Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections (EvaCol): Study Protocol of a Multicentre, Observational Trial

PURPOSE: Overall complication and leak rates in colorectal surgery showed only minor improvements over the last years and remain still high. While the introduction of the WHO Safer Surgery Checklist has shown a reduction of overall operative mortality and morbidity in general surgery, only minor attempts have been made to improve outcomes by standardizing perioperative processes in colorectal surgery. Nevertheless, a number of singular interventions have been found reducing postoperative complications in colorectal surgery. The aim of the present study is to combine nine of these measures to a catalogue called colorectal bundle (CB). This will help to standardize pre-, intra-, and post-operative processes and therefore eventually reduce complication rates after colorectal surgery. METHODS: The study will be performed among nine contributing hospitals in the extended north-western part of Switzerland. In the 6-month lasting control period the patients will be treated according to the local standard of each contributing hospital. After a short implementation phase all patients will be treated according to the CB for another 6 months. Afterwards complication rates before and after the implementation of the CB will be compared. DISCUSSION: The overall complication rate in colorectal surgery is still high. The fact that only little progress has been made in recent years underlines the relevance of the current project. It has been shown for other areas of surgery that standardization is an effective measure of reducing postoperative complication rates. We hypothesize that the combination of effective, individual components into the CB can reduce the complication rate. TRIAL REGISTRATION: Registered in ClinicalTrials.gov on 11/03/2020; NCT04550156. HIGHLIGHTS: Purpose: Overall complications in colorectal surgery remain still high. Standardizing can reduce overall operative mortality and morbidity. Only minor attempts have been made to standardize perioperative processes in colorectal surgery. Singular interventions have been found reducing postoperative complications. The aim is to combine nine of these measures to a colorectal bundle (CB). The CB will help to reduce complication rates after colorectal surgery. Methods: The observational study will be performed among nine hospitals in Switzerland. Six month the patients will be treated according to the local standards. Afterwards patients will be treated according to the CB for another six months. Complication rates before and after the implementation of the CB will be compared. Discussion: Only little progress has been made to reduce complication rate in colorectal surgery. Standardization is an effective measure of reducing complication rates. The combination of effective, individual components into the CB can reduce the complication rate.