Patient-specific Simulated Procedure Rehearsal for Minimally Invasive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Estimated blood loss measured during minimal invasive partial nephrectomy surgery
研究概览
简要总结
The purpose of the study is to evaluate patient-specific surgical simulation by permitting pre-operative rehearsals, in the form of the surgeon completing a dry run of the procedure on a model constructed from the patient's radiological studies that replicates every aspect of their organs. The investigators' aim is to evaluate the effectiveness of this form of practice in optimizing intraoperative and postoperative outcomes . The investigators hope eventually to use these rehearsals as a standard study tool for surgical training.
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
- •All patients scheduled to undergo MIPN surgery at the University of Rochester Medical Center
- •Ability to give informed consent
- •Willing to participate in the study
- •Any racial or ethnic origin
排除标准
- •Inability to give informed consent
结局指标
主要结局
Estimated blood loss measured during minimal invasive partial nephrectomy surgery
时间窗: At the end of each surgical procedure, approximately 24 hours after surgery
Estimated blood loss is reported on completion of minimal invasive partial nephrectomy surgery, it is estimated by the volume of fluid in the suction irrigation at the end of surgery and measured in ml as a continuous variable.
Operative time measured during minimal invasive partial nephrectomy surgery
时间窗: At the end of each surgical procedure, approximately 24 hours after surgery
Operative time is reported on completion of minimal invasive partial
Change in postoperative renal functions
时间窗: Zero at date of randomization and serial measurements at 12 hours , 1 day and 30 days after surgery
The difference between preoperative (within a week prior to surgery) and postoperative (12 hours , 1 day and 30 days after surgery) using estimated GFR measured through serum creatinine blood test.
Warm ischemia time measured during minimal invasive partial nephrectomy surgery
时间窗: At the end of each surgical procedure, approximately 24 hours after surgery
Warm ischemia time is reported on completion of minimal invasive partial nephrectomy surgery, the metric will be measured in minutes as a continuous variable.
Surgical complications
时间窗: From date of surgery up to 30 days postoperative, every complication encountered during that time will be recorded
Intraoperative and postoperative complications will be measured and reported using the modified Clavien-Dindo classification of surgical complications (Grade 1 to 5).
Objective evaluation of surgical performance
时间窗: At the end of each surgical procedure, approximately 24 hours after surgery
All surgical cases will be recorded and reviewed by a third party online tool that specializes in evaluation of surgical performance using the GEARS (Global Evaluative Assessment of Robotic Skills) tool
次要结局
- Positive margins of the tumor specimen(From date of randomization up to 10 days after surgery)
- Change in the volume of ratio of red blood cells to total blood volume (HCT)(Zero at date of randomization and serial measurements at 12 and 24 hours after surgery)
- Hospital readmission(From date of surgery up to 30 days postoperative, every hospital readmission encountered during that time will be recorded)
- Hospital stay(From date of admission up to 30 days after surgery)
研究者
Ahmed Ghazi
Assistant Professor
University of Rochester