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.
Study Type
OBSERVATIONAL
Enrollment
53
A group of surgeons will make determinations as to the material within identical balloons while using the da Vinci Xi System
The Valley Hospital
Ridgewood, New Jersey, United States
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.
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.