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临床试验/NCT02533687
NCT02533687暂停不适用

Comparison of Two Different Bipolar and A Monopolar Energy Sources During Transurethral Resection of Prostate

Selcuk University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年7月最近更新:
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:

  1. 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
  2. Operative data: duration of operation, volume of resected tissue, observation of obturator reflex (if any), kind and size of the urethral catheter used
  3. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Murat AKAND

Assistant Professor, M.D.

Selcuk University

研究点 (2)

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