Overview

Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

Status:
Terminated
Trial end date:
2017-06-01
Target enrollment:
0
Participant gender:
All
Summary
The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Roma La Sapienza
Treatments:
Ampicillin
Anti-Bacterial Agents
Ciprofloxacin
Sulbactam
Sultamicillin
Criteria
Inclusion Criteria:

- elective laparoscopic cholecystectomy;

- patients suffering from gallbladder stones,chronic cholecystitis, cholesterolosis, or
gallbladder polyps.

Exclusion Criteria:

- acute cholecystitis;

- acute cholangitis;

- acute pancreatitis;

- pregnant or lactating women;

- antibiotic allergy;

- antibiotic therapy within 48 hours to 7 days prior to surgery;

- clinically active infection at the moment of surgery;

- evidence of common bile duct stones;

- contraindications for laparoscopic cholecystectomy;

- no other additional procedure;

- indication of obligatory antibiotic prophylaxis because the medical condition was
different from biliary disease (immunosuppression, corticoid use, etc).

- patients unable to give informed consent.