Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04541615 |
| Other study ID # |
22/07/2020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 25, 2020 |
| Est. completion date |
September 20, 2020 |
Study information
| Verified date |
December 2020 |
| Source |
Orsi Academy |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The training of robotic surgical procedural skills has been challenged by changes in work
practices and safety concerns specifically related to training. In surgery and procedural
medicine simulation-based training has been demonstrated to supplant the early part of the
learning curve. Training in the skills laboratory is however expensive because of equipment
and supervision burdens. In this study the investigators will assess the economic impact of
proficiency-based progression (PBP) e-learning training prior to training in the skills
laboratory. 48 trainees will be randomly assigned to one of four groups. 1) will receive an
apprenticeship type training (Group 1 ; n=12), 2) A standard or traditional trained group
(Group 2; n=12) will then receive face-to-face lectures on how to perform the robotic
surgical training task (i.e., ORSI chicken anastomosis task for learning robotic suturing and
knot tying.) 3) The third group (Group 3; n=12) will have e-learning training prior to
training in the skills laboratory and then learn the same task. 4) The fourth group (Group 4;
n=12) will have the exact same pre-course e-learning curriculum as Group 3 but will be
required to study it until they score at the quantitatively defined proficiency benchmark of
experienced robotic surgeons, i.e., the mean performance level of experienced robotic
surgeons - they can complete the task with <10 performance errors.
The research will be conducted at the laboratory skills lab of Orsi Academy, Proefhoevestraat
12 9090 Melle. It will be conducted by Maxime Lasseel and Laura Langhendries, under direct
guidance of Dr. S. Puliatti, Prof. A.G. Gallagher and Prof. A. Mottrie.
Description:
Simulation-based training has been shown to be an effective way to prepare the trainee for
the operating room. Gallagher et al. have demonstrated in a number of studies that
proficiency-based progression (PBP) simulation training works best when it is integrated into
a curriculum. Learning is optimal when trainees receive metric-based feedback on their
performance. Metrics should unambiguously characterize important aspects of procedure or
skill performance. They are developed from a task analysis of the procedure or skills to be
learned. The outcome of the task analysis should also shape how the simulation looks and
behaves. Metric-based performance characterization can be used to establish a benchmark
(i.e., a level of proficiency) which trainees must demonstrate before training progression.
This approach ensures a more homogeneous skill-set in graduating trainees and can be applied
to any level of training. Prospective, randomized and blinded clinical studies have shown
that trainees who acquired their skills to a level of proficiency on a simulator in the
skills laboratory perform significantly better in vivo in comparison to their traditionally
trained colleagues. Although simulation-based training has been shown to be very effective in
helping trainees acquire skills for the operating room. Acquiring skills in the skills
laboratory, outside the operating is no doubt significantly safer for patients as they can
acquire skills at the start of their learning curve, away from the operating room. The skills
laboratory is however a very expensive resource particularly for the acquisition of skills to
used advanced technologies such as surgical robots. It is recognised that inadequate training
in robotic surgery results in increased complications and higher costs. Standardising modular
training with defined steps and the errors to avoid will enable proficiency-based progression
(PBP) training. Skills training for robotic surgery is some of the most expensive training
space in medicine. It therefore should be used efficiently.
E-learning is naturally suited for the delivery of multisensory information such as material
associated with learning to perform surgery. It can provide a flexible learning environment
that can be used as an adjunct to face-to-face teaching, skills laboratory training and
clinical surgery training for both novice and very experienced operators. E-learning offers
particularly exciting opportunities for augmenting the learning process in surgery and
procedural medicine. For example, in a well-delivered traditional lecture, the academic has
very few ways of knowing how effectively they have imparted the information that they are
trying to communicate.
Furthermore, it would be unrealistic to expect that all of the audience would be learning at
the same pace, but the traditional lecture is delivered in the standard 40 - 50 minute time
period to the individuals sitting in the same room. The hope is that by the time of the exam,
everyone is at a sufficient standard to at least pass the course. If the material is
delivered on an e-platform, the progress of each individual can be tracked with a formative
assessment process. This means that individuals who learn at a slower pace can have their
education supplemented automatically or they can be flagged for direct academic intervention.
E-learning also suits the PBP methodology in that only trainees who have demonstrated the
requisite proficiency benchmark actually get training in the skills laboratory. The aim of
this study is to quantitatively assess the economic impact and cost savings (if any) of
requiring trainees to study a robotic surgical task until they demonstrate a defined
performance benchmark before commencing their technical skills training in the skills
laboratory.
As recently outlined during the first European multi-specialty consensus meeting on robotic
surgery training, a fundamental step in creating a proficient robotic surgeon is the
acquisition of basic surgical skills, such as suturing, knotting, coagulating and dissecting.
Among numerous dry models, the Venezuelan chicken model seems to be ideal for suturing,
anastomosis and knotting exercises, not only in the urological field but in all robotic
surgical disciplines. The participants will be working with this model.
Methods:
The design of this study is shown in Figure 1. It is a prospective, randomized and blinded
study where 48 trainees will be randomly assigned to one of four groups. They will all
complete educational and training tasks that prepare them for the completion of the ORSI
chicken anastomosis task. They will continue training on the task until they can perform the
task to quantitatively defined proficiency benchmarks. The outcome of this study is the
amount of resources used by each group to get to the proficiency benchmark.
Subjects:
48 university educated novice subjects will be randomly assigned to four different training
conditions.
Materials:
ORSI robotic surgery chicken anastomosis task:
The chicken has all the abdominal organs removed, except 6-8 cm of the cloaca (starting
measurements from the anus) and the stomach. The stomach will simulate the human bladder neck
and the cloaca will simulate the human urethra. The similarity of the model is increased by
the possibility of positioning a catheter inside the cloaca both during and at the end of the
procedure.
Instruments and Robot positioning:
The model must be placed on the surface of a table, at the same height as a normal operating
table. All models of surgical robots currently on the market can be used to perform the task.
The docking of the robot must be performed following the normal rules used for robotic
surgery. In particular, the camera trocar must be at a distance of 18-20 cm from the target.
Robotic trocars must be positioned at a distance of 8-10 cm apart. The instruments suggested
are 2 large needle drivers and 1 prograsp forceps. 2 polysorb stitches of 10 cm each, knotted
at the end with 4 knots can be used to perform the anastomosis.
Metrics:
The procedure metrics for a reference anastomosis and knotting in a chicken model were
developed by a procedure characterization group consisting of 4 surgeons and a behavioral
scientist. The surgeons had previous large substantial hand-on training experience in the
lab. Procedure phases steps, errors and critical errors were also outlined.
Suturing and knotting task:
The aim of the exercise is to perform a hermetic circular anastomosis that allows connecting
two anatomical tubular structures. Always using an outside-inside direction in the stomach,
and inside-outside in the cloaca, two hemi-continuous sutures must be performed, knotting the
two threads at the end.
The basic steps into which the exercise is divided are:
- posterior Wall (first 4 bites on stomach and cloaca);
- right and left lateral wall (the bites between the posterior and the anterior wall;
- anterior wall (the last 4 bites on stomach and cloaca);
- knotting (one double knot and two single knots to close the anastomosis).
The errors that the trainee can commit during the execution of the task can be divided into
two categories: suturing operative errors and knotting operative errors.
These technical errors result in alterations of the needle, breaking of the suture thread,
lesions to the biological tissue or can lead to inadequate final result.
The breakage of the needle or suture thread and the leakage of water to the final test
performed through the catheter, are considered critical errors.
The time limit for performing the exercise is 25 minutes. The lack of progress made in a
specific step of the anastomosis for the time of 1 minute is considered as a "failure to
progress" error.
Assessment Pre-assessment of subjects Robotic surgery requires two-handed coordination of
instruments with a monitor image, in three-dimensional space and, consequently, necessitates
complex ambidextrous psychomotor, visio-spatial, and perceptual skills. These abilities are
not uniformly distributed in the population and therefore to ensure that subjects are of
comparable abilities all participating subjects will undergo a psychometric assessment which
will assess their visio-spatial, perceptual and psychomotor coordination.
Psychomotor Assessment All participating subjects will be required to perform a simple task
psychomotor task on the robot prior to training proper.
Visuospatial Assessment
The visuospatial assessment includes the use of three fixed length, fixed format,
self-administered tests to evaluate the ability to receive, interpret, and apply meaning to
visual information as measured in constructional skills and visual perceptual tests. The
cognitive tests administered during this study will be:
1. Cube Comparisons Test - designed to evaluate ability to detect differences in 3
dimensional cubes.
2. Card Rotations Test - designed to evaluate ability to detect differences in 2
dimensional figures.
3. Map Planning Test - designed to evaluate ability to determine the shortest route between
two places Perceptual Assessment The perceptual assessment will include a fixed length,
fixed format, self-administered, computer generated test (PicSOr) used to evaluate the
ability to interpret three dimensional (3-D) structures from two dimensional (2D)
displays. It is scored using an interval/ratio scale with values that range between 0.0
and 1.0. A score of 1 = perfect ability to reconstruct 3-D from 2-D cues; a sore of 0 =
inability to reconstruct 3-D from 2D cues. In large-scale international studies most
surgical residents perform the task well but a small group have demonstrated they have
struggle with it.
Procedure Group 1: Pre-trained Group (online didactic to proficiency- PBP++) Group 1
Pre-trained group will receive information on how to optimally perform the ORSI chicken
anastomosis task and the material will be delivered online via the ORSI e-learning platform.
They will be given access to the material two weeks before their training. Unlike the other
groups, Group 1 will be required to study the material to a pre-defined performance benchmark
or proficiency level.
Group 2: Pre-trained Group (online didactic- PBP+) The Pre-trained group (Group 2) will
receive the exact same information as Group 1 on how to optimally perform the ORSI chicken
anastomosis task but the participants are not required to study the material to a pre-defined
proficiency benchmark. The time the subjects spend on the task and effort expended will be
logged.
Group 3: Standard training group The standard trained group will receive face-to-face
lectures on how to perform the ORSI chicken anastomosis task. It will not differ from what
they would normally receive during a traditional surgery training course when they arrive at
the ORSI academy for their training. The content of the face-to face lecture is the same as
in the e-learning courses.
Group 4: Apprenticeship Group The apprenticeship trained group will not receive face-to-face
lectures or e-learning on how to perform the ORSI chicken anastomosis task. They will however
receive hands-on practical one-to-one training during a traditional surgical training course,
with deliberate practice. They will also receive published materials describing how best to
perform the task and mentoring on suturing and knot tying by a task expert who will guide
their performance.
Proficiency definition Proficiency will be quantitatively defined on the mean of the
objectively assessed performance of experienced consultant surgeons who are also experienced
in performing robotic suturing, knot tying and anastomosis.
