Prospective Non-randomized Trial Comparing Holmium Laser Enucleation of the Prostate Versus Greenlight Laser Photoselective Vaporization of the Prostate in Treating Benign Prostate Hyperplasia in Patients With Bleeding Tendency
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- perioperative blood loss
研究概览
简要总结
Patients presented for BPH surgery at our out patient clinic will be assessed for abnormal bleeding profile.
Patients with bleeding tendency will be offered either HoLEP or Greenlight laser PVP based on prostate size cut off point of 80ml Larger prostates will be treated with HoLEP Smaller prostates will be treated with greenlight PVP
详细描述
Elderly patients with bleeding tendency either secondary;
- Strict antiplatelet intake
- Strict anticoagulant intake
- uncorrected natural bleeding tendency e.g; patients with liver cell failure are at higher risk of perioperative bleeding when subjected to prostate surgery.
Laser prostate surery was introduced to overcome this difficulty. However, till now there is no head to head comparision of different types of laser procedures in treating this subset of patients In the current study patients presented for BPH surgery in a tertiarry referral prostate unit will be assessed for bleeding tendency and will be treated either by Holmium laser enucleatiuon of the prostate or Greenlight laser vaporization of the prostate Single surgeon will perform all cases
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •BPH patients candidate for transurethral prostate surgery after failure of medical treatment
- •Perioperative uncorrected Blleding tendency
- •patients with naturally induced uncorrectable bleeding tendency;
- •platelet count less than 100000/mm3
- •INR more than 1.5
- •Patients on oral antiplatlet that deemed unsafe to stop prior to surgery as per intenist
- •Patients on oral anticoagulant that deemed unsafe to stop prior to surgery as per intenist
排除标准
- •Correctable bleeding tendency
结局指标
主要结局
perioperative blood loss
时间窗: 48 hours
次要结局
- flow rate(3 months)
- readmission(30 days)
- blood transfusion(30 days)