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

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ClinicalTrials.gov Identifier: NCT02635490
Recruitment Status : Completed
First Posted : December 18, 2015
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Cheng-Hsing Hsieh, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Brief Summary:
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.

Condition or disease
Ureteral Stones

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Study Type : Observational [Patient Registry]
Actual Enrollment : 52 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Study Start Date : April 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort
prophylactic antibiotics



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Cohort study
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635490


Locations
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Taiwan
Cheng-Hsing Hsieh
Taipei, Xindian, Taiwan, 23142
Sponsors and Collaborators
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Additional Information:

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Responsible Party: Cheng-Hsing Hsieh, Director,Department of Urology, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier: NCT02635490     History of Changes
Other Study ID Numbers: 01-X20-068
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015

Keywords provided by Cheng-Hsing Hsieh, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation:
prophylactic antibiotics, urinary tract infection.

Additional relevant MeSH terms:
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Ureteral Calculi
Ureterolithiasis
Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents