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โ† Trials
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Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection

RecruitingNAAges 18 Years - anyAllHelsinki University Central Hospital
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In plain words

What the trial is, and whether it could suit you

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)).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Patients undergoing anterior resection (resection of the rectum and colorectal or coloanal anastomosis) due to a rectal tumour and a protective stoma is planned. The exclusion criteria are: (1) patient already having a stoma (or another stoma made during surgery), (2) technical inability to create ileo- or colostomy (e.g. previous bowel resection, anatomical factors), (3) age \<18 years, (4) inadequate ability to co-operate.
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What it tests

  • Loop ileostomy
  • Loop colostomy
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Where

3 sites
Helsinki University Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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