NephrolithotomyPCNLNCT03272529
Simulated Rehearsal for Percutaneous Nephrolithotomy
An observational study of Nephrolithotomy, run by University of Rochester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithotomy
- What is being tested?
- Patient-specific simulated rehearsals, Idealized simulated rehearsals and Standard simulation
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2018to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population is comprised of 100 PCNL patients, 2 faculty expert urologists, and 12 urology trainees selected from years PGY3 and above.
Who may be able to join
- 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
Who cannot join
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: 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.
Read the 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
- Being tested
- Patient-specific simulated rehearsals, Idealized simulated rehearsals, Standard simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-specific simulated rehearsalsOther
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 rehearsalsOther
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 simulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Standard simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
The difference between preoperative (within a week prior to surgery) and postoperative (12 and 24 hours after surgery) using the blood test HCT.
Measured: Zero at date of randomization and serial measurements at 12 and 24 hours after surgery
Hospital stay
The length of hospital stay will be measured from time of admission to day of discharge and will be reported in days
Measured: From date of admission up to 30 days after surgery
Hospital readmission
The readmission rates of patients enrolled in the study will be measured and reported in number of patients
Measured: From date of surgery up to 30 days postoperative, every hospital readmission encountered during that time will be recorded
Blood transfusion
The presence or absence (+/-) and how many units will be measured (blood units)
Measured: 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
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.
Measured: Zero at date of randomization and serial measurements at 12 hours , 1 day and 30 days after surgery
Additional stone procedures
The presence or absence (+/-) and how many additonal procedures to achieve complete stone clearance after the procedure will be measured
Measured: From date of surgery up to 30 days postoperative, every additional procedure performed during that time will be recorded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start10 Apr 2018
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithotomyStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ghazi, University of Rochester
- Investigators
- Ahmed Ghazi, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272529
- Sponsor's protocol ID
- 68871
- Acronym
- PCNL
- Status last verified
- Feb 2023
- First submitted
- 22 Aug 2017
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Patient-Specific Simulated Rehearsal for Percutaneous Nephrolithotomy (PCNL)
- ClinicalTrials.gov ID
- NCT03272529
- Acronym / sponsor ID
- PCNL / 68871
- Conditions
- Nephrolithotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient-specific simulated rehearsals | – | Other: Patient-specific simulated rehearsalsParticipants 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. |
| Idealized simulated rehearsals | – | Other: Idealized simulated rehearsalsParticipants 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. |
| Standard simulation | – | Other: Standard simulationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is comprised of 100 PCNL patients, 2 faculty expert urologists, and 12 urology trainees selected from years PGY3 and above.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-specific simulated rehearsalsUsing 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. | Other | Patient-specific simulated rehearsals |
| Idealized simulated rehearsalsUsing 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. | Other | Idealized simulated rehearsals |
| Standard simulationParticipants 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. | Other | Standard simulation |
Primary outcome
Fluoroscopy time measured during percutaneous nephrolithotomy (PCNL)
Time frame: At the end of each surgical procedure, approximately 24 hours after surgery
Fluoroscopy time is reported on completion of PCNL, the metric will be measured in minutes as a continuous variable.
Percutaneous access (PCA) attempts
Time frame: At the end of each surgical procedure, approximately 24 hours after surgery
PCA attempts is reported on completion of the PCNL, the metric will be measured in number of attempts as a continuous variable.
Surgical complications
Time frame: From date of surgery up to 30 days postoperative, every complication encountered during that time will be recorded
Intraoperative and postoperative complications will be measured and reported using the modified Clavien-Dindo classification of surgical complications (Grade 1 to 5).
Objective evaluation of surgical performance (Virtual percutaneous nephrostolithotomy GRS)
Time frame: At the end of each surgical procedure, approximately 24 hours after surgery
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.
Surgeon take-over
Time frame: At the end of each surgical procedure, approximately 24 hours after surgery
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.
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
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).
6 secondary outcomes
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
Hospital stay
Time frame: From date of admission up to 30 days after surgery
Hospital readmission
Time frame: From date of surgery up to 30 days postoperative, every hospital readmission encountered during that time will be recorded
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
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
Additional stone procedures
Time frame: From date of surgery up to 30 days postoperative, every additional procedure performed during that time will be recorded
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Ghazi, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrolithotomy, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluoroscopy time measured during percutaneous nephrolithotomy (PCNL) (time frame: At the end of each surgical procedure, approximately 24 hours after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.