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
Phase: NA
Conditions: Educational Problems
Sponsor: Stefano Puliatti

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PROVESA trial 
 
Proficiency based progression training for robotic vesico-urethral anastomosis chicken model 
versus the Halsted’s model: a cross-specialty, multicentric, randomized and blinded clinical 
trial. 
 
Study Protocol 
 
Principal Investigator: Ruben De Groote, MD 
Research center: ORSI Academy, Melle, Belgium 
July 27th 2020 
NCT ID not yet assigned 
Ethical Committee approval number 22072020  
 
 
 

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Summary 
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 hypothesisied that iimplementation 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. 
 
 

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Proficiency based progression training for robotic vesico-urethral anastomosis chicken model 
versus the Halsted’s model: a prospective, randomized and blinded clinical trial. 
 
Introduction 
 
Current surgical training is outdated.1 The Halsted’s model ‘See one, Do one, Teach one’, is still widely 
used during training of surgeons. Consequently, a patient is still exposed to a novice resident who does 
the procedure for the very first time. For too long, surgical training is dependent on the quality of the 
trainer with a lack of systematics, standardization and objective scoring systems.2 Because of financial 
and ethical reasons, it can no longer be justified that the beginning of a learning curve takes place in the 
operating room on real life patients. By mitigating the initial learning curve in an out-of-hospital setting 
and by developing a standardized, novel training system, patient safety could be improved. 
Proficiency Based Progression (PBP)3-5 training or Quality Assured Training is a novel training method 
that already has demonstrated its value in different surgical specialties.6-12 In this kind of training a 
specific level of performance defined by a quantitative score (benchmark) or scores on a standardized 
assessment must be demonstrated to gain the proficiency level. Only demonstrating the ability to meet 
quantitatively defined performance benchmarks permits progression in training (i.e., proficiency-based 
progression [PBP] training).  
 
Background 
Suturing and knot tying are fundamental skills for all surgical disciplines. They serve an important 
clinical function but using a minimally invasive approach means that they are even more challenging to 
complete.  A curricular approach to learning laparoscopic suturing and knot tying has been successfully 
demonstrated for Nissen fundoplication.10    
Fundamental in creating a proficient robotic surgeon is the acquisition of basic surgical skills, such as 
suturing and knot tying.13  Some training models mimic the real anatomical environment in which a 
procedure will be performed and provide trainees with the opportunity to learn and practice their skills 
before starting their practice on real cases in the operating room. Numerous dry-lab, wet-lab, and virtual 
reality simulation models have been described.14  The “Venezuelan chicken model” is generally 
accepted as a optimal model for trainees to learn robotic suturing, anastomosis and knot tying tasks (for 
all surgical disciplines).14-16 We will use the Venezuelan chicken model in this study.  It has several 
advantages; it is inexpensive, widely available, easy to prepare, it is a good model for the urethro-vesical 
anastomosis training, it is possible to introduce a catheter and performing the leakage test, it takes the 
trainee approx. 20 mins to complete the task. Over the past 12 months ORSI has developed and validated 
(Delphi consensus and Construct Validity) performance metrics for the task. 
This study aims to compare the effectiveness of Halsted’s apprenticeship approach to training with the 
Proficiency Based Progression (PBP) approach for teaching the robotic suturing of a vesico-urethral 
anastomosis (VUA) on a chicken model.  
 
Methods 
Subjects 
Robotic naïve urology (n = 12), surgery (n = 12) and gynecology (n = 12) residents (n = 36) from the 
UKU Leuven and University of Gent residency training programs will participate. They will be 
randomized (using an online randomizer https://www.random.org/) to teaching of VUA suturing 
with either Halsted’s (n = 18) or the PBP method including procedure-specific, validated metrics (n = 
18).  

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Procedure and training 
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 a 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.  
Students 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.17 
Both groups of subjects will receive the exact same amount of training and have access the same didactic 
and training resources. Both groups will also complete a baseline assessment on the chicken model 
before technical skills training. Assessors, blinded to group membership and procedure order (first or 
last procedure) will evaluate each student’s first and final VUA with the validated chicken anastomosis 
metrics. They will also assess performance with the GEARS18 assessment tool (Figure 2). Additionally, 
the student’s satisfaction of the training method will be assessed using a Likert scale 1-5 (Figure 3). 
Proficiency Definition: In the study proposed here proficiency levels will be quantified and defined on 
the objectively assessed performance of surgeons experienced in performing that VUA task being 
trained.  This performance level will be established from the construct validation study of the 
procedure metrics derived from the procedure characterizations.4, 5, 19 
Performance assessments 
Investigators will be trained in pairs to assess performance from a pre-defined set of explicitly defined 
metric events reliably (inter-rater reliability > 0.8).  They will be blinded as to the identity of the 
trainee performing the procedure, how they were trained (i.e., group) and procedure order.  
Procedure performance assessment  
We will record how long subjects took to perform the procedure, the number of steps correctly 
completed and procedure errors/deviations from optimal performance. We will also record and cost 
the instrumentation/needles/suture etc utilised in the performance of the procedure. 
Baseline Assessment: -Prior to the commencement of education and training protocol all subjects 
from both groups will be assessed on their performance of the VUA task. Performance on the 
procedure will be video recorded and assessed as previously described. 
Statistical Analysis: From previous similar studies, it has been found that data has been reasonably 
normally distributed and suitable for parametric statistical analysis.  If the data violates any of the 
assumptions of normality, data will be compared for statistical significance with Mann-Whitney U for 
comparison between two independent samples and Wilcoxon signed-rank test. Where data are normally 
distributed with approximately equal variance differences between groups, task performance will be 
compared for statistical significance with two-factor Analysis of Variance where factor one is the type 
of training subjects received and factor two is the order the task was performed (i.e, baseline 

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performance and end of training performance).  The same analysis will be used to assess the binary 
checklist metric scores and the GEARS scores (seperatly) for the Standard trained and the PBP trained 
groups. Specific post hoc statistical contrasts between surgeon groups performance within a training 
condition (i.e., between the objectively assessed performance of urology, surgery and gynecology 
residents) will be done with Scheffe F-tests.    
Statistical power calculation: A pilot study has shown that novices on average make 16.6 (SD = 4) 
performance errors on the task. Assuming a reduction of ~40% with PBP training (i.e., 16.6 vs 10 errors) 
with a standard deviation of n = 4, an Alpha – 1% with 16 subjects in each group would yield a statistical 
power of 0.998 for the proposed study.  
 
 
 
Figure 1. the design of the prospective randomized study to evaluate the impact of PBP on learning the 
robotic surgical skills for a vesico-urethral anastomis (VUA) on a chicken model. 
 
Hypothesis 
H1 
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. 
H0  
There will be no difference in the procedure knowledge prior to VUA training   
H0  
There will be no difference in the objectively assessed procedure performance of the urology, 
surgery and gynecology residents at the end of training in the PBP group 
H0  
There will be a difference in the objectively assessed procedure performance of the urology, 
surgery and gynecology residents at the end of training in the Traditional trained groups.  
H0  
There will be no difference in student satisfaction with the two approaches to training. 

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Figures 2. The GEARS assessment tool 
 
 

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Figure 3: Likert-scale for the assessment of training satisfaction 
 
 

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