Robotic Assisted Surgery in Upper Aerodigestive Tract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions
研究概览
简要总结
To evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time.
详细描述
This trial is a single institution non-randomized study to evaluate the efficacy and safety of the da Vinci® Robotic Surgical System. This study will evaluate the use of the daVinci Robotic System for better visibility and access of head and neck lesions and decreased amount of surgery time. This is a robotic system used by surgeons to perform surgery in a less invasive manner.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Head and neck lesions requiring surgical resection, biopsy, or invasive treatment;
- •Lesion amendable to robotic assisted surgery treatment;
- •Age > 19 years;
- •Patient must sign informed consent.
排除标准
- •Psychological condition that renders the patient unable to understand the informed consent;
- •Poor mouth opening, with maximal opening less than 1.5 cm.
结局指标
主要结局
Number of Participants With Adequate Exposure and Access to Oropharyngeal and Hypopharyngeal Head and Neck Lesions
时间窗: Intraoperatively average of 2 hours
Number of participants with adequate exposure and access for use of the da Vinci® Robotic System in oropharyngeal and hypopharyngeal head and neck lesions
次要结局
- Assessment of Patients Safety by Evaluating the Number of Participants Who Experienced Known Complications From the Use of the da Vinci® Robotic System During Surgery, Experienced a Need for Conversion to Open Surgery or Required Additional Surgery.(3 - 24 months postoperatively)
研究者
William Carroll, MD
Professor of Surgery
University of Alabama at Birmingham