Hand Versus Foot Controls for Robotic Surgery Simulation

Why is the study being done? Robotic-assisted surgery offers high precision and ergonomic benefits, but it requires specialized console skills that differ significantly from traditional open or laparoscopic surgery. A fundamental part of operating a robotic surgical system is clutch control, which allows surgeons to reposition their controllers without moving the actual surgical instruments. Inefficient clutching can disrupt workflow, increase mental workload, and lead to operator fatigue. Modern platforms like the Da Vinci Xi offer two main options for clutching: hand-controlled clutching and foot-controlled clutching. Currently, there is limited research isolating how these different clutch options affect performance, especially for novice operators who have no prior robotic experience. This study aims to evaluate and compare hand clutch versus foot clutch methods to determine which approach better supports efficient skill acquisition, precision, and comfort for beginners. What happens during the study? Surgical trainees with no prior robotic surgery experience will be recruited for this study. After completing an initial baseline questionnaire and receiving a standardized orientation on the equipment, all participants will undergo a 20-minute practice session where they get to try both hand and foot clutching mechanisms. One week after the practice session, participants will return for the formal evaluation and be randomly assigned to one of two groups: 1. Hand Clutch Group: Participants will complete a standardized simulation task using only the hand clutch button. 2. Foot Clutch Group: Participants will complete the exact same simulation task using only the foot clutch pedal. The simulator automatically tracks performance metrics such as task completion time, movement efficiency, instrument collisions, and technical errors. Immediately following the test, participants will fill out a short survey rating their satisfaction, comfort, and the learning difficulty of their assigned clutch method.

NCT Number	NCT07618429
Lead Sponsor	Prince of Songkla University
Conditions	No Disease or Condition is Being Studied, Surgical Procedures, Minimally Invasive
Enrollment	86 participants
Start Date	2026-06-15
Primary Completion	2026-09-30 (estimated)
Study Completion	2026-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-02