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New stitch technique may lower risks after hysterectomy

NCT ID NCT07313839

Disease control Sponsor: Azienda Ospedaliero-Universitaria di Parma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways to close the vaginal vault after laparoscopic hysterectomy in women with gynecologic cancers. One method uses a self-locking barbed suture, the other a traditional braided suture. The goal is to see which leads to fewer complications like cuff tears, infections, or bleeding within three months after surgery. About 310 participants will be randomly assigned to one of the two techniques.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Double-layer self-locking (barbed) suture vs. traditional Polyglactin 910 suture
What this could lead to
If the self-locking suture works better, it could reduce serious complications like vaginal cuff tears, infections, and bleeding after hysterectomy.
What could go wrong
This is a mid-stage trial with 310 participants, so results may not apply to everyone. The self-locking suture might not be safer or could have unknown risks.

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

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

About 310 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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 laparoscopic or robotically assisted hysterectomy for gynecologic malignant disease * Age ≥ 18 years * Ability to provide written informed consent Exclusion Criteria: * Laparotomic or vaginal hysterectomy * Contraindication to laparoscopic vaginal vault closure

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Conditions

The condition(s) this trial relates to.

female reproductive organ cancer Postoperative Complications

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gynecologic cancers Postoperative complications Vaginal cuff dehiscence

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Clinic of Obstetrics and Gynecology, "Santa Maria della Misericordia" University Hospital, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.

    NOT_YET_RECRUITING

    Udine, Italy

  • Department of Gynecologic Oncology. Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.

    NOT_YET_RECRUITING

    Milan, Italy

  • Department of Medicine and Surgery, University Hospital of Parma

    RECRUITING

    Parma, Italy, 43125, Italy

  • Department of Obstetrics and Gynecology, Ospedale Santa Croce e Carle, Cuneo, Italy.

    RECRUITING

    Cuneo, Italy

  • Division of Oncologic Gynecology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, 40138 Bologna, Italy.

    NOT_YET_RECRUITING

    Bologna, Italy

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