Simulated Surgery Rehearsal (MIPN)

February 8, 2023 updated by: Ahmed Ghazi, University of Rochester

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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 (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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
From date of surgery up to 30 days postoperative, every complication encountered during that time will be recorded
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.
At the end of each surgical procedure, approximately 24 hours after surgery
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.
At the end of each surgical procedure, approximately 24 hours after surgery
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.
Zero at date of randomization and serial measurements at 12 hours , 1 day and 30 days after surgery
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
At the end of each surgical procedure, approximately 24 hours after surgery
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
At the end of each surgical procedure, approximately 24 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
Hospital stay
Time Frame: From 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
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
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
Positive margins of the tumor specimen
Time Frame: From date of randomization up to 10 days after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ahmed Ghazi, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 12, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2023

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 67280

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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