A Prospective Randomised Non-Inferiority Study Comparing Infectious Complications After Transperineal Prostate Biopsy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The incidence of post-biopsy infectious complications.
研究概览
简要总结
Prostate biopsy performed through the perineal skin (the area between the testicles and the anus), known as a transperineal biopsy, is currently considered the standard procedure for diagnosing prostate tumors, having replaced the biopsy performed directly through the rectum. A prostate biopsy involves taking small samples of tissue from the prostate in order to confirm or rule out suspicious changes. The reason for this shift is the lower risk of infectious complications. For this type of biopsy, it has not yet been clearly established whether preventive administration of antibiotics is necessary. Existing studies indicate that the incidence of infection is similar even without antibiotic prophylaxis. The aim of the monitoring is to confirm the safety of performing transperineal prostate biopsy without the use of antibiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Suspicion of prostate cancer based on an elevated PSA level and/or findings on prostate MRI and/or a positive finding on digital rectal examination
- •Cognitive ability sufficient to understand and sign informed consent
- •Health status allowing for local anesthesia and a surgical procedure
排除标准
- •Indwelling urinary catheter
- •Active (symptomatic) urinary tract infection
- •Immunodeficiency
- •Use of immunosuppressive therapy
- •Ongoing antibiotic therapy for another reason
- •Uncontrolled diabetes mellitus
- •Cardiac conditions requiring antibiotic prophylaxis for invasive procedures (e.g., prosthetic heart valves, etc.)
- •Ongoing chemotherapy
- •History of infectious complications following prostate biopsy
研究组 & 干预措施
Antibiotic prophylaxis group
The study arm includes patients who received antibiotic prophylaxis for prostate biopsy.
干预措施: Antibiotic prophylaxis (fosfomycin-trometamol) for prostate biopsy. (Drug)
NO-Antibiotic prophylaxis group
The study arm includes patients who received no antibiotic prophylaxis for prostate biopsy.
干预措施: No antibiotic prophylaxis for prostate biopsy (Diagnostic Test)
结局指标
主要结局
The incidence of post-biopsy infectious complications.
时间窗: At 3 weeks and at 2 months after the procedure
次要结局
未报告次要终点
研究者
Viktor Kováčik
Mr.
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
