Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy: A Randomized Controlled Trial
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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Operative time
We will record the operative time from beginning to completion of suturing each fibroid separately, as well as total operative time for the entire procedure.
No
Jamie Kroft, MD, FRCSC
Principal Investigator
Sunnybrook Health Sciences Centre, University of Toronto
Canada: Ethics Review Committee
MIS-1
NCT01347385
January 2012
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