ROBYN Study - Robotic Assisted Surgery in Gynecological Indications Compared to Conventional Laparoscopy - A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Describe treatment decision
研究概览
简要总结
Robotic Assisted Surgery (da Vinci System) in gynecological indications compared to conventional laparoscopy
详细描述
A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient is willing to participate and to comply with the study procedures
- •Patient present with gynecological disease that may be treated with surgical intervention
排除标准
- •Life expectancy for less than 1 year
结局指标
主要结局
Describe treatment decision
时间窗: Enrollment Completion
Describe treatment decision for the procedure of choice
Describe patient outcome
时间窗: 12 Months
Describe patient outcome from robotic-assisted surgery and conventional laparoscopy by using physiological parameter such as relief or improvement of symptoms, number of complications or number of re-operations and changes in the patient reported quality of life (EQ-5D-5L) between baseline and FU at 12 Months (changes in the score)
Describe impact of patient factors on outcome
时间窗: 12 Months
Describe impact of patient factors on outcome by using physiological parameter, such as age, BMI, uterus size, report co-morbidities
Complications of medical interest
时间窗: 90 days
Describe complication of medical interest
次要结局
- Quality of Life Impact per patient reported questionnaires(12 Months)
- Describe the impact of surgeon experience on outcome(12 Months)
- Describe the performance and use of Intuitive systems(12 Months)
- Describe the performance and use of Intuitive instruments(12 Months)