Implementación de un programa de mejora en cirugía colorrectal y diagnóstico precoz de sus complicaciones

Abstract

Background and aim of the study: Colorectal surgery has been marked throughout history by its high rate of complications, especially Surgical Site Infection (SSI) directly related to Anastomotic Leakage (AL), supposing a threat to the patient`s recovery, a large consumption of healthcare resources and a handicap for the surgeon. The objective of this study is to analyze the incidence of severe complications and AL in elective colorectal surgery, to evaluate the usefulness of inflammatory markers (C-Reactive Protein and Procalcitonin) in the early diagnosis of these complications and implement an improvement program to minimize and diagnose them earlier. Methods: A first analytical, prospective, observational study was performed, including patients undergoing scheduled colorectal surgery with anastomosis, at Morales Meseguer General Hospital from October 1, 2017 to May 30, 2018, to determine the incidence of complications, their morbidity and mortality and associated risk factors, checking whether the alteration of inflammatory markers (CRP and PCT) served as a tool for the early diagnosis of AL. In addition, an analysis of sensitivity, specificity and predictive values was performed, and the ROC curves of these markers and their cut-off points were calculated using AUC. After monitoring our results and validating the usefulness of inflammatory markers in our environment, an early diagnosis and improvement protocol was implemented in elective colorectal surgery between March 2019 and May 2020. Subsequently, a before-and-after study was carried out following the application of the new protocol through: (1) A descriptive analysis of the variables of the two groups. (2) A univariate comparison between both groups. (3) A multivariate study describing the significant variables for our study. Results: 234 patients were included: 95 from the inflammatory marker validation study (Pre-protocol group) and 139 from the group after application of the improvement protocol (Protocol group). After applying the ROC curves and calculating the AUC of the inflammatory markers (PCT and CRP) on the 3rd and 5th postoperative day, an AUC for PCT of 0.698 and 0.703 was obtained on the 3rd and 5th postoperative day, respectively (considered a poorly or moderately reliable test). In contrast, the AUC for CRP at postoperative day 3 was 0.808 for a cutoff point of 15.3 mg/dL. CRP determination on the 5th postoperative day was found to be the best predictor of anastomotic leakage, with an AUC of 0.939 for levels above 9.1 mg/dL. After application of the improvement protocol, both groups were compared, obtaining a significant decrease in severe complications (especially Clavien-Dindo grade IV) in the protocol group (from 22.7% to 6.3%), as well as a reduction in the incidence of AL (from 14.7% to 2.2%). A significant decrease in reoperations, less need for admission to the Intensive Care Unit, a shorter hospital stay and fewer readmissions were also observed. In the multivariate analysis, the application of the new protocol was a protective factor for the development of AL (OR 0.144, - 95% CI (0.039 - 0.526)). Conclusions: The morbidity of elective colorectal surgery in the Pre-protocol group was 46.3%, mostly associated with serious complications (Clavien-Dindo grade IV and V), with the AL rate being 14.7%. CRP has shown to be a reliable early marker of AL between the 3rd and 5th postoperative days, allowing early discharge with values below the cut-off points obtained. Our improvement protocol significantly reduced morbidity, severity of complications, AL rate, hospital stay and readmissions