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Could a special mesh stop hernias after colostomy?

NCT ID NCT02121743

Prevention Sponsor: Centre Hospitalier Universitaire, Amiens 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This trial investigates whether placing a biological mesh (Strattice) during colostomy creation can prevent parastomal hernia, a common complication. About 81 adults undergoing colorectal surgery with a terminal colostomy will be randomly assigned to receive the mesh or standard care. The study tracks hernia occurrence, pain, and surgical complications over two years.

What this could mean

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

Active substance
Strattice (biological mesh)
What this could lead to
If effective, this mesh could become a standard way to prevent parastomal hernia after colostomy, reducing the need for additional surgeries.
What could go wrong
This is a relatively small study (81 participants) and results may not apply to all patients. The mesh could cause infection or other complications.

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

81 people

The number who actually took part.

Started

Apr 2014

Finished

Dec 2025

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: * Patient requiring a colorectal surgery with a terminal colostomy * Elective or emergency surgery Exclusion Criteria: * Has collagen-vascular, connective tissue, or uncorrectable bleeding disorders as determined clinically by the PI. * Has any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability. * Has an autoimmune disease, an immune deficiency, or is on immune suppression drugs * Is pregnant, or lactating. * Allergic to any porcine or collagen products. * survival \< 6 months

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As listed by the trial registrant

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

Parastomal hernia Terminal colostomy

Contacts and locations

Locations

  • Amiens Universitary Hospital

    Amiens, France

  • Amiens university hospital

    Amiens, France

  • Beauvais hospital

    Beauvais, France

  • Caen hospital

    Caen, France

  • Charles Nicolle Hospital

    Rouen, France

  • Claude Huriet Hospital

    Lille, France

  • Lariboisiere Hospital

    Paris, France

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