Bile culture and phenotypic antibiogram resistance test
Diagnostic TestExtraction of 3-5ml of bile from surgical specimen (gallbladder) to be taken for bacterial culture testing and phenotypical antibiogram resistance if positive
NCT Number: NCT06314399
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.
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Notify Me18 year and older
All sexes
Observational
Hospital Universitario Mayor-Méderi, Bogota, Cundinamarca, Colombia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Extraction of 3-5ml of bile from surgical specimen (gallbladder) to be taken for bacterial culture testing and phenotypical antibiogram resistance if positive
Time frame: Perioperatively, during the procedure and immediately after the intervention
Bile culture is tested positive for at least one (1) microorganism
Time frame: Perioperatively, during the procedure and immediately after the intervention
If bile culture is positive, evaluation for possible antibiotic resistance vs sensitivity
Time frame: Immediately after the intervention
To describe the microbial characteristics of the bile cultures and their phenotypical antibiogram resistance
Time frame: Immediately after the intervention
Explore the relationship between positive bile cultures and phenotypical antibiogram resistance with surgical outcomes
Time frame: Pre-intervention
To describe and compare the demographic and clinical characteristics of the study population.
Time frame: During the 15 day postoperative follow-up appointment
To describe and compare the surgical characteristics and outcomes of the study population
Time frame: Through study completion, around 1 year and a half
To determine demographic and clinical predictive factors for positive bile cultures and phenotypical antibiogram resistance.
Hospital Universitario Mayor Méderi
Other
Predictive Factors Associated with Bile Culture Positivity and PhenotypiCal AntIbiogram Resistance Patterns in Patients Taken to LaparOscopic Cholecystectomy (BACILO): a Protocol for a Prediction Model Study
Acronym: BACILO
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