Preoperative education and site marking for patients needing a digestive stoma
Tests marking and teaching about a future stoma before surgery in adults needing fecal diversion.
Key facts
- Who runs it
- Assistance Publique Hopitaux De Marseille
- Where
- Marseille, FranceSee the site
- Trial code
- Registry title
- Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion
- Status
- Not yet recruiting
- People taking part
- 100 people, planned
- Started
- 1 Mar 2026
- Expected to end
- 1 Mar 2028
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- preoperative stoma identification and education
- Record updated
- 18 November 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are going to have a fecal diversion stoma, either in planned or emergency surgery. It compares quality of life after surgery with or without stoma marking and education before surgery.
- Age
- 18 years and older
- Sex
- Men and women
- Disease stage
- A fecal diversion stoma (digestive stoma) is planned, either in scheduled surgery or in emergency surgery.
Main reasons for not taking part
- Currently in an exclusion period from another research protocol
- Minors, adults under guardianship or trusteeship, people deprived of their liberty, pregnant or breast-feeding women
- No digestive stoma or fecal diversion planned
- Does not understand French
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in France
- Assistance Publique Hôpitaux de MarseilleMarseille, FranceContact: Maéva Donadieu-MasseNot yet recruiting
About the trial
What the trial wants to find out
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. The most frequent complications are necrosis, retraction, bleeding, evisceration, occlusion, abscess, hyperflow with hydroelectrolytic consequences, skin lesions, prolapse or eventration. What's more, a temporary stoma can become permanent.
Read full original descriptionShow less
The positioning and fabrication of the digestive stoma for fecal diversion must therefore comply with well-defined criteria to reduce the risk of stomal complications and the difficulties of fitting the stoma, and thus improve the autonomy and therefore the quality of life of the ostomate patient. The guide to good stoma therapy practice recommends that the site of the future stoma should be marked out preoperatively. What's more, the psychological impact of a stoma is such that preoperative and regular postoperative education is essential. This identification and initiation of education is carried out by stoma nurses and/or surgeons.
The impact of preoperative stoma identification and education on stoma complications, quality of life and patient autonomy has been reported in a few comparative series. The impact of preoperative education on quality of life has also been reported.
However, despite this "Evidence Based Medicine", and the guide to good stoma therapy practice, the identification and education of the future fecal diversion stoma are not always carried out preoperatively. Reasons for this may include lack of time, lack of human resources, in the general context of a shrinking public hospital, or in the current context of distancing and dehumanization of the profession, or lack of conviction on the part of practitioners.
To this end, the investigators would like to propose a prospective observational study aimed at evaluating the impact of identification and education prior to the performance of a fecal diversion stoma in a programmed situation on the one hand, and an emergency situation on the other.
The main objective will be to compare quality of life specifically related to the stoma at 30 days postoperatively with the StomaQOL score, between 2 groups of patients:
* unexposed group: no preoperative stoma identification and education * exposed group: preoperative stoma identification and education. This comparison will be stratified according to whether surgery is scheduled or emergency surgery.
Total 100 patients :
* In scheduled surgery: 30 exposed and 30 unexposed patients * In emergency surgery: 10 exposed and 30 unexposed patients
Timeline:
Inclusion period: 12 months Follow-up period: 12 months Total duration: 24 months
The 2 groups in the trial
- Preoperative identification and educationTreatment being tested
Treatment: preoperative stoma identification and education
- lack of preoperative identification and educationNo study treatment, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion
- Plain-language title
- Preoperative education and site marking for patients needing a digestive stomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 18 November 2025