Comparing two surgical options for reconstructing the bowel after colectomy in ulcerative colitis patients
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.
NA · Linkoeping University · NCT05628701
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Linkoeping University (other gov) |
| Locations | 4 sites (Gothenburg and 3 other locations) |
| Trial ID | NCT05628701 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with rectal inflammation, poor sphincter function, or a history of colorectal cancer may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gothenburg and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ulcerative Colitis, Inflammatory Bowel Diseases, Ileostomy - Stoma, Ulcerative Colitis,, Colectomy, Reconstruction