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Stoma or no stoma? new trial tests safer surgery for bowel infections

NCT ID NCT04604730

Disease control Sponsor: University Hospital, Rouen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at two ways to treat severe peritonitis caused by a burst diverticulitis pocket. Both involve removing the diseased part of the colon and reconnecting the bowel. One group also gets a temporary stoma (a bag on the belly) to protect the new connection, while the other does not. The goal is to see which approach leads to fewer complications and better quality of life. About 204 adults with this condition will take part across multiple hospitals.

What this could mean

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

Active substance
surgical procedure (primary anastomosis with or without protective stoma)
What this could lead to
If this trial succeeds, it could show that avoiding a temporary stoma is safe and reduces complications, improving recovery for patients with severe diverticulitis.
What could go wrong
This is a relatively small, early-stage trial (204 participants) comparing two surgical techniques. Results may not apply to all patients, and there is a risk of serious complications like infection or leakage in both groups.

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 204 people

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

Started

Jun 2021

Expected to finish

Dec 2026

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: 1. Age ≥ 18 years 2. Patients operated for purulent or fecal peritonitis (Hinchey grade III and IV) secondary to perforated diverticulitis of the left colon and treated by resection with primary anastomosis 3. Person informed and having signed his consent. If the patient is unable to sign his consent, the consent will be signed by his representative ((1) the trusted person, or failing that, (2) a family member, or (3) a relative of the person concerned) (Article L1122-1-1 of the CSP). In this case, consent to continue the study will subsequently be requested from the patient. --\> In addition, due to the vital urgency represented by hospitalisation in intensive care for purulent or fecal peritonitis, inclusion without prior collection of the consent of the patient or his/her representative is possible in the case where the patient is not capable of giving consent and his/her representative is not present at the time of inclusion (Article L1122-1-3 of the CSP). In this case, the patient or his/her representative will be informed as soon as possible and his/her written consent will be requested for the possible continuation of this research and the use of the data concerning him/her. 4. Patient able to comply with the study protocol, in the investigator's judgment 5. Patient affiliated with, or beneficiary of a social security (health insurance) category Non-inclusion Criteria: 1. Physical states that prevent patient participation (e.g. septic shock or multivisceral failure) 2. Steroid treatment \> 20 mg daily 3. Prior pelvic irradiation 4. Immunocompromised status 5. Known progressive cancer 6. American Society of Anesthesiologists grade IV 7. Peritonitis secondary to perforated diverticulitis of the right colon 8. Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study 9. Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision) 10. Simultaneous participation in another interventional research Exclusion Criteria: 1\. Failure to obtain the consent of the patient or the patient's representative

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Conditions

The condition(s) this trial relates to.

infectious peritonitis peritonitis

As listed by the trial registrant

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

Peritonitis

How to take part

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

  1. The places running it

    20 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

  • APHM Hôpital Nord

    RECRUITING

    Marseille, France

  • APHM La Timone

    RECRUITING

    Marseille, France

  • APHP Avicenne

    NOT_YET_RECRUITING

    Bobigny, France

  • APHP Henri Mondor

    NOT_YET_RECRUITING

    Créteil, France

  • APHP St Antoine

    NOT_YET_RECRUITING

    Paris, France

  • CH Beauvais

    NOT_YET_RECRUITING

    Beauvais, France

  • CHR Beauvais

    NOT_YET_RECRUITING

    Beauvais, Beauvais, 60021, France

  • CHU Amiens

    RECRUITING

    Amiens, France

  • CHU Besançon

    NOT_YET_RECRUITING

    Besançon, France

  • CHU Brest

    RECRUITING

    Brest, France

  • CHU Caen

    NOT_YET_RECRUITING

    Caen, France

  • CHU Clermont Ferrand

    NOT_YET_RECRUITING

    Clermont-Ferrand, France

  • CHU Grenoble

    NOT_YET_RECRUITING

    Grenoble, France

  • CHU Limoges

    NOT_YET_RECRUITING

    Limoges, France

  • CHU Lyon

    NOT_YET_RECRUITING

    Lyon, France

  • CHU Nancy

    NOT_YET_RECRUITING

    Nancy, France

  • CHU Nantes

    NOT_YET_RECRUITING

    Nantes, France

  • CHU Nimes

    NOT_YET_RECRUITING

    Nîmes, France

  • CHU Rouen

    RECRUITING

    Rouen, France

  • CHU Tours

    RECRUITING

    Tours, France

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