Perineal Versus Rectal Approach for Prostate Biopsy to Prevent Iatrogenic Infections
试验速览
- 阶段
- 不适用
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- Rate of post-biopsy infection from Baseline to four weeks after prostate biopsy
研究概览
简要总结
Retrospective reports from literature have shown a lower rate of infections for transperineal versus transrectal approach for prostate biopsies in the setting of prostate cancer suspicion.
The aim of this study would be to compare in a prospective randomized trial the rate of infection with transperineal versus transrectal approach.
详细描述
Retrospective reports from literature have shown a lower rate of infections for the transperineal versus transrectal approach for prostate biopsies in the setting of prostate cancer suspicion.
Post-biopsy infection is becoming a more and more challenging situation due to the increase of incidence and development of antibiotic resistant germs.
The aim of this study would be to compare in a prospective randomized trial the rate of infection with transperineal vs transrectal approach.
Patient presenting an indication of prostate biopsy (PSA elevation, suspicious lesion at digital rectal, suspicious lesion on MRI) would be randomized 1:1 among transrectal vs transperineal biopsies.
Post-biopsy infection would be monitored by systemic urine analysis at one, two and four weeks after procedure and in case of clinical symptoms.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Indication of prostate biopsy
排除标准
- •No indication of prostate biopsy
- •Impossibility for prostate biopsy (e.g. major anal stenosis or history of anal amputation)
- •Antibiotic treatment within three months before prostate biopsy
研究组 & 干预措施
Transperineal prostate biopsy
Patient will have a transperineal prostate biopsy.
干预措施: Transperineal prostate biopsy (Procedure)
Transrectal prostate biopsy
Patient will have a transrectal prostate biopsy.
干预措施: Transrectal prostate biopsy (Procedure)
结局指标
主要结局
Rate of post-biopsy infection from Baseline to four weeks after prostate biopsy
时间窗: Four weeks post-biopsy
Urinary infection will be assessed based on urinanalysis : 10\^5 germs and 10\^4 leucocytes minimum)
次要结局
- Presence of antibiotic resistant germ(One week, two weeks and four weeks post-biopsy)
- Presence of complication post-biopsy : hematuria, urinary retention, rectoragy, any other complication(One week, two weeks and four weeks post-biopsy)