Simulated Surgery Rehearsal (MIPN)

Completed

• Conditions: Nephrectomy
• Interventions: Other: Virtual reality simulation; Other: Physical reality simulation

• Registration Number: NCT03155295
• Lead Sponsor: University of Rochester

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-16
• Study Start: 2017-10-12
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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Exclusion Criteria

• Inability to give informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Virtual reality simulation	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.
Physical reality simulation (rehearsal)	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. Participants with patients assigned to preoperative rehearsal will undergo pre-operative simulation only once.

Primary Outcome Measures

Name	Time	Method
Estimated blood loss measured during minimal invasive partial nephrectomy surgery	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	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	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	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	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	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

Secondary Outcome Measures

Name	Time	Method
Positive margins of the tumor specimen	From date of randomization up to 10 days after surgery	On pathological examination the presence or absence (+/-) and length in millimeters (mm) will be measured
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	The difference between preoperative (within a week prior to surgery) and postoperative (12 and 24 hours after surgery) using the blood test HCT.
Hospital readmission	From date of surgery up to 30 days postoperative, every hospital readmission encountered during that time will be recorded	The readmission rates of patients enrolled in the study will be measured and reported in number of patients
Hospital stay	From date of admission up to 30 days after surgery	The length of hospital stay will be measured from time of admission to day of discharge and will be reported in days

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States