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Simple Pre-Surgery steps could boost stoma Patients' quality of life

NCT ID NCT06881303

Knowledge-focused Sponsor: Assistance Publique Hopitaux De Marseille 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will follow 100 people who need a stoma (an opening in the belly to pass stool) after surgery. Some will have their stoma site marked and get education before surgery, while others will not. The goal is to see if these steps improve quality of life and reduce problems like skin issues or leaks within 30 days after surgery. The study compares scheduled and emergency surgeries.

What this could mean

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

Active substance
preoperative stoma identification and education
What this could lead to
If this works, it could show that simple steps before surgery—like marking the stoma site and teaching patients—can improve quality of life and reduce complications.
What could go wrong
This is an observational study, not a treatment trial. It only compares groups, so it cannot prove cause and effect. Results may not apply to all hospitals or patients.

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 100 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

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: * Men or women aged 18 and over * for whom a fecal diversion stoma is planned on a scheduled or emergency basis * affiliated with the French social security system Exclusion Criteria: * Patient in a period of exclusion from another research protocol at the time of signing the no-objection form, * Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women), * No digestive stoma or fecal diversion planned * Person who does not understand French

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Conditions

The condition(s) this trial relates to.

Adenomatous Polyposis Coli Crohn disease digestive system cancer digestive system neoplasm endometrium neoplasm familial adenomatous polyposis 1 ulcerative colitis

As listed by the trial registrant

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

Adenomatous polyposis coli, familial Anastomotic leak rectum Colorectal anastomosis Crohn disease Digestive cancers Endometrial Protectomy Ulcerative colitis (disorder)

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

  • Assistance publique - Hôpitaux de Marseille

    Marseille, France

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