Simulated Rehearsal for Percutaneous Nephrolithotomy

Nephrolithotomy Clinical Trial

— PCNL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272529
• Other study ID #: 68871
• Status: Completed
• Start date: April 10, 2018
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nephrolithotomy

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change in the volume of ratio of red blood cells to total blood volume (HCT)	The difference between preoperative (within a week prior to surgery) and postoperative (12 and 24 hours after surgery) using the blood test HCT.	Zero at date of randomization and serial measurements at 12 and 24 hours after surgery
Secondary	Hospital stay	The length of hospital stay will be measured from time of admission to day of discharge and will be reported in days	From date of admission up to 30 days after surgery
Secondary	Hospital readmission	The readmission rates of patients enrolled in the study will be measured and reported in number of patients	From date of surgery up to 30 days postoperative, every hospital readmission encountered during that time will be recorded
Secondary	Blood transfusion	The presence or absence (+/-) and how many units will be measured (blood units)	From date of randomization up to 30 days after surgery every unit of blood transfused during that time will be recorded
Secondary	Change in postoperative renal functions	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.	Zero at date of randomization and serial measurements at 12 hours , 1 day and 30 days after surgery
Secondary	Additional stone procedures	The presence or absence (+/-) and how many additonal procedures to achieve complete stone clearance after the procedure will be measured	From date of surgery up to 30 days postoperative, every additional procedure performed during that time will be recorded