Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy

Not Applicable

• Conditions: Fibroids

• Registration Number: NCT01347385
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Study Timeline

• Status Verified: 2011-04
• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-05-02
• Last Update Submitted: 2011-05-02
• Study First Posted: 2011-05-04
• Last Update Posted: 2011-05-04
• Study Start: 2012-01
• Primary Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Hospital stay		We will document the length of hospital stay post-operatively in days.
Blood loss	Intra-operative	We will subtract the amount of irrigation fluid used from the total amount of fluid suctioned during the procedure to arrive at an estimated blood loss in millilitres. We will also measure the patient's hemoglobin at the routine pre-operative visit and then on the morning of the first post-operative day to determine the difference in hemoglobin. The amount of intravenous fluids administered to the patients intra- and post-operatively will be documented in order to account for any changes in hemoglobin that are spurious due to fluid administration.
Adverse events	Intra-operatively until 6 weeks post-operatively	All adverse events that occur until 6 weeks post-operatively will be documented including injury to the bladder, bowel, ureter or blood vessel, infection/abscess, fever, blood transfusion, readmission to hospital, re-operation, and venous thromboembolism.
Fertility and pregnancy-related outcomes	2 and 5 years post-operatively	Telephone interviews will be conducted at 2 and 5 years post-operatively to determine pregnancy rates, live birth rates and adverse pregnancy outcomes of participants.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada