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

NCT07347834 | Recruiting

• 1 other identifier: KI 4-3290/2024
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis (UC)

Keywords

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

Outcome Measures

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.

  Primary endpoint evaluated six months after enrollement.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Patients with UC with active disease
• failed at least two lines of advanced medical therapies
• are eligible for both continued AMT and colectomy

You may not qualify if:

• diagnostic uncertainty
• diagnosis of impaired cognitive function
• non-domestic and non-English speaking

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator
• University Hospital, Linkoeping: collaborator
• Linkoeping University: collaborator

Study Sites (1)

Karolinska University Hospital

Solna, Stockholm County, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Caroline Nordenvall, Ass. professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carl Kördel, MD, PhD-student

CONTACT

+46702545871; carl.kordel@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 16, 2026
• Study Start: October 22, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 1, 2038
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

SE (1)