Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

This study is currently recruiting participants.
Verified June 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Erasmo Spaziani, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01888822
First received: June 13, 2013
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Cholelithiasis
Drug: Ciprofloxacin
Drug: Ampicillin-sulbactam
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ciprofloxacin, Ampicillin-sulbactam and Placebo Prophylaxis in Laparoscopic Cholecystectomy. A Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: 30 days after operation ] [ Designated as safety issue: No ]
    Surgical site infection defined according to the Centre of Disease Control (CDC) classification, recorded as 'yes' or 'no'.


Secondary Outcome Measures:
  • Extra-abdominal infections [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Extra-abdominal infections defined according to the CDC classification, recorded as 'yes' or 'no'.

  • Adverse events. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Adverse events, defined as allergic reactions to antibiotics.

  • Quality of life [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Quality of life measured with the 36-Item Short Form Health Survey


Estimated Enrollment: 138
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Drug: Placebo
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.
Drug: Ampicillin-sulbactam
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.
Drug: Ciprofloxacin
Prophylactic ciprofloxacin infusion before 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01888822

Contacts
Contact: Marcello Picchio, MD +39-0773695488 marcellopicchio@libero.it

Locations
Italy
Sapienza University of Rome- Polo Pontino Recruiting
Terracina, Latina, Italy, 04019
Contact: Erasmo Spaziani, MD, PhD    +39-0773708759    erasmo.spaziani@uniroma1.it   
Contact: Annalisa Di Filippo, MD, PhD    +39-0773708759    annalisa.difilippo@alice.it   
Principal Investigator: Annalisa Di Filippo, MD, PhD         
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Study Director: Erasmo Spaziani, MD, PhD Sapienza University of Rome
  More Information

Publications:
Responsible Party: Erasmo Spaziani, Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01888822     History of Changes
Other Study ID Numbers: MarPic63
Study First Received: June 13, 2013
Last Updated: June 25, 2013
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University of Roma La Sapienza:
Laparoscopic cholecystectomy
Prophylactic antibiotics

Additional relevant MeSH terms:
Gallbladder Diseases
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical
Ampicillin
Anti-Bacterial Agents
Sulbactam
Sultamicillin
Ciprofloxacin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014