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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Enrolling

Conditions: Ileostomy - Stoma; Ulcerative Colitis

Treatments: Procedure: ileal pouch-anal anastomosis with diverting loop ileastomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03872271

2019-A00687-50 (Other Identifier)

2019-04

Details and patient eligibility

About

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.

Enrollment: 194 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 2 patient groups

Experimental

Experimental group

Description:

ileal pouch-anal anastomosis without diverting loop ileostomy

Treatment:

Procedure: ileal pouch-anal anastomosis with diverting loop ileastomy

Control

Active Comparator group

Description:

ileal pouch-anal anastomosis with diverting loop ileostomy

Treatment:

Procedure: ileal pouch-anal anastomosis with diverting loop ileastomy