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Can a simple mesh stop hernias after emergency surgery?

NCT ID NCT07753551

Prevention Sponsor: University of Rome Tor Vergata Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial tests whether placing a special mesh during emergency abdominal surgery can prevent incisional hernias, a common complication. Adults undergoing emergency midline laparotomy will be randomly assigned to receive either the mesh reinforcement or standard suture closure. The main goal is to compare the rate of hernias at one year after surgery, with additional monitoring of complications, pain, and quality of life.

What this could mean

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

Active substance
A biosynthetic mesh (poly-4-hydroxybutyrate) placed during abdominal wall closure to reinforce the incision, compared with standard suture closure.
What this could lead to
If effective, this approach could reduce the risk of incisional hernias after emergency abdominal surgery, potentially improving recovery and quality of life for many patients.
What could go wrong
The trial is relatively small and results may not apply to all patients. Mesh placement could carry risks such as infection or increased pain, and the benefit may not be significant.

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 189 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2031

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

Anyone

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: All adult patients (≥18 years) undergoing emergency midline laparotomy will be eligible for inclusion, without upper age limit, to reflect real-world clinical practice. Exclusion Criteria: * Age \< 18 years * Minimally invasive surgery (laparoscopic or robotic approaches) * Elective surgery * Surgery requiring an open abdomen and its closure * Fecal peritonitis * Previous midline laparotomy * Pregnancy or breastfeeding * Conditions that would impair the possibility of understanding and giving of informed consent.

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Conditions

The condition(s) this trial relates to.

Emergencies Incisional Hernia

As listed by the trial registrant

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

Emergency abdominal surgery Incisional hernia after midline laparotomy

How to take part

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

  1. The places running it

    1 site. 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

  • Policlinico di Roma Tor Vergata

    Roma, Italy

More trials for these conditions

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