Freehand Transperineal Prostate Biopsies Without Antibiotic Prophylaxis - the New Gold Standard?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 923
- 试验地点
- 1
- 主要终点
- Complications
研究概览
简要总结
Background: Prostate biopsies are essential to diagnose prostate cancer (PCa). Transrectal prostate biopsies (TR-PB) are commonly performed, however disadvantages include the requirement of antibiotic prophylaxis (AP) and higher complication rates than transperineal prostate biopsies (TP-PB). Guidelines still recommend the use of AP for TP-PB due to the limited evidence regarding complication rates after their omission. However, the rising rates of antibiotic resistance is of concern. The aim of this study was to compare the complication and detection rates of freehand TP-PB without AP versus TR-PB with AP.
Methods: This single center retrospective study was performed in an academic hospital. TP-PB were introduced in 2019 and implemented as the main technique by late 2020. To compare the two techniques, data was collected for freehand TR-PB with AP between 2017-2018 and freehand TP-PB without AP between 2021-2022. The data from 2019 and 2020 were excluded to rule out the effects of the initial learning curve during the transition period. Primary outcome measure was post-biopsy complications occurring within 2 weeks, focusing on infectious complications. Secondary outcome measures were detection rates and upgrading/reclassification in the repeat biopsy in active surveillance (AS). Statistical analysis was performed using a Fisher exact or Chi-Squared test.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •men who underwent prostate biopsy between 2017-2018 (transrectal)
- •men who underwent prostate biopsy between 2012-2022 (transperineal)
排除标准
- •positive urine culture before biopsy
- •patients in the transrectal biopsy group who did not take the prescribed course of antibiotic prophylaxis
- •incomplete medical dossier where the occurrence of a complication could not be assessed
结局指标
主要结局
Complications
时间窗: 2 weeks
Urinary tract infections, urinary retention, hematuria
次要结局
- Detection rate(2 weeks)
