Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion

NCT ID: NCT06881303

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2028-03-01

Brief Summary

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.

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

Conditions

Colorectal Anastomosis; Endometrial; Anastomotic Leak Rectum; Ulcerative Colitis (Disorder); Adenomatous Polyposis Coli, Familial; Crohn Disease; Digestive Cancers; Protectomy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Preoperative identification and education

Group Type: EXPERIMENTAL

preoperative stoma identification and education

Intervention Type: 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 stoma nurses and/or surgeons.

lack of preoperative identification and education

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

preoperative stoma identification and education

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 stoma nurses and/or surgeons.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance publique - Hôpitaux de Marseille

Marseille, , France

Countries

France

Central Contacts

Maéva Donadieu-Masse

Role: CONTACT

promotion.interne@ap-hm.fr

0491435817 ext. 33

Diane MEGE, dr

Role: CONTACT

promotion.interne@ap-hm.fr

0491435817 ext. 33

Facility Contacts

Maéva Donadieu-Masse

Role: primary

promotion.interne@ap-hm.fr

0491435817 ext. 33

Other Identifiers

2023-A01631-44

Identifier Type: OTHER

Identifier Source: secondary_id

RCAPHM23_0029

Identifier Type: -

Identifier Source: org_study_id