The BACILO study was designed with the objective of having robust data on local epidemiological bacterial colonisation information on bile cultures with patients taken to laparoscopic cholecystectomy in our institution to find which predictive factors are associated with culture positivity and antibiotic resistance patterns. Secondary endpoints include evaluating demographical, clinical and surgical variables and establishing comparison between both positive and negative bile cultures and between antibiotic sensitive and resistant microorganism strain isolations.
BACILO is single-centre, observational, analytical, prospective study with a prognostic prediction model with the objective of identifying predictive factors associated with microbial and antibiotic resistance patterns in bile cultures of patients taken to laparoscopic cholecystectomy in our institution. Primary outcomes are bile culture positivity and phenotypical resistance antibiogram patterns while secondary outcomes include demographic, clinical and surgical characteristics and surgical outcomes. The main objective is to determine predictive factors using a prediction model, variables included are: Age, diabetes mellitus, C-reactive protein test, choledocholithiasis/ERCP, cholecystitis and severity of cholecystitis according to the 2018 Tokyo guidelines.This in the nature of describing the relationship between bile culture positivity and phenotypical antibiogram resistance patterns in our institution, and establish thus better treatment strategies based on higher quality local evidence.
Study Type
OBSERVATIONAL
Enrollment
703
Extraction of 3-5ml of bile from surgical specimen (gallbladder) to be taken for bacterial culture testing and phenotypical antibiogram resistance if positive
Hospital Universitario Mayor-Méderi
Bogota, Cundinamarca, Colombia
Hospital Universitario Méderi Barrios Unidos
Bogota, Cundinamarca, Colombia
Bile culture positivity
Bile culture is tested positive for at least one (1) microorganism
Time frame: Perioperatively, during the procedure and immediately after the intervention
Phenotypical antibiogram resistance
If bile culture is positive, evaluation for possible antibiotic resistance vs sensitivity
Time frame: Perioperatively, during the procedure and immediately after the intervention
Microbial characteristics
To describe the microbial characteristics of the bile cultures and their phenotypical antibiogram resistance
Time frame: Immediately after the intervention
Bile culture and antibiotic resistance relationship
Explore the relationship between positive bile cultures and phenotypical antibiogram resistance with surgical outcomes
Time frame: Immediately after the intervention
Demographical and clinical characteristics
To describe and compare the demographic and clinical characteristics of the study population.
Time frame: Pre-intervention
Surgical characteristics and outcomes
To describe and compare the surgical characteristics and outcomes of the study population
Time frame: During the 15 day postoperative follow-up appointment
Determination of predictive factors (age, diabetes mellitus, choledocholithiasis / ERCP, C-reactive protein, cholecystitis and Tokyo guidelines severity of cholecystitis)
To determine demographic and clinical predictive factors for positive bile cultures and phenotypical antibiogram resistance.
Time frame: Through study completion, around 1 year and a half
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