NCT01347385

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Last Updated

May 4, 2011

Status Verified

April 1, 2011

Enrollment Period

2 years

First QC Date

April 26, 2011

Last Update Submit

May 2, 2011

Conditions

Fibroids

Keywords

FibroidsLaparoscopic myomectomyBarbed suture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Blood loss

    Intra-operative

  • Adverse events

    Intra-operatively until 6 weeks post-operatively

  • Hospital stay

  • Fertility and pregnancy-related outcomes

    2 and 5 years post-operatively

Study Arms (2)

Barbed suture

EXPERIMENTAL
Procedure: Laparoscopic myomectomy with unidirectional barbed suture

Traditional suture material

ACTIVE COMPARATOR
Procedure: Traditional suture material

Interventions

Laparoscopic myomectomy with unidirectional barbed suturePROCEDURE

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
Barbed suture
Traditional suture materialPROCEDURE

Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using traditional extracorporeal suturing using absorbable monofilament suture material.

Traditional suture material

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • women who are planning to undergo laparoscopic myomectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie Kroft, MD, FRCSC

CONTACT

416-480-6100jamie.kroft@utoronto.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2011

First Posted

May 4, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Last Updated

May 4, 2011

Record last verified: 2011-04

Locations

CA(1)