Bipolar Enucleation of the Prostate Versus Bipolar TURP (TURP)
A Comparative Study Of Clinical Outcomes Of Bipolar Enucleation Of The Prostate Versus Bipolar TURP In Management Of Benign Prostatic Hyperplasia : A Randomized Controlled Clinical Trial
研究概览
详细说明
Recent literature suggests that enucleation techniques may provide superior functional results, reduced bleeding, and lower retreatment rates. Nevertheless, there remains limited high-quality randomized controlled data directly comparing bipolar TURP and bipolar enucleation of prostate as a head to head comparison regarding functional outcomes and peri-operative complications.
In this study, a randomized controlled trial was performed to compare bipolar enucleation of the prostate versus bipolar transurethral resection of the prostate in BPH regarding symptoms relief, residual adenoma, urine flow rate and post-operative morbidity.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Cairo Governorate
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Cairo、Cairo Governorate、埃及、11566
- Ain shams university hospitals
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- All male patients above the age of 40 years who presented to the urology clinic in Ain Shams university hospitals with BPH with prostate size 80 - 120 g and have any of the following criteria:
- Voiding symptoms that are poorly responsive to medical treatment (IPSS more than 18 and Qmax less than 15 ml/sec)
- Persistent or recurrent attacks of urine retention due to BPH.
- Large bladder stones from BPH.
- Recurrent UTI due to BPH.
- Severe gross hematuria from BPH.
Exclusion Criteria:
- Patients with untreated or active UTI.
- Previous pelvic radiation or pelvicl trauma.
- Patients with anesthesia contraindications such as uncontrolled diabetes mellitus, severe coagulation disorders and severe cardiac diseases.
- Known or suspected neurogenic bladder.
- Urethral stricture or urethral cancer.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：bipolar TURP
transurethral resection of the prostate by bipolar current
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transurethral resection of the prostate by bipolar current
其他名称：
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有源比较器：BEEP
endoscopic enucleation of the prostate by bipolar current
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endoscopic enucleation of the prostate by bipolar current
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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volume of residual prostatic adenoma
大体时间：one month postoperative
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measurement of volume of residual prostatic adenoma post bipolar TURP and BEEP was done by pelvi-abdominal ultrasound
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one month postoperative
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change in international prostate symptoms score
大体时间：pre-operative, one, three, six and twelve months postoperative
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The international prostate symptoms score is a patient-completed questionnaire for standardized assessment of lower urinary tract symptoms (LUTS). It includes seven questions that evaluate the following urinary symptoms:
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pre-operative, one, three, six and twelve months postoperative
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change in maximum urine flow rate(Q max)
大体时间：pre-operative, 1, 3, 6 and 12 months postoperative
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Maximum urine flow rate was evaluated by Uroflowmetry
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pre-operative, 1, 3, 6 and 12 months postoperative
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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operation time
大体时间：during operation
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Operation time was calculated from insertion of the cystoscope/resectoscope into the urethra to final removal of the scope
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during operation
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change in post voiding residual urine
大体时间：pre-operative, 1, 3, 6 and 12 months postoperative
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post voiding residual urine in bladder was evaluated by Trans-abdominal ultrasound
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pre-operative, 1, 3, 6 and 12 months postoperative
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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