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NCT Number: NCT06881303

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 stoma nurses and/or surgeons.

Primary outcomes

  1. Questionnary : quality of life

    Time frame: From enrollment to the end of the study at 24 months

Secondary outcomes

  1. 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

  2. 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

  3. rate of long-term stomatal complications at 1 year

    Time frame: From intervention to1 year after intervention

    prolapse, occlusion, ventration

  4. 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

  5. Questionnaire on ostomy-specific quality of life, assessed by the StomaQOL score at 1 years

    Time frame: From intervention to 1 year after intervention

  6. SF36 quality of life questionnaire at 30 days and 1 year

    Time frame: From intervention to 1 year after intervention

  7. Rate of restoration of digestive continuity at 1 year

    Time frame: From intervention to 1 year after intervention

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Diane MEGE, dr

CONTACT

[email protected]

0491435817 ext. 33

Maéva Donadieu-Masse

CONTACT

[email protected]

0491435817 ext. 33

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: RESTODIG

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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