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Standard Antibiotic Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy

Primary Purpose

Urinary Tract Infections

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.
Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths
Sponsored by
Egyptian Biomedical Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients subjected to flexible ureteroscopy for management of ureteral and/or renal stones.

Exclusion Criteria:

  • Symptomatic urinary tract infection.
  • Use of rigid ureteroscopy and antegrade ureteroscopy.

Sites / Locations

  • Armed forced Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard antibiotic prophylaxis

enhanced prophylaxis

Arm Description

IV fluoroquinolone 1 hour preoperatively and oral antibiotics were used for 24h postoperatively.

Patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.

Outcomes

Primary Outcome Measures

Urinary tract infection
Postoperative UTI was defined as the occurrence of a temperature higher than 38 °C associated with pyuria and/or bacteriuria without any other focal infectious sites.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2021
Last Updated
January 28, 2021
Sponsor
Egyptian Biomedical Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT04731090
Brief Title
Standard Antibiotic Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy
Official Title
Effect of Standard Antibiotic Prophylaxis Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egyptian Biomedical Research Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background and aim: Urinary tract infections (UTIs) are commonly seen after flexible ureteroscopy. Prevention of UTIs remains controversial. The present randomized study aimed to compare the rate of post-procedural UTI in patients subjected to the standard antibiotic prophylaxis alone versus enhanced prophylactic measures. Patients and methods: The study included 100 patients subjected to fURS for management of ureteral and/or renal stones. Patients were equally and randomly allocated into one of the two treatment groups using randomly computer-generated allocation tables and concealed envelope technique. Treatment groups included standard antibiotic prophylaxis group and enhanced prophylaxis group. Patients in the standard antibiotic prophylaxis group IV fluoroquinolone 1 hour preoperatively and oral antibiotics were used for 24h postoperatively. In the enhanced prophylaxis group, patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard antibiotic prophylaxis
Arm Type
Active Comparator
Arm Description
IV fluoroquinolone 1 hour preoperatively and oral antibiotics were used for 24h postoperatively.
Arm Title
enhanced prophylaxis
Arm Type
Experimental
Arm Description
Patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.
Intervention Type
Drug
Intervention Name(s)
IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.
Intervention Description
IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.
Intervention Type
Other
Intervention Name(s)
Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths
Intervention Description
Patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.
Primary Outcome Measure Information:
Title
Urinary tract infection
Description
Postoperative UTI was defined as the occurrence of a temperature higher than 38 °C associated with pyuria and/or bacteriuria without any other focal infectious sites.
Time Frame
30-day postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients subjected to flexible ureteroscopy for management of ureteral and/or renal stones. Exclusion Criteria: Symptomatic urinary tract infection. Use of rigid ureteroscopy and antegrade ureteroscopy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Elhelaly
Organizational Affiliation
Al-Azhar Universiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed forced Hospital
City
Mecca
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Standard Antibiotic Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy

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