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
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 design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Region Stockholm
Lead sponsor
Karolinska Institutet
Collaborator
University Hospital, Linkoeping
Collaborator
Linkoeping University
Collaborator