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

Ureteral Stones Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02635490
• Other study ID #: 01-X20-068
• Status: Completed
• Phase: Phase 0
• First received: August 6, 2014
• Last updated: December 16, 2015
• Start date: April 2013
• Est. completion date: March 2015

Study information

• Verified date: December 2015
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: National Health Research Institutes
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ureteral Calculi
• Ureteral Stones
• Ureterolithiasis

Locations

Country	Name	City	State
Taiwan	Cheng-Hsing Hsieh	Taipei	Xindian

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of clinically definite urinary tract infection confirmed by urinary analysis or urinary culture.		within the first 10 days (plus or minus 5 days) after surgery	Yes