Clinical Trials Directory

Trials / Completed

CompletedNCT04913753

Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
2,200 (actual)
Sponsor
University Hospital, Tours · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

Summary

The value of cytobacteriological examination of urine (CBEU) before double J catheter removal has not been demonstrated. The aim of this study is to define the interest of this CBEU.

Detailed description

Double J stents are ureteral catheters that allow urine to flow from the kidney without difficulty. These catheters protect the ureterovesical anastomosis of a renal transplant or reduce the postoperative oedema, for example after stone removal by ureteroscopy. These catheters are removed in an outpatient setting under local anaesthesia. Post ablation infections of double J catheters have been poorly studied but their incidence varied according to the populations and the definition used (10 to 54% for colonization, 1 to 10% for symptomatic infection). The national and international guidelines advocate a routine urine bacterial culture (UBC) before double J catheter removal as the procedure is in contact with urine; but there is no evidence of its interest. In case of positivity of this culture, it is recommended to delay the intervention or, what is more often chosen, to treat with antibiotic to cover the procedure. Investigators can thus ask 2 questions: is it rightful to withdraw a double J removal while the UBC is falsely negative and in case of a positive bacterial culture is there an increased risk of post-ablation infection?

Conditions

Interventions

TypeNameDescription
PROCEDURECBEUPatients in the control group will have bacterial culture and double J removal will be performed as usual. .
PROCEDURENo CBEUPatients in the experimental group will have bacterial culture and double J removal will be performed as usual. .

Timeline

Start date
2021-06-10
Primary completion
2025-12-03
Completion
2025-12-03
First posted
2021-06-04
Last updated
2025-12-12

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04913753. Inclusion in this directory is not an endorsement.