Safety and Efficacy of Pelvic Autonomic Nerve Monitoring and Mapping During Robot Assisted Laparoscopic Radical Prostatectomy for Preservation of Erectile Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Completion rate of nerve monitoring and mapping during RALP
研究概览
简要总结
To evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during robot assisted laparoscopic radical prostatectomy for preservation of erectile function.
详细描述
Using NIM-Eclipse monitoring instrument (Medtronic), we will check action potential of cavernous nerve, bulbocavernosus reflex and pudendal nerve somatosensory evoked potential in real time during robot assisted laparoscopic radical prostatectomy for preservation of erectile function. In this feasibility and protocol setting phase I/II study, we will evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping using NIM-Eclipse monitoring instrument.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •pathologically proven localized prostate cancer (≤cT3a)
- •patients to undergo robot-assisted laparoscopic prostatectomy at our center
排除标准
- •prior hormone therapy
- •prior radiation treatment on prostate or pelvis
- •refused to participate
研究组 & 干预措施
Nerve monitoring arm
They will receive pelvic autonomic nerve monitoring and mapping using NIM-Eclipse (Medtronic) during robot-assisted laparoscopic prostatectomy.
干预措施: NIM-Eclipse (Device)
结局指标
主要结局
Completion rate of nerve monitoring and mapping during RALP
时间窗: During the operation
Completion rate of planed surgery without significant intra-operative complication
次要结局
- Quantification of erectile nerve preservation(During the operation)
- Correlation between the quantification and subjective nerve preservation grade(During the operation)
- Adverse event(12 months)
- Correlation between the quantification of erectile nerve preservation and the postoperative recovery of erectile function(12 months)
研究者
Chang Wook Jeong
Seoul National University Hospital
Seoul National University Hospital