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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00323648
First received: May 7, 2006
Last updated: February 1, 2013
Last verified: February 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of hospitalisation [ Time Frame: Day O to day of discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2006
Estimated 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00323648     History of Changes
Other Study ID Numbers: 2006/111
Study First Received: May 7, 2006
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

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
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 23, 2014