RecruitingNCT07347834

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


Sponsor

Region Stockholm

Enrollment

500 participants

Start Date

Oct 22, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is helping people with ulcerative colitis (UC) — a chronic condition causing inflammation of the large bowel — decide between two options: continuing to try advanced medications or having surgery to remove the colon (colectomy). The study is comparing outcomes for both groups to guide future treatment decisions. **You may be eligible if...** - You have active ulcerative colitis - You have already tried and failed at least two different advanced medical therapies - You are a suitable candidate for both continued medication and surgery - You are an English speaker living domestically **You may NOT be eligible if...** - There is uncertainty about your diagnosis - You have been diagnosed with cognitive impairment - You do not speak English or live outside the region Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Karolinska University Hospital

Solna, Stockholm County, Sweden

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NCT07347834


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