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Medical Conference 2012 - Charles Miller, MD

Medical Conference 2012 - Charles Miller, MD

Endometriosis Foundation of America
Medical Conference – 2012
Laparoscopic Surgical Treatment for Pelvic Pain
Charles Miller, MD

2 hours & 30 minutes

This truly is a pleasure, especially to follow Dr. Koh’s keynote lecture. It is to kind of say, “Alright, given this elegant surgery what does the literature say? How do we translate from what we are doing, and what we are thinking about, to ultimately how do patients do?” I am really going to discuss it from a standpoint of endometriosis and because we could go all day long in terms of discussing pelvic pain and treatments for pelvic pain.

If you look at women with endometriosis and compare them to women with normal pelvises in a study that was done recently in Fertility and Sterility, Ballard found that indeed there are certain symptoms that go along with endometriosis; throbbing pain, gnawing pain, that dragging pain to the legs that unfortunately I am sure looking into this room many of you have had to deal with. If you look at it from a standpoint of superficial and deep endometriosis, particularly if you talk about your insides being pulled down at that sharp rectal pain, that is the kind of pain that Ballard saw that was more likely to be deep endometriosis rather than superficial. You can see all these other different types of pains, whether it was superficial or deep you really had no correlation at all.

Fauconnier in 2002 did believe that indeed when you are looking at symptomatic deep infiltrating endometriosis, depending on where it was, what type of symptoms you had was the type of pain that was noted. For example, if you had severe dysmenorrhea, severely painful menses there was more likely to be adhesions behind the uterus and it was associated with decreased pregnancy. Pain with intercourse, well that was the ligaments right underneath the uterus, the uterosacral ligaments was the spot for the deep infiltrative endometriosis. Or on the bladder – obviously because both the bladder, rectum, uterosacral ligaments are all very close to the vagina. If you are looking at non-cyclic pain this is more of a bowel type of problem. Dyskesia, painful bowel movements is again increased with endometriosis of the vagina. Lower urinary symptoms reflect back to the bladder. GI symptoms again bowel and vagina. He thought that you could isolate endometriosis, suggested that you could isolate where you anticipate endometriosis based indeed on symptom recognition in a careful, detailed, physical and history.

Back to Ballard - and this was a later article, nearly a decade later, she found that indeed there was no correlation between the site of the lesion and the type of pain that was demonstrated. None of these “P” values showed anywhere close to significance whether you were dealing with right or left sided pain, low back pain, etc., etc., etc.

This is a study, a lot of the literature that we look at on endometriosis, as well as fibroids for that matter, comes from the Italians. The Italians have done an excellent job in terms of really having very, very inquisitive minds at looking at literature. This is a study that was done by Gruppo Italiano, their endoscopy group. This was a multi-center, but was an observational study, and for those of you who are not as into research it is always nice to have that comparative study where you have a control group, etc. but this was an observational study. Not perfect but nevertheless there was felt to be no clear cut association between the stage, site or characteristics of endometriosis and the pelvic pain.

A study that was done by Hsu, a later study looking at 133 patients, both with endometriosis and probably pain without endometriosis, Hsu found that indeed women with endometriosis had for the most part lower mass indexes, were most likely Caucasian, had more previous surgeries, more frequent dysmenorrhea and indeed incapacitation with that severe menses. Dysuria, painful urination was most likely associated with endometriosis of the bladder but that really was the only correlation. Ovarian endometriomas did not correlate to pain site nor did deep endometriosis, etc. The depth, the burden, the lesions all did not correlate.

Weir in 2005 looked at nearly 8,000 patients, so certainly a large number of patients. These were patients who were treated either for minor or intermediate conservative surgery for endometriosis. As you can see nearly one in four ended up with additional surgery with hysterectomy being the conclusion in one in eight. This is a list, a compendium of a number of studies by some of the leading investigators in the world. One of the things that you can see whether you look at reoperation rate or pain recurrence what you see here is nearly one in four patients will either note recurrence or will have a reoperation. Those are staggering numbers when you look at the number of patients worldwide being treated for endometriosis. If you look at the effect of surgery stage one to four, these are non-comparative studies, so again, they lack that control group but in Vignali’s study 24 percent recurrence. The recurrences were greatest when you were dealing with cul-de-sac obliteration, that group of deep endometriosis that Dr. Koh talked about and you saw stripping out the rectum, etc. These are particularly the hard group to get at. Now, are these really recurrences? Or, are they just undertreated? That is something for us all to ask.

Paulo Vercellini – 24 percent recurrence at three years, and look ladies and gentlemen, it really did not matter what stage the disease was at. There was recurrence in stage one as well as recurrence at stage four. The only co-variant that was thought to be different was the fact that younger women had greater incidents of recurrence.

A study by Shakiba – relative risk of surgery; as you can see relative risk the number is greater. If there is a greater risk and you see age 19 to 28, much greater relative risk of potential need for surgery. If you look at pain free you can see that by five years look at the difference, only one in three are pain free at 19 to 29. Whereas at 30 to 39 it is nearly 60 percent, and over 40 it is greater. Why is that? Is Dr. Koh correct when he says perhaps we are missing something else in our diagnosis. Perhaps it is endometriosis plus something that Dr. Chung has talked about, Maurice has talked about in terms of looking at interstitial cystitis as well.

There are three controls. Despite all this literature on endometriosis and despite all the surgery that we do there is very little, very few studies that are randomized controlled studies. One of these has been with Chris Sutton who I was fortunate when I was president of the AAGL with scientific chairman of the AAGL, I honored him as our Honorary Chairman. It was on the basis of his work with endometriosis I felt compelled to do so. He had the very first randomized controlled study on endometriosis, Jason Abbott from Australia and Jarrell as well. If you look back at Chris Sutton’s data it is with double blind study looking at women with minimal to moderate endometriosis. Now what is confounding in this study is you see he treated this laser vaporization of endometriosis but he also used uterosacral nerve ablation. Besides dealing directly with endometriosis he transected the uterosacral nerve thinking that also could give pain relief. Indeed, he did show that there was an advantage at six months in the laser group. But here is what is interesting. Nearly one in four of the expectant group was comfortable as well. He did not do anything with that group. Placebo – okay? - another confounder in terms of looking at data on pelvic pain. Again Chris followed this up and showed that the laser group did better but the expectant group did better as well.

Jason Abbott looked again at an excision group and expectant group as well. He had a randomized controlled study. What is interesting in this group is that the symptoms in his group markedly improved with excision versus the expectant group. No real gain in terms of pain control. Then he went back and excised the rest of the disease, at a second look. What is interesting from Jason’s study is, is that doing it a second time it did not do as well in terms of symptom treatment, Saying that first, and these days I will be politically correct, first woman in, first surgeon in has the best opportunity to deal with the disease.

This was a study done by Jarrell with mild to moderate endometriosis, severe symptoms, again, comparing excision to observation and that indeed there was really no difference in the pain at three, six and twelve months. When they looked at the dropouts along the way, again, there was no real difference. Was this the fact that we were missing other disease factors that were not taken into account?

In terms of long term follow up, this is kind of interesting, the group that ended up having to have surgery, now it was not significant, the “P” value was not there, but even more people in the excision group ended up having treatment – at least as many. Long term, what is the real effect of this baseline surgery? What does the literature really show us?

Well this is a study that was done by Wright. We talk about excision, we talk about ablation. If I went all around to you, if I went to all of you today because you are a very smart group on endometriosis and I said to you, “Is endometriosis excision for pelvic pain better than desiccation?” I am sure every one of you would say excision is better. But I am going to you to read the literature. Indeed, there was somewhat of a difference in pain score, there was the trend toward – and trends toward are important – but it was not significant. If you look at ovarian endometriomas, so when I come to you with excision of disease, with mild to moderate disease, I cannot tell you that there is a distinct advantage to treatment. I can tell you that a significant number of women ultimately who are treated will by necessity of their symptoms be treated again. I herald what Charles said absolutely it is imperative that we look at other options in terms of diagnoses and treatments.

Well, if one looks at excision versus desiccation of the endometriomas one will see that indeed excision is better from a standpoint of rate of occurrence, recurrence, reoperation, dysmenorrhea, dyspareunia and non-menstrual pelvic pain. Across the board, excision of endometriomas appears to be better.

I will cite two studies; one was in Fert and Stert, Fertility and Sterility by Berretta in 1998. Randomized controlled studies just what we like. Indeed if you look at recurrence of symptoms you add a doubling of the time to recurrence in the excision group, 19 verus 9.5 months. Alborzi’s 2007 study, a later study, again randomized controlled excision versus desiccation. There was definitely greater recurrence at two years in the coagulation group. I think one of the messages clearly is if you are going to have an endometrioma removed the patient should know it should be excised and not desiccated. BUT, but, but, but, but we just had an article out about it in our Journal of Minimally Invasive Gynecology, the AAGL’s journal. It is important that you remember, and back to what Dr. Koh says, it is like we are twin sons with different mothers here, back to what Dr. Koh says, it is important that you find the right surgeon. Because what we showed in our article the fact that you can injure the ovary if you do not meticulously dissect out that endometrioma and minimize energy in the process. That can have a real negative effect on subsequent pregnancy. There is wide literature to support that.

Remember I talked about uterosacral ligament transecting the nerves? In literature there does not seem to be any reason to support that but there is some work to show that if you dissect out the nerves over the sacral promontory the superior hypogastric nerve bundle, that indeed you can have some advantage to that in terms of pain relief.

This was a study by a friend, Fulvio Zullo, who looked at laparoscopic presacral neurectomy versus conservative surgery alone. And his pain relief both at six and 12 months were better when presacral neurectomy was performed.

I want to spend the end of my talk on a subject that again Dr Koh showed us some beautiful examples of, deep infiltrative disease. Now Vercellini feels that indeed endometriosis infiltrating the vagina and anterior rectal walls can be symptomatic and particular types of symptoms such as pain with intercourse, pain with bowel movements, pain with menses. Rectovaginal endometriosis has limited tendency to progress. About one in six patients will have deep endometriosis in the Pouch of Douglas so in the cul-de-sac behind the uterus and around 10 percent with endometriosis will have deep endometriosis of the bowel, mainly rectal involvement.

But this is a study done by Chapron from France and indeed you can see two out of three patients - rectosigmoid or rectum involvement. But yes, we do see endometriosis of the cecum, we do see endometriosis of the small bowel, we do see endometriosis of the appendix. One has to be cognizant of other areas, listen to our patients and really look at the time of our laparoscopies.

This is a little thing that I do it is called OBGYN News. It is a throw away journal for physicians but it is kind of relatively important because it is actually the most widely read article in gynecology. We have an ongoing article called the Masters Class in Surgery that I edit. This was our first international author, Mauricio Abrao, who is an excellent, excellent laparoscopic endometriosis surgeon. We talked about current diagnosis in treatment. Mauricio talked about imaging, transvaginal ultrasonography, MRI, urography MRI and rectal endoscopy.

Ultimately, I believe that vaginal, transvaginal ultrasound is a very good way of detecting the disease and we use that along with colonoscopy.

But here you are “between a rock and hard place”. Incomplete resection negatively impacts success we have already heard from Dr. Koh. Radical interventions increase risk. Where are we at? This is a comment done by Verrcellini when we looked at over 30 publications on endometriosis. He talked about the fact that we do not have randomized controlled studies. The studies oftentimes are very small. They are single surgeons so they are not a multi center study. You get the effect, you get the thought process of a single surgeon. There are different types of techniques that are utilized. Some people resect, some people just remove a portion, some people do a bowel resection, so there are different types of techniques involved. Follow up is short, drop outs are not included, oftentimes physicians are not willing to share their bad results. Physicians have egos too. All that negatively impacts the data that you can get. The same thing was seen with the cecum in his look at this. All of them saying there are concerns about bringing in data.

This was a study that was done, however, by Vercellini in 2006, who indeed showed that if one goes ahead and excises this deep infiltrative endometriosis that whether it be painful menses, pain with intercourse or painful bowel movement there is a definite advantage of doing so.

Muelemann looked at 49 different studies, nearly 4,000 patients, different types of surgery, bowel resections, partial resection with discs or simply shaving. What he saw in those studies was if you did not do a bowel resection and then went back and someone did a bowel resection, subsequently 40 percent of those patients who previously had a partial resection now showed endometriosis within the bowel. The recurrence rate was greater in the patients who were treated conservatively, not with bowel resection.

However, this is a study done by Roman which looked at colorectal resection, bowel resection versus nodule excision. Really ladies and gentlemen, there was no difference between the two groups in his hands. We do know that short – there is oftentimes excellent short term relief but over time things do get worse. And then think about that woman at age 24 who is getting a bowel resection. Where does she go? What impact does this have on future fertility? We also know there is a risk of post-op bowel complications, such as urinary retention that neurogenic bladder, as well as fistulas.

At least one thing we know, and this is excellent, this was a study that was done by Darai that complications with bowel resections can be decreased with a laparoscopic approach. Again, something that Charles talked about earlier today.

We also know that quality of life can certainly be improved. This was a study looking at segmental resection of the rectosigmoid with laparoscopy and was designed to look at quality of life. There was significant improvement in all pain related symptoms, physical as well as mental health. You can see, just going down the different types of pains that we have talked about as well as even vitality, general health, etc. Patients following the resection did better.

This was another study that was done by Mabrouk, looking at both resection as well as shaving, same type of questionnaire, pre and postoperatively. In this group, both groups did very, very well whether you shaved, removed the nodule or you did the bowel resection, quality of life can be improved.

I leave you with this quote from Dr. Roman in human reproduction from this past year, “The choice of the best surgical approach in the management of deep infiltrating endometriosis of the rectum (DIER) is the subject of a debate that is far from being closed”.

“Yes We Can” – we know this quote very, very well. Yes, we can do it. I ask you, should we?

Thank you for your attention.