RecruitingNot ApplicableNCT07669974

Comparing Two Training Methods for Learning Robot-Assisted Radical Prostatectomy

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


Sponsor

Orsi Academy

Enrollment

56 participants

Start Date

Jun 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Inclusion Criteria2

  • 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 Criteria2

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

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Interventions

BEHAVIORALIMRA-Enhanced 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.

BEHAVIORALStandard Training Pathway

Standard robot-assisted radical prostatectomy training pathway without use of the IMRA Surgical Prostatectomy Class V Hydrogel Model


Locations(1)

Orsi Academy

Melle, Belgium, Belgium

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NCT07669974


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