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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00323648
Other study ID # 2006/111
Secondary ID
Status Completed
Phase Phase 2
First received May 7, 2006
Last updated December 4, 2014
Start date May 2006
Est. completion date August 2013

Study information

Verified date December 2014
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 2013
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Uncomplicated acute cholecystitis < 5 days(confirmed by echography and blood sample)

- > 18 years old

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Belgium University Hospital Ghent Ghent
Qatar Hamad Medical Corporation Doha

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Ghent

Countries where clinical trial is conducted

Belgium,  Qatar, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative complications (abces, infection of the wound) day 2, day of discharge and dag 21 Yes
Secondary Duration of hospitalisation Day O to day of discharge No