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

Locations

3
Helsinki University Hospital Helsinki Finland
Tampere University Hospital Tampere Finland
Turku University Hospital Turku Finland

Sponsors and collaborators

Helsinki University Central Hospital

Lead sponsor

Mary and Georg Ehrnrooth's foundation

Collaborator

Helsinki University Hospital Research Funds

Collaborator