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AI takes on colorectal surgery: smarter risk assessment or just hype?

NCT ID NCT06645015

Knowledge-focused Sponsor: Zealand University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This trial tests whether an AI tool can help surgeons better predict risks for patients undergoing colorectal cancer surgery. About 1,200 patients across Denmark will be randomly assigned to have their risk assessed by a surgeon using standard methods or with AI assistance. The goal is to see if AI leads to more personalized care, fewer complications, and lower costs, without harming patient outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-driven risk assessment tool (AIDPRO manual CRC)
What this could lead to
If successful, this could show that AI helps surgeons personalize care, potentially reducing complications and hospital costs for colorectal cancer patients.
What could go wrong
This is an early-stage trial focused on decision support, not a direct treatment. The AI may not improve outcomes or could lead to over- or under-treatment. Results may not apply outside Denmark.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria - patients To be eligible for study participation, the following criteria must be met: * Histologically confirmed diagnosis or strong clinical suspicion of first-time colon or rectal cancer, clinical stage I-IV. * Signed written informed consent obtained prior to any study-specific procedures. * Age ≥18 years at the time of consent. * Scheduled for potentially curative surgery as determined by a multidisciplinary team (MDT) conference. * Availability of all required input variables for the AI model not directly assessed by the surgeon (e.g., ASA score, WHO performance status). Exclusion criteria - patients A patient will be excluded from the study if: • Surgery with curative intent is no longer planned despite previous eligibility. Healthcare Professionals Surgeons and other healthcare professionals involved in the use of the AI-based platform will be invited to participate in two sub-studies: a user satisfaction survey and a simulation-based study. Eligible personnel will be automatically invited upon registration as platform users. Inclusion criteria - healthcare professionals To be eligible to participate in the survey and simulation study, individuals must: * Be licensed medical doctors. * Be either board-certified specialists in surgical oncology or currently in training to become one. Exclusion criteria - healthcare professionals There are no exclusion criteria for participation in the survey or simulation study.

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colo-rectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aalborg University Hospital, Department of Gastrointestinal Surgery

    RECRUITING

    Aalborg, 9000, Denmark

  • Bispebjerg Hospital, University of Copenhagen, Digestive disease Center, Department of Surgery

    RECRUITING

    Copenhagen NV, 2400, Denmark

  • Copenhagen University Hospital - North Zealand, Hillerød, Department of Surgery

    NOT_YET_RECRUITING

    Hillerød, 3400, Denmark

  • Copenhagen University Hospital Hvidovre, Gastro Unit, Surgical Division

    RECRUITING

    Hvidovre, 2650, Denmark

  • Odense University Hospital, Svendborg, Department of Colorectal Surgery

    NOT_YET_RECRUITING

    Svendborg, 5700, Denmark

  • Regional Hospital Gødstrup, Department of Surgery

    RECRUITING

    Herning, 7400, Denmark

  • Regional Hospital Randers, Department of Surgery

    RECRUITING

    Randers, 8930, Denmark

  • Viborg Regional Hospital, Hospitalunit Midt, Department of Surgery

    RECRUITING

    Viborg, 8800, Denmark

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