Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.
CRUISE
1 other identifier
interventional
100
2 countries
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2017
CompletedFirst Submitted
Initial submission to the registry
October 28, 2022
CompletedFirst Posted
Study publicly available on registry
November 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
ExpectedNovember 29, 2022
November 1, 2022
7.7 years
October 28, 2022
November 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Patient satisfaction
yes/no question if the patient is satisfied with his/her choice of operation
2months
Patient satisfaction
yes/no question if the patient is satisfied with his/her choice of operation
1year
Patient satisfaction
yes/no question if the patient is satisfied with his/her choice of operation
5 years
Secondary Outcomes (35)
SF-36(short form-36 item)
2 months
SF-36(short form-36 item)
6 months
SF-36(short form-36 item)
1 year
SF-36(short form-36 item)
2 years
SF-36(short form-36 item)
5 years
- +30 more secondary outcomes
Study Arms (5)
IPAA CRUISE
EXPERIMENTALPatients eligible for both operations choosing ileal pouch anal anastomosis.
IRA CRUISE
EXPERIMENTALPatients eligible for both operations choosing ileorectal anastomosis.
IRA Control
ACTIVE COMPARATORPatients only eligible for ileorectal anastomosis.
IPAA Control
ACTIVE COMPARATORPatients only eligible for ileal pouch anal anastomosis.
Ileostomy Control
ACTIVE COMPARATORPatients who decline reconstruction.
Interventions
After subtotal colectomy for ulcerative colitis the patients can either keep their end ileostomy or be reconstructed with an anastomosis (connection) between the ileum and the rectal remnant (Ileorectal anastomosis(IRA))
The rectum is removed and a pouch constructed with the distal part opf the ileum which in subsequently anastomosed (connected) to the anus(Ileal pouch anal anastomosis (IPAA)).
no reconstruction is performed and the patient is left with his/her ileostomy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Linkoeping Universitylead
- Karolinska University Hospitalcollaborator
- Göteborg Universitycollaborator
- University College London Hospitalscollaborator
Study Sites (4)
Sahlgrenska Univercity Hospital
Gothenburg, SE-413 45, Sweden
Linkoeping University hospital
Linköping, 58731, Sweden
Karolinska University Hospital
Solna, se-171 76, Sweden
St. Mark's Hospital
London, HA1 3UJ, United Kingdom
Related Publications (1)
Risto A, Nordenvall C, Deputy M, Hermanson M, Lindforss U, Block M, Faiz O, Myrelid P. 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. (CRUISE-study). BMC Surg. 2023 Apr 21;23(1):96. doi: 10.1186/s12893-023-01984-x.
PMID: 37085812DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Caroline Nordenvall, Ass. Prof
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 28, 2022
First Posted
November 29, 2022
Study Start
April 4, 2017
Primary Completion
December 31, 2024
Study Completion (Estimated)
December 31, 2029
Last Updated
November 29, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share