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Recruiting NCT05628701

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

No phase Interventional Ulcerative Colitis Inflammatory Bowel Diseases Ileostomy - Stoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ileorectal anastomosis (IRA), Ileal pouch anal anastomosis (IPAA), ileostomy.
Who it may be relevant to
Registry conditions: Ulcerative Colitis, Inflammatory Bowel Diseases, Ileostomy - Stoma. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • 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))
  • 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)).
  • Procedure ileostomy
    no reconstruction is performed and the patient is left with his/her ileostomy

Primary outcome measures

  • Patient satisfaction [Time frame: 2months]
  • Patient satisfaction [Time frame: 1year]
  • Patient satisfaction [Time frame: 5 years]
Secondary outcome measures (12)
  • SF-36(short form-36 item) [Time frame: 2 months]
  • SF-36(short form-36 item) [Time frame: 6 months]
  • SF-36(short form-36 item) [Time frame: 1 year]
  • SF-36(short form-36 item) [Time frame: 2 years]
  • SF-36(short form-36 item) [Time frame: 5 years]
  • Female Sexual Function Index-6 (FSFI-6) [Time frame: 2months]
  • Female Sexual Function Index-6 (FSFI-6) [Time frame: 6months]
  • Female Sexual Function Index-6 (FSFI-6) [Time frame: 1 year]
  • Female Sexual Function Index-6 (FSFI-6) [Time frame: 2 years]
  • Female Sexual Function Index-6 (FSFI-6) [Time frame: 5 years]
  • International Index of Erectile Function-5 (IIEF-5) [Time frame: 2 months]
  • International Index of Erectile Function-5 (IIEF-5) [Time frame: 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 3 centers
  • Sahlgrenska Univercity Hospital — Gothenburg
  • Linkoeping University hospital — Linköping
  • Karolinska University Hospital — Solna
United Kingdom · 1 center
  • St. Mark's Hospital — London

Publications

  • 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 37085812

Identifiers

NCT: NCT05628701 · 2017/124-31/2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗