of patients and the resected myomas between the two groups (Tables 1 and 2). In terms of operative results, there were no significant differences between the groups
14
(Table 3). One patient in the conventional-LM group underwent fimbrioplasty, and four
15
patients in each group with chronic lower abdominal pain and an edematous appendix during
16
the operation underwent selective appendectomy.
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Thirteen women had a surgical complication less than grade III, according to the Dindo-
18
Clavien classification. These complications included intraoperative bleeding that required
19
transfusion, postoperative ileus, voiding difficulty, and supra-pubic wound infection. These
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complications were resolved with conservative treatment. One woman in the conventional-
2
LM group underwent reoperation for bleeding of the uterine incision. We converted the
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LESS-M to two-port LM in 3 cases with severe pelvic adhesions.
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The obstetrical outcomes are summarized in Table 4; 8 women in the LESS-M group and
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9 women in the conventional-LM achieved pregnancy. One woman experienced 3
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consecutive pregnancy losses at 23, 26, and 39 months after conventional-LM and was
7
diagnosed with recurrent abortion.
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Discussion
2
Laparoscopic myomectomy (LM) has become popular since its introduction by Semm in
4
the 1970s [2]. Since the 1990s, laparoendoscopic single site surgery (LESS)has been
5
performed in various surgical fields, and these procedures include cholecystectomy,
6
appendectomy, and hysterectomy [3-5,9]. Unlike LESS, articles regarding the surgical
7
technique of LESS-M were published in the late 2010s. This seems to be related to the
8
technical difficulty of suturing while performing LESS-M.
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To our knowledge, there are several reports on the surgical technique of LESS-M, but no
10
study has proved the feasibility and safety of LESS-M [1,7,10]. In addition, because many of
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the patients who underwent myomectomy were young women who wanted to preserve their
12
fertility, obstetric outcomes following LESS-M are an essential issue. However, no studies
13
have reported on this issue. Therefore, the authors performed this study to investigate the
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operative and obstetric outcomes of LESS-M.
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15
Objectively assessing and comparing the operative and obstetric outcome of LESS-M and
16
conventional-LM is an extremely complex process. Patient age, the number of resected
17
myomas, the type of resected myomas, the diameter of resected myomas, and other issues
18
can have considerable influence on these outcomes. Therefore, to minimize the influence of
19
those confounding factors, we matched the LESS-M group 1:2 against patients undergoing
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1
conventional-LM by age and clinical characteristics (including the number, type, maximal
2
diameter, and mean diameter) of the resected myomas. This study compared the feasibility and safety of LESS-M and conventional-LM. As
4
shown in Table 3, there were no statistically significant differences in operating time,
5
hemoglobin change, hospital stay, complication rate, or conversion rate to multiport
6
laparoscopy or laparotomy between the two groups. These results show that LESS-M is
7
feasible and safe in selected women with symptomatic myomas. However, the LESS-M and
8
conventional-LM groups yielded approximately the same results of 135 minutes and 140
9
minutes, respectively. The mean operating time for conventional-LM was 97.1 - 155 minutes
10
in recent studies, and 25.2% (34 women) of the patients involved in this study underwent
11
concomitant surgery [11-13]. Considering this, our result seems to be reasonably acceptable.
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The remarkable point of this study is that while a longer operating time is considered to
13
be the disadvantage of LESS, such a longer operating time was not observed the LESS-M
14
group. This result seems to be caused by the following factors: 1) rapid morcellation and
15
extraction of resected myomas through a relatively large, transumbilical incision using a
16
scalpel; 2) proper selection criteria for LESS-M; 3) usage of extracorporeal knotting with a
17
conventional knot pusher to minimize technical difficulty of LESS-M; and 4) the surgeon’s
18
accumulated experience over approximately 600 cases of LESS since 2009.
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Regarding obstetric outcomes, previous studies reported that pregnancy rate and abortion
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rate after conventional-LM were 40.7-65.4% and 20.4-27.2%, respectively [14-16]. In this
2
study, there were no statistically significant differences between the LESS-M group and the
3
conventional-LM group in terms of the pregnancy rate (9 women (66.7%) vs. 12 women
4
(52.9%), respectively) or abortion rate (1 woman (11.1%) vs. 3 women (25.0%), respectively)
5
during the follow-up (24.4 vs. 23.2 months, respectively). There were no cases of premature
6
delivery or uterine rupture. All women who became pregnant following ART had been
7
transferred to our institution from the infertility clinic after failure of ART. These results are
8
acceptable comparison to those obtained in previous studies, and we can conclude that
9
obstetric outcomes following LESS-M do not differ from those following conventional-LM.
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However, LESS-M is inevitably accompanied by technical difficulty, especially in terms
11
of laparoscopic suturing and knotting. This handicap can negatively influence the
12
development of uterine rupture in women who underwent LESS-M, potentially resulting in
13
maternal and fetal death [17]. To diminish the risk of uterine rupture, as described in our
14
previous report on the surgical technique of LESS-M, we repaired the defect of the
15
myometrial and serosal layers in one or two layer with interrupted sutures of 1-0 polyglactin
16
910 (Vicryl®, Ethicon Inc., Somerville, NJ) with extracorporeal knots using a conventional
17
knot pusher and limited the use of electrocautery. Although there were no cases of uterine
18
rupture before or during labor in this study, further studies are needed to confirm this finding
19
because the result of this study is limited by either its small sample size or its short duration
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of follow-up. Especially considering LESS-M with three arms and conventional-LM with
2
four arms, obstetric outcomes following LESS-M using techniques such as continuous
3
suturing or intracorporeal knotting that require expert surgical skills might differ from the
4
outcomes of this study.
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The advantages of this study are as follows: 1) recall bias was avoided because this study
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was a prospective design; 2) the effects of the possible confounding factors were minimized
7
by matching with various variables such as patient age and clinical characteristics (including
8
number, type, maximal diameter, and mean diameter) of the resected myomas; 3) this is a
9
first report on the obstetric outcomes following LESS-M; and 4) this study has a relatively
10
large number of LESS-M cases and extended follow-up. There are also some limitations of
11
our study. First, the study was not able to assess the safety of vaginal delivery after LESS-M
12
because all women who delivered after LESS-M underwent elective Cesarean delivery.
13
Second, the study was not a large prospective randomized study, although selection bias was
14
minimized by a patient’s selection of LESS-M or conventional-LM. Third, the study was not
15
able to evaluate a learning curve of LESS-M and the effect of LESS-M on the postoperative
16
pain and cosmetic outcome, which are theoretical advantages of LESS.
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In addition, although the result of our study shows the feasibility and safety of LESS-M,
18
this may not apply to all surgeons because this study was carried out by expert laparoscopists.
19
So, surgeons without the experience of LESS-M need sufficient practice of suturing using
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articulating laparoscopic instruments before performing it. Considering the goal of LESS-M
2
is not LESS itself but the myomectomy, if necessary, surgeons should not be afraid of
3
conversion from LESS-M to multiport laparoscopic myomectomy for achieving the original
4
purpose of a complete myomectomy.
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Conclusions
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In conclusion, LESS-M is feasible and safe and has comparable obstetric outcomes to
4
conventional-LM in selected women with symptomatic myomas. However, a large
5
prospective randomized study is required to confirm these findings.
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Disclosure Statement
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No competing financial interests exist.
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Gargiulo AR SS, Missmer SA, Correia KF, Vellinga T, Einarsson JI. Robot-assisted laparoscopic myomectomy compared with standard laparoscopic myomectomy.
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and pregnancy outcome in infertile patients. Fertil Steril. 1999; 71:571-574. Parker WH EJ, Istre O, Dubuisson JB. Risk factors for uterine rupture after laparoscopic myomectomy. J Minim Invasive Gynecol. 2010; 17:551-554.
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http://www.AAGL.org/jmig-21-6-JMIG-D-14-00163R1
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Précis
2 Laparoendoscopic single site myomectomy is feasible and safe and has comparable
4
obstetric outcomes to conventional laparoscopic myomectomy.
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Table 1. Clinical characteristics of the patients Conventional
-LM group
p- value
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SP-LM group
Median (range) / Number (percent) Number of patients
Age (years) 26-30 31-35
0.301 a
18 (20.0)
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45
11 (24.4)
19 (21.1)
14 (31.1)
27 (30.0)
8 (17.8)
21 (23.3)
3 (6.6)
5 (5.5)
30 (66.7)
54 (60.0)
15 (33.0)
36 (40.0)
22.2 (16.6-28.4)
22.2 (15.4-37.2)
0.259 b
7 (15.5)
27 (30.0)
0.051 a
Number of surgeries = 1
4 (8.9)
19 (21.1)
Number of surgeries = 2
3 (6.7)
7 (7.8)
36-40 41-45
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46-52 Parity
Multiparous
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Nulliparous
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Body mass index (kg/m2)
Number of patients with previous ab-
dominal surgeries
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Number of surgeries = 3
0 (0)
1 (1.1)
Indication for myomectomy
0.591 a 2 (4.4)
14 (15.6)
Dysmenorrhea
7 (15.6)
8 (8.9)
Menorrhagia
8 (17.8)
12 (13.3)
Pelvic pain
8 (17.8)
Infertility
7 (15.6)
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Dysfunctional uterine bleeding
Palpable pelvic mass Urinary symptom
20 (22.2) 3 (3.3)
11 (24.4)
28 (31.1)
2 (4.4)
5 (5.6)
SP-LM group, group underwent single-port laparoscopic myomectomy; Conventional LM
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group, group underwent conventional laparoscopic myomectomy. By the general estimating equation
b
By the mixed model
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Table 2. Characteristics of the removed myomas Conventional LM SP-LM group p- value
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group Median (range) / Number (percent) 73
Mean diameter of myoma in a pa5.0 (2.5-8.0)
Maximal diameter of largest myo-
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tient (cm)
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Total number of removed myomas
5.4 (3.2-8.0)
ma in a patient (cm) Location of myomas
5.9 (2.7-8.0)
0.162 a
30 (41.1)
45 (30.8)
25 (34.2)
61 (41.8)
6 (8.2)
23 (15.8)
12 (16.4)
17 (11.6)
Subserosal
29 (40.0)
58 (39.7)
Intramural
44 (60.0)
88 (60.3)
TE D
Anterior
4.8 (2.0-8.0)
Posterior
Fundal
AC C
Type of myoma
EP
Lateral
SP-LM group, group underwent single-port laparoscopic myomectomy; Conventional LM group, group underwent conventional laparoscopic myomectomy. a
By the Pearson’s χ2 test
ACCEPTED MANUSCRIPT
Table 3. Operative results Conventional LM SP-LM group p- value
RI PT
group Median (range) / Number (percent) 135 (65-185)
140 (40-480)
0.319 a
Hemoglobin change (g/dL)
1.9 (0.2-5.8)
1.9 (0.1-5.3)
0.695 a
31.4 (5.2-76.2)
0.641 a
Hospital stay (days)
5 (4-7)
Concomitant surgery Bilateral adnexal surgery
TE D
Unilateral adnexal surgery Incidental appendectomy
EP
Surgical complications
28.8 (7.5-70.1)
M AN U
Return of bowel activity (hours)
SC
Operating time (minutes)
5 (3-20)
0.146 b
1 (2.2)
4 (4.4)
9 (20.0)
16 (17.8)
2 (4.4)
2 (2.2) 0.737 b
5 (11.1)
7 (7.8)
Dindo-Clavien class ≥3
0
1 (1.1)
3 (6.6)
-
AC C
Dindo-Clavien class < 3
Conversion to multiport laparoscopy or laparotomy
Conversion to multiport laparoscopy
0.663 a
ACCEPTED MANUSCRIPT
Conversion to laparotomy
0
-
SP-LM group, group underwent single-port laparoscopic myomectomy; Conventional LM
By the mixed model
b
By the general estimating equation
AC C
EP
TE D
M AN U
SC
a
RI PT
group, group underwent conventional laparoscopic myomectomy.
ACCEPTED MANUSCRIPT
Table 4. Obstetrical outcomes Conventional LM
p- value
SP-LM group
RI PT
group Median (range) / Number (percent) Duration of follow up (months)
24.4 (3.0-41.1)
23.2 (3.9-41.1)
0.501 a
12 (26.7)
26 (20.0)
0.300 b
9 (50.0)
0.380 b
9
12
0.698 c
7 (77.8)
10 (83.3)
2 (22.2)
2 (16.7)
7.6 (3.1-21.7)
10.1 (0.8-26.8)
ceive
Number of pregnancies Spontaneous pregnancy
TE D
Pregnancy following ART Time to first pregnancy (months) Pregnancy outcome
AC C
Miscarriage
EP
Ongoing pregnancy
Full-term delivery
8 (66.7)
M AN U
Number of patient who conceived
SC
Number of patients who want to con-
0.442 d 0.380 c
2 (22.2)
2 (16.7)
1 (11.1)
3 (25.0)
6 (66.7)
7 (58.3) 0.192 c
Delivery method
Vaginal delivery
0 (0)
3 (42.9)
Cesarean delivery
6 (100.0)
4 (57.1)
0.400 c
ACCEPTED MANUSCRIPT
6 (100.0)
3 (75.0)
Fetal distress
0 (0)
0 (0)
Dynamic dystocia
0 (0)
1 (25.0)
RI PT
Elective
SP-LM group, group underwent single-port laparoscopic myomectomy; Conventional LM
group, group underwent conventional laparoscopic myomectomy; ART, assisted reproductive
b
By the mixed model By the Pearson’s χ2 test By the Fisher’s exact test
d
By the unpaired t test
AC C
EP
TE D
c
M AN U
a
SC
technique
