An interventional study of Laparoscopic myomectomy with unidirectional barbed suture and Traditional suture material in Fibroids, sponsored by Sunnybrook Health Sciences Centre. Status unknown at 1 site in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2011-05-04.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
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.
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's planned enrollment of 80 is above the median of 62 across 345 interventional studies indexed under Leiomyoma.
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Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
Procedure: Laparoscopic myomectomy with unidirectional barbed suture
Procedure: Traditional suture material
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.
Also known as: V-Loc 180TM, CovidienTM
Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using traditional extracorporeal suturing using absorbable monofilament suture material.
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.
Blood loss
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.
Time frame: Intra-operative
Adverse events
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.
Time frame: Intra-operatively until 6 weeks post-operatively
Hospital stay
We will document the length of hospital stay post-operatively in days.
Fertility and pregnancy-related outcomes
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.
Time frame: 2 and 5 years post-operatively
This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre