What side effects are associated with this type of intervention?

The use of barbed suture material in the surgical treatment of uterine fibroids, such as in laparoscopic myomectomy, has been associated with several side effects. These include an increased risk of adhesion formation, which can lead to complications such as small bowel obstruction. Inflammatory responses, including higher scores for macrophages and mononuclear cells, have also been observed. General side effects of surgical treatments for uterine fibroids include blood loss, infection, and post-operative pain. While barbed sutures may improve surgical efficiency by reducing operative time, these potential adverse outcomes should be carefully considered.

What prior FDA approvals exist?

The FDA has approved several treatments for uterine fibroids, including medications like GnRH agonists (e.g., leuprolide) that reduce fibroid size and symptoms. Additionally, devices such as the Acessa System, which uses radiofrequency ablation, and the Sonata System, which employs ultrasound-guided radiofrequency ablation, have been approved to treat fibroids minimally invasively. While these treatments differ from the barbed suture material studied for improving surgical outcomes in laparoscopic myomectomy, they share the goal of enhancing procedural efficiency and patient outcomes.

What other types of research exist?

Promising alternatives to barbed suture material for uterine fibroids patients include absorbable knotless wound closure devices, robotic-assisted laparoscopic myomectomy, and the use of oxidized regenerated cellulose absorbable barriers to prevent adhesion formation. These options aim to enhance surgical efficiency, reduce complications, and improve patient outcomes.

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Barbed Suture for Uterine Fibroids

N/A

Waitlist Available

Led By Grace Y Liu, 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

No Placebo-Only Group

Summary

This trial tests a new type of stitching thread with hooks for patients having fibroid removal surgery. The hooks help the thread stay in place without knots, which might make the surgery quicker and safer.

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.

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.

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Adverse events

Blood loss

Fertility and pregnancy-related outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Barbed sutureExperimental Treatment1 Intervention

Group II: Traditional suture materialActive Control1 Intervention

0 / 4Eligibility criteria met

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.