Predictive factors associated with Bile culture positivity And phenotypiCal antIbiogram resistance patterns in patients taken to LaparOscopic cholecystectomy (BACILO): protocol for a prospective observational cohort study and development of a prognostic prediction model.

INTRODUCTION

Bile fluid is aseptic under normal conditions; however, in the presence of cholecystitis, its susceptibility to bacterial colonisation varies, with reported rates of 20%-70% of cases. This process is referred to as bactibilia and/or bacteriobilia and can be considered a secondary complication of biliary stasis and cholecystitis in general. In the management of acute cholecystitis, the antibiotic regimen should be prescribed based on the presumed pathogens involved, taking into consideration the risk factors for resistance patterns according to demographics and local exposure. The aim of this study is to determine the predictive factors for bile culture positivity and antibiotic resistance in patients who underwent laparoscopic cholecystectomy in the Méderi Hospital Network. We hope to develop a predictive model that allows us to better guide antibiotic therapy.

METHODS AND ANALYSIS

This is a prospective observational cohort study with prognostic prediction model. Patients who will undergo laparoscopic cholecystectomy and have bile cultures taken in the Méderi Hospital Network during the study period will be included. The dependent variables will be positive bile culture and antibiotic resistance, and the predictive variables will be age, presence of diabetes, diagnosis of choledocholithiasis, diagnosis of cholecystitis and severity of cholecystitis according to the Tokyo criteria. The minimum sample size has been calculated at 703 patients. Follow-up will continue until a control appointment 15 days after the procedure. The primary outcomes are bile culture positivity and phenotypical antibiogram resistance. For each outcome, a multivariate logistic regression will be performed using frequentist and Bayesian prediction techniques.

ETHICS AND DISSEMINATION

This study was approved by the Méderi network research department committee (CIMED) and by Universidad del Rosario's Research Ethics Committee (CEI-UR; DVO005 2555-CV1837). Written informed consent is required for participation. The results will be disseminated through the submission of an academic article to a high-impact scientific journal, presentations at academic conferences, and sharing with our institution's faculty to inform antimicrobial therapy management based on local epidemiological data.

TRIAL REGISTRATION NUMBER

NCT06314399.