Ulcerative Colitis Clinical Trials

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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with UC with active disease

• failed at least two lines of advanced medical therapies

• are eligible for both continued AMT and colectomy

Locations
Other Locations
Sweden
Karolinska University Hospital
RECRUITING
Solna
Contact Information
Primary
Carl Kördel, MD, PhD-student
carl.kordel@ki.se
+46702545871
Time Frame
Start Date: 2024-10-22
Estimated Completion Date: 2038-12
Participants
Target number of participants: 500
Treatments
Contunued advanced medical therapy
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
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.
Sponsors
Collaborators: Linkoeping University, Karolinska Institutet, University Hospital, Linkoeping
Leads: Region Stockholm

This content was sourced from clinicaltrials.gov