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Cholecystitis From a Microbiological and Histopathological Perspective

O

Organkirurgisk afdeling, sygehus lillebælt, Kolding

Status

Enrolling

Conditions

Antibiotic Resistant Infection
Gallbladder Inflammation
Calculous Cholecystitis

Treatments

Other: Microbiological and histopathological investigation of bile and gallbladder wall specimens.

Study type

Observational

Funder types

NETWORK

Identifiers

NCT05712733
MBDissing

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age above 18 years
  • Signed consent form
  • Patients having cholecystectomy performed at the Department of Surgery, Sygehus Lillebælt, Kolding.

Exclusion criteria

  • Administration of any type of antibiotics one month prior to surgery in the control group.
  • Previous instrumentation of the bileducts
  • Previous clinical acute cholecystitis treated conservatively with antibiotics

Patients will be precluded from the studypopulation in cases of pPerioperative perforation of the gallbladder, or conversion to open cholecystectomy or in cases of failed attempts to extract bile or samples from the gallbladder wall.

Trial design

60 participants in 2 patient groups

Case group
Description:
Patients suffering from acute calculous cholecystitis undergoing subacute laparoscopic cholecystectomy. Samples of bile and gallbladder wall specimens will be taken during surgery and will be sent for microbiological and pathological investigation
Treatment:
Other: Microbiological and histopathological investigation of bile and gallbladder wall specimens.
Control group
Description:
Patients suffering from painattacks due to gallstones, who have not symptoms of cholecystitis. The patients will undergo elective laparoscopic cholecystectomy. Samples of bile and gallbladder wall specimens will be taken during surgery and will be sent for microbiological and pathological investigation
Treatment:
Other: Microbiological and histopathological investigation of bile and gallbladder wall specimens.

Trial contacts and locations

1

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Central trial contact

Louise L Pontoppidan, MD; Malene B Dissing, MD

Data sourced from clinicaltrials.gov

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