Use of the Da Vinci Single Port Robotic System in Urological Surgery: A Prospective Observational Study (SP-URO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Perioperative complication rate
研究概览
简要总结
A prospective observational study aimed at evaluating the feasibility, safety, and effectiveness of the Da Vinci SP robotic system for urologic procedures at IRCCS Candiolo. The study collects perioperative, oncologic, and functional outcomes, with exploratory comparisons to the multiport Da Vinci Xi system.
详细描述
Minimally invasive surgery has significantly evolved with the introduction of robotic systems. The Da Vinci Single Port (SP) system, FDA-approved in 2018, allows procedures to be performed through a single incision. This single-center, prospective observational study conducted at IRCCS Candiolo aims to assess the safety, feasibility, and perioperative, oncologic, and functional outcomes of urologic procedures performed with the Da Vinci SP system.
Patients will be followed for up to 60 months post-surgery, with exploratory analysis comparing outcomes to those from procedures performed with the Da Vinci Xi (multiport) system. Data will include perioperative variables, complications, renal function, urinary continence, sexual potency, and oncologic parameters. Statistical analyses will be performed using Stata.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent and data privacy consent
- •Clinical indication for urologic robotic surgery per EAU guidelines or clinical trial eligibility
- •ECOG Performance Status 0-1
- •Life expectancy ≥ 10 years
- •Availability of preoperative clinical data
- •Willingness to comply with follow-up visits and data collection
- •Eligibility for robotic surgery
排除标准
- •Unsuitability for anesthesia
- •Cognitive or psychiatric disorders affecting consent or compliance
结局指标
主要结局
Perioperative complication rate
时间窗: Within 30 days post-surgery
The complication rate will be evaluated using the Clavien-Dindo classification, tracking complications during the perioperative period (30 days after surgery).
Conversion rate of SP robotic surgery
时间窗: Surgery through 30 postoperative days
Feasibility of performing urologic surgeries using the Da Vinci SP system will be evaluated in terms of conversion rate to multiport surgeries or open approach
次要结局
- Surgical margins(Up to 60 months)
- BCR(Up to 60 months)
- CSM(Up to 60 months)
- OM(Up to 60 months)
- Continence recovery(3 to 60 months post-surgery)
- Potency(3 to 60 months post-surgery)
- Renal Function(3 to 60 months post-surgery)
- Exploratory Endpoints (Comparison to Da Vinci Xi System)(End-of-study analysis (60 months))