Prospective randomised study comparing the outcome of Bipolar enucleation of prostate with transurethral resection of prostate (TURP)and Thulium laser enucleation of prostate(ThuLEP)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Safety and efficacy of bipolar enucleation of prostate
研究概览
简要总结
A randomized study to compare the outcome ( intraoperative, immediate post operative and short term ) of bipolar enucleation of prostate with transurethral resection of prostate (TURP) and thulium laser enucleation of prostate ( ThuLEP). Patients with prostatomegaly ( bothersome LUTS and complications of prostatomegaly) attending outdoor will be recruited for study ( after applying exclusion criteria). Patients will undergo any of the three surgical procedures and intraoperative ( operative time , weight of respected tissue) ,immediate post op ( drop in hemoglobin, traction duration , need for blood transfusion , change in sodium level, need for irrigation , clot retention , re catheterisation , TUR syndrome , hospital stay ) and short term( Qmax , Qavg, PVR , SUI, development of urethral structure , re- do surgery ) outcome will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- Male
入选标准
- •Bothersome LUTS with failed medical management Maximum flow rate less than 15 millilitre per second Complications secondary to BPH- recurrent hematuria of prostatic pathology Refractory urinary retention Recurrent urinary tract infection.
排除标准
- •Neurogenic bladder High bladder neck Diagnosed prostatic cancer.
结局指标
主要结局
Safety and efficacy of bipolar enucleation of prostate
时间窗: One year
次要结局
- Compare intraoperative , immediate postoperative and short term outcome of TURP, ThuLEP and bipolar enucleation of prostate(One year)
研究者
Smita Verma
Institute of post graduate medical education and research