Infective Complications in Transperineal Prostate Biopsy Without Antibiotic Prophylaxis: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,753
- 试验地点
- 2
- 主要终点
- The difference in UTI hospitalization rate between the two groups after biopsy
研究概览
简要总结
This study is a prospective cohort study to delineate the infective outcomes and incidence after transperineal prostate biopsy with no antibiotic prophylaxis, compared to the existing data on outcomes on patients receiving transperineal prostate biopsy with antibiotic prophylaxis.
详细描述
All consecutive patients receiving transperineal prostate biopsy in the PWH will be recruited to the exposure cohort after informed consent. Antibiotic prophylaxis will not be given for patients in the exposure group. All patients will undergo transperineal prostate biopsy in the usual manner and technique, under the Ginsburg protocol. Systematic and MRI-TRUS fusion for systematic plus targeted biopsy will be performed based on the usual clinical indications, depending on the clinical need. Follow-up data will be collected, with particular interest on the assessment of infective complications.
Prospectively collected data will also be retrieved from the electronic patient record (ePR) under the Hospital Authority, to assess relevant information on infective complications for patients who received transperineal prostate biopsy in PWH and NDH from 2019 to 2023. These patients received antibiotic prophylaxis prior to their biopsies, and eligible patients will be included as the control cohort for comparison. Propensity score matching will be utilized in order to create a control group that is similar to the exposure group with balanced baseline. Statistical analysis will be performed on the retrieve data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •All consecutive patients in participating centres receiving transperineal USG-guided biopsy for any indication including:
- •Elevated PSA
- •Abnormal DRE
- •Follow-up biopsy in active surveillance
- •Suspicion of CAP recurrence after radiotherapy
- •Follow-up biopsy after focal therapy
- •Consenting to the study
排除标准
- •Recent suspected UTI within 1 month
- •Recent culture proven bacteriuria within 1 month
- •History of recurrent UTI
- •Indwelling urinary catheter
- •Immunocompromised state
- •High risk of infective endocarditis (including prosthetic heart valve, congenital heart disease, or previous history of infective endocarditis
- •Incompetent or incapable of understanding the nature of the study or giving informed consent
研究组 & 干预措施
TP BIospy without antibiotic prophylaxis
Transperineal Biopsy without antibiotic prophylaxis
干预措施: Transperineal Biopsy without antibiotics prophylaxis (Procedure)
TP BIospy with antibiotic prophylaxis
Transperineal Biopsy with antibiotic prophylaxis
干预措施: Transperineal Biopsy with antibiotics prophylaxis (Procedure)
结局指标
主要结局
The difference in UTI hospitalization rate between the two groups after biopsy
时间窗: Within 14 days of biopsy
UTI hospitalization rate is defined symptomology requiring admission to an in-patient facility
The difference in urosepsis rates between the two groups after biopsy
时间窗: Within 14 days of biopsy
Urosepsis is defined as sepsis of likely urological source either based on symptomology or bacteriology.
次要结局
- Post-biopsy UTI rates between the two groups(At post-biopsy Day 14)
- Assessment of bacteriology and antibiotic resistant profile between the two groups(At post-biopsy Day 14)
研究者
CHIU Ka Fung Peter
Associate Professor
Chinese University of Hong Kong