Hand Versus Foot Controls for Robotic Surgery Simulation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrince of Songkla University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Active surgical trainees (residents or fellows) currently enrolled in a recognized surgical specialty program, including general surgery, obstetrics and gynecology, urology, cardiothoracic surgery or pediatric surgery, at Prince of Songkla University
Complete absence of prior hands-on experience performing clinical robotic surgery or undergoing formalized robotic simulator training
Disqualifiers
Pre-existing physical, orthopedic, or neurological conditions that impair standard motor function of the upper or lower limbs, including active movement disorders or motor control deficits capable of confounding objective simulation performance metrics.
Trial design
Design model
Parallel
Treatments tested in this trial
Hand Clutch
Other interventionParticipants will complete a standardized simulation task using only the hand clutch button
Foot Clutch
Other interventionParticipants will complete the exact same simulation task using only the foot clutch pedal
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Hand ClutchActive comparator 1 intervention
Group B: Foot ClutchActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall Clutch Simulation Score
The overall clutch simulation score is an automated, composite performance score generated by the Da Vinci Xi surgical simulator hardware. The score is automatically calculated by the system's tracking software as the baseline efficiency score minus specific technical penalty points. The efficiency component incorporates total task completion time and economy of instrument motion. Penalty components include discrete technical errors occurring during task performance, such as instrument collisions, instrument out of view. The final score is recorded as a continuous value ranging from 0 to 100, where a score of 100 represents perfect efficiency with zero recorded penalties, and lower scores indicate lower motion efficiency, slower task completion, or a higher frequency of technical errors.
Time frame
1 week after enrollmentSecondary outcomes
1
Total Task Completion Time
The total time required for the participant to complete the standardized simulation exercise. It is measured continuously from the exact moment of task initiation to its completion, as tracked automatically by the surgical simulator software architecture. Lower values indicate greater proficiency and higher operational speed.
Time frame
1 week after enrollment2
Economy of Motion
A metric quantifying instrument movement efficiency, defined as the total tracking distance (measured in centimeters) traveled by all robotic instrument tips during the task performance. Shorter total path lengths reflect higher technical efficiency and smoother instrument handling.
Time frame
1 week after enrollment3
Instrument Collisions
A discrete technical error penalty variable recording the total number of times the active robotic surgical instruments physically collide with each other during the simulation task. This count is registered automatically by the simulator software, where zero represents an error-free performance.
Time frame
1 week after enrollment4
Camera Usage
The discrete count representing the total number of times the participant actively adjusts, repositions, or manipulates the endoscopic camera clutch during the execution of the simulation task. This variable is documented automatically by the control system.
Time frame
1 week after enrollmentSponsors and contacts
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Source ClinicalTrials.gov
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