NCT04935151已完成不适用
Holmium Laser Enucleation Versus Bipolar Resection in the Management of a Large Volume (> 80 gm) Symptomatic BPH: a Randomised Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 4
- 主要终点
- hemoglobin drop postoperatively (gm/dL)
研究概览
简要总结
To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (> 80 gm)
详细描述
To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of symptomatic large BPH (> 80 gm)
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from LUTS secondary to infravesical obstruction from BPH with failed medical treatment
- •International Prostate Symptom Score (IPSS) > 13
- •a peak urinary flow rate (Qmax) < 15 ml/sec
- •a prostate size ≥ 80 gm
排除标准
- •presence of a urethral stricture
- •neurological disorder
- •bladder cancer
- •prostate cancer
- •previous history of bladder neck surgery or TURP
结局指标
主要结局
hemoglobin drop postoperatively (gm/dL)
时间窗: within two hours after surgery
change in hemoglobin concentration postoperatively vs preoperatively
次要结局
- operative duration in minutes(Time lapsed during surgery)
- Hospital stay(From time of randomisation up to last day of admission in hospital (in days) up to 30 days)
- blood transfusion(during surgery and hospitalisation up to 10 days)
研究者
Mohammed Said ElSheemy
Professor
Cairo University
研究点 (4)
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