NCT06650085

Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection

PROtective IleoStomy Versus ProtectivE Colostomy in Anterior Rectal ResectIon - a Multicenter, Open-label, Randomized ConTrolled StudY (PROSPERITY)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)).

Conditions

• Stoma Colostomy
• Stoma Ileostomy

Interventions

Type	Name	Description
PROCEDURE	Loop ileostomy	Patient undergoing anterior rectal resection will receive loop ileostomy
PROCEDURE	Loop colostomy	Patient undergoing anterior rectal resection will receive loop colostomy

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-10-01
• Completion: 2032-10-01
• First posted: 2024-10-21
• Last updated: 2024-10-21

Locations

3 sites across 1 country: Finland