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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.
Full description
Introduction:
The AIDPRO-CRC trial is an investigator-initiated nationwide multicenter randomized controlled trial. The trial aims to investigate the clinical effects of an AI-augmented solution "AIDPRO manual CRC" for optimization of perioperative treatment by personalized risk stratification of patients undergoing CRC surgery. The protocol adheres to the SPIRIT Statement recommendations.
The AIDPRO-CRC trial is a pre-market, pivotal stage, confirmatory clinical investigation designed to evaluate the safety and effectiveness of the AIDPRO manual CRC algorithm. As a pivotal clinical investigation, this study is critical for generating the robust evidence required to support regulatory submissions for CE marking. The investigation involves an interventional approach, meaning that participants will undergo specific procedures or treatments as part of the study. This design has been specifically chosen to rigorously assess the performance of the AIDPRO manual CRC device in a real-world clinical setting, providing the necessary data to demonstrate its safety and effectiveness. The results from this trial will be used to seek CE marking, enabling the AIDPRO manual CRC to be brought to market in the future.
Objective of the Study:
Colorectal cancer (CRC) is the second leading cause of cancer-related mortality worldwide. Despite advances in standardized treatment protocols, significant challenges remain in reducing complications, readmissions, and mortality. Addressing these challenges necessitates a transition toward individualized, data-driven treatment strategies.
The AIDPRO-CRC trial aims to evaluate the effectiveness of using artificial intelligence (AI) to distinguish between high- and low-risk patients to offer a personalized and optimized perioperative care pathway for individuals undergoing surgery for colon and rectal cancer. This pathway is tailored based on each patient's specific risk factors and individual clinical profile.
The trial compares risk assessments made by a surgeon unaided to those made by a surgeon supported by an AI model.
For surgeons, achieving a comprehensive understanding of the numerous factors influencing a patient's postoperative risk can be both complex and time-consuming. This study therefore investigates whether AI-assisted risk assessment can improve the allocation of healthcare resources while simultaneously optimizing patient outcomes.
We aim to evaluate the following three primary hypotheses:
Additionally, the study aims to assess the impact of AI-based risk stratification on the incidence of complicated postoperative courses in cancer patients.
The concept of AI-assisted risk assessment for colorectal cancer patients - enabling individualized perioperative optimization based on risk profiles - has already been pilot-tested at the Department of Surgery, Zealand University Hospital, Køge, under the name AID-SURG. This pilot has been fully implemented for approximately two years. Preliminary results suggest improvements in patient outcomes, including reductions in complications, readmissions, and length of hospital stay. A scientific manuscript describing these findings is currently under peer review for publication in an international journal.
Study Methodology, Design, and Procedures:
The AIDPRO-CRC trial is a nationwide, multicenter randomized clinical trial conducted across hospitals in all five Danish regions. The primary objective is to evaluate whether an artificial intelligence (AI)-driven solution can improve the treatment of patients undergoing surgery for colorectal cancer by tailoring perioperative care to the individual patient's risk profile. In addition to the randomized trial, the study comprises a questionnaire-based survey among healthcare professionals and a simulated substudy. The study has several aims:
Randomized Controlled Trial (RCT) with Patients:
All patients with suspected or confirmed colon and/or rectal cancer at the participating centers will be screened for eligibility. Only patients with a confirmed diagnosis and an indication for curative-intent surgery are eligible for inclusion. All patients will continue to receive care in accordance with national clinical guidelines and the colorectal cancer fast-track program.
Participants will be randomized to one of two risk-assessment arms:
The only difference between the study arms is the method of risk assessment used to guide the treatment plan: either an AI-based model or the surgeon's clinical judgment. All other treatment components follow national guidelines and are identical across all sites.
The aim of the intervention is to determine whether AI-assisted risk stratification can improve the allocation of patients into the four risk-based treatment groups, ensuring that only patients with a high risk of complications receive more intensive optimization, thus improving the efficiency of healthcare resource use.
Study Arms in the RCT AI-based Risk Assessment (Intervention Group)
Surgeon-based Risk Assessment (Control Group)
Perioperative Care Packages (A-D)
These four standardized treatment packages are part of routine clinical practice and are not unique to the AIDPRO-CRC trial. The package assigned depends on the risk assessment method and stratifies patients as follows:
Each package includes:
Healthcare Professional Involvement - Usability and Simulation Studies:
To investigate the final two hypotheses, healthcare professionals involved in using the AI model during the study period will participate in both a usability survey and a simulated decision-making substudy.
Usability Survey Two months after patient inclusion begins at each site, all relevant users will receive an email invitation to complete a questionnaire regarding their experience with the MDTPlatform. Prior to participation, informed consent and eligibility confirmation are required. The survey is repeated after one year and again at study completion.
Simulated Substudy Eligible physicians are contacted by a designated researcher and receive information about the simulated decision-making exercise. Upon consent, participants complete a simulation involving 20 patient cases: 10 cases in a standard format (e.g., Word documents) and 10 via the MDTPlatform with AI support. Each case is presented only once to each physician-either in the standard format or via the platform. Physicians indicate their treatment recommendation for each case. If necessary, multiple sessions may be arranged. Physicians may assess multiple cases until all 75 cases have been reviewed by at least one participant.
Patients
All patients referred to a surgical department with a confirmed first-time diagnosis of colon and/or rectal cancer and deemed eligible for potentially curative surgery will be offered participation in the study. Participants will be randomly assigned to one of two groups:
Based on the estimated risk, patients are assigned to one of four predefined perioperative care pathways (Packages A-D). Patients who decline consent for risk estimation will not be enrolled in the trial but will still be offered optimized perioperative care as per local standard clinical protocols.
Sample size estimation - patients Sample size was calculated based on data from the AID-SURG pilot project to detect a cost-saving effect of the AI-based risk stratification. A simulation-based power analysis determined that 600 participants per group (1,200 total) are needed to achieve 93% statistical power with a 5% significance level, to detect a cost reduction of $94.9 USD per patient in the AI group compared to the control group, assuming a tendency of surgeons to allocate more patients to high-risk groups.
No research biobank will be established, and no biological samples will be collected or used from existing biobanks in this study.
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.
Sample size estimation - user survey User experience will be considered positive if more than 50% of respondents agree that the AI platform provides relevant and actionable information. A minimum of 28 participants is required to detect a statistically significant result with high confidence.
Sample size estimation - simulation study The simulation study aims to assess whether AI support increases inter-rater agreement in treatment decisions. Agreement will be quantified using entropy measures. Based on prior pilot data and 1 million Monte Carlo simulations, a total of 75 unique patient cases (600 assessments in total) are needed, corresponding to participation from approximately 30 physicians.
Adverse Effects, Risks, and Disadvantages
Individual Risk Stratification Using Artificial Intelligence (AI):
The primary difference between the AIDPRO-CRC trial and standard clinical practice lies in the use of an AI-based decision-support tool for pre- and postoperative risk assessment, instead of traditional clinician-based evaluation. The study design ensures that the intervention does not influence decisions regarding overall cancer treatment, such as chemotherapy, radiotherapy, or the determination of eligibility for curative surgery. These treatment decisions are made independently of trial participation and irrespective of group allocation. Both arms in the AIDPRO-CRC trial aim to optimize patient outcomes using four predefined treatment pathways based on the latest ERAS (Enhanced Recovery After Surgery) protocols, which are already implemented at all participating centers.
However, the use of AI introduces specific risks and disadvantages:
• AI-Based Risk Assessment: Patients in the intervention group will receive an optimization plan based on the AI-supported risk stratification model. Although the AI model is designed to improve outcomes by accurately predicting risk, potential issues include:
To mitigate these risks and safeguard patient safety, the AIDPRO-CRC study incorporates the following safety measures:
Recruitment of Study Participants:
Recruitment may only begin once all necessary approvals from regulatory authorities and ethics committees have been obtained. Each potential participant must receive both oral and written information and provide written informed consent before inclusion. Screening will be conducted using information from medical records, including age, radiological findings, indication for curative surgery, blood test results, and overall health status. Screening of medical records will be performed in compliance with the Danish Health Act, Section 46.
The first contact between the patient and a physician will occur during the initial outpatient consultation at one of the participating centers. The consent conversation will take place in a private setting to avoid disruptions. If the patient is eligible and agrees to participate, they will be enrolled by a physician from the surgical department, based on the inclusion and exclusion criteria defined in the protocol. Only patients who meet all inclusion criteria and no exclusion criteria may be included. Any uncertainties must be clarified directly with the coordinating investigator.
In addition to the oral and written explanation, patients will receive written study information and a copy of the national leaflet "Your rights as a research subject in medical device trials" published by the National Committee on Health Research Ethics. Patients will be informed that they may bring a companion to the consent meeting. They may also be contacted by phone within 24-48 hours for a final decision, if needed.
There may be unforeseen risks associated with participation in a clinical trial. If new information arises during the study regarding treatment efficacy, risks, or complications, participants will be informed.
Participants will be withdrawn from the study if:
Publication of Study Results:
The results of this study will be published in international peer-reviewed journals, regardless of whether the findings are positive, negative, or inconclusive. The trial will be registered on www.clinicaltrials.gov and continuously updated. Subsequent publications will cover safety, efficacy, and clinical outcomes. Additionally, results will be published on www.clinicaltrialsregister.eu within one year after the study's completion. Any deviations from the pre-specified statistical analysis plan will be described and justified. Future publications will include long-term survival analyses and any exploratory analyses not outlined in the original plan will be identified as post hoc, with rationale provided.
Study results will be submitted to the Clinical Trial Information System (CTIS) within one year of trial completion.
Ethical Justification:
The central ethical difference between the AIDPRO-CRC trial and standard care is the use of an AI-based risk assessment model instead of traditional clinical judgment for planning perioperative treatment. Importantly, this intervention does not impact decisions related to chemotherapy, radiotherapy, or eligibility for curative surgery-all of which are determined independently of trial participation and before group allocation.
Both arms in the AIDPRO-CRC trial aim to optimize patient outcomes via four predefined perioperative treatment packages, based on current ERAS protocols, already implemented at participating hospitals.
There is a potential risk that the AIDPRO algorithm may misclassify individual patients, shifting their risk category from low (A/B) to high (C/D) or vice versa. Patients classified into a lower-risk group by the algorithm will receive standard ERAS treatment without additional prehabilitation and will undergo surgery sooner, consistent with current Danish practice. Conversely, high-risk classifications may result in a 2-4 week postponement of surgery to allow for intensified pre- and postoperative optimization. Research suggests this does not negatively affect outcomes.
Although international concerns exist regarding delays in cancer surgery, national data (under publication) and a systematic review show that surgical delays of up to 7 weeks in stage I-III colorectal cancer do not reduce long-term survival. Furthermore, a 4-week optimization period aligns with the latest guidelines developed by the study team. Importantly, delays in categories C and D are accompanied by active interventions (e.g., physical training, nutritional optimization, and anemia correction), which reduce complications and enhance recovery.
Preliminary data from the AID-SURG pilot study showed that implementation of AI-guided risk assessment and individualized care plans halved the rate of postoperative medical complications-benefiting both the individual and the healthcare system, where such complications account for up to 30% of healthcare spending (manuscript in preparation).
This clinical investigation will be conducted in compliance with applicable regional and national laws, ISO 14155:2020 for medical device trials, the ethical principles of the Declaration of Helsinki (1964 and subsequent revisions), and relevant ICH/GCP and GDPR regulations. It will also conform to the EU Medical Device Regulation (EU) 2017/745 (EU MDR).
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Inclusion and exclusion criteria
Inclusion criteria - patients
To be eligible for study participation, the following criteria must be met:
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:
Exclusion criteria - healthcare professionals There are no exclusion criteria for participation in the survey or simulation study.
Primary purpose
Allocation
Interventional model
Masking
1,200 participants in 2 patient groups
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Central trial contact
Ismail Gögenur, Professor; Magnus N Jung, MD
Data sourced from clinicaltrials.gov
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