RecruitingNot ApplicableNCT06645015

The AIDPRO-CRC Trial

AI-Driven Personalized Perioperative Management in Colorectal Cancer: A Randomized Controlled Clinical Trial - The AIDPRO-CRC Trial


Sponsor

Zealand University Hospital

Enrollment

1,200 participants

Start Date

Oct 24, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The AIDPRO-CRC trial is studying whether an AI-based decision-support tool can help surgeons and care teams better plan surgery for colon and rectal cancer — potentially improving how surgical risk is predicted and communicated. **You may be eligible if...** - You are 18 years or older - You have been diagnosed (or are strongly suspected) to have colon or rectal cancer for the first time, at any stage - You are scheduled for potentially curative surgery as decided by a multidisciplinary medical team - You have signed informed consent **You may NOT be eligible if...** - Curative surgery is no longer being planned despite previous eligibility Healthcare professionals (surgeons and surgical oncology trainees) may also be invited to participate in a satisfaction survey and simulation sub-study. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAI augmented risk-stratification

A state-of-the-art artificial intelligence (AI) model called AIDPRO manual CRC is used as a decision support tool to estimate the 1-year mortality risk for each patient

OTHERExpert-based Risk-stratification

Experienced colorectal surgeons assess patient risk based on clinical judgment and national guidelines.


Locations(7)

Aalborg University Hospital, Department of Gastrointestinal Surgery

Aalborg, Denmark

Regional Hospital Gødstrup, Department of Surgery

Herning, Denmark

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

Hillerød, Denmark

Copenhagen University Hospital Hvidovre, Gastro Unit, Surgical Division

Hvidovre, Denmark

Regional Hospital Randers, Department of Surgery

Randers, Denmark

Odense University Hospital, Svendborg, Department of Colorectal Surgery

Svendborg, Denmark

Viborg Regional Hospital, Hospitalunit Midt, Department of Surgery

Viborg, Denmark

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NCT06645015


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