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Completed

NCT Number: NCT06314399

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Mayor-Méderi, Bogota, Cundinamarca, Colombia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bile culture and phenotypic antibiogram resistance test

Diagnostic Test

Extraction of 3-5ml of bile from surgical specimen (gallbladder) to be taken for bacterial culture testing and phenotypical antibiogram resistance if positive

Primary outcomes

  1. Bile culture positivity

    Time frame: Perioperatively, during the procedure and immediately after the intervention

    Bile culture is tested positive for at least one (1) microorganism

  2. Phenotypical antibiogram resistance

    Time frame: Perioperatively, during the procedure and immediately after the intervention

    If bile culture is positive, evaluation for possible antibiotic resistance vs sensitivity

Secondary outcomes

  1. Microbial characteristics

    Time frame: Immediately after the intervention

    To describe the microbial characteristics of the bile cultures and their phenotypical antibiogram resistance

  2. Bile culture and antibiotic resistance relationship

    Time frame: Immediately after the intervention

    Explore the relationship between positive bile cultures and phenotypical antibiogram resistance with surgical outcomes

  3. Demographical and clinical characteristics

    Time frame: Pre-intervention

    To describe and compare the demographic and clinical characteristics of the study population.

  4. Surgical characteristics and outcomes

    Time frame: During the 15 day postoperative follow-up appointment

    To describe and compare the surgical characteristics and outcomes of the study population

  5. Determination of predictive factors (age, diabetes mellitus, choledocholithiasis / ERCP, C-reactive protein, cholecystitis and Tokyo guidelines severity of cholecystitis)

    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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Mayor Méderi

Other

Collaborators

  • Universidad del Rosario

Registry information

Official study 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

Acronym: BACILO

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 18, 2024
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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