Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID05628701

Colectomy Reconstruction for Ulcerative Colitis in Sweden and England: A Multicenter Prospective Comparison Between Ileorectal Anastomosis and Ileal Pouch-Anal Anastomosis After Colectomy

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

100

Participants Needed

4

Research Sites

260 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

Researchers are comparing two main surgical reconstruction options after colectomy for adult patients with ulcerative colitis: ileal pouch anal anastomosis (IPAA) and ileorectal anastomosis (IRA). This study aims to provide detailed information on patient satisfaction, quality of life, function, and complications between these two approaches, addressing a gap due to lack of prospective randomized trials. Patients are informed and choose their preferred surgery, with some followed as controls based on eligibility or choice to decline reconstruction. Participants who are eligible for both procedures choose either IPAA or IRA, while others may only qualify for one method or decline reconstruction and keep an ileostomy. The study includes multiple groups: those selecting either surgery, those eligible for only one, and those who decline reconstruction. The surgeries involve either connecting the ileum to the rectum (IRA) or creating a pouch from the ileum connected to the anus (IPAA). Patients are followed over time to assess outcomes. During the study, patient satisfaction is measured at 2 months, 1 year, and 5 years after surgery. Additional assessments include quality of life surveys, sexual function indexes for females and males, health scales, and scores related to bowel function. Researchers also monitor complications such as failure and reoperations at multiple time points. The study spans long-term follow-up to evaluate the impact of each reconstructive method on patient well-being and function.

CONDITIONS

Brief 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 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 with Mayo Score greater than 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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Varies per participant

Participants undergo surgery to reconstruct the bowel with either ileorectal anastomosis, ileal pouch-anal anastomosis, or continue with ileostomy, followed by immediate post-operative care.

1 surgery visit and several immediate post-operative visits

Post-operative Follow-up

Duration - Up to 5 years

Participants are followed up after surgery to monitor recovery, complications, and patient satisfaction.

Multiple visits at 2 months, 6 months, 1 year, 2 years, and 5 years

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

P

Pär Myrelid, Prof.

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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Published Research Related To This Trial

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).

Anton Risto, Caroline Nordenvall, Mohammed Deputy...

https://pubmed.ncbi.nlm.nih.gov/37085812