跳至主要内容
临床试验/NCT04263987
NCT04263987已完成3 期

A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicholas Kavoussi

Clinical Instructor

Vanderbilt University Medical Center

研究点 (2)

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