Simulated Surgery Rehearsal (MIPN)

Study Overview
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Brief Summary
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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.

Official Title
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Patient-specific Simulated Procedure Rehearsal for Minimally Invasive Surgery

Conditions
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Nephrectomy

Intervention / Treatment
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* Other: Physical reality simulation
* Other: Virtual reality simulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Physical reality simulation (rehearsal)<br>Using 3-D printing and polymer technology, the investigators will construct patient specific simulated hydrogel models designed from patients' imaging, incorporating the necessary anatomy, physiology and pathology specific to each patient. Participants with patients assigned to preoperative rehearsal will undergo pre-operative simulation only once. | Other: Physical reality simulation<br>* Using 3-D printing and polymer technology, the investigators will construct patient specific simulated hydrogel models designed from patients' imaging, incorporating the necessary anatomy, physiology and pathology specific to each patient. These models are constructed at the Laboratory for Simulation-based Translational Research at the Department of Urology. Group 1 urologists will rehearse the minimally-invasive partial nephrectomy (MIPN) surgery using these patient-specific models.<br>|
| Virtual reality simulation<br>The DaVinci surgical skills simulator (DVSSS) uses a virtual reality surgical simulation platform that encompasses a variety of basic exercises specifically designed to give users the opportunity to improve their proficiency with the da Vinci surgeon console controls and basic robotic surgical skills. Participants with patients assigned to preoperative simulation will complete a refresher module on the Virtual reality simulator. | Other: Virtual reality simulation<br>* The DaVinci surgical skills simulator system uses a virtual reality surgical simulation platform that encompasses a variety of basic exercises specifically designed to give users the opportunity to improve their proficiency with the da Vinci surgeon console controls and basic robotic surgical skills. All urologists have already completed a basic robotic skills curriculum. Group 2 urologists will complete a refresher module on the virtual reality simulator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Warm ischemia time measured during minimal invasive partial nephrectomy 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. | At the end of each surgical procedure, approximately 24 hours after surgery | 
| Estimated blood loss measured during minimal invasive partial nephrectomy 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. | At the end of each surgical procedure, approximately 24 hours after surgery | 
| Change in postoperative renal functions | 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. | Zero at date of randomization and serial measurements at 12 hours , 1 day and 30 days after surgery | 
| Surgical complications | Intraoperative and postoperative complications will be measured and reported using the modified Clavien-Dindo classification of surgical complications (Grade 1 to 5). | From date of surgery up to 30 days postoperative, every complication encountered during that time will be recorded | 
| Objective evaluation of surgical performance | 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 | At the end of each surgical procedure, approximately 24 hours after surgery | 
| Operative time measured during minimal invasive partial nephrectomy surgery | Operative time is reported on completion of minimal invasive partial | At the end of each surgical procedure, approximately 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive margins of the tumor specimen | On pathological examination the presence or absence (+/-) and length in millimeters (mm) will be measured | 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) | The difference between preoperative (within a week prior to surgery) and postoperative (12 and 24 hours after surgery) using the blood test HCT. | Zero at date of randomization and serial measurements at 12 and 24 hours after surgery | 
| Hospital stay | The length of hospital stay will be measured from time of admission to day of discharge and will be reported in days | From date of admission up to 30 days after surgery | 
| Hospital readmission | The readmission rates of patients enrolled in the study will be measured and reported in number of patients | From date of surgery up to 30 days postoperative, every hospital readmission encountered during that time will be recorded |