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

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Begins enrollment this month

Conditions

Endometrial

Anastomotic Leak Rectum

Colorectal Anastomosis

Adenomatous Polyposis Coli, Familial

Digestive Cancers

Ulcerative Colitis (Disorder)

Protectomy

Crohn Disease

Treatments

Other: preoperative stoma identification and education

Study type

Interventional

Funder types

Other

Identifiers

NCT06881303

RCAPHM23_0029

2023-A01631-44 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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