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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07347834
Acronym
TRIOCOL
Enrollment
500
Registered
2026-01-16
Start date
2024-10-22
Completion date
2038-12-01
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis (UC)

Keywords

Ulcerative colitis, Advanced medical therapy, Colectomy, Health related quality of life, Shared decision-making

Brief 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.

Interventions

None listed

Sponsors

Region Stockholm
Lead SponsorOTHER_GOV
Karolinska Institutet
CollaboratorOTHER
University Hospital, Linkoeping
CollaboratorOTHER
Linkoeping University
CollaboratorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HRQoL at six monthsPrimary endpoint evaluated six months after enrollement.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.

Countries

Sweden

Contacts

CONTACTCarl Kördel, MD, PhD-student
carl.kordel@ki.se+46702545871
PRINCIPAL_INVESTIGATORCaroline Nordenvall, Ass. professor

Karolinska Institutet

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026