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.