NCT05628701Recruiting
Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.
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.
Source: ClinicalTrials.gov · Last updated 29 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 28 Oct 2022
- Start date
- 4 Apr 2017
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Linkoeping University
- Diseases
- Ulcerative colitis
- NCT number
- NCT05628701
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 4 Apr 2017 to the primary completion date, 31 Dec 2024
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous colorectal cancer or severe dysplasia
Other illness
- Poor sphincter function, perianal disease
Other
- Rectal inflammation of Mayo Score \>1
- Uncertainty regarding UC diagnosis P
- Primary Sclerosing Colitis diagnosis
- \>2 year since subtotal colectomy
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St Mark's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Sahlgrenska Univercity Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
| Linkoeping University Hospital Coordinator of this site? Confirm its status | Linköping | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.