Simulated Surgery Rehearsal (MIPN)

NCT ID: NCT03155295

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-12
• Study Completion Date: 2023-01-31

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.

Conditions

Nephrectomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Physical reality simulation

Intervention Type: OTHER

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.

Virtual reality simulation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Ghazi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Ghazi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

67280

Identifier Type: -

Identifier Source: org_study_id