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Simulated Surgery Rehearsal (MIPN)

Completed
Conditions
Nephrectomy
Registration Number
NCT03155295
Lead Sponsor
University of Rochester
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
70
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Estimated blood loss measured during minimal invasive partial nephrectomy surgeryAt 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.

Operative time measured during minimal invasive partial nephrectomy surgeryAt the end of each surgical procedure, approximately 24 hours after surgery

Operative time is reported on completion of minimal invasive partial

Change in postoperative renal functionsZero 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.

Warm ischemia time measured during minimal invasive partial nephrectomy surgeryAt 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.

Surgical complicationsFrom 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 performanceAt 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

Secondary Outcome Measures
NameTimeMethod
Positive margins of the tumor specimenFrom date of randomization up to 10 days after surgery

On pathological examination the presence or absence (+/-) and length in millimeters (mm) will be measured

Change in the volume of ratio of red blood cells to total blood volume (HCT)Zero at date of randomization and serial measurements at 12 and 24 hours after surgery

The difference between preoperative (within a week prior to surgery) and postoperative (12 and 24 hours after surgery) using the blood test HCT.

Hospital readmissionFrom date of surgery up to 30 days postoperative, every hospital readmission encountered during that time will be recorded

The readmission rates of patients enrolled in the study will be measured and reported in number of patients

Hospital stayFrom date of admission up to 30 days after surgery

The length of hospital stay will be measured from time of admission to day of discharge and will be reported in days

Trial Locations

Locations (1)

University of Rochester Medical Center

🇺🇸

Rochester, New York, United States

University of Rochester Medical Center
🇺🇸Rochester, New York, United States

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