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Clinical Trials in Sweden / NCT07347834
Recruiting Observational

TRIOCOL - The Study of Continued Advanced Medical Therapy or Colectomy in Patients With Ulcerative Colitis

NCT07347834 · tracked via the Priya Life Science Sweden tracker
Sponsor
Region Stockholm
Phase
Observational
Started
2024-10-22
Last updated
2026-01-21

Condition(s) studied

Ulcerative Colitis (UC)

Study summary

Ulcerative colitis is an inflammatory disease affecting the rectum and colon, most commonly presenting in late adolescence or early adulthood. The primary treatment approach is pharmacological. Over the past two decades, there has been significant progress in the development of so-called advanced medical therapies, and new drugs in this category continue to emerge. These medications are highly effective for many patients, but not for all. If the first advanced therapy fails or is not tolerated, patients may switch to a second, third, or subsequent drugs. Unfortunately, the likelihood of success decreases with each additional line of therapy.

An alternative is surgery, specifically colectomy, which is a potentially curative treatment but may have a major impact on the individual. The overall objective of the study is to evaluate quality of life, functional outcomes, and patient satisfaction among those who choose continued medical therapy, compared to those who undergo colectomy, after at least two failed advanced medical therapies. Before making their treatment decision and enrolling in the study, patients will receive standardized information about all treatment options from a gastroenterologist and a colorectal surgeon. The aim is that the results of this study will provide valuable insights to better guide future patients with ulcerative colitis in choosing between continued advanced medical therapy and surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • HRQoL at six months — Primary endpoint evaluated six months after enrollement.
    The patients will be evaluated with electronically distributed questionnaires at six months. The primary endpoint, health related quality of life (HRQOL), will be evaluated with 36-Item Short Form Survey (SF-36). Range 0-100. Higher number indicated better HRQOL.

Trial sites (1)

FacilityCityRegionStatus
Karolinska University Hospital Solna Stockholm County Recruiting

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Other trials for the same condition

Food Limitations In Crohn's Disease and Ulcerative coliTis Enrolling by invitation
ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery Starting soon
Uneven Nutrition and Life Style as IBD Triggers in Adolescents and Adults Recruiting
A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) Active, not recruiting
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07347834 on ClinicalTrials.gov ↗ ← All trials in Sweden