RecruitingNot ApplicableNCT06650085

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)


Sponsor

Helsinki University Central Hospital

Enrollment

350 participants

Start Date

Oct 6, 2025

Study Type

INTERVENTIONAL

Conditions

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)).


Eligibility

Min Age: 18 Years

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Interventions

PROCEDURELoop ileostomy

Patient undergoing anterior rectal resection will receive loop ileostomy

PROCEDURELoop colostomy

Patient undergoing anterior rectal resection will receive loop colostomy


Locations(3)

Helsinki University Hospital

Helsinki, Finland

Tampere University Hospital

Tampere, Finland

Turku University Hospital

Turku, Finland

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NCT06650085


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