Actively Recruiting
The AIDPRO-CRC Trial
Led by Zealand University Hospital · Updated on 2026-01-30
1200
Participants Needed
7
Research Sites
118 weeks
Total Duration
On this page
Sponsors
Z
Zealand University Hospital
Lead Sponsor
A
Aalborg University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The AIDPRO-CRC Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis or strong clinical suspicion of first-time colon or rectal cancer, clinical stage I-IV
- Signed written informed consent before any study procedures
- Age 18 years or older at time of consent
- Scheduled for potentially curative surgery as decided by a multidisciplinary team
- Availability of all required input variables for the AI model not directly assessed by the surgeon (e.g., ASA score, WHO performance status)
You will not qualify if you...
- Surgery with curative intent is no longer planned despite previous eligibility
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Aalborg University Hospital, Department of Gastrointestinal Surgery
Aalborg, Denmark, 9000
Actively Recruiting
2
Regional Hospital Gødstrup, Department of Surgery
Herning, Denmark, 7400
Not Yet Recruiting
3
Copenhagen University Hospital - North Zealand, Hillerød, Department of Surgery
Hillerød, Denmark, 3400
Not Yet Recruiting
4
Copenhagen University Hospital Hvidovre, Gastro Unit, Surgical Division
Hvidovre, Denmark, 2650
Actively Recruiting
5
Regional Hospital Randers, Department of Surgery
Randers, Denmark, 8930
Actively Recruiting
6
Odense University Hospital, Svendborg, Department of Colorectal Surgery
Svendborg, Denmark, 5700
Not Yet Recruiting
7
Viborg Regional Hospital, Hospitalunit Midt, Department of Surgery
Viborg, Denmark, 8800
Actively Recruiting
Research Team
I
Ismail Gögenur, Professor
CONTACT
M
Magnus N Jung, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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