<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03272529</url>
  </required_header>
  <id_info>
    <org_study_id>68871</org_study_id>
    <nct_id>NCT03272529</nct_id>
  </id_info>
  <brief_title>Simulated Rehearsal for Percutaneous Nephrolithotomy</brief_title>
  <acronym>PCNL</acronym>
  <official_title>Comparative Effectiveness of Patient-Specific Simulated Rehearsal for Percutaneous Nephrolithotomy (PCNL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgical simulation provides opportunities for surgeons to practice specific skills, prior to&#xD;
      performing complex tasks on patients, with the goal of reducing potential errors and&#xD;
      providing a safer procedure for the patient. The investigators will use a novel approach to&#xD;
      simulation (patient-specific rehearsals) i.e., practice a short time prior to the live event&#xD;
      that uses gel models of organs created by a 3D printer, and that are specific to each patient&#xD;
      versus models that represent an ideal training model. The investigators' overarching goals&#xD;
      are to improve patient outcomes by developing the best platform for surgeons to efficiently&#xD;
      enhance performance prior to live surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical simulation provides opportunities for both medical residents and expert surgeons to&#xD;
      practice specific skills, prior to performing complex tasks on patients, with the goal of&#xD;
      reducing potential errors and providing a safer procedure for the patient. Most studies have&#xD;
      addressed surgical simulation carried out in dry and animation laboratories at a&#xD;
      significantly different time than the actual surgery on patients. For most&#xD;
      surgeons-in-training, there is no intermediate stage between practice and performance.&#xD;
      Learning takes place in isolation, and surgeons do not routinely experience how dexterity&#xD;
      skills are affected by context until they perform an actual operation. The investigators will&#xD;
      use a unique approach to simulation (just-in-time simulation i.e., practicing in close&#xD;
      proximity to live surgery). The investigators believe that this approach will be most&#xD;
      beneficial for highly technical procedures such as Percutaneous Nephrolithotomy (PCNL),&#xD;
      because this approach could familiarize the surgeon with the case, enable them to try&#xD;
      different approaches, identify potential dangers, and even optimize the selection of tools&#xD;
      for the procedure. This type of simulation is usually performed using idealized or generic&#xD;
      models that can improve a surgeon's technical, cognitive, and hand - eye coordination&#xD;
      performance, of this specific procedure prior to the live surgery but is not personalized for&#xD;
      an individual patient.&#xD;
&#xD;
      The investigators' efforts at the Simulation Innovation Laboratory (SIL) at the University of&#xD;
      Rochester in combining 3D printing technology with polymer research has provided a platform&#xD;
      for reproducing patient specific water-based gel models with accurate portrayal of anatomical&#xD;
      characteristics including individual patient variations, but also with the capacity to&#xD;
      reproduce tissue characteristics and replicate the comprehensive operative experience.&#xD;
      Patient specific simulations, however, allow surgeons to practice, plan and address potential&#xD;
      problems related to a specific patient's surgery before performing the actual surgery. The&#xD;
      investigators developed three-dimensional (3D) models, which reproduce patient-specific&#xD;
      anatomy and tissue characteristics, allowing for a rehearsal that is an accurate&#xD;
      representation of an actual procedure to be done, in this case Percutaneous Nephrolithotomy&#xD;
      for the treatment of complex renal stones.&#xD;
&#xD;
      In the present era of simulation, no standard form of simulation exists that is performed&#xD;
      directly prior to the live surgery, nor is there any form of personalized simulation for each&#xD;
      patient. In this study the investigators aim to compare just-in-time simulation using either&#xD;
      patient-specific or idealized training models and compare their impact on operative&#xD;
      performance following Percutaneous Nephrolithotomy (PCNL). Secondary objectives are to assess&#xD;
      their impact on patient outcomes following PCNL. The investigators overarching goals are to&#xD;
      improve patient outcomes by developing the best platform for surgeons to efficiently enhance&#xD;
      their performance prior to live surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2018</start_date>
  <completion_date type="Actual">January 31, 2023</completion_date>
  <primary_completion_date type="Actual">January 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Fluoroscopy time measured during percutaneous nephrolithotomy (PCNL)</measure>
    <time_frame>At the end of each surgical procedure, approximately 24 hours after surgery</time_frame>
    <description>Fluoroscopy time is reported on completion of PCNL, the metric will be measured in minutes as a continuous variable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percutaneous access (PCA) attempts</measure>
    <time_frame>At the end of each surgical procedure, approximately 24 hours after surgery</time_frame>
    <description>PCA attempts is reported on completion of the PCNL, the metric will be measured in number of attempts as a continuous variable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgical complications</measure>
    <time_frame>From date of surgery up to 30 days postoperative, every complication encountered during that time will be recorded</time_frame>
    <description>Intraoperative and postoperative complications will be measured and reported using the modified Clavien-Dindo classification of surgical complications (Grade 1 to 5).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective evaluation of surgical performance (Virtual percutaneous nephrostolithotomy GRS)</measure>
    <time_frame>At the end of each surgical procedure, approximately 24 hours after surgery</time_frame>
    <description>All surgical cases will be recorded and reviewed by expert surgeons using a tool that specializes in evaluation of PCNL surgical performance, the Virtual percutaneous nephrostolithotomy GRS (a validated assessment of percutaneous Nephrolithotomy using a 5-point Likert-type scale, of 5 domains including knowledge of renal anatomy, trajectory planning, instrument use, need for instructor assistance and overall task performance), these will be measured as a continuous variable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgeon take-over</measure>
    <time_frame>At the end of each surgical procedure, approximately 24 hours after surgery</time_frame>
    <description>Surgeon take-over is reported on completion of the PCNL; the metric will be measured as a nominal variable (yes or no) when the surgeon in the operating room takes over the case.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the volume of stone before and after PCNL surgery (Stone clearance)</measure>
    <time_frame>Zero at date of randomization and serial measurements at 1 and up to 30 days after surgery</time_frame>
    <description>The difference between preoperative (within a month prior to surgery) and postoperative (1-30 days after surgery) in millimeters using imaging techniques (KUB, Ultrasound and CT-IVP).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the volume of ratio of red blood cells to total blood volume (HCT)</measure>
    <time_frame>Zero at date of randomization and serial measurements at 12 and 24 hours after surgery</time_frame>
    <description>The difference between preoperative (within a week prior to surgery) and postoperative (12 and 24 hours after surgery) using the blood test HCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>From date of admission up to 30 days after surgery</time_frame>
    <description>The length of hospital stay will be measured from time of admission to day of discharge and will be reported in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital readmission</measure>
    <time_frame>From date of surgery up to 30 days postoperative, every hospital readmission encountered during that time will be recorded</time_frame>
    <description>The readmission rates of patients enrolled in the study will be measured and reported in number of patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood transfusion</measure>
    <time_frame>From date of randomization up to 30 days after surgery every unit of blood transfused during that time will be recorded</time_frame>
    <description>The presence or absence (+/-) and how many units will be measured (blood units)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in postoperative renal functions</measure>
    <time_frame>Zero at date of randomization and serial measurements at 12 hours , 1 day and 30 days after surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional stone procedures</measure>
    <time_frame>From date of surgery up to 30 days postoperative, every additional procedure performed during that time will be recorded</time_frame>
    <description>The presence or absence (+/-) and how many additonal procedures to achieve complete stone clearance after the procedure will be measured</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">36</enrollment>
  <condition>Nephrolithotomy</condition>
  <arm_group>
    <arm_group_label>Patient-specific simulated rehearsals</arm_group_label>
    <description>Participants recruited to this cohort will complete just-in-time simulation, i.e., practice a short time prior to the live event using hydrogel models designed from patients' imaging, incorporating the necessary anatomy, physiology, and pathology specific to each patient. This is in addition to standard prerequisite simulation training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Idealized simulated rehearsals</arm_group_label>
    <description>Participants recruited to this cohort will complete just-in-time simulation, i.e., practice a short time prior to the live event using hydrogel models that incorporate the necessary anatomy, physiology, and pathology of an ideal training case. This is in addition to standard prerequisite simulation training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard simulation</arm_group_label>
    <description>Participants recruited to this cohort will only have completed the standard prerequisite simulation training similar to the two other groups (didactic lecture, hands-on simulation training to proficiency and live case observation), that represents the current standard of care. No further simulation would be conducted in this group in addition to the standard.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient-specific simulated rehearsals</intervention_name>
    <description>Using 3-D printing and polymer technology, the investigators' team will construct patient-specific simulated hydrogel models designed from patients' imaging, incorporating the necessary anatomy, physiology, and pathology specific to each patient. These models will be constructed at the Simulation Innovation laboratory within the Department of Urology, University of Rochester. The process involves importing DICOM files of patient participants C.T. scans into 3D processing software, creating virtual models of kidney parenchyma incorporating the kidney, urinary system, stone and abdominal wall. Surgical phantoms are then created using 3D printing and polymer hydrogels, to recreate the entire procedure.</description>
    <arm_group_label>Patient-specific simulated rehearsals</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Idealized simulated rehearsals</intervention_name>
    <description>Using 3D printing and polymer technology, the investigators' team will construct a validated generic simulated hydrogel model with a complex kidney stone, incorporating the necessary anatomy, physiology and pathology. These models will be constructed at the Simulation Innovation laboratory within the department of urology at the University of Rochester. Generic models incorporating the kidney, PCS, staghorn stone, abdominal wall, and other relevant anatomical elements (bowel, perinephric fat, solid organs and bony structures) will be constructed. Participants in his group will complete the simulation replicating all steps of the procedure of this ideal training case that is not specific to a particular patient.</description>
    <arm_group_label>Idealized simulated rehearsals</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard simulation</intervention_name>
    <description>Participants recruited to this cohort will only have completed the standard prerequisite simulation training similar to the two other groups (didactic lecture, hands-on simulation training to proficiency and live case observation), that represents the current standard of care. No further simulation would be conducted in participants of this group in addition to the standard.</description>
    <arm_group_label>Standard simulation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population is comprised of 100 PCNL patients, 2 faculty expert urologists, and 12&#xD;
        urology trainees selected from years PGY3 and above.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients scheduled to undergo PCNL surgery at the University of Rochester Medical&#xD;
             Center&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Willing to participate in the study&#xD;
&#xD;
          -  Any racial or ethnic origin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Ghazi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Ahmed Ghazi</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03272529
org study id: 68871
nct id: NCT03272529
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Prospective
measure: Fluoroscopy time measured during percutaneous nephrolithotomy (PCNL)
time frame: At the end of each surgical procedure, approximately 24 hours after surgery
description: Fluoroscopy time is reported on completion of PCNL, the metric will be measured in minutes as a continuous variable.
measure: Percutaneous access (PCA) attempts
time frame: At the end of each surgical procedure, approximately 24 hours after surgery
description: PCA attempts is reported on completion of the PCNL, the metric will be measured in number of attempts as a continuous variable.
measure: Surgical complications
time frame: From date of surgery up to 30 days postoperative, every complication encountered during that time will be recorded
description: Intraoperative and postoperative complications will be measured and reported using the modified Clavien-Dindo classification of surgical complications (Grade 1 to 5).
measure: Objective evaluation of surgical performance (Virtual percutaneous nephrostolithotomy GRS)
time frame: At the end of each surgical procedure, approximately 24 hours after surgery
description: All surgical cases will be recorded and reviewed by expert surgeons using a tool that specializes in evaluation of PCNL surgical performance, the Virtual percutaneous nephrostolithotomy GRS (a validated assessment of percutaneous Nephrolithotomy using a 5-point Likert-type scale, of 5 domains including knowledge of renal anatomy, trajectory planning, instrument use, need for instructor assistance and overall task performance), these will be measured as a continuous variable.
measure: Surgeon take-over
time frame: At the end of each surgical procedure, approximately 24 hours after surgery
description: Surgeon take-over is reported on completion of the PCNL; the metric will be measured as a nominal variable (yes or no) when the surgeon in the operating room takes over the case.
measure: Change in the volume of stone before and after PCNL surgery (Stone clearance)
time frame: Zero at date of randomization and serial measurements at 1 and up to 30 days after surgery
description: The difference between preoperative (within a month prior to surgery) and postoperative (1-30 days after surgery) in millimeters using imaging techniques (KUB, Ultrasound and CT-IVP).
measure: 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
description: The difference between preoperative (within a week prior to surgery) and postoperative (12 and 24 hours after surgery) using the blood test HCT.
measure: Hospital stay
time frame: From date of admission up to 30 days after surgery
description: The length of hospital stay will be measured from time of admission to day of discharge and will be reported in days
measure: Hospital readmission
time frame: From date of surgery up to 30 days postoperative, every hospital readmission encountered during that time will be recorded
description: The readmission rates of patients enrolled in the study will be measured and reported in number of patients
measure: Blood transfusion
time frame: From date of randomization up to 30 days after surgery every unit of blood transfused during that time will be recorded
description: The presence or absence (+/-) and how many units will be measured (blood units)
measure: 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
description: 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.
measure: Additional stone procedures
time frame: From date of surgery up to 30 days postoperative, every additional procedure performed during that time will be recorded
description: The presence or absence (+/-) and how many additonal procedures to achieve complete stone clearance after the procedure will be measured
arm group label: Patient-specific simulated rehearsals
description: Participants recruited to this cohort will complete just-in-time simulation, i.e., practice a short time prior to the live event using hydrogel models designed from patients' imaging, incorporating the necessary anatomy, physiology, and pathology specific to each patient. This is in addition to standard prerequisite simulation training.
arm group label: Idealized simulated rehearsals
description: Participants recruited to this cohort will complete just-in-time simulation, i.e., practice a short time prior to the live event using hydrogel models that incorporate the necessary anatomy, physiology, and pathology of an ideal training case. This is in addition to standard prerequisite simulation training.
arm group label: Standard simulation
description: Participants recruited to this cohort will only have completed the standard prerequisite simulation training similar to the two other groups (didactic lecture, hands-on simulation training to proficiency and live case observation), that represents the current standard of care. No further simulation would be conducted in this group in addition to the standard.
intervention type: Other
intervention name: Patient-specific simulated rehearsals
description: Using 3-D printing and polymer technology, the investigators' team will construct patient-specific simulated hydrogel models designed from patients' imaging, incorporating the necessary anatomy, physiology, and pathology specific to each patient. These models will be constructed at the Simulation Innovation laboratory within the Department of Urology, University of Rochester. The process involves importing DICOM files of patient participants C.T. scans into 3D processing software, creating virtual models of kidney parenchyma incorporating the kidney, urinary system, stone and abdominal wall. Surgical phantoms are then created using 3D printing and polymer hydrogels, to recreate the entire procedure.
arm group label: Patient-specific simulated rehearsals
intervention type: Other
intervention name: Idealized simulated rehearsals
description: Using 3D printing and polymer technology, the investigators' team will construct a validated generic simulated hydrogel model with a complex kidney stone, incorporating the necessary anatomy, physiology and pathology. These models will be constructed at the Simulation Innovation laboratory within the department of urology at the University of Rochester. Generic models incorporating the kidney, PCS, staghorn stone, abdominal wall, and other relevant anatomical elements (bowel, perinephric fat, solid organs and bony structures) will be constructed. Participants in his group will complete the simulation replicating all steps of the procedure of this ideal training case that is not specific to a particular patient.
arm group label: Idealized simulated rehearsals
intervention type: Other
intervention name: Standard simulation
description: Participants recruited to this cohort will only have completed the standard prerequisite simulation training similar to the two other groups (didactic lecture, hands-on simulation training to proficiency and live case observation), that represents the current standard of care. No further simulation would be conducted in participants of this group in addition to the standard.
arm group label: Standard simulation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmed Ghazi, MD
role: Principal Investigator
affiliation: University of Rochester
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Ahmed Ghazi
investigator title: Assistant Professor
sharing ipd: No