- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01888822
Antibiotic Prophylaxis in Laparoscopic Cholecystectomy
March 24, 2020 updated by: Erasmo Spaziani, University of Roma La Sapienza
Ciprofloxacin, Ampicillin-sulbactam and Placebo Prophylaxis in Laparoscopic Cholecystectomy. A Randomized Controlled Study
The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
138
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Latina
-
Terracina, Latina, Italy, 04019
- Sapienza University of Rome- Polo Pontino
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
|
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.
|
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.
|
Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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'.
|
30 days after operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extra-abdominal infections
Time Frame: 30 days
|
Extra-abdominal infections defined according to the CDC classification, recorded as 'yes' or 'no'.
|
30 days
|
Adverse events.
Time Frame: 30 days
|
Adverse events, defined as allergic reactions to antibiotics.
|
30 days
|
Quality of life
Time Frame: 30 days
|
Quality of life measured with the 36-Item Short Form Health Survey
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Erasmo Spaziani, MD, PhD, Sapienza University of Rome
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
June 13, 2013
First Submitted That Met QC Criteria
June 25, 2013
First Posted (Estimate)
June 28, 2013
Study Record Updates
Last Update Posted (Actual)
March 25, 2020
Last Update Submitted That Met QC Criteria
March 24, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathological Conditions, Anatomical
- Gallbladder Diseases
- Biliary Tract Diseases
- Calculi
- Gallstones
- Cholelithiasis
- Cholecystolithiasis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- beta-Lactamase Inhibitors
- Ampicillin
- Ciprofloxacin
- Sulbactam
- Sultamicillin
Other Study ID Numbers
- MarPic63
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cholelithiasis
-
Mayo ClinicCompletedCHOLELITHIASISUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruiting
-
Ankara City Hospital BilkentCompleted
-
Hospital Son EspasesUnknownCholecystitis/Cholelithiasis
-
G. Hatzikosta General HospitalUniversity of Ioannina; Demokrition University of ThraceCompletedLaparoscopy | Cholecystectomy | Uncomplicated Cholelithiasis | Standard Technique | Single Port LaparoscopyGreece
-
Kepler University HospitalCompletedCholelithiasis, Common Bile DuctAustria
-
Peking Union Medical College HospitalUnknownCholecystitis; Gallstone | Cholecystitis/Cholelithiasis | Polyp GallbladderChina
-
Uludag UniversityRecruitingCerebral Hypoperfusion | Cholecystitis; Gallstone | Cholecystitis/Cholelithiasis | Cerebral OcclusionTurkey
-
Konya Meram State HospitalUnknownCholecystitis; Acute, With CholelithiasisTurkey
-
Bezmialem Vakif UniversityUnknownCholelithiasis Associated With Common Bile Duct StonesTurkey
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States