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

Completed

• Conditions: Antibiotic Resistant Strain; Biliary Infection

• Registration Number: NCT06314399
• Lead Sponsor: Hospital Universitario Mayor Méderi

Brief 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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-18
• Study Start: 2024-04-01
• Primary Completion: 2024-10-26
• Study Completion: 2024-12-24
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 703

Inclusion Criteria

• Patients included must be over 18 years of age and be taken to laparoscopic cholecystectomy between March 2024 and February 2026 in any institution of the Méderi hospital network (Hospital Universitario Mayor and Hospital Universitario Barrios Unidos), have signed the written informed consent to be included in the study and have both bile culture and antibiogram.

Exclusion Criteria

• • Patients that will be taken to laparoscopic cholecystectomy with another concomitant surgical procedure (including but not exclusive to gastrectomy, pancreatoduodenectomy, oesophagectomy, splenectomy, abdominal wall reconstruction, colectomy, amongst others) with the exception of umbilical herniorrhaphy.
• Patients without a postoperative control appointment.
• Patients with an untreated HIV diagnosis.
• Patients with diagnosis of a malignant gallbladder or biliary tract disease documented preoperatively.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phenotypical antibiogram resistance	Perioperatively, during the procedure and immediately after the intervention	If bile culture is positive, evaluation for possible antibiotic resistance vs sensitivity
Bile culture positivity	Perioperatively, during the procedure and immediately after the intervention	Bile culture is tested positive for at least one (1) microorganism

Secondary Outcome Measures

Name	Time	Method
Bile culture and antibiotic resistance relationship	Immediately after the intervention	Explore the relationship between positive bile cultures and phenotypical antibiogram resistance with surgical outcomes
Determination of predictive factors (age, diabetes mellitus, choledocholithiasis / ERCP, C-reactive protein, cholecystitis and Tokyo guidelines severity of cholecystitis)	Through study completion, around 1 year and a half	To determine demographic and clinical predictive factors for positive bile cultures and phenotypical antibiogram resistance.
Demographical and clinical characteristics	Pre-intervention	To describe and compare the demographic and clinical characteristics of the study population.
Microbial characteristics	Immediately after the intervention	To describe the microbial characteristics of the bile cultures and their phenotypical antibiogram resistance
Surgical characteristics and outcomes	During the 15 day postoperative follow-up appointment	To describe and compare the surgical characteristics and outcomes of the study population

Trial Locations

Locations (2)

Hospital Universitario Mayor-Méderi; 🇨🇴 Bogota, Cundinamarca, Colombia

Hospital Universitario Méderi Barrios Unidos; 🇨🇴 Bogota, Cundinamarca, Colombia