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Barbed Suture for Uterine Fibroids

N/A
Waitlist Available
Led By Jamie Kroft, MD, FRCSC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women who are planning to undergo laparoscopic myomectomy
Must not have
Greater than five fibroids
Patients undergoing concomitant surgical procedures at the time of myomectomy (such as resection of endometriosis or ovarian cystectomy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 and 5 years post-operatively
Awards & highlights

Summary

This trial is testing whether a new type of barbed suture is better than the traditional suture for laparoscopic myomectomy. They will compare operative time, blood loss, post-operative events, and hospital stay.

Who is the study for?
This trial is for women planning to have laparoscopic myomectomy, a surgery to remove uterine fibroids. It's not for those with more than five fibroids, abnormal pathology, pregnancy, a very large uterus, or serious health or psychiatric issues that could affect their participation.Check my eligibility
What is being tested?
The study compares the use of a new barbed suture material against traditional sutures in closing the uterus after removing fibroids via laparoscopy. The focus is on whether it can reduce operation time, blood loss, complications and shorten hospital stays.See study design
What are the potential side effects?
While specific side effects are not listed for the suture materials themselves, typical risks may include bleeding, infection at the incision site, pain during recovery and potential reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am planning to have surgery to remove fibroids via a laparoscope.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have more than five fibroids.
Select...
I am having surgery for fibroids and possibly other procedures like removing endometriosis or ovarian cysts.
Select...
My uterus is enlarged beyond my belly button.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 and 5 years post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 and 5 years post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Operative time
Secondary outcome measures
Adverse events
Blood loss
Fertility and pregnancy-related outcomes
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Barbed sutureExperimental Treatment1 Intervention
Group II: Traditional suture materialActive Control1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for uterine fibroids include surgical options like myomectomy and hysterectomy, and non-surgical options like hormone-regulating medications. Myomectomy removes fibroids while preserving the uterus, and hysterectomy removes the entire uterus. Hormone treatments, such as GnRH agonists, shrink fibroids by lowering estrogen and progesterone levels. The use of barbed sutures in laparoscopic myomectomy, which grip tissue without knots, aims to improve surgical efficiency by reducing operative time and blood loss. This matters for patients as it can lead to quicker recovery and fewer complications.
Role of Barbed Sutures in Repairing Uterine Wall Defects in Laparoscopic Myomectomy: A Systemic Review and Meta-Analysis.The use of barbed suture for laparoscopic hysterectomy and myomectomy: a systematic review and meta-analysis.Uncomplicated full term pregnancy after da Vinci-assisted laparoscopic myomectomy.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
661 Previous Clinical Trials
1,553,971 Total Patients Enrolled
Jamie Kroft, MD, FRCSCPrincipal InvestigatorSunnybrook Health Sciences Centre, University of Toronto
Grace Y Liu, MD, FRCSCPrincipal InvestigatorSunnybrook Health Sciences Centre, University of Toronto

Media Library

Laparoscopic myomectomy with unidirectional barbed suture Clinical Trial Eligibility Overview. Trial Name: NCT01347385 — N/A
Uterine Fibroids Research Study Groups: Barbed suture, Traditional suture material
Uterine Fibroids Clinical Trial 2023: Laparoscopic myomectomy with unidirectional barbed suture Highlights & Side Effects. Trial Name: NCT01347385 — N/A
Laparoscopic myomectomy with unidirectional barbed suture 2023 Treatment Timeline for Medical Study. Trial Name: NCT01347385 — N/A
~6 spots leftby Jul 2025