Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT05628701

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

Led by Linkoeping University · Updated on 2022-11-29

100

Participants Needed

4

Research Sites

664 weeks

Total Duration

On this page

Sponsors

L

Linkoeping University

Lead Sponsor

K

Karolinska University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with Ulcerative colitis (UC) aged between 18 and 60
  • Scheduled for or have previously undergone subtotal colectomy and ileostomy
  • Sufficient rectal compliance and controllable inflammation in the rectum using topical Mesalazin only
Not Eligible

You will not qualify if you...

  • Rectal inflammation of Mayo Score >1
  • Poor sphincter function or perianal disease
  • Uncertainty regarding Ulcerative Colitis diagnosis
  • Previous colorectal cancer or severe dysplasia
  • Primary Sclerosing Cholangitis diagnosis
  • More than 2 years since subtotal colectomy

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Sahlgrenska Univercity Hospital

Gothenburg, Sweden, SE-413 45

Actively Recruiting

2

Linkoeping University hospital

Linköping, Sweden, 58731

Actively Recruiting

3

Karolinska University Hospital

Solna, Sweden, se-171 76

Actively Recruiting

4

St. Mark's Hospital

London, United Kingdom, HA1 3UJ

Actively Recruiting

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Research Team

A

Anton Risto

CONTACT

P

Pär Myrelid, Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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