Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy

Sunnybrook Health Sciences Centre

Status

Unknown

Conditions

Fibroids

Treatments

Procedure: Laparoscopic myomectomy with unidirectional barbed suture

Procedure: Traditional suture material

Study type

Interventional

Funder types

Other

Identifiers

NCT01347385

MIS-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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