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

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Trial Information

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Operative time

Outcome Description:

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.

Safety Issue:


Principal Investigator

Jamie Kroft, MD, FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Health Sciences Centre, University of Toronto


Canada: Ethics Review Committee

Study ID:




Start Date:

January 2012

Completion Date:

Related Keywords:

  • Fibroids
  • Fibroids
  • Laparoscopic myomectomy
  • Barbed suture
  • Leiomyoma
  • Myofibroma