Rotary Mechanical Resector (RMR) / Intrauterine Shaver/IntraUterine Morcellator

OBGYN.net Conference Coveragefrom the 18th Annual Meeting of ESHRE - Vienna, Austria

Hans van der Slikke, MD, PhD: “It’s July of 2002 and we’re at the ESHRE Conference in Vienna. Next to me is Dr. Mark Emanuel from Haarlem in the Netherlands, welcome, Mark.”

Mark Emanuel, MD, PhD: “Thank you, Hans.”

Hans van der Slikke, MD, PhD: “You gave a presentation about your uterine shaver and I’m afraid not everybody knows what this instrument that you developed yourself is so please tell us about it.”

Mark Emanuel, MD, PhD: “There is discussion about a name already and because shaver is probably not an appropriate name for this instrument we are thinking about another name which might be the intrauterine rotary mechanical resector - the RMR or the IntraUterine Morcellator-the IUM. What it does is it’s a kind of little cutting device, which is introduced into the uterus. The technique is a lot like the orthopedic shaver blades which are used, for instance, for arthroscopic meniscectomies. What we did is we rebuilt this technique and made it suitable for intrauterine use for the resection especially of pedunculated abnormalities like uterine fibroids without deep intramural extension and endometrial polyps.”

Hans van der Slikke, MD, PhD: “And this instrument cuts and it sucks together?”

Mark Emanuel, MD, PhD: “Exactly, yes. What it does is it cuts the tissue and aspirates it immediately so it’s much more easier to handle than the conventional resectoscopy, and that’s one of the reasons why we developed it. I’m working in the Hysteroscopic Surgical Unit in the Spaarne Hospital in Haarlem in the Netherlands, and we are affiliated with the Academic Medical Center at the University of Amsterdam. Actually, it’s a reference center for intrauterine surgery so we see a lot of young gynecologists and residents for training. If we train them the main problems they have with conventional resectoscopy are, first, handling of the cutting loop and the tissue which is cut away and has to be taken out of the uterus which is takes many steps, is very tiring in the long run, and it can even become annoying. The other problem is intravasation of electrolyte fluid as we are using monopolar electrosurgery, high frequency surgery. So these two problems with conventional resectoscopy are solved with this new technique because it sucks and cuts the tissue and we use saline instead of electrolyte irrigation and distention fluids like glycine or sorbitol.”

Hans van der Slikke, MD, PhD: “Yes, so technically it’s easier, has a much shorter learning curve, and it’s less dangerous for the woman not only because it doesn’t cause intravasation of the fluid but it’s a shorter operating time.”

Mark Emanuel, MD, PhD: “Right, actually our clinical experience is rather limited because we just started and we’ve performed about eighty procedures now and we haven’t yet encountered any severe problems with intravasation or intra- or post-operative bleeding. Indeed, if you compare it, we were only able to do a retrospective comparison with resectoscopy. It does go a lot quicker so, yes, it’s absolutely time saving.”

Hans van der Slikke, MD, PhD: “Which figures did you present this afternoon?”

Mark Emanuel, MD, PhD: “The average procedure time we had for polyps, if we looked in the last forty polyp resections with the traditional resectoscope, was an average operating time of twenty-seven minutes which we reduced with this new technique to nine minutes.”

Hans van der Slikke, MD, PhD: “Were they all operated on by yourself or also by residents?”

Mark Emanuel, MD, PhD: “They were operated on by me and all of our experienced staff. For the fibroids it’s a bit similar although the gain of time is a little bit less because the tissue is much tougher and more difficult to resect and to aspirate. For polyps it’s absolutely perfect and for fibroids it does work but it’s less spectacular, it takes a little bit more time. What we achieve now is that we brought back the average operating time of thirty-seven minutes for fibroids which is a very large series I presented in my thesis with conventional resectoscopy, and we brought it back with the new technique to seventeen minutes so that’s a gain of operating time also.”

Hans van der Slikke, MD, PhD: “Was there a difference with intravasation in these two groups?”

Mark Emanuel, MD, PhD: “All of the figures are equal. The big advantage is that in the new technique it’s saline; what we normally use for resectoscopy in the former group was sorbitol.”

Hans van der Slikke, MD, PhD: “So it is less dangerous.”

Mark Emanuel, MD, PhD: “Yes, we did electrolyte checks and as you can expect with saline there are no changes whatever the amount of intravasation is, of course, there are limits with saline also.”

Hans van der Slikke, MD, PhD: “So there’s no coagulation involved and that’s the reason you can use the saline.”

Mark Emanuel, MD, PhD: “Right.”

Hans van der Slikke, MD, PhD: “Doesn’t it cause bleeding?”

Mark Emanuel, MD, PhD: “What we experience now and that’s something we experienced in resectoscopy also, if you achieve a complete resection the myometrium normally will stop any significant bleeding. We rarely do any coagulation of vessels during resectoscopy and we are using cutting current. If you, for instance, look at endometrial resection where you resect all the endometrium out of the cavity and you end up with an open myometrium with a lot of vessels you don’t go after all these little vessels to coagulate them.”

Hans van der Slikke, MD, PhD: “Because they contract.”

Mark Emanuel, MD, PhD: “Yes, by just removing the instrument and natural contraction of the uterine muscular wall all significant bleeding stops. If you compare it with a D&C, which we performed for many years and millions of procedures have been performed over the last decade all over the world where we actually were scrapping off tissue with a sharp curette blindly, it’s very rare that it caused significant bleeding.”

Hans van der Slikke, MD, PhD: “You don’t unless you remove it incompletely so that’s your point.”

Mark Emanuel, MD, PhD: “Even if you scrap off fibroid tissue during a D&C you very rarely have to do an emergency hysterectomy in the past so I think, theoretically, there is a lack of coagulation possibilities but in practice that’s not an issue.”

Hans van der Slikke, MD, PhD: “What will be the next step?”

Mark Emanuel, MD, PhD: “We are already CE marked, and actually I’m still working with the only prototype available so we are expecting in August or in September we will have the first set of scopes available so that we can expand the use to a feasibility study where we are planning to do a study in four centers in Europe and four centers in the U.S. It will be a randomized control study of about one hundred patients where we want to compare resectoscopy with the new technique in a randomized way and it will be multi-centered because we want to know if other surgeons are as enthusiastic as we are. Actually, at this very moment there is an FDA 510K procedure going on which of course is very important for the product and the technique.”

Hans van der Slikke, MD, PhD: “So we have to wait until this is approved before we can broadcast this interview in the United States.”

Mark Emanuel, MD, PhD: “Yes, probably.”

Hans van der Slikke, MD, PhD: “Thank you very much.”

Mark Emanuel, MD, PhD: “You’re very welcome.”