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临床试验/NCT07618429
NCT07618429尚未招募不适用

Control Location Using Two Commands: Hand Versus Foot, Workload and Accuracy Response Trial: A Randomized Controlled Trial in Robotic Surgery Simulation

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2026年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
86
试验地点
1

研究概览

简要总结

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.

详细描述

Study Rationale and Scientific Background Surgical techniques have evolved from conventional open surgery to minimally invasive laparoscopic approaches, which reduce surgical trauma, postoperative pain, and length of hospital stay. Despite these advancements, complex operations remain time-consuming and physically demanding, placing significant ergonomic strain on surgeons. Robotic-assisted surgery addresses these limitations by enhancing precision, improving visualization, and optimizing ergonomics.[4] As robotic platforms become integrated into modern surgical practice, trainees face exposure to these systems early in their careers. Effective use of robotic technology requires motor and cognitive skills that differ fundamentally from open or laparoscopic approaches.[7] Among these skills, mastery of clutch control plays a pivotal role in ensuring efficient instrument positioning, maintaining a stable working posture, and minimizing unnecessary movements.[6,8,10] Inappropriate or inefficient clutch use can disrupt surgical workflow, increase cognitive workload, prolong task completion time, and contribute to early operator fatigue.[3,6] These challenges are particularly evident during the initial learning phase of robotic surgery. Inefficiencies during this early period have downstream clinical implications, as increased operative time, excessive instrument movement, and higher cognitive workload are associated with technical errors, surgeon fatigue, and potentially compromised patient safety.[1,5] Optimizing fundamental console skills like clutch control may improve simulator performance and contribute to safer, more efficient operative performance in clinical practice.[7,10] Foundational habits established early may persist throughout a surgeon's career, making early training critical.

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 has primarily focused on validating simulator platforms, assessing general psychomotor skill acquisition, or comparing novice and expert performance. Few investigations have specifically examined how different clutch control modalities influence performance metrics during early skill acquisition, as existing literature largely evaluates overall proficiency rather than isolating clutch control as a specific technical component. Consequently, the relative advantages of hand clutch versus foot clutch in facilitating efficient instrument repositioning and minimizing cognitive workload remain poorly defined. Additionally, prior studies often include heterogeneous participant groups with varying laparoscopic or robotic exposure, making it difficult to isolate the true effect of clutch modality on individuals without prior robotic experience. Clarifying this effect in true novice users is essential for developing structured training curricula.

Definitions for Intervention Group

The trial isolates and compares the two distinct control interfaces provided by the Da Vinci Xi console for instrument clutching:

  1. Hand Clutch group This control utilizes a dedicated finger clutch button located on the master controllers. Proper execution requires the user to place their thumb and middle finger into the Velcro loops of the controllers, leaving the index finger free to manipulate the button. To execute a clutch, the user must pull back the button and hold it, move their hand to the desired ergonomic location, and then release the button to re-engage instrument control. This modality allows for the repositioning of individual hands independently to optimize workspace placement.
  2. Foot Clutch group: This control utilizes the footswitch panel located at the base of the console. The master clutch pedal allows for the simultaneous repositioning of both hands without moving the surgical instruments. Depressing the pedal disengages the master controllers from the instrument arms, allowing the user to reposition their hands to a neutral, ergonomic posture before releasing the pedal to resume active manipulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ponlagrit Kumwichar

Assistant Professor

Prince of Songkla University

研究点 (1)

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