- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07669974
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Eva Vanderstraeten
- Telefonní číslo: 09 334 69 26
- E-mail: eva.vanderstraeten@orsi.be
Studijní záloha kontaktů
- Jméno: Niki Rashidian
- Telefonní číslo: 09 334 69 26
- E-mail: niki.rashidian@orsi.be
Studijní místa
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-
Belgium
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Melle, Belgium, Belgie, 9090
- Nábor
- Orsi Academy
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Kontakt:
- Niki Rashidian
- Telefonní číslo: 09 334 69 26
- E-mail: niki.rashidian@orsi.be
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
|
Structured robotic surgery training pathway incorporating the IMRA Surgical Prostatectomy Class V Hydrogel Model as part of a proficiency-based progression training pathway.
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Aktivní komparátor: 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.
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Standard robot-assisted radical prostatectomy training pathway without use of the IMRA Surgical Prostatectomy Class V Hydrogel Model
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Achievement of Proficiency During Day 5 Human Cadaver Assessment Using Validated Robot-Assisted Radical Prostatectomy Assessment Metrics
Časové okno: At completion of Day 5 human cadaver training assessment
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Technical Performance Assessed Using Validated Robot-Assisted Radical Prostatectomy Assessment Metrics
Časové okno: At completion of Day 5 human cadaver training assessment
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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.
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At completion of Day 5 human cadaver training assessment
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Self-Reported Confidence Assessed Using a Study-Specific Participant Confidence Questionnaire
Časové okno: End of training course - Day 5
|
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.
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End of training course - Day 5
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Workload Assessed Using the NASA Task Load Index (NASA-TLX)
Časové okno: Immediately after completion of the relevant training session
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Participant workload measured using the NASA Task Load Index questionnaire.
Total score range: 0-100, with higher scores indicating greater perceived workload.
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Immediately after completion of the relevant training session
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Feasibility and Acceptability Assessed Using a Study-Specific Training Evaluation Questionnaire
Časové okno: End of training course - Day 5
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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.
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End of training course - Day 5
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Niki Rashidian, Orsi Academy
- Vrchní vyšetřovatel: Alexandre Mottrie, Orsi Academy
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- ORSI-IMRA-2026-01
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