NephrectomyNCT03155295
Simulated Surgery Rehearsal (MIPN)
An observational study of Nephrectomy, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of the study is to evaluate patient-specific surgical simulation by permitting pre-operative rehearsals, in the form of the surgeon completing a dry run of the procedure on a model constructed from the patient's radiological studies that replicates every aspect of their organs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrectomy
- What is being tested?
- Physical reality simulation and Virtual reality simulation
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2017to 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 minimally invasive partial nephrectomy (MIPN) patients), 5 faculty expert urologists, and 5 trainees including four urology residents and one endourology fellow.
Who may be able to join
- All patients scheduled to undergo MIPN 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: Patient-specific Simulated Procedure Rehearsal for Minimally Invasive Surgery
The purpose of the study is to evaluate patient-specific surgical simulation by permitting pre-operative rehearsals, in the form of the surgeon completing a dry run of the procedure on a model constructed from the patient's radiological studies that replicates every aspect of their organs. The investigators' aim is to evaluate the effectiveness of this form of practice in optimizing intraoperative and postoperative outcomes . The investigators hope eventually to use these rehearsals as a standard study tool for surgical training.
- Conditions
- Nephrectomy
- Being tested
- Physical reality simulation, Virtual reality simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical reality simulationOther
Using 3-D printing and polymer technology, the investigators will construct patient specific simulated hydrogel models designed from patients' imaging, incorporating the necessary anatomy, physiology and pathology specific to each patient. These models are constructed at the Laboratory for Simulation-based Translational Research at the Department of Urology. Group 1 urologists will rehearse the minimally-invasive partial nephrectomy (MIPN) surgery using these patient-specific models.
Virtual reality simulationOther
The DaVinci surgical skills simulator system uses a virtual reality surgical simulation platform that encompasses a variety of basic exercises specifically designed to give users the opportunity to improve their proficiency with the da Vinci surgeon console controls and basic robotic surgical skills. All urologists have already completed a basic robotic skills curriculum. Group 2 urologists will complete a refresher module on the virtual reality simulator.
| Study group | Role | What they receive |
|---|---|---|
| Physical reality simulation (rehearsal) | Using 3-D printing and polymer technology, the investigators will construct patient specific simulated hydrogel models designed from patients' imaging, incorporating the necessary anatomy, physiology and pathology specific to each patient. Participants with patients assigned to preoperative rehearsal will undergo pre-operative simulation only once. Receives: Other: Physical reality simulation | |
| Virtual reality simulation | The DaVinci surgical skills simulator (DVSSS) uses a virtual reality surgical simulation platform that encompasses a variety of basic exercises specifically designed to give users the opportunity to improve their proficiency with the da Vinci surgeon console controls and basic robotic surgical skills. Participants with patients assigned to preoperative simulation will complete a refresher module on the Virtual reality simulator. Receives: Other: Virtual reality simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Warm ischemia time measured during minimal invasive partial nephrectomy surgery
Warm ischemia time is reported on completion of minimal invasive partial nephrectomy surgery, the metric will be measured in minutes as a continuous variable.
Measured: At the end of each surgical procedure, approximately 24 hours after surgery
Estimated blood loss measured during minimal invasive partial nephrectomy surgery
Estimated blood loss is reported on completion of minimal invasive partial nephrectomy surgery, it is estimated by the volume of fluid in the suction irrigation at the end of surgery and measured in ml as a continuous variable.
Measured: At the end of each surgical procedure, approximately 24 hours after surgery
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
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
All surgical cases will be recorded and reviewed by a third party online tool that specializes in evaluation of surgical performance using the GEARS (Global Evaluative Assessment of Robotic Skills) tool
Measured: At the end of each surgical procedure, approximately 24 hours after surgery
Operative time measured during minimal invasive partial nephrectomy surgery
Operative time is reported on completion of minimal invasive partial
Measured: At the end of each surgical procedure, approximately 24 hours after surgery
Secondary outcomes (4)
Positive margins of the tumor specimen
On pathological examination the presence or absence (+/-) and length in millimeters (mm) will be measured
Measured: From date of randomization up to 10 days after surgery
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start12 Oct 2017
- 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 NephrectomyStudies 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
- 70 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
- NCT03155295
- Sponsor's protocol ID
- 67280
- Status last verified
- Feb 2023
- First submitted
- 10 May 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
- Patient-specific Simulated Procedure Rehearsal for Minimally Invasive Surgery
- ClinicalTrials.gov ID
- NCT03155295
- Acronym / sponsor ID
- 67280
- Conditions
- Nephrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 16 May 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.
The purpose of the study is to evaluate patient-specific surgical simulation by permitting pre-operative rehearsals, in the form of the surgeon completing a dry run of the procedure on a model constructed from the patient's radiological studies that replicates every aspect of their organs. The investigators' aim is to evaluate the effectiveness of this form of practice in optimizing intraoperative and postoperative outcomes . The investigators hope eventually to use these rehearsals as a standard study tool for surgical training.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical reality simulation (rehearsal) | – | Other: Physical reality simulationUsing 3-D printing and polymer technology, the investigators will construct patient specific simulated hydrogel models designed from patients' imaging, incorporating the necessary anatomy, physiology and pathology specific to each patient. Participants with patients assigned to preoperative rehearsal will undergo pre-operative simulation only once. |
| Virtual reality simulation | – | Other: Virtual reality simulationThe DaVinci surgical skills simulator (DVSSS) uses a virtual reality surgical simulation platform that encompasses a variety of basic exercises specifically designed to give users the opportunity to improve their proficiency with the da Vinci surgeon console controls and basic robotic surgical skills. Participants with patients assigned to preoperative simulation will complete a refresher module on the Virtual reality simulator. |
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 minimally invasive partial nephrectomy (MIPN) patients), 5 faculty expert urologists, and 5 trainees including four urology residents and one endourology fellow.
Key inclusion criteria (4 listed)
- All patients scheduled to undergo MIPN 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 |
|---|---|---|
| Physical reality simulationUsing 3-D printing and polymer technology, the investigators will construct patient specific simulated hydrogel models designed from patients' imaging, incorporating the necessary anatomy, physiology and pathology specific to each patient. These models are constructed at the Laboratory for Simulation-based Translational Research at the Department of Urology. Group 1 urologists will rehearse the minimally-invasive partial nephrectomy (MIPN) surgery using these patient-specific models. | Other | Physical reality simulation (rehearsal) |
| Virtual reality simulationThe DaVinci surgical skills simulator system uses a virtual reality surgical simulation platform that encompasses a variety of basic exercises specifically designed to give users the opportunity to improve their proficiency with the da Vinci surgeon console controls and basic robotic surgical skills. All urologists have already completed a basic robotic skills curriculum. Group 2 urologists will complete a refresher module on the virtual reality simulator. | Other | Virtual reality simulation |
Primary outcome
Warm ischemia time measured during minimal invasive partial nephrectomy surgery
Time frame: At the end of each surgical procedure, approximately 24 hours after surgery
Warm ischemia time is reported on completion of minimal invasive partial nephrectomy surgery, the metric will be measured in minutes as a continuous variable.
Estimated blood loss measured during minimal invasive partial nephrectomy surgery
Time frame: At the end of each surgical procedure, approximately 24 hours after surgery
Estimated blood loss is reported on completion of minimal invasive partial nephrectomy surgery, it is estimated by the volume of fluid in the suction irrigation at the end of surgery and measured in ml as a continuous variable.
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
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.
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
Time frame: At the end of each surgical procedure, approximately 24 hours after surgery
All surgical cases will be recorded and reviewed by a third party online tool that specializes in evaluation of surgical performance using the GEARS (Global Evaluative Assessment of Robotic Skills) tool
Operative time measured during minimal invasive partial nephrectomy surgery
Time frame: At the end of each surgical procedure, approximately 24 hours after surgery
Operative time is reported on completion of minimal invasive partial
4 secondary outcomes
Positive margins of the tumor specimen
Time frame: From date of randomization up to 10 days after surgery
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
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 Nephrectomy, 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?
Warm ischemia time measured during minimal invasive partial nephrectomy surgery (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.