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NCT06881303: RESTODIG
Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion
NA trial testing preoperative stoma identification and education in Colorectal Anastomosis in 100 participants. Not yet recruiting.
1 March 2027
Quick facts
| Lead sponsor | Assistance Publique Hopitaux De Marseille |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 100 |
| Start date | 1 March 2026 |
| Primary completion | 1 March 2027 |
| Estimated completion | 1 March 2028 |
| Sites | 1 location across France |
Drugs / interventions tested
- preoperative stoma identification and education
Conditions studied
- Colorectal Anastomosis — all drugs for Colorectal Anastomosis →
- Endometrial — all drugs for Endometrial →
- Anastomotic Leak Rectum — all drugs for Anastomotic Leak Rectum →
- Ulcerative Colitis (Disorder) — all drugs for Ulcerative Colitis (Disorder) →
Sponsor
Assistance Publique Hopitaux De Marseille — full company profile →
Who can join
18 and older, any sex, with Colorectal Anastomosis or Endometrial. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06881303
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Assistance Publique Hopitaux De Marseille trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06881303 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille
- Last refreshed: 18 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06881303.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing