92 Chapter 4 STUDY OBJECTIVES This protocol presents the first definitions of CAL-RADS, along with the expected next steps. The objectives of the CAL-RADS study are twofold. The primary aim is to validate and assess clinical feasibility of the CAL-RADs score by assessing interobserver variability of the proposed system. Secondary, we want to estimate a correlation between the performed clinical reinterventions and the given CAL-RADS score. METHODS This is a study protocol for a multicenter, retrospective observational study (non-WMO research). This study is approved by the Medical Ethical Committee of the Maastricht University Medical Centre (no. 2023-0348), and additional participating centers that contribute to patient inclusion. Research group and participating centers The CAL-RADS study will be a collaboration between Maastricht Universitair Medisch Centrum (MUMC+), Amsterdam Universitair Medisch Centrum (Amsterdam UMC), Catharina Ziekenhuis Eindhoven (CZE) and Antoni van Leeuwenhoek (AVL). Besides radiologists, there will be a surgeon from every hospital involved as well. Study population and definitions An observer study will be conducted on a set of randomly selected abdominal CT scans from a group of consecutive patients who presented with a possible AL after oncological colorectal surgery between 2018 and 2024. Specifically, all patients underwent CT scanning within 90 days after their primary surgery due to clinical deterioration, raising the question of a possible leak for the radiologist to assess. This group will include 100 patients who were officially diagnosed with an AL, and 50 patients who did not have an official AL diagnosis or any registered complications. An AL was defined as any defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments, as proposed by the ISREC group 5. All patients will be retrospectively included from MUMC+, Amsterdam UMC, and CZE. Data collected will include patient characteristics (age, sex, comorbidities), type of surgical procedure, CT scan details (postoperative day, use of contrast, technical details, and report), clinical signs, biochemical markers, and re-interventions. These data will be stored in an online database in Castor. CAL-RADS proposal The CAL-RADS assessment scheme allows for the categorization of a given non-enhanced abdominal CT scan into groups related to the likelihood of a patient having AL after colorectal
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