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Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Sunnybrook Health Sciences Centre.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01347385
First received: April 26, 2011
Last updated: May 2, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Fibroids
Procedure: Laparoscopic myomectomy with unidirectional barbed suture
Procedure: Traditional suture material

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Operative time [ Designated as safety issue: No ]
    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:
  • Blood loss [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347385

Contacts
Contact: Jamie Kroft, MD, FRCSC 416-480-6100 ext 5063 jamie.kroft@utoronto.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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
  More Information

No publications provided

Responsible Party: Jamie Kroft, MD, FRCSC, Sunnybrook Health Sciences Centre, University of Toronto
ClinicalTrials.gov Identifier: NCT01347385     History of Changes
Other Study ID Numbers: MIS-1
Study First Received: April 26, 2011
Last Updated: May 2, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Fibroids
Laparoscopic myomectomy
Barbed suture

ClinicalTrials.gov processed this record on November 25, 2014