Use of the Intuitive Surgical da Vinci® Single-Site™ With Instruments and Accessories for Single-Port Laparoscopic Nephrectomies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Successful Completion of the Surgical Procedure
研究概览
简要总结
Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci instrumentation and Single-Site platforms.
详细描述
Our center has performed over 200 single-port donor nephrectomies with standard laparoscopy and has reported patient benefits associated with a single port approach. The single port robotic platform offers the potential to ameliorate the significant technical and ergonomic challenges that currently limit more widespread application of single port donor surgery. After being informed of the potential risks and off-label use of the da Vinci Single-Site approach in our study, patients will undergo a robotic-assisted single-site donor nephrectomy performed by a two-surgeon team utilizing existing da Vinci instrumentation and Single-Site platforms. Renal mobilization and vascular dissection will be performed with manual laparoscopy performed for vascular division utilizing stapling devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient must be approved by the Living Donor Center.
- •Patient must have compatible blood type with the recipient.
- •Patient must have body mass index less than
- •Patient must have appropriate anatomy for left kidney donation.
排除标准
- •Any patient receiving anticoagulant drugs such as Coumadin or warfin
- •Any patient suffering from an active urinary tract infections
- •Any patients suffering from cancer.
- •Any patients suffering from diabetes.
- •Any patients suffering from kidney disease.
- •Any patients suffering from heart disease.
- •Any patients suffering from liver disease.
- •Any patients suffering from HIV or hepatitis
- •Any patients suffering from previous major abdominal surgery.
- •Any patients suffering from more than two left renal arteries.
结局指标
主要结局
Successful Completion of the Surgical Procedure
时间窗: during operation
The primary objective is to determine the feasibility measure of the current Single-Site platform to perform donor nephrectomy prior to vascular division and extraction. Specifically, it will be recorded which portions of the operation utilized the robotic device. The primary outcome variable is the completion of the operation for kidney donation.
次要结局
- Blood Loss(during operation)
- Operative Times(during operation)
- The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies.(intra-operative experience collected within 24 hours)
研究者
Rolf Barth
Director of Liver Transplantation
University of Maryland, Baltimore