Comparing Two Training Methods for Learning Robot-Assisted Radical Prostatectomy

NCT07669974 | Recruiting

• 1 other identifier: ORSI-IMRA-2026-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Robot-Assisted Radical Prostatectomy Training; Prostatectomy

Keywords

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

Outcome Measures

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.

  At completion of Day 5 human cadaver training assessment

Secondary Outcomes (4)

• Technical Performance Assessed Using Validated Robot-Assisted Radical Prostatectomy Assessment Metrics

  At completion of Day 5 human cadaver training assessment

• Self-Reported Confidence Assessed Using a Study-Specific Participant Confidence Questionnaire

  End of training course - Day 5

• Workload Assessed Using the NASA Task Load Index (NASA-TLX)

  Immediately after completion of the relevant training session

• Feasibility and Acceptability Assessed Using a Study-Specific Training Evaluation Questionnaire

  End of training course - Day 5

Study Arms (2)

IMRA-Enhanced Training Pathway

EXPERIMENTAL

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

Standard Training Pathway

ACTIVE COMPARATOR

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

Interventions

IMRA-Enhanced Training Pathway BEHAVIORAL

Structured robotic surgery training pathway incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model as part of a proficiency-based progression training pathway.

IMRA-Enhanced Training Pathway

Standard Training Pathway BEHAVIORAL

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

Standard Training Pathway

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Orsi Academy: lead

Study Sites (1)

Orsi Academy

Melle, Belgium, 9090, Belgium

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Study Officials

• Niki Rashidian

  Orsi Academy

  PRINCIPAL INVESTIGATOR

• Alexandre Mottrie

  Orsi Academy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Vanderstraeten

CONTACT

09 334 69 26; eva.vanderstraeten@orsi.be

Niki Rashidian

CONTACT

09 334 69 26; Niki.rashidian@orsi.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 25, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)