PROtective ileoStomy Versus ProtectivE Colostomy in Anterior Rectal resectIon - a Multicenter, Open-label, Randomized conTrolled studY (PROSPERITY)
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
Locations
Other Locations
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Tampere University Hospital
RECRUITING
Tampere
Turku University Hospital
RECRUITING
Turku
Contact Information
Primary
Laura Koskenvuo, MD, PhD
laura.koskenvuo@hus.fi
+358-9-4711
Backup
Ville Sallinen, MD, PhD
ville.sallinen@helsinki.fi
+358-9-4711
Time Frame
Start Date: 2025-10-06
Estimated Completion Date: 2033-10
Participants
Target number of participants: 350
Treatments
Experimental: Loop ileostomy
Active_comparator: Loop colostomy
Sponsors
Collaborators: Mary and Georg Ehrnrooth's foundation, Helsinki University Hospital Research Funds
Leads: Helsinki University Central Hospital