Enhanced perioperative care for the prevention of anastomotic leakage – DOUBLE CHECK: study protocol for an international, multicenter open-label trial with historical controls

Abstract

Background: Colorectal anastomotic leakage (CAL) remains a severe complication after bowel surgery. Recent research has identified several modifiable perioperative CAL risk factors. The aim of this study is to implement an enhanced perioperative care protocol, to optimize the intraoperative condition of the patient and minimalize exposure to modifiable CAL risk factors. Secondly, this study will investigate whether implementation of this new protocol results in a decreased CAL rate. Methods: The DOUBLE CHECK study will be performed using an open-label, international, multicenter design in 11 participating hospitals. The aim is to include an intervention group of 943 adult patients that underwent a colorectal resection with creation of a primary anastomosis. The patients in the intervention group will be treated according to an enhanced perioperative care protocol focusing on optimizing the intraoperative condition of the patient by minimalizing exposure to the following perioperative factors: anemia, hyperglycemia, hypothermia, epidural anesthesia, vasopressor drug administration, and incorrect or lack of antibiotic prophylaxis. The control group will consist of 1562 historical patients that were treated with standard perioperative practice (LekCheck study cohort). The patient’s intraoperative condition defined by exposure to the six perioperative risk factors, compliance to the DOUBLE CHECK study protocol, 30-day and 90-day CAL and other postoperative complications, length of hospital-stay, and ICU stay, hospital readmission and 30-day mortality will be measured. Discussion: The strength of this study is that it is an implementation study of an enhanced perioperative practice protocol for patients that are scheduled for colorectal resection in combination with a comparative study. This protocol could be a tool for other hospitals that want to improve their perioperative care pathway.