Cholelithiasis
Conditions
Keywords
Laparoscopic cholecystectomy, Prophylactic antibiotics
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.
Interventions
DRUGCiprofloxacin
Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy
Prophylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy
DRUGPlacebo
Prophylactic placebo infusion before elective laparoscopic cholecystectomy
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | 30 days after operation | Surgical site infection defined according to the Centre of Disease Control (CDC) classification, recorded as 'yes' or 'no'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extra-abdominal infections | 30 days | Extra-abdominal infections defined according to the CDC classification, recorded as 'yes' or 'no'. |
| Adverse events. | 30 days | Adverse events, defined as allergic reactions to antibiotics. |
| Quality of life | 30 days | Quality of life measured with the 36-Item Short Form Health Survey |
Countries
Italy
Outcome results
None listed