Barbed Suture in Single-port Laparoscopic Myomectomy

CHA University

Status and phase: Completed; Phase 3

Conditions: Uterine Myoma

Treatments: Procedure: Multi-port laparoscopic myomectomy; Procedure: Single-port laparoscopic myomectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01984632

MYO04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Single-port laparoscopic myomectomy

Experimental group

Description:

We will use barbed suture (V-Loc) under intervention of single-port laparoscopic myomectomy

Treatment:

Procedure: Single-port laparoscopic myomectomy

Multi-port laparoscopic myomectomy

Active Comparator group

Description:

We will use barbed suture(V-Loc) under intervention of multi-port laparoscopic myomectomy.

Treatment:

Procedure: Multi-port laparoscopic myomectomy