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Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

Primary Purpose

Cholelithiasis

Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ciprofloxacin
Ampicillin-sulbactam
Placebo
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholelithiasis focused on measuring Laparoscopic cholecystectomy, Prophylactic antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sapienza University of Rome- Polo Pontino

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Ampicillin-sulbactam

Ciprofloxacin

Arm Description

Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.

Intravenous infusion of 3gr ampicillin-sulbactam in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.

Intravenous infusion of 400 mg ciprofloxacin in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.

Outcomes

Primary Outcome Measures

Surgical site infection
Surgical site infection defined according to the Centre of Disease Control (CDC) classification, recorded as 'yes' or 'no'.

Secondary Outcome Measures

Extra-abdominal infections
Extra-abdominal infections defined according to the CDC classification, recorded as 'yes' or 'no'.
Adverse events.
Adverse events, defined as allergic reactions to antibiotics.
Quality of life
Quality of life measured with the 36-Item Short Form Health Survey

Full Information

First Posted
June 13, 2013
Last Updated
March 24, 2020
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT01888822
Brief Title
Antibiotic Prophylaxis in Laparoscopic Cholecystectomy
Official Title
Ciprofloxacin, Ampicillin-sulbactam and Placebo Prophylaxis in Laparoscopic Cholecystectomy. A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
Keywords
Laparoscopic cholecystectomy, Prophylactic antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Arm Title
Ampicillin-sulbactam
Arm Type
Active Comparator
Arm Description
Intravenous infusion of 3gr ampicillin-sulbactam in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Arm Title
Ciprofloxacin
Arm Type
Active Comparator
Arm Description
Intravenous infusion of 400 mg ciprofloxacin in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy
Intervention Type
Drug
Intervention Name(s)
Ampicillin-sulbactam
Intervention Description
Prophylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Prophylactic placebo infusion before elective laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
Surgical site infection
Description
Surgical site infection defined according to the Centre of Disease Control (CDC) classification, recorded as 'yes' or 'no'.
Time Frame
30 days after operation
Secondary Outcome Measure Information:
Title
Extra-abdominal infections
Description
Extra-abdominal infections defined according to the CDC classification, recorded as 'yes' or 'no'.
Time Frame
30 days
Title
Adverse events.
Description
Adverse events, defined as allergic reactions to antibiotics.
Time Frame
30 days
Title
Quality of life
Description
Quality of life measured with the 36-Item Short Form Health Survey
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erasmo Spaziani, MD, PhD
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Study Director
Facility Information:
Facility Name
Sapienza University of Rome- Polo Pontino
City
Terracina
State/Province
Latina
ZIP/Postal Code
04019
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21154360
Citation
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.
Results Reference
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Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

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