Can Intraoperative Nerve Monitoring Predict and Improve Functional Outcomes After Robotic-assisted Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Return of continence following robotic-assisted radical prostatectomy
研究概览
简要总结
The purpose of this study is to evaluate whether the use of intraoperative nerve monitoring during robotic-assisted radical prostatectomy (RARP) can predict and improve post-surgery urinary continence and erectile function.
详细描述
Study design:
This is a single center, randomized, single blinded, prospective, clinical trial. The study population will comprise of 100 men that will undergo either a non-nerve sparring or unilateral-nerve sparring RARP. This means that the preoperative evaluation has suggested that it will not be possible to preserve the cavernous parasympathetic nerves lying in the fascia on either side of the prostate gland during surgery (called bilateral-nerve sparring). Despite the term, non-nerve sparring surgery, the surgeon will still attempt to preserve the somatic fibers of the pudendal nerve as best possible. However, due to the extent of cancer tissue the surgeon will generally need to operate closer to the pudendal nerve then when performing bilateral-nerve sparring surgery. So, the somatic fibers of the pudendal nerve are more likely to be severed. The same is the case on one side when performing unilateral surgery.
The treatment group will consist of 50 subjects that will undergo nerve monitoring during RARP. Results will be compared to a control cohort consisting of 50 patients that will undergo contemporary RARP.
Aside from the usage of nerve monitoring in the intervention-group, all procedures and care from admission to the hospital through discharge will be standard of care for subjects in both the control and Intervention-group.
Baseline evaluation and collection of data:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients that are planned to undergo either non-nerve or unilateral nerve sparring surgery.
- •Patients that deemed able to understand the protocol and to return for all the required post-treatment follow-up visits.
排除标准
- •Incontinence prior to surgery
- •Known neurological disease that can affect urinary/erectile function
- •Condition with Pacemaker
- •Previous pelvic trauma
- •Previous pelvic surgery including transurethral resection of the prostate
- •Previous pelvic radiation therapy
结局指标
主要结局
Return of continence following robotic-assisted radical prostatectomy
时间窗: 12 months
Difference in total International consultation on incontinence questionnaire (ICIQ)-score between the 2 groups after a follow-up of 1 year. ICIQ is a self-reported survey and screening tool for incontinence. It consists of 3 questions regarding symptoms in the past 4 week, with an overall 0-21 score, where greater values indicate increased severity. Question 1 scores from 0-5, question 2 scores either 0,2,4 or 6 and question 3 scores from 0-10. Only the total score is evaluated. Furthermore there is 1 self-diagnostic question.
次要结局
- Return of erectile function following robotic-assisted radical prostatectomy(12 months)
- Nerve function after removal of the prostate correlated to patient's postoperative erectile function(12 months)
- Difference in the degree of incontinence between the two groups for incontinent patients.(12 months)
- Difference in Time to continence between the two groups(12 months)
- Nerve function prior to removal of the prostate correlated to patient's preoperative erectile function(1 day)
- Nerve function after removal of the prostate correlated to patient's postoperative urinary function(12 months)
- Nerve function prior to removal of the prostate correlated to patient's preoperative urinary function(1 day)
研究者
Alexander Nolsøe
MD
Herlev and Gentofte Hospital