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NCT Number: NCT05628701

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Ileostomy - Stoma Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska Univercity Hospital, Gothenburg, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ileorectal anastomosis (IRA)

Procedure

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)

Procedure

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

Procedure

no reconstruction is performed and the patient is left with his/her ileostomy

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Anton Risto

CONTACT

[email protected]

0702510374

Pär Myrelid, Prof.

CONTACT

[email protected]

+46 0 10 1031581

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • Göteborg University
  • Karolinska University Hospital
  • University College London Hospitals

Registry information

Official study 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.

Acronym: CRUISE

Important dates

Study start
2017
Primary completion
2024
Study completion
2029
First posted
Nov 29, 2022
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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