Trial record 14 of 47 for:    Open Studies | "Cholelithiasis"

Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Ampicillin
Anti-Bacterial Agents
Ciprofloxacin
Sulbactam
Sultamicillin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 26, 2014