Antibiotic Resistant Strain, Biliary Infection
Conditions
Keywords
biliary infection, bactibilia, antibiotic resistance, laparoscopic cholecystectomy
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.
Interventions
DIAGNOSTIC_TESTBile 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
Sponsors
Universidad del Rosario
Hospital Universitario Mayor Méderi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bile culture positivity | Perioperatively, during the procedure and immediately after the intervention | Bile culture is tested positive for at least one (1) microorganism |
| Phenotypical antibiogram resistance | Perioperatively, during the procedure and immediately after the intervention | If bile culture is positive, evaluation for possible antibiotic resistance vs sensitivity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| Bile culture and antibiotic resistance relationship | Immediately after the intervention | Explore the relationship between positive bile cultures and phenotypical antibiogram resistance with surgical outcomes |
Countries
Colombia
Outcome results
None listed