Simulated Rehearsal for Percutaneous Nephrolithotomy

NCT ID: NCT03272529

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-10
• Study Completion Date: 2023-01-31

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.

Detailed Description

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.

Conditions

Nephrolithotomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Patient-specific simulated rehearsals

Intervention Type: 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.

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.

Idealized simulated rehearsals

Intervention Type: 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.

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.

Standard simulation

Intervention Type: 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.

Interventions

Patient-specific simulated rehearsals

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.

Intervention Type: OTHER

Idealized simulated rehearsals

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.

Intervention Type: OTHER

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 participants of this group in addition to the standard.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Ghazi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Ghazi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

68871

Identifier Type: -

Identifier Source: org_study_id