Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

Phase 4

Terminated

• Conditions: Cholelithiasis
• Interventions: Drug: Placebo; Drug: Ciprofloxacin; Drug: Ampicillin-sulbactam

• Registration Number: NCT01888822
• Lead Sponsor: University of Roma La Sapienza

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

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-28
• Primary Completion: 2016-06
• Study Completion: 2017-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Ciprofloxacin	Ciprofloxacin	Intravenous infusion of 400 mg ciprofloxacin in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Ampicillin-sulbactam	Ampicillin-sulbactam	Intravenous infusion of 3gr ampicillin-sulbactam in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.

Primary Outcome Measures

Name	Time	Method
Surgical site infection	30 days after operation	Surgical site infection defined according to the Centre of Disease Control (CDC) classification, recorded as 'yes' or 'no'.

Secondary Outcome Measures

Name	Time	Method
Extra-abdominal infections	30 days	Extra-abdominal infections defined according to the CDC classification, recorded as 'yes' or 'no'.
Adverse events.	30 days	Adverse events, defined as allergic reactions to antibiotics.
Quality of life	30 days	Quality of life measured with the 36-Item Short Form Health Survey

Trial Locations

Locations (1)

Sapienza University of Rome- Polo Pontino; 🇮🇹 Terracina, Latina, Italy