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Does it Make Sense to Give Postoperative Antibiotics to Patients With an Uncomplicated Acute Cholecystitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00323648
First Posted: May 9, 2006
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose
Each patient is preoperatively treated once profylactic with intraveneous antibiotics. Postoperatively, one group will be treated with intraveneous antibiotics during 5 days. The other group will receive no antibiotics.

Condition Intervention Phase
Uncomplicated Acute Cholecystitis Drug: Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does it Make Sense to Give Postoperative Antibiotics to Patients With an Uncomplicated Acute Cholecystitis

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Postoperative complications (abces, infection of the wound) [ Time Frame: day 2, day of discharge and dag 21 ]

Secondary Outcome Measures:
  • Duration of hospitalisation [ Time Frame: Day O to day of discharge ]

Enrollment: 50
Study Start Date: May 2006
Study Completion Date: August 2013
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: postoperatively antibiotics Drug: Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis
Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uncomplicated acute cholecystitis < 5 days(confirmed by echography and blood sample)
  • > 18 years old

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323648


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Qatar
Hamad Medical Corporation
Doha, Qatar
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Frederik Berrevoet, MD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00323648     History of Changes
Other Study ID Numbers: 2006/111
First Submitted: May 7, 2006
First Posted: May 9, 2006
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents