A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Operative Time
研究概览
简要总结
Holmium laser enucleation of the prostate (HOLEP) has proven to be efficacious and safe for the treatment of benign prostatic hypertrophy (BPH). New laser technologies such as the Moses Pulse laser system provide for improved energy delivery which may decrease blood loss and operative time. We seek to evaluate Moses technology for enucleation of the prostate in the setting of BPH.
详细描述
This is a single-center, prospective, double-blinded, randomized controlled trial comparing MOLEP to HOLEP. Inclusion criteria included all symptomatic BPH patients desiring enucleation with prostate sizes > 80ccs based on cross-sectional imaging. Patients are randomized in a 1:1 fashion and the study is powered to evaluate for a difference in operative time (i.e. alpha=0.05,N=21 per group). All surgeries will be performed with a 550 μm fiber. At the start of each case, a laser technician would be notified of randomization via envelope and randomize the settings to either Moses or traditional mode. The surgeons and patients were blinded to which mode was used. All surgeries will be performed using a two lobe technique and laser settings between 2J and 20-40Hz. Further recorded endpoints include change in blood loss, reduction in International Prostate Symptom Score (IPSS), improvement in uroflow parameters, and complications postoperatively at 6 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 90 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Any man with clinical symptoms fo BPH requiring surgery who has a prostate sized at greater than 80 grams
排除标准
- •Anyone actively on anticoagulation perioperatively
研究组 & 干预措施
Holmium Laser Enucleation of Prostate
Traditional holmium laser enucleation of the prostate as currently performed
干预措施: Moses laser enucleation of prostate (Procedure)
Moses Holmium Laser Enucleation of Prostate
holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated.
干预措施: Moses laser enucleation of prostate (Procedure)
结局指标
主要结局
Operative Time
时间窗: intraoperatively
time for surgery to take place
次要结局
- Percentage of Change of Hematocrit(Baseline to postoperatively day 1)
研究者
Nicholas Kavoussi
Clinical Instructor
Vanderbilt University Medical Center
