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 type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Linkoeping University Government |
| Locations | 4 sites (Gothenburg and 3 other locations) |
| Status | Recruiting |
| Started | April 4, 2017 |
| Main results expected | December 31, 2024 |
| Study ends | December 31, 2029 |
| Registry record updated | November 29, 2022 |
| Trial ID | NCT05628701 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
- Study coordinator: Anton Risto
- Email: anton.risto@liu.se
- Phone: 0702510374
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.