Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion
Not applicable · Testing preoperative stoma identification and education · 1 site · Assistance Publique Hopitaux De Marseille
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing preoperative stoma identification and education as supportive care (to help with symptoms or quality of life). Condition(s) listed: Colorectal Anastomosis, Endometrial and Anastomotic Leak Rectum.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2026-03-01 (planned).
- Main results expected around 2027-03-01 (estimate from the record).
- 1 study site listed in France.
Main thing being measured
- Questionnary : quality of life (From enrollment to the end of the study at 24 months)
In the researchers’ words
There are many indications for performing a fecal diversion stoma. In both scheduled and emergency situations, and whatever the context (indication or type of fecal diversion stoma), stomal complications can occur early (10-60%) or late (25%), and may require repeat surgery.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Colorectal Anastomosis; Endometrial; Anastomotic Leak Rectum; Ulcerative Colitis (Disorder); Adenomatous Polyposis Coli, Familial; Crohn Disease; Digestive Cancers; Protectomy |
| Lead sponsor | Assistance Publique Hopitaux De Marseille |
| Enrollment | 100 (estimated) |
| Start date | 2026-03-01 |
| Primary completion (est.) | 2027-03-01 |
| First posted | 2025-03-18 |
| Last updated | 2025-11-18 |
| Official title | Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion |
| ClinicalTrials.gov ID | NCT06881303 |
Interventions
- preoperative stoma identification and education (Other)
The guide to good stoma therapy practice recommends that the site of the future stoma should be marked out preoperatively, in the lying, sitting and standing positions, so that the patient can see the stoma. What's more, the psychological impact of the stoma is such that preoperative and regular postoperative education is essential. This identification and initiation of education is carried out by…
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Assistance publique - Hôpitaux de Marseille | Marseille | France |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.