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

Last updated: November 16, 2022
Sponsor: Linkoeping University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcerative Colitis

Gastrointestinal Diseases And Disorders

Inflammatory Bowel Disease

Treatment

N/A

Clinical Study ID

NCT05628701
2017/124-31/2
  • Ages 18-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 100
Study Start date:
April 04, 2017
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Sahlgrenska Univercity Hospital

    Gothenburg, SE-413 45
    Sweden

    Active - Recruiting

  • Linkoeping University hospital

    Linköping, 58731
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Solna, se-171 76
    Sweden

    Active - Recruiting

  • St. Mark's Hospital

    London, HA1 3UJ
    United Kingdom

    Active - Recruiting

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