Comparison of Pain Levels in Fusion Prostate Biopsy and Standard TRUS-Guided Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- To detect painful steps of biopsy procedure by asking patients verbally
研究概览
简要总结
The aim of this study was to compare the pain levels in transrectal ultrasound (TRUS)-guided standard 12-core prostate biopsy (SPB) and multiparametric prostate magnetic resonance imaging (MpMRI)-guided fusion prostate biopsy (FPB).
详细描述
The study included patients that underwent prostate biopsy under local anesthesia (intrarectal 2% lidocaine gel + periprostatic nerve block) due to suspected prostate cancer. Patients detected with a Prostate Imaging Reporting and Data System score (PIRADS) ≥3 lesion on MpMRI underwent MpMRI-guided FPB (Group I) and the patients who had no suspected lesions or had a PI-RADS <3 lesion on MpMRI underwent TRUS-guided SPB (Group II). Pain assessment was performed using Visual Analog Scale (VAS) 5 min after the procedure. Following the procedure, the patients were asked to indicate the most painful biopsy step among the three steps (1: insertion of the probe into the rectum, 2: probe manipulation, 3: the piercing of the biopsy needle).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Elevated blood prostate specific antigen (PSA) levels according to patients age. PSA >2ng/ml for whom aged between 50-60, and PSA >4ng/ml for whom were above 60 years old
- •Having suspicious digital rectal examination
- •having multi-parametric prostate MRI before prostate biopsy
- •Having MRI defined lesions which were PIRADS - 3 -4-5
排除标准
- •PSA > 50 ng/ml
- •previous negative biopsy
- •neurological disorders that could affect the pain level such as paraplegia or hemiplegia, analgesics use for any reason on the day of or the day before the procedure,
- •patients underwent biopsy under general anesthesia,
- •having such diseases as anal fissure or hemorrhoidal disease that could alter the pain threshold
研究组 & 干预措施
Group 1
In Group 1, Patients detected with a PI-RADS (Prostate Imaging Reporting and Data System) ≥3 lesion on MpMRI underwent MpMRI-guided MRI- US fusion prostate biopsy. In this fusion biopsy, 12 core standard biopsy and 2-4 cores of biopsies from lesions defined on multiparametric prostate MRI
干预措施: MRI- US fusion prostate biopsy (FPB) (Procedure)
Group 2
In Group 2, patients who had no suspected lesions or had a PI-RADS <3 lesion on MpMRI underwent Transrectal ultrasound guided 12 core prostate biopsy (SPB).
干预措施: Standard transrectal 12 core biopsy (Procedure)
结局指标
主要结局
To detect painful steps of biopsy procedure by asking patients verbally
时间窗: Within 5 minutes after biopsy
to ask patients most painful step of procedure that verbally defined them before biopsy as 1: insertion of the probe into the rectum, 2: probe manipulation, and 3: the piercing of the biopsy needle
Over all Visual analogue Score (VAS) score of procedure(From 0 to 100 points, 100 is max pain score according to patient)
时间窗: Within 5 minutes after prostate biopsy
pain assessment was performed using Visual Analogue Scale (VAS)
次要结局
未报告次要终点
研究者
Abdullah Demirtas
Abdullah Demirtas, Md, Assoc. Prof.
TC Erciyes University