Actively Recruiting
Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.
Led by Linkoeping University · Updated on 2022-11-29
100
Participants Needed
4
Research Sites
664 weeks
Total Duration
On this page
Sponsors
L
Linkoeping University
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with Ulcerative colitis (UC) aged between 18 and 60
- Scheduled for or have previously undergone subtotal colectomy and ileostomy
- Sufficient rectal compliance and controllable inflammation in the rectum using topical Mesalazin only
You will not qualify if you...
- Rectal inflammation of Mayo Score >1
- Poor sphincter function or perianal disease
- Uncertainty regarding Ulcerative Colitis diagnosis
- Previous colorectal cancer or severe dysplasia
- Primary Sclerosing Cholangitis diagnosis
- More than 2 years since subtotal colectomy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Sahlgrenska Univercity Hospital
Gothenburg, Sweden, SE-413 45
Actively Recruiting
2
Linkoeping University hospital
Linköping, Sweden, 58731
Actively Recruiting
3
Karolinska University Hospital
Solna, Sweden, se-171 76
Actively Recruiting
4
St. Mark's Hospital
London, United Kingdom, HA1 3UJ
Actively Recruiting
Research Team
A
Anton Risto
CONTACT
P
Pär Myrelid, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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