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

NCT ID: NCT04731090

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Standard antibiotic prophylaxis

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

enhanced prophylaxis

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

Group Type EXPERIMENTAL

Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths

Intervention Type OTHER

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

Interventions

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

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

Intervention Type DRUG

Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths

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 OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Egyptian Biomedical Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed Elhelaly

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar Universiy

Locations

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Armed forced Hospital

Mecca, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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N2113

Identifier Type: -

Identifier Source: org_study_id