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When conclusions don’t tell the whole story, and on paracervical blocks for IUDs

I recently was looking into whether or not you should place a paracervical block before placing an intrauterine device, after a particular patient had a difficult time with a placement.   Over my career, I generally haven’t done so, as the vast majority of patients don’t seem to have a significant amount of pain, and the literature I have read has not been very supportive of the practice.

Today I looked at the literature again, and was a little irritated at what I found.  One particular study was Mody et al, which concluded “Compared with no anesthetic, a 1% lidocaine paracervical block did not result in a statistically significant decrease in perceived pain with IUD insertion.”

So clearly most would read this and say that it doesn’t matter if you put in a paracervical block or not.

But’s here’s the kicker;  the summary of their data is the following: ” Twenty-six women received the paracervical block before IUD insertion, and 24 received no local anesthesia. Groups were similar in age, parity, ethnicity, education and complications. Women who received the paracervical block reported a median VAS score of 24.0 mm with IUD insertion, and women who did not receive local anesthetic reported a median VAS score of 62.0 mm with IUD insertion; p=.09.”

So patients who got a block had pain of 2 on a scale of 2 to 10, and patinets who did not have a block had pain of 6 on the same scale.  So did the paracervical block really not work?
I would say it did.  What didn’t work was the study, or at least most likely so.   The p value, or likelihood that the outcome was do to statistical chance alone, was 0.09. In translation, there was a 9% chance that the difference between the groups was due to chance alone, and a 91% chance that it was due to an actual effect of the paracervical block.  Since we arbitrarily say that a p of 0.05 is statistically significant, the authors say that the study was negative.

But isn’t this quite misleading?  It is 10 to 1 likely that the paracervical block actually made the procedure less painful, and we just didn’t reach a p of < 0.05 because there weren’t enough patients in the study to adequately separate the groups mathematically (lack of power).

P values are important, but we can’t consider them to be everything.  Statistical significance is a continuous variable, not a nominal one.  If we say that p=0.049 means that the study shows a difference and p=0.051 means there was no difference, we are just being foolish, and in the end quite ignorant of the actual mathematics that goes into how the p value was created.

Here’s how I would like to see such a study concluded : “Compared with no anesthetic, a 1% lidocaine paracervical block showed a strong trend towards decreasing pain with IUD insertion, that did not reach statistical significance.  Further study with a greater number of patients is warranted.”

If you read their conclusion, you would probably take from that that paracervical blocks don’t work.  But if you read mine, you take a different message, which is actually supported by the data, which would be “It is very likely that paracervical blocks decrease pain with IUD insertion”, which of course makes sense

Mody SK; Kiley J; Rademaker A; Gawron L; Stika C; Hammon C.  Pain control for intrauterine device insertion: a randomized trial of 1% lidocaine paracervical block. Contraception. 2012; 86(6): 704-9.

 

On the Funding of Endometriosis Surgery

January 23, 2016 4 comments

As many of my readers know, I spend a fair amount of time online. I love interacting with other docs that do what I do, and even more so, I love interacting with women that have the conditions that I treat. Even though I have left academics, I am a teacher at heart, and enjoy the opportunity to pass on what I have learned when I can.

One of the biggest questions I see is about how endometriosis care is paid for.Cash-Loan

Unlike typical care, many endometriosis physicians are not under contract with insurers for care. This creates a whole different system for payment of medical care that is confusing to many patients – so let me explain it here. Read more…

On Lena Dunham, and Why it is Hard to Find a Skilled Endometriosis Physician

January 4, 2016 6 comments

Recently I read an article by Lena Dunham, describing her life with endometriosis, treatment she has undergone, and how her life has been since.  Its a very poignant article about a successful woman who has been held back by her condition, yet also a story of incredible perseverance despite tremendous barriers.  Ms Dunham is a successful actress, producer, writer, and director, having created multiple films and the wildly successful (and awesome!) HBO series Girls, both as writer/director/producer and as principal actress.  She is also a woman who did these things despite tremendous pain from endometriosis.

Read more…

Surgical Video: Resection of Rectal Endometriosis

This video discusses  a case involving partial thickness colonic/rectal endometriosis with severe pain with defecation.  The video demonstrates dissection technique for bowel mobilization and resection of the lesion, as well as generalized intraperitoneal and retroperitoneal dissection techniques.
For clinical consultation with Dr Fogelson in Portland, OR, contact Pearl Women’s Center at 503-771-1883

 

Academic OB/GYN Videos – Stage I Endometriosis Resection

September 23, 2015 2 comments

This is a video describing and demonstrating technique for resection of stage I endometriosis, performed and narrated by Dr Nicholas Fogelson of Pearl Women’s Center in Portland, OR.  Drs Fogelson and Rosenfield are available for clinical consultation, seeing patients from Portland, the Pacific Northwest, and around world.

Top 5 Questions at Pearl Women’s Center – #1 Why am I bleeding so much?

September 3, 2015 6 comments

The following is a cross post of a blog post we wrote for the MIRI network (http://www.miriwomen.com), a network of expert gynecologic surgeons.

Nicholas Fogelson, MD, Richard Rosenfield, MD

Pearl Women’s Center, Portland, OR

  1. Why am I bleeding so much?

Heavy menstrual bleeding (menorrhagia) is one of the top reasons that women seek gynecologic care with us. When we consider bleeding, we have to think of two different systems that are involved – the endocrine (or hormone ) system, and the structural system, which in this case is the uterus itself.

The uterus is a muscular sac that in its normal function serves as a place to carry a pregnancy and to deliver the baby. As far as we know, that’s its only function. In order to serve that function it works in concert with the endocrine system to prepare a place for an embryo to implant and grow every month. If a pregnancy occurs, there is no bleeding that month and a pregnancy ensues. If there is no pregnancy, the bed of endometrium (uterine lining) is shed in what we know as a menstrual cycle. If a woman has normal hormonal function, and the uterus is normal in shape and contour, then in most cases she will have a relatively light and short menstrual cycle.   At least that’s the way it is supposed to work! In women who are having exceedingly heavy menstrual, some part of this system is having a problem.

A woman with a normally functioning endocrine system will ovulate once a month, leading to the typical once a month menstrual cycle. Some women will have problems that lead them to have irregular ovulation, including polycystic ovarian syndrome, thyroid disorders, extremes of weight (both obesity and extreme thinness). Any one of these problems can lead to heavy or irregular menstrual cycles, because the uterus fails to receive the hormonal signals it needs to have a short and light menstrual period.   When patients have these problems, there are often medical treatments that can improve their hormonal system that will in turn improve their menstrual cycles. These treatment can include birth control pills, progesterone based drugs, and in some cases insulin related drugs. Hormonal intrauterine devices can also be quite effective in controlling this type of issue.

In some cases, the hormonal system is functioning correctly, but the uterus itself can be structurally abnormal leading to heavy menstrual cycles. Fibroids are a common cause of bleeding. These are muscle tumors that are within the walls of or within the cavity of the uterus. Fibroids can cause very heavy long menstrual cycles, irregular bleeding, and in some cases can contribute to infertility or miscarriage. Another structural cause of bleeding is a condition called adenomyosis, which is common in patients who have had many children. In this condition the lining of the uterus has grown into the muscle wall of the uterus, effectively causing the women to menstruate directly in the muscle of the uterus.   Women with this condition tend to have painful, heavy menstrual cycles, and often have uterine tenderness that may cause pain with intercourse.   Additionally, there are some rare conditions of the uterus that are congenital (present at birth) that can cause problematic bleeding patterns.

Structural issues of the uterus can also be treated with the previously mentioned medical treatment options,  though this may be less effective depending on the severity of the structural issue.   Fibroids of the uterus can be removed surgically, which can be done either through an open incision or laparoscopically. A number of procedures exist to remove or burn the lining of the uterus, which in many cases can significantly decrease bleeding. This option works best in women who have uterus that are normal to mostly normal from a structural point of view. The entire uterus can also be removed (hysterectomy), which entirely eliminates bleeding.   This procedure can also be open, laparoscopically, or vaginally.

Hysterectomy is a procedure that is thought of differently by women from different backgrounds. Some women want to preserve their uterus, even after childbearing, while other women absolutely giddy to be rid of the source of their bleeding.   At Pearl Women’s Center we are excited to work with women with their bleeding issues and provide the treatment that best fits their needs. Both of our surgeons have extensive experience with minimally invasive techniques and can provide myomectomy and hysterectomy procedures through very small incisions and minimal downtime in the vast majority of their cases.   In the last 10 years we have completed over 1000 laparoscopic hysterectomy procedures and have been a driving force on a national level in showing that these procedures can be safely performed in the outpatient surgery center setting. Our rate of conversion from laparoscopy to open procedures (having to open up) is less than 1%, compared to a national average of 10-20% depending on surgeon experience and setting.

Stay tuned for four more posts from Pearl Women’s Center in the near future!

The Pearl Women’s Center is a gynecologic surgery and aesthetic medicine practice in Portland, OR. Staffed by national expert level physicians and surgeons, the Pearl Women’s Center provides cutting edge care in a beautiful environment. Drs Rosenfield and Fogelson participate in the MIRI network and are look forward to serving new patients every day.

Categories: Gynecology

Thoughts on Abdominal Wall Endometriosis

August 28, 2015 11 comments

In my first year out of residency I practiced in Honolulu, HI.  One day in my outlying clinic in Kapolei, on the west side of Oahu, I entered an exam room to find a woman crying in pain.   She said she had pain in her belly wall that had been present for years and no doctor could help her or tell what was wrong with it.  She said that several months after her last cesarean delivery she started to feel this hard lump on the side of her belly.  Every month right before her menstrual cycle, this lump would become exceedingly painful, both at rest and even more so with any kind of pressure.

She was absolutely distraught, and was really in my office to ask for some narcotic pain medications to treat the severe pain.  So many doctors had failed to make a diagnosis on this issue that she thought it was something she would have to live with for the rest of her life.

But, that day was different, because her doctor that day had been fortunate enough to be exposed to this condition in his training.   The woman had abdominal wall endometriosis that had been ignored or missed for years.  I scheduled her for surgery that afternoon and by that evening she was completely cured of the problem.   I asked her as she woke up whether it still hurt, and she said that she felt some pain from the surgery, but the pain from that mass was gone.  It felt good to help her, and I was thankful that I had gotten training in the diagnosis and management of this condition in my residency, something that is lacking in the training of most gynecologists in this country.

Since that time, I have been fortunate to be able to help a lot of women with this condition.  The first few came randomly, and to my disappointment each one had been missed by at least a few doctors before I saw them.   Eventually I became known as a competent manager of this condition, along with my general expertise in endometriosis, and at that point I started to see a lot of referrals and do a significant number of surgical repairs for this problem.

ORIGINS:

Abdominal wall endometriosis is a predominantly iatrogenic condition, meaning that it is the result of something that we are doing – and that something is cesarean delivery.  The vast majority of these cases are subsequent to cesarean delivery, presumably via seeding of the abdominal incision with endometrial tissue at some point during the case.   We do not know exactly what are the risk factors in cesarean delivery that cause this condition, but we do know from animal models that if you take a little piece of endometrium and stick it in the fascia when you close it after surgery, abdominal wall endometriosis will result – so presumably that is what is happening.

There are a few things I think we can do to reduce the incidence of this cesarean related endometriosis.  Thorough irrigation of the wound prior to closure is likely to reduce or eliminate flecks of endometrium that might implant in the abdominal wall.  I also believe, based on my experience but lacking data, that closure of the parietal peritoneum will reduce the incidence of this disease.  I say this because of multiple experiences where uteri are adherent to the abdominal wall contiguous with masses of abdominal wall endometriosis.  In one of these cases a hysterectomy was required to entirely remove the disease.

Interestingly, people with cesarean related abdominal wall endometriosis do not necessarily have typical peritoneal endometriosis, as it is caused by direct deposit of endometrium into the abdominal wall during a surgery.   However, women that have abdominal wall endometriosis who did not have prior surgery most likely do have peritoneal disease, and it is probably severe. Papers suggest that only 50% of these cases are post-surgical, but in my experience cases without prior surgery are very rare.

DIAGNOSIS:

Abdominal wall endometriosis is a disease that is easy to diagnose if you know what the condition is and how it presents, and impossible to diagnose if you don’t. This is called availability heuristic – it is impossible to make a correct diagnosis if the disease state doesn’t exist in your brain’s medical knowledge banks.

In almost every case I have diagnosed, the patient came right out and told me they had it.  Not literally of course, but rather they said the words that made the diagnosis certain.  The disease presents with a hard mass that is painful at all times, but become larger and dramatically more painful prior to and during the menses.  It is exquisitely tender to the touch, particularly during the most painful part of the month. With those symptoms, the diagnosis is almost certain.   I can tell you that I have heard this story over and over and over, and I come right out and tell the patient what is wrong before I even look at their abdomen, and in each case it is there to be found on abdominal exam, just missed by well-intentioned people who didn’t know what to look for.

Imaging studies are useful in confirming the disease, though in my experience it is useful only to for surgical planning, as history is enough to make the diagnosis.  The proper imaging should be an axial cut CT or MRI.   MRI is better at showing the depth of invasion into the fascia and muscle, but either modality is adequate.  If cost were an issue one could certainly get away without imaging.   Some people (mostly general surgeons) will do a fine needle biopsy to confirm that it isn’t a malignant tumor, though I don’t think that is necessary and it drives up costs.

AWE #1 AWE #2

TREATMENT:

There are three things one can do with abdominal wall endometriosis, only one of which clearly leads to lasting cure of the problem.

As AWE is endometrial tissue, it will respond to high dose progestin therapy or continuous birth control pills.  It will also respond to Depot-Lupron (leuprolide), and perhaps to aromatase inhibitors (eg letrozole).  The upside is that these agents do work.  The downside is that the patient is stuck taking them forever, or at least until menopause, and that they are not really treating the problem.

There are some recent trials that suggest efficacy in ultrasound guided injection of phenol directly into the endometrial tissue.  These injections destroy whatever tissue they go into, so properly guided this probably does work.  It is however something that is still in a research stage and only supported by a few recent papers (in international press.)

The final intervention, which is both curative and reliable, is surgical resection of the abdominal wall disease.  In my experience, complete resection of the indurated tissue in the subcutaneous space, including resection of underlying fascia if necessary, is curative of the problem.   I have had only one patient who did not experience complete relief, and subsequent imaging showed that she had a satellite area of disease that was not resected in the first surgery. She was cured in a subsequent surgery to remove this additional disease.

SURGICAL TECHNIQUE:

This procedure is performed under anesthesia by opening up the old cesarean scar, identifying the endometrial implants, and resecting them.  In some cases the implant is superficial enough that removal does not require entry in the rectus fascia.  In other cases the disease is invasive into the fascia or even the underlying recurs muscle, requiring resecting a portion of the abdominal fascia.   Small fascial defects can be closed primarily, while larger ones can require mesh reconstruction of the fascia prior to closure.

AWE 017

I have removed quite a number of these, and in my experience about half require some level of mesh reconstruction.   There are some studies that show a much lower likelihood than that, though I suspect they had a population with less severe disease than I have seen.   My criteria for mesh reconstruction is a lack of ability to reapproximate the fascia without significant tension.  I have predominantly used a biologic mesh (either Strattice (porcine dermis) or Veritas (bovine pericardium)) which is reabsorbed and replaced with fibrosis over time.   Some operators use a permanent mesh.  Permanent mesh is likely superior for large defects, though it comes with a chance of infection requiring removal.   Porcine or bovine mesh will not get infected easily (if placed in a sterile field), but there is greater risk of subsequent hernia formation. We lack any randomized trials to direct us on exactly what type of mesh we should use in this diseases state, other than the general surgery literature on general abdominal wall reconstruction.

Placement of mesh is does by a simple inlay technique.  I use 2-0 PDS suture to secure the mesh.  Very large defects may require underlay or component separation techniques, in which case I will involve a general surgeon in the closure.

With the placement of any biologic mesh, drainage is imperative as seroma formation is quite common without it.  Drains are left in place until drainage is minimal (10-20 cc a day), which can be as long as a month.   My experience with inadvertent (gets pulled out accidentally) or impatient (resident pulls it out thinking that 50cc a day was little enough) has been consistently negative, with seroma reformation being common.  While patients dislike drains, they can be managed, and they are preferable to a wound that is draining clear fluid for a period of time.

AWE 018AWE 019

CONCLUSION:

If you are a physician seeing a patient with the symptoms I mention, please think about this diseases state.  If you make the diagnosis you will be doing better than 90+% of people out there.

If you are a patient with these symptoms, tell your physician your own diagnosis.  If they are not able to help you with it, consider visiting beautiful Portland, OR and I would be honored to help you.

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Dr Fogelson practices gynecologic surgery with a specialty in pelvic pain and endometriosis at Pearl Women’s Center in Portland, OR, where he sees patients from Oregon, the northwest region, and the nation.

For more information contact us at info@pearlwomenscenter.com, or call (503) 771-1883

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