Authors
»
Prince of Songkla University -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
Study Rationale and Scientific Background Surgical techniques have evolved fromconventional open surgery to minimally invasive laparoscopic approaches, which reducesurgical trauma, postoperative pain, and length of hospital stay. Despite theseadvancements, complex operations remain time‐consuming and physically demanding, placingsignificant ergonomic strain on surgeons. Robotic‐assisted surgery addresses theselimitations by enhancing precision, improving visualization, and optimizingergonomics.[4] As robotic platforms become integrated into modern surgical practice,trainees face exposure to these systems early in their careers. Effective use of robotictechnology requires motor and cognitive skills that differ fundamentally from open orlaparoscopic approaches.[7] Among these skills, mastery of clutch control plays a pivotalrole in ensuring efficient instrument positioning, maintaining a stable working posture,and minimizing unnecessary movements.[6,8,10] Inappropriate or inefficient clutch use candisrupt surgical workflow, increase cognitive workload, prolong task completion time, andcontribute to early operator fatigue.[3,6] These challenges are particularly evidentduring the initial learning phase of robotic surgery. Inefficiencies during this earlyperiod have downstream clinical implications, as increased operative time, excessiveinstrument movement, and higher cognitive workload are associated with technical errors,surgeon fatigue, and potentially compromised patient safety.[1,5] Optimizing fundamentalconsole skills like clutch control may improve simulator performance and contribute tosafer, more efficient operative performance in clinical practice.[7,10] Foundationalhabits established early may persist throughout a surgeon's career, making early trainingcritical.Modern platforms like the Da Vinci Xi system offer multiple clutch control modalities,most commonly the hand clutch and the foot clutch. Previous simulation research hasprimarily focused on validating simulator platforms, assessing general psychomotor skillacquisition, or comparing novice and expert performance. Few investigations havespecifically examined how different clutch control modalities influence performancemetrics during early skill acquisition, as existing literature largely evaluates overallproficiency rather than isolating clutch control as a specific technical component.Consequently, the relative advantages of hand clutch versus foot clutch in facilitatingefficient instrument repositioning and minimizing cognitive workload remain poorlydefined. Additionally, prior studies often include heterogeneous participant groups withvarying laparoscopic or robotic exposure, making it difficult to isolate the true effectof clutch modality on individuals without prior robotic experience. Clarifying thiseffect in true novice users is essential for developing structured training curricula.Definitions for Intervention GroupThe trial isolates and compares the two distinct control interfaces provided by the DaVinci Xi console for instrument clutching: 1. Hand Clutch group This control utilizes a dedicated finger clutch button located onthe master controllers. Proper execution requires the user to place their thumb andmiddle finger into the Velcro loops of the controllers, leaving the index fingerfree to manipulate the button. To execute a clutch, the user must pull back thebutton and hold it, move their hand to the desired ergonomic location, and thenrelease the button to re‐engage instrument control. This modality allows for therepositioning of individual hands independently to optimize workspace placement. 2. Foot Clutch group: This control utilizes the footswitch panel located at the base ofthe console. The master clutch pedal allows for the simultaneous repositioning ofboth hands without moving the surgical instruments. Depressing the pedal disengagesthe master controllers from the instrument arms, allowing the user to repositiontheir hands to a neutral, ergonomic posture before releasing the pedal to resumeactive manipulation.Phase I: Enrollment, Baseline, and Practice Session All prospective participants undergoan initial screening phase. Eligible surgical trainees from participating specialties(general surgery, obstetrics and gynecology, urology, cardiothoracic surgery, andpediatric surgery) are brought into the simulation suite outside of regular academic orclinical working hours (specifically between 16:00 and 18:00 on weekdays or 08:00 and16:00 on weekends) to prevent clinical conflicts.Upon entering the study, participants complete a baseline questionnaire requiringapproximately 5 to 10 minutes to capture demographic data, including sex, age, year ofresidency or fellowship training, and verification of zero prior robotic surgicalexperience.Following the baseline documentation, a standardized pre‐simulation orientation isprovided by the research staff for 10 to 15 minutes. This orientation features a scriptedintroduction to the Da Vinci Xi console architecture, a detailed mechanical explanationof both the hand clutch and foot clutch mechanisms, and a live or recorded demonstrationof the designated clutch simulation task.Participants then initiate an equal‐exposure practice session lasting approximately 20minutes. During this session, every participant is required to perform exactly twopractice attempts using the hand clutch configuration and exactly two practice attemptsusing the foot clutch configuration. This ensures all individuals possess identicalbaseline mechanical familiarity with both interfaces prior to the trial washout period. Adesignated question and clarification period concludes the session, allowing participantsto ask specific questions about the console or software mechanics to ensure completeunderstanding.Phase II: Washout Period and Experimental Testing To minimize the immediate learningeffects and psychomotor memory carryover from the practice session, a strict one‐weekinterval is enforced for all participants.Upon returning exactly one week later for their formal testing session, individual groupallocation is determined using a concealed randomization process: participants draw asealed envelope that assigns them to either Group A (Hand Clutch) or Group B (FootClutch).The experimental testing phase is conducted individually at the Da Vinci Xi surgicalconsole. The software environment initializes a standardized, automated clutch simulationmodule. Participants must perform the task utilizing exclusively their assigned clutchmodality; inter‐group cross‐contamination or utilization of the alternative clutchinterface is strictly prohibited. The test is executed exactly once per participant overa duration of approximately 10 minutes.To ensure safety and uniform testing conditions, a research staff member remains presentthroughout the simulation to monitor for physical symptoms, system errors, or protocoldeviations, and to provide technical assistance if required. The simulator trackingsoftware records all motion, error, and time variables directly from the consolearchitecture.Immediately following the simulation test, participants complete a post‐simulationsatisfaction questionnaire. This 5‐minute psychometric assessment uses a 5‐point Likertscale (ranging from 1: Strongly Disagree to 5: Strongly Agree) to evaluate subjectivedomains, specifically user‐reported ease of use, physical comfort during manipulation,intuitive learning difficulty, precise instrument control, and overall satisfaction withthe assigned modality.Risk Alleviation and Safety Protocol The simulation testing involves minimal risk;however, localized physical and psychological discomforts may occur. Anticipated risksinclude localized muscle fatigue or strain within the hands, arms, or feet due torepetitive simulator control manipulation. Eye strain or visual fatigue may arise fromcontinuous focus within the console's 3D viewer, and mild dizziness or tension headachescan occur during continuous simulator operation. Additionally, participants mayexperience psychological discomfort or performance‐related stress stemming from perceivedevaluation anxiety.To mitigate these risks, the investigator or a trained research assistant remainspositioned adjacent to the console throughout the session to actively monitor theparticipant for objective indicators of distress, vertigo, or physical exhaustion. Theprotocol restricts the duration of active testing, and participants maintain the absoluteright to pause, suspend, or permanently terminate the simulation at any point if theyexperience physical discomfort or performance anxiety.If a participant flags symptoms, standard basic supportive care is deployed immediately,including providing a dedicated resting area, drinking water, and clinical monitoring oftheir condition. In instances where minor symptoms do not quickly resolve, theindividual's participation is discontinued.To protect against coercion or academic pressure, recruitment is conducted solely viageneral electronic announcements or public notices rather than direct supervisorinvitations. Participants are explicitly informed during consent that their objectiveperformance metrics are entirely confidential, will not be shared with instructors orauthorities, and hold no bearing on their academic evaluations, clinical trainingassessments, or professional status within the university.
Epistemonikos ID: de6de43f89f3757ae800caaf7d3acfe99b0b0d10
First added on: Jun 02, 2026