Clinical Assessment of Intraoperative Nerve Monitoring During Robot-assisted Laparoscopic Prostatectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Return of urinary continence following robotic-assisted laparoscopic prostatectomy
研究概览
简要总结
The purpose of this study is to determine whether the use of intraoperative nerve monitoring during robotic-assisted laparoscopic prostatectomy surgery improves post-surgery urinary continence and erectile function.
详细描述
Study Design:
This is a single surgeon, single institution prospective post-market study of patients undergoing a robotic-assisted laparoscopic prostatectomy (RALP) with intraoperative nerve monitoring of pelvic nerves using the ProPep Nerve Monitoring System. The treatment group will consist of 80 subjects (with 69 anticipated to be evaluable) undergoing RALP with intraoperative nerve monitoring (IONM). This will be compared to a consecutive group of contemporary control cohort patients who have underwent RALP without nerve monitoring by the same single surgeon.
Baseline Evaluations and Data Collection:
Pre-operative baseline evaluations and data collection will be used to determine eligibility for enrollment and to document subject clinical status prior to surgical procedure. This information is recorded on the Screening case report forms (CRF).
The following data will be collected at screening/baseline:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects 40-70 years of age diagnosed with adenocarcinoma of the prostate;
- •Subjects scheduled for robotic assisted radical prostatectomy for removal of localized prostate cancer;
- •Subjects, who, in the opinion of the clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-up visits
排除标准
- •Subjects with pre-operative urinary incontinence defined as use of pads or adult diapers;
- •Subjects with previous pelvic or abdominal radiation therapy;
- •Subjects with current or previous malignancy other than prostate or non-melanoma skin cancer;
- •Subjects who have previously had a transurethral resection of the prostate (TURP) or holmium laser enucleation of the prostate (HoLEP), high intensity focused ultrasound (HIFU) or cryotherapy;
- •Subjects with a prostate volume of >80mL
- •Subjects with a body mass index (BMI) of ≥ 34;
- •Subjects with current or suspected urinary tract or bladder infection(s);
- •Subjects with reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening;
- •Subjects with a history of diabetes;
- •Subjects with drug, alcohol, or substance abuse reported within the last three years (subject reported);
- •Subjects with a life expectancy less than study duration;
- •Subjects with systemic autoimmune disorder;
- •Subjects with any significant psychological disturbance that, in the opinion of the Investigator, could impair the consent process or ability to complete self-assessment questionnaires.
- •Subjects with known sensitivity to any device or products required for the RALP surgery; and
- •Subjects with any other condition that would contraindicate participation, as determined by the Investigator.
研究组 & 干预措施
Intraoperative nerve monitoring
Patients for which intraoperative nerve monitoring (electromyography) is used to identify the location of somatic pelvic nerves critical to urinary continence control and erectile function in real time during robotic-assisted laparoscopic prostatectomy surgery
干预措施: Intraoperative nerve monitoring (Device)
结局指标
主要结局
Return of urinary continence following robotic-assisted laparoscopic prostatectomy
时间窗: 6 month
The proportion of subjects who have urinary continence following robotic-assisted laparoscopic prostatectomy (RALP) at 6 months postoperatively.
次要结局
- Return of erectile function following robotic-assisted laparoscopic prostatectomy(catheter removal which typically occurs at 1 week, 1 month, 3 month, 6 month, 12 month)
- Time to urinary continence(catheter removal which typically occurs at 1 week, 1 month, 3 month, 6 month, 12 month)