AI-Driven Personalized Perioperative Management in Colorectal Cancer: A Randomized Controlled Clinical Trial - The AIDPRO-CRC Trial
Trial ID: NCT06645015
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-10-24
Completion date: 2028-02-01
Sponsor: Zealand University Hospital
Collaborators: Aalborg University Hospital; Randers Regional Hospital; Gødstrup Hospital; Odense University Hospital; Hvidovre University Hospital; Viborg Regional Hospital; Hillerod Hospital, Denmark
Conditions: Colo-rectal Cancer
Interventions: AI augmented risk-stratification; Expert-based Risk-stratification
Locations: Aalborg University Hospital, Department of Gastrointestinal Surgery; Regional Hospital Gødstrup, Department of Surgery; Copenhagen University Hospital - North Zealand, Hillerød, Department of Surgery; Copenhagen University Hospital Hvidovre, Gastro Unit, Surgical Division; Regional Hospital Randers, Department of Surgery; Odense University Hospital, Svendborg, Department of Colorectal Surgery; Viborg Regional Hospital, Hospitalunit Midt, Department of Surgery
Countries: Denmark; Denmark; Denmark; Denmark; Denmark; Denmark; Denmark
Enrollment: 1200
Age range: 18 Years - None
Sex: ALL

Summary:
The AIDPRO-CRC trial aims to improve outcomes for patients undergoing surgery for colorectal cancer by using artificial intelligence (AI) to assist surgeons in risk assessment. The trial will evaluate whether AI can help surgeons better predict the risk of complications and death, leading to improved care, fewer complications, and better use of healthcare resources.

In this nationwide, randomized clinical trial, participants will be divided into two groups. One group will have their risk assessed by a surgeon using standard clinical methods, while the other group will have their risk assessed by a surgeon using AI assistance. Based on the risk level, patients will receive varying levels of perioperative care. The AI-assisted risk assessment aims to tailor the treatment more precisely to each patient's individual needs, precisely allocating care to those who need it to more efficiently allocate heath system resources while having no deterioration in patient outcomes.

The primary hypothesis is that AI-assisted risk assessment will lead to more efficient and economic patient care without a deterioration in patient outcomes. The trial also aims to explore clinician satisfaction with the platform and its perceived effect. This is paired with a substudy exploring the variability of suggested treatment plans by clinicians with and without access to the MDT presentation platform.

The trial will include patients at seven hospitals across Denmark, involving patients diagnosed with colorectal cancer who are scheduled for curative surgery. All patients will receive standard treatment according to national guidelines, with the only difference being the modality of risk assessment. For the evaluation of the clinicians satisfactory with the device and the substudy of variability of suggested treatment plans, the trial will enroll clinicians using the device.

This study is a researcher-initiated, nationwide, randomized clinical trial involving patients diagnosed with colorectal cancer across eight hospitals in Denmark. Participants will be randomly assigned to one of two groups: AI-assisted risk assessment or standard surgeon-led assessment. The intervention focuses on optimizing perioperative care based on individual risk levels determined by either AI or the surgeon's clinical judgment.

The study builds on a successful pilot project (AID-SURG) that showed promising results in reducing complications, hospital stays, and readmissions.

Eligibility 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.

Outcomes:
Cost Effectiveness; Perceived Effect of Clinical Support Tool & User Feedback; Variability of Suggested Treatment With and Without MDTPlatform