Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 5:18 PM
Study NCT ID:
NCT05712733
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2023-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cholecystitis From a Microbiological and Histopathological Perspective
Sponsor:
Organkirurgisk afdeling, sygehus lillebælt, Kolding
Organization:
Study Overview
Official Title:
Cholecystitis From a Microbiological and Histopathological Perspective
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
The aim of this project is to investigate the presence of bacteria in the gallbladder wall and the bile in patients undergoing cholecystectomy, to determine if the standard empirical antibiotic treatment used currently is effective against the most common pathogens.
Detailed Description:
The investigators will compare two groups of patients; patients with acute calculous cholecystitis undergoing acute laparoscopic cholecystectomy and patients without cholecystitis undergoing elective laparoscopic cholecystectomy.
Secondly, the investigators wish to investigate if the presence of bacteria correlates with the grade of inflammation, and whether this can predict when cholecystitis is caused by infection.
In a clinical setting, this can provide important knowledge regarding the choice of antibiotics currently used to treat and prevent infection in the gallbladder.
The investigators will conduct two studies, one investigating the bacteria in bile and in the gallbladder wall and the resistens of the bacteria to antibiotics and another study investigating the histopathology of the gallbladder wall to see if the bacteria present is the cause of inflammation or an actual infection.
Secondly, the investigators wish to investigate if the presence of bacteria correlates with the grade of inflammation, and whether this can predict when cholecystitis is caused by infection.
In a clinical setting, this can provide important knowledge regarding the choice of antibiotics currently used to treat and prevent infection in the gallbladder.
The investigators will conduct two studies, one investigating the bacteria in bile and in the gallbladder wall and the resistens of the bacteria to antibiotics and another study investigating the histopathology of the gallbladder wall to see if the bacteria present is the cause of inflammation or an actual infection.
Study Oversight
Has Oversight DMC:
True
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?: