Clinical trial NCT03155295: Simulated Surgery Rehearsal (MIPN)
Official title: Patient-specific Simulated Procedure Rehearsal for Minimally Invasive Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrectomy
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Warm ischemia time measured during minimal invasive partial nephrectomy surgery
timeFrame: At the end of each surgical procedure, approximately 24 hours after surgery
measure: Estimated blood loss measured during minimal invasive partial nephrectomy surgery
timeFrame: At the end of each surgical procedure, approximately 24 hours after surgery
measure: Change in postoperative renal functions
timeFrame: Zero at date of randomization and serial measurements at 12 hours , 1 day and 30 days after surgery
measure: Surgical complications
timeFrame: From date of surgery up to 30 days postoperative, every complication encountered during that time will be recorded
measure: Objective evaluation of surgical performance
timeFrame: At the end of each surgical procedure, approximately 24 hours after surgery
measure: Operative time measured during minimal invasive partial nephrectomy surgery
timeFrame: At the end of each surgical procedure, approximately 24 hours after surgery
Secondary outcomes:
measure: Positive margins of the tumor specimen
timeFrame: From date of randomization up to 10 days after surgery
measure: Change in the volume of ratio of red blood cells to total blood volume (HCT)
timeFrame: Zero at date of randomization and serial measurements at 12 and 24 hours after surgery
measure: Hospital stay
timeFrame: From date of admission up to 30 days after surgery
measure: Hospital readmission
timeFrame: From date of surgery up to 30 days postoperative, every hospital readmission encountered during that time will be recorded
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Ahmed Ghazi, MD
role: PRINCIPAL_INVESTIGATOR
References: