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

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis (UC)

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Carl Kördel, MD, PhD-student; Phone Number: +46702545871; Email: carl.kordel@ki.se

Study Locations

• Sweden
  • Stockholm County
    • Solna, Stockholm County, Sweden, 17176
      • Recruiting
      • Karolinska University Hospital
      • Contact: Carl Kördel, MD, PhD-student; Phone Number: +46702545871; Email: carl.kordel@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Region Stockholm
• Collaborators: Karolinska Institutet; Linkoeping University; University Hospital, Linkoeping
• Investigators: Principal Investigator: Caroline Nordenvall, Ass. professor, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 1, 2038

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Ulcerative colitis; Colectomy; Health related quality of life; Shared decision-making; Advanced medical therapy
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: KI 4-3290/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Legal agreements will be set up between all sites that will contribute data to the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No