AI-assisted risk-guided perioperative care for colorectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

AIDPRO-CRC is a nationwide, multicenter, randomized interventional trial comparing standard surgeon risk stratification with surgeon risk stratification aided by an AI algorithm. Adult patients scheduled for potentially curative colorectal cancer surgery will be randomized to have perioperative care tailored by either expert-based risk estimation or AI-augmented risk estimates. Risk level from each approach determines allocation of prehabilitation and perioperative resources, with outcomes including complications, mortality, readmissions, and healthcare resource use. The investigation is a pre-market pivotal study intended to generate evidence for CE marking of the AIDPRO manual CRC algorithm.

Why it matters

Who can join: the full rules

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.

Where it's running

• Aalborg University Hospital, Department of Gastrointestinal Surgery
  Aalborg, Denmark Recruiting
• Bispebjerg Hospital, University of Copenhagen, Digestive disease Center, Department of Surgery
  Copenhagen NV, Denmark Recruiting
• Regional Hospital Gødstrup, Department of Surgery
  Herning, Denmark Recruiting
• Copenhagen University Hospital Hvidovre, Gastro Unit, Surgical Division
  Hvidovre, Denmark Recruiting
• Regional Hospital Randers, Department of Surgery
  Randers, Denmark Recruiting
• Viborg Regional Hospital, Hospitalunit Midt, Department of Surgery
  Viborg, Denmark Recruiting

Study contacts

• Study coordinator: Ismail Gögenur, Professor
• Email: igo@regionsjaelland.dk
• Phone: +4526336426

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.