Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

March 24, 2020 updated by: Erasmo Spaziani, University of Roma La Sapienza

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

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

Study Overview

Status

Terminated

Conditions

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 Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Latina
      • Terracina, Latina, Italy, 04019
        • Sapienza University of Rome- Polo Pontino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Erasmo Spaziani, MD, PhD, Sapienza University of Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (Estimate)

June 28, 2013

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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