About this trial
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
Qualifiers
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.
Disqualifiers
Rectal inflammation of Mayo Score >1
Poor sphincter function, perianal disease
Uncertainty regarding UC diagnosis P
Previous colorectal cancer or severe dysplasia
Trial design
Treatments tested in this trial
- Ileorectal anastomosis (IRA)
- Ileal pouch anal anastomosis (IPAA)
- ileostomy
Treatment groups
Sponsors and collaborators
Linkoeping University
Lead sponsor
Karolinska University Hospital
Collaborator
Göteborg University
Collaborator
University College London Hospitals
Collaborator