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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostatectomy; Robot-Assisted Radical Prostatectomy Training
• Intervention / Treatment: Behavioral: IMRA-Enhanced Training Pathway; Behavioral: Standard Training Pathway

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Vanderstraeten; Phone Number: 09 334 69 26; Email: eva.vanderstraeten@orsi.be
• Study Contact Backup: Name: Niki Rashidian; Phone Number: 09 334 69 26; Email: niki.rashidian@orsi.be

Study Locations

• Belgium
  • Belgium
    • Melle, Belgium, Belgium, 9090
      • Recruiting
      • Orsi Academy
      • Contact: Niki Rashidian; Phone Number: 09 334 69 26; Email: niki.rashidian@orsi.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Behavioral: Standard Training Pathway; Standard robot-assisted radical prostatectomy training pathway without use of the IMRA Surgical Prostatectomy Class V Hydrogel Model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At completion of Day 5 human cadaver training assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At completion of Day 5 human cadaver training assessment
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.	End of training course - Day 5
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.	Immediately after completion of the relevant training session
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.	End of training course - Day 5

Collaborators and Investigators

• Sponsor: Orsi Academy
• Investigators: Principal Investigator: Niki Rashidian, Orsi Academy; Principal Investigator: Alexandre Mottrie, Orsi Academy

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Surgical Education; Robot-Assisted Radical Prostatectomy; Surgical Simulation; Non-Inferiority Trial; Robotic Surgery Training; Proficiency-Based Progression Methodology; Hydrogel Model
• Other Study ID Numbers: ORSI-IMRA-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No