Clinical trial NCT06147128: PBP vs Traditional Training: the T-REC Trial
Official title: Proficiency Based Progression Training Versus Traditional Training During a Robotic Emergency Conversion Due to a Vessel Injury in a Simulated Setting: a Prospective, Randomized, Multicenter Clinical Trial: The T-REC Trial
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Educational Problems
Keywords: Training
Robotic surgery
Proficiency based progression
Emergency undocking
Lead sponsor: Orsi Academy
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents in urology, surgery and gynecology from Belgium universities (i.e. the KU Leuven and University of Gent residency training programs) from the first to the last year.

Brief summary: This randomized controlled trial aims to compare the effectiveness of traditional training approach to training with the proficiency-based progression (PBP) approach for teaching the technical skills (TS) and non-technical skills (NTS) for surgeons in the context of an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery.

Detailed description: In a prospective, randomized and blinded study surgical residents (n = 48) from Belgium university (i.e. the Katholieke Universiteit \[KU\] Leuven and University of Gent residency training programs) will be enrolled and randomized to Traditional type training proficiency-based progression (PBP) training to learn how to perform an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model. Specifically, this study will include four independent arms, each employing different training methodologies for technical skills (TS) and non-technical skills (NTS).

Group 1 will receive standard training for both TS and NTS. Group 2 will receive PBP training for TS and standard training for NTS. Group 3 will receive standard training for TS and PBP training for NTS. Group 4 will receive PBP training for both TS and NTS.

All four group will receive the same e-learning on TS and NTS (on an emergency scenario where (simulated) open conversion is necessary due to vessel injury during robotic surgery on a dry lab model). The PBP trained group will however be required to demonstrate quantitively defined proficiency benchmarks for training progression (i.e., for the e-learning, TS and NTS). The Traditional trained group will train in the same 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.

Investigators will be trained in pairs to assess 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 TS and NTS for surgeons in the context of an emergency scenario where (simulated) open conversion is necessary due to vessel injury during robotic surgery, leads to better surgical training outcomes (i.e., lower number of performance errors) when compared to traditional training.

Eligibility criteria: Inclusion Criteria:

* recently accepted, form first to last year residents' gynecology and obstetrics, urology and general surgery.
* Ability to perform a laparotomy

Exclusion Criteria:

* Any robotic experience with emergency undocking.

Primary outcomes:
measure: Comparison between PBP training versus traditional training for an emergency scenario where an open conversion is necessary due to a (simulated) vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system.
timeFrame: 1 year
Secondary outcomes:
measure: Trainee's satisfaction as assessed by questionnaire. Does it influence outcome of surgical training? Comparison between PBP training versus traditional training group.
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.
timeFrame: 2 years
Other outcomes:
Locations:
city: Melle
country: Belgium
facility: Orsi Academy
state: Oost - Vlaanderen
Study officials:
affiliation: Orsi Academy
name: Claudia Collà Ruvolo, MD
role: PRINCIPAL_INVESTIGATOR
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