Barbed Suture in Single-port Laparoscopic Myomectomy

Phase 3

Completed

• Conditions: Uterine Myoma
• Interventions: Procedure: Multi-port laparoscopic myomectomy; Procedure: Single-port laparoscopic myomectomy

• Registration Number: NCT01984632
• Lead Sponsor: CHA University

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-03
• Study First Submitted QC: 2013-11-14
• Study First Posted: 2013-11-15
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-30
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-port laparoscopic myomectomy	Multi-port laparoscopic myomectomy	We will use barbed suture(V-Loc) under intervention of multi-port laparoscopic myomectomy.
Single-port laparoscopic myomectomy	Single-port laparoscopic myomectomy	We will use barbed suture (V-Loc) under intervention of single-port laparoscopic myomectomy

Primary Outcome Measures

Name	Time	Method
Suturing time	Intra-operative	the time duration for the suture of uterine wall defect after myoma enucleation during laparoscopic myomectomy

Secondary Outcome Measures

Name	Time	Method
Cosmetic satisfaction	Post-surgery 1 month and 3 month	We will compare patient's cosmetic satisfaction through self-reported questionnaire (Body image Questionnaire).

Trial Locations

Locations (4)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

National Health Insurance Service Ilsan Hospital; 🇰🇷 Goyang, Korea, Republic of

CHA Gangnam Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of