Cholecystitis From a Microbiological and Histopathological Perspective
NCT ID: NCT05712733
Last Updated: 2024-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2023-04-01
2025-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case group
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
Microbiological and histopathological investigation of bile and gallbladder wall specimens.
Bile and gallbladder wall specimens will be taken from all patients included in the study. The material will be sent for microbiological and histopathological investigation.
Control group
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
Microbiological and histopathological investigation of bile and gallbladder wall specimens.
Bile and gallbladder wall specimens will be taken from all patients included in the study. The material will be sent for microbiological and histopathological investigation.
Interventions
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Microbiological and histopathological investigation of bile and gallbladder wall specimens.
Bile and gallbladder wall specimens will be taken from all patients included in the study. The material will be sent for microbiological and histopathological investigation.
Eligibility Criteria
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Inclusion Criteria
* Signed consent form
* Patients having cholecystectomy performed at the Department of Surgery, Sygehus Lillebælt, Kolding.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Organkirurgisk afdeling, sygehus lillebælt, Kolding
NETWORK
Responsible Party
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Malene Borgager Dissing
Malene Børgager Dissing, MD
Principal Investigators
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Malene B Dissing, MD
Role: PRINCIPAL_INVESTIGATOR
Organkirurgisk afdeling, sygehus lillebælt, Kolding
Locations
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Sygehus Lillebælt
Kolding, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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MBDissing
Identifier Type: -
Identifier Source: org_study_id
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