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

Recruiting now

Conditions studied: Ulcerative Colitis (UC)

In brief

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.

Key facts

Study ID

NCT07347834

Run by

Region Stockholm

People needed

500

Starts

2024-10-22

Expected to finish

2038-12-01

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with UC with active disease
• failed at least two lines of advanced medical therapies
• are eligible for both continued AMT and colectomy

You may not qualify if…

• diagnostic uncertainty
• diagnosis of impaired cognitive function
• non-domestic and non-English speaking

Where it is running

• Karolinska University Hospital — Solna, Stockholm County, Sweden (enrolling)

Full record on ClinicalTrials.gov

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