34 | wetenschapsdag 2023 Sessie 1b: Ticks, Checks and Balances x2 Auteurs A. de Wit, B.T. Bootsma, D.E. Huisman, F. Daams Abstract titel Comparison of compliance to an enhanced study protocol to prevent from colorectal anastomotic leakage between the DoubleCheck and SmartCheck study Background Colorectal anastomotic leakage (CAL) remains a severe complication after bowel resection with creation of an anastomosis. Our recent LekCheck study (LC) identified six modifiable CAL risk factors. The DoubleCheck (DC) and SmartCheck (SC) studies were designed to improve the intraoperative condition of patients by implementing an enhanced intervention bundle, and determining its effect on CAL. This observational study aims to examine which introduction style results in better compliance to a new study protocol. Methods Both are multi-center open-labelled trials with historical controls, implementing an enhanced care protocol during creation of the anastomosis to minimize exposure to: anemia, hyperglycemia, hypothermia, epidural anesthesia, inotropic drug administration and incorrect antibiotic prophylaxis. Both studies used identical protocols, but they were only obligated in the DC, whereas the SC study consisted of a purely observational checklist. The study endpoint is the intraoperative condition measured as exposure to the risk factors. Results 1100 patients were included in this study (867 DC; 233 SC). In the previous LC study patients were exposed to a mean of 1.62 (0 – 6) risk factors at the time of the creation of the anastomosis, compared to 1.54 (0 – 4) in the DC and 1.88 (0 – 5) in the SC (p <0.001). Conclusion Obligated implementation of a quality improvement protocol proved to have superior compliance over an observational checklist. Additional results are being collected to assess whether different compliance results in different CAL rates.
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