Matthew Ong: Do gynecologists need to pay attention to the Yale studies?
David Olive: We need to pay attention to it. It’s reasonably good data on what can happen in these “benign” surgeries. There are some problems with the first paper of which we should also to be aware. I haven’t seen the second paper, only the abstract, so I haven’t had the chance to really analyze it.
The first paper is suggestive of a high rate of cancer in what was preoperatively considered benign disease, but there are some problems. The biggest is that they did not have pre-operative diagnoses, so they used four criteria to try and exclude women who were not undergoing surgery for presumed benign disease: (1) procedures related to obstetric indications, (2) patients undergoing radical hysterectomy, (3) Cases with grossly visible malignancy at the end of surgery, and (4) cases by a surgeon whose specialty was gynecologic oncology.
What they neglect to consider is that there are a lot of gynecologists who are not gynecologic oncologists who live in rural areas, who don’t have access to oncologists, or who just have big egos, who will operate on patients with known premalignant disease or early stage cancer—regardless of the fact that they know that it is cancer—and these cases were included as they did not fit the abovementioned criteria for exclusion.
What? Really?
DO:Of course. You can find them here in town all over the place. Stage Ia grade 1 endometrial carcinoma is very commonly operated on by regular gynecologists, especially in rural areas or by older physicians. In fact, many oncologists will send them back to the gynecologist because it’s merely a hysterectomy, with removal of tubes and ovaries most of the time.
How are they doing these surgeries, and are they doing it in a way that follows oncological principles?
DO: That’s a good question, and I don’t know the answer to that. Nor do these papers address that. Just because our organizations come out with recommended treatment guidelines doesn’t necessarily mean the gynecologic community as a whole is going to follow those practice guidelines. That’s one reason why these papers are important.
The American College of OBGYN, the American Association of Gynecologic Laparoscopists, and others are very much interested in the issues of actual practice patterns among OBGYNs. They have practice guidelines and recommendations, and now the question is how often are they being adhered to?
To that end, we have Board Certification and mandatory Maintenance of Certification, which is required by most hospitals to practice OBGYN. These are the type of issues that candidates are examined over, and it is the hope of the American Board of OBGYN that such testing will help maintain high quality practice in all communities. However, the issue of adherence versus lack of adherence to recommendations and guidelines for practice is a concern in every medical field.
If these prevalence rates in the Yale studies are reliable, do guidelines for preoperative evaluation of patients need to change?
DO: The preoperative evaluation necessary depends upon a variety of different factors. Some of these factors are the age of the patient, the symptoms of the patient, and the reason they are having a hysterectomy.
For example, if a patient is having a hysterectomy for uterine prolapse, there may not be a need to biopsy the endometrium. Requiring that on every patient, or requiring imaging studies on every patient undergoing hysterectomy, will add to the cost of medical care substantially. It is up to society to determine how far such preoperative evaluations should go.
On the other hand, in a 65-year-old woman with post-menopausal bleeding, you would always want to thoroughly investigate that patient.
One final point: guidelines are based on current technological limitations. As more research is performed on diagnostic methodology, the practice guidelines will undoubtedly change.
The CDC is interested in comparing gynecology to other specialties in terms of how preoperative workup is done. Is it true that gynecologists don’t biopsy as routinely or as extensively as other surgical specialists do?
DO: It’s true, here’s the reason why. It depends on what is being investigated. Regarding the cervix, there is routine use of Pap smears and frequent follow-up with directed biopsies when a significant abnormality is suspected. However, it is different for fibroids.
In all other specialties, a mass is quite unusual, and there is a high risk of malignancy. However, with fibroids in the uterus, we are talking about benign tumors that occur in 70 to 80 percent of women at some point in their lives. We obviously cannot biopsy every woman with fibroids, and we can’t biopsy every fibroid in women who have multiple fibroids.
There are only a handful of studies looking at biopsies of fibroids preoperatively, and some of them are encouraging. But there are no data yet that demonstrate that preoperative biopsies reduce morbidity or mortality for these patients.
We also shouldn’t biopsy every fibroid in every patient that is going to surgery. The cost would be prohibitive, the amount of intervention unacceptable to most patients, and the biopsy itself will possibly increase the risk of spreading cancer if it were unexpectedly present.
As of today, there are only a handful of studies looking at biopsies of fibroids preoperatively, and some of them are encouraging. But there are no data yet that demonstrate that preoperative biopsies reduce morbidity or mortality for these patients.
That doesn’t mean it wouldn’t help. It doesn’t mean that we can’t utilize biopsies in a better, more effective way. It just means that we don’t have data yet to support the concept. Since 2014, we have spent an enormous amount of time discussing whether or not to use morcellation, while rarely discussing or investigating new and better diagnostic techniques. That needs to change.
Besides surgery for fibroids, there are other approaches that are used on many patients. An example is uterine artery embolization, performed by interventional radiology and a non-surgical technique. Should these patients be biopsied? If not all, which ones? What of patients with fibroids and no resulting problems in whom we choose to do nothing? Do we biopsy these fibroids? The cost becomes extravagant for very little gain, so I’m hesitant to recommend biopsies without hardcore data that says that it’s a good thing to do.
These are some of the many questions that need to be answered before we start proclaiming fibroid biopsy as a panacea that will save lives.
It looks like we have three clinical scenarios in which morcellation, or cutting into uterine tissue, might upstage occult cancer: power and manual morcellation in hysterectomies, and myomectomies, especially for women who want to preserve fertility. Does that cover it?
DO: Yes, I think so. I think those are good clinical scenarios. There are really two surgeries we are talking about: hysterectomy and myomectomy: any type of morcellation can be used for either surgery.
Let’s start with myomectomies. This is a problem because you are cutting through uterine tissue in every case, in order to separate the fibroid from the surrounding uterus. If there is an occult cancer, you are likely to penetrate the tumor and risk worsening the prognosis regardless of how you approach the myomectomy.
Our original data suggested that it didn’t matter if you morcellated the fibroid or simply penetrated it with sharp instruments during the case—the outcome was the same. Unfortunately, penetrating the fibroid tissue occurs in nearly all myomectomies. We need to continue to research this issue to better understand how to perform myomectomies.
For hysterectomies, I believe there is probably less morcellation being performed, and more abdominal hysterectomies being done. The data would support that. However, there is still significant morcellation being done, just without the electromechanical morcellator.
Everyone is under the impression that morcellation with an instrument in the abdomen, or with scalpel or scissors at the time of vaginal hysterectomy, is safer than the electromechanical morcellator. However, there is no evidence at present that this is the case.
That means the only surgical route in which morcellation cannot be avoided is myomectomy?
DO: We could avoid morcellation, but not penetration of an occult tumor at surgery. If there is no difference in outcome between simple penetration and morcellation, then morcellation will likely continue to be used to allow a patient to undergo minimally invasive surgical removal of the fibroids.
Who might be candidates for morcellation? The patient without obvious risk factors such as postmenopausal age, a suspicious ultrasound or MRI, or some other factor that suggests that the fibroid is unusual. And of course these patients would need to undergo appropriate informed consent, understanding that there is in fact a risk that the fibroid is in fact a cancer, albeit a very small risk.
I would never do it in an older patient, a patient who has a suspicious ultrasound or MRI, who has something that clues you to the fact it’s unusual. Those are the patients that you don’t want to morcellate, because it’s just a risk. The chance that you’re going to run into a sarcoma, particularly a leiomyosarcoma, is the one that we are most worried about.
It would be great if every patient undergoing these procedures had an MRI and a biopsy of every fibroid. However, that’s not practical. We need to develop better diagnostic tools that are less costly and invasive, as well as better determine which patients are appropriate for vigorous pre-operative evaluation.
Where are we on containment bags? The last time I wrote about it, it was a paper on a nearly 10 percent leakage rate. Are these containment systems more reliable now?
DO: There are data that suggest it might be a good thing to use. Regarding leakage, it doesn’t seem to be significant in the laboratory in a majority of the new bags. The problem, however, is that we don’t have long term follow-up and rigorous prospective evaluation to assess whether or not the theoretical advantage of a containment system is in fact a real advantage.
I think most people are not using electromechanical morcellation without containment systems these days. But I think if you asked most of us if we believe there is an advantage to using such systems, I think we would say, “Yes.”
