New study tests if barbed sutures can prevent Post-Hysterectomy complications
NCT ID NCT05833204
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of sutures used to close the vaginal cuff after laparoscopic hysterectomy: barbed absorbable sutures versus standard absorbable sutures. The goal is to see if barbed sutures reduce the risk of vaginal cuff separation and other complications. Over 1,600 women undergoing hysterectomy for non-cancer reasons will be randomly assigned to one suture type and followed for outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- barbed absorbable suture (V-Loc) vs standard absorbable suture (Vicryl)
- What this could lead to
- If barbed sutures prove better, this could reduce serious complications like vaginal cuff separation after hysterectomy, improving recovery for many women.
- What could go wrong
- This is a large but early-stage trial; previous studies were small or retrospective, so results may not confirm a clear benefit. Risks include infection or suture-related issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,614 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients undergoing elective total laparoscopic hysterectomy * Surgery performed for the treatment of benign pathology * Age \> 18 years * Surgery performed by laparoscopy * Signature of informed consent Exclusion Criteria: * Patients undergoing emergent surgery * Patients candidates for hysterectomy for oncological indication * Patients who underwent previous radiation therapy * Patients allergic to the suture material used in the study * Patients unable to express adequate informed consent to participate in the study
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, 37125, Italy
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