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Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy

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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
Sponsor:
Information provided by:

April 26, 2011
May 4, 2011
May 4, 2011
January 2012
January 2014   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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 stay
    We 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.
Same as current
Not Provided
Not Provided
 
Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy
Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy: A Randomized Controlled Trial
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Fibroids
  • 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
  • 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.
  • Experimental: Barbed suture
    Intervention: Procedure: Laparoscopic myomectomy with unidirectional barbed suture
  • Active Comparator: Traditional suture material
    Intervention: Procedure: Traditional suture material
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
Not Provided
January 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01347385
MIS-1
No
Not Provided
Not Provided
Jamie Kroft, MD, FRCSC, Sunnybrook Health Sciences Centre, University of Toronto
Sunnybrook Health Sciences Centre
Not Provided
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
Sunnybrook Health Sciences Centre
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP