PBP vs Traditional Training: the T-REC Trial (T-REC)

November 25, 2023 updated by: Orsi Academy

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost - Vlaanderen
      • Melle, Oost - Vlaanderen, Belgium, 9090
        • Orsi Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active Comparator: Traditional Trained
Trainees in the Traditional trained group will have an e-learning didactic component (specifically on the steps of the procedure, clinical aspects of the procedure, published evidence etc) which they must complete before training by a procedure expert. On completion of the e-learning module the trainees will complete a summative assessment of their knowledge. The trainees will then be shown how and then trained to perform an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery task. The scenario will be demonstrated initially by an expert and who will then proctor the trainees in the same technique.
Procedure: Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model
Performance of emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system
Other Names:
  • Robotic emergency conversion
Experimental: PBP for Technical emergency undocking skills
Participants in the PBP trained group will follow the exact same e-learning didactic course as the Traditional trained group but the PBP group will be required to pass a test of procedure knowledge on TS before continuing to the robotic surgical training element. The trainees knowledge will be assessed in a formative and summative fashion. After the trainees initial assessment, procedure-specific and validated procedure metrics will be used to teach them the steps of the emergency undocking procedure, as well as the correct (and incorrect) way to perform it. The metrics will be used to give to the trainees performance feedback with specific advice on how they might improve their performance, in the regards of technical skills.
Procedure: Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model
Performance of emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system
Other Names:
  • Robotic emergency conversion
Experimental: PBP for Non-Technical emergency undocking skills
Participants in the PBP trained group will follow the exact same e-learning didactic course as the Traditional trained group but the PBP group will be required to pass a test of procedure knowledge on NTS before continuing to the robotic surgical training element. The trainees knowledge will be assessed in a formative and summative fashion. After the trainees initial assessment, procedure-specific and validated procedure metrics will be used to teach them the steps of the emergency undocking procedure, as well as the correct (and incorrect) way to perform it. The metrics will be used to give to the trainees performance feedback with specific advice on how they might improve their performance, in the regards of non-technical skills.
Procedure: Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model
Performance of emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system
Other Names:
  • Robotic emergency conversion
Experimental: PBP for Technical and Non-Technical emergency undocking skills
Participants in the PBP trained group will follow the exact same e-learning didactic course as the Traditional trained group but the PBP group will be required to pass a test of procedure knowledge on both TS and NTS before continuing to the robotic surgical training element. The trainees knowledge will be assessed in a formative and summative fashion. After the trainees initial assessment, procedure-specific and validated procedure metrics will be used to teach them the steps of the emergency undocking procedure, as well as the correct (and incorrect) way to perform it. The metrics will be used to give to the trainees performance feedback with specific advice on how they might improve their performance, in the regards of technical and non-technical skills.
Procedure: Emergency scenario in a simulated setting where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model
Performance of emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system
Other Names:
  • Robotic emergency conversion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 1 year

Proficiency level will be determined by objectively assessed, validated, binary performance operative metrics where the proficiency benchmark is defined on the mean of the objectively assessed performance of experienced practitioners.

The aim of this study is to report the main performance outcomes of the T-REC trial. The investigators will compare differences between four groups in performance level as assessed by binary performance metrics of an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system.

The four groups deffers for the training methodology used (PBP vs traditional training). The dependant variables will be the i) time required to complete the procedure, ii) the number of procedure steps completed, iii) the number of errors made, iv) the number of critical errors made and whether the procedure was completed or not.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trainee's satisfaction as assessed by questionnaire. Does it influence outcome of surgical training? Comparison between PBP training versus traditional training group.
Time Frame: 2 years

Satisfaction of a surgical trainee is often thought to be key for training quality and a predictor of good outcome of surgical training. At the end of the T-REC trial, all participants were asked to complete an online questionnaire where their satisfaction with the adopted training method was asked for using a Likert scale.

Hypothesis is that trainee's satisfaction does NOT correlate with training outcome and that satisfaction is NOT a good determinator of training quality.
2 years
Correlation between live and video-based scoring of surgical performance
Time Frame: 2 years

Surgical performance is often assessed live during surgery. However, one might miss specific details of performance. A possible answer to this query lies in video-based scoring of a surgical task. However, does video-based scoring reflects the same surgical quality? Moreover, one could question the ethical aspect of non-live scoring of surgical performance.

In the T-REC trial, all surgical tasks were scored live and video-based afterwards. The correlation in metrics-based performance scores between live and video-based assessment will be investigated.

Hypothesis is that there will be no differences. The investigators will try to answer the question which scoring method will give the trainee the highest chance of reaching proficiency?
2 years
Reporting the outcome of the e-learning scores from an online proficiency questionnaire on an online learning platform.
Time Frame: 2 years
During the T-REC trial, all participants will be required to complete an online assessment. This will done on an online learning platform. A proficiency benchmark will be defined based on the mean score of experts on the same assessment. The PBP group will be required to pass this assessment in order to move forward to the clinical training in the lab. The Control group will be required to complete the exact same online assessment before and after their training and after performing the final task. The investigators aim to do a comparison between proficiency based progression training versus traditional training for a emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model with Da Vinci robotic system task in the regard of the e-learning scores.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orsi Academy

Investigators

  • Principal Investigator: Claudia Collà Ruvolo, MD, Orsi Academy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2023

Primary Completion (Estimated)

December 3, 2023

Study Completion (Estimated)

January 31, 2024

Study Registration Dates

First Submitted

November 19, 2023

First Submitted That Met QC Criteria

November 19, 2023

First Posted (Actual)

November 27, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 25, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • T-REC

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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