Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-06-30

Brief Summary

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

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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.

Conditions

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Cholelithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Prophylactic placebo infusion before elective laparoscopic cholecystectomy

Ampicillin-sulbactam

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

Group Type ACTIVE_COMPARATOR

Ampicillin-sulbactam

Intervention Type DRUG

Prophylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy

Ciprofloxacin

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

Group Type ACTIVE_COMPARATOR

Ciprofloxacin

Intervention Type DRUG

Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy

Interventions

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Ciprofloxacin

Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy

Intervention Type DRUG

Ampicillin-sulbactam

Prophylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy

Intervention Type DRUG

Placebo

Prophylactic placebo infusion before elective laparoscopic cholecystectomy

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No