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Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01888822
Recruitment Status : Terminated
First Posted : June 28, 2013
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Erasmo Spaziani, University of Roma La Sapienza

Tracking Information
First Submitted Date  ICMJE June 13, 2013
First Posted Date  ICMJE June 28, 2013
Last Update Posted Date March 25, 2020
Study Start Date  ICMJE June 2013
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
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'.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
  • Extra-abdominal infections [ Time Frame: 30 days ]
    Extra-abdominal infections defined according to the CDC classification, recorded as 'yes' or 'no'.
  • Adverse events. [ Time Frame: 30 days ]
    Adverse events, defined as allergic reactions to antibiotics.
  • Quality of life [ Time Frame: 30 days ]
    Quality of life measured with the 36-Item Short Form Health Survey
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotic Prophylaxis in Laparoscopic Cholecystectomy
Official Title  ICMJE Ciprofloxacin, Ampicillin-sulbactam and Placebo Prophylaxis in Laparoscopic Cholecystectomy. A Randomized Controlled Study
Brief Summary The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cholelithiasis
Intervention  ICMJE
  • Drug: Ciprofloxacin
    Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy
  • Drug: Ampicillin-sulbactam
    Prophylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy
  • Drug: Placebo
    Prophylactic placebo infusion before elective laparoscopic cholecystectomy
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Ampicillin-sulbactam
  • Active Comparator: Ciprofloxacin
    Intravenous infusion of 400 mg ciprofloxacin in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
    Intervention: Drug: Ciprofloxacin
Publications * Sanabria A, Dominguez LC, Valdivieso E, Gomez G. Antibiotic prophylaxis for patients undergoing elective laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD005265. doi: 10.1002/14651858.CD005265.pub2. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 25, 2013)
138
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888822
Other Study ID Numbers  ICMJE MarPic63
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erasmo Spaziani, University of Roma La Sapienza
Study Sponsor  ICMJE University of Roma La Sapienza
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Erasmo Spaziani, MD, PhD Sapienza University of Rome
PRS Account University of Roma La Sapienza
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP