CTRI/2024/03/063862尚未招募3 期
A Randomized control trial comparing HoLEP versus TURP in the treatment of Benign Prostatic Hyperplasia
Kushal Kumar1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年3月14日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- IPSS score, Serum prostate specific antigen (PSA), pre voiding residual volume, post voiding residual Volume (PVRV) Peri-operative parameters include total operating time, resected tissue weight, drop in hemoglobin level, requirement of Blood transfusion, hospital stay, time for catheter removal.
研究概览
简要总结
In this RCT we would like compare the new surgical modality for prostate surgery HoLEP against TURP ( gold standard) in terms of perioperative and postoperative parameters in Indian population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Male
入选标准
- •Inclusion criteria:
- •BPH patient with prostatic volume greater than 30cc.
- •IPSS score of 8 or more.
- •urinary peak flow Qmax 15ml/sec or low
- •BPH with recurrent UTI
- •BPH leading to obstructive uropathy and relieved following per urethral catheterization
- •Serum PSA greater than >4ng/ml with normal Biopsy.
排除标准
- •Exclusion criteria:
- •Neurogenic bladder
- •Confirmed Carcinoma prostate
- •Those who doesn’t consent.
结局指标
主要结局
IPSS score, Serum prostate specific antigen (PSA), pre voiding residual volume, post voiding residual Volume (PVRV) Peri-operative parameters include total operating time, resected tissue weight, drop in hemoglobin level, requirement of Blood transfusion, hospital stay, time for catheter removal.
时间窗: 0,1 & 3 moth after suegery
次要结局
- IPSS score, Serum prostate specific antigen (PSA), pre voiding residual volume, post voiding residual Volume (PVRV)(0,1 & 3 moth after suegery)
研究者
KUSHAL KUMAR
Indira Gandhi Medical College, Shimla
研究点 (1)
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