Status:
UNKNOWN
Is Diverting Loop Ileostomy Necessary in Completion Proctectomy With Ileal Pouch Anal- Anastomosis: A Multicentre, Randomized Study of the GETAID Chirurgie Group. IDEAL Trial
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Ulcerative Colitis
Ileostomy - Stoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Defunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality eviden...
Eligibility Criteria
Inclusion
- patients aged ≥ 18 years,
- patients presenting with ulcerative colitis or indeterminate colitis requiring completion proctectomy
- patients who have given informed consent
Exclusion
- indication for total proctocolectomy in one-stage or traditional 2-stage fashion
- Crohn's disease,
- pelvic radiotherapy,
- indication for total mésorectum excision
- vulnerable patient under the French laws
Key Trial Info
Start Date :
November 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 24 2025
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT03872271
Start Date
November 26 2019
End Date
May 24 2025
Last Update
February 8 2023
Active Locations (1)
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1
Assistance Publique Hôpitaux de Marseille
Marseille, France, 13354