90 ABSTRACT Introduction. Surgery is the primary curative option for colorectal cancer (CRC), but it can lead to significant post-operative complications, including anastomotic leakage (AL). AL occurs in 8-15% of cases and is associated with high morbidity and mortality. Diagnosing AL can be challenging due to ambiguous clinical presentations and high false-negative rates in imaging. The Colorectal Anastomotic Leakage Reporting and Data System (CAL-RADS) project aims to standardize the radiological (computed tomography; CT) assessment of AL. Study Objectives. This study protocol outlines the first definitions of CAL-RADS. The primary objective is to validate the CAL-RADS score by assessing interobserver variability. The secondary objective is to correlate CAL-RADS scores with clinical re-interventions. Methods. This multicenter, retrospective observational study involves collaboration among several Dutch medical centers. It includes 150 patients who underwent abdominal CT scanning within 90 days after colorectal surgery. Six categories were included in the CALRADS. Categories 1 to 5 follow an increasing risk for AL, from unlikely risk to a known leak. Category 0 indicates an inadequate imaging. Six radiologists will assess the CT scans using the CAL-RADS score. Initial test cases will be reviewed and discussed to ensure consistency. Interobserver agreement will be evaluated using Fleiss’ kappa on the final CAL-RADS scores. Results. Patient inclusion and data extraction were completed in April 2024. The test cases were finalized in May 2024 and showed good results. Radiologists are currently assessing the CT scans, with final results expected in early 2025. Discussion. Standardizing CT scan reporting for AL through CAL-RADS is expected to improve early detection, reduce diagnostic errors, and enhance patient outcomes. The system aims to provide a clear framework for assessing AL, facilitating better communication among healthcare providers in a consistent manner, providing recommendations for subsequent management. The established standardization in reporting offers advantages for different stakeholders with the potential to ultimately enhance the overall quality of care. Keywords: Anastomotic leakage, Reporting and Data System, abdominal computed tomography scans, colorectal surgery.
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