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Piperacllin Versus Placebo in Patients Undergoing Surgery for Acute Cholecystitis

NCT02619149 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-03-06

No results posted yet for this study

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.

Conditions

  • Cholecystitis, Acute

Interventions

DRUG

Piperacillin-tazobactam combination product

Piperacillin-Tazobactam (extended-spectrum, beta-lactamase inhibitor) iv peroperatively as prophylaxis

DRUG

Saline solution

Saline iv as placebo control

Sponsors & Collaborators

Principal Investigators

  • Folke Hammarqvist, Ass Prof · Karolinska Institutet, CLINTEC, Stockholm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2017-12-31
Completion
2018-01-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02619149 on ClinicalTrials.gov