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.

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Sahlgrenska Univercity Hospital
RECRUITING
Gothenburg
Linkoeping University hospital
RECRUITING
Linköping
Karolinska University Hospital
RECRUITING
Solna
United Kingdom
St. Mark's Hospital
RECRUITING
London
Contact Information
Primary
Anton Risto
anton.risto@liu.se
0702510374
Backup
Pär Myrelid, Prof.
par.myrelid@liu.se
+46 0 10 1031581
Time Frame
Start Date: 2017-04-04
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 100
Treatments
Experimental: IPAA CRUISE
Patients eligible for both operations choosing ileal pouch anal anastomosis.
Experimental: IRA CRUISE
Patients eligible for both operations choosing ileorectal anastomosis.
Active_comparator: IRA Control
Patients only eligible for ileorectal anastomosis.
Active_comparator: IPAA Control
Patients only eligible for ileal pouch anal anastomosis.
Active_comparator: Ileostomy Control
Patients who decline reconstruction.
Sponsors
Collaborators: Karolinska University Hospital, Göteborg University, University College London Hospitals
Leads: Linkoeping University

This content was sourced from clinicaltrials.gov