RecruitingRecruiting
Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.
NCT05628701 · Linkoeping University
In plain English
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Official title
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.
About this study
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 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
Enrollment target: 100 participants
Allocation: non_randomized
Masking: none
Age groups: adult
Timeline
Starts: 2017-04-04
Estimated completion: 2029-12-31
Last updated: 2022-11-29
Interventions
Procedure: Ileorectal anastomosis (IRA)Procedure: Ileal pouch anal anastomosis (IPAA)Procedure: ileostomy
Primary outcomes
- • Patient satisfaction (2months)
- • Patient satisfaction (1year)
- • Patient satisfaction (5 years)
Sponsor
Linkoeping University · other_gov
With: Karolinska University Hospital, Göteborg University, University College London Hospitals
Contacts & investigators
ContactAnton Risto · contact · anton.risto@liu.se · 0702510374
ContactPär Myrelid, Prof. · contact · par.myrelid@liu.se · +46 0 10 1031581
InvestigatorCaroline Nordenvall, Ass. Prof · study_chair, Karolinska Institutet
All locations (4)
Sahlgrenska Univercity HospitalRecruiting
Gothenburg, Sweden
Linkoeping University hospitalRecruiting
Linköping, Sweden
Karolinska University HospitalRecruiting
Solna, Sweden
St. Mark's HospitalRecruiting
London, United Kingdom