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

Region Stockholm

Status: Enrolling

Conditions: Ulcerative Colitis (UC)

Study type: Observational

Funder types: Other

Identifiers

NCT07347834

KI 4-3290/2024

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

Contunued advanced medical therapy

Description:

If the patient chooses continued medical therapy, the gastroenterologist evaluates the patient for a new line of AMT in accordance with clinical practice. The study period starts on the date of initiation of the new drug.

Colectomy

Description:

If the patient chooses colectomy the surgeon will inform the patient further, schedule the surgery, and if needed commence with preoperative optimization in accordance with standard clinical practice. The study period starts at the date of surgery.