NCT06314399

Predictive Factors Associated to Bile Cultures and Antibiogram Resistance in Patients with Laparoscopic Cholecystectomy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 703 (actual)
• Sponsor: Hospital Universitario Mayor Méderi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Biliary Infection
• Antibiotic Resistant Strain

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Bile culture and phenotypic antibiogram resistance test	Extraction of 3-5ml of bile from surgical specimen (gallbladder) to be taken for bacterial culture testing and phenotypical antibiogram resistance if positive

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-10-26
• Completion: 2024-12-24
• First posted: 2024-03-18
• Last updated: 2025-03-18

Locations

2 sites across 1 country: Colombia