Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy
|ClinicalTrials.gov Identifier: NCT01347385|
Recruitment Status : Unknown
Verified April 2011 by Sunnybrook Health Sciences Centre.
Recruitment status was: Not yet recruiting
First Posted : May 4, 2011
Last Update Posted : May 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Fibroids||Procedure: Laparoscopic myomectomy with unidirectional barbed suture Procedure: Traditional suture material||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy: A Randomized Controlled Trial|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||January 2014|
|Experimental: Barbed suture||
Procedure: Laparoscopic myomectomy with unidirectional barbed suture
Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using unidirectional barbed suture material (V-Loc 180TM, CovidienTM). For patients randomized to the barbed suture arm of the trial, any secondary fibroid that is greater than 5cm intra-operatively (as measured by a laparoscopic measurement instrument) will also be closed with barbed suture material. The cut-off of 5cm will be used, since it is generally above this size when uterine defects need to be closed in multiple layers, making the barbed suture potentially useful. Any other secondary fibroids less than 5cm will be closed with traditional extracorporeal suturing in both arms of the trial, since these can usually be closed in one layer.
Other Name: V-Loc 180TM, CovidienTM
|Active Comparator: Traditional suture material||
Procedure: Traditional suture material
Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using traditional extracorporeal suturing using absorbable monofilament suture material.
- Operative timeWe will record the operative time from beginning to completion of suturing each fibroid separately, as well as total operative time for the entire procedure.
- Blood loss [ Time Frame: 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 [ Time Frame: 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.
- Hospital stayWe will document the length of hospital stay post-operatively in days.
- Fertility and pregnancy-related outcomes [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347385
|Contact: Jamie Kroft, MD, FRCSC||416-480-6100 ext firstname.lastname@example.org|
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Jamie Kroft, MD, FRCSC||Sunnybrook Health Sciences Centre, University of Toronto|
|Principal Investigator:||Grace Y Liu, MD, FRCSC||Sunnybrook Health Sciences Centre, University of Toronto|