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Comparing Two Training Methods for Learning Robot-Assisted Radical Prostatectomy

2026年6月22日 更新者:Orsi Academy

A Randomized Non-Inferiority Trial Comparing Two Training Modalities for Achieving Proficiency in Robot-Assisted Radical Prostatectomy

This randomized non-inferiority study evaluates whether a robot-assisted radical prostatectomy (RARP) training pathway incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model is as effective as the current standard training pathway in achieving surgical proficiency.

Participants enrolled in a standardized robotic surgery training course will be randomly assigned to one of two training pathways that differ only in the training model used during one phase of the course. All participants will subsequently undergo assessment during human cadaver training.

The primary outcome is the proportion of participants who achieve predefined proficiency criteria during the final assessment. Secondary outcomes include technical performance scores, technical errors, self-reported confidence, perceived readiness to perform robot-assisted radical prostatectomy, and feasibility of implementing a synthetic model-based training pathway.

The study aims to determine whether a high-fidelity hydrogel model can provide training outcomes comparable to those achieved with biological models, supporting more ethical, scalable, and standardized robotic surgery training.

研究概览

详细说明

Robot-assisted radical prostatectomy (RARP) is one of the most technically demanding procedures in robotic urologic surgery and requires structured training to ensure safe and effective skill acquisition. The Certified Curriculum in Robotic Radical Prostatectomy (CC-ERUS) is a proficiency-based training pathway developed by the European Association of Urology Robotic Urology Section (ERUS) to standardize training and assessment in RARP. The curriculum includes simulation-based training, biological models, and human cadaver training before participants are assessed for proficiency.

The use of biological training models presents ethical, logistical, regulatory, and scalability challenges. High-fidelity synthetic hydrogel models have recently been developed as potential alternatives that may provide realistic anatomical representation and tissue handling characteristics while reducing reliance on biological models. The present study evaluates whether incorporation of the IMRA Surgical Prostatectomy Class V Hydrogel Model within a standardized RARP training pathway results in training outcomes that are non-inferior to those achieved using the current standard training pathway.

This study is a prospective, randomized, controlled, non-inferiority trial embedded within a standardized five-day robotic surgery training course at ORSI Academy. Participants will be randomized in a 1:1 ratio to one of two training pathways. Both pathways are identical in educational content, duration, faculty supervision, and learning objectives. The only difference between groups is the training modality used during Day 4 of the course. Participants assigned to the standard pathway will train on human cadaver models, whereas participants assigned to the experimental pathway will train using the IMRA Surgical Prostatectomy Class V Hydrogel Model.

On Day 5, all participants will undergo training and assessment on human cadaver models under identical conditions. Technical performance will be evaluated using validated procedure-specific metrics for robot-assisted radical prostatectomy. The primary objective is to determine whether the hydrogel-based training pathway is non-inferior to the standard pathway with respect to achievement of predefined proficiency criteria during the final human cadaver assessment. Additional analyses will evaluate technical performance metrics, procedural errors, task completion parameters, participant confidence, perceived readiness to perform RARP, cognitive workload, and participant evaluation of the training pathway.

研究类型

介入性

注册 (估计的)

56

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Belgium
      • Melle、Belgium、比利时、9090

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Enrollment in the CC-ERUS training course or participants attending the same robotic RARP training course at ORSI Academy outside the formal CC-ERUS curriculum at ORSI Academy during the study period
  • Willingness and ability to provide informed consent for participation in the study

Exclusion Criteria:

  • Decline or inability to provide informed consent
  • Incomplete participation in the on-site training course preventing assessment on Day 5

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:IMRA-Enhanced Training Pathway
Participants receive a robotic surgery training pathway incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model during day 4 of the training pathway.
Structured robotic surgery training pathway incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model as part of a proficiency-based progression training pathway.
有源比较器:Standard Training Pathway
Participants receive the standard robot-assisted radical prostatectomy training pathway (Human Cadaver on day 4) without the IMRA Surgical Prostatectomy Class V Hydrogel Model.
Standard robot-assisted radical prostatectomy training pathway without use of the IMRA Surgical Prostatectomy Class V Hydrogel Model

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Achievement of Proficiency During Day 5 Human Cadaver Assessment Using Validated Robot-Assisted Radical Prostatectomy Assessment Metrics
大体时间:At completion of Day 5 human cadaver training assessment
Proportion of participants achieving predefined proficiency criteria during the final human cadaver training assessment. Technical performance will be assessed using validated robot-assisted radical prostatectomy assessment metrics (Mottrie et al., doi:10.1111/bju.15311). Participants will be classified as proficient if they complete the assessed procedure with no more than 20 General Errors and 0 Critical Errors. The primary outcome will be the proportion of participants meeting these proficiency criteria.
At completion of Day 5 human cadaver training assessment

次要结果测量

结果测量
措施说明
大体时间
Technical Performance Assessed Using Validated Robot-Assisted Radical Prostatectomy Assessment Metrics
大体时间:At completion of Day 5 human cadaver training assessment
Technical performance during the final human cadaver assessment will be evaluated using validated robot-assisted radical prostatectomy assessment metrics (Mottrie et al., doi:10.1111/bju.15311). The number of General Errors, the number of Critical Errors, and the time required to complete the procedure will be recorded and compared between study groups. Lower numbers of errors and shorter completion times indicate better technical performance.
At completion of Day 5 human cadaver training assessment
Self-Reported Confidence Assessed Using a Study-Specific Participant Confidence Questionnaire
大体时间:End of training course - Day 5
Participant confidence in performing robot-assisted radical prostatectomy will be assessed using the ORSI RARP Confidence Questionnaire, a study-specific Likert-scale questionnaire. Responses will be collected using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater confidence.
End of training course - Day 5
Workload Assessed Using the NASA Task Load Index (NASA-TLX)
大体时间:Immediately after completion of the relevant training session
Participant workload measured using the NASA Task Load Index questionnaire. Total score range: 0-100, with higher scores indicating greater perceived workload.
Immediately after completion of the relevant training session
Feasibility and Acceptability Assessed Using a Study-Specific Training Evaluation Questionnaire
大体时间:End of training course - Day 5
Participant evaluation of the training pathway and educational experience will be assessed using the ORSI Training Pathway Evaluation Questionnaire, a study-specific post-course questionnaire. Responses will be collected using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater acceptability and satisfaction.
End of training course - Day 5

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Niki Rashidian、Orsi Academy
  • 首席研究员:Alexandre Mottrie、Orsi Academy

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月15日

初级完成 (估计的)

2027年6月15日

研究完成 (估计的)

2027年6月15日

研究注册日期

首次提交

2026年6月5日

首先提交符合 QC 标准的

2026年6月22日

首次发布 (实际的)

2026年6月25日

研究记录更新

最后更新发布 (实际的)

2026年6月25日

上次提交的符合 QC 标准的更新

2026年6月22日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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