Objective: The DoubleCheck study aimed to introduce pre- and perioperative interventions minimizing exposure to modifiable risk factors and determine its effect on CAL.
Summary background data: Colorectal anastomotic leakage (CAL) is a severe complication. In order to predict and prevent its occurrence, the LekCheck study identified intraoperative modifiable risk factors for CAL: anemia, hyperglycemia, hypothermia, incorrect timing of antibiotic prophylaxis, administration of vasopressors and epidural analgesia.
Methods: This international open-labelled interventional study was performed between September 2021 and December 2023. An enhanced care bundle consisting of anemia correction, glucose measurement, attaining normothermia, antibiotics administration within 60 to 15 minutes preoperatively, refraining from vasopressors and epidural analgesia was introduced. Primary outcome was the occurrence of intraoperative risk factors just prior to the anastomosis creation. Secondary outcomes were CAL and mortality. Univariate and multivariate regression analysis were performed to establish the relationship between the enhanced care bundle, exposure to the six factors and CAL.
Results: The historical LekCheck group consisted of 1572 patients versus 902 in the DoubleCheck. The LekCheck group had a mean of 1.84 risk factors versus 1.63 in DoubleCheck ( P <0.001). In the DoubleCheck significantly less patients had ≥3 risk factors ( P <0.001). CAL was significantly lower in the DoubleCheck group (8.6% vs. 6.2%, P =0.039). The reduction of CAL was associated with the enhanced care bundle in multivariate regression analysis (OR 1.521, 95% CI 1.01-2.29, P =0.045). The mortality rate did not differ significantly (1.3%, vs. 0.8%, P =0.237).
Conclusions: The DoubleCheck study showed that optimization of modifiable risk factors reduced CAL in colorectal surgery.
Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.