Comparing Two Training Methods for Learning Robot-Assisted Radical Prostatectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorOrsi Academy
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Decline or inability to provide informed consent
Incomplete participation in the on-site training course preventing assessment on Day 5
Trial design
Design model
Parallel
Treatments tested in this trial
IMRA-Enhanced Training Pathway
BehavioralStructured robotic surgery training pathway incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model as part of a proficiency-based progression training pathway.
Standard Training Pathway
BehavioralStandard robot-assisted radical prostatectomy training pathway without use of the IMRA Surgical Prostatectomy Class V Hydrogel Model
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: IMRA-Enhanced Training PathwayExperimental treatment 1 intervention
Group B: Standard Training PathwayActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Achievement of Proficiency During Day 5 Human Cadaver Assessment Using Validated Robot-Assisted Radical Prostatectomy Assessment Metrics
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.
Time frame
At completion of Day 5 human cadaver training assessmentSecondary outcomes
1
Technical Performance Assessed Using Validated Robot-Assisted Radical Prostatectomy Assessment Metrics
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.
Time frame
At completion of Day 5 human cadaver training assessment2
Self-Reported Confidence Assessed Using a Study-Specific Participant Confidence Questionnaire
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.
Time frame
End of training course - Day 53
Workload Assessed Using the NASA Task Load Index (NASA-TLX)
Participant workload measured using the NASA Task Load Index questionnaire. Total score range: 0-100, with higher scores indicating greater perceived workload.
Time frame
Immediately after completion of the relevant training session4
Feasibility and Acceptability Assessed Using a Study-Specific Training Evaluation Questionnaire
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.
Time frame
End of training course - Day 5Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov