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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07669974
Enrollment
56
Registered
2026-06-25
Start date
2026-06-15
Completion date
2027-06-15
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatectomy, Robot-Assisted Radical Prostatectomy Training

Keywords

Robot-Assisted Radical Prostatectomy, Robotic Surgery Training, Surgical Education, Proficiency-Based Progression Methodology, Hydrogel Model, Non-Inferiority Trial, Surgical Simulation

Brief 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.

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

BEHAVIORALStandard Training Pathway

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

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.

Sponsors

Orsi Academy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Participants are randomized in a 1:1 ratio to one of two parallel training pathways. The intervention group receives training incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model, while the control group follows the standard training pathway. Both groups complete the same robotic surgery curriculum and undergo identical final assessment during human cadaver training. The primary comparison evaluates whether the IMRA-enhanced pathway is non-inferior to the standard pathway in achieving predefined proficiency criteria.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Achievement of Proficiency During Day 5 Human Cadaver Assessment Using Validated Robot-Assisted Radical Prostatectomy Assessment MetricsAt completion of Day 5 human cadaver training assessmentProportion 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.

Secondary

MeasureTime frameDescription
Technical Performance Assessed Using Validated Robot-Assisted Radical Prostatectomy Assessment MetricsAt completion of Day 5 human cadaver training assessmentTechnical 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.
Self-Reported Confidence Assessed Using a Study-Specific Participant Confidence QuestionnaireEnd of training course - Day 5Participant 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.
Workload Assessed Using the NASA Task Load Index (NASA-TLX)Immediately after completion of the relevant training sessionParticipant workload measured using the NASA Task Load Index questionnaire. Total score range: 0-100, with higher scores indicating greater perceived workload.
Feasibility and Acceptability Assessed Using a Study-Specific Training Evaluation QuestionnaireEnd of training course - Day 5Participant 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.

Countries

Belgium

Contacts

CONTACTEva Vanderstraeten
eva.vanderstraeten@orsi.be09 334 69 26
CONTACTNiki Rashidian
Niki.rashidian@orsi.be09 334 69 26
PRINCIPAL_INVESTIGATORNiki Rashidian

Orsi Academy

PRINCIPAL_INVESTIGATORAlexandre Mottrie

Orsi Academy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026