Relevance of the Urine Bacterial Culture Performed Before Double J Ablation for Post-operative Urinary Tract Infection Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,200
- 试验地点
- 2
- 主要终点
- Incidence of infection
研究概览
简要总结
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.
详细描述
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients already receiving antibiotics other than urological reasons and transplanted patients
- •Study interventions contraindications
- •Pregnancy, breastfeeding
- •Patient under tutorship or curators
- •Deprivation of liberty
结局指标
主要结局
Incidence of infection
时间窗: 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.
Incidence of infection
时间窗: 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.
次要结局
- Incidence of bacteriuria measured by CBEU(1 month post double J removal)
- Description of the resistance type of pre-operative distribution of bacteriuria by CBEU(10 days to 4 days before double J removal)
- Description of the pre-operative distribution of bacteriuria by CBEU(10 days to 4 days before double J removal)
- Description of the resistance type of post operative distribution of bacteriuria by CBEU(1 month after double J removal)
- Description of the post operative distribution of bacteriuria by CBEU(1 month after double J removal)
- Composition of microbiome by bacterial urinary analysis(1 month post double J removal)
- Health-economic outcome(1 month post double J removal)
- Description of the pre-operative distribution of bacteriuria by CBEU(10 days to 4 days before double J removal)
- Description of the resistance type of post operative distribution of bacteriuria by CBEU(1 month after double J removal)
- Description of the post operative distribution of bacteriuria by CBEU(1 month after double J removal)
- Health-economic outcome(1 month post double J removal)
- Incidence of bacteriuria measured by CBEU(1 month post double J removal)
- Description of the resistance type of pre-operative distribution of bacteriuria by CBEU(10 days to 4 days before double J removal)
- Composition of microbiome by bacterial urinary analysis(1 month post double J removal)