Piperacllin Versus Placebo in Patients Undergoing Surgery for Acute Cholecystitis

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet
• Treatments: Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Tazobactam

Criteria

Inclusion Criteria:

• Clinical and radiologic signs of acute cholecystitis

• First acute symptoms occurring within five days before surgery

Exclusion Criteria:

• Anamnesis exceeding five days

• Any contraindication for laparoscopic surgery

• Allergy against beta-lactame antibiotics