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临床试验/NCT06027203
NCT06027203已完成不适用

Freehand Transperineal Prostate Biopsies Without Antibiotic Prophylaxis - the New Gold Standard?

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 923 人开始时间: 2023年4月15日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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