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NCT05712733 | Recruiting | Calculous Cholecystitis


Cholecystitis From a Microbiological and Histopathological Perspective
Sponsor:

Organ surgery department, Lillebælt Hospital, Kolding

Information provided by (Responsible Party):

Malene Borgager Dissing

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.

Condition or disease

Calculous Cholecystitis

Antibiotic Resistant Infection

Gallbladder Inflammation

Intervention/treatment

Microbiological and histopathological investigation of bile and gallbladder wall specimens.

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.}}

Study Type : Observational
Estimated Enrollment : 60 participants
Official Title : Cholecystitis From a Microbiological and Histopathological Perspective
Actual Study Start Date : April 1, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : October 2025

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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.

Cholecystitis From a Microbiological and Histopathological Perspective

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Cholecystitis From a Microbiological and Histopathological Perspective

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Locations


Recruiting

Denmark,

Lillebælt Hospital

Cold weather, Denmark, 6000

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