Retrospective Study on Colorectal Robotic Surgery Results Obtained Using a New Robotic Platform
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Evaluation adverse events
研究概览
简要总结
The ALF-X (Advanced Laparoscopy through Force reflection) Robotic Surgery System is a medical device that is available for distribution in the EU (European Union) under CE Mark for use in general surgery, thoracic surgery, gynecological surgery and urological surgery. The main research question is to assess, from a retrospective poit of view, the safety and feasibility of this new robotic platform in the colorectal surgery.
详细描述
The rationale of this study is to investigate the perioperative and the short term perioperative outcomes of this new robotic Platform in minimally invasive colorectal surgery. Tha ALF-X utilizes fully reusable along with haptic feedback and an innovative vision control system.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients affected by colorectal disease (benign or malignant) having undergone surgery using ALF-X platform
排除标准
- 未提供
结局指标
主要结局
Evaluation adverse events
时间窗: from the surgery up to 30 days after the surgery
Adverse events occurred during the surgery and during the 30 days after the surgery evaluated using Clavien-Dindo Classification, conversion rate to traditional laparoscopy or open surgery
次要结局
- Setup for surgery - collision rate(from to the start to the end of the surgery)
- Setup for surgery - reduced mobility(from to the start to the end of the surgery)
- Adverse events(Up to 30 days post-surgery)
- Duration of hospitalisation(from surgery to hospital discharge, up to 30 days)
- Duration of surgery(from to the start to the end of the surgery)