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Horace Roman, MD, PhD - Primum Non Nocere vs. Definitive Bowel Surgery for Endometriosis

Horace Roman, MD, PhD - Primum Non Nocere vs. Definitive Bowel Surgery for Endometriosis

Horace Roman, MD, PhD - Primum Non Nocere vs. Definitive Bowel Surgery for Endometriosis

Endometriosis Foundation of America
Medical Conference 2019
Targeting Inflammation:
From Biomarkers to Precision Surgery
March 8-9, 2019 - Lenox Hill Hospital, NYC
https://www.endofound.org/medicalconference/2019

Ladies and gentlemen, thank you very much to Professor Martin for this nice presentation of my activity. I am very grateful to Tamer to invite me to this prestigious meeting and to let me speak about my favorite topic, which is the surgery of deep endometriosis of colorectal endometriosis. And I choose for this topic the title Primum Non Nocere, meaning, first, don't harm.

So, as usual, I would like to declare my conflict of interest, because as I am involved in master classes and workshops, I receive fees from these four societies. However, these fees represent less than 1% of my overall income, so there are few influences on my feeling about the disease.

Now, what does mean a reasonable surgical approach in deep endometriosis? And to introduce this topic, I will present you three cases, three young women with comparable age and comparable disease. The first one, I recently met her. And three days ago, I perform a biopsy. She's 36-year-old nullipara. And she has one symptom, 10 days a month. She has a cyclic pain involving the anterior face of the right thigh, with troubles of walking and climbing stairs. Despite my analysis, I did not find any deep dyspareunia, dysgeusia, dysuria, bowel movements trouble, left sciatic pain, nothing. And when I performed an examination, I found a huge infiltration of the posterior and left vagina, while the symptoms are on the right side. The AMH is very, very low, so it's no chance for an IVF.

And here you have the MRI. She has a huge nodule of the right iliopsoas muscle, involving the cecum and the abdominal wall. Now, complete excision of this mass, is it possible? Yes, we can. Can we remove it? Yes, we can. However, should we do it? I think, no, because the risk of sequelae is huge in this woman who continues to climb stairs and to walk. So, I choose to perform cryotherapy in a hospital in Paris. And I administrate her continuous hormonal treatment, particularly, because she has no chance to get pregnant naturally or with IVF.

However, the MRI also shows a huge nodule of the mid rectum, vagina left, right parameter left sacral roots. It is the nodule I found at the vaginal examination. However, no symptoms are related with this nodule. So, can you remove it? Yes, we can. Should we do it right now? I think not, because the expected postoperative risk, functional risk are huge related to this nodule, which does not do any pain or symptoms. So, I decided to attend her to see her every year, and to administrate medical therapy, and to refer her for OC donation.

So, the decision of no surgery, in this case, is not the consequence of my lack of skill, because I have performed not far from 900 colorectal endometriosis, low rectal endometriosis, sacral surgery. So, it's the consequence of the awareness of possible expected postoperative risk in a patient free of symptoms and having no probability of natural or assisted reproductive technology of pregnancy.

Second case. 32-year nullipara. She has symptoms mainly during periods, but she's very symptomatic. She has dyscrasia. She has dysuria. She has a right sciatic pain. She has deep dyspareunia, right shoulder pain. She has a pregnancy intention, and her AMH level is correct. So, she has severe painful endometriosis. You can see a big nodule, rectovaginal nodule involving the lower rectum, a big piece of the vagina, sacral roots, and diaphragm. So, should we perform surgical removal of endometriosis in this case? Yes, we should, because she's symptomatic. But how? How doing it? The nodule of the rectum is three to four centimeter above the anus. If you perform a low rectal resection, we have a huge risk of low anterior recto resection syndrome, which may impair the quality of life.

That's why I decided to perform a disc excision because in Rouen we introduced a technique of low rectal disc excision by a combined vagina laparoscopic and transanal route. And we performed what we are calling the Rouen technique. And we moved a five-centimeter large disc of the low rectum. We perform the unilateral resection of the right parameter. We dissected the sacral roots, vaginal excision, and diaphragmatic lesion ablation. And after that, 14 months later, so today, she has normal bowel movements, normal bladder voiding, no sciatic symptoms, no shoulder pain, no dyspareunia, normal quality of life, and she's pregnant naturally.

Third case. 34-year prepared. She came with subocclusive phenomena, pre-IVF performed during the last two years. Subocclusive phenomena, dysuria, right sciatic pain, right hydronephrosis and partial atrophy of the right kidney due to the huge endometriosis lesion involved in both parameters, with her stenosis of the ureter, and the subocclusive stenosis of the rectum. So, can you remove it? Yes, we can. Had we to remove it? Yes, we should because she is very symptomatic. She's about to lose a kidney and to have a subocclusion.

However, in this case, we could not do a disc excision. We had to do a low colorectal resection, your uterine implantation, right parameters resection, limited left parameter ... So, I choose to perform a large parameter resection on the side of the hydronephrosis. And the very limited parameter is actually in order to reduce the risk of bladder atony, incomplete innervation of all the pelvis.

However, two years after, the overall results are not good, because she has a LARS syndrome, meaning she has five to ten stools a day, urgency, incontinence of gas, self-catheterization for bladder denervation, probably definitive. She has no sacral roots, no sciatic pain. However, she has an impaired quality of life, and she does not longer wish pregnancy because of her health problem.

So, we have three cases. Three, somehow, similar diseases, but with small differences, and those differences made a huge difference in outcomes. So, we had three different strategies, were based on symptoms, on rectal nodule features, on risk expected functional outcomes, and pregnancy intention. And we had three major different results.

So, when you choose the strategy, if you choose the curative surgery and you're the first surgeon, you must keep on mind that there is a one-shot strategy. Meaning, that you have to do the good surgery, the complete surgery because the friend who comes after you to complete the surgery will be maybe in big, big trouble. Because of the second surgery, it's always more challenging, and the risk of complications is higher.

Now, primum non nocere. There are two circumstances where the surgeon may inadvertently harm the patient. If he performs too aggressive surgery, another treatment, and the consequences, the injuries are immediate. But also, conversely, when he is too prudent when he hesitated, he undergoes the patient. There will be delayed injuries because the disease will progress.

But let's speak about the overtreatment. When you perform too aggressive surgery inadvertently or voluntarily, you may have a risk for three major organs. You may injure the rectum with an impairment of digestive functions. You may injure the nerves, if denervation, a pain, dysfunction of various organs of the pelvis. And you may injury the ovary with ovarian failure and definitive infertility.

Now, in this presentation, I will leave the nerves, because Marc Possover is here. I won't speak about ovaries because it's a huge field. And I will focus on the rectum. So, the surgery in colorectal endometriosis, because, we, all in this room, we perform surgery of colorectal endometriosis.

But how we can do this surgery? So, we have to choose between two approaches. One is conservative, meaning that we do not remove the organ. We remove the disease, but not organ itself. We can do shaving and disc excision. And the radical, more radical surgery, we'll remove a piece or completely the rectum. If you look back, you see that the first articles, the first pioneers of the surgery ... And I am very happy to see in this room some of them. So, they did nodulectomy shaving, so a more conservative surgery. And then progressively, multidisciplinary teams involved colorectal surgeons. And the rate of colorectal resection in colorectal endometriosis progressively rise.

However, rectal endometriosis is very, very different from all other diseases of the rectum, because it's sole, it's the unique disease where the disease starts extra-rectally, outside the bowel, and progressively involves the bowel. That's why conservative surgery is possible.

This paper published by David Redwine has been seated a hundred times. So, he published in 2001, and he treated patients with very severe disease at the moment where the large series of such patients were less than 100 patients. And if you have a look at this table one, you see that he completely treated the patient. But he performed in almost 90% of cases a conservative rectal surgery.

However, 10 years after, 10 years later, [Kristan Moolman 00:13:29] from Leuven reported in human reproduction update a large systematic review. He pulled together all the series retrospective or prospective series with surgery of colorectal endometriosis. And she observed that 70% of patients had a colorectal resection. So, 10%, 11%, in David's paper 70% 10 years later.

However, beginning in 2010, 2006, 2010, the surgeon has started paying attention to the quality of life to the secular of their surgery. And I think that now there is a decreasing in the rate of colorectal reaction in the sudden discovery, again, the shaving and the disc excision.

And I recently published this survey involving all the patients of a large, majority of patients per manage for colorectal endometriosis in France in 2015. There were 1135 patients. Maybe we lost 100, 200 patients managed in small departments and not recorded in databases. But I think it's a good snapshot of what has happened in colorectal surgery in endometriosis in France.

And you see there was 56 team who published their results. This is my team, and progressive. You have here 10 on hospital, Goshen, Hospital, Clermont-Ferrand hospital. So, a good point is more than 90% of patients who are managed by minimally invasive surgery. 55% of them had a conservative procedure. So, colorectal resection decreased from 70% in the systematic review of Kristan Moolman to 45% in France.

But if you pay attention at these figures, where I put shaving in red, disc excision in yellow, and colorectal resection, sigmoid colon resection in blue and green, you may see that H team perform his particular technique. So, there was a team performing the only colorectal resection. There was team performing in a large majority of case, disc shaving. There is no rule in the choice of the technique in France.

In my experience, I systematically tried to balance and to choose the technique depending on the patient, and not promote a technique which should be suitable for everybody.

Now, how rectosigmoid endometriosis can be managed? So, we have three techniques. We have shaved. The shaving means that we try to excise the nodule without opening the rectum. We can use scissors, laser, plasma, harmony scalpel, everything you want. The goal is to perform a complete macroscopic excision and to conserve the bowel and not opening the bowel. You have to check the bowel perforation, particularly when the shaving is very deep. Because in this case, you may take the risk of a delayed fistula if the bowel wall is very thin and you use instruments with heat diffusion.

However, shaving in a large majority of cases, it is microscopically incomplete excision. However, it presents several advantages. There is a very low rate of complications. There is a very low rate of worse functional outcomes, meaning that if you perform a shaving it's very less likely that your patients will be worse from a functional point of view, then preoperatively.

However, preoperative constipation is incompletely relieved, and long-term recurrences, of course, or probably more frequent, because the surgery is less complete. However, I think it should be the first line technique, particularly in an elderly woman with a short time for at risk of recurrences.

And you have to know that beginning with 2009, all the patients managed for endometriosis in Rohan, now in Bordeaux, were recorded in the databases, huge database of 3,000 patients, followed-up every two years with questionary of quality of life. And we could have an accurate look and to have accurate results in terms of functional outcomes after shaving, and the results or overall good.

However, rectal shaving presents a big disadvantage. This is an unstandardized technique. And several surgeons perform several shavings. The depth of the infiltration should be assessed, should be checked before shaving by MRI or ultrasound in order to be sure that you go enough deeply to remove the nodule. And an inappropriate indication of shaving, inappropriate technique of shaving, particularly when the research is published in the literature, this serves the validity of data, particularly in recurrences rate. And once a surgeon performs the shaving which is incomplete and the patient is too symptomatic, the second surgeon coming after taking a lot of risk of postoperative complications because the procedure is much more difficult. Whatever the procedure would be, a disc excision or segmental resection.

And as an example, you have three MRI of patients. I had to manage by disc excision or colorectal resection. Two years after shaving on this kind of lesions and the surgery, the shaving was performed by experienced surgeons. But I think that they had not a good with an idea about the nodule, they have to shave.

Disc excision. It's a procedure I know very well because it's my favorite procedure. The goal is to go far than the shaving and to remove the shaved area in order to provide a more complete excision. The advantage is that you can survey the rectum; the length of the rectum, the volume of the rectum. Do not perform the innervation because you do not go on back on the rectum, so you do not touch of vascularization or nerves. And the functional outcomes are more favorable than after colorectal resection.

However, when you perform a disc excision, you may leave behind microscopic foci in 27, 40% in case nobody knows very well. But in less than half of cases, the microscopical resection is not excision is not complete. However, as you preserve the mesorectum and as the suture is somehow semicircular, there are no stenosis effects after the disc excision.

And here, you have several papers published by our team, where we found a good improvement in functional outcomes and gastrointestinal score one year every year after the disc excision.

And my personal experience is about 235 discs excisions in the rectum. And we used two techniques; the Rouen technique in the low rectum, 82 cases, and the transoral circular stapler to perform this excision in the upper rectum and sigmoid colon, 150 cases. And this technique with circular stapler I will go faster, because this afternoon, I present a procedure I performed yesterday morning in live for Congress in Bern. And Tamer asked me to fully record the procedure and to present this afternoon a delayed live surgery.

So, the approach is the same. We performed deep shaving. And then you put a stitch on the shaved area in order to invaginate the shaved area into the circular stapler, and then to remove a piece of a disc of the rectal wall of three centimeter, four centimeter, and rarely, more than four centimeters.

And the second one is the Rouen technique, is the technique we introduced in Rouen in 2009. And we performed it in more than 80 patients with good results. Why only 18? Because the lesions of the lower rectum were not so frequent, but they were particularly, the patients with high risk of functional complications, high risk of low anterior resection syndrome after a low colorectal resection. And we observed that the results were good.

And I will come back within a couple of minutes.

Now, the colorectal segmental resection, everybody knows it is the most radical management because the nodule is removed with the segment of the rectum of the sigmoid colon. In my experience, I reserved this technique in huge subocclusive nodules, but today has become more and more frequent. Nodule is responsible for a long bowel infiltration where the disc excision is no longer possible because of the length of the patch we have to remove. In circumferential lesions and multifocal rectal lesions, which are very close. So, we cannot perform two separate techniques because the distance between two consecutive suture is too short.

Recurrences rate after colorectal resection when correctly done, they were very, very low, 1% to 2% after 10 after ten years. However, there is a complication maybe incompletely, insufficiently described in the literature is the stenosis of the anastomosis. And we observed it, we recorded it at 8%, even in 15% in our randomized trial. The stenosis of the anastomosis after colorectal resection for endometriosis seems to be a bit more frequent than after colorectal resection for cancer or other diseases.

So, multiple nodules of the digestive tract. There are several experienced surgeons who say that if you have several modules you have to remove them in a block, long colorectal resection. I do not agree, particularly, when you have 5, 7, 10 centimeters of healthy colon, healthy rectum between 2 consecutive nodules. And today, to date, we have performed this excision associated with short sigmoid colon resection in 32 patients with good outcome. And we could avoid very long and low colorectal sections.

Now, primum non nocere. Let's have a look at immediate complications. So, it is obvious that more you perform, more the aggressive the surgery, higher the risk of immediate complications. As an example, the rectovaginal fistula increased progressively from shaving to this excision and to colorectal resection. We observed it in our French survey, in our experience in Rouen, and also in a systematic review, I performed recently with Olivia Dones.

The risk of Clavien IIIb complications, meaning that complications where we have to perform a second surgery, also progressively increase from shaving, to disk excision, and to colorectal resection. So, immediate complication; less you're aggressive, less you have morbidity. But I think that immediate complications are less important then delayed complication. Because even though you have a fistula in three or six months, it's past history, and the patient as well.

However, the functional outcomes, the delayed complication may be much more embarrassing, particularly on the low rectum and after colorectal resection. Because when you perform a colorectal resection, you may have four consequences due to the technique itself. You made denervate the rectum because you have to cut the mesocolon and you pull to move the colon on the rectum, and you may denervate the rectum you keep inside.

Stenosis of colorectal anastomosis. Pay attention to your patients. And I am sure that in your own database, you may find at least 8% of stenosis of colorectal anastomosis which is symptomatic. The colorectal resection, particularly, low colorectal resection reduced the rectal reservoir. And the rectal reservoir means the capacity, the possibility to delay the defecation. So, this reduction of rectal reservoir results in urgency and frequent bowel movements.

And also, there is a risk for fecal incontinence and urgency, because the rectum is a very elastic structure, and it decreased the intracolic pressure toward the anal sphincter. So, it protects the rectal, protects anal sphincter against the pressure of the colon.

And these data were also observed by the team of Aarhus, which is the most experienced team in Scandinavian countries. And they observed that the major LARS syndrome is similar before and one year after the surgery. So, they concluded that the surgery by colorectal resection does not impair the overall outcomes. However, in my opinion, as we see patients improved after the surgery, it means that for each patient improved, there is another one which is impaired to have the same mean or result.

As regards, the last score after the Rouen technique, meaning the patients where the high of the suture is four to five centimeters above the anus. You observed only 14% of major low anterior resection syndrome, which threefold less than in the CDF of the team of Aarhus. And the surgeons from Aarhus, I know them very well. They are my friends, and so very, very good surgeons. So, it is the technique itself and not the surgeon.

Now, we try to compare functional outcomes after shaving and disc excision versus colorectal resection. When we perform the study retrospectively on our database, we systematically found that the gastrointestinal scores are better after conservative surgery than after characterization. However, Ray Gary told us that if we do not perform randomized trial, we may have a myriad of bias. And sure, as we perform colorectal resection in more severe disease, we may have a confounding bias of this difference. That's why we performed a randomized trial in Rouen where we randomized 60 patients between conservative surgery and radical surgery in the big rectal nodule, meaning a nodule involving the rectum on more than two-centimeter length.

And we do not find a hugely significant difference. Of course, the sample is small. But we do not find a significant difference between the quality of life, gastrointestinal quality of life scores, except it may be the Wexner score, which represents the anal continence. I think that increasing the sample. Will show better continence after the conservative surgery.

However, we concluded that if you perform a conservative surgery, you have no worse results than if you perform the radical surgery, the colorectal resection.

My last slide. Because when the surgeons who promote the colorectal resection said, "Yes, you should be radical because in this case, you reduce the risk of recurrence." Okay. When you perform a shaving, in 90% of cases, you leave behind a microscopic lesion. When you perform disk excision, you find microscopic foci on the edges, meaning that maybe you will leave behind, in 40% of cases, macroscopic foci.

However, here you have three studies where we checked the microscopic foci far from the macroscopic nodule in pieces and specimen of colorectal resection. And here, there is an editorial of David Redwine, was a reviewer of one of our papers. And we found microscopic foci in 30% of cases, as far as three centimeters from the macroscopic nodule. Meaning that when you cut the rectum under the nodule and you keep one-centimeter margin, you may leave behind a microscopic foci on the mid rectum, too. So, the microscopic complete removal of endometriosis foci is probably, and not a realistic goal.

Now, I want to end with a look at this excellent book, The Emperor of all Maladies. Probably, you read it some years ago. The author says that the surgeons who had so painstakingly created the world of radical surgery had no incentive to change it. He was speaking about the surgery of the breast. Because for years and years, the Halsted, the radical surgery Halsted was the best surgery to do in the breasts. And then it was proved that performing a more conservative surgery does not impair the results. And I think it only depends on us. That depends. The majority of surgery does not follow the same path.

And I would like to emphasize the experience of the first 10 years of the colorectal surgery who performed the shaving and not the [rectomy 00:35:17] with very good results.

So, thank you very much. And I also invite you to have a look at my YouTube channel or LinkedIn account. We have hundreds of procedures for free. And also, I would be very, very proud and very happy to receive you when you visit in Bordeaux whenever you wish. Thank you very much. And thank you, Tamir [Was 00:35:46].

Thank You, Horace. First of all, I'd like to re-thank Tamir for a great meeting. I mean, the speakers that you've assembled, I don't know how you did it. But this is your best effort ever. So, can we give Tamir a hand?

In the '90s, I'd say late '80s and '90s, most of the advances in laparoscopic surgery were here in the United States. And somewhere over in the '90s to 2000, all of a sudden, we heard about all these great surgeons coming out of Europe. Now, there was a big three that was, of course, [Arma Wati S 00:36:36], Mario Malzoni, and Shailesh Puntambekar from India. But there's always a bit of a ghost behind them all. You'd have people say there's somebody who could do these things even better than us. Who?

But finally, I saw this article on excising vaginal endometriosis vaginally using a laparoscope as a combination. And then finally ... And I go to a lot of meetings, and I hadn't met this character. But I went to his meeting. And we're at a seafood restaurant in Lisbon on paper napkins, papers all over the ... It's great seafood, by the way. Probably one of the best. Anyway, so I met Marc Possover. He's our next speaker. He's developed the laparoscopic skills to be able to dissect nerves, and not only dissect them out, so we could all see the anatomy, but to really be able to excise disease from them. So, very incredible stuff. I think we'll all hear about it now. So, Marc. It's your turn.