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Mesh may stop hernias after colostomy

NCT ID NCT01380860

Prevention Sponsor: Centre Hospitalier Universitaire de Nīmes 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether placing a special mesh during colostomy creation can prevent hernias from forming around the stoma. 200 patients having their first colostomy were randomly assigned to get the mesh or not. They were checked every three months for two years to see if a hernia developed.

What this could mean

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

Active substance
surgical mesh
What this could lead to
If successful, this could establish a simple surgical step to prevent painful hernias in people who need a colostomy.
What could go wrong
The trial is completed but results are not yet widely known. Mesh use may carry its own risks like infection or discomfort.

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

200 people

The number who actually took part.

Start date

Nov 2012

Finished

Dec 2018

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: * The patient has given informed consent * The patient must be affiliated with a health insurance programme * The patient must be available for 24 months of follow-up * The patient requires a colostomy (primo-event, ie first colostomies only) Exclusion Criteria: * The patient is currently participating in another interventional study * The patient is in an exclusion period determined by a previous study * The patient is under guardianship * The patient refuses to sign the consent * It is impossible to communicate information to the patient (does not read French) * The patient is pregnant * The patient is breastfeeding * There is a contra-indication for any treatment used in this study * The subject has already had a colostomy * The subject has peritonitis * The subject needs a colostomy for infectious reasons

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Conditions

The condition(s) this trial relates to.

Hernia

As listed by the trial registrant

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

Parastomal hernia

Contacts and locations

Locations

  • APHM - Hôpital La Timone Adultes

    Marseille, 13385, France

  • APHP - Centre Hospitalier Universitaire de Bicêtre

    Le Kremlin-Bicêtre, 94275, France

  • APHP - Groupe Hospitalier Pitié-Salpetrière

    Paris, 75651, France

  • APHP - Hôpital Beaujon

    Clichy, 92110, France

  • APHP - Hôpital Lariboisière

    Paris, 75010, France

  • APHP - Hôpital Saint-Antoine

    Paris, 75571, France

  • CH de Vichy - Jacques Larin

    Vichy, 03207, France

  • CHRU de Besancon

    Besançon, 25030, France

  • CHRU de Clermont Ferrand

    Clermont-Ferrand, 63058, France

  • CHRU de Lille - Hôpital Claude Huriez

    Lille, 59037, France

  • CHU de Bordeaux

    Bordeaux, 33075, France

  • CHU de Lyon

    Lyon, 69317, France

  • CHU de Nantes

    Nantes, 44093, France

  • CHU de Rouen

    Rouen, 76038, France

  • CHU de Toulouse

    Toulouse, France

  • Centre Hospitalier Universitaire de Nîmes

    Nîmes, 30029, France

  • Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes

    Marseille, 13009, France

  • Centre Régional de Lutte Contre le Cancer Val d'Aurelle - Paul Lamarque

    Montpellier, 34298, France

  • Centre Régional de Lutte contre le Cancer Centre Paul Strauss

    Strasbourg, 67065, France

  • Centre de Lutte Contre le Cancer - Centre Oscar Lambret

    Lille, 59020, France

  • Hôpital Albert Michallon, CHU de Grenoble

    Grenoble, 38043, France

  • Hôpital Pontchailou

    Rennes, 35033, France

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