Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelsinki University Central Hospital

About this trial

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 criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Loop ileostomy
  • Loop colostomy

Treatment groups

350 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Helsinki University Central Hospital

Lead sponsor

Mary and Georg Ehrnrooth's foundation

Collaborator

Helsinki University Hospital Research Funds

Collaborator