Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

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

Detailed Description
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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.

Official Title
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Ciprofloxacin, Ampicillin-sulbactam and Placebo Prophylaxis in Laparoscopic Cholecystectomy. A Randomized Controlled Study

Conditions
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Cholelithiasis

Intervention / Treatment
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* Drug: Ciprofloxacin
* Drug: Ampicillin-sulbactam
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy. | Drug: Placebo<br>* Prophylactic placebo infusion before elective laparoscopic cholecystectomy<br>|
| Active Comparator: Ampicillin-sulbactam<br>Intravenous infusion of 3gr ampicillin-sulbactam in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy. | Drug: Ampicillin-sulbactam<br>* Prophylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy<br>|
| Active Comparator: Ciprofloxacin<br>Intravenous infusion of 400 mg ciprofloxacin in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy. | Drug: Ciprofloxacin<br>* Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | Surgical site infection defined according to the Centre of Disease Control (CDC) classification, recorded as 'yes' or 'no'. | 30 days after operation | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic cholecystectomy, Prophylactic antibiotics