Informations générales (source: ClinicalTrials.gov)
Is Diverting Loop Ileostomy Necessary in Completion Proctectomy With Ileal Pouch Anal- Anastomosis: A Multicentre, Randomized Study of the GETAID Chirurgie Group. IDEAL Trial (IDEAL)
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
novembre 2019
mai 2025
31 mai 2025
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 evidences in case of ileal pouch-anal anastomosis (IPAA)
performed for inflammatory bowel disease (IBD). However, most surgical teams do protect
systematically IPAA by an ileostomy.
Total proctocolectomy with IPAA is the gold standard for surgical management of
ulcerative colitis (UC). This demanding procedure is often performed in 2 or 3 stages,
namely subtotal colectomy, completion proctectomy with IPAA and defunctioning ileostomy
closure. Subtotal colectomy with double stoma is first performed to allow nutritional
support, reduce inflammation and stop immunosuppressive agents. Completion proctectomy
with IPAA is then performed on a healthier patient. Hence, the need for a systematic
defunctioning ileostomy is questioned. No study addressed specifically the question of
completion proctectomy, whereas it concerns 36% to 42% of patients undergoing IPAA.
Globally, the overall 6-month morbidity rate is 55% in case of stoma creation vs. 30%
otherwise in IPAA.
Moreover, defunctioning ileostomy has several drawbacks including an additional surgical
procedure (stoma closure), a worse quality of life before closure, and the risk of
dehydration that may require readmission. Following stoma closure, the risk of
anastomotic leakage is around 4%. Overall, during the stoma period, 8% of patients will
require reoperation. Finally, the risk of incisional hernia is 15-20% at the ex-ileostomy
site.
Therefore, the aim of this trial is to assess the need for a systematic defunctioning
ileostomy after completion proctectomy with IPAA.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Marseille - 13354 - Marseille - France | Laura Beyer, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- patients aged ≥ 18 years,
- patients presenting with ulcerative colitis or indeterminate colitis requiring
completion proctectomy
- patients who have given informed consent
- patients aged ≥ 18 years,
- patients presenting with ulcerative colitis or indeterminate colitis requiring
completion proctectomy
- patients who have given informed consent
- 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