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Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.

RecruitingNAAges 18 Years - 60 YearsAllLinkoeping University
NCT05628701 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background There are no prospective trials comparing the two main reconstructive options after colectomy for Ulcerative colitis, ileal pouch anal anastomosis and ileorectal anastomosis. An attempt on a randomized controlled trial has been made but after receiving standardized information patients insisted on choosing operation themselves. Methods Adult Ulcerative colitis patients subjected to colectomy eligible for both ileal pouch anastomosis and ileorectal anastomosis are asked to participate and after receiving standardized information the get to choose reconstructive method. Patients not declining reconstruction or not considered eligible for both methods will be followed as controls. The CRUISE study is a prospective, non-randomized, multi-center, controlled trial on satisfaction, QoL, function, and complications between ileal pouch anal anastomosis and ileorectal anastomosis. Dis

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📋 Eligibility rules (as published)
Inclusion criteria: * Patients with Ulcerative colitis (UC) aged between 18 and 60 * Scheduled for or have previously undergone subtotal colectomy and ileostomy. * Patients should have sufficient rectal compliance and controllable inflammation in the rectal using topical Mezalasin only. Exclusion criteria * Rectal inflammation of Mayo Score \>1 * Poor sphincter function, perianal disease * Uncertainty regarding UC diagnosis P * Previous colorectal cancer or severe dysplasia * Primary Sclerosing Colitis diagnosis * \>2 year since subtotal colectomy
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What it tests

  • Ileorectal anastomosis (IRA)
  • Ileal pouch anal anastomosis (IPAA)
  • ileostomy
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Where

4 sites
Sahlgrenska Univercity Hospital
Gothenburg, Sweden
Linkoeping University hospital
Linköping, Sweden
Karolinska University Hospital
Solna, Sweden
St. Mark's Hospital
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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