NCT02533687暂停不适用
Comparison of Two Different Bipolar and A Monopolar Energy Sources During Transurethral Resection of Prostate
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Uroflowmetry test
研究概览
简要总结
With this study, it is aimed to compare the operative results and complication rates in transurethral resection of the prostate (TUR-P) performed by resectoscopes with two different bipolar and a monopolar energy sources.
详细描述
Following data will be collected and evaluated prospectively for the three groups of patients who will undergo TUR-P due to benign prostate hyperplasia (BPH) with one of the resectoscopes using different energy sources:
- Preoperative data: age, height, weight, body-mass index, concomitant morbidities, use of any drug, history of operation, duration of lower urinary tract symptoms, history of any previous treatment taken for BPH, serum level of prostate specific antigen, prostate volume, maximum and average urine flow rate, postmicturation residual urine volume, hemoglobin level
- Operative data: duration of operation, volume of resected tissue, observation of obturator reflex (if any), kind and size of the urethral catheter used
- Postoperative data: time to removal of urethral catheter, hospitalization duration, change in hemoglobin, rate of blood transfusion, any other complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Having an indication due to BPH
- •Aged between 40 and 80 years old
排除标准
- •Kidney failure due to BPH
- •Any kind of coagulopathy or use of anticoagulants in the preoperative period
- •History of any previous open or endoscopic prostate surgery
结局指标
主要结局
Uroflowmetry test
时间窗: Within the first 30 days after surgery.
Determining the improvement in maximal urine flow (mL/s) and average urine flow (mL/s).
次要结局
- Overall complication rates(Within the first 30 days after surgery.)
研究者
Murat AKAND
Assistant Professor, M.D.
Selcuk University
研究点 (2)
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