Comparing Two Training Methods for Learning Robot-Assisted Radical Prostatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMRA-Enhanced Training Pathway, Standard Training Pathway.
- Who it may be relevant to
- Registry conditions: Robot-Assisted Radical Prostatectomy Training, Prostatectomy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Non-Inferiority Trial Comparing Two Training Modalities for Achieving Proficiency in Robot-Assisted Radical Prostatectomy
Overview
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.
Detailed description
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.
Interventions
- Behavioral IMRA-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. - Behavioral Standard Training Pathway
Standard robot-assisted radical prostatectomy training pathway without use of the IMRA Surgical Prostatectomy Class V Hydrogel Model
Primary outcome measures
- Achievement of Proficiency During Day 5 Human Cadaver Assessment Using Validated Robot-Assisted Radical Prostatectomy Assessment Metrics [Time frame: At completion of Day 5 human cadaver training assessment]
Secondary outcome measures (4)
- Technical Performance Assessed Using Validated Robot-Assisted Radical Prostatectomy Assessment Metrics [Time frame: At completion of Day 5 human cadaver training assessment]
- Self-Reported Confidence Assessed Using a Study-Specific Participant Confidence Questionnaire [Time frame: End of training course - Day 5]
- Workload Assessed Using the NASA Task Load Index (NASA-TLX) [Time frame: Immediately after completion of the relevant training session]
- Feasibility and Acceptability Assessed Using a Study-Specific Training Evaluation Questionnaire [Time frame: End of training course - Day 5]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Belgium · 1 center
- Orsi Academy — Melle
Publications
- Mottrie A, Mazzone E, Wiklund P, Graefen M, Collins JW, De Groote R, Dell'Oglio P, Puliatti S, Gallagher AG. Objective assessment of intraoperative skills for robot-assisted radical prostatectomy (RARP): results from the ERUS Scientific and Educational Working Groups Metrics Initiative. BJU Int. 2021 Jul;128(1):103-111. doi: 10.1111/bju.15311. Epub 2020 Dec 20. PMID 33251703
Identifiers
NCT: NCT07669974 · ORSI-IMRA-2026-01