Clinical trial NCT01347385: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibroids
Keywords: Fibroids
Laparoscopic myomectomy
Barbed suture
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2011-05-04
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Operative time
Secondary outcomes:
measure: Blood loss
timeFrame: Intra-operative
measure: Adverse events
timeFrame: Intra-operatively until 6 weeks post-operatively
measure: Hospital stay
measure: Fertility and pregnancy-related outcomes
timeFrame: 2 and 5 years post-operatively
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre, University of Toronto
name: Jamie Kroft, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre, University of Toronto
name: Grace Y Liu, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: