Simulated Rehearsal for Percutaneous Nephrolithotomy

NCT03272529 | Completed

• 1 other identifier: 68871
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nephrolithotomy

Outcome Measures

Primary Outcomes (6)

• Fluoroscopy time measured during percutaneous nephrolithotomy (PCNL)

  Fluoroscopy time is reported on completion of PCNL, the metric will be measured in minutes as a continuous variable.

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

• Percutaneous access (PCA) attempts

  PCA attempts is reported on completion of the PCNL, the metric will be measured in number of attempts as a continuous variable.

  At the end of each surgical procedure, approximately 24 hours 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 (Virtual percutaneous nephrostolithotomy GRS)

  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.

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

• Surgeon take-over

  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.

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

• Change in the volume of stone before and after PCNL surgery (Stone clearance)

  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).

  Zero at date of randomization and serial measurements at 1 and up to 30 days after surgery

Secondary Outcomes (6)

• 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

• Blood transfusion

  From date of randomization up to 30 days after surgery every unit of blood transfused during that time will be recorded

• Change in postoperative renal functions

  Zero at date of randomization and serial measurements at 12 hours , 1 day and 30 days after surgery

Study Arms (3)

Patient-specific simulated rehearsals

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.

Other: Patient-specific simulated rehearsals

Idealized simulated rehearsals

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.

Other: Idealized simulated rehearsals

Standard simulation

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.

Other: Standard simulation

Interventions

Patient-specific simulated rehearsals OTHER

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.

Patient-specific simulated rehearsals

Idealized simulated rehearsals OTHER

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.

Idealized simulated rehearsals

Standard simulation OTHER

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.

Standard 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 PCNL patients, 2 faculty expert urologists, and 12 urology trainees selected from years PGY3 and above.

You may qualify if:

• 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

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: August 22, 2017
• First Posted: September 5, 2017
• Study Start: April 10, 2018
• 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)