Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.
NCT ID: NCT05628701
Last Updated: 2022-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2017-04-04
2029-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IPAA CRUISE
Patients eligible for both operations choosing ileal pouch anal anastomosis.
Ileal pouch anal anastomosis (IPAA)
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)).
IRA CRUISE
Patients eligible for both operations choosing ileorectal anastomosis.
Ileorectal anastomosis (IRA)
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))
IRA Control
Patients only eligible for ileorectal anastomosis.
Ileorectal anastomosis (IRA)
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))
IPAA Control
Patients only eligible for ileal pouch anal anastomosis.
Ileal pouch anal anastomosis (IPAA)
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)).
Ileostomy Control
Patients who decline reconstruction.
ileostomy
no reconstruction is performed and the patient is left with his/her ileostomy
Interventions
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Ileorectal anastomosis (IRA)
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))
Ileal pouch anal anastomosis (IPAA)
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)).
ileostomy
no reconstruction is performed and the patient is left with his/her ileostomy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Göteborg University
OTHER
University College London Hospitals
OTHER
Linkoeping University
OTHER_GOV
Responsible Party
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Anton Risto
Principal investigator
Principal Investigators
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Caroline Nordenvall, Ass. Prof
Role: STUDY_CHAIR
Karolinska Institutet
Locations
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Sahlgrenska Univercity Hospital
Gothenburg, , Sweden
Linkoeping University hospital
Linköping, , Sweden
Karolinska University Hospital
Solna, , Sweden
St. Mark's Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Pär Myrelid
Role: backup
Caroline Nordenvall
Role: primary
Mohammed Deputy
Role: primary
Maria Hermansson
Role: primary
References
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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.
Other Identifiers
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2017/124-31/2
Identifier Type: -
Identifier Source: org_study_id
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