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

November 17, 2025 updated by: Assistance Publique Hopitaux De Marseille

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Marseille, France
        • Assistance Publique - Hôpitaux de Marseille
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative identification and education
Other: 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.
No Intervention: lack of preoperative identification and education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Questionnary : quality of life
Time Frame: From enrollment to the end of the study at 24 months
From enrollment to the end of the study at 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of short-term stomatal complications (within 30 days days post-operatively)
Time Frame: From intervention to 30 days after intervention
edema, necrosis, retraction, bleeding, evisceration, occlusion, abscess, hyperflow with hydroelectrolytic consequences, skin lesions
From intervention to 30 days after intervention
Questionnaire about the patient's autonomy when returning home (stoma therapist needed or not; if present, for how long)
Time Frame: From intervention to 30 days after intervention
stoma therapist needed or not; if present, for how long
From intervention to 30 days after intervention
rate of long-term stomatal complications at 1 year
Time Frame: From intervention to1 year after intervention
prolapse, occlusion, ventration
From intervention to1 year after intervention
questionnaire on ostomy-specific quality of life, assessed by the StomaQOL score at 30 days, for comparison between identification and education by the stoma nurse or surgeon
Time Frame: From intervention to 30 days after intervention
From intervention to 30 days after intervention
Questionnaire on ostomy-specific quality of life, assessed by the StomaQOL score at 1 years
Time Frame: From intervention to 1 year after intervention
From intervention to 1 year after intervention
SF36 quality of life questionnaire at 30 days and 1 year
Time Frame: From intervention to 1 year after intervention
From intervention to 1 year after intervention
Rate of restoration of digestive continuity at 1 year
Time Frame: From intervention to 1 year after intervention
From intervention to 1 year after intervention
Reasons for not carrying out preoperative identification and education
Time Frame: From enrollment to the end of the study at 24 months
emergency, surgery at night or on weekends or public holidays, insufficient preoperative time, stoma nurse absent, surgeon's choice, patient's wishes.
From enrollment to the end of the study at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCAPHM23_0029
  • 2023-A01631-44 (Other Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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