Study Results
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View full resultsBasic Information
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TERMINATED
NA
7 participants
INTERVENTIONAL
2022-01-01
2022-02-02
Brief Summary
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Detailed Description
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Surgical theater has FDA clearance for patient interaction and engagement. Our study is to take surgical theater into our clinics and, after a patient is defined as a surgical candidate, use surgical theater to provide spatial learning and comprehension through modeling so they better understand their surgical plan. Only the SRP system will be used for this study (Surgical Planner).
The intervention is showing surgical theater to patients identified for surgery in clinic routinely. Surgical theater will be offered to all patients offered surgery. No other changes in practice will be done.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Evaluation of usefulness
To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults.
Surgical Theater
The surgical theater platform uses data from MRI and CT scans, creating a 3d image that can be seen by the patient.
Interventions
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Surgical Theater
The surgical theater platform uses data from MRI and CT scans, creating a 3d image that can be seen by the patient.
Eligibility Criteria
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Inclusion Criteria
2. Patients undergoing elective lumbar or cervical spine surgeries
3. Those who are receiving Surgical Theater consultation as part of their clinical care
Exclusion Criteria
2. Non-elective surgery due to emergency, trauma
3. Patients undergoing correction for spinal deformities
18 Years
89 Years
ALL
No
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Principal Investigators
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Gabriel Smith, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University Hospitals at Southwest General Medical Center
Middleburg Heights, Ohio, United States
Countries
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References
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Altieri R, Melcarne A, Junemann C, Zeppa P, Zenga F, Garbossa D, Certo F, Barbagallo G. Inferior Fronto-Occipital fascicle anatomy in brain tumor surgeries: From anatomy lab to surgical theater. J Clin Neurosci. 2019 Oct;68:290-294. doi: 10.1016/j.jocn.2019.07.039. Epub 2019 Jul 19.
Bambakidis NC, Selman WR, Sloan AE. Surgical rehearsal platform: potential uses in microsurgery. Neurosurgery. 2013 Oct;73 Suppl 1:122-6. doi: 10.1227/NEU.0000000000000099.
Ehlers JP, Uchida A, Srivastava SK. THE INTEGRATIVE SURGICAL THEATER: Combining Intraoperative Optical Coherence Tomography and 3D Digital Visualization for Vitreoretinal Surgery in the DISCOVER Study. Retina. 2018 Sep;38 Suppl 1(Suppl 1):S88-S96. doi: 10.1097/IAE.0000000000001999.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY20210810
Identifier Type: -
Identifier Source: org_study_id
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