Pros & Cons of Robotics Tool in Endometriosis Surgery - Arnold Advincula, MD

Pros & Cons of Robotics Tool in Endometriosis Surgery	 - Arnold Advincula, MD

Endometriosis Foundation of America
Endometriosis 2013 / Pros & Cons of Robotics Tool in Endometriosis Surgery
Arnold Advincula, MD

I was initially wondering why I was asked to talk about this particular subject in terms of the role of robotics in endometriosis, pros and cons because really, at the end of the day, robotics is a surgical tool. When you look at the discussions today this is really the only one that stands out as a discussion that surrounds a surgical tool. But I think I can understand after I gave it more thought about why we are going to have this discussion. I think what this does is it sheds a little bit of a spotlight on a lot of different issues that we face surgically with endometriosis.

These are my disclosures.

I am proud to say I am representing our endometriosis center down at Celebration Health. We are not a center of excellence so we are not a center of expertise. We are actually just a group of individuals that are very dedicated to trying to figure out the best way to manage our patients and to individualize their treatment plans.

What I would like to do is basically go over what really are the benefits that are seen today or perceived with regard to robotics. I am going to talk about some of the limitations of robotics and the issues and controversies that surround it, particularly with rapid technology adoption. Then we are going to go over some of the platforms that are evolving that I think will help shape the role of robotics in the management of endometriosis.

Certainly when we talk about robotics I think it is really on the forefront of everybody's discussions nowadays. This was just a magazine that one of my patients just last week gave to me in the waiting room. I went out to talk to the family and here was this article that she was reading the front cover of Atlantic magazine. You can see it is something that has been in the news quite a bit lately.

When we talk about robotics I put in parenthesis here Laparoscopic Tool, these are the things that people talk about when we refer to robotics. We refer to the ability to operate in 3D, the ability to utilize wristed instrumentation, ergonomics, tremor filtration - these are a lot of what we talk about as assets to the technology. Some of the limitations that we see with the technology are things like lack of haptic feedback or tactile sensation, which is often brought up when we talk about endometriosis. But these are the highlights surrounding the technology.

And certainly when we look at what has been done with robotics in the specialty of gynecology it has really kind of crossed all procedural aspects really from hysterectomy, cancer staging, the whole realm of reproductive surgery and pelvic reconstruction. I think every aspect of GYN has been touched by robotics. A lot of the reasons why there has been this interest in the role of robotics with endometriosis resection is just the complexity. I think a lot of people understand what I mean by putting up an iceberg realizing that what you see on the top does not really predict what else is going on down below. I think when we talk about endometriosis that is often what we refer to when we refer to deeply infiltrating disease.

As you can see here, this is just an example of really one of the reasons why we would consider utilizing robotics. This is an example of a stage four endometriosis case, essentially a frozen pelvis, you do not really see much normal anatomy, barely have a hint of an ovary, you have the top of uterus there and otherwise bowel obliterating the entire posterior cul-de-sac. These are the types of thinking that those of us who utilize this technology bring into play when we look at technologies like robotics. What is interesting is you have to look at technology adoption lifecycles.

This is an interesting curve that a lot of people know about. It is the same thing that applies to things like your iPhone or iPad. There are always going to be individuals or innovators and those that are early adopters and then all of a sudden you hit the early majority. I think with robotics and endometriosis we are just now trying to cross the chasm, right. That is a critical period in technology adoption where if you can figure out how to transcend that you really start to rapidly work your way up the early majority and find yourself having some significant adoption of that technology.

We are somewhere in this transition point right now. We are trying to understand the role of robotics as a tool in the surgical management of this disease. You have heard the issues throughout the day today. A lot of the speakers basically said, "You know, we know we leave disease behind" and I agree with that. Even in the best of hands and those of us who struggle with this disease day in day out managing it - it is hard, you have to be honest, you have to realize that with some of these cases it is difficult to really feel like you have eradicated everything in the pelvis. That is why we look at these tools as potential solutions to that.

As you look at technology adoption in trying to cross that chasm this is an editorial that had to do with just conventional laparoscopy years ago. At that time people thought laparoscopy was a gimmick. You have seen a lot of the videos today are based on conventional laparoscopy and it is very much an accepted standard of care for how we manage disease in the pelvis. Interestingly enough 18 years later after that initial editorial was written, one of the authors along with the secondary author, revisited that whole topic. They realized that what they said years ago was incorrect and that really things have evolved. It is just unfortunate that what was said back in 1992 had not really changed. People still did not really fully accept laparoscopy as a standard with which to treat women when it comes to gynecologic pathology. I really think there are a lot of interesting analogies with conventional laparoscopy in the role that robotics may be playing in our specialty as a tool.

Certainly ACOG has been interested in how this is going to fit in to health care and how it is going to fit in with the practicing gynecologic surgeon. Even the AAGL I am proud to say has put out a position statement although it was fraught with a lot of gnashing of the teeth as it came out. Certainly what it did was it addressed the issues that surround the use of robotics in gynecologic surgery. It even looked specifically at endometriosis and you can see here that there are really not a lot of studies out there that exist right now in the realm of endometriosis. There is one by Nezhat and colleagues that looked at it but it was retrospective. It did not really shed a lot of light on the subject but clearly you can see there is just a dearth of information of the role of this technology in endometriosis surgery.

With that there have been some interesting developments over the last several weeks. This is out of the Wall Street Journal referencing a study that came out just a couple of weeks ago raising doubts about the role of robotic surgery in terms of hysterectomy. This was a JAM article that came out looking at hysterectomy and benign gynecologic disease. Essentially it said that it did not really see any advantages in terms of reducing complication rates for hysterectomy or increasing responsible utilization outside of just raising cost, which are certainly all the issues that surround the role of this technology. Not just with our specialty but across all specialties involved with this technology.

It is interesting there have been a lot of commentaries and editorials that have gone back and forth about this particular article. But again, it really sheds light on sort of the times that we are dealing with right now with health care reform and how to utilize technology in our surgical arena.

One of the major issues though that we really see that I think explains a lot of the problems we face today is this "cart before the horse" phenomenon. I really think that at the end of the day the issues do not surround the disease itself, they do not surround the surgical tool itself, but issues that I call related to what I call the "cart before the horse". I will give you one example. A lot of times people look at robotics, and again we are looking at this as a pro and con of the technology, as a way to overcome limitations of surgeons and the operative field. But one of the things that I think is important to take home from what you have seen today in all the videos is you have to know your anatomy. The reason I put this image up here is this is just a schematic drawing of some key anatomical landmarks within the pelvis. One of the things I think is a major issue with robotics today is that there are a lot of individuals who think that robotics will compensate for needing to know this. This is an extremely important roadmap. So the robot is only as good as the user. At the end of the day if you do not understand dissection planes and how to approach the pelvis it is a useless tool. That is something that is very important and not to forget that as a foundation for what we do in endometriosis surgery.

Another thing to respect is the learning curve. It is a technology like any other tool that requires a learning curve. It varies amongst surgeons. In the GYN literature it is anywhere from 20 to 90 cases to get through an initial phase learning curve with the use of this technology. It really occurs in stages and impacted by things like your volume, how you select patients, again knowledge of anatomy and technical prowess. All these things are not compensated for by technology, they need to be known by the surgeon.

This is an interesting study that came out a couple of years ago. This was the impact of surgeon volume on patient safety in laparoscopic gynecologic surgery. The bottom line here, and I am going to pull the table up to summarize this all here, is that these complex surgeries, medium to high complex surgeries, are best performed by those individuals who have medium to high level of volume. A lot of the discussions that were brought up, particularly by C.Y. Liu talking about developing a "center of excellence" really centers around these types of issues. This is not a disease that needs to be treated by the masses it is a disease that the masses need to be educated about. But individuals that develop that expertise and that dedication need to be doing it. As you can see high volume surgeons have lower conversion rates, overall post-operative complications are reduced, shorter mean length of hospital stay when compared to low volume surgeons.

It is another thing when you talk about learning curve and volumes. It is very important when you look at a technology. When we ignore these indicators this is why you see issues like this surrounding technology. I have been fortunate enough to have worked with robotics for the last 12 years and it has nothing to do with the tool. The tool in its purest form is an excellent piece of technology. It is what happens when it is not utilized properly. You can see this is a major website here on the approach people who have prostate surgery and hysterectomies and all the complications associated with it.

This was driving around Vegas this past year at the AAGL meeting, badrobotsugery.com. This certainly does not help clinicians or patients get access to things that may potentially help them if you see that. There have been publications surrounding this. Medical legal review of liability risk for lack of training - that is a no brainer to me. Obviously you are going to see that when you do not have the proper training.

What does that raise? It raises concerns. We have seen in it with transvaginal mesh. I suspect we will definitely see it with robotics. The FDA is seeking data on surgical robots. They call it post-marketing analysis to make sure things are safe. But to me it is like any other tool that if it gets misused you are going to see these types of ramifications.

The other thing that is very dangerous with technology it is inappropriate commercialization. There are a lot of hospitals that advertise the use of robotics that they can treat endometriosis and deal with deep disease but there is no data around it. We need to have good data otherwise it is just a lot of hot air.

We are definitely at a dangerous intersection. You know what I mean by dangerous intersection? We are a dangerous intersection between pathology, in this case endometriosis, and the role of robotics. I was asked to give this pro and con critique and I do not like to give critiques without having some constructive criticism behind it. I to start with some positive thoughts put the negative ones in the middle and end with some positive things.

Now certainly the limitations that we need to deal with are, again, let us avoid that cart before the horse phenomenon with this tool. Cost is definitely in the forefront. As I said before, learning curves do not go away. Best practice techniques for credentialing privileging guidelines, we need outcomes data. These will all help us understand if this is one of the best applications for this technology.

Can robotics positively impact surgical management of endometriosis? That is really the question. And what I would like to do is end in the last couple of minutes with just some thoughts. One is we really are moving rapidly in the realm of robotics in terms of simulation. Here we are talking about not just surgical skill simulation anymore what we are talking about is evolving into procedural simulation. You can see that we can learn to develop the skills that we need to do surgery but also we are working nowadays, and I have a whole team that I work with at my facility, on how we can actually procedurally simulate now. So we are actually taking surgical procedures that I do on a day to day basis, like hysterectomies, endometriosis resection and we are actually taking those and integrating that actually surgical video footage into a virtual environment. Walking the individual through that environment so they can understand how to think, how to deduce what the next step is within a surgical case, how to actually treat the pathology that they are dealing with.

To me, when we are talking about how do we get surgeons better equipped with how to manage the disease this is extremely important, to be able to simulate, to practice and not do that in a patient where the stakes are high.

Another thing that you hear a lot about now is this thing called fluorescence imaging. It is something that has been approved for use with revascularization when you do solid organ surgery and when you are trying to revascularize the bowel. It takes a dye called indigo cyanine green and injecting it into the patient and then utilizing it to help identify vascularity. It fluoresces with the imaging tools that exist on a robotic platform. So while you really do not see the vessels as clearly as here when you hit the light it actually lights it up. A lot of talk about can this have some impact on endometriosis? I do not know. It is not approved for that. Actually there is no tag that has been developed for endometriosis. But what it does raise is some, to me, a positive look into the future that we may be able to have some technology that we can figure out a good biomarker or some way of tagging the disease. Again, because we do not want to leave disease behind, right? We want to be able to identify those lesions that are more subtle and difficult to identify. It is just going to be a way that we can identify disease in the future. This is where we need to be able to do research that needs to be done in this area in order to make sure that we are not utilizing tools because it is just for in terms of use of just a gimmick but actually to impact patient outcome.

I am going to end with this last quick video here and it has to do with just showing you I think a picture - a picture is worth a thousand words, I think a video is worth ten thousand. I am just talking about the value that robotics may bring to individuals as a tool set for GYN surgery. This was brought up earlier that in Denmark they are really one of the only places that I know of in the world that actually does have centralization of how endometriosis is managed. I had the fortune of working with the surgeon there for six months who spent time with me trying to learn robotics and how that might play a role in their country. So I am going to play this and let you see some of it. We do not need to play the whole thing but to show you how we utilize robotics for deep disease:

"She presented with the symptoms of...disease. She underwent colonoscopy and the biopsy confirmed endometriosis. This video will outline the steps and demonstrate the technique to perform robotics...resection with primary reanastomosis for colorectal endometriosis in collaboration with... A...technique is used with the da Vinci surgical system with the...system port. Monopolar scissors that keep...bipolar...and long-tipped forceps are used to carry out the dissection. A...area is also... The procedure started with ureterolysis. In this patient this is found only on the affected left side. Fibrotic tissue is carefully dissected to recreate the peritoneal spaces. This is performed bilaterally. ...help delineate the curve for dissection. It is not uncommon to encounter bleeding when perforating that suture. Then...definition 3D vision system facilitates the surgeon to limit bleeding that would otherwise obstruct the surgical field...throughout the entire procedure. The third instrument arm could be used to assist in retraction and...visualization deep in the posterior cul-de-sac. The rectovaginal stasis develop releasing the vagina and posterior cervix from the rectovaginal model. Despite the lack of haptic feedback the surgeon develops visual feedback cues to appropriately identify the correct surgical..."

Audience Member: Have you ever probed in the rectum?

Dr. Advincula: I do.

"This can also be done...during this portion of the dissection...sizer."

Audience Member: How long...are here?

Dr. Advincula: For about an hour.

"An assistant...in the posterior vaginal fornix. ...to facilitate the development of the rectovaginal septum".

Dr. Advicula: I work in concert with the colorectal surgeon so as soon as I develop the surgical field and prep everything, once the bowel is ready for resection we tag the colorectal surgeon. He comes in and he will do the physical resection and reanastomosis.

"...of the rectum are divided off the...sacral ligaments posteriorly to the presacral fascia completing the dissection of the sacral promontory down to the levator muscles."

Audience Member: I would exchange here.

Dr. Advincula: The pilot is not changed at this point.

"It is fully mobilized and outfitted. Endo GIA 45 stapling device is fired across the rectum requiring three... The disease area bowel can be seen in this frame crossing to the sigmoid. The bowel is mobilized further proximal to the inferior mesentery artery in order to bring it to the small...position. This will allow the site of reanastomosis to... End to end anastomosis is performed with a 29 mm EEA... The anastomosis is re-examined to confirm that it is off tension. ...confirm the rigid sigmoidoscopy. Gross pathology revealed a 3 x 2 cm formed...area through the...in focal...pigmentation through the serosa. Microscopic examination revealed endometriosis involving muscularis..."

So I am going to end with that. The reason I wanted to play that video through is to make sure folks have an understanding of what you can actually do with the technology. These are the types of things that unfortunately are not quantifiable in a study but you almost have to see it yourself to understand why there is the subgroup of those of us who look to see how this technology may enhance what we do with endometriosis.

Bottom line and conclusion, I think this technology will evolve. But again, critical to its success is the fact that we need to be critical about the technology. Thanks.