Gyne Endoscopy

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Dr. Ellis Downes: "It's nice to be here in Stockholm, Sweden, and it's great to be with OBGYN.net. We're here are at the European Society for Gynecological Endoscopy, one of the biggest meetings in the world for gynecologists who have an interest in endoscopic surgery. We're taking a few minutes out from a crowded meeting schedule with two distinguished doctors to talk in a little bit more detail about some of the exciting and emerging aspects of what's new here at the conference, particularly in the areas of endometrial ablation. Our special guests who are with us today are also here to talk about what's new in the treatment of menorrhagia. I like to introduce first, Dr. Jay Cooper, who's a Clinical Assistant Professor in Obstetrics and Gynecology, working at the University of Arizona. He has a private practice in Phoenix at the Women's Health Research, and Jay has a distinguished record in assessing and evaluating new areas for endometrial ablative technology. Leading the discussion is my good friend and colleague, Dr. Peter O'Donovan, from England. Peter works in Bradford, in the north of England, and Peter's got wide experience, particularly in endometrial resection and hysteroscopic surgery. Peter, what have you seen at the conference that you think is interesting enough to find out a bit more about?"

Dr. Peter O'Donovan: "The conference so far has been very interesting. The focus on this morning's conversation was David Redwine's presentation on the use of evidence-based medicine in the management of patients with their problems. In particular, he really gave a good overview on the role of trials to assess the response to the management of patients with endometriosis. However, I think the most exciting event I attended was the symposium we just had on the management of women with abnormally heavy periods. I feel that this area was particularly interesting because it was concerned with very exciting new developments in conservative surgery, particularly with respect to conserving the uterus and shifting a lot of the surgery to an office-based setting. I wonder if Dr. Jay Cooper would like to comment on his views as to whether he feels this area of practice will grow in the future, and particularly, locally?"

Dr. Jay Cooper: "I think so. I think endometrial ablation is a concept that will grow significantly over the ensuing five or ten years, particularly now that there are newer technologies-we call them global, or less complicated, ablation technologies. Until now physicians thought that a patient's endometrial ablation required a rather skillful physician who was able to arrive at this level of skill only after many years of experience. Consequently, there are a limited number of physicians who will invest that time and effort to arrive at that skill level so they'll be able to provide for their patients this method of endometrial ablation, which is an excellent alternative to hysterectomy for women who have a problem with excessive or heavy menstrual bleeding."

Dr. Peter O'Donovan: "I endorse what Jay says. In particular, I actually train juniors in these hysteroscopic surgery skills, and I had a discussion with Jay at a previous meeting we attended in Miami this year, the World Congress on Alternatives to Hysterectomy. I can remember our conversation was very much along the lines that having trained doctors in hysteroscopic techniques does require a certain level of skill to actually perform an endometrial resection. And certainly, I actually had about twenty patients which I had to do under supervision before I was reasonably confident in the technique. I think with the new procedures, particularly in respect to the microwave ablations and alternatives, it does seem to be a lesser level of skill dependence. I wonder if Jay would like to comment on this because I know he's been involved in training, particularly in the United States."

Dr. Jay Cooper: "I've been involved with training, but as a criminal investigator in the United States. The way technology receives approval from our governing agency, the Food and Drug Administration, is by conducting what's called a 'randomized perspective clinical trial,' and what we do there is we compare the new technology to the known technology. The known technology, of course, is traditional resection ablation, and the new technologies are these alternatives-global ablation, MEA technology, or what have you. There is no doubt that in training physicians, the ease in which you're able to impart this knowledge or learning curve is so much simpler with the newer technologies than it has been for traditional resection ablation. You feel so much more comfortable as the training physician to hand this off, and you feel comfortable allowing the junior physician to take on this surgery and to not expect significant trepidation-'oh my God, what might happen!?-or maybe just a case or two, after which the physician is now able to be rather expert doing the procedure. So I think there's no doubt that this is going to significantly impact the penetration of these technologies into the marketplace."

Dr. Peter O'Donovan: "Having listened to the seminar during the last hour or so concerning a comparative trial of, for example, what I think is the gold standard-endometrial ablation versus microwave ablation-the results from the Aberdeen study where they actually looked at 260 patients come to mind. The actual findings, particularly at twelve months, were particularly satisfying. I must admit that I am a great believer in actually measuring things against the gold standards, and currently the gold standard is endometrial ablation. I wonder, would Ellis make any comment possibly on any particular safety aspects one would consider forming when actually doing office-based ablative procedures, or so-called office-based procedures in the U.S., but in many ways outpatient procedures in the U.K.? Can you make any comment on any particular aspects that you focus on?"

Dr. Ellis Downes: "I think it's a very important area. I think the real answer for the surgical treatment for menorrhagia will be the procedure that we can perform in the office setting. It's good for the patient, it avoids general anesthetic, and it's good for the physician because it means they can give the best care to their patients in the convenience of their offices. If you do it, I think it's essential that you are very happy about the technique, and you have plenty of experience doing the technique under general anesthesia in an operating theater environment. I think that it's clear that one must have basic resuscitation facilities available, and it's also clear that some patients will not be suitable for an office-based procedure. Certainly, once we take the new technology-which when used in the office setting increases the resource and the coming of that, the newer procedures such as microwave endometrial ablation-as surgeons get more experienced with them, then they're much more comfortable doing them in an office setting. Some of the big centers are now doing more than 50% of their treatments in the office setting, and I think that's going to continue to improve and ultimately give women more of a choice about how they want to treat their menorrhagia."

Dr. Peter O'Donovan: "The only comment I'd make is that the actual studies that are being done in the field of microwave ablation, certainly the company would need to report it by the way they approach this problem similarly. There are fourteen different pro-ablative procedures on the market, and I feel that any technique that needs to be widely introduced first needs to be assessed very carefully in terms of long term follow-up. Also, randomized control trials are a very good standard. I would endorse that every particular point needs to be assessed, and we need to assess all three."

Dr. Jay Cooper: "I would agree 100%. I think that everyone's-patient, insurance company, government-goal is to bring down costs. Certainly, whatever technology we are offering our patients, if it can be offered in a lower cost setting and in a setting that causes less anxiety, i.e. an office setting or an ambulatory surgical facility. That's clearly where we want to be going. More importantly, are putting the cart before the horse? We must be sure that the technology in question is safe and advocatus, and the only way to make that determination is with a randomized clinical trial. That's why all the records have been done at Aberdeen, because it is the closest to what is required by the Food and Drug Administration in the United States, in the form of comparing the gold standard endometrial ablation technology to a new technology, that being MEA."

Dr. Ellis Downes: "I think certainly the forthcoming clinical trials which are about to start in five states in the U.S. will be gathering the data for submission to the FDA so that marketing can begin. I think those trial sites, which have been chosen, will give us some very good data in terms of actually demonstrating that, yes, we can use data in the population that we want to serve. Far too many women are having, in my view, unnecessary hysterectomies. What is your view of the way that gynecologists can reduce the numbers of women who are undergoing hysterectomy?"

Dr. Jay Cooper: "I think that we are seeing an evolution here. The Internet and all other kinds of media are reaching our patient population, and that's dramatically changing their abilities to come to their own decisions. In many cases it happens even before they reach the physician's office, whereas years ago, women would come to me and say, 'what do you think of this?' In many cases they now come to me and ask me what I think about it, but they'll say, 'what physician should I go to to have this done?' They're already beginning to appreciate that the physician's office is not necessarily the only place to come for information about healthcare needs. So I think that will be one significant way that the pendulum will swing. I think the newer physician will be more comfortable and the younger physician will be more comfortable with sharing knowledge with patients and allowing them to make informed choices. I have always found that the more information that I can import to the patient, the better off I am. When a patient makes an informed choice rather than me dictating that she should choose this or that, I feel so much more comfortable because she's now aware of the benefits and risks. And if there is a down side, she's chosen that-I haven't chosen it for her. So I think you will see this happening, and I think the unquestioned lowering of the risk-reward ratio with these new ablation technologies will move women in this direction. Traditional resection ablation is a wonderful procedure, but it traditionally requires general anesthesia and significant potential complications. With the newer technologies, we can lower those risks, minimize those complications, and by doing so, allow more women to opt for this trust."

Dr. Ellis Downes: "I think on that positive note of empowerment, we should bring this discussion to an end. We've been having a chat at the European Society of Gynecological Endoscopy meeting here in Stockholm with Dr. Jay Cooper and Dr. Peter O'Donovan. I think we've reached a consensus that OBGYN.net is about empowerment of choice for physicians and for patients. Thank you very much, and I look forward to writing the Hospital Cuttings in future editions."