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Spots Global Cancer Trial Database for Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy

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Trial Identification

Brief Title: Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy

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

Study ID: NCT01347385

Conditions

Fibroids

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Contact Details

Name: Jamie Kroft, MD, FRCSC

Affiliation: Sunnybrook Health Sciences Centre, University of Toronto

Role: PRINCIPAL_INVESTIGATOR

Name: Grace Y Liu, MD, FRCSC

Affiliation: Sunnybrook Health Sciences Centre, University of Toronto

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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