Is Prophylactic Antibiotics Necessary In Otherwise Healthy Adult Patients Undergoing Ureteroscopic Procedures for Ureteral Stones?

December 16, 2015 updated by: Cheng-Hsing Hsieh, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
The present study aims to investigate the relative efficacy, safety and risk of a single-dose prophylaxis in otherwise healthy adult patients undergoing ureteroscopic procedures for ureteral stones.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Xindian
      • Taipei, Xindian, Taiwan, 23142
        • Cheng-Hsing Hsieh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cohort study

Description

Inclusion Criteria:

  • 100 otherwise healthy adult patients.
  • Aged from 20 to 65 years.
  • Undergoing ureteroscopic procedures for ureteral stones.

Exclusion Criteria:

  • Have the urine road the infection before the surgical operation, the surgical operation once took antibiotics the first 2 week.
  • Pregnant or the women been breast feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
prophylactic antibiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of clinically definite urinary tract infection confirmed by urinary analysis or urinary culture.
Time Frame: within the first 10 days (plus or minus 5 days) after surgery
within the first 10 days (plus or minus 5 days) after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

December 16, 2015

First Posted (Estimate)

December 18, 2015

Study Record Updates

Last Update Posted (Estimate)

December 18, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-X20-068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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