A Phase 4 interventional study of Ciprofloxacin and Ampicillin-sulbactam in Cholelithiasis, sponsored by University of Roma La Sapienza. Terminated at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by University of Roma La Sapienza · Phase 4, Interventional, and Treatment
The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy.
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.
286 studies on the registry are indexed under Cholelithiasis; 48 are open to participants now.
This study's enrollment of 138 is above the median of 90 across 197 interventional studies indexed under Cholelithiasis.
Browse Cholelithiasis studies →University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Drug: Placebo
Intravenous infusion of 3gr ampicillin-sulbactam in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Drug: Ampicillin-sulbactam
Intravenous infusion of 400 mg ciprofloxacin in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.
Drug: Ciprofloxacin
Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy
Prophylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy
Prophylactic placebo infusion before elective laparoscopic cholecystectomy
Surgical site infection
Surgical site infection defined according to the Centre of Disease Control (CDC) classification, recorded as 'yes' or 'no'.
Time frame: 30 days after operation
Extra-abdominal infections
Extra-abdominal infections defined according to the CDC classification, recorded as 'yes' or 'no'.
Time frame: 30 days
Adverse events.
Adverse events, defined as allergic reactions to antibiotics.
Time frame: 30 days
Quality of life
Quality of life measured with the 36-Item Short Form Health Survey
Time frame: 30 days
This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza