BRUYERE
Tours, 37044, France
NCT Number: NCT04913753
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.
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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Tours, 37044, France
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?
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in the control group will have bacterial culture and double J removal will be performed as usual. .
Patients in the experimental group will have bacterial culture and double J removal will be performed as usual. .
Time frame: 1 month post double J removal
Incidence over a month period of post-ablation symptomatic urinary infection defined by the presence of symptoms validated by an adjudication committee (urine burning, fever, urgencies… associated to a significant bacteriuria) - each patient will be contacted by phone at month 1 (± 5 days) and will be asked to contact us in case of suspicion of urinary infection.
Time frame: 1 month post double J removal
Incidence of post-ablation bacteriuria (urosepsis and antibiotic use) in different groups of patients (reason of the stent, duration of the insertion, previous infection, immunodepression….) in the 1 month post-ablation period
Time frame: 10 days to 4 days before double J removal
Epidemiology of the resistance type of pre-operative bacteriuria
Time frame: 10 days to 4 days before double J removal
Epidemiology of pre-operative bacteriuria
Time frame: 1 month after double J removal
Epidemiology of the resistance type of post-ablation bacteriuria
Time frame: 1 month after double J removal
Epidemiology of post-ablation bacteriuria
Time frame: 1 month post double J removal
Comparison of the pre-operative urinary microbiome to the post-ablation urinary microbiome in patient with post-ablation infection.
Time frame: 1 month post double J removal
Proportion of incremental costs-effects pairs that lies in the non-inferiority area, for various values of economic non-inferiority
University Hospital, Tours
Other
Acronym: AblaJ
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