Is Diverting Loop Ileostomy Necessary in Completion Proctectomy With Ileal Pouch Anal- Anastomosis: A Multicentre, Randomized Study of the GETAID Chirurgie Group. IDEAL Trial

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis; Ileostomy - Stoma
• Interventions: Procedure: ileal pouch-anal anastomosis with diverting loop ileastomy

• Registration Number: NCT03872271
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-13
• Study Start: 2019-11-26
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-05-24
• Study Completion: 2025-05-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

• patients aged ≥ 18 years,
• patients presenting with ulcerative colitis or indeterminate colitis requiring completion proctectomy
• patients who have given informed consent

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	ileal pouch-anal anastomosis with diverting loop ileastomy	ileal pouch-anal anastomosis without diverting loop ileostomy
Control	ileal pouch-anal anastomosis with diverting loop ileastomy	ileal pouch-anal anastomosis with diverting loop ileostomy

Primary Outcome Measures

Name	Time	Method
6-month global postoperative morbidity	6 months	Number and qualification of surgical and medical complications that may require redmission during the 6 months following the operative procedure: * SBO; * ileostomy prolapse; * parastomial hernia; * dehydration; * skin erosions, that may require readmission; * anastomotic leakage; * incisional hernia.

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France