NCT06987552招募中不适用
A Pilot Study of Single-Port Robot-Assisted Surgery Using Da Vinci SP Surgical System for Patients With Upper Tract Urothelial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence of conversion rate
研究概览
简要总结
To evaluate patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery
详细描述
To evaluate safety, surgical outcomes, patient characteristics, and patient-reported outcomes of radical nephroureterectomy using single-port robotic surgery
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
- •Age 20 years or more
- •Histologically or cytologically diagnosed upper tract urothelial cancer
- •Fitting indications of radical nephroureterectomy and ipsilateral bladder cuff resection, and deemed feasible for robotic surgery
- •ASA physical status classification 1-2 and adequate organ function
- •Patients willing and able to comply with study protocol requirements and follow-up
- •With informed consent
排除标准
- •Synchronous bladder cancer
- •Distant metastasis of cancer
- •BMI ≥30 or BMI <18.5
- •Unable to tolerate lateral decubitus or Trendelenburg position (relative contra-indication)
- •Severe adhesion due to prior abdominopelvic surgery (relative contra-indication)
- •Previous radiation treatment to the pelvic area
- •Active infectious disease
- •Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions, such as: severe heart disease (NYHA functional class III-IV) or severe lung disease (GOLD Group C-D)
- •Cannot follow trial-required procedures
- •Concomitant systemic or pelvic disease that increases the risk of surgery
- •Long-term use of anti-coagulant(s)
- •Patients with coagulopathy
- •Emergency surgery
结局指标
主要结局
Incidence of conversion rate
时间窗: During Surgery
The primary performance endpoint will be assessed as the ability to successfully completed the planned procedure with da Vinci SP System, with no conversion to alternative surgery including open surgery or laparoscopy.
次要结局
- Perioperative Parameters: Operative Time(immediately after the surgery)
- Perioperative Parameters: Console Time(immediately after the surgery)
- Perioperative Parameters: Transfusion(immediately after the surgery)
- Perioperative Parameters: Estimated Blood Loss(immediately after the surgery)
- Postoperative Parameters: Length of Stay(30 days post operation)
- Complication(30 days post operation)
- Postoperative Parameters: Readmission(30 days post operation)
- Postoperative Parameters: Reoperation(30 days post operation)
- Perioperative Mortality(30 days post operation)
- Pain Score(30 days post operation)
研究者
研究点 (1)
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