A Prospective Study About the Safety of Omitting Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB): the prophylaxis001-trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,350
- 试验地点
- 1
- 主要终点
- % of patients with a post-operative infection.
研究概览
简要总结
To investigate the use of antibiotic prophylaxis in patients undergoing TURP and TURB. The investigators set up a prospective, randomized controlled trial in which (after exclusion of risk factors) patients will be randomized in receiving levofloxacin (Tavanic) orally or no antibiotics. The exclusion criteria for TURP are a pre-operative transurethral catheter or > 100 urinary white blood cells in the pre-operative urine sample. The exclusion criteria for TURB are a pre-op catheter or clinical signs of infection.
详细描述
Main objective:
To investigate the safety of omitting antibiotic prophylaxis in TURP (transurethral resection of the prostate) and TURB (transurethral bladder tumour resection) in patients without a pre-operative catheter or > 100 WBC in the pre-operative urinary sample (TURP) or clinical signs of urinary infection (TURB).
Secondary objective:
To investigate post-operative bacteriuria after TURB and TURP in our population.
Principal inclusion criterium:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TURP or TURB.
排除标准
- •TURP: pre-operative catheter/DJ/nephrostomy or > 100 white blood cells in the pre- operative urinary sample.
- •TURB: pre-operative catheter/DJ/nephrostomy or clinical signs of infection (fever, myctalgia).
研究组 & 干预措施
Control
The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.
干预措施: Levofloxacin (Drug)
结局指标
主要结局
% of patients with a post-operative infection.
时间窗: From immediately post-op until at the control consultation 4 weeks after surgery.
Urosepsis, fever (t°\> 38.5) or epididymitis.
次要结局
- Incidence of post-operative bacteriuria.(From immediately post-op until at the control consultation 4 weeks after surgery.)