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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Urinary Infection

Treatments: Procedure: CBEU; Procedure: No CBEU

Study type: Interventional

Funder types: Other

Identifiers

NCT04913753

DR200086 - ABLAJ

Details and patient eligibility

About

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.

Full 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?

Enrollment: 2,200 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant ≥ 18 years of age
• Scheduled to have a double J catheter ablation
• Participants covered by or entitled to social security
• Written informed consent obtained from the participant
• Ability for participant to comply with the requirements of the study

Exclusion criteria

• Patients already receiving antibiotics other than urological reasons and transplanted patients
• Study interventions contraindications
• Pregnancy, breastfeeding
• Patient under tutorship or curators
• Deprivation of liberty

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,200 participants in 2 patient groups

No systematic CBEU

Experimental group

Description:

Patients will not have bacterial culture performed before double J removal.

Treatment:

Procedure: No CBEU

Systematic CBEU

Active Comparator group

Description:

Patients will have a systematic urine culture performed before double J removal.

Treatment:

Procedure: CBEU