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

This study is currently recruiting participants.

Verified by University Hospital, Ghent, April 2009

First Received: May 7, 2006 Last Updated: April 9, 2009 History of Changes

Sponsored by:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00323648

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 II

MedlinePlus related topics: Antibiotics

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Does it Make Sense to Give Postoperative Antibiotics to Patients With an Uncomplicated Acute Cholecystitis

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Postoperative complications (abces, infection of the wound)

Secondary Outcome Measures:

Duration of hospitalisation

Estimated Enrollment:	50
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323648

Contacts

Contact: Frederik Berrevoet, MD

+ 32 9 332.48.92

frederik.berrevoet@UGent.be

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Contact: Frederik Berrevoet, MD + 32 9 332.48.92 frederik.berrevoet@UGent.be
Principal Investigator: Frederik Berrevoet, MD

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:

Frederik Berrevoet, MD

University Hospital, Ghent

More Information

Additional Information:

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital Ghent ( Frederik Berrevoet )
Study ID Numbers:	2006/111
Study First Received:	May 7, 2006
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00323648 History of Changes
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Gallbladder Diseases
Anti-Bacterial Agents
Digestive System Diseases
Cholecystitis, Acute

Acalculous Cholecystitis
Biliary Tract Diseases
Cholecystitis

Additional relevant MeSH terms:

Gallbladder Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Digestive System Diseases
Cholecystitis, Acute

Acalculous Cholecystitis
Therapeutic Uses
Biliary Tract Diseases
Cholecystitis
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009