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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|