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

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.
ClinicalTrials.gov Identifier: NCT00323648
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Uncomplicated Acute Cholecystitis Drug: Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Study Start Date : May 2006
Primary Completion Date : May 2010
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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

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

Eligibility Criteria

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 Posted: May 9, 2006    Key Record Dates
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