PBP Versus Halsted's Model: the PROVESA Trial (PROVESA)

March 3, 2021 updated by: Stefano Puliatti

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

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

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Traditional training group
Trainees in the Traditional trained group will be trained according to the traditional approach of 'See one, do one, teach one' principle. Trainees will have an e-learning didactic component (specifically on the anatomy & physiology 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 they will complete a summative assessment of their knowledge. They will then be shown how and then trained to suture and tie knots using the robot. The VUA will be demonstrated initially by an expert and who will then proctor the trainees in the same technique for repeated training trials., i.e., repeated practice for a period of time matched to the PBP group.
Procedure: Vesico urethral anastomosis on chicken model
Performance of a vesico urethral anastomosis on a chicken model with Da Vinci robotic system
EXPERIMENTAL: Proficiency based progression (PBP) training group: a new training methodology
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 before continuing to the surgical training. Their knowledge will be assessed in a formative and summative fashion. After their initial VUA assessment, procedure-specific and validated procedure metrics will be used to teach the students the steps of the procedure, as well as the correct (and incorrect) way to perform the procedure. The metrics will be used to give them performance feedback with specific advice on how they might improve their performance, i.e., deliberate practice.
Procedure: Vesico urethral anastomosis on chicken model
Performance of a vesico urethral anastomosis on a chicken model with Da Vinci robotic system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 1 year
The aim of this paper is to report the main outcomes of the PROVESA trial without emphasizing the interspecialty differences. The investigators will however emphasize its methodology, the fact that is well controlled and multicentric. Differences in proficiency level, assessed by binary performance metrics based assessment of a robotic suturing and knot tying task, will be reported.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cross-specialty differences in surgical proficiency levels, assessed by objectively assessed, validated, binary performance operative metrics, for a robotic suturing and knot tying task.
Time Frame: 1 year
Surgical skill is often thought to be associated to surgical discipline. The aim of this study is to compare the objectively assessed training outcomes of different surgical disciplines (Surgery, Gynecology/obstetrics and Urology) performing the robotic suturing of a vesico-urethral anastomosis (VUA) on a chicken model. Participants were trained according to a traditional versus a proficiency based progression methodology and were assessed by the use of validated, binary performance operative metrics.
1 year
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.
Time Frame: 2 years

Nowadays, different methods are used to assess surgical performance. One of the most commonly used methods is the GEARS (Global Evaluative Assessment of Robotic Skills). This is, however, a qualitative scoring method which uses a Likert scale for scoring and which might be prone to poor interrater reliability and subjectiveness.

The aim of this paper will be to report the interrater reliability of both scoring methods and the correlation between each other. Hypothesis is that interrater reliability will be superior for performance metrics. The investigators will try to answer the question which is the best tool to assess surgical performance.
2 years
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.
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 PROVESA, 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 PROVESA 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. Comparison between proficiency based progression training versus traditional training for a robotic suturing and knot tying task.
Time Frame: 2 years

During the PROVESA trial, all participants had to do an online assessment. This was done on an online learning platform using a questionnaire. A proficiency benchmark was set based on the mean score of experts on the same questionnaire.

The PBP group needed to do this after doing an online curriculum during which the operative metrics were explained. In order to move forward to the clinical training in the lab, they had to show proficiency on the test by reaching a pre-defined benchmark.

The Control group needed to do the online assessment after their day of training and after performing the final VUA. The investigators noted a significant correlation between the score on the online assessment and the number of metrics-based performance errors. The lower the score on the online test, the more performance errors they made.

The aim of this paper will be to stipulate the importance of e-learning and online scoring and its correlation with surgical performance.
2 years

Collaborators and Investigators

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

Sponsor

Stefano Puliatti

Investigators

  • Principal Investigator: Ruben De Groote, 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

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)

July 27, 2020

Primary Completion (ACTUAL)

August 15, 2020

Study Completion (ACTUAL)

August 15, 2020

Study Registration Dates

First Submitted

January 9, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (ACTUAL)

March 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PROVESA

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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