drugset / Trial / NCT02619149

Piperacllin Versus Placebo in Patients Undergoing Surgery for Acute Cholecystitis

NCT02619149

Phase 3 Completed 100 enrolled Karolinska Institutet
RandomizedParallel-groupTriple-blindTreatment

Summary

The benefit from antibiotic prophylaxis in patients undergoing laparoscopic cholecystectomy for acute cholecystitis is insufficiently known. The aim of the present double-blind randomized controlled is to compare piperacilin with placebo in patients undergoing cholecystectomy for acute cholecystitis with anamnesis not exceeding 5 days. Altogether 100 patients are intended to be included. Primary endpoint is biliary contamination. Secondary endpoints are postoperative hospital stay, health-related quality of life, pain perception, postoperative markers of inflammatory response, surgical site infections, infectious complications other than surgical site infections, health economy and relationship between symptom anamnesis and bile contamination.

Timeline

Start
2009-03
Primary completion
2017-12
Completion
2018-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Piperacillin Small molecule 4 g Intravenous
Comparator Tazobactam Small molecule Intravenous

Indications