NCT02991794已完成不适用
Prospective, Multi-centre, Non-interventional Trial on Laparoscopic Radical PROSTatectomies Using EinsteinVISion® 3D Visualization System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Time needed to perform the vesicourethral anastomosis using EinsteinVision® in a group of different surgeons [min. sec.]
研究概览
简要总结
The aim of the study is collecting clinical data on the learning curve of different surgeons using the EinsteinVision® 3D visualization system in laparoscopic radical prostatectomies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing planned radical prostatectomy prostatectomy because of histologically proven prostate cancer using EinsteinVision®
- •Written informed consent
- •Age ≥ 18 years
排除标准
- •Previous TURP (= transurethral resection of the prostate)
- •Previous operations on the sigmoid colon or rectum (e.g. because of carcinoma, perforation, diverticulum)
- •BMI > 35 kg/m²
- •Participation in another clinical study
- •Representation by a legal guardian or under involuntary commitment
结局指标
主要结局
Time needed to perform the vesicourethral anastomosis using EinsteinVision® in a group of different surgeons [min. sec.]
时间窗: Intraoperatively
learning curve of different surgeons with diverse level of experience using EinsteinVision® 3D visualization system
次要结局
- Intraoperative blood loss [ml](Intraoperatively)
- Surgeon's experience with different operation methods and application systems(After first intervention for each hospital and after study completion, an average of 1 year later)
- Incontinence pads/pants per day [quantity](5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively)
- Intraoperative blood transfusions [quantity](Intraoperatively)
- Intraoperative incidence of complications [percentage](Intraoperatively)
- Patient's quality of life(Preoperatively, 5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively)
- Intraoperative usability of the device(Intraoperatively)
- Incontinence after catheterization [percentage](During stay in Hospital (5-12 days postoperatively))
- Return to erectile function [percentage](12 months)
- Postoperative blood transfusions [quantity](Postoperatively)
- Operation time [min.](Intraoperatively)
- Postoperative hospital stay [days](During stay in Hospital (5-12 days postoperatively))
- Postoperative patient satisfaction(5-12 days postoperatively, 3 months, 6 months, 12 months postoperatively)
- Postoperative incidence of complications [percentage](During stay in Hospital (5-12 days postoperatively))
- Return to continence function [percentage](12 months)
研究者
研究点 (2)
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