A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Primary safety endpoint: Incidence of device related or possibly related complications meeting the Clavien-Dindo Grading System level 3 or above criteria within 30 days after the surgery
研究概览
简要总结
Study name：A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries Study purpose：This clinical trial is a real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robotic surgeries of gynecological benign and malignant tumors in the real world, providing a real world evidence for clinical application of the product in the Chinese population.
Study design：Retrospective + prospective, real-world study
English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female patients who have received or plan to receive gynecological surgeries with the SP single-port robot such as radical hysterectomy, salpingectomy/oophorectomy, vaginal hysterectomy, total hysterectomy, myomectomy, ovarian cystectomy, deep endometriosis resection, pelvic and abdominal lymphadenectomy, sentinel lymph node resection by image development, uterus/vagino-sacral colpopexy, and high uterosacral ligament suspension.
- •Patients who voluntarily participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).
排除标准
- •Patients with missing data on the primary endpoint in retrospective cases;
- •Patients having any contraindications of single-port robot surgery;
- •The intraoperative anatomy demonstrate that minimally invasive surgery is not suitable;
- •Patients who are considered inappropriate to participate in this Study by investigators.
结局指标
主要结局
Primary safety endpoint: Incidence of device related or possibly related complications meeting the Clavien-Dindo Grading System level 3 or above criteria within 30 days after the surgery
时间窗: 30 days
Primary efficacy endpoint: Intraoperative conversion rate
时间窗: Intraoperative
次要结局
- Intraoperative blood transfusion rate(Intraoperative)
- Surgical duration(Intraoperative)
- Intraoperative bleeding volume(Intraoperative)
- Length of stay (LOS)(During the follow-up 1 day before discharge.The LOS is defined as the total inpatient days of each subject from the day of the surgery to the day of discharge (unit: days).)
- Admission to ICU and ICU LOS(During the follow-up 1 day before discharge, the admission to ICU and ICU LOS (unit: days) of each subject should be recorded.)
- Postoperative pain score(during the follow-ups 1 day (24±4 h), 3 days (72±4 h) and 1 month (30±5 days) after the surgery)