NCT01347385

Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy

Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine if the use of a new type of barbed suture material for laparoscopic myomectomy (surgical removal of fibroids) versus the traditional approach of suturing with conventional suture material to close the uterine defect once the fibroid has been removed, improves surgical outcomes. Specifically, the investigators will investigate the effect of barbed suture on operative time, blood loss, adverse post-operative events and hospital stay.

Detailed description

Although the laparoscopic myomectomy has benefits over the abdominal approach, such as less blood loss, less hemoglobin drop post-operatively, decreased post-operative pain and fewer overall complications, it is a difficult procedure, which often requires greater operative time to perform. In the current climate of attempting to reduce health care expenditures, even though the minimally invasive approach offers the advantage of reduced hospital stay, a deterrent for hospital administration and surgeons may be the increased operative time it may require. Barbed suture is a relatively new material available in gynecologic surgery. Barbs are cut into the suture with the barbs facing in a direction opposite that of the needle. The barbs allow for anchoring of the suture in tissues, which prevents migration and allows suturing without knot tying. This study will be a single-centre non-blinded randomized controlled trial comparing laparoscopic myomectomy with barbed suture versus traditional suture material.

Conditions

• Fibroids

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic myomectomy with unidirectional barbed suture	Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using unidirectional barbed suture material (V-Loc 180TM, CovidienTM). For patients randomized to the barbed suture arm of the trial, any secondary fibroid that is greater than 5cm intra-operatively (as measured by a laparoscopic measurement instrument) will also be closed with barbed suture material. The cut-off of 5cm will be used, since it is generally above this size when uterine defects need to be closed in multiple layers, making the barbed suture potentially useful. Any other secondary fibroids less than 5cm will be closed with traditional extracorporeal suturing in both arms of the trial, since these can usually be closed in one layer.
PROCEDURE	Traditional suture material	Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using traditional extracorporeal suturing using absorbable monofilament suture material.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-01-01
• First posted: 2011-05-04
• Last updated: 2011-05-04

Locations

1 site across 1 country: Canada