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Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis. (CRUISE)

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ClinicalTrials.gov Identifier: NCT05628701
Recruitment Status : Recruiting
First Posted : November 29, 2022
Last Update Posted : November 29, 2022
Sponsor:
Collaborators:
Karolinska University Hospital
Göteborg University
University College London Hospitals
Information provided by (Responsible Party):
Anton Risto, Linkoeping University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Inflammatory Bowel Diseases Ileostomy - Stoma Procedure: Ileorectal anastomosis (IRA) Procedure: Ileal pouch anal anastomosis (IPAA) Procedure: ileostomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The CRUISE study is a prospective, non-randomized, non-blinded, multi-center, controlled trial on satisfaction, QoL, function, and complications between IRA and IPAA and permanent stoma among adult UC patients subjected to subtotal colectomy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: IPAA CRUISE
Patients eligible for both operations choosing ileal pouch anal anastomosis.
 Procedure: 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)).
Experimental: IRA CRUISE
Patients eligible for both operations choosing ileorectal anastomosis.
 Procedure: 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))
Active Comparator: IRA Control
Patients only eligible for ileorectal anastomosis.
 Procedure: 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))
Active Comparator: IPAA Control
Patients only eligible for ileal pouch anal anastomosis.
 Procedure: 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)).
Active Comparator: Ileostomy Control
Patients who decline reconstruction.
 Procedure: ileostomy
no reconstruction is performed and the patient is left with his/her ileostomy


Outcome Measures
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Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 2months ]
    yes/no question if the patient is satisfied with his/her choice of operation

  2. Patient satisfaction [ Time Frame: 1year ]
    yes/no question if the patient is satisfied with his/her choice of operation

  3. Patient satisfaction [ Time Frame: 5 years ]
    yes/no question if the patient is satisfied with his/her choice of operation


Secondary Outcome Measures :
  1. SF-36(short form-36 item) [ Time Frame: 2 months ]
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability

  2. SF-36(short form-36 item) [ Time Frame: 6 months ]
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability

  3. SF-36(short form-36 item) [ Time Frame: 1 year ]
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability

  4. SF-36(short form-36 item) [ Time Frame: 2 years ]
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability

  5. SF-36(short form-36 item) [ Time Frame: 5 years ]
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability

  6. Female Sexual Function Index-6 (FSFI-6) [ Time Frame: 2months ]
    6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.

  7. Female Sexual Function Index-6 (FSFI-6) [ Time Frame: 6months ]
    6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.

  8. Female Sexual Function Index-6 (FSFI-6) [ Time Frame: 1 year ]
    6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.

  9. Female Sexual Function Index-6 (FSFI-6) [ Time Frame: 2 years ]
    6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.

  10. Female Sexual Function Index-6 (FSFI-6) [ Time Frame: 5 years ]
    6 item questionnaire on female sexual function with total score rangeing from 0-34 with lower scores indicating worse sexual functioning.

  11. International Index of Erectile Function-5 (IIEF-5) [ Time Frame: 2 months ]
    5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.

  12. International Index of Erectile Function-5 (IIEF-5) [ Time Frame: 6 months ]
    5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.

  13. International Index of Erectile Function-5 (IIEF-5) [ Time Frame: 1 year ]
    5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.

  14. International Index of Erectile Function-5 (IIEF-5) [ Time Frame: 2 years ]
    5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.

  15. International Index of Erectile Function-5 (IIEF-5) [ Time Frame: 5 years ]
    5 item questionnaire on erectile (dys)function rangeing from 5 to 25 with lower scores indicating worse erectile functioning.

  16. Shor health scale (SHS) [ Time Frame: 2 months ]
    IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.

  17. Shor health scale (SHS) [ Time Frame: 6 months ]
    IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.

  18. Shor health scale (SHS) [ Time Frame: 1 year ]
    IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.

  19. Shor health scale (SHS) [ Time Frame: 2 years ]
    IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.

  20. Shor health scale (SHS) [ Time Frame: 5 years ]
    IDB specific 4 item qualit of life scale rangeing from 0-24 with higher scores indicating worse quality of life.

  21. Öresland Score [ Time Frame: 2 months ]
    Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.

  22. Öresland Score [ Time Frame: 6 months ]
    Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.

  23. Öresland Score [ Time Frame: 1 year ]
    Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.

  24. Öresland Score [ Time Frame: 2 years ]
    Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.

  25. Öresland Score [ Time Frame: 5 years ]
    Bowel function score rangeing from 0-17 with higher scores indicating worse functioning.

  26. failure [ Time Frame: 2 months ]
    Extirpation of reconstruction or permanant stoma deviation

  27. failure [ Time Frame: 6 months ]
    Extirpation of reconstruction or permanant stoma deviation

  28. failure [ Time Frame: 1 year ]
    Extirpation of reconstruction or permanant stoma deviation

  29. failure [ Time Frame: 2 years ]
    Extirpation of reconstruction or permanant stoma deviation

  30. failure [ Time Frame: 5 years ]
    Extirpation of reconstruction or permanant stoma deviation

  31. reoperations [ Time Frame: 2 months ]
    number of reoperations

  32. reoperations [ Time Frame: 6 months ]
    number of reoperations

  33. reoperations [ Time Frame: 1 year ]
    number of reoperations

  34. reoperations [ Time Frame: 2 years ]
    number of reoperations

  35. reoperations [ Time Frame: 5 years ]
    number of reoperations


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05628701


Contacts
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Contact: Anton Risto 0702510374 anton.risto@liu.se
Contact: Pär Myrelid, Prof. +46 0 10 1031581 par.myrelid@liu.se

Locations
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Sweden
Sahlgrenska Univercity Hospital Recruiting
Gothenburg, Sweden, SE-413 45
Contact: Maria Hermansson    +46 0 76 0401039      
Linkoeping University hospital Recruiting
Linköping, Sweden, 58731
Contact: Anton Risto    0702510374    anton.risto@liu.se   
Contact: Pär Myrelid         
Karolinska University Hospital Recruiting
Solna, Sweden, se-171 76
Contact: Caroline Nordenvall    +46 0 70 6579109      
United Kingdom
St. Mark's Hospital Recruiting
London, United Kingdom, HA1 3UJ
Contact: Mohammed Deputy         
Sponsors and Collaborators
Linkoeping University
Karolinska University Hospital
Göteborg University
University College London Hospitals
Investigators
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Study Chair: Caroline Nordenvall, Ass. Prof Karolinska Institutet
More Information
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Responsible Party: Anton Risto, Principal investigator, Linkoeping University
ClinicalTrials.gov Identifier: NCT05628701    
Other Study ID Numbers: 2017/124-31/2
First Posted: November 29, 2022    Key Record Dates
Last Update Posted: November 29, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anton Risto, Linkoeping University:
Ulcerative Colitis,
Colectomy
Reconstruction
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes