Antibiotic Prophylaxis in Laparoscopic Cholecystectomy
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|ClinicalTrials.gov Identifier: NCT01888822|
Recruitment Status : Suspended
First Posted : June 28, 2013
Last Update Posted : April 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cholelithiasis||Drug: Ciprofloxacin Drug: Ampicillin-sulbactam Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Ciprofloxacin, Ampicillin-sulbactam and Placebo Prophylaxis in Laparoscopic Cholecystectomy. A Randomized Controlled Study|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2017|
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
- 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'.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888822
|Sapienza University of Rome- Polo Pontino|
|Terracina, Latina, Italy, 04019|
|Study Director:||Erasmo Spaziani, MD, PhD||Sapienza University of Rome|