NCT07020364招募中不适用
Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
A prospective feasibility study would be a practical first step, focusing on real-time assessment and ensuring the new working element's integration is safe and effective before broader clinical trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with benign prostatic hyperplasia (BPH) requiring surgical intervention.
- •Prostate volume ≥40 cc (as assessed by transrectal ultrasound).
- •No prior history of prostate cancer.
排除标准
- •Patients with ongoing urinary tract infections.
- •Prior prostate surgeries.
- •Coagulation disorders or patients on long-term anticoagulation therapy.
- •Known urethral strictures or other anatomical abnormalities complicating endoscopic procedures.
结局指标
主要结局
Feasibility
时间窗: the operative time
Successful completion of enucleation using the single working element. Time taken to switch between bipolar and laser modalities.
Safety
时间窗: 1 month
intraoperative complications (bleeding, urethral damage). Postoperative complications (infections, catheterization time, hospital stay).
次要结局
- Efficacy(1 month)
- Cost Analysis(the operative time)
研究者
Mohamed Kamal Omar
Assistant professor
Menoufia University
研究点 (1)
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