Ulcerative Colitis (UC)TRIOCOLNCT07347834
TRIOCOL - The Study of Continued Advanced Medical Therapy or Colectomy in Patients With Ulcerative Colitis
An observational study of Ulcerative Colitis (UC), run by Region Stockholm at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC)
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 22 Oct 2024to Dec 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with UC with active disease
- failed at least two lines of advanced medical therapies
- are eligible for both continued AMT and colectomy
Who cannot join
- diagnostic uncertainty
- diagnosis of impaired cognitive function
- non-domestic and non-English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Solna, Stockholm County, 17176
Carl Kördel, MD, PhD-student, +46702545871, carl.kordel@ki.se
About this study
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
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Primary endpoint evaluated six months after enrollement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start22 Oct 2024
- Primary completion31 Dec 2028 (estimated)
- Study completionDec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, University Hospital, Linkoeping, Linkoeping University
- Responsible party
- Sponsor
- Investigators
- Caroline Nordenvall, Ass. professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347834
- Sponsor's protocol ID
- KI 4-3290/2024
- Acronym
- TRIOCOL
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Legal agreements will be set up between all sites that will contribute data to the study.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRIOCOL - The Study of Continued Advanced Medical Therapy or Colectomy in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT07347834
- Acronym / sponsor ID
- TRIOCOL / KI 4-3290/2024
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- Ulcerative colitis, Advanced medical therapy, Colectomy, Health related quality of life, Shared decision-making
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet, University Hospital, Linkoeping, Linkoeping University
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- Dec 2038 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients with UC with active disease
- failed at least two lines of advanced medical therapies
- are eligible for both continued AMT and colectomy
Key exclusion criteria (3 listed)
- diagnostic uncertainty
- diagnosis of impaired cognitive function
- non-domestic and non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HRQoL at six months
Time frame: Primary 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. Legal agreements will be set up between all sites that will contribute data to the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline Nordenvall, Ass. professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis (UC), run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carl Kördel, MD, PhD-student (+46702545871, carl.kordel@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQoL at six months (time frame: Primary endpoint evaluated six months after enrollement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.