CTRI/2024/09/074019尚未招募2 期
A comparison of Safety of Transrectal Prostate Biopsy to Transperineal Prostate Biopsy A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- AIIMS BHOPAL
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence of infectious complications within 30 days post-biopsy
研究概览
简要总结
Purpose: To compare the safety of transrectal prostate biopsy versus transperineal prostate biopsy by evaluating the incidence of infectious complications, specifically sepsis, fever, and urinary tract infections (UTIs).
Hypothesis:There is no difference in the incidence of infectious complications or patient-reported outcomes between transrectal prostate biopsy and transperineal prostate biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male patients aged 40 years and above.
- •Patients with a clinical indication for prostate biopsy (elevated PSA levels, abnormal digital rectal exam, or suspicious MRI findings).
- •Patients who provide written informed consent.
- •Patients who are capable of understanding and complying with study requirements and procedures.
排除标准
- •Patients with a history of allergic reaction to iodine or antibiotics used in the study.
- •Patients with a history of rectal surgery.
- •Patients with active urinary tract infection or prostatitis at the time of biopsy.
- •Patients with immunocompromised status (e.g., HIV, ongoing chemotherapy).
- •Patients currently receiving anticoagulant therapy that cannot be safely interrupted for the biopsy procedure.
- •Patients unwilling or unable to comply with follow-up requirements.
结局指标
主要结局
Incidence of infectious complications within 30 days post-biopsy
时间窗: Incidence of infectious complications within 30 days post-biopsy
次要结局
- a) Pain scores: Assessed using Visual Analog Scale (0-10) immediately post-procedure(b) Patient-Reported Outcome Measures (PROMs):)
研究者
研究点 (1)
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