Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314399
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-08
Brief Title:
Predictive Factors Associated to Bile Cultures and Antibiogram Resistance in Patients With Laparoscopic Cholecystectomy
Sponsor:
Hospital Universitario Mayor Méderi
Organization:
Hospital Universitario Mayor Méderi
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BACILO
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 choledocholithiasisERCP cholecystitis and severity of cholecystitis according to the 2018 Tokyo guidelinesThis 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DVO005 2555-CV1837 | OTHER | Universidad del Rosario Research Ethics Committee | None |