An observational study in Nephrectomy, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-10.
Sponsored by University of Rochester · Observational
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.
University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Other: Physical 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.
Other: Virtual reality simulation
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: At the end of each surgical procedure, approximately 24 hours after surgery
Positive margins of the tumor specimen
On pathological examination the presence or absence (+/-) and length in millimeters (mm) will be measured
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)
The difference between preoperative (within a week prior to surgery) and postoperative (12 and 24 hours after surgery) using the blood test HCT.
Time frame: 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
Time frame: 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
Time frame: From date of surgery up to 30 days postoperative, every hospital readmission encountered during that time will be recorded
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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