NCT06141421已完成不适用
A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Colorectal Surgeries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Intraoperative conversion rate
研究概览
简要总结
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 robot-assisted colorectal surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population.
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
- •Subjects who have received or plan to receive colorectal surgeries with the SP single-port robot, such as low anterior resection of the rectum with or without total mesorectal excision; right hemicolectomy, left hemicolectomy and sigmoidectomy with or without transanal total mesocolic excision and central blood vessel ligation; and transanal minimally invasive surgery.
- •Patients who voluntarily decide to 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;
- •Subjects having any contraindications of single-port robot surgery;
- •The intraoperative anatomy determined that minimally invasive surgery was not suitable;
- •Patients who are considered inappropriate to participate in this study by investigator.
结局指标
主要结局
Intraoperative conversion rate
时间窗: Intraoperative
The incidence of device-related or likely related complications of Clavien-Dindo classification grade III or higher at postoperative 30 days
时间窗: 30 days
次要结局
- Urethral catheter indwelling duration(in the follow-up 1 month after the surgery)
- Postoperative pain score(follow-ups 1 day (24±4 h), 3 days (72±4 h) and 1 month (30±5 days) after the surgery.)
- Admission to ICU and ICU LOS(During the follow-up 1 day before discharge)
- Surgical duration(Intraoperative)
- Length of stay (LOS)(During the follow-up 1 day before discharge)
- Intraoperative bleeding volume(Intraoperative)
- The rate of intraoperative blood transfusion(Intraoperative)
- Short-term recovery of functions(in the follow-up 1 month after the surgery)
研究者
研究点 (1)
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