Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

University of Roma La Sapienza

Status and phase: Terminated; Phase 4

Conditions: Cholelithiasis

Treatments: Drug: Placebo; Drug: Ampicillin-sulbactam; Drug: Ciprofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT01888822

MarPic63

Details and patient eligibility

About

The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy.

Full 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, and placebo to reduce the rate of surgical site infection.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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138 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.

Treatment:

Drug: Placebo

Ampicillin-sulbactam

Active Comparator group

Description:

Intravenous infusion of 3gr ampicillin-sulbactam in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.

Treatment:

Drug: Ampicillin-sulbactam

Ciprofloxacin

Active Comparator group

Description:

Intravenous infusion of 400 mg ciprofloxacin in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.

Treatment:

Drug: Ciprofloxacin