Jon Einarsson, MD, PhD, MPH - Medical Conference 2014

Jon Einarsson, MD, PhD, MPH - Medical Conference 2014

Endometriosis Foundation of America 2014
Robotics vs conventional laparoscopy
- Jon Einarsson, MD, PhD, MPH    

Thank you Harry for the introduction, and thank you all for inviting me to speak here. I only have 15 minutes so I am going to try to get into this right away.

I wanted to focus on endometriosis because in a bigger scheme you can talk about robotics for GYN surgery in general but we are going to focus on just endometriosis in the next 15 minutes. I have no disclosures.

Robotic assisted surgery is something that has been around since 2005 when it was FDA approved. It really has enjoyed a rapid incorporation into surgical practice, especially in GYN, with GYN surgery being the most common application of robotic surgery, hysterectomy number one. It has surpassed prostatectomies as the most utilized technology. Urology obviously still uses it and others specialties have started to use it as well. You can see on this graph the growth where hysterectomy has not surpassed urologic procedures.

I think that the growth has been overstated somewhat though by the company and if you look at this graph that a lot of the speakers for Intuitive are showing I think that the growth of robotics is overstated because one of the issues with this graph is that it goes to 2012. There are no public available data on hysterectomy rates in 2012. They show on this graph laparoscopic and vaginal going down which is actually the opposite of what is happening, at least according to data that has been published recently.

Nevertheless it has been widely incorporated but this widespread use really has been without any good supporting evidence for its use. In 2012 the Cochrane Review looked at over 200, almost 300 citations and they found only two randomized clinical trials. The AAGL subsequently came out with a position statement in 2013 on robotic surgery and benign gynecologic surgery. The goal of this statement was to provide an accurate assessment of the current literature and it only pertained to benign GYN surgery. It was not meant to be a standard of care document or to replace clinical judgment.

If you look at what available evidence is there for endometriosis specifically there really is not much. There is one retrospective study by the Nezhads et al and they compared robotic assisted versus conventional laparoscopy in surgical treatment of endometriosis in 78 patients. This was published in Fertility and Sterility. The only difference was that operating time was longer with the robotic group and there were no differences in blood loss, length of stay or complications.

We have an ongoing randomized trial at the Brigham, which is a collaboration between the Mayo Clinic, the Cleveland Clinic and the Brigham on laparoscopic vs robotic excision of endometriosis. The primary input is skin to skin operating time. The secondary inputs are post operative pain, intra-operative, peri-operative and post-operative complications. We are also doing quality of life and health questionnaires as well as a cost effective analysis. The enrollment goal is 74 patients and we have enrolled 49 so far. And these are the inclusion/exclusion criteria, I am not going to go through them for the sake of time.

The problem with clinical trials in surgery is that the main bias is the surgeon. It is very hard to make a trial where you have a surgeon that is equally versed in both or however many modes of access you are trialing. Of these two randomized trials that were in the Cochrane data base I was enrolling into one of them, which was on hysterectomy and I did about two thirds of the cases both robotic and laparoscopic. I will be the first to admit that I am a better laparoscopic than robotic surgeon. That is the main bias of these studies. You have to take them somewhat with a grain of salt. You can try also to compare two or more surgeons that are really adept at one mode of access and we did that on myomectomies at my institution where I compared a laparoscopic myomectomy performed by me and robotic myomectomies performed by our…endocrinology surgeons. That is another way.

We have a different style of operating. I look at efficiency as important to me. They are more sort of they take their time. A little bit of an apples to oranges problem there. You could also do a larger population randomized trial like the evaluate study that was done for hysterectomy where you have multiple sites and can kind of see what is happening in the real world. But to that you need probably several million dollars and a lot of resources so those studies are very difficult to do.

Does the robot make you a better surgeon?  This is an extreme example from the MAUDE data base basically saying, not proving, but demonstrating not necessarily. The robot is a tool and if the surgeon does not know how to use the tool or does not know the steps of the procedure it does not make them a better surgeon. This is a horrible case where the surgeon was using the system for the fourth time and they had a proctor in the room for eight hours. The proctor left, which is hard to explain, the surgeon continued and unfortunately the patient died from complications. Of course, as I said, one case is not conclusive and there are people that are doing robotic surgery out there who are doing an outstanding job. Again, it is more the surgeon not the tool. The tool does not really make you a better surgeon, which is something that has been somewhat touted by certain spokespeople of Intuitive.

I think Arne is going to talk about robotics later. If some of you came here hoping for a fist fight between Arne and I that is not going to happen because I think we have very similar philosophies and we are actually good friends. We just look at this maybe a little bit differently but I think overall in the big picture we have a very similar philosophy on this.

My personal bias is what I was going to talk about, so laparoscopy. Why do I prefer laparoscopy or traditional laparoscopy over robotic surgery? I think because I like the simplicity of it. I like the fact that I can move my instruments, take instruments out, put them in at a flash. I can easily suture just as well as anyone can suture robotically. It does not take a very long time for you to master that you just have to put some time into it. We can do port hopping putting a camera wherever you want so it offers more flexibility.

I also like to be at the patient’s bedside. I do not like to be away from the patient because if I am at their bedside I can palpate through the vagina or rectum at any time if I am not sure where I am at. I can guide my assistant. If you are working robotically and you have an assistant that is not very well trained that can be a nightmare because they do not know how to use the manipulator, they do not know how to change the instruments so you really need a good team for robotic surgery and if you do not have that it is better not to, honestly, use the robotics I think.

I also like to have tactile sensations, especially with endometriosis surgery. I like to feel the tissue as firm or not firm. You can compensate for that in robotics with sort of visual haptics but I like to have real haptics. I think that is nice to have.

We have 3D as well, which is nice but is not necessary. We now have 3D for…laparoscopy and that is nice, it gives you a greater appreciation for anatomy.

Harry wanted a bunch of videos. I put in a compilation of several videos here. This is how I start most of my cases at the left pelvic brim mobilizing the rectosigmoid medially, finding the ureter, which is actually – the ureter is right there. Mobilize the rectosigmoid medially and getting the ovary off the pelvic sidewall usually suspending the ovary either to the abdominal wall like that or to the ipsilateral ligament. This is working on the right side. Again, the same thing now suspending it to the wrong ligament with…then you are left with that rectovaginal disease. It is nice to have that exposure for that and start with the other things and then you can focus on that and often open that pararectal space if you have an opening there. Make use of it, take any low hanging fruit. Make sure you mobilize that and then you get a better sense of where the bowel is going. Sometimes it is kind of going into a sort of S shape and you ideally want to try to avoid cutting into the bowel if you do not have to. Then you can attack the rectovaginal disease. I have been using the harmonic for the most part so I will usually use the harmonic and a combination of that and cold scissors. The harmonic has fairly limited thermal spread. There you can see my finger in the vagina. It just helps me to figure out where I am at. And there is the rectal probe now in the rectum and you can see the disease is left on the rectum. Usually I will leave the disease on the rectum because then you can look at the rectum and figure out if you need to do a bowel resection or if you can do shaving, or partial excision which is my preference by the way. These are young, healthy patients, we are not dealing with cancer we want to offer them symptomatic control. I do not want them to end up with a fistula or stenosis of the bowel or dysfunctional bowel or a bladder apnea because we denervated all their automatic nerves. We want to be conservative but we also want to be effective.

A lot of times these look bad at the beginning but then at the end it looks pretty good. Sometimes when we are cutting off the rectum we will enter the rectum. You will see there is the hole in the rectum there. If there is a trans through and through hole that is fine. I do not use mechanical bowel preparation on my patients and they do very well with primary closure of these defects. The main goal is to identify and repair that defect. As long as you do that they do very well these patients. You do have to cut into the rectum sometimes because they do have sometimes full thickness defects. In my hospital I do not have privileges for using staplers so in this case we could have used a circular stapler for example and do an anterior resection with that. But I just cut it out and I did a two layer closure with sutures. I accomplished the same job in just maybe 10 to 15 more minutes than I would have with the stapler. For me that works. But of course, if you have privileges use staplers or if you have a colorectal surgeon that is right there available for you then you can do that as well. There is the end product there. Obviously we always check to make sure that this is watertight or air tight closure. Then just getting rid of the mass there.

This is a different case, so a lot of times we are dealt with this. It looks like a mess and everything is really stuck together. It is hard to identify anything. This patient actually had had irradiation of her pelvis as well because she had a spinal tumor and her left kidney was not functioning at all. So her ureter was not peristalsing on the left and the right was not peristalsing very well either. That is the left ureter right at the end of my suction irrigator. It was very hard to identify it because she had almost no peristalsis in it and she had basically a completely concrete type pelvis but at the end it started to look fairly normal. That is rewarding. You can say you have actually done something for these patients and generally they do very well.

But as we all know surgery is not always the only thing that you can do for them and you have to do other things as well.

This is another case again involving the rectum here that I have a hole in the vagina so I can palpate with my finger. She had endometriosis that traversed through the vagina wall so I had to excise it, so why not use that as an axis port and I can just palpate and I can feel the lesion there, which is nice because I am right there by the bedside. All I have to do is change my glove and I can do that. If I were doing robotics I would have to scrub and go there, so it is a little bit of a hassle factor. There is the rectal probe in there and then I am mobilizing the rectum off the pelvic floor. This one was sort of an unusual lesion which was really involving the entire pelvic floor so when you examined this patient it was like she had cancer. There was just no mobility at all. So we have to get that off the pelvic floor and then once we have that delineated and we mobilize the bowel then we can decide whether she needs a bowel resection or not. As I said, I am fairly conservative on that so in this case this lesion is only encompassing maybe 20 percent of the bowel or so. We can just excise it and then do suturing to close it up. Again, that works very well for me. You can see the extent of the excision here all deep down in the pelvis. All this is pelvic floor muscle that you can see there in the middle of the screen. The bowel is over to the right and the ureter is on the left. And again, checking the integrity of the bowel and that was fine here and again you have to show in the end the radicality of this excision.

I think we have a couple of more cases here. This is just showing the pelvic splanchnic nerves. This is on the right side of the patient. You can see the ureter peristalsing right there and here you can see the pelvic splanchnic nerves and here is the uterosacral ligament. This just highlights the fact that if you have very infiltrative disease right here and you take that on both sides, see the ovary here, uterosacral ligament, ureter and pelvic splanchnic nerves, they are right there medial, they are right there between the uterosacral and the ureter. So you have to try to conserve these nerves if you can to allow for continuous good bladder function. Otherwise these patients can end up with an atonic bladder, which is not good. Sometimes you have to cut a piece of the ureter out. That is unusual, usually you just have constrictive scar tissue around the ureter. As long as you release that you do not have to cut the ureter but sometimes if it is infiltrating you may have to cut it and then you can usually reanastomose the ureter. The ureter actually is somewhat like a rubber band. If you cut it it will spring apart and it will actually come together pretty easily too. It is not a very difficult surgery to do but it is obviously something that most of us as gynecologists do not do day in and day out. In this case I did have a urologist in the room and he just watched me do it because he did not feel comfortable doing it himself laparoscopically.

Again, another case – so here we have to basically do a parametrectomy so this is the origin of the uterine artery. It is on the right side the ureter is right next to me there because I just did a TLH but if I had just done a total laparoscopic hysterectomy and left it at that this patient would have certainly have continued with symptoms and pain. That is not going to be the cure for this patient. I have to basically take out that whole parametrium and it turns out that she also had another nodule that was extending all the way down to the pelvic floor. You can see that we are sort of doing a modified radical approach here, somewhat like what you would do in a radical hysterectomy where you basically have to lateralize the ureter and basically take the whole perimetrium out. This extended all the way to the pelvic floor and it was completely excised.

You have to take your time and try to get all these lesions out and it can be quite challenging. You have to be very comfortable with deep retroperitoneal anatomy otherwise you are going to get yourself into trouble. There is the pelvic floor again we have basically closed that off. A lot of times I will suspend the ovaries like you see there and then I will take them down later at the end. You see the ureter going into the bladder and the…has been closed and this is the end result there. I think that was the last video.

My main criticism of the robotic system is the cost. As you know acquiring the robot will add some cost to your institution and then you have a maintenance cost that is usually about ten percent of the purchase price per year. The disposable proprietary instrument costs about $2000 to $3000 and you can only use them ten times, and then you have drapes as well. It has been estimated that if you did all 600,000 hysterectomies, actually today it is probably closer to 500,000, with the robot it would really add a significant amount of money to our health care cost.

And I think that the really the rise of robotic surgery, the continued rise, is unsustainable. I think that it probably has a place but I think that place has not really been fully defined yet. The role is going to change as robotic surgery is going to evolve as well because I think that it really is at the stage now, to me, of a clunky big phone that we used early on where you definitely could not put it in your pocket. It has not turned into an iPhone yet. It may, and then I will use it, but it is not there yet I think.

I think that with the advent of accountable care organizations I think we are going to care more about how we are spending our health care dollars. It is going to maybe dampen the growth of robotic surgery potentially but you know we will have to see what happens in the next few years.

In conclusion there is really no available good evidence showing that robotic surgery has any benefits over conventional laparoscopic surgery. There are no patient benefits and operating times are generally longer and costs are higher. This was both in the AAGL position statement as well as the Cochrane data base. I think that the conclusion really is that robotic surgery should not replace conventional laparoscopy.