Status:
TERMINATED
Antibiotic Prophylaxis in Laparoscopic Cholecystectomy
Lead Sponsor:
University of Roma La Sapienza
Conditions:
Cholelithiasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy.
Detailed Description
All patients enrolled will be submitted to laparoscopic cholecystectomy. The primary aim of the trial will be to assess the role of prophylactic i.v. infusion of ampicillin-sulbactam, ciprofloxacin, a...
Eligibility Criteria
Inclusion
- elective laparoscopic cholecystectomy;
- patients suffering from gallbladder stones,chronic cholecystitis, cholesterolosis, or gallbladder polyps.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT01888822
Start Date
June 1 2013
End Date
June 1 2017
Last Update
March 25 2020
Active Locations (1)
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1
Sapienza University of Rome- Polo Pontino
Terracina, Latina, Italy, 04019