N. PELLICANO' Gastric Banding

And Professor Costamagna, that is the head of the surgical endoscopy unit of the Policlinico Gemelli in Rome,

is the hospital of the poop, just to give you an idea.

And he's a very expert surgeon and endoscopist.

And Marco Lirici, that is a good friend and is one of the pioneers of laparoscopy and especially single-port surgery in Italy.

So, the session is basically the philosophy is to show what has been done already in the

notes field, basically is to show the current clinical application of this new approach

and also what could be achieved in the next future thanks to the new technology and what

what we have to, especially to work on

in the field of education.

And so, just to introduce to the audience,

Brian Duncan is a sergeant,

is the head of the Surgical Endoscopic Unit

of the Methodist Hospital in Houston.

But I think above all those things,

he's the medical director

of the Methodist Institute for Technology,

is the MITI, MITI.

How do you pronounce that correctly, Brian?

Mighty, of course. It's Texas.

Mighty, okay.

And I think, I hope that he would introduce this institute

that is a fantastic facility that is just opened in the United States.

It's the first of such a size in all the United States.

And it's basically devoted to teaching, training,

and research in the field of new technology.

So, he's a very expert in this field.

And he's also on the board of the SAGES, that is the American Society for Endoscopic Surgery.

And so, he's really one of the most relevant experts in the field.

So, Brian, I would say that we don't want to take more of your time because you have to go, I know, to the clinical work.

So, if you want to start your presentation, it would be welcome.

I'm more than happy to.

and good morning everyone from Houston, Texas. It's a beautiful sunny morning here. I understand

you just finished your lunch, and I'm hoping that the conference is going well. I really

appreciate the honor of being able to join the conference by audio-video link this morning.

I was asked to talk about new technologies and educational challenges for notes,

particularly from the American perspective and so I'm going to spend

our time talking about giving some examples of technology that is being

brought to the field of notes and then talking about the challenges of

introducing that technology into the hands of surgeons who are trying to pick

up these techniques so we'll be discussing challenges of measuring skill

particularly in flexible endoscopy how do you retool the surgical workforce

force, the concept of establishing an educational home through your career as a practicing surgeon,

and then give some examples of what I think are some novel ways of measuring procedural

competence.

So I want to begin by just giving some examples of technology that you're going to see and

hear about in the conference around notes as a way of introducing this idea of how do

you introduce this safely to our patients for the first time? And a few examples, this is the

notes toolbox from Ethicon, a very robust toolbox of different tools meant to work through a

flexible endoscopic platform in order to allow surgeons to do surgical procedures on that

platform. Other examples are the overstitch from Apollo Endosurgical, a suturing device that can

can put meaningful, full-thickness sutures into the wall of the GI tract

and is mounted on the end of a flexible scope.

We even have computer-driven endoscopes now, like this one from NeoGuide,

actually technology that's been purchased by Intuitive,

the company that makes the surgical robots.

And so this is an example of a computer-driven endoscope

that can add navigation and stability to that flexible endoscopic platform,

something that I believe is going to be critical for doing meaningful notes procedures.

And even in other specialties like cardiology, there are amazing technologies.

This is the Hansen device.

This is a catheter that's driven by a robotic system for doing endovascular procedures, particularly within the heart.

And our institution actually has two of these devices in our cardiac catheterization lab.

And so we're using robotics to drive a flexible platform to do endovascular procedures.

So, and also another example of technology, this is a mini robot platform by Dr. Dmitry

Aliknikov at the University of Nebraska.

This is a, you can see the scale of it, that's an American 10 cent dime next to it.

This is a small device that folds up and can be put into the abdomen and then unfolds with

those two arms.

It has stereoscopic vision and mounts to the underside of the abdominal wall using a magnetic

coupling device and allows you to drive around in the abdomen.

Another example of really sophisticated technology that's being brought to bear in minimally

invasive procedures.

So we have this terrific technology.

technology you're going to hear from clinicians this afternoon about how they're using different

technologies to do some amazing things in the area of notes and as clinicians we see the technology

we see the techniques and we're ready to go we want to take this into the operating room and

start doing this for our patients well particularly in the U.S. there are a number of forces that say

say, wait a minute, hold on. Let's talk about this for a second. You're a surgeon and you want to use

a flexible endoscopy platform to do surgery. What are your credentials for doing that? What is the

training that you've had that assures me and assures our patients that you're able to use

that flexible endoscopic platform well? And in fact, we often get into this kind of struggle

where we have gastroenterologists who are experts on flexible endoscopic platforms

and surgeons who are experts at surgery and minimally invasive techniques

kind of struggling against each other to decide who does what

and who has the skills to do procedures using a flexible platform.

And our real problem is this.

We don't have an objective, reliable, and validated tool to assess endoscopic technical skill.

guilt. And because we don't have this tool, we substitute other things that we try to have

tell us if you're any good or not at doing this procedure. One of the things we substitute is

numbers. How many have you done? Logically, this makes sense. If you've done a number of procedures,

you should have experience and be better at it. And there's a lot of studies out there to try to

look at numbers as a measure of procedural competence in flexible endoscopy, and the data

it is quite messy. This abstract, which actually has never been published as a peer-reviewed

article, is the most quoted abstract in the U.S. literature about the number of procedures

required to be able to do upper or lower endoscopy well. Basically, Cass did a study looking

at GI fellows from multiple institutions and following their learning curve through their

training and determined that it took about 130 upper endoscopies and 140 colonoscopies

in order to do those procedures successfully. There are other studies like the one from Reed

that was published in Surgical Endoscopy looking at literally thousands of upper endoscopies

and trying to determine the learning curve and actually could not discern the learning curve.

It took only 10 cases for experts and novices to have about the same procedure time and success rate doing upper endoscopy.

Wexner looked at thousands of cases of colonoscopy and determined that if he had done about 50 colonoscopies in a training program

and then averaged 100 colonoscopies per year, you were as successful with the same number of complications as experts who had done more than that.

So numbers don't seem to work well as a surrogate, and we know this from the surgical field.

We need better measures of procedural competence.

There are other pressures that are pushing surgeons to pick up the flexible endoscopy platform,

not just notes, although that has certainly awakened the surgical community to flexible endoscopy.

This is a partial list of disease states that all used to be managed with surgery,

And now every one of these has the option for managing that problem with a flexible endoscopic alternative.

And many of them, flexible endoscopy is the preferred choice for managing that problem.

So as a minimally invasive surgeon, you have to see the writing on the wall that says the natural evolution of our specialty is to get less invasive.

And to do that, we need to be able to use a flexible platform.

flung. In my country, the other force that's pushing surgeons to do flexible endoscopy

is rural surgery. We have many surgeons who are in small communities in the United States,

and when they report to the American Board of Surgery what their surgical experience is,

the number one procedure that they do day in and day out is colonoscopy. And so we have

have surgeons in environments in our country that need to become experts at flexible endoscopy,

and we have to have ways to assure that they're competent to do that. So how do we resolve this?

We want to use a flexible endoscopic platform. We want to introduce new technology into our OR,

and we want to do that safely. What are strategies to do this well? I would point you to this

article. This was a paper published a year ago. It is a report by a group of surgeons from the

American Surgical Association, a leading academic surgical association in the U.S., discussing the

issues around privileging and credentialing for surgeons in the United States. And they identified

a few interesting issues. First of all, they said, look, this is a large issue. Surgical education

for practicing surgeons is a large issue. In fact, it's a larger issue than dealing with our

trainees. In surgical education, we often focus on trainees, residents and fellows, and trying to get

them the best experience possible. But the real part of the workforce that's in need is the

practicing surgeon. Once you go out into practice and you're in that busy environment, how do you

learn new techniques and new technology like notes and then bring that safely into your

practice without having to leave your practice for significant periods of time.

The other thing this article did was it identified eight areas or eight principles that they

thought were important to improve the privileging and credentialing process for surgeons.

I'm only going to focus on two.

One of them is this one, principle number five, and it states that we should be granting

privileges for new procedures by having surgeons demonstrate technical proficiency in a proctored

environment, and then we should follow the early part of their learning curve and have them report

to us how they're doing when they first start doing these on real patients. This sounds like

a very logical approach, but I would tell you I think the public would be amazed that we don't

do this now. There is no structured way to introduce new technology into our operating rooms

and assure everyone that we're doing that safely.

The other principle is this one, that this group said,

we need a new infrastructure to support surgical training.

We need places that surgeons can go to retool, to learn about these new devices.

And I tend to call that we need an educational home.

We need a place where surgeons can intermittently, through their career,

go back to a place and learn new techniques and new technology

and demonstrate the expertise that they say they have.

So as Antonello mentioned, I'm at the Methodist Institute of Technology, Innovation, and Education in Houston, Texas.

This is a very large, comprehensive education and research institute

that was built specifically for that principle number eight.

How do we help practicing clinicians learn new things?

And so our mission statement is to be an educational resource for practicing healthcare professionals

professionals, seeking to maintain excellent skills and acquire new ones.

And like some of the places that you've seen and that you're in today, it is a comprehensive

facility, about 40,000 square feet, a large procedural training lab, and all of the components

that you need to have a very meaningful experience so that when a practicing surgeon comes into

this environment and wants to learn something, they're in a professional facility that knows

how to do that well. We also think it's extremely important to be able to show

surgeons live procedures where they can see experts in action dealing with the

typical problems of a procedure so that they're ready to to handle that when

they go back to their home institution. And so you can see that kind of

connectivity that's built into MITEI. We're a busy place although we're young

so I came to Houston in the end of 2006 to build MITEI.

We've had over 5,000 professionals come through and train so far,

and we expect another 5,000 to come through this year alone.

And I give MITEI as an example of some ways that we're trying to impact this world

of introducing new techniques and the credentialing environment.

We have physicians from multiple specialties and multiple disciplines coming to train,

And one of those areas in particular is around minimally invasive techniques and flexible endoscopy.

And I want to give a few examples of how the institution is using MITEI as a credentialing platform for clinicians in our environment.

One of them is around flexible endoscopy.

So the Digestive Disease Center at the Methodist Hospital in Houston, Texas, has decided that any new procedure that's brought into our center that is substantially different from what we do now must be first rehearsed in MITEI before it's brought to the real clinical environment.

And we bring not only the physicians, but the nurses and the technicians into that environment to rehearse those procedures.

procedures. Here's a partial list of the things we've done. So when we've introduced radiofrequency

ablation for Barrett's esophagus, that was done in a training environment. Also for peroral

choledocoscopy, electrohydraulic lithotripsy, and new endoscopic therapies for gastroesophageal

reflux disease. In our surgical environment, we do the same. So if you're a surgeon at Methodist

and you want to use the surgical robot in the operating room,

you must go through a hands-on training program that helps you to do that.

And we've used MITEI to develop new surgeries as well.

One of them was our mitral valve repair using a robotic platform.

That surgery was rehearsed in MITEI with the entire operative team.

And when they had the steps of that surgery rehearsed well

and they had the timing of that surgery down to a point that it equaled what they were able to do

in open surgery, then and only then did they bring it to the real clinical environment.

We also do interesting things. I implant electrodes in patients who have quadriplegia.

I implant electrodes into their diaphragm so that we can help them to breathe without their

ventilator. That new technique was introduced first and mighty before we did our first case

in the operating room. We also use it for other things across the hospital. So when the

anesthesiologists have a new platform that they're going to be using for patients, that was rehearsed

in MITEI. Procedural devices, endomechanical devices, even everyday things like new IV infusion

pumps, all of those are introduced through the MITEI platform before they're rolled out to the

hospital. And as a final example, we used MITEI as a platform for doing what we call root cause

analysis. So as an example, one of our orthopedic operating room suites unexpectedly developed an

infection issue which we had not seen before. And we were able to close that operating room,

rehearse with the entire operating room team all of the steps of doing joint replacement surgery

in a simulated environment in MITEI. And we were able to isolate what the problem was in that

operating room, eliminate it, and go back to delivering the excellent care that we were

used to doing in those suites. Another thing that we need to be able to do better is we need to be

able to measure procedural competence without using things like numbers. And this video is

illustrating an example of a very novel platform for measuring procedural competence. So what

you're seeing are surgeons doing laparoscopic surgery while we have a thermal camera pointed

at their face. The thermal camera allows us to quantitatively measure the level

of stress in these surgeons and we've been able to reliably show that stress

level is related to procedural competence in laparoscopic surgery and I

can point this camera at a surgeon's face while they're doing laparoscopic

procedures and I can reliably give them a measurement that says that they're

doing that at an expert, intermediate, or beginner level. This is exciting to us because now I have

a way of measuring procedural competence that is separate from the procedure. It's simply monitoring

the surgeon's response to that procedure, and I could plug in any type of procedure that we want

to do to measure procedural competence. An exciting platform. We also think that tele-mentoring is key.

key. We're learning today via a tele-mentoring or a tele-conference environment. We need to bring

that environment into the operating room in a meaningful way. This is one example of a platform

that we have at MITEI that uses a laptop computer and the wide area network to communicate into the

operating room in a meaningful way so that we can mentor clinicians through the early part of their

are learning her. We're working to make this kind of environment as mobile as possible. And we have

a mighty telemetry package that allows this type of communication to be done using a cart-based

system. And we're now in the process of moving it to wearable technology so that as a surgeon,

you'll be able to put on glasses that allow me to see what you see, a computer mounted on your

belt and I will be able to have real-time communication with you over the wide area

network that allows us to go through the early part of your learning curve when you're doing

a new procedure.

Well, this concept of having an educational home is certainly spreading through the United

States.

In fact, the American College of Surgeons is developing what they call a network of

accredited education institutes.

These are institutes that have met specific criteria in order to be accredited from the college, focused on teaching surgeons new procedures and new techniques.

There are now 62 accredited education institutes through the American College of Surgeons, and while most are in North America, it is now spreading worldwide, and we just recently accredited an institute in China.

Right. You're familiar with institutes around the world for sure, and this is an example of a

growing network of this type of environment. And so in Strasbourg, France, the European Institute

of Telesurgery is an example, really a leader in teaching minimally invasive procedures over the

last 17 years. In Surrey, England, there is MATU, which is another unit that grew around the time

of ERCAD in Strasbourg, also a professional unit for teaching new procedures. And this unit is

focused on retooling the surgical workforce in the United Kingdom to teach them how to do

laparoscopic colon surgery. And then, of course, in Milano, Italy, we have the AIMS Academy,

which is another comprehensive education institute added to this international armamentarium

of expert places where surgeons can go to learn things like notes and new technology.

And finally, I want to say that we need to be able to do surgical education better. We need

to bring technology into our surgical environment to help us to do things better, and simulation is

going to help us to do that. Now, when we think of simulators, most people think of computer

simulators or maybe even airline simulators, but I would argue to you that the most validated

validated simulators out there in the world right now are actually quite simple and quite effective.

And this is one of them. This is called the Fundamentals of Laparoscopic Surgery.

This is a test of knowledge and skill in laparoscopic surgery that's been validated

as a high-stakes exam. This is the only validated test of knowledge and skill in surgery that's

available in the world. And because of the validity that's been put into it, it is now

a requirement for any resident who is completing their surgical training in the United States,

they must become FLS certified before they can sit for their board examinations and become

board certified by the American Board of Surgery. We now have FES, which is the Fundamentals of

of endoscopic surgery, a program that I've had the privilege of helping to develop through

SAGES, the Society of American Gastrointestinal and Endoscopic Surgeons.

This is the equivalent of FLS for flexible endoscopy.

So it's a test of knowledge and skill in flexible endoscopy.

There's a robust didactic content platform that lives on the web.

There is a written examination to test your cognitive knowledge about flexible endoscopy.

And then there's a hands-on skills test in flexible endoscopy that lives on this computer-generated flexible endoscopic simulator.

There are multiple modules for FES, which include domains like navigation, retroflexion, mucosal inspection, and targeting as critical features of being able to do flexible endoscopy well.

And we believe that FES is going to be an important part of training surgeons to do flexible endoscopy.

I don't think I'm going to let our residents walk into the endoscopy unit without going

through the FDS program, and this may become important in credentialing surgeons to do

flexible endoscopy in the future.

Finally, I want to say that there is a discussion going on among members of the American Board

of Surgery focused on trying to help surgeons stay abreast of their field, and a concept

has been introduced of a surgical sabbatical.

This is the idea that the American Board of Surgery may, in the future, require surgeons

who are in practice to intermittently leave their practice, go to an education institute,

perhaps one of the accredited institutes through the American College of Surgeons, and demonstrate

that they have the skill that they say they have, and then learn new procedures that we

think are necessary to keep them abreast of their field.

And so I think that within my career, I'm going to be expected to do a surgical sabbatical

as part of my board certification through the American Board of Surgery.

So I want to summarize by saying that I think it's inevitable that the future of surgical

training, privileging, and credentialing will include hands-on simulated environment in

expert institutions like AIMS, like MITEI, and like ERCAD around the world.

Again, I appreciate the opportunity to be part of the conference this afternoon, and

I'm happy to entertain any questions.

So I'm asking the colleagues if they have any questions for you right now.

Okay.

So the presentation is very much in the sense of the educational challenge that we are facing

For example, when I was a resident, my specialization, it was in digestive surgery and operative endoscopy.

So basically, we have already this in some of our schools.

But there are other countries around Europe where the surgeons, they are not allowed to touch a flexible endoscope.

So that's a very important issue.

I don't know if you want to add anything to Brian.

First of all, thank you very much for your very interesting presentation and congratulations

for all the work you have done.

My question is very simple.

Concerning flexible GI simulator, are you happy with the current available simulator?

The short answer is no.

And the reason is that most simulators, whether that's flexible endoscopy or surgery, have

have really been designed backwards.

And by that I mean that a very smart group of people,

engineers and clinicians, get together

and they tend to design an environment on the simulator

that they think looks like the real environment.

And then they deliver that to us and they say,

is this helpful to you?

Does it make you any better in doing procedures?

The real way that that process should go

is that a group of expert endoscopists

should sit down in a room and carefully define what are the unique skills that are required

to do flexible endoscopy well. And once that deconstructed list is put together,

then a simulated environment should be created for each one of those skill sets. That's actually

how FES was developed. So even though FES will work on the Symbionics platform, it is a completely

completely new simulated environment and does not use any of the standard commercially available

modules that the Symbionics platform has.

And so I agree with you in general that the virtual reality environments for procedures

have not been done well so far.

But I think if we do that in the right steps, we'll have much better simulators in the future.

Yeah, I agree completely.

The problem is that the amount of money that is necessary to develop a good simulator is enormous.

We have been following the efforts in the UK done by Chris Williams with the Imperial College and Olympus together

to develop a simulator for colonoscopy.

And we are still at the prototype after many, many years with a lot of efforts and a lot of money to be put in.

So I think that probably next year we'll see less cost of this kind of electronic devices.

But for the moment, I think that still the animal simulators or ex vivo organs play an important role to deconstruct the act,

I completely agree.

We use explanted tissue very frequently in flexible endoscopy, and at a beginner level

in colonoscopy, we tend to use a physical simulator before we use a computer simulator.

There are some very exciting developments in the world of technology and gaming and

and simulation that are allowing this technology

to really come down in price.

And I think you're going to see an acceleration over the next

five to 10 years in what we can do on a computer environment

at a cost-effective way.

Hello, Brian, this is Marco Lirici.

First of all, congratulations for your very

interesting presentation.

I have a couple of questions.

You have shown the new landscape of educational methods in endoscopic surgery, but I would

like to focus more on the field of notice.

You also mentioned how to get the privilege and the credential for the new high-tech procedures,

In other words, do you think that the new educational platforms are really enough to perform advanced notice procedures or they are only a gymnasium for performing the future more advanced pure endoluminal procedures?

future. So it's a good question about, you know, who should be performing notes and where does

that technique fall? My opinion, and Antonella knows I've spoken about this, is that as of today

in the current environment of notes, it's a surgical procedure. And I think it is much less

of a leap for a surgeon to be able to pick up a flexible endoscopic tool and perform an operative

procedure using notes. I think that's an easier leap than it is for a gastroenterologist to use

a flexible endoscopic platform to perform procedures which are really typically out of

their realm. So I think in today's day, notes is an operative procedure done in an operating room

by surgeons, perhaps in conjunction with gastroenterologists. However, I would say that

we have to look at where things have gone in flexible endoscopy and surgery for other examples.

For instance, gastrostomy, simple bedside 10-minute endoscopic procedure now. When PEG was

first introduced back in the 80s, that was an operative procedure done by surgeons in the

the operating room under general anesthesia. And so there is the precedent of evolving techniques

so that they become simpler to do, they become defined in their steps, and they can move out of

the operative environment and into another environment. And you may see that happen with

what we consider notes. For instance, I think we will get to full thickness colon resection

done on an endoscopic platform, and that may or may not require being done in the operating room.

So to embrace that, I think this will still say in surgery, but surgery is going to reorient itself

into disease-specific areas in their training. So my residents won't learn how to do everything

there is in vascular and thoracic and general and pediatric and orthopedic. They will have a

a baseline education, and then they'll transition into digestive diseases where they learn flexible

endoscopic platforms, minimally invasive platforms, and how to use those to do minimally invasive

surgical procedures. That's my vision of the future in notes and in minimally invasive surgery

in general. Thank you very much, Brian. It's a very, very interesting discussion, and we thank

Thank you very much.

We have to pass to the next speaker.

That is Professor Leroy from Strasbourg.

And so the schedule is quite tight.

So thank you so much, and see you soon again.

Fantastic.

Have a good afternoon, everyone.

Ciao.

Ciao.