AI-assisted risk-guided perioperative care for colorectal cancer surgery
AI-Driven Personalized Perioperative Management in Colorectal Cancer: A Randomized Controlled Clinical Trial - The AIDPRO-CRC Trial
This trial will test whether AI-assisted risk assessment helps surgeons better predict complications and guide perioperative care for adults undergoing colorectal cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 7 sites (Aalborg and 6 other locations) |
| Trial ID | NCT06645015 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with a first-time clinical or histologic diagnosis of colon or rectal cancer who are scheduled for potentially curative surgery and have the required clinical input data available for the AI model.
Not a fit: Patients who are no longer planned for curative surgery or who lack required clinical input variables (e.g., ASA score, WHO performance status) are unlikely to benefit from the intervention.
Why it matters
Potential benefit: If successful, the AI tool could help target perioperative care more precisely, reducing complications and using healthcare resources more efficiently.
How similar studies have performed: Related AI risk models have shown promising retrospective accuracy, but randomized, multicenter confirmatory trials of AI-guided perioperative allocation remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aalborg and 6 other locations
- Aalborg University Hospital, Department of Gastrointestinal Surgery — Aalborg, Denmark (Recruiting)
- Regional Hospital Gødstrup, Department of Surgery — Herning, Denmark (Not_yet_recruiting)
- Copenhagen University Hospital - North Zealand, Hillerød, Department of Surgery — Hillerød, Denmark (Not_yet_recruiting)
- Copenhagen University Hospital Hvidovre, Gastro Unit, Surgical Division — Hvidovre, Denmark (Recruiting)
- Regional Hospital Randers, Department of Surgery — Randers, Denmark (Recruiting)
- Odense University Hospital, Svendborg, Department of Colorectal Surgery — Svendborg, Denmark (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.