Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

Phase 4TerminatedNCT01888822

University of Roma La Sapienza138 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

138

Conditions

Cholelithiasis

Interventions

CiprofloxacinDRUG

Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy

Ampicillin-sulbactamDRUG

Prophylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy

PlaceboDRUG

Prophylactic placebo infusion before elective laparoscopic cholecystectomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sapienza University of Rome- Polo Pontino

Terracina, Latina, Italy

Outcomes

Primary Outcomes

Surgical site infection

Surgical site infection defined according to the Centre of Disease Control (CDC) classification, recorded as 'yes' or 'no'.

Time frame: 30 days after operation

Secondary Outcomes

Extra-abdominal infections

Extra-abdominal infections defined according to the CDC classification, recorded as 'yes' or 'no'.

Time frame: 30 days

Adverse events.

Adverse events, defined as allergic reactions to antibiotics.

Time frame: 30 days

Quality of life

Quality of life measured with the 36-Item Short Form Health Survey

Time frame: 30 days

Data from ClinicalTrials.gov

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