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

NCT06881303 | Not Yet Recruiting

• 2 other identifiers: RCAPHM23_00292023-A01631-44
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Questionnary : quality of life

  From enrollment to the end of the study at 24 months

Secondary Outcomes (8)

• occurrence of short-term stomatal complications (within 30 days days post-operatively)

  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)

  From intervention to 30 days after intervention

• rate of long-term stomatal complications at 1 year

  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

  From intervention to 30 days after intervention

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

  From intervention to 1 year after intervention

Study Arms (2)

Preoperative identification and education

EXPERIMENTAL

Other: preoperative stoma identification and education

lack of preoperative identification and education

NO INTERVENTION

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 stoma nurses and/or surgeons.

Preoperative identification and education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance publique - Hôpitaux de Marseille

Marseille, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Adenomatous Polyposis Coli; Crohn Disease; Gastrointestinal Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Maéva Donadieu-Masse

CONTACT

0491435817; promotion.interne@ap-hm.fr

Diane MEGE, dr

CONTACT

0491435817; promotion.interne@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 18, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

FR (1)