Simulated Surgery Rehearsal (MIPN)

NCT03155295 | Completed

• 1 other identifier: 67280
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrectomy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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 stay

  From date of admission up to 30 days after surgery

• Hospital readmission

  From date of surgery up to 30 days postoperative, every hospital readmission encountered during that time will be recorded

Study Arms (2)

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

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

Interventions

Physical reality simulation OTHER

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.

Physical reality simulation (rehearsal)

Virtual reality simulation OTHER

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.

Virtual reality simulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Inability to give informed consent

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Study Officials

• Ahmed Ghazi, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 16, 2017
• Study Start: October 12, 2017
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)