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Completed

NCT Number: NCT03155295

Simulated Surgery Rehearsal (MIPN)

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.

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Key information

Conditions

Nephrectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Warm ischemia time measured during minimal invasive partial nephrectomy surgery

    Time frame: 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.

  2. Estimated blood loss measured during minimal invasive partial nephrectomy surgery

    Time frame: 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.

  3. Change in postoperative renal functions

    Time frame: 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.

  4. Surgical complications

    Time frame: 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).

  5. Objective evaluation of surgical performance

    Time frame: 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

  6. Operative time measured during minimal invasive partial nephrectomy surgery

    Time frame: At the end of each surgical procedure, approximately 24 hours after surgery

    Operative time is reported on completion of minimal invasive partial

Secondary outcomes

  1. Positive margins of the tumor specimen

    Time frame: 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

  2. Change in the volume of ratio of red blood cells to total blood volume (HCT)

    Time frame: 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.

  3. Hospital stay

    Time frame: 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

  4. Hospital readmission

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Patient-specific Simulated Procedure Rehearsal for Minimally Invasive Surgery

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
May 16, 2017
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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