Simulated Surgery Rehearsal (MIPN)

Nephrectomy Clinical Trial

Official title:

Patient-specific Simulated Procedure Rehearsal for Minimally Invasive Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155295
• Other study ID #: 67280
• Status: Completed
• Start date: October 12, 2017
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• 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 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

Exclusion Criteria:

• Inability to give informed consent

Related Conditions & MeSH terms

• Nephrectomy

Intervention

Other:
• Physical 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.
• Virtual reality simulation
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.

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	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.	At the end of each surgical procedure, approximately 24 hours after surgery
Primary	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.	At the end of each surgical procedure, approximately 24 hours after surgery
Primary	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
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	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	At the end of each surgical procedure, approximately 24 hours after surgery
Primary	Operative time measured during minimal invasive partial nephrectomy surgery	Operative time is reported on completion of minimal invasive partial	At the end of each surgical procedure, approximately 24 hours after surgery
Secondary	Positive margins of the tumor specimen	On pathological examination the presence or absence (+/-) and length in millimeters (mm) will be measured	From date of randomization up to 10 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