Background/Introduction
Our proposed study aims to identify current practice in the use of antibiotic prophylaxis at the time of cystoscopy in the pediatric population across different Institutions/Countries as well as the rate of postoperative febrile urinary tract infection (fUTI). This could lead to further research questions and develop future research projects aimed at minimizing the use of antibiotics without jeopardizing patients’ safety.
Research Question
What antibiotic prophylaxis protocols are currently in use among different Institutions/Countries?
What is rate of post-cystoscopy febrile UTI (fUTI)?
Is there any difference based upon geography/institution/center protocol?
Primary and Secondary Aims
Primary Aim: To identify the current practice across different Countries
Secondary Aim:
-To estimate rate of post-cystoscopy fUTI
-To identify possible risk factors for post-cystoscopy fUTI
Study Design
Multi-center, international, non-interventional observational study
Target Population
Pediatric population - all patients <16 years of age undergoing a diagnostic or therapeutic cystoscopy
Inclusion/Exclusion Criteria
Inclusion criteria:
- All patients <16 years of age undergoing a diagnostic or therapeutic cystoscopy at the participating centers
Exclusion criteria:
- incomplete outcome data
- withdrawal from study
Data collection
- Participating centers will be identified before the study period
- Participating centers will provide data concerning all cystoscopies performed in children <16 years of age during the study period including indications, type of cystoscopy performed, type of prophylaxis if any and presence of a postoperative fUTI.
- No identifiable patient data will be collected.
- Data will be collected and stored online through a secure server running the Research Electronic Data (clinsight)
- Hospital Leads will be provided with Clinsight server login details, allowing them to securely submit data
- The Clinsight server is managed by the Centre Hospitalier Universitaire de La Réunion
Study Procedures
All patients will receive their routine care as planned without any modification to each centers standard care. All data will be entered into an anonymized, secured database.
A local investigator will be identified and invited to ensure maximum data collection from his/her center.
Data Analysis
The analysis will describe the primary and secondary outcomes in the cohort.
Local approvals for the patient-level component
The study will be conducted in accordance with national and international guidelines and legislation, as well as the basic principles of the protection of the rights and dignity of Human Beings, as set out in the Helsinki Declaration.
This is an investigator-led, non-commercial, observational (no changes to normal patient care) study which is extremely low risk; only routinely available non-identifiable data will be collected.
Hospital Leads are responsible for obtaining necessary local approvals at each participating site in line with hospital and country regulations. Collaborators will be required to confirm that local approval is in place at the time of uploading each patient record to the study database
Administrative Organization/Roles and Responsibilities
Promotor : CHU de La Réunion
Use of Study Results
The results of the study will be used for presentations and publications.
Up to 2 investigators per participating center will get recognition on subsequent publications.
