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The purpose of this study is to compare surgeons' discernment of 4 balloons filled with different materials when using their eyes and hands versus using the da Vinci robot.
The study design is a non-randomized parallel group study in which a group of surgeons (Group A) will make determinations as to the material within each of four visually identical balloons that contain air, water, petroleum jelly or a firm substance similar to the consistency of a non-ripe banana using their hands and eyes while another group of experienced robotic surgeons (Group B) will do so using the da Vinci Xi System (Intuitive Surgical, Sunnyvale, CA).
Before making their "hands on" determinations as to balloon contents, each participant will be asked to first determine whether they can visually determine the balloon contents without any manipulation. For the purposes of outcome measurement, only two possible outcomes are considered - namely that the 4 balloons are ordered correctly or not.
Investigators will also record each "guess" for all participants in order to report any trends of mis-assortment that may occur.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Board Certified Surgeons |
| |
| Group B | Robotic Board Certified Surgeons |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| da Vinci Xi System | Device | A group of surgeons will make determinations as to the material within identical balloons while using the da Vinci Xi System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Farrington-Manning test of Binary Non-Inferiority | Using the Farrington-Manning test of binary non-inferiority, investigators hypothesize that 100% correct balloon discernment by hands-on surgeons and prospectively set 80% correct discernment by robotic surgeons as their definition of non-inferiority. A correct response is a binary outcome for each of the four balloons. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
• Non Board Certified Surgeon
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Targeted population are board certifed surgeons and those who are robotic certified surgeons
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 24, 2023 | Aug 19, 2024 | Prot_000.pdf |
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