Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06645015

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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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