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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegion Stockholm

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with UC with active disease

failed at least two lines of advanced medical therapies

are eligible for both continued AMT and colectomy

Disqualifiers

diagnostic uncertainty

diagnosis of impaired cognitive function

non-domestic and non-English speaking

Trial population

The study population consists of all adult patients (≥18 years) with UC with active disease, at any of the participating centres, who have failed at least two lines of AMTs, and are eligible for both continued AMT and colectomy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 2 trial groups
Group A: Contunued advanced medical therapy
Group B: Colectomy

Trial outcomes

Primary outcomes

1

HRQoL at six months

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.

Time frame
Primary endpoint evaluated six months after enrollement.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Stockholm

Lead sponsor

Karolinska Institutet

Collaborator

University Hospital, Linkoeping

Collaborator

Linkoeping University

Collaborator