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Predictive Factors Associated to Bile Cultures and Antibiogram Resistance in Patients With Laparoscopic Cholecystectomy — BACILO  

Antibiotic Resistant Strain Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06314399
Study type Observational
Source Hospital Universitario Mayor Méderi
Contact
Status Not yet recruiting
Phase
Start date April 1, 2024
Completion date June 2026
View Details
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