Simulated Surgery Rehearsal (MIPN)

Patient-specific Simulated Procedure Rehearsal for Minimally Invasive Surgery

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.

Study Overview

• Status: Completed
• Conditions: Nephrectomy
• Intervention / Treatment: Other: Physical reality simulation; Other: Virtual reality simulation

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population is comprised of 100 minimally invasive partial nephrectomy (MIPN) patients), 5 faculty expert urologists, and 5 trainees including four urology residents and one endourology fellow.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Physical reality simulation (rehearsal); 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; 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.
Virtual reality simulation; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Ahmed Ghazi, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 12, 2017
• Primary Completion (ACTUAL): January 31, 2023
• Study Completion (ACTUAL): January 31, 2023

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (ACTUAL): May 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 67280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No