NCT01984632

Barbed Suture in Single-port Laparoscopic Myomectomy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: CHA University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Myoma

Interventions

Type	Name	Description
PROCEDURE	Single-port laparoscopic myomectomy	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).
PROCEDURE	Multi-port laparoscopic myomectomy	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).

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-11-15
• Last updated: 2015-07-31

Locations

4 sites across 1 country: South Korea