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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 and 5 years post-operatively

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 and 5 years post-operatively

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,362 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies open to participants for this trial?

"Unfortunately, this clinical trial is not currently enrolling patients. Initially posted on the 1st of January 2012 and last edited on May 2nd 2011, it does not appear to be accepting any new recruits at present. Nevertheless, 47 other studies are actively recruiting participants as we speak."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy

2012. "Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01347385.

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