Comparative Effectiveness of Patient-Specific Simulated Rehearsal for Percutaneous Nephrolithotomy (PCNL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Surgeon take-over
研究概览
简要总结
Surgical simulation provides opportunities for surgeons to practice specific skills, prior to performing complex tasks on patients, with the goal of reducing potential errors and providing a safer procedure for the patient. The investigators will use a novel approach to simulation (patient-specific rehearsals) i.e., practice a short time prior to the live event that uses gel models of organs created by a 3D printer, and that are specific to each patient versus models that represent an ideal training model. The investigators' overarching goals are to improve patient outcomes by developing the best platform for surgeons to efficiently enhance performance prior to live surgery.
详细描述
Surgical simulation provides opportunities for both medical residents and expert surgeons to practice specific skills, prior to performing complex tasks on patients, with the goal of reducing potential errors and providing a safer procedure for the patient. Most studies have addressed surgical simulation carried out in dry and animation laboratories at a significantly different time than the actual surgery on patients. For most surgeons-in-training, there is no intermediate stage between practice and performance. Learning takes place in isolation, and surgeons do not routinely experience how dexterity skills are affected by context until they perform an actual operation. The investigators will use a unique approach to simulation (just-in-time simulation i.e., practicing in close proximity to live surgery). The investigators believe that this approach will be most beneficial for highly technical procedures such as Percutaneous Nephrolithotomy (PCNL), because this approach could familiarize the surgeon with the case, enable them to try different approaches, identify potential dangers, and even optimize the selection of tools for the procedure. This type of simulation is usually performed using idealized or generic models that can improve a surgeon's technical, cognitive, and hand - eye coordination performance, of this specific procedure prior to the live surgery but is not personalized for an individual patient.
The investigators' efforts at the Simulation Innovation Laboratory (SIL) at the University of Rochester in combining 3D printing technology with polymer research has provided a platform for reproducing patient specific water-based gel models with accurate portrayal of anatomical characteristics including individual patient variations, but also with the capacity to reproduce tissue characteristics and replicate the comprehensive operative experience. Patient specific simulations, however, allow surgeons to practice, plan and address potential problems related to a specific patient's surgery before performing the actual surgery. The investigators developed three-dimensional (3D) models, which reproduce patient-specific anatomy and tissue characteristics, allowing for a rehearsal that is an accurate representation of an actual procedure to be done, in this case Percutaneous Nephrolithotomy for the treatment of complex renal stones.
In the present era of simulation, no standard form of simulation exists that is performed directly prior to the live surgery, nor is there any form of personalized simulation for each patient. In this study the investigators aim to compare just-in-time simulation using either patient-specific or idealized training models and compare their impact on operative performance following Percutaneous Nephrolithotomy (PCNL). Secondary objectives are to assess their impact on patient outcomes following PCNL. The investigators overarching goals are to improve patient outcomes by developing the best platform for surgeons to efficiently enhance their performance prior to live surgery.
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 PCNL 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
Surgeon take-over
时间窗: At the end of each surgical procedure, approximately 24 hours after surgery
Surgeon take-over is reported on completion of the PCNL; the metric will be measured as a nominal variable (yes or no) when the surgeon in the operating room takes over the case.
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).
Change in the volume of stone before and after PCNL surgery (Stone clearance)
时间窗: Zero at date of randomization and serial measurements at 1 and up to 30 days after surgery
The difference between preoperative (within a month prior to surgery) and postoperative (1-30 days after surgery) in millimeters using imaging techniques (KUB, Ultrasound and CT-IVP).
Percutaneous access (PCA) attempts
时间窗: At the end of each surgical procedure, approximately 24 hours after surgery
PCA attempts is reported on completion of the PCNL, the metric will be measured in number of attempts as a continuous variable.
Objective evaluation of surgical performance (Virtual percutaneous nephrostolithotomy GRS)
时间窗: At the end of each surgical procedure, approximately 24 hours after surgery
All surgical cases will be recorded and reviewed by expert surgeons using a tool that specializes in evaluation of PCNL surgical performance, the Virtual percutaneous nephrostolithotomy GRS (a validated assessment of percutaneous Nephrolithotomy using a 5-point Likert-type scale, of 5 domains including knowledge of renal anatomy, trajectory planning, instrument use, need for instructor assistance and overall task performance), these will be measured as a continuous variable.
Fluoroscopy time measured during percutaneous nephrolithotomy (PCNL)
时间窗: At the end of each surgical procedure, approximately 24 hours after surgery
Fluoroscopy time is reported on completion of PCNL, the metric will be measured in minutes as a continuous variable.
次要结局
- Additional stone procedures(From date of surgery up to 30 days postoperative, every additional procedure performed during that time will be recorded)
- 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)
- Change in postoperative renal functions(Zero at date of randomization and serial measurements at 12 hours , 1 day and 30 days after surgery)
- Blood transfusion(From date of randomization up to 30 days after surgery every unit of blood transfused during that time will be recorded)
研究者
Ahmed Ghazi
Assistant Professor
University of Rochester
