Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

U

University of Roma La Sapienza

Status and phase

Terminated
Phase 4

Conditions

Cholelithiasis

Treatments

Drug: Placebo
Drug: Ampicillin-sulbactam
Drug: Ciprofloxacin

Study type

Interventional

Funder types

Other

Identifiers

NCT01888822
MarPic63

Details and patient eligibility

About

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

Full 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.

Enrollment

138 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

138 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Treatment:
Drug: Placebo
Ampicillin-sulbactam
Active Comparator group
Description:
Intravenous infusion of 3gr ampicillin-sulbactam in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Treatment:
Drug: Ampicillin-sulbactam
Ciprofloxacin
Active Comparator group
Description:
Intravenous infusion of 400 mg ciprofloxacin in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Treatment:
Drug: Ciprofloxacin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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