Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy

NCT ID: NCT01347385

Last Updated: 2011-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Barbed suture

Group Type: EXPERIMENTAL

Laparoscopic myomectomy with unidirectional barbed suture

Intervention Type: PROCEDURE

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.

Traditional suture material

Group Type: ACTIVE_COMPARATOR

Traditional suture material

Intervention Type: PROCEDURE

Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using traditional extracorporeal suturing using absorbable monofilament suture material.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

V-Loc 180TM, CovidienTM

Eligibility Criteria

Inclusion Criteria

• women who are planning to undergo laparoscopic myomectomy

Exclusion Criteria

• greater than five fibroids
• uterus extending beyond the umbilicus
• major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance
• patients undergoing concomitant surgical procedures at the time of myomectomy (such as resection of endometriosis or ovarian cystectomy)
• pregnancy (all patients will have serum pregnancy testing prior to surgery)
• patients with any suggestion of abnormal pathology on imaging or endometrial biopsy

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Sunnybrook Health Sciences Centre, University of Toronto

Principal Investigators

Jamie Kroft, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre, University of Toronto

Grace Y Liu, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre, University of Toronto

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Jamie Kroft, MD, FRCSC

Role: CONTACT

jamie.kroft@utoronto.ca

416-480-6100 ext. 5063

Other Identifiers

MIS-1

Identifier Type: -

Identifier Source: org_study_id