Clinical trial Recruiting at 4 sites Interventional Ages 18 to 60

Comparing two surgical options for reconstructing the bowel after colectomy in ulcerative colitis patients

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.

Run by Linkoeping University · NCT05628701 · Data updated 2026-11-12

This study is testing which of two surgical options for rebuilding the bowel after colectomy works better for people with ulcerative colitis in terms of satisfaction and quality of life.

Quick facts

Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment100 (estimated)
SponsorLinkoeping University
Government
Locations4 sites (Gothenburg and 3 other locations)
StatusRecruiting
StartedApril 4, 2017
Main results expectedDecember 31, 2024
Study endsDecember 31, 2029
Registry record updatedNovember 29, 2022
Trial IDNCT05628701 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 60 with ulcerative colitis who are scheduled for or have previously undergone subtotal colectomy and ileostomy.

Probably not a fit

Patients with rectal inflammation, poor sphincter function, or a history of colorectal cancer may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the two primary reconstructive surgical options available for patients with ulcerative colitis who have undergone colectomy: ileal pouch anal anastomosis (IPAA) and ileorectal anastomosis (IRA). Patients eligible for both procedures will receive standardized information and then choose their preferred surgical method. The study aims to assess patient satisfaction, quality of life, functional outcomes, and complications associated with each reconstructive approach. It is a prospective, non-randomized, multi-center, controlled trial that will also include a control group of patients who do not opt for reconstruction.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into which surgical option offers better outcomes for patients with ulcerative colitis.

How similar studies have gone: While there have been attempts at randomized trials in this area, this study's approach of allowing patient choice after standardized information is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Sahlgrenska Univercity Hospital
    Gothenburg, Sweden
    Recruiting
  • Linkoeping University hospital
    Linköping, Sweden
    Recruiting
  • Karolinska University Hospital
    Solna, Sweden
    Recruiting
  • St. Mark's Hospital
    London, United Kingdom
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.