Choosing continued advanced medicines or colectomy for ulcerative colitis
TRIOCOL - The Study of Continued Advanced Medical Therapy or Colectomy in Patients With Ulcerative Colitis
This project will see if people with ulcerative colitis who have failed at least two advanced medicines have better quality of life and satisfaction when they continue medical therapy versus when they have a colectomy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Solna, Stockholm County) |
| Trial ID | NCT07347834 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort comparing patients with active ulcerative colitis who opt for continued advanced medical therapy to those who choose colectomy after failing at least two lines of advanced treatments. Participants eligible for both options will be followed with standardized quality-of-life, functional outcome, and patient satisfaction measures, along with clinical data from medical records. The design captures real-world decision-making and outcomes rather than randomizing treatment, aiming to reflect typical patient and clinician choices. Findings will be used to inform shared decision-making between patients and providers.
Who should consider this trial
Good fit: Ideal candidates are adults with active ulcerative colitis who have failed at least two advanced medical therapies and are judged eligible for both continued medical therapy and colectomy.
Not a fit: Patients with diagnostic uncertainty, impaired cognitive function, non‑residency/language in the study setting, those who have not yet tried two advanced therapies, or those already post‑colectomy are unlikely to gain from participation.
Why it matters
Potential benefit: If successful, the results could help patients and clinicians choose the option—continued medicines or colectomy—that is most likely to lead to better quality of life and satisfaction.
How similar studies have performed: Previous registry and retrospective studies indicate colectomy can restore disease control for many patients, but prospective comparisons focused on quality of life after multiple advanced therapy failures are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with UC with active disease * failed at least two lines of advanced medical therapies * are eligible for both continued AMT and colectomy Exclusion Criteria: * diagnostic uncertainty * diagnosis of impaired cognitive function * non-domestic and non-English speaking
Where this trial is running
Solna, Stockholm County
- Karolinska University Hospital — Solna, Stockholm County, Sweden (Recruiting)
Study contacts
- Principal investigator: Caroline Nordenvall, Ass. professor — Karolinska Institutet
- Study coordinator: Carl Kördel, MD, PhD-student
- Email: carl.kordel@ki.se
- Phone: +46702545871
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.