Simulated Rehearsal for Percutaneous Nephrolithotomy



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:11/17/2018
Start Date:April 10, 2018
End Date:January 31, 2022
Contact:Ahmed Ghazi, MD
Email:ahmed_ghazi@urmc.rochester.edu
Phone:585-424-6492

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Comparative Effectiveness of Patient-Specific Simulated Rehearsal for Percutaneous Nephrolithotomy (PCNL)

Surgical simulation provides opportunities for surgeons to practice specific skills, prior to
performing complex tasks on patients, with the goal of reducing potential errors and
providing a safer procedure for the patient. The investigators will use a novel approach to
simulation (patient-specific rehearsals) i.e., practice a short time prior to the live event
that uses gel models of organs created by a 3D printer, and that are specific to each patient
versus models that represent an ideal training model. The investigators' overarching goals
are to improve patient outcomes by developing the best platform for surgeons to efficiently
enhance performance prior to live surgery.

Surgical simulation provides opportunities for both medical residents and expert surgeons to
practice specific skills, prior to performing complex tasks on patients, with the goal of
reducing potential errors and providing a safer procedure for the patient. Most studies have
addressed surgical simulation carried out in dry and animation laboratories at a
significantly different time than the actual surgery on patients. For most
surgeons-in-training, there is no intermediate stage between practice and performance.
Learning takes place in isolation, and surgeons do not routinely experience how dexterity
skills are affected by context until they perform an actual operation. The investigators will
use a unique approach to simulation (just-in-time simulation i.e., practicing in close
proximity to live surgery). The investigators believe that this approach will be most
beneficial for highly technical procedures such as Percutaneous Nephrolithotomy (PCNL),
because this approach could familiarize the surgeon with the case, enable them to try
different approaches, identify potential dangers, and even optimize the selection of tools
for the procedure. This type of simulation is usually performed using idealized or generic
models that can improve a surgeon's technical, cognitive, and hand - eye coordination
performance, of this specific procedure prior to the live surgery but is not personalized for
an individual patient.

The investigators' efforts at the Simulation Innovation Laboratory (SIL) at the University of
Rochester in combining 3D printing technology with polymer research has provided a platform
for reproducing patient specific water-based gel models with accurate portrayal of anatomical
characteristics including individual patient variations, but also with the capacity to
reproduce tissue characteristics and replicate the comprehensive operative experience.
Patient specific simulations, however, allow surgeons to practice, plan and address potential
problems related to a specific patient's surgery before performing the actual surgery. The
investigators developed three-dimensional (3D) models, which reproduce patient-specific
anatomy and tissue characteristics, allowing for a rehearsal that is an accurate
representation of an actual procedure to be done, in this case Percutaneous Nephrolithotomy
for the treatment of complex renal stones.

In the present era of simulation, no standard form of simulation exists that is performed
directly prior to the live surgery, nor is there any form of personalized simulation for each
patient. In this study the investigators aim to compare just-in-time simulation using either
patient-specific or idealized training models and compare their impact on operative
performance following Percutaneous Nephrolithotomy (PCNL). Secondary objectives are to assess
their impact on patient outcomes following PCNL. The investigators overarching goals are to
improve patient outcomes by developing the best platform for surgeons to efficiently enhance
their performance prior to live surgery.

Inclusion Criteria:

- All patients scheduled to undergo PCNL 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
We found this trial at
1
site
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Phone: 585-424-6491
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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