Hand Versus Foot Controls for Robotic Surgery Simulation

NCT07618429 | Not Yet Recruiting DMC

• 1 other identifier: MS PSU-691031-030
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Hand Clutch Group: Participants will complete a standardized simulation task using only the hand clutch button.
2. 2.Foot Clutch Group: Participants will complete the exact same simulation task using only the foot clutch pedal.

Conditions

No Disease or Condition is Being Studied; Surgical Procedures, Minimally Invasive

Keywords

Robotic surgery; Surgical simulation; Psychomotor skill acquisition; Technical performance metrics; Randomized controlled trial

Outcome Measures

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.

  1 week after enrollment

Secondary Outcomes (7)

• Total Task Completion Time

  1 week after enrollment

• Economy of Motion

  1 week after enrollment

• Instrument Collisions

  1 week after enrollment

• Camera Usage

  1 week after enrollment

• Instrument Out-of-View Events

  1 week after enrollment

Study Arms (2)

Hand Clutch

ACTIVE COMPARATOR

Participants will complete a standardized simulation task using only the hand clutch button

Other: Hand Clutch

Foot Clutch

ACTIVE COMPARATOR

Participants will complete the exact same simulation task using only the foot clutch pedal

Other: Foot Clutch

Interventions

Hand Clutch OTHER

Participants will complete a standardized simulation task using only the hand clutch button

Hand Clutch

Foot Clutch OTHER

Participants will complete the exact same simulation task using only the foot clutch pedal

Foot Clutch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related Publications (19)

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  PMID: 38098541 BACKGROUND

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  PMID: 40088400 BACKGROUND

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  PMID: 34263057 BACKGROUND

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  PMID: 29926095 BACKGROUND

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  PMID: 37531043 BACKGROUND

• Sridhar AN, Briggs TP, Kelly JD, Nathan S. Training in Robotic Surgery-an Overview. Curr Urol Rep. 2017 Aug;18(8):58. doi: 10.1007/s11934-017-0710-y.

  PMID: 28647793 BACKGROUND

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  PMID: 37204648 BACKGROUND

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  PMID: 38814347 BACKGROUND

• Soomro NA, Hashimoto DA, Porteous AJ, Ridley CJA, Marsh WJ, Ditto R, Roy S. Systematic review of learning curves in robot-assisted surgery. BJS Open. 2020 Feb;4(1):27-44. doi: 10.1002/bjs5.50235. Epub 2019 Nov 29.

  PMID: 32011823 BACKGROUND

• Catchpole K, Cohen T, Alfred M, Lawton S, Kanji F, Shouhed D, Nemeth L, Anger J. Human Factors Integration in Robotic Surgery. Hum Factors. 2024 Mar;66(3):683-700. doi: 10.1177/00187208211068946. Epub 2022 Mar 5.

  PMID: 35253508 BACKGROUND

• Zhao B, Hollandsworth HM, Lee AM, Lam J, Lopez NE, Abbadessa B, Eisenstein S, Cosman BC, Ramamoorthy SL, Parry LA. Making the Jump: A Qualitative Analysis on the Transition From Bedside Assistant to Console Surgeon in Robotic Surgery Training. J Surg Educ. 2020 Mar-Apr;77(2):461-471. doi: 10.1016/j.jsurg.2019.09.015. Epub 2019 Sep 23.

  PMID: 31558428 BACKGROUND

• Huang Y, Lai W, Cao L, Liu J, Li X, Burdet E, Phee SJ. A Three-Limb Teleoperated Robotic System with Foot Control for Flexible Endoscopic Surgery. Ann Biomed Eng. 2021 Sep;49(9):2282-2296. doi: 10.1007/s10439-021-02766-3. Epub 2021 Apr 8.

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  PMID: 27133186 BACKGROUND

• Kumar A, Smith R, Patel VR. Current status of robotic simulators in acquisition of robotic surgical skills. Curr Opin Urol. 2015 Mar;25(2):168-74. doi: 10.1097/MOU.0000000000000137.

  PMID: 25574791 BACKGROUND

• Castaldi MT, Palmer M, Con J, Bergamaschi R. Robotic-Assisted Surgery Training (RAST): Assessment of Surgeon Console Ergonomic Skills. J Surg Educ. 2023 Nov;80(11):1723-1735. doi: 10.1016/j.jsurg.2023.08.019. Epub 2023 Sep 26.

  PMID: 37770293 BACKGROUND

• van der Schatte Olivier RH, Van't Hullenaar CD, Ruurda JP, Broeders IA. Ergonomics, user comfort, and performance in standard and robot-assisted laparoscopic surgery. Surg Endosc. 2009 Jun;23(6):1365-71. doi: 10.1007/s00464-008-0184-6. Epub 2008 Oct 15.

  PMID: 18855053 BACKGROUND

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  BACKGROUND

Related Links

• Operational definition and Variables of the study
• clutch simulation video

Study Officials

• Supakool Jearanai, MD

  Department of Surgery, Faculty of Medicine, Prince of Songkla University

  STUDY CHAIR

Central Study Contacts

Juthamas Jenyongsak, MD

CONTACT

+66891988848; juthamasjen@outlook.com

Ponlagrit Kumwichar, MD, PhD

CONTACT

66887613028; ponlagrit.k@psu.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study utilizes a investigator and outcome assessor masked design to minimize bias during the enrollment, testing administration, and data recording phases: 1. Investigator Masking: Investigators responsible for recruiting, screening, obtaining consent, and providing the initial pre-simulation orientation remain masked to group assignments. Participants are handed a sealed, opaque envelope containing their random group allocation before entering the isolated simulation room. The envelope is opened only by the participant once the doors are closed and they are alone in the room, ensuring the investigator has no knowledge of whether the participant is using the hand clutch or foot clutch modality. 2. Outcome Assessor Masking: The simulation task is performed entirely in isolation. Once the participant completes the simulation and exits the room, the outcome assessor enters the room to record the objective performance metrics directly from the simulator software report screen. Becaus
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: The identified IPD will be shared after completion of the study in GitHub. There is no end date.
• Access Criteria: Anyone.

Locations

TH (1)