Clinical trial NCT06314399: Predictive Factors Associated to Bile Cultures and Antibiogram Resistance in Patients with Laparoscopic Cholecystectomy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Infection
Antibiotic Resistant Strain
Keywords: biliary infection
bactibilia
antibiotic resistance
laparoscopic cholecystectomy
Lead sponsor: Hospital Universitario Mayor Méderi
Sponsor class: OTHER
Collaborators: name: Universidad del Rosario
First posted: 2024-03-18
Enrollment: 703
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are over 18 years that have an indication for laparoscopic cholecystectomy in our institution without any of the exclusion criteria, which had bile cultures taken from the surgical specimen (gallbladder) during the surgery and attended the postoperative15 day follow-up appointment after hospital discharge.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bile culture positivity
timeFrame: Perioperatively, during the procedure and immediately after the intervention
measure: Phenotypical antibiogram resistance
timeFrame: Perioperatively, during the procedure and immediately after the intervention
Secondary outcomes:
measure: Microbial characteristics
timeFrame: Immediately after the intervention
measure: Bile culture and antibiotic resistance relationship
timeFrame: Immediately after the intervention
measure: Demographical and clinical characteristics
timeFrame: Pre-intervention
measure: Surgical characteristics and outcomes
timeFrame: During the 15 day postoperative follow-up appointment
measure: Determination of predictive factors (age, diabetes mellitus, choledocholithiasis / ERCP, C-reactive protein, cholecystitis and Tokyo guidelines severity of cholecystitis)
timeFrame: Through study completion, around 1 year and a half
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital Universitario Mayor-Méderi
state: Cundinamarca
city: Bogota
country: Colombia
facility: Hospital Universitario Méderi Barrios Unidos
state: Cundinamarca
Study officials:
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