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BackTable / OBGYN / Podcast / Transcript #70

Podcast Transcript: Endometriosis Surgery: Techniques & Lessons Learned

with Dr. Tomasso Falcone

Surgical approaches to endometriosis continue to move towards greater levels of precision and efficacy as we learn more about the intricacies of this complex condition. Still, endometriosis continues to challenge gynecologic surgeons worldwide. How has endometriosis surgery evolved, and how can we apply what we’ve learned to continue to improve patient outcomes? In this episode of BackTable OBGYN, Dr. Tommaso Falcone, a renowned surgeon and expert in reproductive endocrinology and fertility, discusses the past, present, and future of endometriosis surgery. You can read the full transcript below and listen to this episode here on BackTable.com.

Table of Contents

(1) Dr. Tommasso Falcone’s Career & Journey

(2) The Evolution & Advancement of MIGS

(3) Innovations in Endometriosis Treatment & Management

(4) Endometriosis Research: Looking Forward

(5) Which Comes First: Fibrosis or Inflammation?

(6) How to Foster a Culture of Surgical Innovation

(7) Walking the Line Between Innovation & Complications

(8) The Importance of Teamwork in Pioneering Surgical Techniques

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Endometriosis Surgery: Techniques & Lessons Learned with Dr. Tomasso Falcone on the BackTable OBGYN Podcast)
Ep 70 Endometriosis Surgery: Techniques & Lessons Learned with Dr. Tomasso Falcone
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[Dr. Mark Hoffman]
Welcome back to another episode of BackTable OBGYN. This is your host, Mark Hoffman, and I've got with me my co-host, Dr. Amy Park. Amy, how are you?

[Dr. Amy Park]
Good. How are you, Mark?

[Dr. Mark Hoffman]
I'm good. We've got someone from your neck of the woods. We have a lot of big guests that come through this show. We've been very fortunate to have some pretty big names come through here. I would say, I don't know that we've had a bigger one than this one today. We'll get to introduce our listeners to Dr. Tommaso Falcone. Dr. Falcone, Tommaso, how are you? Welcome to the show.

[Dr. Tommaso Falcone]
Thank you. Thank you for having me, taking the time to explore some ideas.

(1) Dr. Tommasso Falcone’s Career & Journey

[Dr. Mark Hoffman]
No, it's our pleasure. For our one listener who may not know, Dr. Falcone is a professor of OB-GYN and reproductive biology at the Cleveland Clinic Lerner College of Medicine. He's a REI, Reproductive Endocrinology and Infertility Specialist by training. He is an Executive Vice President at Cleveland Clinic and President of International Operations and Emerging Markets at Cleveland Clinic. Tommaso, thank you so much for coming. As we like to do at the beginning of every episode, we like for our guests to tell us how did you get here? What was your journey? You can go into as much detail as you like, but it helps a lot of us understand the journey. How did you get to your current position?

[Dr. Tommaso Falcone]
Well, I trained in Canada at McGill University, and I did my residency and then a fellowship there under someone named Tobias Tolandi. He was the Head of Reproductive Endocrinology. I was a resident there, and then did a fellowship there with him. Then after I had finished, I grew up in Canada, Italian parents, Italian neighborhood. As you would imagine, I went to school in English at McGill University, but the patients were French. Therefore, we spent our time or I spent my time speaking three languages every day until I moved to the United States. That experience gave me an international focus.

Then growing up in Montreal is very international, as everyone knows that has been there, and therefore, gave me a perspective on international medicine. I had a taste of Canadian socialized medicine, then came to the United States. I came here because of the Cleveland Clinic. I had just finished my fellowship practice for a few years. Then the Cleveland Clinic wanted to start a minimally invasive program and continue the IVF program. They recruited four people. One was someone named Jeff Nilsson, who was a colorectal surgeon in New York. Someone from Quebec as well named Michel Gagner, who was a general surgeon, but was a big innovator in minimally invasive pancreatic surgery. Someone named Howard Winfield, who was a urologist and started doing a lot of laparoscopic surgery, and then myself to head up the gynecological focus.

Then I came here and after a few years, the previous chairman stepped down so I was appointed chair, but I had no intention actually of staying here. We are Canadian, our family, my wife and I are Canadian. We grew up in Canada. We wanted to go back to Canada, but then we had children that grew up in the United States. We figured, well, we better become citizens because it doesn't seem like the children want to go back. Then at that time, I stayed on as chair of OB-GYN. We created a bigger and bigger department and we're nationally ranked as one of the best. My link to Dr. Park here is that she was a fellow. Although she's a urogynecologist, at the time, we did not have an REI fellowship. We had a few other fellowships and the UROGYN fellows spent some time with me in their first year. Specifically, they learned endometriosis, which is basically what I do. They spent a lot of time for those who were really interested, a lot of dissection, retroperitoneal, et cetera, et cetera. They learned to be surgeons that went away from the midline. A good colleague and friend, Mark Walters, would always say, "I'm a midline surgeon. I don't go left or right," But we brought them that way.

Anyway, so after OB-GYN and establishing a really what I think is outstanding department, and I had done it for 15 years, I figured I wanted to do something new and different. At that time, our youngest boy had just started college. It was a good time to go somewhere else. They were just starting Cleveland Clinic London. My role was to go to Cleveland Clinic London. For those that have been to Cleveland Clinic London, it's across the street from Buckingham Palace. For five years, we lived there, my wife and I. My role is exactly what you were talking about before, chief of staff, chief academic officer, and medical director. Chief of staff, because I recruited all the doctors, very few gynecologists actually, but most of those doctors like cardiac surgeons, et cetera, to build the clinical programs. I was recruiting doctors and establishing programs, medical director, because that's the official term for the person who is the leader of the medical pool, and then chief academic officer, because it was my role to build the academic medicine as well, basically recruiting.

I was there from 2018 to 2023. At that time, it was COVID. All the construction, all the recruitment of every doctor, interviewed almost 1,000 doctors. We hired about 250. It was all done with a promise that we would have this beautiful hospital and we would be finished with COVID. Then at the end of the time, I became president of that hospital and opened it up, and so on, and established clinical programs. Then at the end, it was time to come back. I was still in an international role so I became, at that time, the executive VP and then president of international operations and emerging markets. What I'm responsible for now is anything to do with basically moving patients around internationally. If they want to go to Cleveland Clinic Abu Dhabi, or London, Florida, or here, we have a group. We also have Cleveland Clinic Canada in Toronto, and Cleveland Clinic in Nevada, which are emerging markets.

Finally, we have relationships with affiliations in Mexico, in Chile. We have Cleveland Clinic connected in Vietnam, and a variety of other places. That's my role. I get to be international again. That's what I do. I also have a clinical practice, which is highly focused on endometriosis. That pretty much sums up 25 years in 4 minutes and 30 seconds.

[Dr. Amy Park]
I do want to say, just as a footnote, as being on the sidelines, well, involved and so lucky to be one of your trainees and mentees. It's like there was no minimally invasive, there was no robotics, there was no MIGS. This is all predating all of that. Interestingly, when I look at MIGS now, and I say I've said this, and I think a lot of people have the same take, but MIGS is really where UROGYN was 20 years ago. You're one of the few REIs who does the surgery. The SRS is a Society of Reproductive Surgeons. Mindy Christianson, one of my colleagues, is the president of that organization. I noticed it's the same 20 or 30 surgeons, the same people.

[Dr. Tommaso Falcone]
It’s the same group, like when you look at IVF versus reproductive surgery, I always tell people, why do a lot of IVF doctors not do as much surgery anymore? I said, well, let me tell you an anecdote. One Monday, I was doing three surgeries with the colorectal cut people, and they needed bowel resection. All three. We would just bounce from one room to the other. We started in the morning at 7.30, and we finished at 9:00 PM. Very tiring. I went home. I stayed up all night because I was wondering, "Did that patient do well? Was I too close to the ureter? Is she bleeding? Et cetera. Then in the same week on Wednesday, I did three egg retrievals, two embryo transfers, went home at 3:00 PM, and slept all night well.

[Dr. Mark Hoffman]
Get paid a lot more for your Wednesday than your Monday, probably.

[Dr. Tommaso Falcone]
You got it. The colorectal surgeons did well, though, but the gynecologist, we don't get paid for it, whether you have early-stage disease or bad disease.

(2) The Evolution & Advancement of MIGS

[Dr. Mark Hoffman]
That was Alan DeCherney's article, right? Initially, he wrote an article about the transition of open surgery to the laparoscope and then wrote a follow-up piece about 20 years later, REIs are replacing the laparoscope for the lab and saying this is the transition. That was right around the time of my fellowship. I realized someone's got to be doing these surgeries, but it's just a different way of practicing for the reproductive surgeons, and when someone else has to pick up the mantle for endometriosis, and fibroids, and pelvic pain and all that stuff. That's where MIGS came in.

[Dr. Tommaso Falcone]
Yes, the MIGS surgeons, they're very good. REI has evolved. There are still people that do surgery, but it has evolved into very much understanding basic science, like cell cultures, and genetics, and the whole thing like that. It is very complex, but it's much more cognitive. The surgical part has evolved towards the MIGS surgeons. The good thing in this institution, at the Cleveland Clinic, is that the MIGS surgeons, the REIs, we have joint meetings, we discuss because there is an overlap in a patient who just wants to have her urethra removed or endometriosis removed or for pain or something, it's pretty straightforward. In a patient who wants infertility, oftentimes IVF, pretty straightforward. If you have an overlap of those two, that's when it requires insight, and experience, and what to do with these patients. Fortunately, our MIGS group, the REI group, works at the same institution, side by side.

[Dr. Amy Park]
You guys do a lot of fibroids too, not just the endo.

[Dr. Tommaso Falcone]
Right, we do. Fibroids, basically, just like the MIGS people will do hysterectomy surgery, psoriasis hysterectomies, but we do a lot of fibroids. Again, we have a tendency to be very conservative. If someone is infertile and has fibroids, they may not need any surgery. The recent data support the fact that although fibroids, for example, may cause decreased implantation, it does not necessarily mean that the surgery improves it. The concept is like someone having melanoma or something on the skin, you remove the lesion. It doesn't mean that you've cured the melanoma. Therefore, the fibroids have a lasting effect on the uterus, and therefore, we're just removing them. There are some that do, we certainly talk about it, but endometriosis. The difference between those two diseases, you need to know pubic anatomy or else it's very difficult to do endometriosis surgery. Fibroid surgery, in my opinion, is an approach to removing diseases within the uterus, an orientation because you can get disoriented very quickly.

I've seen disasters as people remove big fibroids, and then take half the endometrium with it, or you're close to the tube, especially people doing it by mini lap. It's really an exercise in orientation of removing the disease within an organ. Okay, you don't have to know usually, sometimes you obviously do, but where the ureter is or how close to the bowel, et cetera. Endometriosis is truly a knowledge of anatomy. Where are you? You can get very disoriented with severe disease very quickly. I think endometriosis and fibroids is basically what we do, obviously do a few other things.

A lot of infertility surgeons are still very good hysteroscopists because of the fact that if you do not have an optimal urine cavity outcome, no matter how good your embryo is, it's very difficult to actually improve IVF outcome.

(3) Innovations in Endometriosis Treatment & Management

[Dr. Mark Hoffman]
Well, I feel like we should have you on for two or three different episodes, to be honest, but I want to try to focus on endometriosis today just because, again, we could have multiple episodes on that, but you're someone who has seen patients with endometriosis throughout your career. What's changed over that time in what we know or what we think we understand about endometriosis?

[Dr. Tommaso Falcone]
The reason I got into managing endometriosis patients is because when we started to do it by laparoscopy, I'd just finished my fellowship at the time in Canada. We were doing basically diagnostic scopes and some adhesions, maybe. Nobody wanted to do it by laparoscopy because we were basically looking to see how we could do it and it took a long time and as you said, didn't pay and nobody wanted to do it. Therefore, I didn't mind doing it and I don't mind taking a long time. I was a salaried assistant professor for the few years there that was part of the group.

We were surgically removing, and there were pioneers, obviously, in the field, like David Redwine, for example, who passed away, as you know. You may not have agreed with him, but he certainly started to look at the disease in a very different way. I listened to him and I said, "He has something here." If we look at what we had when I started 30 years ago, that was the beginning for me, was surgery and the birth control pill, non-steroidals and a GnRH agonist because Leuprolide was there even then. 30 years later, we have a lot of surgery, the birth control pill, Leuprolide, but now it's true we do have the GnRH antagonists, like relugolix, for example. It is a step forward, but it is not a great leap for mankind, if I can paraphrase someone who did a great thing.

Although it's a pill and it gives more flexibility, the concept is the same and it doesn't treat endo, it just shuts off the hypothalamic-gonadal axis, the uterine-gonadal axis. You're basically blocking in a more flexible way, and a more tolerable way. We do not have any drugs that go specifically either to the fibrotic lesion, which is really the main area of research, for example, now around endometriosis. We don't have anything for that. Therefore, when I started, we were operating and we learned how to do the surgery much better with fewer complications. That is true. The modern MIGS surgeons are better than anybody than when they started. I think they learned, and now we have a very low complication rate. We can do it, the equipment is better. We can actually do the surgery with fewer complications, with more insight, more complete surgery, more understanding of the visibility, the phenotyping of the disease, the fibrosis that occurs with it. We are better surgeons at endometriosis. Far better, but we're still removing disease. The medical therapy, again, we have a progestin, we have a birth control pill, we have non-steroidals, and we block the hypothalamic-pituitary-ovarian axis more efficiently, maybe more tolerance, fewer side effects, but we're still doing the same thing, but we're very good at it now as compared to before.

[Dr. Mark Hoffman]
Now, I was just going to ask with advances in surgical techniques and technology, are we making progress on patient symptoms? Again, like the outcomes, they may have better perioperative outcomes, but are they doing any better from a symptomatic perspective in the long run? Do we have that data?

[Dr. Tommaso Falcone]
We do, but when you look at 7, 10, 15-year data, it's really quite delayed. I reported 10 years ago, my seven-year data. The seven-year data didn't have a crucial thing. We didn't realize at that time that we had to put patients on suppressive medical therapy to prevent recurrence. What happened is the initial concept, we did the surgery, then we put them on for six months, maybe a year. We did the bulking surgery, six months of medical therapy. Then we took them off the medical therapy, waited a year and asked them how they're doing. Well, that's true. That's what they do in oncology. You do bulk, chemo and then see if you live. For us, we realized that was not the right approach. The right approach is to keep them on for as long as they are in reproductive age or pregnant. We learned some nuances there. Then, of course, the most recent data, again, is that there is a big recurrence rate in patients that are not suppressed. We did learn that we have to suppress patients post-op, and that's the standard now, till they want to get pregnant. We also learned a few other things from a fertility point of view. From the fertility point of view, what we learned was that endometriosis is a pro-inflammatory disease, and has a tremendous amount of inflammation. Many other diseases, like inflammatory bowel disease, asthma, cell arthritis. We did learn that when you do in vitro fertilization and you do a fresh embryo transfer, there's still a lot of inflammation. Therefore, the success rates were not as good. What we do know now, the tendency is to do the egg retrieval, freeze the embryos, wait for the IVF patient to recover, put them on suppressive medical therapy, which we usually do for embryo transfers, and then do an embryo transfer, and the pregnancy rates are no different than a woman who does not have endometriosis.

What we learned is that for patients that are interested solely in fertility, we need to suppress the inflammation, which we can do quite well with progesterone. We did learn that. Again, is it innovative? We did learn how to do that better. We did learn that IVF does not make endometriosis worse as people think, but you do have higher complications when you're doing the IVF from the egg retrieval or something of that nature. But it isn't worse than the disease.

[Dr. Amy Park]
Culturally, though, I remember this because I wrote some review articles and chapters with you in 2006 to 2009, that's when I did my fellowship. It was still a debate, like should we be even excising all this endometriosis? Remember, it was just people who would be doing biopsies and then they would turn it in. It was a totally different thing. It was excision versus ablation. That was also a big debate which I think the culture has changed around that.

[Dr. Tommaso Falcone]
Well, I don't know.

[Dr. Amy Park]
Oh, you don't think so? Oh, well, I don't know. I'm around all the mixed people, so I don't know.

[Dr. Tommaso Falcone]
Yes, that's right, you're right. Just to tell you the excision versus ablation story. It's somewhat unimportant. If you have a lesion under the ovary, just imagine the ovary, lift the ovary. You see the lesion. You have a choice. You can burn it or excise it. If you burn it, what do you think is under there? The ureter. You can either, two choices, burn it, and then burn the ureter, or laser the top of it and leave the lesion. You have to excise the lesion. You have no choice. Now, if it's under your sacral ligament, it is true, and where the ureter is, you can probably burn it or excise it, and you get the same results if you can go deep enough.

There's no question, all those studies that they're equivalent were all done in patients with very early stage disease that was away from the ureter or the ovary, which we can talk about in a minute. Excision is mandatory if you want to remove all the disease, if you're near the ureter, and half the time you don't know where it is, or it's near the rectum. What are you going to do? Take your bipolar and burn it right on the right. No, you have to excise it. Therefore, excision and the cochlear review and the systematic analysis all say, "Oh, there's no difference," but within the parameters that you are dealing with early stage disease that is not near very important structures.

Now in the ovary, it is true that if you excise, you have less recurrence. You have probably a higher pregnancy rate. Again, within the parameters of what you have to do, if you have a patient who has an endometrioma, and she has no pain, and if you say, okay, I'm going to do IVF, well, removing that cyst is not going to make any difference in the IVF outcome under most circumstances except those where it's so big, you can't get around it to get to do an egg retrieval. To that patient, you say, removing it is not going to make any difference, keep the cyst. Now, if the patient has pain, then you have to operate. Many times, that patient with the ovarian cyst has endometriosis underneath it, which is probably causing most of the pain, the deep endo.

Then finally, we do know that every time you remove the cyst, that you can cause damage. You have to know, but sometimes you have no choice. You have to know the principles of removing an endometrioma in a way in which you damage the ovary the least, which means minimal use of electrosurgery, using suture to close, maybe hemostatic agents, just the concept that you're just going to remove every cyst.

Then finally, there's something that we use now, and it's called the endometriosis fertility index. Now, this was pioneered by a gynecologist named Adamson, who was in California. If you remove a cyst and the patient's tubes are beautiful and there are no adhesions, then the pregnancy rate will be fine or improved. How about that? If you remove the cyst and the tubes look like a wreck because there's so much scar tissue, and the cul-de-sac is completely frozen, the tubes have no movement, the patient's not going to get pregnant. Therefore, you have to be far more conservative. That's where there's an overlap between the MIGS and the infertility group. If the purpose is to become pregnant, and the pelvis does not look like it will allow a spontaneous pregnancy because the tubes are affected, et cetera, then you have to be much more conservative with managing the ovarian cyst.

The ovarian cyst can be managed by different energy forms. Don't overuse electrosurgery, you can use plasma energy, which is what I use, to oblate perhaps part of it. I think that the experience that we have in excision versus oblation, it's not as clear as that. Then the purists in MIGS, some people say, not only do you have to remove the lesion, but you have to remove the normal peritoneum in case there's a microscopic lesion. Well that’s a fundamental misunderstanding of the evolution of endometriosis? Because if you biopsy the peritoneum in an early stage disease, like stage one, you will find that these implants will go away on their own. In fact, we know this from the trials where people have not treated endometriosis and then re-sculpt them six months later, and we'll find regression of disease in some patients, the early stage, not the advanced stage. To take it back, are we closer to the pathophysiology of endometriosis? Most likely, we're closer, but the unifying theory of endometriosis is not going to appear.

We're looking for those genes that predispose you. It turns out there are multiple genes and probably none that will say, "Oh, you're going to get it for sure," just like many polygenic diseases. If there's an environmental component, there's a component of delayed childbearing, there's a multitude of different things, environmental toxins, anomalies, obviously, if you have an obstructive one. There's not going to be a clear pathway where you can say it's unifying and that we're going to have a tremendous burden of inflammation. It's like almost all infectious diseases. Think about it, some people get influenza and die. Others get influenza, they have a sniveling nose. Why? Host response, et cetera. The unifying theory is not going to be there, which means that right now, therapeutics is still based on a very primitive idea that we have to aim for the clinical manifestation of that disease in the pelvis or elsewhere.

[Dr. Mark Hoffman]
I think that's similar to cancer. I've said this on the show a few times, but we're treating a disease that is at the cellular level or likely the DNA level with steel. I think that ultimately you can't get it all. These surgeons say, "Well, I'm going to take all the peritoneum," but you're not. There's always, first of all, peritoneum left behind, right? You're not taking the peritoneum off the sigmoid. You're not stripping the entire belly, so what are we talking about? Over the uterus, you're not taking the cirrhosis off. There's tons of it left behind. There's always going to be disease left behind. Your pelvis and abdominal cavity are reperitonealizing in what, 24 hours?

Down the road, we can talk about this too if you want, but the idea of what healing and all the changes that occur with that, and the impact on that in terms of chronic pelvic pain or disease progress and those things. As much as we have a better idea of how to manage the effects of the disease, it doesn't seem like we've made a whole lot of progress on managing the disease. It's at least identifying the cause and truly addressing the disease at its nature. All the progress in cancer care is understanding how cancer works. Cutting off more didn't help in certain patients, if it was already spread outside of the initial organ.


[Dr. Tommaso Falcone]
The research though in cancer, for example, like immunotherapy is a big thing now and treatment is becoming less, and less invasive even. Probably in different areas of gynecology, there hasn't been as much investment in research for benign diseases like endometriosis or fibroids. We understand the treatment better, what we should do or not do. Like I said, if a patient says, "I have no pain," we're not going to remove the cyst because we're not treating the pain. If she wants to get pregnant, we can do IVF or she can do spontaneous pregnancy to remove the cyst, but it depends what the pelvis looks like. There is more understanding of the therapeutic benefit of what we have today, but the interventions are the same over the last 25 years. Surgery, as we stated, minimally invasive, fewer side effects, highly skilled, like our MIGS group, that are being trained, I find them amazing. They can do lots of surgery very efficiently, very effectively, and with a low risk in a patient. I just think that we must understand the disease sufficiently as to not over-treat, just like with fibroids and everything else. If you have fibroids and you have no symptoms, even if they're up to your umbilicus, why am I treating it? I'm not curing you, so therefore, I think it's very important to understand that over-treatment causes problems.

(4) Endometriosis Research: Looking Forward

[Dr. Mark Hoffman]
The hardest thing to do in our specialty is to make an asymptomatic patient feel better.

[Dr. Tommaso Falcone]
Yes.

[Dr. Mark Hoffman]
It's a very challenging thing.

[Dr. Amy Park]
It is hard to stand down from this problem if you see and you want to help with their fertility and do something, like there's just an urge to do something. I hear what you're saying though, because I know the arc of your career, not only have you done all these amazing administrative achievements and surgeries, but you also had a basic science lab. I remember we would aspirate the fluid from the cul-de-sac and you send it into the lab and look for the cytokines. You mentored Elliot Richards, who's one of our amazing staff members here, doing the spearheading uterine transplantation, and all the immune therapies that you have to do for that. You've been intimately involved in all these advances, but it is true when you think about the cancer therapies and people are having all this precision genomic profiles and they're literally on in angiogenesis inhibitor and some sort of immune blocker, and then having a genetic profile, microsatellite instabilities, and looking at your prognosis, we don't have any of that.

[Dr. Tommaso Falcone]
Then the genomics of the tumor, like brain tumors, have a total genomic profile that helps them with therapeutics. We don't do that.

[Dr. Mark Hoffman]
Is that the future though? Honestly, the advances in cancer care have come in the lab and have come with targeted therapies.

[Dr. Tommaso Falcone]
Yes, and targeted, so therefore, it is different, but fundamentally, we've been trying. You're right. The basic research we're looking at, the first research was on looking at what inflammatory cytokines do we have in the perineal fluid. Inflammatory cytokines, there's a large group of them, TNF-alpha, for example. We said, I'll tell you how, you have to prove every step. You can't just say, "Okay, if you have an inflammation and I give you anti-inflammatories, you get better." We showed as many others, we have a lot of inflammatory cytokines in the pelvis. When you treat Crohn's disease, you use these TNF-alpha blockers, right? Somebody said, "Oh, well, if they have a lot of cytokines out of inflammation, I'm going to give them TNF-alpha blockers, and look at their results." Well, the results were not spectacular because they used pain as the endpoint.

In a lot of cancer trials, for example, what they'll do is they use the lesion, like if you have a lung cancer, say I give you medication, do a chest x-ray, your lesion's smaller. Okay, I guess it's working. What we did, not me, but someone as they used symptoms and they said, "Okay, let me see if the symptoms got better." Now with chronic pain, the post-placebo effect of chronic pain is at least 30%. What happens is that 30% of patients get better with the placebo and they did not show any marginal improvement in TNF-alpha blockers. Every time, if you look at a study with anything, oftentimes for pain, they use placebo rather than a comparative group because it's very difficult given the fact that a lot of chronic pain gets better during the clinical trial anyway. The problem with pain is it's multifactorial as you remember for people that do pelvic floor. I tell patients all the time, I'm going to remove all the disease, but you may still have pelvic floor pain.

It's the same as someone who has spine surgery. They still have to go to physical therapy. It's not like you get up tomorrow morning after spine surgery or shoulder surgery or neck surgery or whatever. A lot of this is so complex that it's very difficult at times to show improvement in the actual pain symptom. I think though, from the point of view of basic science, there are a lot of people that have, like Elliot Richards who's here, looking at different models to see if we can understand better. If I tell you that the main thing that I would think nowadays that people are looking for is the fibrosis around the lesion. The fibrosis, even for you that have both have removed an endometrioma, what you're stripping off is the fibrotic layer. The actual glands and stroma on the inside probably covers maybe 30% or 40% of the surface area. That's why sometimes when the pathologist looks at it, he/she will say that it's a fibrotic cyst and nothing else because of the fact that it's not. Fibrosis in bowel endometriosis, tremendous fibrosis. Those are the types of things which we could aim for perhaps to see. In cancers, for example, they are working on fibrosis because the fibrosis prevents chemo or something from getting into the lesion.

(5) Which Comes First: Fibrosis or Inflammation?

[Dr. Mark Hoffman]
The fibrosis is more the result of the inflammation of the tissue response to inflammation or is it, do you think it's a primary part of the disease? I always saw it as like scar tissue from an injury. It's what's left over and it's irreversible. We can suppress the glandular tissue or the endometriosis tissue, but once the fibrosis is there, it's scar tissue, and now the only role is either surgery or PT or whatever.

[Dr. Tommaso Falcone]
I'm not sure anymore if the fibrosis is a result of the inflammatory lesion. Even in the ovary, the cysts themselves are highly inflammatory. If you look at anti-Müllerian hormone, which is a sign of very reserve, even without surgery, it's lower in patients that have endometriosis in the ovary cyst. I'm not 100% sure anymore that it's a reaction. It could be simply part of the actual disease itself. We're in the evolution.

In the last, I suppose, two weeks, I have seen early 20s, with advanced disease, which I removed. I was surprised, like I said, boy, this is really bad disease. One woman had bilateral 11 centimeter cysts from endometriosis. It was amazing. She was in the emergency room. You looked at her abdomen, she was very slim. It was big. I said to myself, why is this patient at 21 like this? Then I could do another patient at 39, and they have small lesions. I don't know if it goes from one to two to three to four. I think you probably are a four. You start as a four and other people start as a one and stay as one. Sometimes it evolves. According to the studies, it's true. There was so much fibrosis. It was intense, like the amount of fibrosis there was. I don't know, but I do know that we do need to look at it and see what happens. The admonition is always just because you remove it doesn't mean that the disease is gone, or the symptom. Pain may not be gone. Fertility may not be gone. It's not as clear as that. The one that I feel that I disagree the most with are people that are removing the naked eye. It is a completely normal peritoneum and then you may find a microscopic spot. That is a misunderstanding, in my opinion of the underlying pathophysiology of the way these lesions regress. In many studies, they exclude even stage one endometriosis because they're not sure of its contribution. Sometimes they start at stage two, which we know is real.

[Dr. Mark Hoffman]
That's a big component of our AAGL MIGS world right now. There's a large subset of surgeons who are doing these, again, like I said earlier, peritoneal stripping that I think colleagues like Frank Tu would argue, we just don't know when this peritoneum comes back and the new nerves that are forming. We don't have any sense that it's going to help. More importantly, we have really no understanding of the risks of these surgeries, besides, again, the acute perioperative complications and those things, but long-term, we don't know what we're doing to these folks and so I have patients that come say, "Oh, I saw this person traveled away, came back, and they said they took it all out." I'm going," Who's saying that to patients? Who's saying I got it all? Right, it happens all the time.

[Dr. Tommaso Falcone]
Yes, of course. Why not?

[Dr. Mark Hoffman]
Well, I don't know. Honesty, sleeping at night.

[Dr. Tommaso Falcone]
Yes, with patients. I can see it from the patient point of view, it's not just us for endo. They ask all the time, Did you get it? " Did you get it all?" It's an attack. I don't blame people. People do the best they can. I just feel that it is becoming too radical for very small diseases. First of all, there are studies that show repetitive surgery can actually increase pain in patients with endometriosis. Therefore, we have to be cognizant of what we're doing, but I have to tell you, the patients that were the angriest with me are the ones that I told them, "I don't think I can help you with more surgery." Patients would come in from out of town, they would spend three months getting an appointment. They come and I would take my time, review all the records before they got here. I would say, "Look, if you look at these records, not one says on the pathology report, you have endo. If the person on the operative report said you have endo based on severe scar tissue or something. There are two possibilities, either it's still there or there was none. It's not a problem. People just over call it and because they say it's complex, but those patients are very unhappy with me when I tell them, "I don't think I can help you with more surgery, can we try something else? I'm not saying that you don't have the pain. I believe you. I'm not saying that we should not offer you some type of therapy. I will not abandon you. The surgery is not gonna do it. I don't know how some surgeons, patients come to see me and have had six surgeries by 25 years old.

[Dr. Amy Park]
Yes, no, that's excessive. Mark and I talk about this all the time. The community, it is a community and you said this too, it becomes part of the identity and part of the support. Then you pull the rug under them and they're angry about it. I just wanted to pivot. I have two questions. One is you've always had a sense of innovation and surgery and research. You were editor in chief of JMIG. We didn't even mention that at the beginning of this session. How did you hone your sense for that in your own career? Number one. Number two, a lot of the surgical techniques you were doing for endometriosis and also robotics, you had to forge yourself. Togus Jolande is obviously a super famous REI surgeon. I don't know, is he practicing anymore? He's probably retired, right?

[Dr. Tommaso Falcone]
He's actually chair of OB-GYN still in McGill University.

(6) How to Foster a Culture of Surgical Innovation

[Dr. Amy Park]
Then we go, okay. How did you pioneer the techniques and become a better surgeon? You know the anatomy, and the spaces, and we just got better over time, but you just had to put yourself out there. Cleveland Clinic has very good lawyers because a lot of people are afraid of litigation and innovation, you know what I mean? I feel like that's part of it. Having a culture, you also set the culture at Cleveland Clinic for innovation for a long time. How did you, and just individually, but also for the Institute, and then also, surgical techniques because a lot of people in our section, and across the field honed their innovation and their surgical techniques here as well.

[Dr. Tommaso Falcone]
The first thing is, like innovation or being around at the right time, there's a certain amount of good luck. You happen to be there when it happens. For example, robotic surgery in the year 2000, the first robot, which they don't have anymore, was called a computer motion data. It was called the Zeus. They came to the Cleveland Clinic. I happened to be here. I had been here for four or five years. I wasn't sure yet. They came and we asked, "This robot will work if we take maximally invasive surgery and turn it into a minimally invasive surgery," which would be cardiac. They went to the cardiac surgeons and they said, "We want to do this." If you look at the original studies, they were all with cardiac, but they were open. Nobody said that he would put the doctor robot after the chest result. When they wanted to do it, without it, they came down and there was one surgeon here who said, "Oh, we should try this in the same type of suture," which was the 8090 for coronary bypass. Then we're going to try it though in gynecology because you don't die if it doesn't work.

They came to me and they said, "You do the trial on tubal reversals." We use the 8090. I just happened to be here, and the robots, like companies, were here with the heart surgeons and the other ones. I said, "Okay, I'm going to try it, and let's see what happens." I started trying it and I did the first FDA trial in the world in gynecology for robotic surgery. Now it's a robot that doesn't happen anymore, but the concepts were that we were doing this, but I happened to be here. Then what happened, the reason why it didn't take off in heart surgery is because at the same time they developed the stents. The robotic coronary bypass surgery was meant for simple disease. The stent guy said, "We don't even need a robot," but now they're actually going back in time for some of the stuff in cardiac. I happened to be there first.

Then the next phase, ovarian tissue cryopreservation and auto-transplantation. That took off and people said, "Oh, we're going to do it with this particular technique." I said, "Well, this is the time when I was doing it with an on-sheet model." I said, "Hey, you know something, let's try it with vascular anastomosis." The plastic surgeons here were developing all sorts of microvascular techniques. That took off and I was involved with that.

Then the final one of those things was uterus transplantation. Again, I happened to be here. At the time I said, "This is absolutely crazy. Why would anybody do a uterus transplant?" Well, there happened to be a transplant surgeon named Andy Cherkas who was in Florida who said, "Oh no, it's a great idea." I said to Andy, "No, I think it's a crazy idea, but I'm willing to listen." I said to Andy who was part of the team in Sweden. This is maybe 10 years ago. I said, "I'll go to Sweden. I want to talk to the patients. I want to talk to patients because they're the ones that are going to tell me the truth. I'm not just going to be some crazy doctor." Andy Cherkas and I fly to Sweden to learn this. At that time, Matz, who was the pioneer, truly the pioneer of it. I said, can I speak to the patients, the ones who speak English anyway? I sat down and I said to them, why did you do this? Well I want to have a baby. Why did you do surrogacy or gestational carriers? Dr. Valkner, it's illegal in Sweden to use a gestational carer. In fact, commercial surrogates are banned in all of Europe and Canada. They couldn't do it anyway. These patients were strong-minded. This is what they wanted. We were responding. I said, "Well, okay, maybe there's more to this than I thought."

We learned the technique. We flew back and we tried it on many cadavers when they were doing transplant. There was a transplant surgeon named Andy Cherkas, world-renowned liver transplant surgeon, extremely innovative person. If you look at something called the H-index, he's one of the highest there is. He convinced me to do it. I was part of the team that did the first one in the United States. All this has to do with a mindset. You have to have luck too. You have to have a hardworking mindset and be open to changing your mind about all of these things.

[Dr. Mark Hoffman]
Being in the right place though.

[Dr. Tommaso Falcone]
Right place, yes.

[Dr. Mark Hoffman]
You’re at a place where innovation is prioritized and you're with other people who are like-minded. Yes, for sure. It's an amazing place.

(7) Walking the Line Between Innovation & Complications

[Dr. Tommaso Falcone]
The surgical skill is learning to be part of learning a new thing, doing something new is, it has to be part of a team because if you're as a solo player, it's very difficult on your morale because you may fail, you didn't know if you did the right thing. I was here as part of a team. There was always a team and the team were not necessarily in gynecology, like I had the colorectal surgeons, urologists, and to a certain extent, they're braver than we are because like a urologist, they accept that I injured the bowel, I cut the ureter, I'll fix it. For us, it's the end of the world.

[Dr. Amy Park]
I know it's true. The colorectal surgeons, especially, they're like, "Hey, hey, no big deal.”

[Dr. Tommaso Falcone]
Yes, and we don't like that. It is a big deal for my patient. "No, no, no. It's just a little ostea. I'll reverse it in three months." "No, you don't understand. It's not that." I had the same thing with a thoracic surgeon. I was learning to do diaphragmatic endometriosis. I called the guy in and the guy said, "Here is the diaphragmatic endometriosis, when we wake her up, we'll talk." "No, I can remove it right away." I said, I don't know. The guy's name is Tom. I said, "Should we really be doing this? After all, I don't want a complication. She's 22 years old. She came here with pelvic endo." "No, I'm a thoracic surgeon. I can do anything I want. "All right, fine, go ahead." He takes it and then 30 seconds later, I can see the lung, all right? He says, "Oh, it's no problem. We should put a chest tube." "No," I said, "Tom, this patient came for a laparoscopy. She can't wake up with a chest tube. You understand this? This is not standard of care." He says, "Well, what's the big deal? I'll remove it tomorrow." "No, it is a big deal. Anyway, you fixed it and you didn't have to put a chest tube in." You can imagine, they have a different level of things. Even our G1 oncologists, "Oh, yes, we hit a vessel, we'll sew it up." "No, it's not the way we do it in benign disease. Not like we can't hit the vessel and put a few stitches in." The same thing with these, you work as a team, and I learned from them. I learned a lot, like from the colon surgeons and the urologists. Hey, they put a hole in the bladder. Yes, it's okay, just put a Foley in. Well, I don't know. I'd rather sew it up.

It did teach me about that, you learn, we learned, I learned, like when I first got here, I said, "We need to do laparoscopic burches, okay?" Laparoscopic burch procedure. I went to Mark, and I said, "Mark, I don't see you're in contact with patients, but you do. He was doing burches. I said, "Mark, we do a laparoscopic burch?" "You're crazy." He said, so I said, "No, we can try it." I said, people are doing it all over the world. Then, of course, with the TVTs and all that, afterwards, it went away. The first time we did one, we got in the bladder I'd say, in under 30 seconds. Mark says, "I'm never going to do this again. We don't do this." I said, "Well, Mark, just give me another chance. You need to be in a team." Mark knew, obviously, I would put the stitches in. I said, "This is really good, yes." Then I went to a meeting, and there's a guy there who died now.”

[Dr. Amy Park]
Stuart Stanton, yes.

[Dr. Tommaso Falcone]
He was doing TVTs, or, and he says, "Dr. Falcone," and I was presenting the laparoscopic burch, he was an REI with it. He says, "What's your learning curve?" I said, "Well, what's the learning curve for TVTs?" The guy goes, four. I said, once you've done four, you know how to do a TVT. How many for laparoscopic burch? I lied. I said, well, I think we can teach people with 12. Of course, you really need 50. You don't like to do it. The burch went out, completely out of place, but I didn't mind doing it. The interesting thing, when I was in London, they absolutely eliminated it completely, all mesh, even for TVTs. You can't do an anti-incontinence procedure.

[Dr. Amy Park]
Oh, yes, I know.

[Dr. Tommaso Falcone]
There's nothing left.

[Dr. Mark Hoffman]
Is it all native, is it natural harvesting, or?

[Dr. Tommaso Falcone]
Oh burch.

[Dr. Mark Hoffman]
Back to burch.

[Dr. Tommaso Falcone]
Yes.

[Dr. Amy Park]
They do a lot of bulkamid, and it's a lot of pelvic floor ultrasound if you go to IUGA. That's why, I'm just curious, because it's like, the innovation, and the culture of it, and then fostering it, and then also that pushing the envelope, and the curiosity, that just takes a lot of vision?

[Dr. Tommaso Falcone]
I doubt it, but it's all part of the team. If you're a solo player, probably. They encourage, plus I have to tell you that innovation nowadays, and it is more difficult because for better or for worse, maybe we're wrong, we tolerate complications. For transplant, we have uterus transplant but there was a 15% prevalence of ureter injury. You couldn't do that with anything else, for the donor, not for the recipient. Therefore, transplant surgeons said, what's the big deal, 15% ureter stenosis, they're saving lives. They are, we're not. We're trying to make people better. Anyway, so a lot of things nowadays, even for all the other surgeons, even colorectal surgeons, the reason why in our institution, they bring up a lot of ostomies because they cannot take any leak. If a leak happens prophylactically, does it prevent leaks? Probably not, but if a leak occurs, you're not taking the patient back to the OR for another surgery.

A lot of people have moved towards that. They don't mind innovation. There's a robotic surgeon here named Jihad Kaouk, he was showing me how he does prostate surgery now right through the bladder, not like the scope, and then you disconnect the bladder from the urethra, take out the prostate. He puts the robot into the bladder, so they go into the bladder, and then they have this single port robot, and they remove the prostate gland, not all patients that way, and that way, you remove the scope, and all you're doing is closing the bladder. It's amazing what people can do, and the innovation that's in, for our group, but this is how we learn from each other.

(8) The Importance of Teamwork in Pioneering Surgical Techniques

[Dr. Mark Hoffman]
Your point about the teams is crucial, right? You've got people who are comfortable doing things that you're not comfortable doing, and we've talked about that a bunch in the show, but the other piece is expectations. I tell folks and people on training like patients understand complications. I think they don't like surprises. When I talk to patients, I send them to my colorectal colleague and say, "Look, significant concern for colorectal disease, risk of an ostomy is not zero. It's something you need to think about and weigh, and do we want to focus more on medical management for now? Is that a road I want to go down knowing that that's a risk?" Informed consent, informed is a crucial piece of that. When they're part of the decision-making process, knowing that whatever happens is fine. If they wake up with an ostomy, that's what we discussed. If they don't, they're happy. When you wake up with the surprise chest tube, it's a different thing entirely.

I try to counsel patients honestly, not try to scare them out of anything. It's to be truthful and say, "Look, this could happen." With endometriosis, we have to really think a lot more about those conversations that are the past with benign disease, cancer, sure, all sorts of stuff can happen. Endometriosis is not an easy surgery either. Ureteral injury and bowel injury and all those things are just sometimes part of it. You can't end as wrapped around the ureter. You may have to cut that section of ureter out. It's not a small thing. I think the pre-op counseling and doing this a lot and doing it enough to know what could happen is a huge piece of what you said is dealing with having good teams, but also really preparing patients for what could happen.

[Dr. Amy Park]
Yes, managing expectations is the main thing. I always say under-promise, over-deliver, and then you have to focus on what your outcome is for endometriosis. Is it pain? Is it infertility? Is it symptoms? Of course, it's like the goal is symptoms for urogynecology. Asymptomatic prolapse, don't touch it. [chuckles] Same with the fibroids, don't touch it. You know what I mean?

[Dr. Tommaso Falcone]
That makes something better if it's pretty good to start with.

[Dr. Amy Park]
Yes, exactly.

[Dr. Mark Hoffman]
Well, this has been pretty good. That's an understatement. I know we've got a lot more we could talk about. We've kept you on for over an hour already. I would love to have you back on the show one of these days to talk about fibroids or about any of the other things you've done in your career. I'm a chief medical officer now, and so to understand your transition into more administrative work. What percentage of clinical are you still right now?

[Dr. Tommaso Falcone]
I'm approximately 25% clinical and 75% traveling salesman, almost.

[Dr. Mark Hoffman]
I'm about 30% clinical so I'm doing some of that myself. We'd love to have you back on one of these days to talk about that transition as well. Personally, selfishly, I'm dying to learn more about it. I'll definitely pick your brain when I see you in New Orleans in a month or so. I just want to say thank you for coming on the show. I've heard so much about you. You are a legend in our field. You are someone that..

[Dr. Amy Park]
A Legend.

[Dr. Mark Hoffman]
If you're doing this work and you don't know who Dr. Falcone is, you're not doing this work. You're not paying attention because you truly are one of the Mount Rushmore folks in our field.

[Dr. Tommaso Falcone]
Thank you.

[Dr. Mark Hoffman]
Thanks again. We'll see you back soon.

Podcast Contributors

Dr. Tomasso Falcone discusses Endometriosis Surgery: Techniques & Lessons Learned on the BackTable 70 Podcast

Dr. Tomasso Falcone

Dr. Thomaso Falcone is an OBGYN at the Cleveland Clinic in Cleveland, Ohio.

Dr. Mark Hoffman discusses Endometriosis Surgery: Techniques & Lessons Learned on the BackTable 70 Podcast

Dr. Mark Hoffman

Dr. Mark Hoffman is a minimally invasive gynecologic surgeon at the University of Kentucky.

Dr. Amy Park discusses Endometriosis Surgery: Techniques & Lessons Learned on the BackTable 70 Podcast

Dr. Amy Park

Dr. Amy Park is the Section Head of Female Pelvic Medicine & Reconstructive Surgery at the Cleveland Clinic, and a co-host of the BackTable OBGYN Podcast.

Cite This Podcast

BackTable, LLC (Producer). (2024, November 12). Ep. 70 – Endometriosis Surgery: Techniques & Lessons Learned [Audio podcast]. Retrieved from https://www.backtable.com

Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.

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