Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection (PROSPERITY)

Helsinki University Central Hospital (HUCH)

Status: Not yet enrolling

Conditions: Stoma Colostomy; Stoma Ileostomy

Treatments: Procedure: Loop ileostomy; Procedure: Loop colostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06650085

PROSPERITY

Details and patient eligibility

About

Loop ileostomy and loop colostomy are both used as protective stomas after anterior resection. There is a lack of evidence on the superiority of loop ileostomy versus loop colostomy. This is a multicenter, open-label, superiority, individually randomized controlled trial including patients undergoing anterior rectal resection with primary anastomosis and a protective stoma. Patients scheduled for anterior rectal resection are randomized 1:1 to loop ileostomy or loop colostomy intraoperatively. Primary outcome is cumulative stoma-related adverse events within 60 days post-primary surgery (scored using Comprehensive Complication Index (CCI)).

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Patients undergoing anterior resection (resection of the rectum and colorectal or coloanal anastomosis) due to a rectal tumour and a protective stoma is planned.

The exclusion criteria are: (1) patient already having a stoma (or another stoma made during surgery), (2) technical inability to create ileo- or colostomy (e.g. previous bowel resection, anatomical factors), (3) age <18 years, (4) inadequate ability to co-operate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Loop ileostomy

Experimental group

Treatment:

Procedure: Loop ileostomy

Loop colostomy

Active Comparator group

Treatment:

Procedure: Loop colostomy