Back to resultsDoes it Make Sense to Give Postoperative Antibiotics to Patients With an Uncomplicated Acute Cholecystitis
Primary Purpose
Uncomplicated Acute Cholecystitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis
Sponsored by
About this trial
This is an interventional prevention trial for Uncomplicated Acute Cholecystitis
Eligibility Criteria
Inclusion Criteria: Uncomplicated acute cholecystitis < 5 days(confirmed by echography and blood sample) > 18 years old Exclusion Criteria: -
Sites / Locations
- University Hospital Ghent
- Hamad Medical Corporation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
postoperatively antibiotics
Arm Description
Outcomes
Primary Outcome Measures
Postoperative complications (abces, infection of the wound)
Secondary Outcome Measures
Duration of hospitalisation
Full Information
NCT ID
NCT00323648
First Posted
May 7, 2006
Last Updated
December 4, 2014
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00323648
Brief Title
Does it Make Sense to Give Postoperative Antibiotics to Patients With an Uncomplicated Acute Cholecystitis
Official Title
Does it Make Sense to Give Postoperative Antibiotics to Patients With an Uncomplicated Acute Cholecystitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Acute Cholecystitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
postoperatively antibiotics
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis
Intervention Description
Whether or not giving postoperatively antibiotics to patients with an uncomplicated acute cholecystitis.
Primary Outcome Measure Information:
Title
Postoperative complications (abces, infection of the wound)
Time Frame
day 2, day of discharge and dag 21
Secondary Outcome Measure Information:
Title
Duration of hospitalisation
Time Frame
Day O to day of discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Uncomplicated acute cholecystitis < 5 days(confirmed by echography and blood sample)
> 18 years old
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederik Berrevoet, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Hamad Medical Corporation
City
Doha
Country
Qatar
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Does it Make Sense to Give Postoperative Antibiotics to Patients With an Uncomplicated Acute Cholecystitis
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