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Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection

Study acronym: PROSPERITY
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Oct 2027 to Oct 2028
    • Start date changed from estimate of Oct 2024 to Oct 6, 2025
    • Study completion date: Oct 2032 to Oct 2033
    • Site details revised at 3 of 3 sites
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)).
Trial Details
NCT Number NCT06650085
Lead Sponsor Helsinki University Central Hospital
Collaborators: Mary and Georg Ehrnrooth's foundation, Helsinki University Hospital Research Funds
Conditions
(from sponsor)		 Stoma Colostomy, Stoma Ileostomy
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov