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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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).

⁃ 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.

Locations
Other Locations
Denmark
Aalborg University Hospital, Department of Gastrointestinal Surgery
RECRUITING
Aalborg
Regional Hospital Gødstrup, Department of Surgery
NOT_YET_RECRUITING
Herning
Copenhagen University Hospital - North Zealand, Hillerød, Department of Surgery
NOT_YET_RECRUITING
Hillerød
Copenhagen University Hospital Hvidovre, Gastro Unit, Surgical Division
NOT_YET_RECRUITING
Hvidovre
Regional Hospital Randers, Department of Surgery
RECRUITING
Randers
Odense University Hospital, Svendborg, Department of Colorectal Surgery
NOT_YET_RECRUITING
Svendborg
Viborg Regional Hospital, Hospitalunit Midt, Department of Surgery
RECRUITING
Viborg
Contact Information
Primary
Ismail Gögenur, Professor
igo@regionsjaelland.dk
+4526336426
Backup
Magnus N Jung, MD
majuj@regionsjaelland.dk
+4524825249
Time Frame
Start Date: 2025-10-24
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 1200
Treatments
Experimental: AI-augmented risk-stratification
* Description: An advanced AI model functions as a decision-support tool to estimate each patient's perioperative risk.~* Purpose: The AI model uses various patient-specific data inputs to predict risk and assign a tailored care pathway, based on a large historical dataset.~* Expected Outcome: The use of AI is expected to improve the precision of risk stratification, thereby optimizing resource utilization.
Active_comparator: Expert-based Risk-stratification
* Description: Experienced colorectal surgeons assess patient risk based on clinical judgment and national guidelines.~* Purpose: Traditional clinical assessment is used to assign patients to the appropriate care pathway.~* Expected Outcome: This arm serves as the clinical standard-of-care comparator against which the effectiveness of AI-guided decision-making is evaluated.
Related Therapeutic Areas
Sponsors
Collaborators: Viborg Regional Hospital, Gødstrup Hospital, Odense University Hospital, Randers Regional Hospital, Hillerod Hospital, Denmark, Aalborg University Hospital, Hvidovre University Hospital
Leads: Zealand University Hospital

This content was sourced from clinicaltrials.gov