Health Services Research
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEda Vinci Xi System
A group of surgeons will make determinations as to the material within identical balloons while using the da Vinci Xi System
Sponsors
Valley Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Board Certified Surgeon * Robotic Board Certified Surgeon
Exclusion criteria
• Non Board Certified Surgeon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Farrington-Manning test of Binary Non-Inferiority | 1 month | 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. |
Countries
United States
Outcome results
None listed