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Comparison of Multiple-, Single- and Zero-dose of Ciprofloxacin Prophylaxis in Retrograde Intrarenal Surgery

NCT02304822 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2017-04-13

No results posted yet for this study

Summary

The purpose of this study is to compare the postoperative systemic inflammatory response syndrome (SIRS) rates undergoing retrograde intrarenal surgery (RIRS) after multiple-, single-, zero-dose of ceftriaxone prophylaxis in a prospective randomized trail.

The investigators will enroll 450 patients who are candidates for RIRS in the investigators study. By simple random sampling technique, patients will be assigned to three groups (multiple-, single-, zero-dose of ceftriaxone prophylaxis,respectively). In addition to the difference of usage of ciprofloxacin prophylaxis, the rest of the procedure is the same in all three groups.The end point of the study is the comparison of outcome of procedure including SIRS rate, stone free rate (SFR), operation time, length of stay,and hematuresis.

Conditions

  • Kidney Stones

Interventions

DRUG

Zero-dose of Ciprofloxacin prophylaxis

Zero-dose of ciprofloxacin prophylaxis with none intravenous ciprofloxacin either preoperatively or postoperatively

DRUG

Multiple-dose of Ciprofloxacin prophylaxis

Multiple-dose prophylactic antibiotic of 200mg intravenous ciprofloxacin, 30 minutes before surgery and within 12 hours after surgery additionally

DRUG

Single-dose of Ciprofloxacin prophylaxis

Single-dose prophylactic antibiotic of 200mg intravenous ciprofloxacin, 30 minutes before surgery only.

Sponsors & Collaborators

  • Guohua Zeng

    lead OTHER

Principal Investigators

  • Guohua Zeng, PH.D and M.D · The First Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • China

Study Locations

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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 NCT02304822 on ClinicalTrials.gov