- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02635490
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
-
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Xindian
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Taipei, Xindian, Taiwan, 23142
- Cheng-Hsing Hsieh
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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 |
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prophylactic antibiotics
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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.
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
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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