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Comparing two surgical reconstructions after colon removal for ulcerative colitis

Compares two bowel reconstruction surgeries in adults with ulcerative colitis after colectomy.

Plain-language title generated from the registry record
Registry title: Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.

Key facts

Where
Gothenburg, Linköping, and Solna, SwedenSee the 3 sites

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 60 years old?

Source: NCT05628701, who can take part

Where in Sweden

  • Sahlgrenska Univercity HospitalGothenburg, SwedenTaking people
  • Linkoeping University HospitalLinköping, SwedenTaking people
  • Karolinska University HospitalSolna, SwedenTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Linkoeping University
Trial code
NCT05628701
Record updated
29 November 2022
Original description
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.Read full original descriptionShow less

Colectomy Reconstruction for Ulcerative Colitis In Sweden and England: a Multicenter Prospective Comparison Between Ileorectal Anastomosis and Ileal Pouch-Anal Anastomosis After Colectomy in Patients With Ulcerative Colitis.

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.

Discussion Reconstruction after colectomy is a morbidity-associated as well as a resource-intensive activity with the sole purpose of enhancing function, Quality of Life and patient satisfaction. The aim of this study is to provide the best possible information on the risks and benefits of each reconstructive treatment.

Inclusion: 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: Previous colorectal cancer or severe dysplasia; Poor sphincter function, perianal disease; Rectal inflammation of Mayo Score >1; Uncertainty regarding UC diagnosis P; Primary Sclerosing Colitis diagnosis; >2 year since subtotal colectomy.

ClinicalTrials.gov NCT05628701