Barbed Suture in Single-port Laparoscopic Myomectomy

Study Overview
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Brief Summary
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The aim of this study is to test our hypothesis that the use of unidirectional knotless barbed suture in single-port laparoscopic myomectomy could facilitate the suture of uterine wall defect after myoma enucleation as multi-port laparoscopic myomectomy did.

Detailed Description
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The investigators plan to perform a multi-center randomized clinical trial on women scheduled for laparoscopic myomectomy. All women will get the same preoperative and postoperative care. Women will be assigned by chance to one of two groups: one group will receive single-port laparoscopic myomectomy using V-Loc™ suture material (study group). The other group will receive conventional multi-port laparoscopic myomectomy using V-Loc™ suture material (control group). The investigators will collect information on suturing time and complications related to surgery.

Official Title
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Single-port Laparoscopic Myomectomy Using Barbed Suture Versus Multi-port One: a Multi-center Randomized Controlled Trial

Conditions
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Uterine Myoma

Intervention / Treatment
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* Procedure: Single-port laparoscopic myomectomy
* Procedure: Multi-port laparoscopic myomectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 55 years Image-confirmed uterine myoma Number of myoma ≤2 and largest size ≤10cm Women who were scheduled to have laparoscopic myomectomy Appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2) Exclusion Criteria: Women with pedunculated subserosal myoma or submucosal myoma Women undergoing concomitant complex surgical procedures at the time of laparoscopic myomectomy such as severe adhesiolysis or resection for severe endometriosis Women with any suggestion of malignant uterine or adnexal diseases Women with diabetics, malignancy, or malnutrition, which can affect wound healing Women having major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance Women who refuse to participate or give consent to the procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single-port laparoscopic myomectomy<br>We will use barbed suture (V-Loc) under intervention of single-port laparoscopic myomectomy | Procedure: Single-port laparoscopic myomectomy<br>* The aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture (control group) in terms of operative time (esp. suturing time).<br>|
| Active Comparator: Multi-port laparoscopic myomectomy<br>We will use barbed suture(V-Loc) under intervention of multi-port laparoscopic myomectomy. | Procedure: Multi-port laparoscopic myomectomy<br>* The aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture(control group) in terms of operative time (esp. suturing time).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suturing time | the time duration for the suture of uterine wall defect after myoma enucleation during laparoscopic myomectomy | Intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic satisfaction | We will compare patient's cosmetic satisfaction through self-reported questionnaire (Body image Questionnaire). | Post-surgery 1 month and 3 month |