Clinical trial NCT04786834: PBP Versus Halsted's Model: the PROVESA Trial
Official title: Proficiency Based Progression Training Versus the Halsted's Model for a Robotic Vesico-urethral Anastomosis on an Avian Tissue Model: a Prospective, Randomized, Multicenter and Blinded Clinical Trial: the PROVESA Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Keywords: surgery
robotics
training
vesico-urethral anastomosis
Proficiency Based Progression
Basic skills training
Lead sponsor: Orsi Academy
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This randomized controlled trial aims to compare the effectiveness of Halsted's apprenticeship approach to training with the PBP approach for teaching the robotic suturing of a VUA on a chicken model.

Detailed description: In a prospective, randomized and blinded study robotic naïve (urology (n = 12), surgery (n = 12) and gynecology (n = 12)) residents (n = 36) from the KU Leuven and University of Gent residency training programs will be randomized (in equal discipline numbers) to Traditional Halstedian apprenticeship type training or proficiency based progression (PBP) training to learn to perform a vesico-urethral anastomosis (VUA) on a chicken model. Both groups will receive the same e-learning (on how to perform the VUA on the chicken model) and skills laboratory robotic training curriculum. The PBP trained group will however be required to demonstrate quantitively defined proficiency benchmarks for training progression (i.e., from e-learning to the skills lab). The PBP group will also have a defined benchmark to demonstrate before training is deemed completed. The Traditional trained group will train in the same skills laboratory for a case-matched period of time as the PBP group, with the same level of supervising faculty proctors and using the same training resources but with no proficiency benchmarks or metric-based feedback. Both groups will be required to perform a VUA on the chicken model before skills training proper and at the end of training. Investigators will be trained in pairs to assess VUA performance from a pre-defined set of explicitly defined binary metric events reliably (inter-rater reliability \> 0.8). They will also be blinded as to the identity of the trainee performing the procedure, how they were trained (i.e., group) and procedure order.

H1 It is hypothesized that implementation of PBP training in teaching the robotic suturing of VUA leads to better surgical training outcomes (i.e., lower number of performance errors) when compared to Halsted's method.

Eligibility criteria: Inclusion Criteria:

* recently accepted, first or second year residents gynecology and obstetrics (n=12), urology (n=12) and general surgery (n=12). Novice in robotic surgery.

Exclusion Criteria:

* Any robotic experience

Primary outcomes:
measure: Surgical proficiency level determined by objectively assessed, validated, binary performance operative metrics. Comparison between PBP training versus traditional training for a robotic suturing and knot tying task.
timeFrame: 1 year
Secondary outcomes:
measure: Cross-specialty differences in surgical proficiency levels, assessed by objectively assessed, validated, binary performance operative metrics, for a robotic suturing and knot tying task.
timeFrame: 1 year
measure: Difference in interrater reliability for metrics-based scoring determined by objectively assessed, validated, binary performance operative metrics versus GEARS-based scoring of a robotic suturing and knot tying task.
timeFrame: 2 years
measure: Trainee's satisfaction as assessed by questionnaire with Likert scale. Does it influence outcome of surgical training? Comparison between proficiency based progression training versus traditional training for a robotic suturing and knot tying task.
timeFrame: 2 years
measure: Correlation between live and video-based scoring of surgical performance
timeFrame: 2 years
measure: Reporting the outcome of the e-learning scores from an online proficiency questionnaire on an online learning platform. Comparison between proficiency based progression training versus traditional training for a robotic suturing and knot tying task.
timeFrame: 2 years
Other outcomes:
Locations:
city: Melle
country: Belgium
facility: Orsi Academy
state: Oost-Vlaanderen
Study officials:
affiliation: Orsi Academy
name: Ruben De Groote, MD
role: PRINCIPAL_INVESTIGATOR
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