Master Class

Despite several decades of extensive research into its pathogenesis, preeclampsia continues to be a syndrome of unknown etiology.

Several theories on the mechanisms leading to preeclampsia have been proposed, all based on numerous pathophysiological abnormalities reported in association with the heterogeneous disorder.

These theories, which have been developed largely during the past 2 decades, involve abnormalities such as impaired trophoblast differentiation and invasion, placental and endothelial dysfunction, immune maladaptation to paternal antigens, an exaggerated systemic inflammatory response, and a state of imbalance between proangiogenic and antiangiogenic factors.

As evidence for these theories has unfolded, investigators have identified numerous risk factors for preeclampsia. Most of them are preexisting risk factors that can be identified either before a patient becomes pregnant or early in the pregnancy. (See box below.)

The disorder's pathogenesis can vary in women with different risk factors or different times of onset. In women with previous preeclampsia, for example, the risk for developing recurrent preeclampsia varies depending on the underlying mechanism and the outcome in the previous pregnancy.

What this means is that even as investigators work to improve our understanding of the disorder, we as clinicians have an immediate opportunity—and responsibility—to identify patients who are at risk for preeclampsia, or recurrent preeclampsia, during preconception counseling or early in gestation.

We can then work with at-risk patients to optimize their health before conception and to carefully manage maternal and fetal well-being during pregnancy.

Women with a history of previous preeclampsia—even those who suffered serious adverse outcomes—should be counseled about their risks and reassured about our ability to optimize outcomes through vigilant monitoring, early detection of complications, and timely delivery.

And in an effort to improve their long-term health, these women should also be counseled about an increased risk for cardiovascular disease and ischemic stroke later in their lives.

Common Scenarios

A healthy 22-year-old woman with an ideal body weight and no preexisting medical risk factors who plans to become pregnant for the first time.

This patient's risk for preeclampsia is low (only 1%-2%). If preeclampsia occurs, it is likely to be mild, with an onset near term or intrapartum, and with generally good outcomes.

Nevertheless, it is important to inquire about any family history of preeclampsia or cardiovascular disease in this type of patient, and to be aware that women who themselves were born small for gestational age have an increased risk for preeclampsia, as does any woman whose husband or partner fathered a preeclamptic pregnancy in another woman.

Certain changes and events can also occur during pregnancy that will increase her risk. If, during antenatal care, ultrasound reveals multifetal gestation or unexplained fetal growth restriction, for instance, her risk of preeclampsia will increase substantially. (See box, page 9, top right.)

Likewise, if she develops gestational hypertension, her risk will increase to 25%-50% based on gestational age at the time the hypertension developed.

Several recently published studies have reported an association between maternal infections and an increased risk of preeclampsia as well. (Infections probably increase a maternal inflammatory response that already is engendered by the pregnancy itself.)

A systematic review published in 2006 found that the odds ratio for preeclampsia was 1.57 in women with urinary tract infections, and 1.76 in women with periodontal disease (N. Engl. J. Med. 2006;355:992-1005).

Unfortunately, the various biomarkers that have been proposed to predict which women are likely to develop preeclampsia—from serum placental growth factor to asymmetric dimethylarginine—have not been shown to be reliable and are not predictive or specific enough for use in clinical practice.

Likewise, supplementation with fish oil, vitamin E, vitamin C, low-dose aspirin, or calcium is not recommended for the prevention of preeclampsia in the young woman with no risk factors.

A 42-year-old who is trying to become pregnant for the first time.

This patient's older age is itself a risk factor for preeclampsia. An older age also often means more body weight and a higher likelihood of chronic hypertension or diabetes, as well as an increased likelihood that donated gametes were used, all of which can significantly increase risk.

As in the case of the younger patient, risk evaluation and management should begin before conception. Family history, personal birth history, and the history of the patient's husband or partner should be explored.

And because a high body mass index is a proven risk factor—as is insulin resistance, which is often linked with obesity—patients who are overweight or obese should be encouraged to lose weight and achieve a healthy BMI.

The risks associated with preexisting medical conditions like hypertension and diabetes vary depending on the conditions' severity.

Studies show, for instance, that women with mild hypertension before conception or early in pregnancy have a 15% rate of preeclampsia, whereas women with severe prepregnancy hypertension have a nearly 50% risk.

In all cases, women with chronic hypertension or diabetes should have their blood pressure and glucose levels optimized before conception, and then controlled throughout their pregnancy.

When assisted reproductive technology is planned, a discussion about the increased risk for preeclampsia that is caused by donated gametes is important, because donor insemination or the use of donated oocytes affects the maternal-fetal immune interaction and increases the risk of preeclampsia to as much as 35%.

Because multifetal gestation is more common with ART than with natural birth and is another risk factor for preeclampsia, this patient's overall risk can also be minimized by reducing the number of transferred embryos and by avoiding hyperstimulation when ovulation induction is required.

Just as in the case of the younger woman, unfortunately, we have little if anything else to offer this patient for the prevention of preeclampsia.

These women can be offered calcium, however. A recent review by the Food and Drug Administration concluded that any benefit with respect to preeclampsia is inconclusive and “unlikely” (Nutr. Rev. 2007;65:78-87).

However, in a 2007 Cochrane review of 12 clinical studies, calcium supplementation was associated with a reduction in the rate of preeclampsia, particularly in populations at high risk and in those with diets deficient in calcium (BJOG 2007;114:933-43).

Management should include a baseline metabolic profile and complete blood count, as well as baseline urinalysis; this information can be helpful if later laboratory studies are needed to assess the function of organ systems likely to be affected by preeclampsia.

Serial ultrasonography as well as uterine Doppler studies at 18-20 weeks should also be employed. The Doppler studies are a useful tool for assessing the velocity of the uterine artery blood flow.

An increased resistance index and/or the presence of uterine artery diastolic notching suggests an increased risk of preeclampsia (as much as a sixfold increased risk) and the need for more vigilant monitoring and care.

A woman who developed severe preeclampsia at 26 weeks' gestation in her first pregnancy. She wants a child but is afraid—terribly and understandably frightened—of a second pregnancy because her first baby was born prematurely and died after about 100 days in the NICU.

We can and should reassure this patient that her loss does not mean she should forego becoming pregnant again, and that with proper monitoring, she has a significant chance of having a healthy baby.

A woman's risk of preeclampsia recurrence will depend on whether or not she has any preexisting risk factors, as well as the gestational age at the time of onset of preeclampsia in her first pregnancy.

The reported rate of recurrent preeclampsia ranges from 11.5% to 65%, with the highest rates being reported in women whose previous preeclampsia occurred in the second trimester. This patient's risk of recurrent preeclampsia is about 50%.

In general, recurrent preeclampsia is more likely to be severe and to develop preterm than is first-time preeclampsia. We can reassure this patient, however, that an early onset of preeclampsia in the first pregnancy does not necessarily mean that the disorder will have an early onset in the second pregnancy.

In a study published in 1991, among women with previous preeclampsia in the second trimester, preeclampsia recurred in the second trimester in 21%, at 28-36 weeks in 21%, and at term in 23% (Am. J. Obstet. Gynecol. 1991;165:1408-12).

Women with a history of eclampsia have a rate of recurrence of 1%-2% and a rate of subsequent preeclampsia of 22%-35%. Women with a history of HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome have a rate of preeclampsia in subsequent pregnancies of 16%-52% and, according to the most reliable data, a rate of recurrent HELLP syndrome of less than 5%.

Management for this patient ideally begins before conception, with an extensive evaluation and an in-depth history to uncover preexisting risk factors and/or medical conditions associated with the disorder.

This will allow proper counseling about the magnitude of risk for preeclampsia recurrence, and will guide you as you manage the pregnancy. (See box, bottom left.)

Knowing when she developed preeclampsia is important, as are details about maternal complications such as HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome, pulmonary edema, or renal failure, for instance; about fetal complications, such as fetal growth restriction; and about previous laboratory test results, as well as placental pathology.

The status of any comorbidities, such as high BMI or high blood pressure, should be optimized before conception, and vigilant monitoring—including early and serial ultrasonography, uterine Doppler assessment at 18-20 weeks, and laboratory testing as indicated—should be instituted to minimize and manage her risk.

By detecting complications early and monitoring for signs and symptoms of preeclampsia—and then hospitalizing her if you detect severe gestational hypertension, fetal growth restriction, or recurrent preeclampsia—you can ensure optimal outcomes.

This patient will probably want to know about the value of various biomarkers and supplements, such as fish oil and vitamins C and E, and again, we need to explain that the best studies have shown minimal to no benefit and do not support their use.

The three large randomized trials looking at vitamin E supplementation, for example, showed no effect on the rate of preeclampsia, its severity, or the rate of adverse neonatal outcomes.

None of the randomized trials on calcium supplementation included women with a previous history of preeclampsia, so the benefit for this indication remains unclear. Nevertheless, because calcium is beneficial for any pregnancy, we recommend it.

The greatest benefits of low-dose aspirin may come for this patient. A recent meta-analysis of 31 randomized trials found a 14% reduction in recurrent preeclampsia—higher than that seen for first-time preeclampsia (Lancet 2007;369:1791-8). Low-dose aspirin has also proved to be safe. We recommend 81 mg daily beginning at 12 weeks' gestation, and suggest discontinuing aspirin with the development of preeclampsia.

If the patient has documented evidence of antiphospholipid antibody syndrome, she should receive prophylactic-dose heparin in addition to low-dose aspirin once fetal viability is confirmed.

A woman who had late-occurring mild preeclampsia in her first pregnancy, and is planning a second child.

This patient experienced the most common presentation of preeclampsia, and fortunately has a fairly low risk for recurrence (about 10%). Chances are also likely that if preeclampsia recurs, it will recur at term.

This risk can be minimized and a good outcome ensured by following the same approach to history taking, counseling, and optimizing health before conception, as well as careful monitoring during pregnancy to detect complications early.

Risks Later in Life

Today, counseling women with a history of preeclampsia involves more than assessing and minimizing risks for recurrence of the disorder. It also involves discussing the now-substantial body of literature that suggests that women whose pregnancies are complicated by preeclampsia and/or fetal growth restriction have an increased risk for future cardiovascular disease and ischemic stroke.

These women require close follow-up after their pregnancies so that their long-term risks can be reduced or avoided through the use of preventive strategies and approaches to care.

Preeclampsia and fetal growth restriction are both vascular-related pregnancy complications, and they share similar risk factors and pathophysiological abnormalities, such as endothelial dysfunction.

It's unclear exactly what mechanisms account for the relationship among these complications and the increased risk of subsequent cardiovascular disease, but it increasingly seems likely that these women have a predisposition to vascular and metabolic disease: a constitutional risk.

Epidemiologic and case-control studies published in the last 10 years—many of them in the nonobstetric literature—have evaluated the associations, and last year a systematic review and meta-analysis of these studies reported a relative risk for chronic hypertension of 3.7 after approximately 14 years of average follow-up, a relative risk of 2.16 for ischemic heart disease after about 11 years of follow-up, and a relative risk of 1.8 for ischemic stroke after about 10 years (BMJ 2007;335:974-85).

In addition, overall mortality after preeclampsia was increased by a relative risk of approximately 1.5 after 14.5 years of follow-up.

In a recently published intergenerational case-control study, Dutch investigators looked at 106 women whose pregnancies were complicated by preeclampsia or fetal growth restriction, a control group of 106 women with normal pregnancies, and each woman's mother and father.

They found significant intergenerational similarities in cardiovascular risk profiles between the women after preeclampsia or fetal growth restriction and their parents, such as higher fasting glucose levels that could not be explained by differences in BMI.

Intergenerational similarities were also found for hypertension, waist circumference, and metabolic syndrome (Hypertension 2008;51:1034-41).

ELSEVIER GLOBAL MEDICAL NEWS

Preeclampsia, Part 3

The exact incidence of preeclampsia is unknown, but in its mild form it is estimated to affect up to 10% of all pregnancies. Indeed, it is one of the most common complications of pregnancy. In a smaller number of cases (just under 1% of pregnancies), the disorder develops as severe preeclampsia.

In the past two Master Class installments on preeclampsia, we have discussed how the disorder presents in various ways, afflicting women of different age groups, of varying parity, and with associated medical complications or the lack thereof.

We have also discussed appropriate evaluation and management protocols. The spectrum of disease is such that it spans the very mild (requiring modest intervention) to the very severe (requiring immediate and aggressive intervention strategies). As we saw in the last installment, it is important to view preeclampsia as a multifaceted disease continuum in which designations of “mild” and “severe” are not necessarily fixed.

The variable presentation of the disorder—and the fact that it cannot be precisely predicted or prevented—may in itself be challenging to the practitioner, as he or she counsels patients who are contemplating pregnancies and may be at risk for preeclampsia.

There are certain predisposing medical and sociodemographic factors, however, that are clearly important and that can be useful if they are integrated into an evaluation and management algorithm. Integrating our knowledge of risk factors allows for the most appropriate counseling to be delivered, and the most appropriate management plan to be developed, on a case-by-case basis.

I have invited Dr. Baha Sibai to once again address the topic of preeclampsia in this third and final installment of our series on the disorder. Dr. Sibai is professor of obstetrics and gynecology at the University of Cincinnati and an international expert on preeclampsia and eclampsia, as well as a leader in both clinical care and research in this area.

In this case, we've taken a different approach to presenting the material. We think our case-by-case format will be practical and applicable to the practitioner who is counseling a number of patients who present with varying histories and risk factors.

How to Manage Recurrence Risk

Preconception

▸ Identify risk factors.

▸ Review outcome of previous pregnancy.

▸ Optimize maternal health.

First Trimester

▸ Perform ultrasonography for dating and assessing fetal number.

▸ Order baseline metabolic profile and complete blood count.

▸ Perform baseline urinalysis.

▸ Offer first-trimester combined screening.

▸ If antiphospholipid syndrome is documented, start low-dose aspirin and heparin. Otherwise, offer low-dose aspirin therapy at 12 weeks' gestation.

Second Trimester

▸ Monitor for signs and symptoms of preeclampsia.

▸ Perform ultrasonography at 18-22 weeks' gestation for fetal anomaly evaluation and to rule out molar gestation.

▸ Perform uterine Doppler studies at 18-20 weeks.

Third Trimester

▸ Monitor for signs and symptoms of preeclampsia.

▸ As indicated by the clinical situation, perform laboratory testing, serial ultrasonography (for fetal growth and amniotic fluid assessment), and umbilical artery Doppler with a nonstress test and/or biophysical profile.

▸ Hospitalize for severe gestational hypertension, fetal growth restriction, or recurrent preeclampsia.

Post Partum

▸ Counsel patient about an increased risk for cardiovascular disease and ischemic stroke.

▸ Encourage close follow-up and prevention.

Source: Adapted from Obstet. Gynecol. 2008;112:359-72

Risk Factors for Preeclampsia

The magnitude of risk depends on the number of factors, which include the following:

▸ Multifetal gestation.

▸ Unexplained fetal growth restriction.

▸ Gestational hypertension.

▸ Hydrops/hydropic degeneration of placenta (triploidy, trisomy 13).

▸ Urinary-tract and periodontal infections.

▸ Biophysical and biochemical markers.

Source: Adapted from Obstet. Gynecol. 2008;112:359-72

Despite several decades of extensive research into its pathogenesis, preeclampsia continues to be a syndrome of unknown etiology.

Several theories on the mechanisms leading to preeclampsia have been proposed, all based on numerous pathophysiological abnormalities reported in association with the heterogeneous disorder.

These theories, which have been developed largely during the past 2 decades, involve abnormalities such as impaired trophoblast differentiation and invasion, placental and endothelial dysfunction, immune maladaptation to paternal antigens, an exaggerated systemic inflammatory response, and a state of imbalance between proangiogenic and antiangiogenic factors.

As evidence for these theories has unfolded, investigators have identified numerous risk factors for preeclampsia. Most of them are preexisting risk factors that can be identified either before a patient becomes pregnant or early in the pregnancy. (See box below.)

The disorder's pathogenesis can vary in women with different risk factors or different times of onset. In women with previous preeclampsia, for example, the risk for developing recurrent preeclampsia varies depending on the underlying mechanism and the outcome in the previous pregnancy.

What this means is that even as investigators work to improve our understanding of the disorder, we as clinicians have an immediate opportunity—and responsibility—to identify patients who are at risk for preeclampsia, or recurrent preeclampsia, during preconception counseling or early in gestation.

We can then work with at-risk patients to optimize their health before conception and to carefully manage maternal and fetal well-being during pregnancy.

Women with a history of previous preeclampsia—even those who suffered serious adverse outcomes—should be counseled about their risks and reassured about our ability to optimize outcomes through vigilant monitoring, early detection of complications, and timely delivery.

And in an effort to improve their long-term health, these women should also be counseled about an increased risk for cardiovascular disease and ischemic stroke later in their lives.

Common Scenarios

A healthy 22-year-old woman with an ideal body weight and no preexisting medical risk factors who plans to become pregnant for the first time.

This patient's risk for preeclampsia is low (only 1%-2%). If preeclampsia occurs, it is likely to be mild, with an onset near term or intrapartum, and with generally good outcomes.

Nevertheless, it is important to inquire about any family history of preeclampsia or cardiovascular disease in this type of patient, and to be aware that women who themselves were born small for gestational age have an increased risk for preeclampsia, as does any woman whose husband or partner fathered a preeclamptic pregnancy in another woman.

Certain changes and events can also occur during pregnancy that will increase her risk. If, during antenatal care, ultrasound reveals multifetal gestation or unexplained fetal growth restriction, for instance, her risk of preeclampsia will increase substantially. (See box, page 9, top right.)

Likewise, if she develops gestational hypertension, her risk will increase to 25%-50% based on gestational age at the time the hypertension developed.

Several recently published studies have reported an association between maternal infections and an increased risk of preeclampsia as well. (Infections probably increase a maternal inflammatory response that already is engendered by the pregnancy itself.)

A systematic review published in 2006 found that the odds ratio for preeclampsia was 1.57 in women with urinary tract infections, and 1.76 in women with periodontal disease (N. Engl. J. Med. 2006;355:992-1005).

Unfortunately, the various biomarkers that have been proposed to predict which women are likely to develop preeclampsia—from serum placental growth factor to asymmetric dimethylarginine—have not been shown to be reliable and are not predictive or specific enough for use in clinical practice.

Likewise, supplementation with fish oil, vitamin E, vitamin C, low-dose aspirin, or calcium is not recommended for the prevention of preeclampsia in the young woman with no risk factors.

A 42-year-old who is trying to become pregnant for the first time.

This patient's older age is itself a risk factor for preeclampsia. An older age also often means more body weight and a higher likelihood of chronic hypertension or diabetes, as well as an increased likelihood that donated gametes were used, all of which can significantly increase risk.

As in the case of the younger patient, risk evaluation and management should begin before conception. Family history, personal birth history, and the history of the patient's husband or partner should be explored.

And because a high body mass index is a proven risk factor—as is insulin resistance, which is often linked with obesity—patients who are overweight or obese should be encouraged to lose weight and achieve a healthy BMI.

The risks associated with preexisting medical conditions like hypertension and diabetes vary depending on the conditions' severity.

Studies show, for instance, that women with mild hypertension before conception or early in pregnancy have a 15% rate of preeclampsia, whereas women with severe prepregnancy hypertension have a nearly 50% risk.

In all cases, women with chronic hypertension or diabetes should have their blood pressure and glucose levels optimized before conception, and then controlled throughout their pregnancy.

When assisted reproductive technology is planned, a discussion about the increased risk for preeclampsia that is caused by donated gametes is important, because donor insemination or the use of donated oocytes affects the maternal-fetal immune interaction and increases the risk of preeclampsia to as much as 35%.

Because multifetal gestation is more common with ART than with natural birth and is another risk factor for preeclampsia, this patient's overall risk can also be minimized by reducing the number of transferred embryos and by avoiding hyperstimulation when ovulation induction is required.

Just as in the case of the younger woman, unfortunately, we have little if anything else to offer this patient for the prevention of preeclampsia.

These women can be offered calcium, however. A recent review by the Food and Drug Administration concluded that any benefit with respect to preeclampsia is inconclusive and “unlikely” (Nutr. Rev. 2007;65:78-87).

However, in a 2007 Cochrane review of 12 clinical studies, calcium supplementation was associated with a reduction in the rate of preeclampsia, particularly in populations at high risk and in those with diets deficient in calcium (BJOG 2007;114:933-43).

Management should include a baseline metabolic profile and complete blood count, as well as baseline urinalysis; this information can be helpful if later laboratory studies are needed to assess the function of organ systems likely to be affected by preeclampsia.

Serial ultrasonography as well as uterine Doppler studies at 18-20 weeks should also be employed. The Doppler studies are a useful tool for assessing the velocity of the uterine artery blood flow.

An increased resistance index and/or the presence of uterine artery diastolic notching suggests an increased risk of preeclampsia (as much as a sixfold increased risk) and the need for more vigilant monitoring and care.

A woman who developed severe preeclampsia at 26 weeks' gestation in her first pregnancy. She wants a child but is afraid—terribly and understandably frightened—of a second pregnancy because her first baby was born prematurely and died after about 100 days in the NICU.

We can and should reassure this patient that her loss does not mean she should forego becoming pregnant again, and that with proper monitoring, she has a significant chance of having a healthy baby.

A woman's risk of preeclampsia recurrence will depend on whether or not she has any preexisting risk factors, as well as the gestational age at the time of onset of preeclampsia in her first pregnancy.

The reported rate of recurrent preeclampsia ranges from 11.5% to 65%, with the highest rates being reported in women whose previous preeclampsia occurred in the second trimester. This patient's risk of recurrent preeclampsia is about 50%.

In general, recurrent preeclampsia is more likely to be severe and to develop preterm than is first-time preeclampsia. We can reassure this patient, however, that an early onset of preeclampsia in the first pregnancy does not necessarily mean that the disorder will have an early onset in the second pregnancy.

In a study published in 1991, among women with previous preeclampsia in the second trimester, preeclampsia recurred in the second trimester in 21%, at 28-36 weeks in 21%, and at term in 23% (Am. J. Obstet. Gynecol. 1991;165:1408-12).

Women with a history of eclampsia have a rate of recurrence of 1%-2% and a rate of subsequent preeclampsia of 22%-35%. Women with a history of HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome have a rate of preeclampsia in subsequent pregnancies of 16%-52% and, according to the most reliable data, a rate of recurrent HELLP syndrome of less than 5%.

Management for this patient ideally begins before conception, with an extensive evaluation and an in-depth history to uncover preexisting risk factors and/or medical conditions associated with the disorder.

This will allow proper counseling about the magnitude of risk for preeclampsia recurrence, and will guide you as you manage the pregnancy. (See box, bottom left.)

Knowing when she developed preeclampsia is important, as are details about maternal complications such as HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome, pulmonary edema, or renal failure, for instance; about fetal complications, such as fetal growth restriction; and about previous laboratory test results, as well as placental pathology.

The status of any comorbidities, such as high BMI or high blood pressure, should be optimized before conception, and vigilant monitoring—including early and serial ultrasonography, uterine Doppler assessment at 18-20 weeks, and laboratory testing as indicated—should be instituted to minimize and manage her risk.

By detecting complications early and monitoring for signs and symptoms of preeclampsia—and then hospitalizing her if you detect severe gestational hypertension, fetal growth restriction, or recurrent preeclampsia—you can ensure optimal outcomes.

This patient will probably want to know about the value of various biomarkers and supplements, such as fish oil and vitamins C and E, and again, we need to explain that the best studies have shown minimal to no benefit and do not support their use.

The three large randomized trials looking at vitamin E supplementation, for example, showed no effect on the rate of preeclampsia, its severity, or the rate of adverse neonatal outcomes.

None of the randomized trials on calcium supplementation included women with a previous history of preeclampsia, so the benefit for this indication remains unclear. Nevertheless, because calcium is beneficial for any pregnancy, we recommend it.

The greatest benefits of low-dose aspirin may come for this patient. A recent meta-analysis of 31 randomized trials found a 14% reduction in recurrent preeclampsia—higher than that seen for first-time preeclampsia (Lancet 2007;369:1791-8). Low-dose aspirin has also proved to be safe. We recommend 81 mg daily beginning at 12 weeks' gestation, and suggest discontinuing aspirin with the development of preeclampsia.

If the patient has documented evidence of antiphospholipid antibody syndrome, she should receive prophylactic-dose heparin in addition to low-dose aspirin once fetal viability is confirmed.

A woman who had late-occurring mild preeclampsia in her first pregnancy, and is planning a second child.

This patient experienced the most common presentation of preeclampsia, and fortunately has a fairly low risk for recurrence (about 10%). Chances are also likely that if preeclampsia recurs, it will recur at term.

This risk can be minimized and a good outcome ensured by following the same approach to history taking, counseling, and optimizing health before conception, as well as careful monitoring during pregnancy to detect complications early.

Risks Later in Life

Today, counseling women with a history of preeclampsia involves more than assessing and minimizing risks for recurrence of the disorder. It also involves discussing the now-substantial body of literature that suggests that women whose pregnancies are complicated by preeclampsia and/or fetal growth restriction have an increased risk for future cardiovascular disease and ischemic stroke.

These women require close follow-up after their pregnancies so that their long-term risks can be reduced or avoided through the use of preventive strategies and approaches to care.

Preeclampsia and fetal growth restriction are both vascular-related pregnancy complications, and they share similar risk factors and pathophysiological abnormalities, such as endothelial dysfunction.

It's unclear exactly what mechanisms account for the relationship among these complications and the increased risk of subsequent cardiovascular disease, but it increasingly seems likely that these women have a predisposition to vascular and metabolic disease: a constitutional risk.

Epidemiologic and case-control studies published in the last 10 years—many of them in the nonobstetric literature—have evaluated the associations, and last year a systematic review and meta-analysis of these studies reported a relative risk for chronic hypertension of 3.7 after approximately 14 years of average follow-up, a relative risk of 2.16 for ischemic heart disease after about 11 years of follow-up, and a relative risk of 1.8 for ischemic stroke after about 10 years (BMJ 2007;335:974-85).

In addition, overall mortality after preeclampsia was increased by a relative risk of approximately 1.5 after 14.5 years of follow-up.

In a recently published intergenerational case-control study, Dutch investigators looked at 106 women whose pregnancies were complicated by preeclampsia or fetal growth restriction, a control group of 106 women with normal pregnancies, and each woman's mother and father.

They found significant intergenerational similarities in cardiovascular risk profiles between the women after preeclampsia or fetal growth restriction and their parents, such as higher fasting glucose levels that could not be explained by differences in BMI.

Intergenerational similarities were also found for hypertension, waist circumference, and metabolic syndrome (Hypertension 2008;51:1034-41).

ELSEVIER GLOBAL MEDICAL NEWS

Preeclampsia, Part 3

The exact incidence of preeclampsia is unknown, but in its mild form it is estimated to affect up to 10% of all pregnancies. Indeed, it is one of the most common complications of pregnancy. In a smaller number of cases (just under 1% of pregnancies), the disorder develops as severe preeclampsia.

In the past two Master Class installments on preeclampsia, we have discussed how the disorder presents in various ways, afflicting women of different age groups, of varying parity, and with associated medical complications or the lack thereof.

We have also discussed appropriate evaluation and management protocols. The spectrum of disease is such that it spans the very mild (requiring modest intervention) to the very severe (requiring immediate and aggressive intervention strategies). As we saw in the last installment, it is important to view preeclampsia as a multifaceted disease continuum in which designations of “mild” and “severe” are not necessarily fixed.

The variable presentation of the disorder—and the fact that it cannot be precisely predicted or prevented—may in itself be challenging to the practitioner, as he or she counsels patients who are contemplating pregnancies and may be at risk for preeclampsia.

There are certain predisposing medical and sociodemographic factors, however, that are clearly important and that can be useful if they are integrated into an evaluation and management algorithm. Integrating our knowledge of risk factors allows for the most appropriate counseling to be delivered, and the most appropriate management plan to be developed, on a case-by-case basis.

I have invited Dr. Baha Sibai to once again address the topic of preeclampsia in this third and final installment of our series on the disorder. Dr. Sibai is professor of obstetrics and gynecology at the University of Cincinnati and an international expert on preeclampsia and eclampsia, as well as a leader in both clinical care and research in this area.

In this case, we've taken a different approach to presenting the material. We think our case-by-case format will be practical and applicable to the practitioner who is counseling a number of patients who present with varying histories and risk factors.

How to Manage Recurrence Risk

Preconception

▸ Identify risk factors.

▸ Review outcome of previous pregnancy.

▸ Optimize maternal health.

First Trimester

▸ Perform ultrasonography for dating and assessing fetal number.

▸ Order baseline metabolic profile and complete blood count.

▸ Perform baseline urinalysis.

▸ Offer first-trimester combined screening.

▸ If antiphospholipid syndrome is documented, start low-dose aspirin and heparin. Otherwise, offer low-dose aspirin therapy at 12 weeks' gestation.

Second Trimester

▸ Monitor for signs and symptoms of preeclampsia.

▸ Perform ultrasonography at 18-22 weeks' gestation for fetal anomaly evaluation and to rule out molar gestation.

▸ Perform uterine Doppler studies at 18-20 weeks.

Third Trimester

▸ Monitor for signs and symptoms of preeclampsia.

▸ As indicated by the clinical situation, perform laboratory testing, serial ultrasonography (for fetal growth and amniotic fluid assessment), and umbilical artery Doppler with a nonstress test and/or biophysical profile.

▸ Hospitalize for severe gestational hypertension, fetal growth restriction, or recurrent preeclampsia.

Post Partum

▸ Counsel patient about an increased risk for cardiovascular disease and ischemic stroke.

▸ Encourage close follow-up and prevention.

Source: Adapted from Obstet. Gynecol. 2008;112:359-72

Risk Factors for Preeclampsia

The magnitude of risk depends on the number of factors, which include the following:

▸ Multifetal gestation.

▸ Unexplained fetal growth restriction.

▸ Gestational hypertension.

▸ Hydrops/hydropic degeneration of placenta (triploidy, trisomy 13).

▸ Urinary-tract and periodontal infections.

▸ Biophysical and biochemical markers.

Source: Adapted from Obstet. Gynecol. 2008;112:359-72

Despite several decades of extensive research into its pathogenesis, preeclampsia continues to be a syndrome of unknown etiology.

Several theories on the mechanisms leading to preeclampsia have been proposed, all based on numerous pathophysiological abnormalities reported in association with the heterogeneous disorder.

These theories, which have been developed largely during the past 2 decades, involve abnormalities such as impaired trophoblast differentiation and invasion, placental and endothelial dysfunction, immune maladaptation to paternal antigens, an exaggerated systemic inflammatory response, and a state of imbalance between proangiogenic and antiangiogenic factors.

As evidence for these theories has unfolded, investigators have identified numerous risk factors for preeclampsia. Most of them are preexisting risk factors that can be identified either before a patient becomes pregnant or early in the pregnancy. (See box below.)

The disorder's pathogenesis can vary in women with different risk factors or different times of onset. In women with previous preeclampsia, for example, the risk for developing recurrent preeclampsia varies depending on the underlying mechanism and the outcome in the previous pregnancy.

What this means is that even as investigators work to improve our understanding of the disorder, we as clinicians have an immediate opportunity—and responsibility—to identify patients who are at risk for preeclampsia, or recurrent preeclampsia, during preconception counseling or early in gestation.

We can then work with at-risk patients to optimize their health before conception and to carefully manage maternal and fetal well-being during pregnancy.

Women with a history of previous preeclampsia—even those who suffered serious adverse outcomes—should be counseled about their risks and reassured about our ability to optimize outcomes through vigilant monitoring, early detection of complications, and timely delivery.

And in an effort to improve their long-term health, these women should also be counseled about an increased risk for cardiovascular disease and ischemic stroke later in their lives.

Common Scenarios

A healthy 22-year-old woman with an ideal body weight and no preexisting medical risk factors who plans to become pregnant for the first time.

This patient's risk for preeclampsia is low (only 1%-2%). If preeclampsia occurs, it is likely to be mild, with an onset near term or intrapartum, and with generally good outcomes.

Nevertheless, it is important to inquire about any family history of preeclampsia or cardiovascular disease in this type of patient, and to be aware that women who themselves were born small for gestational age have an increased risk for preeclampsia, as does any woman whose husband or partner fathered a preeclamptic pregnancy in another woman.

Certain changes and events can also occur during pregnancy that will increase her risk. If, during antenatal care, ultrasound reveals multifetal gestation or unexplained fetal growth restriction, for instance, her risk of preeclampsia will increase substantially. (See box, page 9, top right.)

Likewise, if she develops gestational hypertension, her risk will increase to 25%-50% based on gestational age at the time the hypertension developed.

Several recently published studies have reported an association between maternal infections and an increased risk of preeclampsia as well. (Infections probably increase a maternal inflammatory response that already is engendered by the pregnancy itself.)

A systematic review published in 2006 found that the odds ratio for preeclampsia was 1.57 in women with urinary tract infections, and 1.76 in women with periodontal disease (N. Engl. J. Med. 2006;355:992-1005).

Unfortunately, the various biomarkers that have been proposed to predict which women are likely to develop preeclampsia—from serum placental growth factor to asymmetric dimethylarginine—have not been shown to be reliable and are not predictive or specific enough for use in clinical practice.

Likewise, supplementation with fish oil, vitamin E, vitamin C, low-dose aspirin, or calcium is not recommended for the prevention of preeclampsia in the young woman with no risk factors.

A 42-year-old who is trying to become pregnant for the first time.

This patient's older age is itself a risk factor for preeclampsia. An older age also often means more body weight and a higher likelihood of chronic hypertension or diabetes, as well as an increased likelihood that donated gametes were used, all of which can significantly increase risk.

As in the case of the younger patient, risk evaluation and management should begin before conception. Family history, personal birth history, and the history of the patient's husband or partner should be explored.

And because a high body mass index is a proven risk factor—as is insulin resistance, which is often linked with obesity—patients who are overweight or obese should be encouraged to lose weight and achieve a healthy BMI.

The risks associated with preexisting medical conditions like hypertension and diabetes vary depending on the conditions' severity.

Studies show, for instance, that women with mild hypertension before conception or early in pregnancy have a 15% rate of preeclampsia, whereas women with severe prepregnancy hypertension have a nearly 50% risk.

In all cases, women with chronic hypertension or diabetes should have their blood pressure and glucose levels optimized before conception, and then controlled throughout their pregnancy.

When assisted reproductive technology is planned, a discussion about the increased risk for preeclampsia that is caused by donated gametes is important, because donor insemination or the use of donated oocytes affects the maternal-fetal immune interaction and increases the risk of preeclampsia to as much as 35%.

Because multifetal gestation is more common with ART than with natural birth and is another risk factor for preeclampsia, this patient's overall risk can also be minimized by reducing the number of transferred embryos and by avoiding hyperstimulation when ovulation induction is required.

Just as in the case of the younger woman, unfortunately, we have little if anything else to offer this patient for the prevention of preeclampsia.

These women can be offered calcium, however. A recent review by the Food and Drug Administration concluded that any benefit with respect to preeclampsia is inconclusive and “unlikely” (Nutr. Rev. 2007;65:78-87).

However, in a 2007 Cochrane review of 12 clinical studies, calcium supplementation was associated with a reduction in the rate of preeclampsia, particularly in populations at high risk and in those with diets deficient in calcium (BJOG 2007;114:933-43).

Management should include a baseline metabolic profile and complete blood count, as well as baseline urinalysis; this information can be helpful if later laboratory studies are needed to assess the function of organ systems likely to be affected by preeclampsia.

Serial ultrasonography as well as uterine Doppler studies at 18-20 weeks should also be employed. The Doppler studies are a useful tool for assessing the velocity of the uterine artery blood flow.

An increased resistance index and/or the presence of uterine artery diastolic notching suggests an increased risk of preeclampsia (as much as a sixfold increased risk) and the need for more vigilant monitoring and care.

A woman who developed severe preeclampsia at 26 weeks' gestation in her first pregnancy. She wants a child but is afraid—terribly and understandably frightened—of a second pregnancy because her first baby was born prematurely and died after about 100 days in the NICU.

We can and should reassure this patient that her loss does not mean she should forego becoming pregnant again, and that with proper monitoring, she has a significant chance of having a healthy baby.

A woman's risk of preeclampsia recurrence will depend on whether or not she has any preexisting risk factors, as well as the gestational age at the time of onset of preeclampsia in her first pregnancy.

The reported rate of recurrent preeclampsia ranges from 11.5% to 65%, with the highest rates being reported in women whose previous preeclampsia occurred in the second trimester. This patient's risk of recurrent preeclampsia is about 50%.

In general, recurrent preeclampsia is more likely to be severe and to develop preterm than is first-time preeclampsia. We can reassure this patient, however, that an early onset of preeclampsia in the first pregnancy does not necessarily mean that the disorder will have an early onset in the second pregnancy.

In a study published in 1991, among women with previous preeclampsia in the second trimester, preeclampsia recurred in the second trimester in 21%, at 28-36 weeks in 21%, and at term in 23% (Am. J. Obstet. Gynecol. 1991;165:1408-12).

Women with a history of eclampsia have a rate of recurrence of 1%-2% and a rate of subsequent preeclampsia of 22%-35%. Women with a history of HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome have a rate of preeclampsia in subsequent pregnancies of 16%-52% and, according to the most reliable data, a rate of recurrent HELLP syndrome of less than 5%.

Management for this patient ideally begins before conception, with an extensive evaluation and an in-depth history to uncover preexisting risk factors and/or medical conditions associated with the disorder.

This will allow proper counseling about the magnitude of risk for preeclampsia recurrence, and will guide you as you manage the pregnancy. (See box, bottom left.)

Knowing when she developed preeclampsia is important, as are details about maternal complications such as HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome, pulmonary edema, or renal failure, for instance; about fetal complications, such as fetal growth restriction; and about previous laboratory test results, as well as placental pathology.

The status of any comorbidities, such as high BMI or high blood pressure, should be optimized before conception, and vigilant monitoring—including early and serial ultrasonography, uterine Doppler assessment at 18-20 weeks, and laboratory testing as indicated—should be instituted to minimize and manage her risk.

By detecting complications early and monitoring for signs and symptoms of preeclampsia—and then hospitalizing her if you detect severe gestational hypertension, fetal growth restriction, or recurrent preeclampsia—you can ensure optimal outcomes.

This patient will probably want to know about the value of various biomarkers and supplements, such as fish oil and vitamins C and E, and again, we need to explain that the best studies have shown minimal to no benefit and do not support their use.

The three large randomized trials looking at vitamin E supplementation, for example, showed no effect on the rate of preeclampsia, its severity, or the rate of adverse neonatal outcomes.

None of the randomized trials on calcium supplementation included women with a previous history of preeclampsia, so the benefit for this indication remains unclear. Nevertheless, because calcium is beneficial for any pregnancy, we recommend it.

The greatest benefits of low-dose aspirin may come for this patient. A recent meta-analysis of 31 randomized trials found a 14% reduction in recurrent preeclampsia—higher than that seen for first-time preeclampsia (Lancet 2007;369:1791-8). Low-dose aspirin has also proved to be safe. We recommend 81 mg daily beginning at 12 weeks' gestation, and suggest discontinuing aspirin with the development of preeclampsia.

If the patient has documented evidence of antiphospholipid antibody syndrome, she should receive prophylactic-dose heparin in addition to low-dose aspirin once fetal viability is confirmed.

A woman who had late-occurring mild preeclampsia in her first pregnancy, and is planning a second child.

This patient experienced the most common presentation of preeclampsia, and fortunately has a fairly low risk for recurrence (about 10%). Chances are also likely that if preeclampsia recurs, it will recur at term.

This risk can be minimized and a good outcome ensured by following the same approach to history taking, counseling, and optimizing health before conception, as well as careful monitoring during pregnancy to detect complications early.

Risks Later in Life

Today, counseling women with a history of preeclampsia involves more than assessing and minimizing risks for recurrence of the disorder. It also involves discussing the now-substantial body of literature that suggests that women whose pregnancies are complicated by preeclampsia and/or fetal growth restriction have an increased risk for future cardiovascular disease and ischemic stroke.

These women require close follow-up after their pregnancies so that their long-term risks can be reduced or avoided through the use of preventive strategies and approaches to care.

Preeclampsia and fetal growth restriction are both vascular-related pregnancy complications, and they share similar risk factors and pathophysiological abnormalities, such as endothelial dysfunction.

It's unclear exactly what mechanisms account for the relationship among these complications and the increased risk of subsequent cardiovascular disease, but it increasingly seems likely that these women have a predisposition to vascular and metabolic disease: a constitutional risk.

Epidemiologic and case-control studies published in the last 10 years—many of them in the nonobstetric literature—have evaluated the associations, and last year a systematic review and meta-analysis of these studies reported a relative risk for chronic hypertension of 3.7 after approximately 14 years of average follow-up, a relative risk of 2.16 for ischemic heart disease after about 11 years of follow-up, and a relative risk of 1.8 for ischemic stroke after about 10 years (BMJ 2007;335:974-85).

In addition, overall mortality after preeclampsia was increased by a relative risk of approximately 1.5 after 14.5 years of follow-up.

In a recently published intergenerational case-control study, Dutch investigators looked at 106 women whose pregnancies were complicated by preeclampsia or fetal growth restriction, a control group of 106 women with normal pregnancies, and each woman's mother and father.

They found significant intergenerational similarities in cardiovascular risk profiles between the women after preeclampsia or fetal growth restriction and their parents, such as higher fasting glucose levels that could not be explained by differences in BMI.

Intergenerational similarities were also found for hypertension, waist circumference, and metabolic syndrome (Hypertension 2008;51:1034-41).

ELSEVIER GLOBAL MEDICAL NEWS

Preeclampsia, Part 3

The exact incidence of preeclampsia is unknown, but in its mild form it is estimated to affect up to 10% of all pregnancies. Indeed, it is one of the most common complications of pregnancy. In a smaller number of cases (just under 1% of pregnancies), the disorder develops as severe preeclampsia.

In the past two Master Class installments on preeclampsia, we have discussed how the disorder presents in various ways, afflicting women of different age groups, of varying parity, and with associated medical complications or the lack thereof.

We have also discussed appropriate evaluation and management protocols. The spectrum of disease is such that it spans the very mild (requiring modest intervention) to the very severe (requiring immediate and aggressive intervention strategies). As we saw in the last installment, it is important to view preeclampsia as a multifaceted disease continuum in which designations of “mild” and “severe” are not necessarily fixed.

The variable presentation of the disorder—and the fact that it cannot be precisely predicted or prevented—may in itself be challenging to the practitioner, as he or she counsels patients who are contemplating pregnancies and may be at risk for preeclampsia.

There are certain predisposing medical and sociodemographic factors, however, that are clearly important and that can be useful if they are integrated into an evaluation and management algorithm. Integrating our knowledge of risk factors allows for the most appropriate counseling to be delivered, and the most appropriate management plan to be developed, on a case-by-case basis.

I have invited Dr. Baha Sibai to once again address the topic of preeclampsia in this third and final installment of our series on the disorder. Dr. Sibai is professor of obstetrics and gynecology at the University of Cincinnati and an international expert on preeclampsia and eclampsia, as well as a leader in both clinical care and research in this area.

In this case, we've taken a different approach to presenting the material. We think our case-by-case format will be practical and applicable to the practitioner who is counseling a number of patients who present with varying histories and risk factors.

How to Manage Recurrence Risk

Preconception

▸ Identify risk factors.

▸ Review outcome of previous pregnancy.

▸ Optimize maternal health.

First Trimester

▸ Perform ultrasonography for dating and assessing fetal number.

▸ Order baseline metabolic profile and complete blood count.

▸ Perform baseline urinalysis.

▸ Offer first-trimester combined screening.

▸ If antiphospholipid syndrome is documented, start low-dose aspirin and heparin. Otherwise, offer low-dose aspirin therapy at 12 weeks' gestation.

Second Trimester

▸ Monitor for signs and symptoms of preeclampsia.

▸ Perform ultrasonography at 18-22 weeks' gestation for fetal anomaly evaluation and to rule out molar gestation.

▸ Perform uterine Doppler studies at 18-20 weeks.

Third Trimester

▸ Monitor for signs and symptoms of preeclampsia.

▸ As indicated by the clinical situation, perform laboratory testing, serial ultrasonography (for fetal growth and amniotic fluid assessment), and umbilical artery Doppler with a nonstress test and/or biophysical profile.

▸ Hospitalize for severe gestational hypertension, fetal growth restriction, or recurrent preeclampsia.

Post Partum

▸ Counsel patient about an increased risk for cardiovascular disease and ischemic stroke.

▸ Encourage close follow-up and prevention.

Source: Adapted from Obstet. Gynecol. 2008;112:359-72

Risk Factors for Preeclampsia

The magnitude of risk depends on the number of factors, which include the following:

▸ Multifetal gestation.

▸ Unexplained fetal growth restriction.

▸ Gestational hypertension.

▸ Hydrops/hydropic degeneration of placenta (triploidy, trisomy 13).

▸ Urinary-tract and periodontal infections.

▸ Biophysical and biochemical markers.

Source: Adapted from Obstet. Gynecol. 2008;112:359-72

Some surgeons perform the procedure laparoscopically in an effort to decrease morbidity and recovery time, with some success. Overall, however, a laparoscopic approach has not been widely adopted because of the complex suturing and dissection involved, and the subsequently significant learning curve.

Robotic sacrocolpopexy is a new addition to our armamentarium and is an exciting option for me and other surgeons because it combines the advantages of open sacrocolpopexy with the decreased morbidity of laparoscopy.

A robotic approach to the tried-and-true abdominal sacrocolpopexy takes full advantage of all that robotic surgery offers. Instrument articulation, three-dimensional vision, tremor reduction, and improved ergonomics for the surgeon all make managing the mesh and intracorporeal suturing—as well as dissecting in the rectovaginal and presacral spaces—so much easier than would be the case with a standard laparoscopic approach.

Overall, sacrocolpopexy performed with the da Vinci surgical system—the only Food and Drug Administration-approved robotic device for use in gynecologic surgery—offers better access to the pelvis, compared with both the open and laparoscopic approaches.

We can truly replicate what we do in an open approach, but with less postoperative pain, less blood loss and scarring, and faster recovery. Robotic sacrocolpopexy can also be combined with total or supracervical hysterectomy for uterine prolapse.

Outcomes data are emerging. At the American Urogynecologic Society annual meeting last month, we presented our initial short-term data comparing robotic with traditional abdominal sacrocolpopexy for the treatment of both uterine and vaginal vault prolapse.

Postoperatively, based on a 6-week POPQ (Pelvic Organ Prolapse Quantification) examination, there was a similar degree of pelvic organ support in the 73 patients who underwent robotic surgery and the 105 patients who underwent traditional surgery. The length of hospital stay was significantly shorter with the robotic approach (1.3 days vs. 2.7 days), and estimated blood loss was significantly lower (103 mL vs. 255 mL).

The operative time for the colpopexy and all other procedures, including hysterectomy and slings, was significantly longer in the robotic group (328 vs. 225 minutes). This time is expected to decrease, however, as all members of the surgical team, including fellows, residents, and surgical staff, progress through the learning curve.

Patient Selection and Positioning

I now offer the procedure to any patient to whom I would recommend a sacrocolpopexy. In the initial stages of adopting a robotic approach, however, it makes sense to be more selective and to perform relatively straightforward surgeries. This means starting with patients who are relatively thin (with body mass indices less than 30 kg/m

Initial patients should also have a reasonably sized uterus (if present) and few comorbidities. Pulmonary morbidity (emphysema or chronic obstructive pulmonary disease, for instance) is a relative contraindication, especially for initial cases, because these patients may not tolerate the Trendelenburg position, which is required for the surgery.

In addition, although robotic sacrocolpopexy can be used for uterine prolapse, I recommend starting with patients who have vaginal vault prolapse so that the surgeon can focus on a single robotic procedure. As their experience grows, surgeons can easily perform a combined robotic hysterectomy with sacrocolpopexy for the treatment of uterine prolapse. I primarily perform a supracervical hysterectomy in combination with a sacrocolpopexy in an attempt to reduce the risk of mesh erosion.

When the patient is positioned at the start of the surgery, her arms and shoulders and all “pressure points” should be well padded with foam, but I do not find a need for shoulder pads. I typically use an extra-large vacuum bean bag to keep the patient firmly in place while she is in the moderate to steep Trendelenburg position, but the use of a gel pad placed between the patient and the bed is an alternative approach to keep the patient from sliding cephalad during the surgery.

Port Placement, Setup, and Preparation

For robotic sacrocolpopexy, five trocar sites are used with a four-arm robotic system: three for operative robotic arms, one for the camera, and one to be used as the assistant's port for suction and irrigation, assistance with traction/countertraction, and the introduction of suture and mesh. (The bedside assistant is also helpful for instrument swaps, during uterine morcellation, and for any trocar depth repositioning that is necessary.)

Initially, we tried several different port locations. We have found that a “W-like” configuration for our port placement works well. We place the camera trocar at the umbilicus to accommodate the endoscope and the camera arm. This represents the middle of our “W.”

We then place two robotic ports at the two inferior apices of the “W.” The lateral ends of the “W” are each located about 2 cm inferior to the level of the umbilicus. The right lateral port is the assistant's port, which is used to introduce mesh, suture, and the like. The left lateral port is for the third robotic operative arm and is particularly helpful in moving the sigmoid laterally to expose the sacrum.

Using this configuration, we have reduced any competition between the two left robotic arms while we operate either in the pelvis or at the sacrum.

Some surgeons place the camera port higher (above the umbilicus), but I do not care for this placement because it can partially impede the view over the sacral promontory. (Placement of the camera port above the umbilicus is necessary for enlarged uteri, however.) After initial entry, a 0-degree scope should be used to place the other ports.

It is important to maintain at least 10 cm between robotic ports, and at least 6 cm between the robotic port and the assistant's port to reduce external collision of the robotic instrument arms.

Before docking the robotic arms of the patientside cart and placing the various EndoWrist instruments, I laparoscopically remove any small-bowel adhesions or other abdominal wall adhesions. This way, I have the tactile sensation that robotics does not provide. I then retract the sigmoid and move the small bowel out of the pelvis to expose the sacrum and the sacral promontory.

At this point and still prior to docking, it is also important to identify the ureters, the sacral promontory, the midline with the sigmoid retracted, the middle sacral vessels, and the iliac vessels. The left common iliac vessels, particularly the vein, can occasionally be identified crossing very close to the sacral promontory.

The operating table should be lowered and the patientside cart should be positioned as high as possible to clear the patient's legs, and then—after all overhead lights and equipment are moved to the side—the cart can be rolled into position between the patient's legs and aligned in a straight line with the camera arm and umbilical camera port. Docking can then be easily accomplished.

Open communication with the anesthesiology team is important. Robotic sacrocolpopexy is associated with significantly less blood loss (typically less than 25 mL) and less insensible loss than is open sacrocolpopexy. Therefore intravenous fluids should generally be limited to a liter or less.

Surgical Steps

If the patient has uterine prolapse, this can be addressed first with a supracervical or total hysterectomy. I prefer supracervical hysterectomies, assuming that the patient's Pap smears have been normal, in an attempt to reduce the risk of mesh erosion. After the hysterectomy, I place the uterus along the left lateral gutter for morcellation at the end of the procedure and after the system is undocked.

With either type of hysterectomy, the use of a colpotomy ring—either a KOH cup or a VCARE device—works nicely. We find this helpful in manipulating the uterus and defining the cervical-vaginal junction, even during supracervical hysterectomies, because it helps in the dissection of the bladder flap.

After the bladder flap is dissected off the anterior vaginal wall (close to the anterior vaginal wall to avoid cystotomy and to identify the avascular plane), the rectovaginal septum is developed. Approximately 6-8 cm of anterior vaginal wall are exposed.

The placement of round, 31- to 33-mm EEA (end-to-end anastomosis) sizers in the vagina to manipulate the vaginal apex helps with the bladder flap dissection, which can be challenging in patients who have had a previous cesarean section, hysterectomy, or vaginal reconstructive procedure—especially those performed with vaginally placed mesh. Occasionally, the bladder is found densely adherent over the apex of the vagina and adherent to the proximal posterior vaginal wall.

I frequently have an additional, smaller (29-mm) sizer placed in the rectum to help clearly identify the rectovaginal septum and facilitate the dissection.

During the rectovaginal dissection, the vaginal EEA sizer should be oriented anteriorly to better expose the posterior vaginal wall. Between 6 cm and 10 cm of the posterior vaginal wall should be dissected, while the camera is kept at midline and oriented to the horizon.

At this point, I frequently switch to a 30-degree down scope to develop the presacral space. This enables me to see over the sacral promontory and enhances my view. Depending on the configuration of the sacrum, it is possible to complete the surgery with a 0-degree scope. However, the view of the presacral space is generally significantly improved with the 30-degree down scope.

The sigmoid is retracted laterally by the third operative arm, and the peritoneum is lifted up, or tented, over the sacrum in the midline to avoid injury to a vessel. Our goal is to identify the anterior longitudinal ligament, and this area can be fairly vascular. Once the anterior longitudinal ligament is identified, the presacral peritoneal dissection can be extended inferiorly to the vagina.

I use a Y-shaped polypropylene mesh (AMS) and introduce it, trimmed to the appropriate width and length, in the proper anatomical orientation. I place the distal and lateral sutures on the anterior vaginal wall first, and then place several (four to eight) additional sutures to secure the mesh to the anterior vaginal wall. To suture, I use a Mega needle driver in the left hand and a SutureCut needle driver in the right. The SutureCut needle driver is similar to the Mega needle driver, but it also has a cutting mechanism that provides enhanced autonomy to the console surgeon and makes suturing more efficient overall.

Using the third operative robotic arm, I then roll the sacral end of the mesh and lift it anteriorly, which allows the posterior mesh to drape nicely over the posterior vaginal wall. The longer posterior mesh can then be easily sutured to the posterior wall of the vagina. For the posterior vaginal-wall mesh attachment, I usually start at the vaginal apex and work my way inferiorly. Throughout the surgery, I use permanent sutures of CV-2 Gore-Tex.

I then adjust the mesh tension, ensuring that it will be attached to the sacrum without undue tension and with equal distribution of support to the anterior and posterior of the vagina. Once this is determined, the excess mesh is trimmed.

I typically place three sacral sutures to secure the mesh to the sacrum. I place the inferiormost suture first, using a slip (or sliding) knot. This is a one-way knot that allows the mesh to be easily attached to the sacrum without the need for an assistant to hold the mesh against the sacrum while the suturing and knot tying are completed. Two additional sacral sutures are then placed superiorly to allow for adequate visualization of the sacrum during the suturing, and the excess mesh is trimmed.

The mesh should then be retroperitonealized to reduce the risk of small-bowel obstruction. The closure of the peritoneum is facilitated by the extension of the initial peritoneal incision from the sacrum inferiorly in the midline through the cul-de-sac and along the posterior vaginal wall at the time of sacral dissection. An enterocele repair can be accomplished as closure over the mesh obliterates the cul de sac. The peritoneum is closed with a running, locking, braided, absorbable suture.

I typically perform cystoscopy at the end of the procedure to confirm bilateral ureteral patency using intravenous indigo carmine.

Fortunately, presacral bleeding is rare. However, if presacral hemorrhage does occur, it is important to remain calm and remember that pressure can be applied with most available robotic instruments. (For example, even scissors work well if the wrist of the instrument is used.) If the bleeding does not respond to pressure, a bipolar forceps can be used, depending on the location and source of the bleeding. If bleeding continues, then FloSeal—a thrombin matrix that will usually and very effectively stop the bleeding—can be considered.

If the clinical situation warrants additional procedures, such as a posterior repair or a suburethral sling for urinary incontinence, these can easily be performed after the robot is undocked. If necessary, we perform uterine morcellation after undocking the robot.

Our typical patient at Duke has an overnight stay in our 23-hour observation unit and requires minimal oral pain medication.

Dr. Visco is a consultant for Intuitive Surgical Inc.

Port placement: A “W-like” configuration for port placement works well. This configuration reduces any competition between the two left robotic arms. Intuitive Surgical

Presacral dissection: The presacral space is generally best viewed with a 30-degree down scope.

Anterior suturing: A Mega needle driver and SutureCut needle driver are used for anterior vaginal wall suturing.

Mesh to sacrum: The first and most inferior of the three sacral sutures is placed with a sliding knot. Photos courtesy Dr. Anthony Visco

Robotic Sacrocolpopexy

This is the third installment of the Master Class in Gynecologic Surgery dedicated to robotic surgery.

Whether the procedure is called robotic sacrocolpopexy or robotic-assisted laparoscopic sacrocolpopexy, Dr. Anthony Visco's excellent description will help the reader understand how the robot and the laparoscope can be used to modify the standard treatment for vaginal vault prolapse—the abdominal sacrocolpopexy—into a minimally invasive gynecologic procedure that can be incorporated into one's practice.

As Dr. Visco points out, the robotic procedure involves an obligatory learning curve and a need for practiced, efficient teamwork. However, as the surgeon and staff gain experience, robotic sacrocolpopexy can lead to outcomes similar to those of abdominal sacrocolpopexy, but with less blood loss and quicker recovery time.

Dr. Visco is director of the division of urogynecology and reconstructive pelvic surgery; director of gynecologic robotic surgery; and vice chair of the department of obstetrics and gynecology at Duke University Medical Center in Durham, N.C. Dr. Visco has authored or coauthored nearly 50 peer-reviewed articles on, or related to, urogynecology.

In 2007, Dr. Visco performed a live robotic sacrocolpopexy in Madrid for an international conference on pelvic floor disorders, and a second live robotic sacrocolpopexy for the AAGL's 2007 annual meeting.

Some surgeons perform the procedure laparoscopically in an effort to decrease morbidity and recovery time, with some success. Overall, however, a laparoscopic approach has not been widely adopted because of the complex suturing and dissection involved, and the subsequently significant learning curve.

Robotic sacrocolpopexy is a new addition to our armamentarium and is an exciting option for me and other surgeons because it combines the advantages of open sacrocolpopexy with the decreased morbidity of laparoscopy.

A robotic approach to the tried-and-true abdominal sacrocolpopexy takes full advantage of all that robotic surgery offers. Instrument articulation, three-dimensional vision, tremor reduction, and improved ergonomics for the surgeon all make managing the mesh and intracorporeal suturing—as well as dissecting in the rectovaginal and presacral spaces—so much easier than would be the case with a standard laparoscopic approach.

Overall, sacrocolpopexy performed with the da Vinci surgical system—the only Food and Drug Administration-approved robotic device for use in gynecologic surgery—offers better access to the pelvis, compared with both the open and laparoscopic approaches.

We can truly replicate what we do in an open approach, but with less postoperative pain, less blood loss and scarring, and faster recovery. Robotic sacrocolpopexy can also be combined with total or supracervical hysterectomy for uterine prolapse.

Outcomes data are emerging. At the American Urogynecologic Society annual meeting last month, we presented our initial short-term data comparing robotic with traditional abdominal sacrocolpopexy for the treatment of both uterine and vaginal vault prolapse.

Postoperatively, based on a 6-week POPQ (Pelvic Organ Prolapse Quantification) examination, there was a similar degree of pelvic organ support in the 73 patients who underwent robotic surgery and the 105 patients who underwent traditional surgery. The length of hospital stay was significantly shorter with the robotic approach (1.3 days vs. 2.7 days), and estimated blood loss was significantly lower (103 mL vs. 255 mL).

The operative time for the colpopexy and all other procedures, including hysterectomy and slings, was significantly longer in the robotic group (328 vs. 225 minutes). This time is expected to decrease, however, as all members of the surgical team, including fellows, residents, and surgical staff, progress through the learning curve.

Patient Selection and Positioning

I now offer the procedure to any patient to whom I would recommend a sacrocolpopexy. In the initial stages of adopting a robotic approach, however, it makes sense to be more selective and to perform relatively straightforward surgeries. This means starting with patients who are relatively thin (with body mass indices less than 30 kg/m

Initial patients should also have a reasonably sized uterus (if present) and few comorbidities. Pulmonary morbidity (emphysema or chronic obstructive pulmonary disease, for instance) is a relative contraindication, especially for initial cases, because these patients may not tolerate the Trendelenburg position, which is required for the surgery.

In addition, although robotic sacrocolpopexy can be used for uterine prolapse, I recommend starting with patients who have vaginal vault prolapse so that the surgeon can focus on a single robotic procedure. As their experience grows, surgeons can easily perform a combined robotic hysterectomy with sacrocolpopexy for the treatment of uterine prolapse. I primarily perform a supracervical hysterectomy in combination with a sacrocolpopexy in an attempt to reduce the risk of mesh erosion.

When the patient is positioned at the start of the surgery, her arms and shoulders and all “pressure points” should be well padded with foam, but I do not find a need for shoulder pads. I typically use an extra-large vacuum bean bag to keep the patient firmly in place while she is in the moderate to steep Trendelenburg position, but the use of a gel pad placed between the patient and the bed is an alternative approach to keep the patient from sliding cephalad during the surgery.

Port Placement, Setup, and Preparation

For robotic sacrocolpopexy, five trocar sites are used with a four-arm robotic system: three for operative robotic arms, one for the camera, and one to be used as the assistant's port for suction and irrigation, assistance with traction/countertraction, and the introduction of suture and mesh. (The bedside assistant is also helpful for instrument swaps, during uterine morcellation, and for any trocar depth repositioning that is necessary.)

Initially, we tried several different port locations. We have found that a “W-like” configuration for our port placement works well. We place the camera trocar at the umbilicus to accommodate the endoscope and the camera arm. This represents the middle of our “W.”

We then place two robotic ports at the two inferior apices of the “W.” The lateral ends of the “W” are each located about 2 cm inferior to the level of the umbilicus. The right lateral port is the assistant's port, which is used to introduce mesh, suture, and the like. The left lateral port is for the third robotic operative arm and is particularly helpful in moving the sigmoid laterally to expose the sacrum.

Using this configuration, we have reduced any competition between the two left robotic arms while we operate either in the pelvis or at the sacrum.

Some surgeons place the camera port higher (above the umbilicus), but I do not care for this placement because it can partially impede the view over the sacral promontory. (Placement of the camera port above the umbilicus is necessary for enlarged uteri, however.) After initial entry, a 0-degree scope should be used to place the other ports.

It is important to maintain at least 10 cm between robotic ports, and at least 6 cm between the robotic port and the assistant's port to reduce external collision of the robotic instrument arms.

Before docking the robotic arms of the patientside cart and placing the various EndoWrist instruments, I laparoscopically remove any small-bowel adhesions or other abdominal wall adhesions. This way, I have the tactile sensation that robotics does not provide. I then retract the sigmoid and move the small bowel out of the pelvis to expose the sacrum and the sacral promontory.

At this point and still prior to docking, it is also important to identify the ureters, the sacral promontory, the midline with the sigmoid retracted, the middle sacral vessels, and the iliac vessels. The left common iliac vessels, particularly the vein, can occasionally be identified crossing very close to the sacral promontory.

The operating table should be lowered and the patientside cart should be positioned as high as possible to clear the patient's legs, and then—after all overhead lights and equipment are moved to the side—the cart can be rolled into position between the patient's legs and aligned in a straight line with the camera arm and umbilical camera port. Docking can then be easily accomplished.

Open communication with the anesthesiology team is important. Robotic sacrocolpopexy is associated with significantly less blood loss (typically less than 25 mL) and less insensible loss than is open sacrocolpopexy. Therefore intravenous fluids should generally be limited to a liter or less.

Surgical Steps

If the patient has uterine prolapse, this can be addressed first with a supracervical or total hysterectomy. I prefer supracervical hysterectomies, assuming that the patient's Pap smears have been normal, in an attempt to reduce the risk of mesh erosion. After the hysterectomy, I place the uterus along the left lateral gutter for morcellation at the end of the procedure and after the system is undocked.

With either type of hysterectomy, the use of a colpotomy ring—either a KOH cup or a VCARE device—works nicely. We find this helpful in manipulating the uterus and defining the cervical-vaginal junction, even during supracervical hysterectomies, because it helps in the dissection of the bladder flap.

After the bladder flap is dissected off the anterior vaginal wall (close to the anterior vaginal wall to avoid cystotomy and to identify the avascular plane), the rectovaginal septum is developed. Approximately 6-8 cm of anterior vaginal wall are exposed.

The placement of round, 31- to 33-mm EEA (end-to-end anastomosis) sizers in the vagina to manipulate the vaginal apex helps with the bladder flap dissection, which can be challenging in patients who have had a previous cesarean section, hysterectomy, or vaginal reconstructive procedure—especially those performed with vaginally placed mesh. Occasionally, the bladder is found densely adherent over the apex of the vagina and adherent to the proximal posterior vaginal wall.

I frequently have an additional, smaller (29-mm) sizer placed in the rectum to help clearly identify the rectovaginal septum and facilitate the dissection.

During the rectovaginal dissection, the vaginal EEA sizer should be oriented anteriorly to better expose the posterior vaginal wall. Between 6 cm and 10 cm of the posterior vaginal wall should be dissected, while the camera is kept at midline and oriented to the horizon.

At this point, I frequently switch to a 30-degree down scope to develop the presacral space. This enables me to see over the sacral promontory and enhances my view. Depending on the configuration of the sacrum, it is possible to complete the surgery with a 0-degree scope. However, the view of the presacral space is generally significantly improved with the 30-degree down scope.

The sigmoid is retracted laterally by the third operative arm, and the peritoneum is lifted up, or tented, over the sacrum in the midline to avoid injury to a vessel. Our goal is to identify the anterior longitudinal ligament, and this area can be fairly vascular. Once the anterior longitudinal ligament is identified, the presacral peritoneal dissection can be extended inferiorly to the vagina.

I use a Y-shaped polypropylene mesh (AMS) and introduce it, trimmed to the appropriate width and length, in the proper anatomical orientation. I place the distal and lateral sutures on the anterior vaginal wall first, and then place several (four to eight) additional sutures to secure the mesh to the anterior vaginal wall. To suture, I use a Mega needle driver in the left hand and a SutureCut needle driver in the right. The SutureCut needle driver is similar to the Mega needle driver, but it also has a cutting mechanism that provides enhanced autonomy to the console surgeon and makes suturing more efficient overall.

Using the third operative robotic arm, I then roll the sacral end of the mesh and lift it anteriorly, which allows the posterior mesh to drape nicely over the posterior vaginal wall. The longer posterior mesh can then be easily sutured to the posterior wall of the vagina. For the posterior vaginal-wall mesh attachment, I usually start at the vaginal apex and work my way inferiorly. Throughout the surgery, I use permanent sutures of CV-2 Gore-Tex.

I then adjust the mesh tension, ensuring that it will be attached to the sacrum without undue tension and with equal distribution of support to the anterior and posterior of the vagina. Once this is determined, the excess mesh is trimmed.

I typically place three sacral sutures to secure the mesh to the sacrum. I place the inferiormost suture first, using a slip (or sliding) knot. This is a one-way knot that allows the mesh to be easily attached to the sacrum without the need for an assistant to hold the mesh against the sacrum while the suturing and knot tying are completed. Two additional sacral sutures are then placed superiorly to allow for adequate visualization of the sacrum during the suturing, and the excess mesh is trimmed.

The mesh should then be retroperitonealized to reduce the risk of small-bowel obstruction. The closure of the peritoneum is facilitated by the extension of the initial peritoneal incision from the sacrum inferiorly in the midline through the cul-de-sac and along the posterior vaginal wall at the time of sacral dissection. An enterocele repair can be accomplished as closure over the mesh obliterates the cul de sac. The peritoneum is closed with a running, locking, braided, absorbable suture.

I typically perform cystoscopy at the end of the procedure to confirm bilateral ureteral patency using intravenous indigo carmine.

Fortunately, presacral bleeding is rare. However, if presacral hemorrhage does occur, it is important to remain calm and remember that pressure can be applied with most available robotic instruments. (For example, even scissors work well if the wrist of the instrument is used.) If the bleeding does not respond to pressure, a bipolar forceps can be used, depending on the location and source of the bleeding. If bleeding continues, then FloSeal—a thrombin matrix that will usually and very effectively stop the bleeding—can be considered.

If the clinical situation warrants additional procedures, such as a posterior repair or a suburethral sling for urinary incontinence, these can easily be performed after the robot is undocked. If necessary, we perform uterine morcellation after undocking the robot.

Our typical patient at Duke has an overnight stay in our 23-hour observation unit and requires minimal oral pain medication.

Dr. Visco is a consultant for Intuitive Surgical Inc.

Port placement: A “W-like” configuration for port placement works well. This configuration reduces any competition between the two left robotic arms. Intuitive Surgical

Presacral dissection: The presacral space is generally best viewed with a 30-degree down scope.

Anterior suturing: A Mega needle driver and SutureCut needle driver are used for anterior vaginal wall suturing.

Mesh to sacrum: The first and most inferior of the three sacral sutures is placed with a sliding knot. Photos courtesy Dr. Anthony Visco

Robotic Sacrocolpopexy

This is the third installment of the Master Class in Gynecologic Surgery dedicated to robotic surgery.

Whether the procedure is called robotic sacrocolpopexy or robotic-assisted laparoscopic sacrocolpopexy, Dr. Anthony Visco's excellent description will help the reader understand how the robot and the laparoscope can be used to modify the standard treatment for vaginal vault prolapse—the abdominal sacrocolpopexy—into a minimally invasive gynecologic procedure that can be incorporated into one's practice.

As Dr. Visco points out, the robotic procedure involves an obligatory learning curve and a need for practiced, efficient teamwork. However, as the surgeon and staff gain experience, robotic sacrocolpopexy can lead to outcomes similar to those of abdominal sacrocolpopexy, but with less blood loss and quicker recovery time.

Dr. Visco is director of the division of urogynecology and reconstructive pelvic surgery; director of gynecologic robotic surgery; and vice chair of the department of obstetrics and gynecology at Duke University Medical Center in Durham, N.C. Dr. Visco has authored or coauthored nearly 50 peer-reviewed articles on, or related to, urogynecology.

In 2007, Dr. Visco performed a live robotic sacrocolpopexy in Madrid for an international conference on pelvic floor disorders, and a second live robotic sacrocolpopexy for the AAGL's 2007 annual meeting.

Some surgeons perform the procedure laparoscopically in an effort to decrease morbidity and recovery time, with some success. Overall, however, a laparoscopic approach has not been widely adopted because of the complex suturing and dissection involved, and the subsequently significant learning curve.

Robotic sacrocolpopexy is a new addition to our armamentarium and is an exciting option for me and other surgeons because it combines the advantages of open sacrocolpopexy with the decreased morbidity of laparoscopy.

A robotic approach to the tried-and-true abdominal sacrocolpopexy takes full advantage of all that robotic surgery offers. Instrument articulation, three-dimensional vision, tremor reduction, and improved ergonomics for the surgeon all make managing the mesh and intracorporeal suturing—as well as dissecting in the rectovaginal and presacral spaces—so much easier than would be the case with a standard laparoscopic approach.

Overall, sacrocolpopexy performed with the da Vinci surgical system—the only Food and Drug Administration-approved robotic device for use in gynecologic surgery—offers better access to the pelvis, compared with both the open and laparoscopic approaches.

We can truly replicate what we do in an open approach, but with less postoperative pain, less blood loss and scarring, and faster recovery. Robotic sacrocolpopexy can also be combined with total or supracervical hysterectomy for uterine prolapse.

Outcomes data are emerging. At the American Urogynecologic Society annual meeting last month, we presented our initial short-term data comparing robotic with traditional abdominal sacrocolpopexy for the treatment of both uterine and vaginal vault prolapse.

Postoperatively, based on a 6-week POPQ (Pelvic Organ Prolapse Quantification) examination, there was a similar degree of pelvic organ support in the 73 patients who underwent robotic surgery and the 105 patients who underwent traditional surgery. The length of hospital stay was significantly shorter with the robotic approach (1.3 days vs. 2.7 days), and estimated blood loss was significantly lower (103 mL vs. 255 mL).

The operative time for the colpopexy and all other procedures, including hysterectomy and slings, was significantly longer in the robotic group (328 vs. 225 minutes). This time is expected to decrease, however, as all members of the surgical team, including fellows, residents, and surgical staff, progress through the learning curve.

Patient Selection and Positioning

I now offer the procedure to any patient to whom I would recommend a sacrocolpopexy. In the initial stages of adopting a robotic approach, however, it makes sense to be more selective and to perform relatively straightforward surgeries. This means starting with patients who are relatively thin (with body mass indices less than 30 kg/m

Initial patients should also have a reasonably sized uterus (if present) and few comorbidities. Pulmonary morbidity (emphysema or chronic obstructive pulmonary disease, for instance) is a relative contraindication, especially for initial cases, because these patients may not tolerate the Trendelenburg position, which is required for the surgery.

In addition, although robotic sacrocolpopexy can be used for uterine prolapse, I recommend starting with patients who have vaginal vault prolapse so that the surgeon can focus on a single robotic procedure. As their experience grows, surgeons can easily perform a combined robotic hysterectomy with sacrocolpopexy for the treatment of uterine prolapse. I primarily perform a supracervical hysterectomy in combination with a sacrocolpopexy in an attempt to reduce the risk of mesh erosion.

When the patient is positioned at the start of the surgery, her arms and shoulders and all “pressure points” should be well padded with foam, but I do not find a need for shoulder pads. I typically use an extra-large vacuum bean bag to keep the patient firmly in place while she is in the moderate to steep Trendelenburg position, but the use of a gel pad placed between the patient and the bed is an alternative approach to keep the patient from sliding cephalad during the surgery.

Port Placement, Setup, and Preparation

For robotic sacrocolpopexy, five trocar sites are used with a four-arm robotic system: three for operative robotic arms, one for the camera, and one to be used as the assistant's port for suction and irrigation, assistance with traction/countertraction, and the introduction of suture and mesh. (The bedside assistant is also helpful for instrument swaps, during uterine morcellation, and for any trocar depth repositioning that is necessary.)

Initially, we tried several different port locations. We have found that a “W-like” configuration for our port placement works well. We place the camera trocar at the umbilicus to accommodate the endoscope and the camera arm. This represents the middle of our “W.”

We then place two robotic ports at the two inferior apices of the “W.” The lateral ends of the “W” are each located about 2 cm inferior to the level of the umbilicus. The right lateral port is the assistant's port, which is used to introduce mesh, suture, and the like. The left lateral port is for the third robotic operative arm and is particularly helpful in moving the sigmoid laterally to expose the sacrum.

Using this configuration, we have reduced any competition between the two left robotic arms while we operate either in the pelvis or at the sacrum.

Some surgeons place the camera port higher (above the umbilicus), but I do not care for this placement because it can partially impede the view over the sacral promontory. (Placement of the camera port above the umbilicus is necessary for enlarged uteri, however.) After initial entry, a 0-degree scope should be used to place the other ports.

It is important to maintain at least 10 cm between robotic ports, and at least 6 cm between the robotic port and the assistant's port to reduce external collision of the robotic instrument arms.

Before docking the robotic arms of the patientside cart and placing the various EndoWrist instruments, I laparoscopically remove any small-bowel adhesions or other abdominal wall adhesions. This way, I have the tactile sensation that robotics does not provide. I then retract the sigmoid and move the small bowel out of the pelvis to expose the sacrum and the sacral promontory.

At this point and still prior to docking, it is also important to identify the ureters, the sacral promontory, the midline with the sigmoid retracted, the middle sacral vessels, and the iliac vessels. The left common iliac vessels, particularly the vein, can occasionally be identified crossing very close to the sacral promontory.

The operating table should be lowered and the patientside cart should be positioned as high as possible to clear the patient's legs, and then—after all overhead lights and equipment are moved to the side—the cart can be rolled into position between the patient's legs and aligned in a straight line with the camera arm and umbilical camera port. Docking can then be easily accomplished.

Open communication with the anesthesiology team is important. Robotic sacrocolpopexy is associated with significantly less blood loss (typically less than 25 mL) and less insensible loss than is open sacrocolpopexy. Therefore intravenous fluids should generally be limited to a liter or less.

Surgical Steps

If the patient has uterine prolapse, this can be addressed first with a supracervical or total hysterectomy. I prefer supracervical hysterectomies, assuming that the patient's Pap smears have been normal, in an attempt to reduce the risk of mesh erosion. After the hysterectomy, I place the uterus along the left lateral gutter for morcellation at the end of the procedure and after the system is undocked.

With either type of hysterectomy, the use of a colpotomy ring—either a KOH cup or a VCARE device—works nicely. We find this helpful in manipulating the uterus and defining the cervical-vaginal junction, even during supracervical hysterectomies, because it helps in the dissection of the bladder flap.

After the bladder flap is dissected off the anterior vaginal wall (close to the anterior vaginal wall to avoid cystotomy and to identify the avascular plane), the rectovaginal septum is developed. Approximately 6-8 cm of anterior vaginal wall are exposed.

The placement of round, 31- to 33-mm EEA (end-to-end anastomosis) sizers in the vagina to manipulate the vaginal apex helps with the bladder flap dissection, which can be challenging in patients who have had a previous cesarean section, hysterectomy, or vaginal reconstructive procedure—especially those performed with vaginally placed mesh. Occasionally, the bladder is found densely adherent over the apex of the vagina and adherent to the proximal posterior vaginal wall.

I frequently have an additional, smaller (29-mm) sizer placed in the rectum to help clearly identify the rectovaginal septum and facilitate the dissection.

During the rectovaginal dissection, the vaginal EEA sizer should be oriented anteriorly to better expose the posterior vaginal wall. Between 6 cm and 10 cm of the posterior vaginal wall should be dissected, while the camera is kept at midline and oriented to the horizon.

At this point, I frequently switch to a 30-degree down scope to develop the presacral space. This enables me to see over the sacral promontory and enhances my view. Depending on the configuration of the sacrum, it is possible to complete the surgery with a 0-degree scope. However, the view of the presacral space is generally significantly improved with the 30-degree down scope.

The sigmoid is retracted laterally by the third operative arm, and the peritoneum is lifted up, or tented, over the sacrum in the midline to avoid injury to a vessel. Our goal is to identify the anterior longitudinal ligament, and this area can be fairly vascular. Once the anterior longitudinal ligament is identified, the presacral peritoneal dissection can be extended inferiorly to the vagina.

I use a Y-shaped polypropylene mesh (AMS) and introduce it, trimmed to the appropriate width and length, in the proper anatomical orientation. I place the distal and lateral sutures on the anterior vaginal wall first, and then place several (four to eight) additional sutures to secure the mesh to the anterior vaginal wall. To suture, I use a Mega needle driver in the left hand and a SutureCut needle driver in the right. The SutureCut needle driver is similar to the Mega needle driver, but it also has a cutting mechanism that provides enhanced autonomy to the console surgeon and makes suturing more efficient overall.

Using the third operative robotic arm, I then roll the sacral end of the mesh and lift it anteriorly, which allows the posterior mesh to drape nicely over the posterior vaginal wall. The longer posterior mesh can then be easily sutured to the posterior wall of the vagina. For the posterior vaginal-wall mesh attachment, I usually start at the vaginal apex and work my way inferiorly. Throughout the surgery, I use permanent sutures of CV-2 Gore-Tex.

I then adjust the mesh tension, ensuring that it will be attached to the sacrum without undue tension and with equal distribution of support to the anterior and posterior of the vagina. Once this is determined, the excess mesh is trimmed.

I typically place three sacral sutures to secure the mesh to the sacrum. I place the inferiormost suture first, using a slip (or sliding) knot. This is a one-way knot that allows the mesh to be easily attached to the sacrum without the need for an assistant to hold the mesh against the sacrum while the suturing and knot tying are completed. Two additional sacral sutures are then placed superiorly to allow for adequate visualization of the sacrum during the suturing, and the excess mesh is trimmed.

The mesh should then be retroperitonealized to reduce the risk of small-bowel obstruction. The closure of the peritoneum is facilitated by the extension of the initial peritoneal incision from the sacrum inferiorly in the midline through the cul-de-sac and along the posterior vaginal wall at the time of sacral dissection. An enterocele repair can be accomplished as closure over the mesh obliterates the cul de sac. The peritoneum is closed with a running, locking, braided, absorbable suture.

I typically perform cystoscopy at the end of the procedure to confirm bilateral ureteral patency using intravenous indigo carmine.

Fortunately, presacral bleeding is rare. However, if presacral hemorrhage does occur, it is important to remain calm and remember that pressure can be applied with most available robotic instruments. (For example, even scissors work well if the wrist of the instrument is used.) If the bleeding does not respond to pressure, a bipolar forceps can be used, depending on the location and source of the bleeding. If bleeding continues, then FloSeal—a thrombin matrix that will usually and very effectively stop the bleeding—can be considered.

If the clinical situation warrants additional procedures, such as a posterior repair or a suburethral sling for urinary incontinence, these can easily be performed after the robot is undocked. If necessary, we perform uterine morcellation after undocking the robot.

Our typical patient at Duke has an overnight stay in our 23-hour observation unit and requires minimal oral pain medication.

Dr. Visco is a consultant for Intuitive Surgical Inc.

Port placement: A “W-like” configuration for port placement works well. This configuration reduces any competition between the two left robotic arms. Intuitive Surgical

Presacral dissection: The presacral space is generally best viewed with a 30-degree down scope.

Anterior suturing: A Mega needle driver and SutureCut needle driver are used for anterior vaginal wall suturing.

Mesh to sacrum: The first and most inferior of the three sacral sutures is placed with a sliding knot. Photos courtesy Dr. Anthony Visco

Robotic Sacrocolpopexy

This is the third installment of the Master Class in Gynecologic Surgery dedicated to robotic surgery.

Whether the procedure is called robotic sacrocolpopexy or robotic-assisted laparoscopic sacrocolpopexy, Dr. Anthony Visco's excellent description will help the reader understand how the robot and the laparoscope can be used to modify the standard treatment for vaginal vault prolapse—the abdominal sacrocolpopexy—into a minimally invasive gynecologic procedure that can be incorporated into one's practice.

As Dr. Visco points out, the robotic procedure involves an obligatory learning curve and a need for practiced, efficient teamwork. However, as the surgeon and staff gain experience, robotic sacrocolpopexy can lead to outcomes similar to those of abdominal sacrocolpopexy, but with less blood loss and quicker recovery time.

Dr. Visco is director of the division of urogynecology and reconstructive pelvic surgery; director of gynecologic robotic surgery; and vice chair of the department of obstetrics and gynecology at Duke University Medical Center in Durham, N.C. Dr. Visco has authored or coauthored nearly 50 peer-reviewed articles on, or related to, urogynecology.

In 2007, Dr. Visco performed a live robotic sacrocolpopexy in Madrid for an international conference on pelvic floor disorders, and a second live robotic sacrocolpopexy for the AAGL's 2007 annual meeting.

This Master Class is the second in a three-part series on the topic of preeclampsia, which is a relatively common complication of pregnancy that can result in severe morbidity and mortality if not well managed. In light of this, we have decided to dedicate a significant amount of coverage to this topic.

In the previous Master Class article, we covered one end of the spectrum—severe preeclampsia. This Master Class focuses on the more common presentation of mild preeclampsia, which sometimes presents in a manner similar to that of gestational hypertension alone.

Mild gestational hypertension-preeclampsia affects up to 10% of all pregnancies. Because it is a relatively common complication of pregnancy, it is critically important that the practitioner develops a clinical algorithm for diagnosis—one that distinguishes mild gestational hypertension-preeclampsia from gestational hypertension alone—and institutes an appropriate management protocol.

Dr. Baha M. Sibai, our guest professor previously on the topic of severe preeclampsia, will help us with this Master Class. He focuses here on the salient differences between gestational hypertension and mild preeclampsia and how these conditions should be managed in the antepartum, intrapartum, and postpartum periods.

Dr. Sibai is an international expert on preeclampsia and eclampsia and a world leader in clinical care and research in this field. He is professor of obstetrics and gynecology at the University of Cincinnati, and has contributed to more than 350 studies in peer-reviewed journals on these topics.

In the third and final part of the series on preeclampsia, Dr. Sibai will address the risk of recurrent preeclampsia and how subsequent pregnancies in women with a history of previous preeclampsia should be managed.

This Master Class is the second in a three-part series on the topic of preeclampsia, which is a relatively common complication of pregnancy that can result in severe morbidity and mortality if not well managed. In light of this, we have decided to dedicate a significant amount of coverage to this topic.

In the previous Master Class article, we covered one end of the spectrum—severe preeclampsia. This Master Class focuses on the more common presentation of mild preeclampsia, which sometimes presents in a manner similar to that of gestational hypertension alone.

Mild gestational hypertension-preeclampsia affects up to 10% of all pregnancies. Because it is a relatively common complication of pregnancy, it is critically important that the practitioner develops a clinical algorithm for diagnosis—one that distinguishes mild gestational hypertension-preeclampsia from gestational hypertension alone—and institutes an appropriate management protocol.

Dr. Baha M. Sibai, our guest professor previously on the topic of severe preeclampsia, will help us with this Master Class. He focuses here on the salient differences between gestational hypertension and mild preeclampsia and how these conditions should be managed in the antepartum, intrapartum, and postpartum periods.

Dr. Sibai is an international expert on preeclampsia and eclampsia and a world leader in clinical care and research in this field. He is professor of obstetrics and gynecology at the University of Cincinnati, and has contributed to more than 350 studies in peer-reviewed journals on these topics.

In the third and final part of the series on preeclampsia, Dr. Sibai will address the risk of recurrent preeclampsia and how subsequent pregnancies in women with a history of previous preeclampsia should be managed.

This Master Class is the second in a three-part series on the topic of preeclampsia, which is a relatively common complication of pregnancy that can result in severe morbidity and mortality if not well managed. In light of this, we have decided to dedicate a significant amount of coverage to this topic.

In the previous Master Class article, we covered one end of the spectrum—severe preeclampsia. This Master Class focuses on the more common presentation of mild preeclampsia, which sometimes presents in a manner similar to that of gestational hypertension alone.

Mild gestational hypertension-preeclampsia affects up to 10% of all pregnancies. Because it is a relatively common complication of pregnancy, it is critically important that the practitioner develops a clinical algorithm for diagnosis—one that distinguishes mild gestational hypertension-preeclampsia from gestational hypertension alone—and institutes an appropriate management protocol.

Dr. Baha M. Sibai, our guest professor previously on the topic of severe preeclampsia, will help us with this Master Class. He focuses here on the salient differences between gestational hypertension and mild preeclampsia and how these conditions should be managed in the antepartum, intrapartum, and postpartum periods.

Dr. Sibai is an international expert on preeclampsia and eclampsia and a world leader in clinical care and research in this field. He is professor of obstetrics and gynecology at the University of Cincinnati, and has contributed to more than 350 studies in peer-reviewed journals on these topics.

In the third and final part of the series on preeclampsia, Dr. Sibai will address the risk of recurrent preeclampsia and how subsequent pregnancies in women with a history of previous preeclampsia should be managed.

Hysterectomy has been a first natural and successful application for robotics in gynecologic and reproductive care, but it is also now clear that robot-assisted laparoscopic myomectomy takes full advantage—even more so—of what robotic technology brings to the table.

Conventional laparoscopic myomectomy has been so challenging that relatively few gynecologic surgeons have been willing and/or able to move away from the traditional open approach for treating symptomatic leiomyomata. Laparotomy thus has remained the standard for myomectomy, leaving many women with a limited number of minimally invasive options if they want to preserve their uterus or fertility, and leaving our health care system shouldering millions of dollars in costs associated with invasive approaches.

It is interesting to note that the total direct cost of treating uterine fibroids in 2000 was estimated at $2.1 billion. Most of the cost, the authors wrote, resulted from inpatient care, particularly hysterectomy (Am. J. Obstet. Gynec. 2006;195:955-64).

With all that robotics offers to us, I believe this is about to change.

The Rationale

Two prospective trials have shown less postoperative morbidity and faster recovery with laparoscopic myomectomy. Yet the endoscopic management of leiomyomata is so technically challenging that the majority of cases are still performed via laparotomy. (Few would challenge the notion, I believe, that it is one of the more challenging procedures in minimally invasive surgery.)

The complexity of dissection and, in particular, the complexity of repair with multilayer-sutured closures present challenges that not only require advanced laparoscopic skills but also are associated with a steep learning curve. These challenges have consistently raised concerns about whether laparoscopy increases conversion rates and whether it can lead to uterine rupture.

There also are longstanding, published limitations placed on the kinds of tumors that can be treated with conventional laparoscopy in order to minimize the risk of conversion to laparotomy. It is often stated that cases involving fibroids greater than or equal to 5 cm, intramural fibroids, an anterior location, and preoperative use of GnRH agonists are too difficult to handle laparoscopically and are likely to increase the conversion rate (Human Reprod. 2001;16:1726-31).

Current robotic technology essentially erases almost all of the limitations of conventional laparoscopy. The features of the technology—improved dexterity and precision of the instruments as well as the three-dimensional imaging—allow the endoscopic approach to be more accurately modeled after (and reflective of) traditional open techniques.

The da Vinci surgical system, which is the only Food and Drug Administration-approved robotic device for use in gynecologic surgery, provides us with a means to overcome the difficulties associated with hysterotomy, enucleation, repair, and extraction that we encounter with the conventional laparoscopic management of fibroids.

The Setup

The da Vinci system comprises a surgeon's console, a vision system that provides three-dimensional imaging through a 12-mm endoscope, and a patientside cart with robotic arms and various EndoWrist instruments.

At the console, the surgeon controls the instruments, the camera, and an energy source, all via a stereoscopic viewer, hand manipulators, and foot pedals. One of the robotic arms holds the endoscope while the other two or three arms hold the instruments.

The instruments come in either 8- or 5-mm sizes and possess 7 degrees of movement, a range that replicates or surpasses the human hand's full range of motion.

Overall, the technique itself for robot-assisted laparoscopic myomectomy does not differ significantly from what is done in conventional laparoscopy, except that the critical steps of hysterotomy, enucleation, and repair are dramatically facilitated while the surgeon adheres to the principles of open surgery.

The bottom line is that robotics affords us the ability to perform the procedure as if it were being done as an open procedure, with the only change being the route of access.

We first place a 12-mm port at or above the umbilicus, depending on the size of the uterus, to accommodate the endoscope and camera arm. As a general rule, I advise leaving at least a handsbreadth distance (approximately 8-10 cm) between the endoscope and the top of an elevated uterus or leiomyoma during bimanual examination, with the patient under anesthesia.

This spacing is important during myomectomy because the enucleation process will result in the leiomyoma projecting out toward the endoscope. By leaving an adequate working space at the beginning, we are able to compensate for a loss of optical working distance and maintain our ability to manipulate our instruments.

We then place an 8-mm port in the left and right lower quadrants, placing them more cephalad and lateral in the case of larger uteri or leiomyomata. These ports will mount directly to the operating robotic arms.

A fourth trocar (a 12- to 15-mm port that will facilitate the introduction of suture as well as instrumentation used for retraction, suction/irrigation, and other tasks of the assistant) can be placed between the camera port and either the left or right lower-quadrant port.

Just as with robotic hysterectomy, a fourth robotic arm can be added for patients who are obese or have a large uterus; this can be used for added retraction of tissues.

The key point to be made about setup is that the ports must be placed far enough away from each other and from the target tissue to avoid instrument-arm collisions.

We recommend that all patients undergo radiologic imaging prior to myomectomy. In our practice, we favor MRI for assessing the size, number, and location of the fibroids as well as for ruling out adenomyosis and for planning the location(s) of the hysterotomy incision. All of this information is particularly helpful given the absence of haptic (tactile) feedback with the robotic approach.

The Technique

Prior to hysterotomy, a dilute concentration of vasopressin is injected into the myometrium surrounding the myoma, as an adjunct for hemostasis. Once adequate blanching is noted, we begin each case with either a bipolar Maryland forceps or Gyrus ACMI Inc.'s PK dissecting forceps on the left arm, and hot shears or a permanent cautery hook (both monopolar devices) on the right arm. Our hysterotomy can be made in either a horizontal or vertical axis because we will be less limited with robotic instruments than we would be in a conventional laparoscopy.

The fibroid can then be enucleated while the bedside assistant provides additional traction/countertraction with a conventional laparoscopic tenaculum or corkscrew. An alternative is to use the fourth robotic arm with an EndoWrist tenaculum. Care must be taken to avoid excessive traction during the enucleation phase in order to maintain hemostasis and to not prematurely avulse the fibroid. Patience is key.

The removed fibroid is placed in the posterior cul-de-sac—or in one of the paracolic gutters if it is larger—for retrieval at the end of the surgery. When we remove multiple and smaller fibroids, it is important to maintain a myoma count. Tagging each of them with long suture can be helpful for retrieval at the end of the case.

At this point, we usually exchange our instruments for a large needle driver on the left arm and a mega needle driver with a high-force grip and integrated cutting mechanism on the right arm. We typically incorporate a multilayer closure for the myometrium, using either interrupted sutures of 0-Vicryl on CT-2 needles cut to 6 inches, or running sutures of 0-Vicryl on CT-2 needles cut to 11 inches.

With the increased articulation and dexterity of our instruments, our ability to repair a defect is affected much less by the orientation of the incisions or the location than it would be in conventional laparoscopy.

To close the uterine serosa, we use a running baseball stitch with 3-0 Vicryl on an SH needle. If multiple fibroids must be removed, we prefer to repair each uterine defect after enucleation before moving on to another tumor. This way, we're taking advantage of the effects of vasopressin at each site. We try to remove as many fibroids as possible through a given hysterotomy.

Before retrieving excised fibroids, the robot-assist device is undocked. Specimens are then retrieved via a tissue morcellator that is placed through the accessory port. Another option is to use the endoscopic port site, but this requires the use of a 5-mm 0-degree laparoscope placed through one of the lateral trocars.

All operative sites are irrigated, hemostasis is ensured under low-pressure settings, and an adhesion barrier is placed over all uterine incisions. We typically apply a slurry of finely chopped Seprafilm as an adhesion barrier (an off-label use).

With robotic myomectomy, as with any of the robotically assisted gynecologic procedures, the importance of the bedside assistant cannot be overestimated. In addition to providing traction/countertraction (we usually don't need to use a fourth robotic arm because our assistants are skilled), the assistant introduces and removes suture, provides irrigation, and manages any accessory port activity (J. Robotic Surg. 2007;1:69-74).

The Patients, the Outcomes

With robotics, there really are not many patients we cannot address. There are no absolute inclusion criteria, and no absolute cutoffs. It's all relative. We determine whether a patient is a candidate for a robotic myomectomy based on the size and mobility of her uterus as well as the size, number, and location of her fibroids.

For example, a patient whose height is 4 feet 10 inches and who is obese with a short truncated torso, a uterus that is not very mobile, and an 8-cm fibroid located over the broad ligament may be a poorer candidate than would a taller patient of average weight with an 8-cm intramural fibroid in a uterus that is extremely mobile. This is where the art of medicine comes into play.

Overall, however, the robotic approach overcomes challenges like obesity, and puts us at a greater advantage as surgeons—giving us an ability to suture more effectively and to approach complex pathology much more aggressively—than does conventional laparoscopy.

It takes some time to get used to the dramatic paradigm shift of operating remotely from the patient through a robotic interface. Learning to overcome the lack of tactile feedback is also part of the learning curve. The key is to not attempt more than you can handle early in the learning process. Then, as your experience grows, your ability to tackle complex gynecologic pathology will come. In other words, start with a symptomatic 4- to 5-cm fundal subserosal fibroid before approaching the 10-cm broad-ligament fibroid.

We started doing robotic myomectomies in 2001. In our first published series of 35 cases, the mean myoma weight was 223.2 g. The mean number of myomas removed was 1.6, and the mean diameter was 7.9 cm. The average estimated blood loss was 169 mL and no blood transfusions were necessary. Three of the cases were converted to laparotomy, two because of the absence of tactile feedback and a third because of cardiogenic shock secondary to vasopressin (J. Am. Assoc. Gynecol. Laparosc. 2004;11:511-8).

Since that early experience, we have not had to convert a patient to a laparotomy secondary to an absence of tactile feedback.

When we later compared surgical outcomes with those of traditional laparotomy through a retrospective case-matched analysis of 58 patients, we found that although operative times were significantly longer in the robotic group (a mean of 231 minutes vs. a mean of 154 minutes), postoperative complication rates were higher in the laparotomy group.

In all, there were 14 postoperative complications in 12 patients in the laparotomy group, including wound dehiscence; hematoma; blood loss and anemia requiring transfusion; and deep vein thrombosis followed by respiratory arrest and renal failure. In the robotic group, there were three postoperative complications: aspiration pneumonia, port-site cellulitis, and chest pain.

Estimated blood loss was significantly higher in the laparotomy group than in the robotic group (a mean of 365 mL v. 196 mL), and transfusions were required in two patients who underwent laparotomy. Length of stay was also higher: 3.6 days in the laparotomy group, compared with 1.5 days in the robotic group. (J. Min. Invasive Gynecol. 2007;14:698-705).

We have also analyzed the effects of our experience over time and have presented these data at the AAGL annual meeting in November 2007. We found a notable trend toward both lower blood loss and shorter operative time with experience. Additionally, we evolved from an average length of stay of 1.5 days to a completely outpatient procedure. We even noted an increasing ability to tackle more complex fibroid cases over time, particularly those involving submucosal and deep intramural fibroids.

More recently, we have begun long-term follow-up of our patients. Preliminary pregnancy data show us that women who have undergone a robot-assisted laparoscopic myomectomy in the past 5 years have indeed become pregnant and have carried their pregnancies through with no complications and no uterine ruptures.

A hysterotomy is underway with an EndoWrist cautery hook and Gyrus dissecting forceps.

A fibroid enucleation is facilitated by an EndoWrist tenaculum.

A myometrial defect is repaired with EndoWrist needle drivers and 0-Vicryl suture. Photos courtesy Dr. Arnold Advincula

Robotic Myomectomy: The Time Has Come

In the last edition of the Master Class in gynecology, Dr. Javier Magrina, professor of ob.gyn. and director of female pelvic medicine and reconstructive surgery at the Mayo Clinic in Scottsdale, Ariz., ably described the benefits and technique of robotic-assisted hysterectomy.

In this second installment on robotic-assisted surgery, I have asked Dr. Arnold P. Advincula, clinical associate professor of ob.gyn. at the University of Michigan, Ann Arbor, to discuss robotic-assisted laparoscopic myomectomy.

Other than laparoscopic tubal anastomosis, there is no procedure in minimally invasive gynecologic surgery that is more dependent on the ability to be facile with laparoscopic suturing techniques than laparoscopic myomectomy. Certainly, the physician's need to visualize the repair on a television screen while using limited wrist motion for suture placement limits the vast majority of gynecologists from routinely and effectively performing this procedure.

Dr. Advincula holds several departmental positions at the University of Michigan. He is the director of the minimally invasive surgery and chronic pelvic pain program, the director of the minimally invasive surgery fellowship, and the codirector of the university's endometriosis center. Dr. Advincula is also a member of the board of trustees of the AAGL and is associate editor of the journal The Female Patient, coeditor of the Journal of Robotic Surgery, and a member of the editorial board of the International Journal of Gynecology & Obstetrics.

Dr. Advincula not only is an avid clinical researcher and educator, having published nearly 50 articles in peer-reviewed journals, but also is a fixture on both the national and international lecture circuits on the topic of minimally invasive gynecologic surgery.

Hysterectomy has been a first natural and successful application for robotics in gynecologic and reproductive care, but it is also now clear that robot-assisted laparoscopic myomectomy takes full advantage—even more so—of what robotic technology brings to the table.

Conventional laparoscopic myomectomy has been so challenging that relatively few gynecologic surgeons have been willing and/or able to move away from the traditional open approach for treating symptomatic leiomyomata. Laparotomy thus has remained the standard for myomectomy, leaving many women with a limited number of minimally invasive options if they want to preserve their uterus or fertility, and leaving our health care system shouldering millions of dollars in costs associated with invasive approaches.

It is interesting to note that the total direct cost of treating uterine fibroids in 2000 was estimated at $2.1 billion. Most of the cost, the authors wrote, resulted from inpatient care, particularly hysterectomy (Am. J. Obstet. Gynec. 2006;195:955-64).

With all that robotics offers to us, I believe this is about to change.

The Rationale

Two prospective trials have shown less postoperative morbidity and faster recovery with laparoscopic myomectomy. Yet the endoscopic management of leiomyomata is so technically challenging that the majority of cases are still performed via laparotomy. (Few would challenge the notion, I believe, that it is one of the more challenging procedures in minimally invasive surgery.)

The complexity of dissection and, in particular, the complexity of repair with multilayer-sutured closures present challenges that not only require advanced laparoscopic skills but also are associated with a steep learning curve. These challenges have consistently raised concerns about whether laparoscopy increases conversion rates and whether it can lead to uterine rupture.

There also are longstanding, published limitations placed on the kinds of tumors that can be treated with conventional laparoscopy in order to minimize the risk of conversion to laparotomy. It is often stated that cases involving fibroids greater than or equal to 5 cm, intramural fibroids, an anterior location, and preoperative use of GnRH agonists are too difficult to handle laparoscopically and are likely to increase the conversion rate (Human Reprod. 2001;16:1726-31).

Current robotic technology essentially erases almost all of the limitations of conventional laparoscopy. The features of the technology—improved dexterity and precision of the instruments as well as the three-dimensional imaging—allow the endoscopic approach to be more accurately modeled after (and reflective of) traditional open techniques.

The da Vinci surgical system, which is the only Food and Drug Administration-approved robotic device for use in gynecologic surgery, provides us with a means to overcome the difficulties associated with hysterotomy, enucleation, repair, and extraction that we encounter with the conventional laparoscopic management of fibroids.

The Setup

The da Vinci system comprises a surgeon's console, a vision system that provides three-dimensional imaging through a 12-mm endoscope, and a patientside cart with robotic arms and various EndoWrist instruments.

At the console, the surgeon controls the instruments, the camera, and an energy source, all via a stereoscopic viewer, hand manipulators, and foot pedals. One of the robotic arms holds the endoscope while the other two or three arms hold the instruments.

The instruments come in either 8- or 5-mm sizes and possess 7 degrees of movement, a range that replicates or surpasses the human hand's full range of motion.

Overall, the technique itself for robot-assisted laparoscopic myomectomy does not differ significantly from what is done in conventional laparoscopy, except that the critical steps of hysterotomy, enucleation, and repair are dramatically facilitated while the surgeon adheres to the principles of open surgery.

The bottom line is that robotics affords us the ability to perform the procedure as if it were being done as an open procedure, with the only change being the route of access.

We first place a 12-mm port at or above the umbilicus, depending on the size of the uterus, to accommodate the endoscope and camera arm. As a general rule, I advise leaving at least a handsbreadth distance (approximately 8-10 cm) between the endoscope and the top of an elevated uterus or leiomyoma during bimanual examination, with the patient under anesthesia.

This spacing is important during myomectomy because the enucleation process will result in the leiomyoma projecting out toward the endoscope. By leaving an adequate working space at the beginning, we are able to compensate for a loss of optical working distance and maintain our ability to manipulate our instruments.

We then place an 8-mm port in the left and right lower quadrants, placing them more cephalad and lateral in the case of larger uteri or leiomyomata. These ports will mount directly to the operating robotic arms.

A fourth trocar (a 12- to 15-mm port that will facilitate the introduction of suture as well as instrumentation used for retraction, suction/irrigation, and other tasks of the assistant) can be placed between the camera port and either the left or right lower-quadrant port.

Just as with robotic hysterectomy, a fourth robotic arm can be added for patients who are obese or have a large uterus; this can be used for added retraction of tissues.

The key point to be made about setup is that the ports must be placed far enough away from each other and from the target tissue to avoid instrument-arm collisions.

We recommend that all patients undergo radiologic imaging prior to myomectomy. In our practice, we favor MRI for assessing the size, number, and location of the fibroids as well as for ruling out adenomyosis and for planning the location(s) of the hysterotomy incision. All of this information is particularly helpful given the absence of haptic (tactile) feedback with the robotic approach.

The Technique

Prior to hysterotomy, a dilute concentration of vasopressin is injected into the myometrium surrounding the myoma, as an adjunct for hemostasis. Once adequate blanching is noted, we begin each case with either a bipolar Maryland forceps or Gyrus ACMI Inc.'s PK dissecting forceps on the left arm, and hot shears or a permanent cautery hook (both monopolar devices) on the right arm. Our hysterotomy can be made in either a horizontal or vertical axis because we will be less limited with robotic instruments than we would be in a conventional laparoscopy.

The fibroid can then be enucleated while the bedside assistant provides additional traction/countertraction with a conventional laparoscopic tenaculum or corkscrew. An alternative is to use the fourth robotic arm with an EndoWrist tenaculum. Care must be taken to avoid excessive traction during the enucleation phase in order to maintain hemostasis and to not prematurely avulse the fibroid. Patience is key.

The removed fibroid is placed in the posterior cul-de-sac—or in one of the paracolic gutters if it is larger—for retrieval at the end of the surgery. When we remove multiple and smaller fibroids, it is important to maintain a myoma count. Tagging each of them with long suture can be helpful for retrieval at the end of the case.

At this point, we usually exchange our instruments for a large needle driver on the left arm and a mega needle driver with a high-force grip and integrated cutting mechanism on the right arm. We typically incorporate a multilayer closure for the myometrium, using either interrupted sutures of 0-Vicryl on CT-2 needles cut to 6 inches, or running sutures of 0-Vicryl on CT-2 needles cut to 11 inches.

With the increased articulation and dexterity of our instruments, our ability to repair a defect is affected much less by the orientation of the incisions or the location than it would be in conventional laparoscopy.

To close the uterine serosa, we use a running baseball stitch with 3-0 Vicryl on an SH needle. If multiple fibroids must be removed, we prefer to repair each uterine defect after enucleation before moving on to another tumor. This way, we're taking advantage of the effects of vasopressin at each site. We try to remove as many fibroids as possible through a given hysterotomy.

Before retrieving excised fibroids, the robot-assist device is undocked. Specimens are then retrieved via a tissue morcellator that is placed through the accessory port. Another option is to use the endoscopic port site, but this requires the use of a 5-mm 0-degree laparoscope placed through one of the lateral trocars.

All operative sites are irrigated, hemostasis is ensured under low-pressure settings, and an adhesion barrier is placed over all uterine incisions. We typically apply a slurry of finely chopped Seprafilm as an adhesion barrier (an off-label use).

With robotic myomectomy, as with any of the robotically assisted gynecologic procedures, the importance of the bedside assistant cannot be overestimated. In addition to providing traction/countertraction (we usually don't need to use a fourth robotic arm because our assistants are skilled), the assistant introduces and removes suture, provides irrigation, and manages any accessory port activity (J. Robotic Surg. 2007;1:69-74).

The Patients, the Outcomes

With robotics, there really are not many patients we cannot address. There are no absolute inclusion criteria, and no absolute cutoffs. It's all relative. We determine whether a patient is a candidate for a robotic myomectomy based on the size and mobility of her uterus as well as the size, number, and location of her fibroids.

For example, a patient whose height is 4 feet 10 inches and who is obese with a short truncated torso, a uterus that is not very mobile, and an 8-cm fibroid located over the broad ligament may be a poorer candidate than would a taller patient of average weight with an 8-cm intramural fibroid in a uterus that is extremely mobile. This is where the art of medicine comes into play.

Overall, however, the robotic approach overcomes challenges like obesity, and puts us at a greater advantage as surgeons—giving us an ability to suture more effectively and to approach complex pathology much more aggressively—than does conventional laparoscopy.

It takes some time to get used to the dramatic paradigm shift of operating remotely from the patient through a robotic interface. Learning to overcome the lack of tactile feedback is also part of the learning curve. The key is to not attempt more than you can handle early in the learning process. Then, as your experience grows, your ability to tackle complex gynecologic pathology will come. In other words, start with a symptomatic 4- to 5-cm fundal subserosal fibroid before approaching the 10-cm broad-ligament fibroid.

We started doing robotic myomectomies in 2001. In our first published series of 35 cases, the mean myoma weight was 223.2 g. The mean number of myomas removed was 1.6, and the mean diameter was 7.9 cm. The average estimated blood loss was 169 mL and no blood transfusions were necessary. Three of the cases were converted to laparotomy, two because of the absence of tactile feedback and a third because of cardiogenic shock secondary to vasopressin (J. Am. Assoc. Gynecol. Laparosc. 2004;11:511-8).

Since that early experience, we have not had to convert a patient to a laparotomy secondary to an absence of tactile feedback.

When we later compared surgical outcomes with those of traditional laparotomy through a retrospective case-matched analysis of 58 patients, we found that although operative times were significantly longer in the robotic group (a mean of 231 minutes vs. a mean of 154 minutes), postoperative complication rates were higher in the laparotomy group.

In all, there were 14 postoperative complications in 12 patients in the laparotomy group, including wound dehiscence; hematoma; blood loss and anemia requiring transfusion; and deep vein thrombosis followed by respiratory arrest and renal failure. In the robotic group, there were three postoperative complications: aspiration pneumonia, port-site cellulitis, and chest pain.

Estimated blood loss was significantly higher in the laparotomy group than in the robotic group (a mean of 365 mL v. 196 mL), and transfusions were required in two patients who underwent laparotomy. Length of stay was also higher: 3.6 days in the laparotomy group, compared with 1.5 days in the robotic group. (J. Min. Invasive Gynecol. 2007;14:698-705).

We have also analyzed the effects of our experience over time and have presented these data at the AAGL annual meeting in November 2007. We found a notable trend toward both lower blood loss and shorter operative time with experience. Additionally, we evolved from an average length of stay of 1.5 days to a completely outpatient procedure. We even noted an increasing ability to tackle more complex fibroid cases over time, particularly those involving submucosal and deep intramural fibroids.

More recently, we have begun long-term follow-up of our patients. Preliminary pregnancy data show us that women who have undergone a robot-assisted laparoscopic myomectomy in the past 5 years have indeed become pregnant and have carried their pregnancies through with no complications and no uterine ruptures.

A hysterotomy is underway with an EndoWrist cautery hook and Gyrus dissecting forceps.

A fibroid enucleation is facilitated by an EndoWrist tenaculum.

A myometrial defect is repaired with EndoWrist needle drivers and 0-Vicryl suture. Photos courtesy Dr. Arnold Advincula

Robotic Myomectomy: The Time Has Come

In the last edition of the Master Class in gynecology, Dr. Javier Magrina, professor of ob.gyn. and director of female pelvic medicine and reconstructive surgery at the Mayo Clinic in Scottsdale, Ariz., ably described the benefits and technique of robotic-assisted hysterectomy.

In this second installment on robotic-assisted surgery, I have asked Dr. Arnold P. Advincula, clinical associate professor of ob.gyn. at the University of Michigan, Ann Arbor, to discuss robotic-assisted laparoscopic myomectomy.

Other than laparoscopic tubal anastomosis, there is no procedure in minimally invasive gynecologic surgery that is more dependent on the ability to be facile with laparoscopic suturing techniques than laparoscopic myomectomy. Certainly, the physician's need to visualize the repair on a television screen while using limited wrist motion for suture placement limits the vast majority of gynecologists from routinely and effectively performing this procedure.

Dr. Advincula holds several departmental positions at the University of Michigan. He is the director of the minimally invasive surgery and chronic pelvic pain program, the director of the minimally invasive surgery fellowship, and the codirector of the university's endometriosis center. Dr. Advincula is also a member of the board of trustees of the AAGL and is associate editor of the journal The Female Patient, coeditor of the Journal of Robotic Surgery, and a member of the editorial board of the International Journal of Gynecology & Obstetrics.

Dr. Advincula not only is an avid clinical researcher and educator, having published nearly 50 articles in peer-reviewed journals, but also is a fixture on both the national and international lecture circuits on the topic of minimally invasive gynecologic surgery.

Hysterectomy has been a first natural and successful application for robotics in gynecologic and reproductive care, but it is also now clear that robot-assisted laparoscopic myomectomy takes full advantage—even more so—of what robotic technology brings to the table.

Conventional laparoscopic myomectomy has been so challenging that relatively few gynecologic surgeons have been willing and/or able to move away from the traditional open approach for treating symptomatic leiomyomata. Laparotomy thus has remained the standard for myomectomy, leaving many women with a limited number of minimally invasive options if they want to preserve their uterus or fertility, and leaving our health care system shouldering millions of dollars in costs associated with invasive approaches.

It is interesting to note that the total direct cost of treating uterine fibroids in 2000 was estimated at $2.1 billion. Most of the cost, the authors wrote, resulted from inpatient care, particularly hysterectomy (Am. J. Obstet. Gynec. 2006;195:955-64).

With all that robotics offers to us, I believe this is about to change.

The Rationale

Two prospective trials have shown less postoperative morbidity and faster recovery with laparoscopic myomectomy. Yet the endoscopic management of leiomyomata is so technically challenging that the majority of cases are still performed via laparotomy. (Few would challenge the notion, I believe, that it is one of the more challenging procedures in minimally invasive surgery.)

The complexity of dissection and, in particular, the complexity of repair with multilayer-sutured closures present challenges that not only require advanced laparoscopic skills but also are associated with a steep learning curve. These challenges have consistently raised concerns about whether laparoscopy increases conversion rates and whether it can lead to uterine rupture.

There also are longstanding, published limitations placed on the kinds of tumors that can be treated with conventional laparoscopy in order to minimize the risk of conversion to laparotomy. It is often stated that cases involving fibroids greater than or equal to 5 cm, intramural fibroids, an anterior location, and preoperative use of GnRH agonists are too difficult to handle laparoscopically and are likely to increase the conversion rate (Human Reprod. 2001;16:1726-31).

Current robotic technology essentially erases almost all of the limitations of conventional laparoscopy. The features of the technology—improved dexterity and precision of the instruments as well as the three-dimensional imaging—allow the endoscopic approach to be more accurately modeled after (and reflective of) traditional open techniques.

The da Vinci surgical system, which is the only Food and Drug Administration-approved robotic device for use in gynecologic surgery, provides us with a means to overcome the difficulties associated with hysterotomy, enucleation, repair, and extraction that we encounter with the conventional laparoscopic management of fibroids.

The Setup

The da Vinci system comprises a surgeon's console, a vision system that provides three-dimensional imaging through a 12-mm endoscope, and a patientside cart with robotic arms and various EndoWrist instruments.

At the console, the surgeon controls the instruments, the camera, and an energy source, all via a stereoscopic viewer, hand manipulators, and foot pedals. One of the robotic arms holds the endoscope while the other two or three arms hold the instruments.

The instruments come in either 8- or 5-mm sizes and possess 7 degrees of movement, a range that replicates or surpasses the human hand's full range of motion.

Overall, the technique itself for robot-assisted laparoscopic myomectomy does not differ significantly from what is done in conventional laparoscopy, except that the critical steps of hysterotomy, enucleation, and repair are dramatically facilitated while the surgeon adheres to the principles of open surgery.

The bottom line is that robotics affords us the ability to perform the procedure as if it were being done as an open procedure, with the only change being the route of access.

We first place a 12-mm port at or above the umbilicus, depending on the size of the uterus, to accommodate the endoscope and camera arm. As a general rule, I advise leaving at least a handsbreadth distance (approximately 8-10 cm) between the endoscope and the top of an elevated uterus or leiomyoma during bimanual examination, with the patient under anesthesia.

This spacing is important during myomectomy because the enucleation process will result in the leiomyoma projecting out toward the endoscope. By leaving an adequate working space at the beginning, we are able to compensate for a loss of optical working distance and maintain our ability to manipulate our instruments.

We then place an 8-mm port in the left and right lower quadrants, placing them more cephalad and lateral in the case of larger uteri or leiomyomata. These ports will mount directly to the operating robotic arms.

A fourth trocar (a 12- to 15-mm port that will facilitate the introduction of suture as well as instrumentation used for retraction, suction/irrigation, and other tasks of the assistant) can be placed between the camera port and either the left or right lower-quadrant port.

Just as with robotic hysterectomy, a fourth robotic arm can be added for patients who are obese or have a large uterus; this can be used for added retraction of tissues.

The key point to be made about setup is that the ports must be placed far enough away from each other and from the target tissue to avoid instrument-arm collisions.

We recommend that all patients undergo radiologic imaging prior to myomectomy. In our practice, we favor MRI for assessing the size, number, and location of the fibroids as well as for ruling out adenomyosis and for planning the location(s) of the hysterotomy incision. All of this information is particularly helpful given the absence of haptic (tactile) feedback with the robotic approach.

The Technique

Prior to hysterotomy, a dilute concentration of vasopressin is injected into the myometrium surrounding the myoma, as an adjunct for hemostasis. Once adequate blanching is noted, we begin each case with either a bipolar Maryland forceps or Gyrus ACMI Inc.'s PK dissecting forceps on the left arm, and hot shears or a permanent cautery hook (both monopolar devices) on the right arm. Our hysterotomy can be made in either a horizontal or vertical axis because we will be less limited with robotic instruments than we would be in a conventional laparoscopy.

The fibroid can then be enucleated while the bedside assistant provides additional traction/countertraction with a conventional laparoscopic tenaculum or corkscrew. An alternative is to use the fourth robotic arm with an EndoWrist tenaculum. Care must be taken to avoid excessive traction during the enucleation phase in order to maintain hemostasis and to not prematurely avulse the fibroid. Patience is key.

The removed fibroid is placed in the posterior cul-de-sac—or in one of the paracolic gutters if it is larger—for retrieval at the end of the surgery. When we remove multiple and smaller fibroids, it is important to maintain a myoma count. Tagging each of them with long suture can be helpful for retrieval at the end of the case.

At this point, we usually exchange our instruments for a large needle driver on the left arm and a mega needle driver with a high-force grip and integrated cutting mechanism on the right arm. We typically incorporate a multilayer closure for the myometrium, using either interrupted sutures of 0-Vicryl on CT-2 needles cut to 6 inches, or running sutures of 0-Vicryl on CT-2 needles cut to 11 inches.

With the increased articulation and dexterity of our instruments, our ability to repair a defect is affected much less by the orientation of the incisions or the location than it would be in conventional laparoscopy.

To close the uterine serosa, we use a running baseball stitch with 3-0 Vicryl on an SH needle. If multiple fibroids must be removed, we prefer to repair each uterine defect after enucleation before moving on to another tumor. This way, we're taking advantage of the effects of vasopressin at each site. We try to remove as many fibroids as possible through a given hysterotomy.

Before retrieving excised fibroids, the robot-assist device is undocked. Specimens are then retrieved via a tissue morcellator that is placed through the accessory port. Another option is to use the endoscopic port site, but this requires the use of a 5-mm 0-degree laparoscope placed through one of the lateral trocars.

All operative sites are irrigated, hemostasis is ensured under low-pressure settings, and an adhesion barrier is placed over all uterine incisions. We typically apply a slurry of finely chopped Seprafilm as an adhesion barrier (an off-label use).

With robotic myomectomy, as with any of the robotically assisted gynecologic procedures, the importance of the bedside assistant cannot be overestimated. In addition to providing traction/countertraction (we usually don't need to use a fourth robotic arm because our assistants are skilled), the assistant introduces and removes suture, provides irrigation, and manages any accessory port activity (J. Robotic Surg. 2007;1:69-74).

The Patients, the Outcomes

With robotics, there really are not many patients we cannot address. There are no absolute inclusion criteria, and no absolute cutoffs. It's all relative. We determine whether a patient is a candidate for a robotic myomectomy based on the size and mobility of her uterus as well as the size, number, and location of her fibroids.

For example, a patient whose height is 4 feet 10 inches and who is obese with a short truncated torso, a uterus that is not very mobile, and an 8-cm fibroid located over the broad ligament may be a poorer candidate than would a taller patient of average weight with an 8-cm intramural fibroid in a uterus that is extremely mobile. This is where the art of medicine comes into play.

Overall, however, the robotic approach overcomes challenges like obesity, and puts us at a greater advantage as surgeons—giving us an ability to suture more effectively and to approach complex pathology much more aggressively—than does conventional laparoscopy.

It takes some time to get used to the dramatic paradigm shift of operating remotely from the patient through a robotic interface. Learning to overcome the lack of tactile feedback is also part of the learning curve. The key is to not attempt more than you can handle early in the learning process. Then, as your experience grows, your ability to tackle complex gynecologic pathology will come. In other words, start with a symptomatic 4- to 5-cm fundal subserosal fibroid before approaching the 10-cm broad-ligament fibroid.

We started doing robotic myomectomies in 2001. In our first published series of 35 cases, the mean myoma weight was 223.2 g. The mean number of myomas removed was 1.6, and the mean diameter was 7.9 cm. The average estimated blood loss was 169 mL and no blood transfusions were necessary. Three of the cases were converted to laparotomy, two because of the absence of tactile feedback and a third because of cardiogenic shock secondary to vasopressin (J. Am. Assoc. Gynecol. Laparosc. 2004;11:511-8).

Since that early experience, we have not had to convert a patient to a laparotomy secondary to an absence of tactile feedback.

When we later compared surgical outcomes with those of traditional laparotomy through a retrospective case-matched analysis of 58 patients, we found that although operative times were significantly longer in the robotic group (a mean of 231 minutes vs. a mean of 154 minutes), postoperative complication rates were higher in the laparotomy group.

In all, there were 14 postoperative complications in 12 patients in the laparotomy group, including wound dehiscence; hematoma; blood loss and anemia requiring transfusion; and deep vein thrombosis followed by respiratory arrest and renal failure. In the robotic group, there were three postoperative complications: aspiration pneumonia, port-site cellulitis, and chest pain.

Estimated blood loss was significantly higher in the laparotomy group than in the robotic group (a mean of 365 mL v. 196 mL), and transfusions were required in two patients who underwent laparotomy. Length of stay was also higher: 3.6 days in the laparotomy group, compared with 1.5 days in the robotic group. (J. Min. Invasive Gynecol. 2007;14:698-705).

We have also analyzed the effects of our experience over time and have presented these data at the AAGL annual meeting in November 2007. We found a notable trend toward both lower blood loss and shorter operative time with experience. Additionally, we evolved from an average length of stay of 1.5 days to a completely outpatient procedure. We even noted an increasing ability to tackle more complex fibroid cases over time, particularly those involving submucosal and deep intramural fibroids.

More recently, we have begun long-term follow-up of our patients. Preliminary pregnancy data show us that women who have undergone a robot-assisted laparoscopic myomectomy in the past 5 years have indeed become pregnant and have carried their pregnancies through with no complications and no uterine ruptures.

A hysterotomy is underway with an EndoWrist cautery hook and Gyrus dissecting forceps.

A fibroid enucleation is facilitated by an EndoWrist tenaculum.

A myometrial defect is repaired with EndoWrist needle drivers and 0-Vicryl suture. Photos courtesy Dr. Arnold Advincula

Robotic Myomectomy: The Time Has Come

In the last edition of the Master Class in gynecology, Dr. Javier Magrina, professor of ob.gyn. and director of female pelvic medicine and reconstructive surgery at the Mayo Clinic in Scottsdale, Ariz., ably described the benefits and technique of robotic-assisted hysterectomy.

In this second installment on robotic-assisted surgery, I have asked Dr. Arnold P. Advincula, clinical associate professor of ob.gyn. at the University of Michigan, Ann Arbor, to discuss robotic-assisted laparoscopic myomectomy.

Other than laparoscopic tubal anastomosis, there is no procedure in minimally invasive gynecologic surgery that is more dependent on the ability to be facile with laparoscopic suturing techniques than laparoscopic myomectomy. Certainly, the physician's need to visualize the repair on a television screen while using limited wrist motion for suture placement limits the vast majority of gynecologists from routinely and effectively performing this procedure.

Dr. Advincula holds several departmental positions at the University of Michigan. He is the director of the minimally invasive surgery and chronic pelvic pain program, the director of the minimally invasive surgery fellowship, and the codirector of the university's endometriosis center. Dr. Advincula is also a member of the board of trustees of the AAGL and is associate editor of the journal The Female Patient, coeditor of the Journal of Robotic Surgery, and a member of the editorial board of the International Journal of Gynecology & Obstetrics.

Dr. Advincula not only is an avid clinical researcher and educator, having published nearly 50 articles in peer-reviewed journals, but also is a fixture on both the national and international lecture circuits on the topic of minimally invasive gynecologic surgery.

Preeclampsia is one of the most challenging and high-risk conditions that obstetric specialists will confront in their clinical practices.

This condition continues to be a vexing problem because the etiology remains evasive, not only in its onset, but often in its manifestations and complications as well.

Patients who develop preeclampsia fall into three categories. One subset of patients develops preeclampsia that remains mild and does not cause any major complications. Another subset develops a more advanced preeclampsia with some complications that are usually manageable, often without grave risk to the pregnancy.

The third subset of patients develops a severe form of preeclampsia based on precise, defined criteria. This form of preeclampsia may present in premature pregnancies, where the condition creates the greatest challenge and raises a clinical conundrum: Is it best to deliver the patient, or to embrace expectant management?

Because the severe form of preeclampsia is such a difficult problem and the outcome of the pregnancy hinges on the clinician's choice of the right approach, we thought it was important to dedicate a Master Class to the management of these high-risk patients.

I have invited Dr. Baha M. Sibai, an international expert on preeclampsia and eclampsia and a world leader in both clinical care and research in this field, to provide a thorough discussion of this difficult topic.

Dr. Sibai is professor of obstetrics and gynecology at the University of Cincinnati and has contributed to more than 350 studies in peer-reviewed journals on the subject of preeclampsia and eclampsia.

Preeclampsia is one of the most challenging and high-risk conditions that obstetric specialists will confront in their clinical practices.

This condition continues to be a vexing problem because the etiology remains evasive, not only in its onset, but often in its manifestations and complications as well.

Patients who develop preeclampsia fall into three categories. One subset of patients develops preeclampsia that remains mild and does not cause any major complications. Another subset develops a more advanced preeclampsia with some complications that are usually manageable, often without grave risk to the pregnancy.

The third subset of patients develops a severe form of preeclampsia based on precise, defined criteria. This form of preeclampsia may present in premature pregnancies, where the condition creates the greatest challenge and raises a clinical conundrum: Is it best to deliver the patient, or to embrace expectant management?

Because the severe form of preeclampsia is such a difficult problem and the outcome of the pregnancy hinges on the clinician's choice of the right approach, we thought it was important to dedicate a Master Class to the management of these high-risk patients.

I have invited Dr. Baha M. Sibai, an international expert on preeclampsia and eclampsia and a world leader in both clinical care and research in this field, to provide a thorough discussion of this difficult topic.

Dr. Sibai is professor of obstetrics and gynecology at the University of Cincinnati and has contributed to more than 350 studies in peer-reviewed journals on the subject of preeclampsia and eclampsia.

Preeclampsia is one of the most challenging and high-risk conditions that obstetric specialists will confront in their clinical practices.

This condition continues to be a vexing problem because the etiology remains evasive, not only in its onset, but often in its manifestations and complications as well.

Patients who develop preeclampsia fall into three categories. One subset of patients develops preeclampsia that remains mild and does not cause any major complications. Another subset develops a more advanced preeclampsia with some complications that are usually manageable, often without grave risk to the pregnancy.

The third subset of patients develops a severe form of preeclampsia based on precise, defined criteria. This form of preeclampsia may present in premature pregnancies, where the condition creates the greatest challenge and raises a clinical conundrum: Is it best to deliver the patient, or to embrace expectant management?

Because the severe form of preeclampsia is such a difficult problem and the outcome of the pregnancy hinges on the clinician's choice of the right approach, we thought it was important to dedicate a Master Class to the management of these high-risk patients.

I have invited Dr. Baha M. Sibai, an international expert on preeclampsia and eclampsia and a world leader in both clinical care and research in this field, to provide a thorough discussion of this difficult topic.

Dr. Sibai is professor of obstetrics and gynecology at the University of Cincinnati and has contributed to more than 350 studies in peer-reviewed journals on the subject of preeclampsia and eclampsia.

Since the first published report of a robotic hysterectomy appeared in 2001, we have gained enough experience to know that next to vaginal hysterectomy, which I believe is still the preferred approach whenever possible, the robotic approach is the next-best technique that gynecologic surgeons can offer patients.

The robotic system we use today—the da Vinci surgical system—was designed to overcome the surgical limitations of conventional laparoscopy. Indeed, it has.

My colleagues and I at the Mayo Clinic, and others elsewhere, have seen similar operating times, reduced blood loss, and shorter hospitalization for both simple and radical hysterectomies as compared with the laparotomy approach. We have experienced firsthand the increased accuracy and precision that robotics promised. Suturing is easier with robotics than with laparoscopy. The advantages of robotics—from instrument articulation to the steady three-dimensional vision—have been more than expected, surpassing the advantages of conventional laparoscopy. Our operating time for robotic radical hysterectomy, in fact, is significantly shorter than that of laparoscopy.

The learning curve for performing robotic hysterectomy, moreover, seems surprisingly short. In a case-series analysis of robotic simple hysterectomies, we found it interesting that the time spent in the operating room flattened after 20-25 cases.

A prospective, randomized study comparing robotic hysterectomy with conventional laparoscopic surgery should be completed at the Mayo Clinic by the end of this year. In the meantime, robotic hysterectomy is generally offered to patients at Mayo as an alternative whenever a laparoscopic hysterectomy is being considered.

Patients are beginning to ask for it, and indeed, there are instances when we strongly prefer the robotic approach regardless of patient demand—for example, when patients have a history of adhesions, advanced endometriosis, gynecologic cancer, or genitourinary fistula, or when we have to perform pelvic floor repair procedures or other additional procedures that require extensive suturing. Obesity is an excellent application for robotic technology, which is something we have learned as our operating time has not been influenced by a patient's body mass index.

Evolution of Robotics

We started performing hysterectomies with the Zeus MicroWrist surgical system in 2003. The system, which was approved by the Food and Drug Administration in 2002 for general and laparoscopic surgery, enabled the surgeon to operate three robotic arms while sitting a distance away from the operating table.

This Zeus system was an advance over the Aesop robotic device, a voice-activated robotic arm designed to operate the laparoscope. Released in 1994, Aesop was the first robotic system approved to assist in laparoscopic procedures. With Aesop, the surgeon would direct the robotic movement of the laparoscope through voice commands while working manually with regular instruments. Video quality thus improved, and the need for an assistant was obviated when only two instruments were needed.

With the development of the Zeus system, surgeons gained two more robotic arms (in addition to the laparoscope-operating arm) as well as some of the other advantages afforded by robotics, such as articulating tips and a downscaling of movement.

The da Vinci surgical system that we use currently is an improvement over Zeus. It was originally approved for procedures in the abdominal and pelvic cavity, but in 2005 it received special approval for the performance of robotic hysterectomy. At this point, because of various changes in the industry's structure, it is the only robotic system manufactured for laparoscopic procedures.

In an evolution that reflects likely future changes as well, a second generation of the da Vinci system, released in 2006, has longer instruments, lighter arms, and increased flexion-extension and lateral excursion, among other improvements.

Instrumentation and Process

We now refer to the approach as “robotic” hysterectomy rather than “robotic-assisted” laparoscopic hysterectomy because—although a surgical assistant is still needed for several key functions, such as suction and irrigation—the procedure is, with these latest advancements, largely robotic in nature.

With most hysterectomies, as with most pelvic operations, four trocar sites are used: three for the robotic arms (one of which is for the laparoscope) and one for the assistant, who will manually perform suction, irrigation, vessel sealing, tissue retraction, and specimen retrieval. When we have a patient with cancer, obesity, a large uterus, advanced endometriosis, or adhesions, we add a fourth robotic arm. This additional arm allows for the added retraction of tissues.

We use the open Hasson technique to place a 12-mm robotic trocar (the first of the three main trocars) in the umbilical area for the laparoscope. Two 8-mm robotic trocars are then placed bilaterally, 10 cm to the right and left of the umbilicus. This placement provides an operative field that extends, in most patients, from the lower pelvis up to the inferior mesenteric artery.

For the assistant, a 10-mm trocar is placed 3 cm cranial and right between the umbilicus and the left robotic trocar. Through this port, the assistant performs the functions that are not yet available robotically: vessel sealing, suction, irrigation, tissue retraction, specimen retrieval, and the introduction and retrieval of sutures and needles. When a fourth robotic arm is used, that trocar is placed 10 cm lateral and 10 cm caudal to the right robotic trocar.

The robotic tower with three arms is situated between the patient's legs. We have noticed that if the column is parked very close to the patient's perineum, there is inadequate space for the scrub nurse to mobilize and manipulate a vaginal probe, maintain the pneumoperitoneum during vaginal incision, and retrieve specimens vaginally. Ideally, the robotic column should rest at about the level of the patient's feet and not any closer.

The middle robotic arm is attached to the umbilical trocar where the laparoscope has been inserted. A monopolar spatula, or scissors, is inserted through the right lateral trocar, and a plasma-kinetic dissecting forceps is inserted through the left lateral trocar. When needed for suturing, a needle-holder replaces the spatula. When a fourth robotic arm is needed, a robotic instrument called a Prograsp is used.

The surgeon sits, unscrubbed, on a console that in our operating suite is about 12 feet away from the patient. Here the surgeon can manipulate the robotic arms that maneuver the instruments and the laparoscopic camera, as well as communicate verbally with the assistant. When the surgeon is playing the role of assistant and the trainee is at the console, the surgeon can direct the trainee by means of telestration to pinpoint anatomical structures and planes of dissection, or to indicate areas of potential visceral damage by drawing circles, arrows, or dots.

When the ovaries are to be removed, which in our practice is more common than not, our first step with robotic simple hysterectomy is to incise the pelvic peritoneum at the level of the pelvic brim to identify the ureters and the points at which they cross the ovarian vessels. We then coagulate and divide the infundibulopelvic ligament that contains the ovarian vessels.

The ureters are then traced and followed to the point where they cross the uterine arteries. Because we cannot palpate the tissues in robotic surgery and therefore need to see, we dissect the ureters anytime they appear close to the cervix or if there is parametrial pathology. Doing so prevents injury.

After this, the bladder must be dissected from the cervix and upper vagina, and at least 2 cm caudal to the anterior vaginal fornix. A vaginal probe that is inserted into the vagina by the scrub nurse is used to identify where the vagina joins the cervix and to define the level of incision on the vagina.

A vessel-sealing device is used to coagulate and transect the uterine arteries and the cardinal ligaments. At that point—and not any sooner—the vagina is transected immediately distal to the cervix and the uterus is detached and removed, along with the ovaries in most cases, through the vaginal opening. (When the ovaries are not removed, they are left attached to the ipsilateral round ligament.) The scrub nurse holds the labia majora to the midline over the surgical instrument used to remove the uterus, and that is enough to maintain the pneumoperitoneum.

Inflation of a sterile occluding balloon with 60 mL of saline is used to maintain the pneumoperitoneum after removal of the specimen vaginally.

The right monopolar spatula is then removed and replaced with a needle-holder, and the vaginal cuff is closed with a 15-cm precut 0 continuous polyglyconate absorbable suture starting at the right angle and going toward the midline. A similar 15-cm suture is applied from the left to the midline until it meets the other suture. The uterosacral ligaments are incorporated at each vaginal angle and at the midline in order to support the vagina. We use a LapraTy suture clip at each end of the sutures to eliminate the need for intracorporeal knot tying.

Using these small precut sutures is most helpful. A suture that is 30 cm long simply takes too long to pull through the tissues. In general, the use of smaller, shorter sutures is essential in robotic surgery.

For robotic hysterectomies as well as any other robotic gynecologic surgery, I also advise using slow, deliberate, precise movements. Such pacing alleviates the risk of bleeding, which dramatically slows the procedure down when it occurs.

At the end of the procedure, the robotic arms are disengaged from the trocars, the robotic column is moved away, and the fascia at the umbilical site is closed. The other trocar sites require closure of only the skin. We always perform a cystoscopy after injection of intravenous indigo carmine to ensure that there are bilateral ureteral jets and no injury to the bladder.

When we plan to send the patient home on the day of the robotic hysterectomy—something we started doing when we observed how well patients were faring with this approach—we modify the anesthesia regimen somewhat.

We give each patient dexamethasone preoperatively, apply an antinausea patch behind her ear, and administer two additional medications to prevent nausea: Zofran (ondansetron) and aprepitant. Then, at the end of the hysterectomy, we inject both the right and the left pelvic plexus (sympathetic and parasympathetic) with a cocktail of morphine, vasopressin, and Marcaine (bupivacaine). We also infiltrate the trocar sites with Marcaine, and before the patient is awakened from anesthesia, we administer intravenous ketorolac. When she is awake, the patient will then have minimal discomfort.

Additionally, normal saline (200 mL) is left in the bladder at the end of the cystoscopy so that the patient will have the urge to empty her bladder in the next hour rather than the need to wait up to 5 hours to empty her bladder before being able to go home.

In our preoperative discussions with patients, we do inform them that the incisions are placed a little higher than with conventional laparoscopy. Only once has one of our patients expressed cosmetic concern and opted for a laparoscopic approach with suprapubic trocar placement.

Hysterectomy has been a natural beginning application for robotic technology in gynecologic surgery. Experience with the approach has applications, in turn, for other gynecologic procedures because the same instrumentation and usually the same port placement are used.

Patient Outcomes

In a series of 91 consecutive patients who underwent robotic simple hysterectomy at Mayo (with or without salpingo-oophorectomy or concomitant appendectomy) between March 2004 and December 2005, we had no conversions to conventional laparoscopy or laparotomy, no bladder or ureteral injuries, and few intraoperative and postoperative complications (Am. J. Obstet. Gynecol. 2007;197:113.e1-4).

Our one intraoperative complication was an enterotomy that was repaired robotically in a patient with extensive pelvic adhesions. (We have learned that complications can be repaired robotically without having to convert to laparotomy.)

Postoperatively, one patient with cardiomyopathy required admission to intensive care for 24 hours for exacerbation of heart failure, and another patient required admission for vaginal cuff abscess. Three patients were readmitted for ileus, pneumonia, and colitis. The mean estimated blood loss was 79 mL, and the mean hospital stay was 1.3 days. (Indications in the patients, whose mean age was 50 years, included menometrorrhagia in 43% and ovarian neoplasm in 20%.)

In the evaluation of robotic surgery and analysis of the experience, it is important to break down the total process into several components: docking time (the time required to attach the robotic arms to the trocars), console time (the surgeon's time dedicated exclusively to performing the hysterectomy), and total operating time (from incision to closure).

For surgeons who haven't used the robotic system, a common misperception is that it takes a long time to set up for each procedure. In our series, however, the mean docking time was only 2.9 minutes.

The mean console time was 79 minutes, and the total mean operating time was 122 minutes, which was 14 minutes shorter than conventional laparoscopy. A mean of 43 minutes was required for setup and close, which included trocar placement, exploration, and the removal of trocars, closure, and cystoscopy. (The time for setup and close has not been reported before in laparoscopic surgery.)

Our surgical time was minimized by having a dedicated robotic team and by using certain surgical strategies, such as the use of only three instruments (monopolar spatula, bipolar grasper, and needle-holder) for the entire procedure—a practice that also reduces cost—and the use of precut, short sutures and suture clips. The optimal robotic team can comprise two surgeons or one surgeon and one assistant, as well as at least two nurses who are well versed in the robotic instrumentation and system. The assistant also plays a major role in fixing any malfunctions of the robotic instruments or arms, and in switching robotic instruments.

Console time clearly decreased over time as we performed more simple hysterectomies. It was not significantly affected by the performance of an appendectomy, but it was affected by uterine weight and the lysis of adhesions. In our practice, we prefer a vaginal approach for the larger uterus that requires more morcellation. In general, our threshold for the robotic approach is a uterus of 12-14 weeks' gestational size.

All of these findings—from reduced operating times to shorter hospitalizations and fewer complications—have applied to our experience with robotic radical hysterectomy as well. In one analysis of 16 patients undergoing robotic radical hysterectomy, we found that total operating time was 66 minutes shorter than it had been for laparoscopic radical hysterectomy.

An increased body mass index did not prolong operating times in any of our patient groups. In fact, we have noticed that for patients who are obese, surgical time is longer with laparoscopy than with robotics. This reflects one of the advantages of the robotic approach: It bypasses the fulcrum effect, which is inherent to conventional laparoscopy and which is especially challenging in patients with a thick abdominal wall. Surgeons using the articulated instrumentation of a robotic system will use the same manual effort regardless of how thick the abdominal wall is.

The lack of tactile feedback is viewed by some as a limitation of robotics, but after a short time of practice, it is easily compensated for by the depth of perception that three-dimensional vision affords.

In addition, the articulation of the instruments facilitates dissection of the tissues and suturing, such as closure of the vaginal cuff in hysterectomies. And as with other gynecologic surgeries, the downscaling of the surgeon's movements in a 3:1 or 5:1 ratio leads to increased accuracy and precision. (In such downscaling, when the surgeon's hand moves 3 cm or 5 cm, the tip of the instrument moves only 1 cm.)

We still believe that when the hysterectomy can be performed vaginally, the vaginal approach is preferable to robotics or to laparoscopy. This is because any study that has compared vaginal hysterectomy with another approach has demonstrated a faster operating time with the vaginal procedure, as well as lower cost.

When a patient is not a candidate for a vaginal hysterectomy, or when the gynecologist is not comfortable with the approach, however, then the robotic approach is indeed preferable to conventional laparoscopy.

Four robotic trocars are placed in preparation for pelvic surgery with the da Vinci robotic system.

The da Vinci robotic system is shown in operation, with the assistant sitting to the left of the patient.

The Zeus robotic system consists of two working arms and another to hold the laparoscope. Photos courtesy Dr. Javier Magrina

Robotics: Enabling Technology for the Gyn.

The first proponents of robotics in surgery were the cardiac surgeons, but it was the urologists who truly popularized robotic surgery. Hospitals around the country have purchased the da Vinci surgical system mainly for urologists who wanted to perform robot-assisted radical prostatectomies. Interestingly enough, the robot has enabled physicians who were virtually untrained in laparoscopic surgery to feel comfortable with a laparoscopic approach.

Even though gynecologists were the first surgical specialists to perform laparoscopic surgery on a routine basis, the acceptance of minimally invasive gynecologic surgery within our specialty remains dismally low. In a recent study submitted to the National Women's Health Resource Center by the Lewin Group, only 15% of more than 600,000 hysterectomies performed per annum in the United States are accomplished via a minimally invasive technique. This is especially sobering when one considers that 80% of the cholecystectomies are performed laparoscopically.

Given the above, it is interesting to speculate on the potential impact of robotic surgery in gynecology. Initially, it appears that gynecologists who were not previously performing advanced minimally invasive surgery are able to do so with this enabling technology.

I have put together a minisymposium on robotic surgery in gynecology that will be covered in the next four issues. With my esteemed faculty, I will discuss the topics of robotic-assisted laparoscopic hysterectomy, robotic-assisted laparoscopic myomectomy, robotic-assisted laparoscopic sacrocolpopexy, and robotic-assisted node dissection.

The first author is Dr. Javier Magrina, head of the division of gynecologic oncology, director of female pelvic medicine and reconstructive surgery, and professor of obstetrics and gynecology at the Mayo Clinic, Scottsdale, Ariz.

Dr. Magrina has written extensively and lectured throughout the world on robotic surgery, from a standpoint of both benign as well as malignant disease. For the past 2 years, he has served on the board of trustees of the AAGL and remains very active in the Society of Gynecologic Oncologists and the Society of Laparoendoscopic Surgeons.

It is a pleasure to have Dr. Magrina as the author of our Master Class in Gynecologic Surgery on robotic-assisted laparoscopic hysterectomy.

Since the first published report of a robotic hysterectomy appeared in 2001, we have gained enough experience to know that next to vaginal hysterectomy, which I believe is still the preferred approach whenever possible, the robotic approach is the next-best technique that gynecologic surgeons can offer patients.

The robotic system we use today—the da Vinci surgical system—was designed to overcome the surgical limitations of conventional laparoscopy. Indeed, it has.

My colleagues and I at the Mayo Clinic, and others elsewhere, have seen similar operating times, reduced blood loss, and shorter hospitalization for both simple and radical hysterectomies as compared with the laparotomy approach. We have experienced firsthand the increased accuracy and precision that robotics promised. Suturing is easier with robotics than with laparoscopy. The advantages of robotics—from instrument articulation to the steady three-dimensional vision—have been more than expected, surpassing the advantages of conventional laparoscopy. Our operating time for robotic radical hysterectomy, in fact, is significantly shorter than that of laparoscopy.

The learning curve for performing robotic hysterectomy, moreover, seems surprisingly short. In a case-series analysis of robotic simple hysterectomies, we found it interesting that the time spent in the operating room flattened after 20-25 cases.

A prospective, randomized study comparing robotic hysterectomy with conventional laparoscopic surgery should be completed at the Mayo Clinic by the end of this year. In the meantime, robotic hysterectomy is generally offered to patients at Mayo as an alternative whenever a laparoscopic hysterectomy is being considered.

Patients are beginning to ask for it, and indeed, there are instances when we strongly prefer the robotic approach regardless of patient demand—for example, when patients have a history of adhesions, advanced endometriosis, gynecologic cancer, or genitourinary fistula, or when we have to perform pelvic floor repair procedures or other additional procedures that require extensive suturing. Obesity is an excellent application for robotic technology, which is something we have learned as our operating time has not been influenced by a patient's body mass index.

Evolution of Robotics

We started performing hysterectomies with the Zeus MicroWrist surgical system in 2003. The system, which was approved by the Food and Drug Administration in 2002 for general and laparoscopic surgery, enabled the surgeon to operate three robotic arms while sitting a distance away from the operating table.

This Zeus system was an advance over the Aesop robotic device, a voice-activated robotic arm designed to operate the laparoscope. Released in 1994, Aesop was the first robotic system approved to assist in laparoscopic procedures. With Aesop, the surgeon would direct the robotic movement of the laparoscope through voice commands while working manually with regular instruments. Video quality thus improved, and the need for an assistant was obviated when only two instruments were needed.

With the development of the Zeus system, surgeons gained two more robotic arms (in addition to the laparoscope-operating arm) as well as some of the other advantages afforded by robotics, such as articulating tips and a downscaling of movement.

The da Vinci surgical system that we use currently is an improvement over Zeus. It was originally approved for procedures in the abdominal and pelvic cavity, but in 2005 it received special approval for the performance of robotic hysterectomy. At this point, because of various changes in the industry's structure, it is the only robotic system manufactured for laparoscopic procedures.

In an evolution that reflects likely future changes as well, a second generation of the da Vinci system, released in 2006, has longer instruments, lighter arms, and increased flexion-extension and lateral excursion, among other improvements.

Instrumentation and Process

We now refer to the approach as “robotic” hysterectomy rather than “robotic-assisted” laparoscopic hysterectomy because—although a surgical assistant is still needed for several key functions, such as suction and irrigation—the procedure is, with these latest advancements, largely robotic in nature.

With most hysterectomies, as with most pelvic operations, four trocar sites are used: three for the robotic arms (one of which is for the laparoscope) and one for the assistant, who will manually perform suction, irrigation, vessel sealing, tissue retraction, and specimen retrieval. When we have a patient with cancer, obesity, a large uterus, advanced endometriosis, or adhesions, we add a fourth robotic arm. This additional arm allows for the added retraction of tissues.

We use the open Hasson technique to place a 12-mm robotic trocar (the first of the three main trocars) in the umbilical area for the laparoscope. Two 8-mm robotic trocars are then placed bilaterally, 10 cm to the right and left of the umbilicus. This placement provides an operative field that extends, in most patients, from the lower pelvis up to the inferior mesenteric artery.

For the assistant, a 10-mm trocar is placed 3 cm cranial and right between the umbilicus and the left robotic trocar. Through this port, the assistant performs the functions that are not yet available robotically: vessel sealing, suction, irrigation, tissue retraction, specimen retrieval, and the introduction and retrieval of sutures and needles. When a fourth robotic arm is used, that trocar is placed 10 cm lateral and 10 cm caudal to the right robotic trocar.

The robotic tower with three arms is situated between the patient's legs. We have noticed that if the column is parked very close to the patient's perineum, there is inadequate space for the scrub nurse to mobilize and manipulate a vaginal probe, maintain the pneumoperitoneum during vaginal incision, and retrieve specimens vaginally. Ideally, the robotic column should rest at about the level of the patient's feet and not any closer.

The middle robotic arm is attached to the umbilical trocar where the laparoscope has been inserted. A monopolar spatula, or scissors, is inserted through the right lateral trocar, and a plasma-kinetic dissecting forceps is inserted through the left lateral trocar. When needed for suturing, a needle-holder replaces the spatula. When a fourth robotic arm is needed, a robotic instrument called a Prograsp is used.

The surgeon sits, unscrubbed, on a console that in our operating suite is about 12 feet away from the patient. Here the surgeon can manipulate the robotic arms that maneuver the instruments and the laparoscopic camera, as well as communicate verbally with the assistant. When the surgeon is playing the role of assistant and the trainee is at the console, the surgeon can direct the trainee by means of telestration to pinpoint anatomical structures and planes of dissection, or to indicate areas of potential visceral damage by drawing circles, arrows, or dots.

When the ovaries are to be removed, which in our practice is more common than not, our first step with robotic simple hysterectomy is to incise the pelvic peritoneum at the level of the pelvic brim to identify the ureters and the points at which they cross the ovarian vessels. We then coagulate and divide the infundibulopelvic ligament that contains the ovarian vessels.

The ureters are then traced and followed to the point where they cross the uterine arteries. Because we cannot palpate the tissues in robotic surgery and therefore need to see, we dissect the ureters anytime they appear close to the cervix or if there is parametrial pathology. Doing so prevents injury.

After this, the bladder must be dissected from the cervix and upper vagina, and at least 2 cm caudal to the anterior vaginal fornix. A vaginal probe that is inserted into the vagina by the scrub nurse is used to identify where the vagina joins the cervix and to define the level of incision on the vagina.

A vessel-sealing device is used to coagulate and transect the uterine arteries and the cardinal ligaments. At that point—and not any sooner—the vagina is transected immediately distal to the cervix and the uterus is detached and removed, along with the ovaries in most cases, through the vaginal opening. (When the ovaries are not removed, they are left attached to the ipsilateral round ligament.) The scrub nurse holds the labia majora to the midline over the surgical instrument used to remove the uterus, and that is enough to maintain the pneumoperitoneum.

Inflation of a sterile occluding balloon with 60 mL of saline is used to maintain the pneumoperitoneum after removal of the specimen vaginally.

The right monopolar spatula is then removed and replaced with a needle-holder, and the vaginal cuff is closed with a 15-cm precut 0 continuous polyglyconate absorbable suture starting at the right angle and going toward the midline. A similar 15-cm suture is applied from the left to the midline until it meets the other suture. The uterosacral ligaments are incorporated at each vaginal angle and at the midline in order to support the vagina. We use a LapraTy suture clip at each end of the sutures to eliminate the need for intracorporeal knot tying.

Using these small precut sutures is most helpful. A suture that is 30 cm long simply takes too long to pull through the tissues. In general, the use of smaller, shorter sutures is essential in robotic surgery.

For robotic hysterectomies as well as any other robotic gynecologic surgery, I also advise using slow, deliberate, precise movements. Such pacing alleviates the risk of bleeding, which dramatically slows the procedure down when it occurs.

At the end of the procedure, the robotic arms are disengaged from the trocars, the robotic column is moved away, and the fascia at the umbilical site is closed. The other trocar sites require closure of only the skin. We always perform a cystoscopy after injection of intravenous indigo carmine to ensure that there are bilateral ureteral jets and no injury to the bladder.

When we plan to send the patient home on the day of the robotic hysterectomy—something we started doing when we observed how well patients were faring with this approach—we modify the anesthesia regimen somewhat.

We give each patient dexamethasone preoperatively, apply an antinausea patch behind her ear, and administer two additional medications to prevent nausea: Zofran (ondansetron) and aprepitant. Then, at the end of the hysterectomy, we inject both the right and the left pelvic plexus (sympathetic and parasympathetic) with a cocktail of morphine, vasopressin, and Marcaine (bupivacaine). We also infiltrate the trocar sites with Marcaine, and before the patient is awakened from anesthesia, we administer intravenous ketorolac. When she is awake, the patient will then have minimal discomfort.

Additionally, normal saline (200 mL) is left in the bladder at the end of the cystoscopy so that the patient will have the urge to empty her bladder in the next hour rather than the need to wait up to 5 hours to empty her bladder before being able to go home.

In our preoperative discussions with patients, we do inform them that the incisions are placed a little higher than with conventional laparoscopy. Only once has one of our patients expressed cosmetic concern and opted for a laparoscopic approach with suprapubic trocar placement.

Hysterectomy has been a natural beginning application for robotic technology in gynecologic surgery. Experience with the approach has applications, in turn, for other gynecologic procedures because the same instrumentation and usually the same port placement are used.

Patient Outcomes

In a series of 91 consecutive patients who underwent robotic simple hysterectomy at Mayo (with or without salpingo-oophorectomy or concomitant appendectomy) between March 2004 and December 2005, we had no conversions to conventional laparoscopy or laparotomy, no bladder or ureteral injuries, and few intraoperative and postoperative complications (Am. J. Obstet. Gynecol. 2007;197:113.e1-4).

Our one intraoperative complication was an enterotomy that was repaired robotically in a patient with extensive pelvic adhesions. (We have learned that complications can be repaired robotically without having to convert to laparotomy.)

Postoperatively, one patient with cardiomyopathy required admission to intensive care for 24 hours for exacerbation of heart failure, and another patient required admission for vaginal cuff abscess. Three patients were readmitted for ileus, pneumonia, and colitis. The mean estimated blood loss was 79 mL, and the mean hospital stay was 1.3 days. (Indications in the patients, whose mean age was 50 years, included menometrorrhagia in 43% and ovarian neoplasm in 20%.)

In the evaluation of robotic surgery and analysis of the experience, it is important to break down the total process into several components: docking time (the time required to attach the robotic arms to the trocars), console time (the surgeon's time dedicated exclusively to performing the hysterectomy), and total operating time (from incision to closure).

For surgeons who haven't used the robotic system, a common misperception is that it takes a long time to set up for each procedure. In our series, however, the mean docking time was only 2.9 minutes.

The mean console time was 79 minutes, and the total mean operating time was 122 minutes, which was 14 minutes shorter than conventional laparoscopy. A mean of 43 minutes was required for setup and close, which included trocar placement, exploration, and the removal of trocars, closure, and cystoscopy. (The time for setup and close has not been reported before in laparoscopic surgery.)

Our surgical time was minimized by having a dedicated robotic team and by using certain surgical strategies, such as the use of only three instruments (monopolar spatula, bipolar grasper, and needle-holder) for the entire procedure—a practice that also reduces cost—and the use of precut, short sutures and suture clips. The optimal robotic team can comprise two surgeons or one surgeon and one assistant, as well as at least two nurses who are well versed in the robotic instrumentation and system. The assistant also plays a major role in fixing any malfunctions of the robotic instruments or arms, and in switching robotic instruments.

Console time clearly decreased over time as we performed more simple hysterectomies. It was not significantly affected by the performance of an appendectomy, but it was affected by uterine weight and the lysis of adhesions. In our practice, we prefer a vaginal approach for the larger uterus that requires more morcellation. In general, our threshold for the robotic approach is a uterus of 12-14 weeks' gestational size.

All of these findings—from reduced operating times to shorter hospitalizations and fewer complications—have applied to our experience with robotic radical hysterectomy as well. In one analysis of 16 patients undergoing robotic radical hysterectomy, we found that total operating time was 66 minutes shorter than it had been for laparoscopic radical hysterectomy.

An increased body mass index did not prolong operating times in any of our patient groups. In fact, we have noticed that for patients who are obese, surgical time is longer with laparoscopy than with robotics. This reflects one of the advantages of the robotic approach: It bypasses the fulcrum effect, which is inherent to conventional laparoscopy and which is especially challenging in patients with a thick abdominal wall. Surgeons using the articulated instrumentation of a robotic system will use the same manual effort regardless of how thick the abdominal wall is.

The lack of tactile feedback is viewed by some as a limitation of robotics, but after a short time of practice, it is easily compensated for by the depth of perception that three-dimensional vision affords.

In addition, the articulation of the instruments facilitates dissection of the tissues and suturing, such as closure of the vaginal cuff in hysterectomies. And as with other gynecologic surgeries, the downscaling of the surgeon's movements in a 3:1 or 5:1 ratio leads to increased accuracy and precision. (In such downscaling, when the surgeon's hand moves 3 cm or 5 cm, the tip of the instrument moves only 1 cm.)

We still believe that when the hysterectomy can be performed vaginally, the vaginal approach is preferable to robotics or to laparoscopy. This is because any study that has compared vaginal hysterectomy with another approach has demonstrated a faster operating time with the vaginal procedure, as well as lower cost.

When a patient is not a candidate for a vaginal hysterectomy, or when the gynecologist is not comfortable with the approach, however, then the robotic approach is indeed preferable to conventional laparoscopy.

Four robotic trocars are placed in preparation for pelvic surgery with the da Vinci robotic system.

The da Vinci robotic system is shown in operation, with the assistant sitting to the left of the patient.

The Zeus robotic system consists of two working arms and another to hold the laparoscope. Photos courtesy Dr. Javier Magrina

Robotics: Enabling Technology for the Gyn.

The first proponents of robotics in surgery were the cardiac surgeons, but it was the urologists who truly popularized robotic surgery. Hospitals around the country have purchased the da Vinci surgical system mainly for urologists who wanted to perform robot-assisted radical prostatectomies. Interestingly enough, the robot has enabled physicians who were virtually untrained in laparoscopic surgery to feel comfortable with a laparoscopic approach.

Even though gynecologists were the first surgical specialists to perform laparoscopic surgery on a routine basis, the acceptance of minimally invasive gynecologic surgery within our specialty remains dismally low. In a recent study submitted to the National Women's Health Resource Center by the Lewin Group, only 15% of more than 600,000 hysterectomies performed per annum in the United States are accomplished via a minimally invasive technique. This is especially sobering when one considers that 80% of the cholecystectomies are performed laparoscopically.

Given the above, it is interesting to speculate on the potential impact of robotic surgery in gynecology. Initially, it appears that gynecologists who were not previously performing advanced minimally invasive surgery are able to do so with this enabling technology.

I have put together a minisymposium on robotic surgery in gynecology that will be covered in the next four issues. With my esteemed faculty, I will discuss the topics of robotic-assisted laparoscopic hysterectomy, robotic-assisted laparoscopic myomectomy, robotic-assisted laparoscopic sacrocolpopexy, and robotic-assisted node dissection.

The first author is Dr. Javier Magrina, head of the division of gynecologic oncology, director of female pelvic medicine and reconstructive surgery, and professor of obstetrics and gynecology at the Mayo Clinic, Scottsdale, Ariz.

Dr. Magrina has written extensively and lectured throughout the world on robotic surgery, from a standpoint of both benign as well as malignant disease. For the past 2 years, he has served on the board of trustees of the AAGL and remains very active in the Society of Gynecologic Oncologists and the Society of Laparoendoscopic Surgeons.

It is a pleasure to have Dr. Magrina as the author of our Master Class in Gynecologic Surgery on robotic-assisted laparoscopic hysterectomy.

Since the first published report of a robotic hysterectomy appeared in 2001, we have gained enough experience to know that next to vaginal hysterectomy, which I believe is still the preferred approach whenever possible, the robotic approach is the next-best technique that gynecologic surgeons can offer patients.

The robotic system we use today—the da Vinci surgical system—was designed to overcome the surgical limitations of conventional laparoscopy. Indeed, it has.

My colleagues and I at the Mayo Clinic, and others elsewhere, have seen similar operating times, reduced blood loss, and shorter hospitalization for both simple and radical hysterectomies as compared with the laparotomy approach. We have experienced firsthand the increased accuracy and precision that robotics promised. Suturing is easier with robotics than with laparoscopy. The advantages of robotics—from instrument articulation to the steady three-dimensional vision—have been more than expected, surpassing the advantages of conventional laparoscopy. Our operating time for robotic radical hysterectomy, in fact, is significantly shorter than that of laparoscopy.

The learning curve for performing robotic hysterectomy, moreover, seems surprisingly short. In a case-series analysis of robotic simple hysterectomies, we found it interesting that the time spent in the operating room flattened after 20-25 cases.

A prospective, randomized study comparing robotic hysterectomy with conventional laparoscopic surgery should be completed at the Mayo Clinic by the end of this year. In the meantime, robotic hysterectomy is generally offered to patients at Mayo as an alternative whenever a laparoscopic hysterectomy is being considered.

Patients are beginning to ask for it, and indeed, there are instances when we strongly prefer the robotic approach regardless of patient demand—for example, when patients have a history of adhesions, advanced endometriosis, gynecologic cancer, or genitourinary fistula, or when we have to perform pelvic floor repair procedures or other additional procedures that require extensive suturing. Obesity is an excellent application for robotic technology, which is something we have learned as our operating time has not been influenced by a patient's body mass index.

Evolution of Robotics

We started performing hysterectomies with the Zeus MicroWrist surgical system in 2003. The system, which was approved by the Food and Drug Administration in 2002 for general and laparoscopic surgery, enabled the surgeon to operate three robotic arms while sitting a distance away from the operating table.

This Zeus system was an advance over the Aesop robotic device, a voice-activated robotic arm designed to operate the laparoscope. Released in 1994, Aesop was the first robotic system approved to assist in laparoscopic procedures. With Aesop, the surgeon would direct the robotic movement of the laparoscope through voice commands while working manually with regular instruments. Video quality thus improved, and the need for an assistant was obviated when only two instruments were needed.

With the development of the Zeus system, surgeons gained two more robotic arms (in addition to the laparoscope-operating arm) as well as some of the other advantages afforded by robotics, such as articulating tips and a downscaling of movement.

The da Vinci surgical system that we use currently is an improvement over Zeus. It was originally approved for procedures in the abdominal and pelvic cavity, but in 2005 it received special approval for the performance of robotic hysterectomy. At this point, because of various changes in the industry's structure, it is the only robotic system manufactured for laparoscopic procedures.

In an evolution that reflects likely future changes as well, a second generation of the da Vinci system, released in 2006, has longer instruments, lighter arms, and increased flexion-extension and lateral excursion, among other improvements.

Instrumentation and Process

We now refer to the approach as “robotic” hysterectomy rather than “robotic-assisted” laparoscopic hysterectomy because—although a surgical assistant is still needed for several key functions, such as suction and irrigation—the procedure is, with these latest advancements, largely robotic in nature.

With most hysterectomies, as with most pelvic operations, four trocar sites are used: three for the robotic arms (one of which is for the laparoscope) and one for the assistant, who will manually perform suction, irrigation, vessel sealing, tissue retraction, and specimen retrieval. When we have a patient with cancer, obesity, a large uterus, advanced endometriosis, or adhesions, we add a fourth robotic arm. This additional arm allows for the added retraction of tissues.

We use the open Hasson technique to place a 12-mm robotic trocar (the first of the three main trocars) in the umbilical area for the laparoscope. Two 8-mm robotic trocars are then placed bilaterally, 10 cm to the right and left of the umbilicus. This placement provides an operative field that extends, in most patients, from the lower pelvis up to the inferior mesenteric artery.

For the assistant, a 10-mm trocar is placed 3 cm cranial and right between the umbilicus and the left robotic trocar. Through this port, the assistant performs the functions that are not yet available robotically: vessel sealing, suction, irrigation, tissue retraction, specimen retrieval, and the introduction and retrieval of sutures and needles. When a fourth robotic arm is used, that trocar is placed 10 cm lateral and 10 cm caudal to the right robotic trocar.

The robotic tower with three arms is situated between the patient's legs. We have noticed that if the column is parked very close to the patient's perineum, there is inadequate space for the scrub nurse to mobilize and manipulate a vaginal probe, maintain the pneumoperitoneum during vaginal incision, and retrieve specimens vaginally. Ideally, the robotic column should rest at about the level of the patient's feet and not any closer.

The middle robotic arm is attached to the umbilical trocar where the laparoscope has been inserted. A monopolar spatula, or scissors, is inserted through the right lateral trocar, and a plasma-kinetic dissecting forceps is inserted through the left lateral trocar. When needed for suturing, a needle-holder replaces the spatula. When a fourth robotic arm is needed, a robotic instrument called a Prograsp is used.

The surgeon sits, unscrubbed, on a console that in our operating suite is about 12 feet away from the patient. Here the surgeon can manipulate the robotic arms that maneuver the instruments and the laparoscopic camera, as well as communicate verbally with the assistant. When the surgeon is playing the role of assistant and the trainee is at the console, the surgeon can direct the trainee by means of telestration to pinpoint anatomical structures and planes of dissection, or to indicate areas of potential visceral damage by drawing circles, arrows, or dots.

When the ovaries are to be removed, which in our practice is more common than not, our first step with robotic simple hysterectomy is to incise the pelvic peritoneum at the level of the pelvic brim to identify the ureters and the points at which they cross the ovarian vessels. We then coagulate and divide the infundibulopelvic ligament that contains the ovarian vessels.

The ureters are then traced and followed to the point where they cross the uterine arteries. Because we cannot palpate the tissues in robotic surgery and therefore need to see, we dissect the ureters anytime they appear close to the cervix or if there is parametrial pathology. Doing so prevents injury.

After this, the bladder must be dissected from the cervix and upper vagina, and at least 2 cm caudal to the anterior vaginal fornix. A vaginal probe that is inserted into the vagina by the scrub nurse is used to identify where the vagina joins the cervix and to define the level of incision on the vagina.

A vessel-sealing device is used to coagulate and transect the uterine arteries and the cardinal ligaments. At that point—and not any sooner—the vagina is transected immediately distal to the cervix and the uterus is detached and removed, along with the ovaries in most cases, through the vaginal opening. (When the ovaries are not removed, they are left attached to the ipsilateral round ligament.) The scrub nurse holds the labia majora to the midline over the surgical instrument used to remove the uterus, and that is enough to maintain the pneumoperitoneum.

Inflation of a sterile occluding balloon with 60 mL of saline is used to maintain the pneumoperitoneum after removal of the specimen vaginally.

The right monopolar spatula is then removed and replaced with a needle-holder, and the vaginal cuff is closed with a 15-cm precut 0 continuous polyglyconate absorbable suture starting at the right angle and going toward the midline. A similar 15-cm suture is applied from the left to the midline until it meets the other suture. The uterosacral ligaments are incorporated at each vaginal angle and at the midline in order to support the vagina. We use a LapraTy suture clip at each end of the sutures to eliminate the need for intracorporeal knot tying.

Using these small precut sutures is most helpful. A suture that is 30 cm long simply takes too long to pull through the tissues. In general, the use of smaller, shorter sutures is essential in robotic surgery.

For robotic hysterectomies as well as any other robotic gynecologic surgery, I also advise using slow, deliberate, precise movements. Such pacing alleviates the risk of bleeding, which dramatically slows the procedure down when it occurs.

At the end of the procedure, the robotic arms are disengaged from the trocars, the robotic column is moved away, and the fascia at the umbilical site is closed. The other trocar sites require closure of only the skin. We always perform a cystoscopy after injection of intravenous indigo carmine to ensure that there are bilateral ureteral jets and no injury to the bladder.

When we plan to send the patient home on the day of the robotic hysterectomy—something we started doing when we observed how well patients were faring with this approach—we modify the anesthesia regimen somewhat.

We give each patient dexamethasone preoperatively, apply an antinausea patch behind her ear, and administer two additional medications to prevent nausea: Zofran (ondansetron) and aprepitant. Then, at the end of the hysterectomy, we inject both the right and the left pelvic plexus (sympathetic and parasympathetic) with a cocktail of morphine, vasopressin, and Marcaine (bupivacaine). We also infiltrate the trocar sites with Marcaine, and before the patient is awakened from anesthesia, we administer intravenous ketorolac. When she is awake, the patient will then have minimal discomfort.

Additionally, normal saline (200 mL) is left in the bladder at the end of the cystoscopy so that the patient will have the urge to empty her bladder in the next hour rather than the need to wait up to 5 hours to empty her bladder before being able to go home.

In our preoperative discussions with patients, we do inform them that the incisions are placed a little higher than with conventional laparoscopy. Only once has one of our patients expressed cosmetic concern and opted for a laparoscopic approach with suprapubic trocar placement.

Hysterectomy has been a natural beginning application for robotic technology in gynecologic surgery. Experience with the approach has applications, in turn, for other gynecologic procedures because the same instrumentation and usually the same port placement are used.

Patient Outcomes

In a series of 91 consecutive patients who underwent robotic simple hysterectomy at Mayo (with or without salpingo-oophorectomy or concomitant appendectomy) between March 2004 and December 2005, we had no conversions to conventional laparoscopy or laparotomy, no bladder or ureteral injuries, and few intraoperative and postoperative complications (Am. J. Obstet. Gynecol. 2007;197:113.e1-4).

Our one intraoperative complication was an enterotomy that was repaired robotically in a patient with extensive pelvic adhesions. (We have learned that complications can be repaired robotically without having to convert to laparotomy.)

Postoperatively, one patient with cardiomyopathy required admission to intensive care for 24 hours for exacerbation of heart failure, and another patient required admission for vaginal cuff abscess. Three patients were readmitted for ileus, pneumonia, and colitis. The mean estimated blood loss was 79 mL, and the mean hospital stay was 1.3 days. (Indications in the patients, whose mean age was 50 years, included menometrorrhagia in 43% and ovarian neoplasm in 20%.)

In the evaluation of robotic surgery and analysis of the experience, it is important to break down the total process into several components: docking time (the time required to attach the robotic arms to the trocars), console time (the surgeon's time dedicated exclusively to performing the hysterectomy), and total operating time (from incision to closure).

For surgeons who haven't used the robotic system, a common misperception is that it takes a long time to set up for each procedure. In our series, however, the mean docking time was only 2.9 minutes.

The mean console time was 79 minutes, and the total mean operating time was 122 minutes, which was 14 minutes shorter than conventional laparoscopy. A mean of 43 minutes was required for setup and close, which included trocar placement, exploration, and the removal of trocars, closure, and cystoscopy. (The time for setup and close has not been reported before in laparoscopic surgery.)

Our surgical time was minimized by having a dedicated robotic team and by using certain surgical strategies, such as the use of only three instruments (monopolar spatula, bipolar grasper, and needle-holder) for the entire procedure—a practice that also reduces cost—and the use of precut, short sutures and suture clips. The optimal robotic team can comprise two surgeons or one surgeon and one assistant, as well as at least two nurses who are well versed in the robotic instrumentation and system. The assistant also plays a major role in fixing any malfunctions of the robotic instruments or arms, and in switching robotic instruments.

Console time clearly decreased over time as we performed more simple hysterectomies. It was not significantly affected by the performance of an appendectomy, but it was affected by uterine weight and the lysis of adhesions. In our practice, we prefer a vaginal approach for the larger uterus that requires more morcellation. In general, our threshold for the robotic approach is a uterus of 12-14 weeks' gestational size.

All of these findings—from reduced operating times to shorter hospitalizations and fewer complications—have applied to our experience with robotic radical hysterectomy as well. In one analysis of 16 patients undergoing robotic radical hysterectomy, we found that total operating time was 66 minutes shorter than it had been for laparoscopic radical hysterectomy.

An increased body mass index did not prolong operating times in any of our patient groups. In fact, we have noticed that for patients who are obese, surgical time is longer with laparoscopy than with robotics. This reflects one of the advantages of the robotic approach: It bypasses the fulcrum effect, which is inherent to conventional laparoscopy and which is especially challenging in patients with a thick abdominal wall. Surgeons using the articulated instrumentation of a robotic system will use the same manual effort regardless of how thick the abdominal wall is.

The lack of tactile feedback is viewed by some as a limitation of robotics, but after a short time of practice, it is easily compensated for by the depth of perception that three-dimensional vision affords.

In addition, the articulation of the instruments facilitates dissection of the tissues and suturing, such as closure of the vaginal cuff in hysterectomies. And as with other gynecologic surgeries, the downscaling of the surgeon's movements in a 3:1 or 5:1 ratio leads to increased accuracy and precision. (In such downscaling, when the surgeon's hand moves 3 cm or 5 cm, the tip of the instrument moves only 1 cm.)

We still believe that when the hysterectomy can be performed vaginally, the vaginal approach is preferable to robotics or to laparoscopy. This is because any study that has compared vaginal hysterectomy with another approach has demonstrated a faster operating time with the vaginal procedure, as well as lower cost.

When a patient is not a candidate for a vaginal hysterectomy, or when the gynecologist is not comfortable with the approach, however, then the robotic approach is indeed preferable to conventional laparoscopy.

Four robotic trocars are placed in preparation for pelvic surgery with the da Vinci robotic system.

The da Vinci robotic system is shown in operation, with the assistant sitting to the left of the patient.

The Zeus robotic system consists of two working arms and another to hold the laparoscope. Photos courtesy Dr. Javier Magrina

Robotics: Enabling Technology for the Gyn.

The first proponents of robotics in surgery were the cardiac surgeons, but it was the urologists who truly popularized robotic surgery. Hospitals around the country have purchased the da Vinci surgical system mainly for urologists who wanted to perform robot-assisted radical prostatectomies. Interestingly enough, the robot has enabled physicians who were virtually untrained in laparoscopic surgery to feel comfortable with a laparoscopic approach.

Even though gynecologists were the first surgical specialists to perform laparoscopic surgery on a routine basis, the acceptance of minimally invasive gynecologic surgery within our specialty remains dismally low. In a recent study submitted to the National Women's Health Resource Center by the Lewin Group, only 15% of more than 600,000 hysterectomies performed per annum in the United States are accomplished via a minimally invasive technique. This is especially sobering when one considers that 80% of the cholecystectomies are performed laparoscopically.

Given the above, it is interesting to speculate on the potential impact of robotic surgery in gynecology. Initially, it appears that gynecologists who were not previously performing advanced minimally invasive surgery are able to do so with this enabling technology.

I have put together a minisymposium on robotic surgery in gynecology that will be covered in the next four issues. With my esteemed faculty, I will discuss the topics of robotic-assisted laparoscopic hysterectomy, robotic-assisted laparoscopic myomectomy, robotic-assisted laparoscopic sacrocolpopexy, and robotic-assisted node dissection.

The first author is Dr. Javier Magrina, head of the division of gynecologic oncology, director of female pelvic medicine and reconstructive surgery, and professor of obstetrics and gynecology at the Mayo Clinic, Scottsdale, Ariz.

Dr. Magrina has written extensively and lectured throughout the world on robotic surgery, from a standpoint of both benign as well as malignant disease. For the past 2 years, he has served on the board of trustees of the AAGL and remains very active in the Society of Gynecologic Oncologists and the Society of Laparoendoscopic Surgeons.

It is a pleasure to have Dr. Magrina as the author of our Master Class in Gynecologic Surgery on robotic-assisted laparoscopic hysterectomy.

Female sex, exposure to prenatal corticosteroid therapy, singleton birth, and increased birth weight (in 100-g increments) each improve an infant's chances of a positive outcome with intensive care.

The magnitude of the benefit is similar to that of an extra week of gestational age, Dr. Jon E. Tyson and his associates at the National Institute of Child Health and Human Development (NICHD) wrote in the April 17 New England Journal of Medicine.

Decisions about admitting extremely premature infants to intensive care are “highly controversial,” with most centers in the United States selecting patients solely on the basis of gestational age thresholds. “Such care is likely to be routinely administered at 25 weeks' gestation but may be provided only with parental agreement at 23–24 weeks, and only 'comfort care' may be given at 22 weeks,” the investigators noted.

The researchers assessed a cohort of 4,446 infants born at 22–25 weeks' gestation at 19 medical centers in the NICHD's neonatal research network between 1998 and 2004. At a corrected age of 18–22 months, 49% of the study subjects had died, and 61% had died or sustained profound impairment.

Factors that might contribute to outcome were examined, and the four listed above were found to significantly improve the rates of survival and survival without impairment. The improvements were equivalent to a 1-week increase in gestational age, said Dr. Tyson of the University of Texas at Houston and associates.

“For example, among infants born midway between 24 and 25 completed weeks of gestation, the estimated likelihood of death or profound impairment was 33% for a 750-g, appropriate-for-gestational-age female singleton who received prenatal corticosteroids, but 87% for a 525-g, small-for-gestational-age male twin who did not receive prenatal corticosteroids,” they wrote.

Even among the highest-risk infants—those born before 24 weeks with a birth weight of 600 g or less—outcomes varied considerably according to these four risk factors. The maximum potential rate of survival without profound impairment was as low as 5% for boys weighing 401–500 g born at 22 weeks, but as high as 38% for girls weighing 501–600 g born at 24 weeks (N.Engl. J. Med;358:1672–81).

Nevertheless, in actual practice it turned out that girls were less likely than boys and that singletons were less likely than multiples to receive intensive care when they had the same likelihood of a favorable outcome.

Weighing the additional four factors into the decision “is likely to promote treatment decisions that are less arbitrary, more individualized, more transparent, and better justified than decisions based solely on gestational-age thresholds,” the investigators said.

To assist physicians faced with such decisions, the authors provided a Web-based tool (www.nichd.nih.gov/neonatalestimates

Dr. Tyson and associates added that in assessing outcomes, they included factors such as treatment cost, resource use, parental distress, and “infant suffering due to painful procedures, prolonged intubation, and such complications as intracranial hemorrhage, necrotizing enterocolitis, and recurrent episodes of hypoxia.”

“Barring major therapeutic advances, our findings indicate that extending intensive care to all of the most immature infants would entail considerable suffering, resource use, and cost in order to benefit only a small proportion of infants,” they noted.

Female sex, exposure to prenatal corticosteroid therapy, singleton birth, and increased birth weight (in 100-g increments) each improve an infant's chances of a positive outcome with intensive care.

The magnitude of the benefit is similar to that of an extra week of gestational age, Dr. Jon E. Tyson and his associates at the National Institute of Child Health and Human Development (NICHD) wrote in the April 17 New England Journal of Medicine.

Decisions about admitting extremely premature infants to intensive care are “highly controversial,” with most centers in the United States selecting patients solely on the basis of gestational age thresholds. “Such care is likely to be routinely administered at 25 weeks' gestation but may be provided only with parental agreement at 23–24 weeks, and only 'comfort care' may be given at 22 weeks,” the investigators noted.

The researchers assessed a cohort of 4,446 infants born at 22–25 weeks' gestation at 19 medical centers in the NICHD's neonatal research network between 1998 and 2004. At a corrected age of 18–22 months, 49% of the study subjects had died, and 61% had died or sustained profound impairment.

Factors that might contribute to outcome were examined, and the four listed above were found to significantly improve the rates of survival and survival without impairment. The improvements were equivalent to a 1-week increase in gestational age, said Dr. Tyson of the University of Texas at Houston and associates.

“For example, among infants born midway between 24 and 25 completed weeks of gestation, the estimated likelihood of death or profound impairment was 33% for a 750-g, appropriate-for-gestational-age female singleton who received prenatal corticosteroids, but 87% for a 525-g, small-for-gestational-age male twin who did not receive prenatal corticosteroids,” they wrote.

Even among the highest-risk infants—those born before 24 weeks with a birth weight of 600 g or less—outcomes varied considerably according to these four risk factors. The maximum potential rate of survival without profound impairment was as low as 5% for boys weighing 401–500 g born at 22 weeks, but as high as 38% for girls weighing 501–600 g born at 24 weeks (N.Engl. J. Med;358:1672–81).

Nevertheless, in actual practice it turned out that girls were less likely than boys and that singletons were less likely than multiples to receive intensive care when they had the same likelihood of a favorable outcome.

Weighing the additional four factors into the decision “is likely to promote treatment decisions that are less arbitrary, more individualized, more transparent, and better justified than decisions based solely on gestational-age thresholds,” the investigators said.

To assist physicians faced with such decisions, the authors provided a Web-based tool (www.nichd.nih.gov/neonatalestimates

Dr. Tyson and associates added that in assessing outcomes, they included factors such as treatment cost, resource use, parental distress, and “infant suffering due to painful procedures, prolonged intubation, and such complications as intracranial hemorrhage, necrotizing enterocolitis, and recurrent episodes of hypoxia.”

“Barring major therapeutic advances, our findings indicate that extending intensive care to all of the most immature infants would entail considerable suffering, resource use, and cost in order to benefit only a small proportion of infants,” they noted.

Female sex, exposure to prenatal corticosteroid therapy, singleton birth, and increased birth weight (in 100-g increments) each improve an infant's chances of a positive outcome with intensive care.

The magnitude of the benefit is similar to that of an extra week of gestational age, Dr. Jon E. Tyson and his associates at the National Institute of Child Health and Human Development (NICHD) wrote in the April 17 New England Journal of Medicine.

Decisions about admitting extremely premature infants to intensive care are “highly controversial,” with most centers in the United States selecting patients solely on the basis of gestational age thresholds. “Such care is likely to be routinely administered at 25 weeks' gestation but may be provided only with parental agreement at 23–24 weeks, and only 'comfort care' may be given at 22 weeks,” the investigators noted.

The researchers assessed a cohort of 4,446 infants born at 22–25 weeks' gestation at 19 medical centers in the NICHD's neonatal research network between 1998 and 2004. At a corrected age of 18–22 months, 49% of the study subjects had died, and 61% had died or sustained profound impairment.

Factors that might contribute to outcome were examined, and the four listed above were found to significantly improve the rates of survival and survival without impairment. The improvements were equivalent to a 1-week increase in gestational age, said Dr. Tyson of the University of Texas at Houston and associates.

“For example, among infants born midway between 24 and 25 completed weeks of gestation, the estimated likelihood of death or profound impairment was 33% for a 750-g, appropriate-for-gestational-age female singleton who received prenatal corticosteroids, but 87% for a 525-g, small-for-gestational-age male twin who did not receive prenatal corticosteroids,” they wrote.

Even among the highest-risk infants—those born before 24 weeks with a birth weight of 600 g or less—outcomes varied considerably according to these four risk factors. The maximum potential rate of survival without profound impairment was as low as 5% for boys weighing 401–500 g born at 22 weeks, but as high as 38% for girls weighing 501–600 g born at 24 weeks (N.Engl. J. Med;358:1672–81).

Nevertheless, in actual practice it turned out that girls were less likely than boys and that singletons were less likely than multiples to receive intensive care when they had the same likelihood of a favorable outcome.

Weighing the additional four factors into the decision “is likely to promote treatment decisions that are less arbitrary, more individualized, more transparent, and better justified than decisions based solely on gestational-age thresholds,” the investigators said.

To assist physicians faced with such decisions, the authors provided a Web-based tool (www.nichd.nih.gov/neonatalestimates

Dr. Tyson and associates added that in assessing outcomes, they included factors such as treatment cost, resource use, parental distress, and “infant suffering due to painful procedures, prolonged intubation, and such complications as intracranial hemorrhage, necrotizing enterocolitis, and recurrent episodes of hypoxia.”

“Barring major therapeutic advances, our findings indicate that extending intensive care to all of the most immature infants would entail considerable suffering, resource use, and cost in order to benefit only a small proportion of infants,” they noted.

How many of us are thoroughly, truly prepared to manage shoulder dystocia, to use forceps, or to perform a vaginal breech delivery?

It is not a silly question to ask ourselves, since these are critical, high-risk situations and skills that most of us do not encounter as frequently as routine vaginal delivery. When we are not practicing critical skills, we tend to lose them.

The question is increasingly important, moreover, because technological advances are making obstetric simulation more feasible and affordable for a variety of different settings. Realistic, low-fidelity mannequins that take up little space in an office or an old exam room are now relatively inexpensive.

Obstetric simulation training has become a tool that we simply must take advantage of. It is not only making its way into academia, with a small but growing body of literature showing that it improves competence and performance when a real event occurs, but is also gaining acceptance among practicing physicians as a valuable means of practicing skills and preparing for obstetric emergencies, such as shoulder dystocia, breech vaginal delivery, postpartum hemorrhage, and eclampsia.

I see and hear about attending physicians who join residents in the growing number of simulation programs that exist in academic institutions because they realize that they, too, can benefit from the practice. The American College of Obstetricians and Gynecologists is watching this trend; its Task Force on Simulation is examining the role of simulation in obstetrics and ways in which practicing obstetricians can take advantage of simulation technology.

Some professional liability organizations, meanwhile, are considering giving physicians discounts on their malpractice insurance premiums if they practice simulation; Harvard-affiliated obstetricians have been offered such discounts, and Kaiser Permanente is implementing simulation programs (including birth simulation training) as part of its initiatives for quality and patient safety.

It seems only a matter of time before more health care institutions draw on obstetric simulation to help practicing physicians update and reinforce their skills, and before certifying bodies also embrace the notion. (General surgery is on the cusp of establishing simulation centers for certification and recertification.)

In the meantime, obstetricians can take it upon themselves to use available technology and prepare for the high-acuity, low-frequency emergencies that are encountered by every obstetrician at some time.

Safety, Liability

That obstetric simulation is on the radar screen—and probably on its way to becoming mainstream—makes perfect sense.

Professionals in the airline industry, the military, and the nuclear power industry are already using simulation for teaching and for maintaining and evaluating skills. Simulation is a safety-first tool in these industries, and it often utilizes evidence-based protocols.

In medicine, we make evidence-based decisions all the time, and patient safety is a huge issue. The Joint Commission on Accreditation of Healthcare Organizations recently looked at all perinatal sentinel events across the country in all types of institutions, and found that 47% were linked with staff competence issues. Among the other identified root causes were communication issues (72%), the orientation and training process (40%), and organization culture as a barrier to effective communication and teamwork (55%). Simulation could play a significant role in addressing each of these issues.

Shoulder dystocia complicates up to 2% of all vaginal deliveries, and potentially causes permanent brachial plexus injury, clavicular fracture, hypoxic brain injury, and other significant long-term complications. Although we encounter shoulder dystocia infrequently, the risk for serious and permanent injury to the infant is so high that we ought to be prepared.

Similarly, approximately 3%–4% of singleton babies are in the breech position, yet only a minority of obstetricians are able to perform vaginal breech deliveries. In one recent study, only 33% of surveyed attending physicians performed vaginal breech deliveries. The rest do not do them anymore.

Although vaginal breech deliveries are discouraged, vaginal delivery is sometimes unavoidable or even preferable. (When the breech is on the perineum, for instance, it's riskier to go to cesarean delivery). We are putting our patients and ourselves at risk by not practicing and knowing how to do this with proper technique,

We do not like to talk about the litigation aspect, but we cannot hide it: Fetal injury that is related to emergencies like shoulder dystocia is a potential source of medical malpractice lawsuits and one that we can minimize by reinforcing and maintaining our skills through simulation.

Today's Simulators

Obstetricians worry about how they can do a simulation. Many think of simulators as too big, too expensive, and not lifelike. Some worry about doing a simulation in front of others and are too intimidated to try.

Some of the simulators available today are expensive. A full-body, high-fidelity obstetric simulator with all the bells and whistles—touch-screen computer technology that enables manipulation of the labor course, for instance, and varying vital signs and fetal heart rhythms—can cost up to $40,000.

These expensive models are often purchased by academic institutions that are interested in simulation for a multitude of purposes, including team training, but such models are not necessary to simulate at least several obstetric emergencies, including vaginal breech delivery, shoulder dystocia, and the use of forceps.

For these situations, low-fidelity simulators—which may be just a model of the pelvis through which a model baby can be manually pushed—are perfectly fine. They can be purchased for $2,000-$3,000, stored in a closet, and placed in an extra exam room where physicians can practice, either with a mentor or expert or by themselves.

Nothing is as real as a true patient or a real-life situation, of course, but many of these mannequins are surprisingly lifelike, with features like an anatomically correct bony pelvis, a stretchable perineum, and a silicone pelvic-floor musculature. A mannequin's cervix, for instance, really feels like a cervix.

When I was in resident training, I practiced using the forceps on a high-fidelity mannequin. This gave me an opportunity to practice all the necessary maneuvers and to know whether I performed all critical tasks, from inserting the posterior blade first, for instance, to holding the left blade of the forceps with my left hand while using my right hand as a guide.

Later, when I was in a real and urgent situation requiring forceps, I knew just what to do. It worked like clockwork. Simulation on a low-fidelity mannequin, if that was what my institution had had, would have been just as beneficial.

Simulation also provides opportunities to create protocols. In the middle of a forceps delivery simulation, for instance, you may realize that “this needs to be done all the time just like this.” Alternatively, you may think, “Let's not do it this way next time.”

Similarly, simulation affords us opportunities to practice and fine-tune communication and teamwork.

Improved Competence

I recently oversaw a resident who had previously done simulation training with high-fidelity mannequins as part of her curriculum at the Washington Hospital Center, and was now in a real and difficult delivery involving shoulder dystocia.

She performed the recommended initial maneuvers—like placing the patient in the McRobert's position and applying suprapubic pressure—but without success. She then immediately proceeded, without any prompting, to deliver the posterior arm, which relieved the shoulder dystocia. Afterward, the resident told me that “if I hadn't done the shoulder dystocia simulation lab, I would not have known to do that.” I hear such stories often.

Studies are beginning to document the effects of obstetric simulation training on competence and performance.

In a study published several years ago, for instance, residents at Georgetown University in Washington and the Uniformed Services University of Health Sciences in Bethesda, Md., were randomized to receive training on shoulder dystocia management using a high-fidelity obstetric simulator or to receive no special training. Each resident was subsequently tested without prior notice in another simulation scenario.

Those who had practiced shoulder dystocia management on mannequins completed more critical tasks and had significantly higher scores on timeliness of their interactions, proper performance of maneuvers, and overall performance (Obstet. Gynecol. 2004:103;1224–8).

Although not randomized, another more recent study at Georgetown University showed that high-fidelity simulation training improved resident performance of vaginal breech delivery. Residents were more likely after simulation training to perform critical maneuvers correctly and to deliver in a safe manner than they were before the training (Obstet. Gynecol. 2006:107;86–9).

Research from the University of Bristol (England) is also yielding interesting results. Investigators there have reported, for instance, that obstetric emergency training courses using simulation were associated with a significant reduction in low 5-minute APGAR scores and lower rates of hypoxic-ischemic encephalopathy (BJOG 2006;113:177–82).

Another study of shoulder dystocia has shown that, whereas training with high-fidelity mannequins provides additional benefits, training with low-fidelity mannequins is also effective in improving management of the obstetric situation by obstetricians and midwives (Obstet. Gynecol. 2006;108:1477–85).

A study from the Bristol investigators in which participants were tested on a standardized simulation before a simulation workshop, and then at 3 weeks, 6 months, and 12 months afterward, shows that improved performance appears to be sustained. Those who were proficient 3 weeks after the training retained their skills at the later dates. The researchers concluded that annual training may be adequate for some physicians, whereas others may need more frequent practice (Obstet. Gynecol. 2007;110:1069–74).

Soon-to-be-published research that we have recently completed at Georgetown University and the Washington Hospital Center similarly indicates that obstetricians generally should strive for continuing simulation training at least once a year. Residents in our study who were initially taught on the simulator scored higher when tested a year later than did residents who received no simulation training. Overall, however, everyone's scores declined.

Obstetric simulation is part of our future. New physicians of the future will enter practice having done simulation training in a variety of high-acuity, low-frequency scenarios—rather than learning solely through lectures and impromptu teaching after events have occurred—and those of us already in practice will likely find that working occasionally with low-fidelity mannequins enables us to provide better, safer patient care while reducing our liability risk.

Dr. Marsha Solomon, chief resident at the Washington Hospital Center, is shown performing a simulated forceps delivery in the photo at left. In the photo at right, Dr. Solomon performs a simulated breech vaginal delivery. Photos courtesy Dr. Tamika C. Auguste

Obstetric Simulation

Do you think that you would like to have your next airplane flight piloted by someone who has not flown a plane in several years or who has little experience in landing?

Pilots are among the professionals who gain their greatest experience and expertise through the development of skills using various simulation technologies.

Simulation training is common in the aviation industry, as it is in aeronautics and in some branches of engineering, which makes this question significantly less worrisome and less relevant than if simulation were not common.

Medicine in general—and obstetrics in particular—has been practiced worldwide using the apprenticeship model, in which residents and interns work with attending physicians to learn the art of medicine.

While caring for patients with various disorders and in various scenarios, physicians-in-training work alongside the more senior practitioners, taking on progressive amounts of responsibility. Experience is gained accordingly.

This approach has been very successful over the years, and will remain so. It may be enhanced, however, as the simulation approach is slowly integrated into medicine and into obstetrics training.

The use of simulation training in medicine makes intuitive sense. The acquisition of the greatest possible skill or expertise—or the enhancement of skills if there is a hiatus in practice—makes sense from quality-of-care and patient-safety perspectives, and also because of the litigious environment in which we live and practice.

The question, “How would you like to have your baby delivered by an obstetrician who has not used forceps or managed shoulder dystocia in over a year?” is a valid one for patients who realize that less-common delivery scenarios are unpredictable.

This month's Master Class will focus on the utility, practicability, and application of simulation technology in obstetrics as a means of maximizing not only the skills of the resident, but also the skills of the practicing clinician.

Our guest author, Dr. Tamika C. Auguste, is the director of obstetric simulation at Washington Hospital Center and assistant professor of obstetrics/gynecology at Georgetown University in Washington. She speaks in various forums on the issue of simulation for both residents and practicing physicians, and is fast becoming a young leader and expert from whom we can expect to hear more in the future.

Key Points on Simulation

1. Simulation can be used to practice classic obstetric skills and high-risk, low-frequency obstetric emergencies.

2. Simulation is not only for those in academic medicine but also for those in private practice.

3. Low-fidelity simulators can be just as useful as high-fidelity simulators.

4. Simulation is becoming the norm in residency training programs.

How many of us are thoroughly, truly prepared to manage shoulder dystocia, to use forceps, or to perform a vaginal breech delivery?

It is not a silly question to ask ourselves, since these are critical, high-risk situations and skills that most of us do not encounter as frequently as routine vaginal delivery. When we are not practicing critical skills, we tend to lose them.

The question is increasingly important, moreover, because technological advances are making obstetric simulation more feasible and affordable for a variety of different settings. Realistic, low-fidelity mannequins that take up little space in an office or an old exam room are now relatively inexpensive.

Obstetric simulation training has become a tool that we simply must take advantage of. It is not only making its way into academia, with a small but growing body of literature showing that it improves competence and performance when a real event occurs, but is also gaining acceptance among practicing physicians as a valuable means of practicing skills and preparing for obstetric emergencies, such as shoulder dystocia, breech vaginal delivery, postpartum hemorrhage, and eclampsia.

I see and hear about attending physicians who join residents in the growing number of simulation programs that exist in academic institutions because they realize that they, too, can benefit from the practice. The American College of Obstetricians and Gynecologists is watching this trend; its Task Force on Simulation is examining the role of simulation in obstetrics and ways in which practicing obstetricians can take advantage of simulation technology.

Some professional liability organizations, meanwhile, are considering giving physicians discounts on their malpractice insurance premiums if they practice simulation; Harvard-affiliated obstetricians have been offered such discounts, and Kaiser Permanente is implementing simulation programs (including birth simulation training) as part of its initiatives for quality and patient safety.

It seems only a matter of time before more health care institutions draw on obstetric simulation to help practicing physicians update and reinforce their skills, and before certifying bodies also embrace the notion. (General surgery is on the cusp of establishing simulation centers for certification and recertification.)

In the meantime, obstetricians can take it upon themselves to use available technology and prepare for the high-acuity, low-frequency emergencies that are encountered by every obstetrician at some time.

Safety, Liability

That obstetric simulation is on the radar screen—and probably on its way to becoming mainstream—makes perfect sense.

Professionals in the airline industry, the military, and the nuclear power industry are already using simulation for teaching and for maintaining and evaluating skills. Simulation is a safety-first tool in these industries, and it often utilizes evidence-based protocols.

In medicine, we make evidence-based decisions all the time, and patient safety is a huge issue. The Joint Commission on Accreditation of Healthcare Organizations recently looked at all perinatal sentinel events across the country in all types of institutions, and found that 47% were linked with staff competence issues. Among the other identified root causes were communication issues (72%), the orientation and training process (40%), and organization culture as a barrier to effective communication and teamwork (55%). Simulation could play a significant role in addressing each of these issues.

Shoulder dystocia complicates up to 2% of all vaginal deliveries, and potentially causes permanent brachial plexus injury, clavicular fracture, hypoxic brain injury, and other significant long-term complications. Although we encounter shoulder dystocia infrequently, the risk for serious and permanent injury to the infant is so high that we ought to be prepared.

Similarly, approximately 3%–4% of singleton babies are in the breech position, yet only a minority of obstetricians are able to perform vaginal breech deliveries. In one recent study, only 33% of surveyed attending physicians performed vaginal breech deliveries. The rest do not do them anymore.

Although vaginal breech deliveries are discouraged, vaginal delivery is sometimes unavoidable or even preferable. (When the breech is on the perineum, for instance, it's riskier to go to cesarean delivery). We are putting our patients and ourselves at risk by not practicing and knowing how to do this with proper technique,

We do not like to talk about the litigation aspect, but we cannot hide it: Fetal injury that is related to emergencies like shoulder dystocia is a potential source of medical malpractice lawsuits and one that we can minimize by reinforcing and maintaining our skills through simulation.

Today's Simulators

Obstetricians worry about how they can do a simulation. Many think of simulators as too big, too expensive, and not lifelike. Some worry about doing a simulation in front of others and are too intimidated to try.

Some of the simulators available today are expensive. A full-body, high-fidelity obstetric simulator with all the bells and whistles—touch-screen computer technology that enables manipulation of the labor course, for instance, and varying vital signs and fetal heart rhythms—can cost up to $40,000.

These expensive models are often purchased by academic institutions that are interested in simulation for a multitude of purposes, including team training, but such models are not necessary to simulate at least several obstetric emergencies, including vaginal breech delivery, shoulder dystocia, and the use of forceps.

For these situations, low-fidelity simulators—which may be just a model of the pelvis through which a model baby can be manually pushed—are perfectly fine. They can be purchased for $2,000-$3,000, stored in a closet, and placed in an extra exam room where physicians can practice, either with a mentor or expert or by themselves.

Nothing is as real as a true patient or a real-life situation, of course, but many of these mannequins are surprisingly lifelike, with features like an anatomically correct bony pelvis, a stretchable perineum, and a silicone pelvic-floor musculature. A mannequin's cervix, for instance, really feels like a cervix.

When I was in resident training, I practiced using the forceps on a high-fidelity mannequin. This gave me an opportunity to practice all the necessary maneuvers and to know whether I performed all critical tasks, from inserting the posterior blade first, for instance, to holding the left blade of the forceps with my left hand while using my right hand as a guide.

Later, when I was in a real and urgent situation requiring forceps, I knew just what to do. It worked like clockwork. Simulation on a low-fidelity mannequin, if that was what my institution had had, would have been just as beneficial.

Simulation also provides opportunities to create protocols. In the middle of a forceps delivery simulation, for instance, you may realize that “this needs to be done all the time just like this.” Alternatively, you may think, “Let's not do it this way next time.”

Similarly, simulation affords us opportunities to practice and fine-tune communication and teamwork.

Improved Competence

I recently oversaw a resident who had previously done simulation training with high-fidelity mannequins as part of her curriculum at the Washington Hospital Center, and was now in a real and difficult delivery involving shoulder dystocia.

She performed the recommended initial maneuvers—like placing the patient in the McRobert's position and applying suprapubic pressure—but without success. She then immediately proceeded, without any prompting, to deliver the posterior arm, which relieved the shoulder dystocia. Afterward, the resident told me that “if I hadn't done the shoulder dystocia simulation lab, I would not have known to do that.” I hear such stories often.

Studies are beginning to document the effects of obstetric simulation training on competence and performance.

In a study published several years ago, for instance, residents at Georgetown University in Washington and the Uniformed Services University of Health Sciences in Bethesda, Md., were randomized to receive training on shoulder dystocia management using a high-fidelity obstetric simulator or to receive no special training. Each resident was subsequently tested without prior notice in another simulation scenario.

Those who had practiced shoulder dystocia management on mannequins completed more critical tasks and had significantly higher scores on timeliness of their interactions, proper performance of maneuvers, and overall performance (Obstet. Gynecol. 2004:103;1224–8).

Although not randomized, another more recent study at Georgetown University showed that high-fidelity simulation training improved resident performance of vaginal breech delivery. Residents were more likely after simulation training to perform critical maneuvers correctly and to deliver in a safe manner than they were before the training (Obstet. Gynecol. 2006:107;86–9).

Research from the University of Bristol (England) is also yielding interesting results. Investigators there have reported, for instance, that obstetric emergency training courses using simulation were associated with a significant reduction in low 5-minute APGAR scores and lower rates of hypoxic-ischemic encephalopathy (BJOG 2006;113:177–82).

Another study of shoulder dystocia has shown that, whereas training with high-fidelity mannequins provides additional benefits, training with low-fidelity mannequins is also effective in improving management of the obstetric situation by obstetricians and midwives (Obstet. Gynecol. 2006;108:1477–85).

A study from the Bristol investigators in which participants were tested on a standardized simulation before a simulation workshop, and then at 3 weeks, 6 months, and 12 months afterward, shows that improved performance appears to be sustained. Those who were proficient 3 weeks after the training retained their skills at the later dates. The researchers concluded that annual training may be adequate for some physicians, whereas others may need more frequent practice (Obstet. Gynecol. 2007;110:1069–74).

Soon-to-be-published research that we have recently completed at Georgetown University and the Washington Hospital Center similarly indicates that obstetricians generally should strive for continuing simulation training at least once a year. Residents in our study who were initially taught on the simulator scored higher when tested a year later than did residents who received no simulation training. Overall, however, everyone's scores declined.

Obstetric simulation is part of our future. New physicians of the future will enter practice having done simulation training in a variety of high-acuity, low-frequency scenarios—rather than learning solely through lectures and impromptu teaching after events have occurred—and those of us already in practice will likely find that working occasionally with low-fidelity mannequins enables us to provide better, safer patient care while reducing our liability risk.

Dr. Marsha Solomon, chief resident at the Washington Hospital Center, is shown performing a simulated forceps delivery in the photo at left. In the photo at right, Dr. Solomon performs a simulated breech vaginal delivery. Photos courtesy Dr. Tamika C. Auguste

Obstetric Simulation

Do you think that you would like to have your next airplane flight piloted by someone who has not flown a plane in several years or who has little experience in landing?

Pilots are among the professionals who gain their greatest experience and expertise through the development of skills using various simulation technologies.

Simulation training is common in the aviation industry, as it is in aeronautics and in some branches of engineering, which makes this question significantly less worrisome and less relevant than if simulation were not common.

Medicine in general—and obstetrics in particular—has been practiced worldwide using the apprenticeship model, in which residents and interns work with attending physicians to learn the art of medicine.

While caring for patients with various disorders and in various scenarios, physicians-in-training work alongside the more senior practitioners, taking on progressive amounts of responsibility. Experience is gained accordingly.

This approach has been very successful over the years, and will remain so. It may be enhanced, however, as the simulation approach is slowly integrated into medicine and into obstetrics training.

The use of simulation training in medicine makes intuitive sense. The acquisition of the greatest possible skill or expertise—or the enhancement of skills if there is a hiatus in practice—makes sense from quality-of-care and patient-safety perspectives, and also because of the litigious environment in which we live and practice.

The question, “How would you like to have your baby delivered by an obstetrician who has not used forceps or managed shoulder dystocia in over a year?” is a valid one for patients who realize that less-common delivery scenarios are unpredictable.

This month's Master Class will focus on the utility, practicability, and application of simulation technology in obstetrics as a means of maximizing not only the skills of the resident, but also the skills of the practicing clinician.

Our guest author, Dr. Tamika C. Auguste, is the director of obstetric simulation at Washington Hospital Center and assistant professor of obstetrics/gynecology at Georgetown University in Washington. She speaks in various forums on the issue of simulation for both residents and practicing physicians, and is fast becoming a young leader and expert from whom we can expect to hear more in the future.

Key Points on Simulation

1. Simulation can be used to practice classic obstetric skills and high-risk, low-frequency obstetric emergencies.

2. Simulation is not only for those in academic medicine but also for those in private practice.

3. Low-fidelity simulators can be just as useful as high-fidelity simulators.

4. Simulation is becoming the norm in residency training programs.

How many of us are thoroughly, truly prepared to manage shoulder dystocia, to use forceps, or to perform a vaginal breech delivery?

It is not a silly question to ask ourselves, since these are critical, high-risk situations and skills that most of us do not encounter as frequently as routine vaginal delivery. When we are not practicing critical skills, we tend to lose them.

The question is increasingly important, moreover, because technological advances are making obstetric simulation more feasible and affordable for a variety of different settings. Realistic, low-fidelity mannequins that take up little space in an office or an old exam room are now relatively inexpensive.

Obstetric simulation training has become a tool that we simply must take advantage of. It is not only making its way into academia, with a small but growing body of literature showing that it improves competence and performance when a real event occurs, but is also gaining acceptance among practicing physicians as a valuable means of practicing skills and preparing for obstetric emergencies, such as shoulder dystocia, breech vaginal delivery, postpartum hemorrhage, and eclampsia.

I see and hear about attending physicians who join residents in the growing number of simulation programs that exist in academic institutions because they realize that they, too, can benefit from the practice. The American College of Obstetricians and Gynecologists is watching this trend; its Task Force on Simulation is examining the role of simulation in obstetrics and ways in which practicing obstetricians can take advantage of simulation technology.

Some professional liability organizations, meanwhile, are considering giving physicians discounts on their malpractice insurance premiums if they practice simulation; Harvard-affiliated obstetricians have been offered such discounts, and Kaiser Permanente is implementing simulation programs (including birth simulation training) as part of its initiatives for quality and patient safety.

It seems only a matter of time before more health care institutions draw on obstetric simulation to help practicing physicians update and reinforce their skills, and before certifying bodies also embrace the notion. (General surgery is on the cusp of establishing simulation centers for certification and recertification.)

In the meantime, obstetricians can take it upon themselves to use available technology and prepare for the high-acuity, low-frequency emergencies that are encountered by every obstetrician at some time.

Safety, Liability

That obstetric simulation is on the radar screen—and probably on its way to becoming mainstream—makes perfect sense.

Professionals in the airline industry, the military, and the nuclear power industry are already using simulation for teaching and for maintaining and evaluating skills. Simulation is a safety-first tool in these industries, and it often utilizes evidence-based protocols.

In medicine, we make evidence-based decisions all the time, and patient safety is a huge issue. The Joint Commission on Accreditation of Healthcare Organizations recently looked at all perinatal sentinel events across the country in all types of institutions, and found that 47% were linked with staff competence issues. Among the other identified root causes were communication issues (72%), the orientation and training process (40%), and organization culture as a barrier to effective communication and teamwork (55%). Simulation could play a significant role in addressing each of these issues.

Shoulder dystocia complicates up to 2% of all vaginal deliveries, and potentially causes permanent brachial plexus injury, clavicular fracture, hypoxic brain injury, and other significant long-term complications. Although we encounter shoulder dystocia infrequently, the risk for serious and permanent injury to the infant is so high that we ought to be prepared.

Similarly, approximately 3%–4% of singleton babies are in the breech position, yet only a minority of obstetricians are able to perform vaginal breech deliveries. In one recent study, only 33% of surveyed attending physicians performed vaginal breech deliveries. The rest do not do them anymore.

Although vaginal breech deliveries are discouraged, vaginal delivery is sometimes unavoidable or even preferable. (When the breech is on the perineum, for instance, it's riskier to go to cesarean delivery). We are putting our patients and ourselves at risk by not practicing and knowing how to do this with proper technique,

We do not like to talk about the litigation aspect, but we cannot hide it: Fetal injury that is related to emergencies like shoulder dystocia is a potential source of medical malpractice lawsuits and one that we can minimize by reinforcing and maintaining our skills through simulation.

Today's Simulators

Obstetricians worry about how they can do a simulation. Many think of simulators as too big, too expensive, and not lifelike. Some worry about doing a simulation in front of others and are too intimidated to try.

Some of the simulators available today are expensive. A full-body, high-fidelity obstetric simulator with all the bells and whistles—touch-screen computer technology that enables manipulation of the labor course, for instance, and varying vital signs and fetal heart rhythms—can cost up to $40,000.

These expensive models are often purchased by academic institutions that are interested in simulation for a multitude of purposes, including team training, but such models are not necessary to simulate at least several obstetric emergencies, including vaginal breech delivery, shoulder dystocia, and the use of forceps.

For these situations, low-fidelity simulators—which may be just a model of the pelvis through which a model baby can be manually pushed—are perfectly fine. They can be purchased for $2,000-$3,000, stored in a closet, and placed in an extra exam room where physicians can practice, either with a mentor or expert or by themselves.

Nothing is as real as a true patient or a real-life situation, of course, but many of these mannequins are surprisingly lifelike, with features like an anatomically correct bony pelvis, a stretchable perineum, and a silicone pelvic-floor musculature. A mannequin's cervix, for instance, really feels like a cervix.

When I was in resident training, I practiced using the forceps on a high-fidelity mannequin. This gave me an opportunity to practice all the necessary maneuvers and to know whether I performed all critical tasks, from inserting the posterior blade first, for instance, to holding the left blade of the forceps with my left hand while using my right hand as a guide.

Later, when I was in a real and urgent situation requiring forceps, I knew just what to do. It worked like clockwork. Simulation on a low-fidelity mannequin, if that was what my institution had had, would have been just as beneficial.

Simulation also provides opportunities to create protocols. In the middle of a forceps delivery simulation, for instance, you may realize that “this needs to be done all the time just like this.” Alternatively, you may think, “Let's not do it this way next time.”

Similarly, simulation affords us opportunities to practice and fine-tune communication and teamwork.

Improved Competence

I recently oversaw a resident who had previously done simulation training with high-fidelity mannequins as part of her curriculum at the Washington Hospital Center, and was now in a real and difficult delivery involving shoulder dystocia.

She performed the recommended initial maneuvers—like placing the patient in the McRobert's position and applying suprapubic pressure—but without success. She then immediately proceeded, without any prompting, to deliver the posterior arm, which relieved the shoulder dystocia. Afterward, the resident told me that “if I hadn't done the shoulder dystocia simulation lab, I would not have known to do that.” I hear such stories often.

Studies are beginning to document the effects of obstetric simulation training on competence and performance.

In a study published several years ago, for instance, residents at Georgetown University in Washington and the Uniformed Services University of Health Sciences in Bethesda, Md., were randomized to receive training on shoulder dystocia management using a high-fidelity obstetric simulator or to receive no special training. Each resident was subsequently tested without prior notice in another simulation scenario.

Those who had practiced shoulder dystocia management on mannequins completed more critical tasks and had significantly higher scores on timeliness of their interactions, proper performance of maneuvers, and overall performance (Obstet. Gynecol. 2004:103;1224–8).

Although not randomized, another more recent study at Georgetown University showed that high-fidelity simulation training improved resident performance of vaginal breech delivery. Residents were more likely after simulation training to perform critical maneuvers correctly and to deliver in a safe manner than they were before the training (Obstet. Gynecol. 2006:107;86–9).

Research from the University of Bristol (England) is also yielding interesting results. Investigators there have reported, for instance, that obstetric emergency training courses using simulation were associated with a significant reduction in low 5-minute APGAR scores and lower rates of hypoxic-ischemic encephalopathy (BJOG 2006;113:177–82).

Another study of shoulder dystocia has shown that, whereas training with high-fidelity mannequins provides additional benefits, training with low-fidelity mannequins is also effective in improving management of the obstetric situation by obstetricians and midwives (Obstet. Gynecol. 2006;108:1477–85).

A study from the Bristol investigators in which participants were tested on a standardized simulation before a simulation workshop, and then at 3 weeks, 6 months, and 12 months afterward, shows that improved performance appears to be sustained. Those who were proficient 3 weeks after the training retained their skills at the later dates. The researchers concluded that annual training may be adequate for some physicians, whereas others may need more frequent practice (Obstet. Gynecol. 2007;110:1069–74).

Soon-to-be-published research that we have recently completed at Georgetown University and the Washington Hospital Center similarly indicates that obstetricians generally should strive for continuing simulation training at least once a year. Residents in our study who were initially taught on the simulator scored higher when tested a year later than did residents who received no simulation training. Overall, however, everyone's scores declined.

Obstetric simulation is part of our future. New physicians of the future will enter practice having done simulation training in a variety of high-acuity, low-frequency scenarios—rather than learning solely through lectures and impromptu teaching after events have occurred—and those of us already in practice will likely find that working occasionally with low-fidelity mannequins enables us to provide better, safer patient care while reducing our liability risk.

Dr. Marsha Solomon, chief resident at the Washington Hospital Center, is shown performing a simulated forceps delivery in the photo at left. In the photo at right, Dr. Solomon performs a simulated breech vaginal delivery. Photos courtesy Dr. Tamika C. Auguste

Obstetric Simulation

Do you think that you would like to have your next airplane flight piloted by someone who has not flown a plane in several years or who has little experience in landing?

Pilots are among the professionals who gain their greatest experience and expertise through the development of skills using various simulation technologies.

Simulation training is common in the aviation industry, as it is in aeronautics and in some branches of engineering, which makes this question significantly less worrisome and less relevant than if simulation were not common.

Medicine in general—and obstetrics in particular—has been practiced worldwide using the apprenticeship model, in which residents and interns work with attending physicians to learn the art of medicine.

While caring for patients with various disorders and in various scenarios, physicians-in-training work alongside the more senior practitioners, taking on progressive amounts of responsibility. Experience is gained accordingly.

This approach has been very successful over the years, and will remain so. It may be enhanced, however, as the simulation approach is slowly integrated into medicine and into obstetrics training.

The use of simulation training in medicine makes intuitive sense. The acquisition of the greatest possible skill or expertise—or the enhancement of skills if there is a hiatus in practice—makes sense from quality-of-care and patient-safety perspectives, and also because of the litigious environment in which we live and practice.

The question, “How would you like to have your baby delivered by an obstetrician who has not used forceps or managed shoulder dystocia in over a year?” is a valid one for patients who realize that less-common delivery scenarios are unpredictable.

This month's Master Class will focus on the utility, practicability, and application of simulation technology in obstetrics as a means of maximizing not only the skills of the resident, but also the skills of the practicing clinician.

Our guest author, Dr. Tamika C. Auguste, is the director of obstetric simulation at Washington Hospital Center and assistant professor of obstetrics/gynecology at Georgetown University in Washington. She speaks in various forums on the issue of simulation for both residents and practicing physicians, and is fast becoming a young leader and expert from whom we can expect to hear more in the future.

Key Points on Simulation

1. Simulation can be used to practice classic obstetric skills and high-risk, low-frequency obstetric emergencies.

2. Simulation is not only for those in academic medicine but also for those in private practice.

3. Low-fidelity simulators can be just as useful as high-fidelity simulators.

4. Simulation is becoming the norm in residency training programs.

As Dr. James Presthus discussed, in-office hysteroscopy not only makes good economic sense, it is good patient care. The office hysteroscope is critical for thoroughly evaluating abnormal uterine bleeding (the most common indication) and for more accurately diagnosing its common causes while maintaining the valuable ability to “see and treat.” For the diagnosis of abnormal uterine bleeding, hysteroscopy is simply an essential, integral part of good patient care. Once you add the office hysteroscope to your diagnostic armamentarium, you will find it difficult to imagine practicing ambulatory gynecology without it.

Office hysteroscopy plays a much larger role beyond diagnosis, however, because it enables us to remove polyps and adhesions, to do biopsies, and to perform minor therapeutic and operative procedures—such as hysteroscopic sterilization using the Essure system and global endometrial ablation—in a setting where our patients are comfortable and relaxed.

Control of pain (or the perception that patients will not tolerate the procedure) seems to be the greatest concern of physicians who are considering adding in-office hysteroscopy to their practice. It need not be. Patients tolerate in-office hysteroscopy extremely well.

A small hysteroscope is no larger than a Pipelle endometrial suction curette. Showing the patient a picture of both instruments, side by side, is truly worth a thousand words. Add to that the reduction in anxiety thanks to familiar surroundings, the conversations with office staff who often know the patient on a first-name basis, and a visualization of the procedure, and the discomfort that would be experienced in an operating room quickly dissipates.

Diagnostic hysteroscopy with a 3-mm flexible hysteroscope, in fact, does not require any anesthesia. Nevertheless, because studies indicate that a minority of patients find distention of the uterus uncomfortable and because we take a “see and treat” approach to in-office hysteroscopy, we use a small paracervical block. This way, virtually 100% of our patients are completely comfortable, and we are ready to move on to treatment if needed.

This is exactly what we tell our patients: that the small injection of local anesthetic will help them to tolerate the procedure, especially if we find a polyp or other abnormal tissue and want to remove it on the spot rather than subject them to a second procedure at a later date.

Both the Essure procedure and global endometrial ablation—we use a thermal ablation device called the Hydro ThermAblator (HTA) system—can be performed under local anesthesia with oral premedication at home.

When you embark on in-office operative hysteroscopy, it is vital to be aware of state regulations regarding in-office surgery. Almost 20 states now have rules that differentiate procedures into level I surgery and level II surgery, depending largely on the types of anesthesia used.

The South Carolina Board of Medical Examiners, for instance, defines level I surgery as including minor procedures in which “[oral] preoperative medication and/or unsupplemented local anesthesia” is used in quantities no greater than the manufacturer's recommended dose, with “no drug-induced alteration of consciousness other than preoperative minimal [oral] anxiolysis of the patient.”

Level II office surgery includes procedures that “require the administration of minimal or moderate intravenous, intramuscular, or rectal sedation/analgesia, thus making postoperative monitoring necessary.” Offices performing level II surgery must receive certification and follow various regulations and standards aimed at ensuring patient safety. A significant amount of office-based surgery done today involves the use of parenteral narcotics and thus is considered level II surgery. The protocols we use for in-office hysteroscopy and hysteroscopic procedures, however, are all level I.

For ablation, the HTA system is ideally suited for office use under minimal or level I sedation because it operates at low pressure (50 mm Hg) and is a “no touch” technique. Many of the other nonhysteroscopic global ablation technologies have also been used in the office setting, but—in order to ensure patient comfort—they may require parenteral narcotics, which are considered moderate or level II sedation.

Instrumentation and Setup

For diagnostic hysteroscopy, I favor a 3-mm flexible hysteroscope. I also prefer using normal warmed saline as a distension medium, and I have found that hanging the saline in a 1,000-cc bag on a tall IV pole, with standard IV tubing and with a pressure cuff to maintain distention, is an ideal setup. We use the C-Fusor pressure infusor bag.

Injecting the saline with a 60-cc syringe is another option and is certainly adequate for a quick diagnostic procedure. The disadvantage to this approach, however, is the likelihood of needing to continually change syringes if polyp removal or another treatment is needed, or if the patient has a patulous cervix and transcervical fluid loss occurs.

Some physicians prefer not to purchase a flexible scope and instead choose a continuous-flow diagnostic/operative hysteroscope. For the physician who is just starting out and wants one piece of equipment with the most versatility, I would recommend a 5.5-mm continuous flow hysteroscope with a 5-Fr operating channel. The Bettocchi 4.5-mm continuous flow hysteroscope is another alternative.

In either case, the use of these rigid scopes demands the use of a tenaculum as well. Because application of a tenaculum is often uncomfortable for the patient, local anesthetic should be used at the tenaculum site, as well as a small paracervical block in case the cervix needs to be dilated.

When a rigid hysteroscope is used diagnostically, an open-sided speculum should be used, because a closed speculum will restrict the free movement of the scope. After the hysteroscope is inserted through the cervix, the open-sided speculum is removed to allow for free lateral movement of the scope. Such a choice is irrelevant when a flexible hysteroscope is used because the end of the scope moves freely and flexes up to 110 degrees, allowing for adequate visualization of the cornua and the tubal ostia.

[Note: Vaginoscopy, a new technique, popularized in Italy, entails the insertion of a small-diameter rigid or flexible scope directly into the vagina without the use of a speculum, and then right into the cervix and uterus without the use of a tenaculum. The procedure appears to be well tolerated by patients, but it may not work well in patients with a narrow cervical os.]

Insertion of the hysteroscope through the cervix should always be done under direct visualization with fluid running and a camera always at the 12:00 position. It rarely is necessary to dilate the cervix when using a 3-mm flexible hysteroscope, even in nulliparous or postmenopausal women. Once the scope passes the external os, fluid pressure will sufficiently dilate the cervical canal. Dilatation is more often necessary when a 5.5-mm operative hysteroscope is used, though rarely for multiparous women.

When a polyp is visualized during a diagnostic hysteroscopy performed with a 3-mm flexible hysteroscope, the cervix can then be dilated to 5 mm or 6 mm if necessary, and the polyp can be removed using a Randall stone forceps inserted to the area where the polyp was visualized. Alternatively, a 2- to 3-mm-long laryngeal polyp forceps can be placed into the uterus alongside the flexible hysteroscope and used to remove the polyp under direct visualization.

Other forceps that are useful for polyp removal are the Kelly, Sopher, and Javerts polyp forceps. These instruments are 7 mm in diameter and are easily inserted if the cervix is dilated using standard Hegar or Pratt dilators to 6–7 mm. This can be done without any patient discomfort if a paracervical block has been administered initially.

The use of a continuous flow operative scope with a 5-Fr to 7-Fr operative channel instead of the diagnostic scope is another option for polyp removal, foreign body removal, or directed biopsy. It is most important not to attempt to pull a biopsy out through the operative channel, but rather to move the entire scope from the cervix with the specimen in view.

Our basic instrument tray for diagnostic and operative hysteroscopy, therefore, consists of an open-sided speculum; a series of Hagar dilators; a single-tooth tenaculum; a stainless steel or glass medicine cup; polyp forceps and Randall stone forceps; 9-inch ring forceps; two surgical towels; a 10-cc control syringe; a 22-gauge spinal needle; and 10 4-by-4-inch sponges. (We buy nonsterile sponges in packages of 500 and put 10 on each instrument tray, and then we steam-autoclave each kit.)

We always have a second sterile tenaculum in case the patient has a patulous cervix. A Gimpleson four-prong tenaculum is also valuable for the control of transcervical leakage.

Other basic equipment includes a camera system, a monitor (the new flat-panel monitors available from scope manufacturers are lightweight and compact), a light source (preferably xenon), and if possible, a video printer. We do not sterilize our cameras because the cameras will last longer if they are not subject to soaking or steam autoclaving. Instead, we simply fold an 11-by-17-inch Steri-Drape with an adhesive edge over the nonsterile camera.

For the Essure procedure, we use a sterile under-buttock drape with a fluid collection pouch to keep track of inflow and outflow.

Every procedure room should also have basic safety equipment: an oxygen supply with a mask or nasal cannula; a positive pressure manual resuscitator (Ambu bag); and monitoring equipment for pulse and blood pressure. We use a Dinamap automatic blood pressure and pulse monitor, which frees the nurse to concentrate on talking with the patient.

An automatic electronic defibrillator is optional, but it certainly is a good piece of relatively inexpensive equipment for any medical office to have, and I encourage its inclusion in any in-office hysteroscopy setup. A pulse oximeter is mandatory only for level II procedures. With office hysteroscopy, you likely will never use one (we have not), but it is nice to know it's there to use if a patient has a change in consciousness.

When level II procedures are being performed using parenteral narcotics and/or sedatives, a fully stocked crash cart is required, and an ACLS (advanced cardiac life support)-certified staff member who is not performing the procedure must be present to monitor the patient.

Anesthesia and Patient Comfort

At the Kaiser Permanente San Rafael (Calif.) Medical Center, we have performed more than 12,000 gynecologic office procedures—from diagnostic hysteroscopies to hysteroscopic sterilizations and endometrial ablations—under local anesthesia with minimal oral sedation, over a 25-year period.

For diagnostic and minor operative hysteroscopy, we generally instruct patients to take 400–800 mg ibuprofen at home 1 hour before the procedure. We administer a paracervical block consisting of 5–10 mL of 1% lidocaine to the cervical vaginal junction superficially through the mucosa at 3:00 and 9:00.

Whenever a tenaculum is used, we also inject the anterior lip of the cervix with approximately 1–2 mL of local anesthetic before the tenaculum is applied, and then leave the room for 5–10 minutes to allow the block to set properly.

Remember, as with any office gynecologic procedure, it is important to use a “no-touch” technique, as the uterine wall is innervated by both sympathetic and parasympathetic fibers. It is unnecessary to sound the uterus; the old but still common practice of sounding is uncomfortable for the patient and may provoke uterine contractions that make distention of the uterus difficult. It may also cause perforation and is simply unnecessary.

Our oral premedication regimen for HTA and Essure procedures consists of 800 mg ibuprofen (Motrin), 10 mg diazepam (Valium), and two hydrocodone/acetaminophen (Vicodin) tablets taken at home 1–2 hours before the procedure. Patients are instructed to arrive 30 minutes prior to their scheduled appointment, at which time they are given an intramuscular injection of 30 mg ketorolac (Toradol) and 0.4 mg atropine.

Toradol is a prostaglandin synthetase inhibitor and has a peripheral effect as well. Atropine is used to prevent vasovagal reactions. The patient should be warned that she may experience dry mouth, but that this is preferable to the extreme discomfort felt during a vasovagal episode.

We then administer a paracervical/intracervical block with 1% mepivacaine (Carbocaine, Polocaine), which is longer acting than lidocaine. We inject 2 mL in the anterior lip of the cervix before it is grasped with a tenaculum; we place the needle against the cervix and ask the patient to cough, which results in self-injection. We then inject 10 mL in the cervicovaginal junction on each side at 3:00 and 9:00. These injections are given superficially, just under the mucosa, to raise a weal.

We inject an additional 5 mL intracervically about 1–2 cm deep at 8:00 and 4:00, and 5 mL submucosally at 6:00 between the uterosacrals. The total amount of mepivacaine given is 37 mL, or 370 mg (the recommended maximum dose is 400 mg).

Again, it is important to leave the room for 10–15 minutes to allow the block to set properly. We recommend that the physician leave while the nurse stays to monitor the patient and help her relax.

The Essure procedure can be done with less oral anesthesia and a smaller paracervical or intracervical block than endometrial ablation requires, but because our patients tolerate our ablation anesthesia regimen so well, we use it for both procedures.

In a study of 249 endometrial ablations performed at Kaiser Permanente San Rafael over 5.5 years using the HTA system, only one procedure was discontinued because of pain, and two patients were admitted overnight for cramping and nausea. The overall success rate was 90.6%, despite 40% of our patients having submucous myomas. The only complications were four cases of postoperative endometritis, with two of those patients requiring hospitalization for intravenous antibiotics, and two cases of procedure failure due to false passages.

We have not had any adverse anesthetic reactions in our patients who have undergone HTA over the years, or in any of the thousands of other women who were given similar paracervical blocks for office gynecologic procedures.

Postprocedure recovery is rarely necessary for these level I procedures. Our nurses monitor patients' blood pressure for 10–15 minutes after the procedures are completed and ensure that patients are feeling well and are ambulatory. This monitoring is done in the procedure room. Patients who don't feel well enough to leave in that time period are brought into another exam room and are discharged when they are ready. This is very rare.

Our patients also receive written postoperative instructions that tell them to report any increase in abdominal pain, any fever, any foul-smelling discharge, and—after endometrial ablation—the absence of any discharge.

Most of the time, patients will just wave good-bye, pleased to have had their procedure done in the office.

For level II procedures, the postrecovery protocol is much more complex.

The South Carolina rule, for instance, states that monitoring in the recovery area must include both pulse oximetry and noninvasive blood pressure measurement, and that the patient must be assessed for level of consciousness, pain relief, or any untoward complication.

Most states require that the patient be monitored for at least 30 minutes and, depending on which drugs were administered, for as long as 2 hours.

Again, it is important for physicians who plan to use anything but minimal sedation in the office to know their state requirements, if any. These can usually be obtained online from the state department of health services.

A photo of a 3-mm flexible hysteroscope with other commonly used office instruments reassures patients. Courtesy Dr. Mark Glasser

A 42-year-old patient with a 4-cm type 0 myoma was treated in the office with the HTA system (preoperative view at left). The patient has been amenorrheic for more than 6 years (postprocedure view at right). Photos courtesy Dr. Mark Glasser

The Medex C-Fusor is placed around a bag of normal saline, which is used to maintain distention pressure. Courtesy Dr. Mark Glasser

This image shows paracervical block injection sites (dots) and doses of 1% mepivicaine (arrows) injected at each site. Courtesy Dr. Mark Glasser

In-Office Gynecologic Surgery, Part 2

In the last Master Class in Gynecologic Surgery, Dr. James Presthus provided the reader with an overview on in-office gynecologic surgery. Hysteroscopy, the standard of care in the diagnosis and treatment of abnormal uterine bleeding, is a procedure that lends itself especially readily to an office environment.

Dr. Presthus pointed out that the physician “can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.” He emphasized that despite the use of less anesthesia, patients routinely tolerate the procedure well.

Dr. Presthus gave us the “why” behind his recommendation that the gynecologist commit to office-based surgery.

Now, Dr. Mark Glasser provides us with the “how and what” considerations of in-office gynecologic surgery, focusing on hysteroscopy, global endometrial ablation, and the Essure tubal occlusion procedure.

Not only does Dr. Glasser make recommendations on instrumentation, he also discusses the surgical technique of hysteroscopy and the anesthesia concerns that can arise. This article is an excellent primer for those considering in-office hysteroscopy.

From 1992 until 2006, Dr. Glasser was the director of advanced gynecologic laparoscopy training for the Kaiser Northern California Region. He is a past member of the board of trustees of the AAGL and continues to serve on the national advisory committee of the AAGL and the editorial board of the Journal of Minimally Invasive Gynecology.

As Dr. James Presthus discussed, in-office hysteroscopy not only makes good economic sense, it is good patient care. The office hysteroscope is critical for thoroughly evaluating abnormal uterine bleeding (the most common indication) and for more accurately diagnosing its common causes while maintaining the valuable ability to “see and treat.” For the diagnosis of abnormal uterine bleeding, hysteroscopy is simply an essential, integral part of good patient care. Once you add the office hysteroscope to your diagnostic armamentarium, you will find it difficult to imagine practicing ambulatory gynecology without it.

Office hysteroscopy plays a much larger role beyond diagnosis, however, because it enables us to remove polyps and adhesions, to do biopsies, and to perform minor therapeutic and operative procedures—such as hysteroscopic sterilization using the Essure system and global endometrial ablation—in a setting where our patients are comfortable and relaxed.

Control of pain (or the perception that patients will not tolerate the procedure) seems to be the greatest concern of physicians who are considering adding in-office hysteroscopy to their practice. It need not be. Patients tolerate in-office hysteroscopy extremely well.

A small hysteroscope is no larger than a Pipelle endometrial suction curette. Showing the patient a picture of both instruments, side by side, is truly worth a thousand words. Add to that the reduction in anxiety thanks to familiar surroundings, the conversations with office staff who often know the patient on a first-name basis, and a visualization of the procedure, and the discomfort that would be experienced in an operating room quickly dissipates.

Diagnostic hysteroscopy with a 3-mm flexible hysteroscope, in fact, does not require any anesthesia. Nevertheless, because studies indicate that a minority of patients find distention of the uterus uncomfortable and because we take a “see and treat” approach to in-office hysteroscopy, we use a small paracervical block. This way, virtually 100% of our patients are completely comfortable, and we are ready to move on to treatment if needed.

This is exactly what we tell our patients: that the small injection of local anesthetic will help them to tolerate the procedure, especially if we find a polyp or other abnormal tissue and want to remove it on the spot rather than subject them to a second procedure at a later date.

Both the Essure procedure and global endometrial ablation—we use a thermal ablation device called the Hydro ThermAblator (HTA) system—can be performed under local anesthesia with oral premedication at home.

When you embark on in-office operative hysteroscopy, it is vital to be aware of state regulations regarding in-office surgery. Almost 20 states now have rules that differentiate procedures into level I surgery and level II surgery, depending largely on the types of anesthesia used.

The South Carolina Board of Medical Examiners, for instance, defines level I surgery as including minor procedures in which “[oral] preoperative medication and/or unsupplemented local anesthesia” is used in quantities no greater than the manufacturer's recommended dose, with “no drug-induced alteration of consciousness other than preoperative minimal [oral] anxiolysis of the patient.”

Level II office surgery includes procedures that “require the administration of minimal or moderate intravenous, intramuscular, or rectal sedation/analgesia, thus making postoperative monitoring necessary.” Offices performing level II surgery must receive certification and follow various regulations and standards aimed at ensuring patient safety. A significant amount of office-based surgery done today involves the use of parenteral narcotics and thus is considered level II surgery. The protocols we use for in-office hysteroscopy and hysteroscopic procedures, however, are all level I.

For ablation, the HTA system is ideally suited for office use under minimal or level I sedation because it operates at low pressure (50 mm Hg) and is a “no touch” technique. Many of the other nonhysteroscopic global ablation technologies have also been used in the office setting, but—in order to ensure patient comfort—they may require parenteral narcotics, which are considered moderate or level II sedation.

Instrumentation and Setup

For diagnostic hysteroscopy, I favor a 3-mm flexible hysteroscope. I also prefer using normal warmed saline as a distension medium, and I have found that hanging the saline in a 1,000-cc bag on a tall IV pole, with standard IV tubing and with a pressure cuff to maintain distention, is an ideal setup. We use the C-Fusor pressure infusor bag.

Injecting the saline with a 60-cc syringe is another option and is certainly adequate for a quick diagnostic procedure. The disadvantage to this approach, however, is the likelihood of needing to continually change syringes if polyp removal or another treatment is needed, or if the patient has a patulous cervix and transcervical fluid loss occurs.

Some physicians prefer not to purchase a flexible scope and instead choose a continuous-flow diagnostic/operative hysteroscope. For the physician who is just starting out and wants one piece of equipment with the most versatility, I would recommend a 5.5-mm continuous flow hysteroscope with a 5-Fr operating channel. The Bettocchi 4.5-mm continuous flow hysteroscope is another alternative.

In either case, the use of these rigid scopes demands the use of a tenaculum as well. Because application of a tenaculum is often uncomfortable for the patient, local anesthetic should be used at the tenaculum site, as well as a small paracervical block in case the cervix needs to be dilated.

When a rigid hysteroscope is used diagnostically, an open-sided speculum should be used, because a closed speculum will restrict the free movement of the scope. After the hysteroscope is inserted through the cervix, the open-sided speculum is removed to allow for free lateral movement of the scope. Such a choice is irrelevant when a flexible hysteroscope is used because the end of the scope moves freely and flexes up to 110 degrees, allowing for adequate visualization of the cornua and the tubal ostia.

[Note: Vaginoscopy, a new technique, popularized in Italy, entails the insertion of a small-diameter rigid or flexible scope directly into the vagina without the use of a speculum, and then right into the cervix and uterus without the use of a tenaculum. The procedure appears to be well tolerated by patients, but it may not work well in patients with a narrow cervical os.]

Insertion of the hysteroscope through the cervix should always be done under direct visualization with fluid running and a camera always at the 12:00 position. It rarely is necessary to dilate the cervix when using a 3-mm flexible hysteroscope, even in nulliparous or postmenopausal women. Once the scope passes the external os, fluid pressure will sufficiently dilate the cervical canal. Dilatation is more often necessary when a 5.5-mm operative hysteroscope is used, though rarely for multiparous women.

When a polyp is visualized during a diagnostic hysteroscopy performed with a 3-mm flexible hysteroscope, the cervix can then be dilated to 5 mm or 6 mm if necessary, and the polyp can be removed using a Randall stone forceps inserted to the area where the polyp was visualized. Alternatively, a 2- to 3-mm-long laryngeal polyp forceps can be placed into the uterus alongside the flexible hysteroscope and used to remove the polyp under direct visualization.

Other forceps that are useful for polyp removal are the Kelly, Sopher, and Javerts polyp forceps. These instruments are 7 mm in diameter and are easily inserted if the cervix is dilated using standard Hegar or Pratt dilators to 6–7 mm. This can be done without any patient discomfort if a paracervical block has been administered initially.

The use of a continuous flow operative scope with a 5-Fr to 7-Fr operative channel instead of the diagnostic scope is another option for polyp removal, foreign body removal, or directed biopsy. It is most important not to attempt to pull a biopsy out through the operative channel, but rather to move the entire scope from the cervix with the specimen in view.

Our basic instrument tray for diagnostic and operative hysteroscopy, therefore, consists of an open-sided speculum; a series of Hagar dilators; a single-tooth tenaculum; a stainless steel or glass medicine cup; polyp forceps and Randall stone forceps; 9-inch ring forceps; two surgical towels; a 10-cc control syringe; a 22-gauge spinal needle; and 10 4-by-4-inch sponges. (We buy nonsterile sponges in packages of 500 and put 10 on each instrument tray, and then we steam-autoclave each kit.)

We always have a second sterile tenaculum in case the patient has a patulous cervix. A Gimpleson four-prong tenaculum is also valuable for the control of transcervical leakage.

Other basic equipment includes a camera system, a monitor (the new flat-panel monitors available from scope manufacturers are lightweight and compact), a light source (preferably xenon), and if possible, a video printer. We do not sterilize our cameras because the cameras will last longer if they are not subject to soaking or steam autoclaving. Instead, we simply fold an 11-by-17-inch Steri-Drape with an adhesive edge over the nonsterile camera.

For the Essure procedure, we use a sterile under-buttock drape with a fluid collection pouch to keep track of inflow and outflow.

Every procedure room should also have basic safety equipment: an oxygen supply with a mask or nasal cannula; a positive pressure manual resuscitator (Ambu bag); and monitoring equipment for pulse and blood pressure. We use a Dinamap automatic blood pressure and pulse monitor, which frees the nurse to concentrate on talking with the patient.

An automatic electronic defibrillator is optional, but it certainly is a good piece of relatively inexpensive equipment for any medical office to have, and I encourage its inclusion in any in-office hysteroscopy setup. A pulse oximeter is mandatory only for level II procedures. With office hysteroscopy, you likely will never use one (we have not), but it is nice to know it's there to use if a patient has a change in consciousness.

When level II procedures are being performed using parenteral narcotics and/or sedatives, a fully stocked crash cart is required, and an ACLS (advanced cardiac life support)-certified staff member who is not performing the procedure must be present to monitor the patient.

Anesthesia and Patient Comfort

At the Kaiser Permanente San Rafael (Calif.) Medical Center, we have performed more than 12,000 gynecologic office procedures—from diagnostic hysteroscopies to hysteroscopic sterilizations and endometrial ablations—under local anesthesia with minimal oral sedation, over a 25-year period.

For diagnostic and minor operative hysteroscopy, we generally instruct patients to take 400–800 mg ibuprofen at home 1 hour before the procedure. We administer a paracervical block consisting of 5–10 mL of 1% lidocaine to the cervical vaginal junction superficially through the mucosa at 3:00 and 9:00.

Whenever a tenaculum is used, we also inject the anterior lip of the cervix with approximately 1–2 mL of local anesthetic before the tenaculum is applied, and then leave the room for 5–10 minutes to allow the block to set properly.

Remember, as with any office gynecologic procedure, it is important to use a “no-touch” technique, as the uterine wall is innervated by both sympathetic and parasympathetic fibers. It is unnecessary to sound the uterus; the old but still common practice of sounding is uncomfortable for the patient and may provoke uterine contractions that make distention of the uterus difficult. It may also cause perforation and is simply unnecessary.

Our oral premedication regimen for HTA and Essure procedures consists of 800 mg ibuprofen (Motrin), 10 mg diazepam (Valium), and two hydrocodone/acetaminophen (Vicodin) tablets taken at home 1–2 hours before the procedure. Patients are instructed to arrive 30 minutes prior to their scheduled appointment, at which time they are given an intramuscular injection of 30 mg ketorolac (Toradol) and 0.4 mg atropine.

Toradol is a prostaglandin synthetase inhibitor and has a peripheral effect as well. Atropine is used to prevent vasovagal reactions. The patient should be warned that she may experience dry mouth, but that this is preferable to the extreme discomfort felt during a vasovagal episode.

We then administer a paracervical/intracervical block with 1% mepivacaine (Carbocaine, Polocaine), which is longer acting than lidocaine. We inject 2 mL in the anterior lip of the cervix before it is grasped with a tenaculum; we place the needle against the cervix and ask the patient to cough, which results in self-injection. We then inject 10 mL in the cervicovaginal junction on each side at 3:00 and 9:00. These injections are given superficially, just under the mucosa, to raise a weal.

We inject an additional 5 mL intracervically about 1–2 cm deep at 8:00 and 4:00, and 5 mL submucosally at 6:00 between the uterosacrals. The total amount of mepivacaine given is 37 mL, or 370 mg (the recommended maximum dose is 400 mg).

Again, it is important to leave the room for 10–15 minutes to allow the block to set properly. We recommend that the physician leave while the nurse stays to monitor the patient and help her relax.

The Essure procedure can be done with less oral anesthesia and a smaller paracervical or intracervical block than endometrial ablation requires, but because our patients tolerate our ablation anesthesia regimen so well, we use it for both procedures.

In a study of 249 endometrial ablations performed at Kaiser Permanente San Rafael over 5.5 years using the HTA system, only one procedure was discontinued because of pain, and two patients were admitted overnight for cramping and nausea. The overall success rate was 90.6%, despite 40% of our patients having submucous myomas. The only complications were four cases of postoperative endometritis, with two of those patients requiring hospitalization for intravenous antibiotics, and two cases of procedure failure due to false passages.

We have not had any adverse anesthetic reactions in our patients who have undergone HTA over the years, or in any of the thousands of other women who were given similar paracervical blocks for office gynecologic procedures.

Postprocedure recovery is rarely necessary for these level I procedures. Our nurses monitor patients' blood pressure for 10–15 minutes after the procedures are completed and ensure that patients are feeling well and are ambulatory. This monitoring is done in the procedure room. Patients who don't feel well enough to leave in that time period are brought into another exam room and are discharged when they are ready. This is very rare.

Our patients also receive written postoperative instructions that tell them to report any increase in abdominal pain, any fever, any foul-smelling discharge, and—after endometrial ablation—the absence of any discharge.

Most of the time, patients will just wave good-bye, pleased to have had their procedure done in the office.

For level II procedures, the postrecovery protocol is much more complex.

The South Carolina rule, for instance, states that monitoring in the recovery area must include both pulse oximetry and noninvasive blood pressure measurement, and that the patient must be assessed for level of consciousness, pain relief, or any untoward complication.

Most states require that the patient be monitored for at least 30 minutes and, depending on which drugs were administered, for as long as 2 hours.

Again, it is important for physicians who plan to use anything but minimal sedation in the office to know their state requirements, if any. These can usually be obtained online from the state department of health services.

A photo of a 3-mm flexible hysteroscope with other commonly used office instruments reassures patients. Courtesy Dr. Mark Glasser

A 42-year-old patient with a 4-cm type 0 myoma was treated in the office with the HTA system (preoperative view at left). The patient has been amenorrheic for more than 6 years (postprocedure view at right). Photos courtesy Dr. Mark Glasser

The Medex C-Fusor is placed around a bag of normal saline, which is used to maintain distention pressure. Courtesy Dr. Mark Glasser

This image shows paracervical block injection sites (dots) and doses of 1% mepivicaine (arrows) injected at each site. Courtesy Dr. Mark Glasser

In-Office Gynecologic Surgery, Part 2

In the last Master Class in Gynecologic Surgery, Dr. James Presthus provided the reader with an overview on in-office gynecologic surgery. Hysteroscopy, the standard of care in the diagnosis and treatment of abnormal uterine bleeding, is a procedure that lends itself especially readily to an office environment.

Dr. Presthus pointed out that the physician “can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.” He emphasized that despite the use of less anesthesia, patients routinely tolerate the procedure well.

Dr. Presthus gave us the “why” behind his recommendation that the gynecologist commit to office-based surgery.

Now, Dr. Mark Glasser provides us with the “how and what” considerations of in-office gynecologic surgery, focusing on hysteroscopy, global endometrial ablation, and the Essure tubal occlusion procedure.

Not only does Dr. Glasser make recommendations on instrumentation, he also discusses the surgical technique of hysteroscopy and the anesthesia concerns that can arise. This article is an excellent primer for those considering in-office hysteroscopy.

From 1992 until 2006, Dr. Glasser was the director of advanced gynecologic laparoscopy training for the Kaiser Northern California Region. He is a past member of the board of trustees of the AAGL and continues to serve on the national advisory committee of the AAGL and the editorial board of the Journal of Minimally Invasive Gynecology.

As Dr. James Presthus discussed, in-office hysteroscopy not only makes good economic sense, it is good patient care. The office hysteroscope is critical for thoroughly evaluating abnormal uterine bleeding (the most common indication) and for more accurately diagnosing its common causes while maintaining the valuable ability to “see and treat.” For the diagnosis of abnormal uterine bleeding, hysteroscopy is simply an essential, integral part of good patient care. Once you add the office hysteroscope to your diagnostic armamentarium, you will find it difficult to imagine practicing ambulatory gynecology without it.

Office hysteroscopy plays a much larger role beyond diagnosis, however, because it enables us to remove polyps and adhesions, to do biopsies, and to perform minor therapeutic and operative procedures—such as hysteroscopic sterilization using the Essure system and global endometrial ablation—in a setting where our patients are comfortable and relaxed.

Control of pain (or the perception that patients will not tolerate the procedure) seems to be the greatest concern of physicians who are considering adding in-office hysteroscopy to their practice. It need not be. Patients tolerate in-office hysteroscopy extremely well.

A small hysteroscope is no larger than a Pipelle endometrial suction curette. Showing the patient a picture of both instruments, side by side, is truly worth a thousand words. Add to that the reduction in anxiety thanks to familiar surroundings, the conversations with office staff who often know the patient on a first-name basis, and a visualization of the procedure, and the discomfort that would be experienced in an operating room quickly dissipates.

Diagnostic hysteroscopy with a 3-mm flexible hysteroscope, in fact, does not require any anesthesia. Nevertheless, because studies indicate that a minority of patients find distention of the uterus uncomfortable and because we take a “see and treat” approach to in-office hysteroscopy, we use a small paracervical block. This way, virtually 100% of our patients are completely comfortable, and we are ready to move on to treatment if needed.

This is exactly what we tell our patients: that the small injection of local anesthetic will help them to tolerate the procedure, especially if we find a polyp or other abnormal tissue and want to remove it on the spot rather than subject them to a second procedure at a later date.

Both the Essure procedure and global endometrial ablation—we use a thermal ablation device called the Hydro ThermAblator (HTA) system—can be performed under local anesthesia with oral premedication at home.

When you embark on in-office operative hysteroscopy, it is vital to be aware of state regulations regarding in-office surgery. Almost 20 states now have rules that differentiate procedures into level I surgery and level II surgery, depending largely on the types of anesthesia used.

The South Carolina Board of Medical Examiners, for instance, defines level I surgery as including minor procedures in which “[oral] preoperative medication and/or unsupplemented local anesthesia” is used in quantities no greater than the manufacturer's recommended dose, with “no drug-induced alteration of consciousness other than preoperative minimal [oral] anxiolysis of the patient.”

Level II office surgery includes procedures that “require the administration of minimal or moderate intravenous, intramuscular, or rectal sedation/analgesia, thus making postoperative monitoring necessary.” Offices performing level II surgery must receive certification and follow various regulations and standards aimed at ensuring patient safety. A significant amount of office-based surgery done today involves the use of parenteral narcotics and thus is considered level II surgery. The protocols we use for in-office hysteroscopy and hysteroscopic procedures, however, are all level I.

For ablation, the HTA system is ideally suited for office use under minimal or level I sedation because it operates at low pressure (50 mm Hg) and is a “no touch” technique. Many of the other nonhysteroscopic global ablation technologies have also been used in the office setting, but—in order to ensure patient comfort—they may require parenteral narcotics, which are considered moderate or level II sedation.

Instrumentation and Setup

For diagnostic hysteroscopy, I favor a 3-mm flexible hysteroscope. I also prefer using normal warmed saline as a distension medium, and I have found that hanging the saline in a 1,000-cc bag on a tall IV pole, with standard IV tubing and with a pressure cuff to maintain distention, is an ideal setup. We use the C-Fusor pressure infusor bag.

Injecting the saline with a 60-cc syringe is another option and is certainly adequate for a quick diagnostic procedure. The disadvantage to this approach, however, is the likelihood of needing to continually change syringes if polyp removal or another treatment is needed, or if the patient has a patulous cervix and transcervical fluid loss occurs.

Some physicians prefer not to purchase a flexible scope and instead choose a continuous-flow diagnostic/operative hysteroscope. For the physician who is just starting out and wants one piece of equipment with the most versatility, I would recommend a 5.5-mm continuous flow hysteroscope with a 5-Fr operating channel. The Bettocchi 4.5-mm continuous flow hysteroscope is another alternative.

In either case, the use of these rigid scopes demands the use of a tenaculum as well. Because application of a tenaculum is often uncomfortable for the patient, local anesthetic should be used at the tenaculum site, as well as a small paracervical block in case the cervix needs to be dilated.

When a rigid hysteroscope is used diagnostically, an open-sided speculum should be used, because a closed speculum will restrict the free movement of the scope. After the hysteroscope is inserted through the cervix, the open-sided speculum is removed to allow for free lateral movement of the scope. Such a choice is irrelevant when a flexible hysteroscope is used because the end of the scope moves freely and flexes up to 110 degrees, allowing for adequate visualization of the cornua and the tubal ostia.

[Note: Vaginoscopy, a new technique, popularized in Italy, entails the insertion of a small-diameter rigid or flexible scope directly into the vagina without the use of a speculum, and then right into the cervix and uterus without the use of a tenaculum. The procedure appears to be well tolerated by patients, but it may not work well in patients with a narrow cervical os.]

Insertion of the hysteroscope through the cervix should always be done under direct visualization with fluid running and a camera always at the 12:00 position. It rarely is necessary to dilate the cervix when using a 3-mm flexible hysteroscope, even in nulliparous or postmenopausal women. Once the scope passes the external os, fluid pressure will sufficiently dilate the cervical canal. Dilatation is more often necessary when a 5.5-mm operative hysteroscope is used, though rarely for multiparous women.

When a polyp is visualized during a diagnostic hysteroscopy performed with a 3-mm flexible hysteroscope, the cervix can then be dilated to 5 mm or 6 mm if necessary, and the polyp can be removed using a Randall stone forceps inserted to the area where the polyp was visualized. Alternatively, a 2- to 3-mm-long laryngeal polyp forceps can be placed into the uterus alongside the flexible hysteroscope and used to remove the polyp under direct visualization.

Other forceps that are useful for polyp removal are the Kelly, Sopher, and Javerts polyp forceps. These instruments are 7 mm in diameter and are easily inserted if the cervix is dilated using standard Hegar or Pratt dilators to 6–7 mm. This can be done without any patient discomfort if a paracervical block has been administered initially.

The use of a continuous flow operative scope with a 5-Fr to 7-Fr operative channel instead of the diagnostic scope is another option for polyp removal, foreign body removal, or directed biopsy. It is most important not to attempt to pull a biopsy out through the operative channel, but rather to move the entire scope from the cervix with the specimen in view.

Our basic instrument tray for diagnostic and operative hysteroscopy, therefore, consists of an open-sided speculum; a series of Hagar dilators; a single-tooth tenaculum; a stainless steel or glass medicine cup; polyp forceps and Randall stone forceps; 9-inch ring forceps; two surgical towels; a 10-cc control syringe; a 22-gauge spinal needle; and 10 4-by-4-inch sponges. (We buy nonsterile sponges in packages of 500 and put 10 on each instrument tray, and then we steam-autoclave each kit.)

We always have a second sterile tenaculum in case the patient has a patulous cervix. A Gimpleson four-prong tenaculum is also valuable for the control of transcervical leakage.

Other basic equipment includes a camera system, a monitor (the new flat-panel monitors available from scope manufacturers are lightweight and compact), a light source (preferably xenon), and if possible, a video printer. We do not sterilize our cameras because the cameras will last longer if they are not subject to soaking or steam autoclaving. Instead, we simply fold an 11-by-17-inch Steri-Drape with an adhesive edge over the nonsterile camera.

For the Essure procedure, we use a sterile under-buttock drape with a fluid collection pouch to keep track of inflow and outflow.

Every procedure room should also have basic safety equipment: an oxygen supply with a mask or nasal cannula; a positive pressure manual resuscitator (Ambu bag); and monitoring equipment for pulse and blood pressure. We use a Dinamap automatic blood pressure and pulse monitor, which frees the nurse to concentrate on talking with the patient.

An automatic electronic defibrillator is optional, but it certainly is a good piece of relatively inexpensive equipment for any medical office to have, and I encourage its inclusion in any in-office hysteroscopy setup. A pulse oximeter is mandatory only for level II procedures. With office hysteroscopy, you likely will never use one (we have not), but it is nice to know it's there to use if a patient has a change in consciousness.

When level II procedures are being performed using parenteral narcotics and/or sedatives, a fully stocked crash cart is required, and an ACLS (advanced cardiac life support)-certified staff member who is not performing the procedure must be present to monitor the patient.

Anesthesia and Patient Comfort

At the Kaiser Permanente San Rafael (Calif.) Medical Center, we have performed more than 12,000 gynecologic office procedures—from diagnostic hysteroscopies to hysteroscopic sterilizations and endometrial ablations—under local anesthesia with minimal oral sedation, over a 25-year period.

For diagnostic and minor operative hysteroscopy, we generally instruct patients to take 400–800 mg ibuprofen at home 1 hour before the procedure. We administer a paracervical block consisting of 5–10 mL of 1% lidocaine to the cervical vaginal junction superficially through the mucosa at 3:00 and 9:00.

Whenever a tenaculum is used, we also inject the anterior lip of the cervix with approximately 1–2 mL of local anesthetic before the tenaculum is applied, and then leave the room for 5–10 minutes to allow the block to set properly.

Remember, as with any office gynecologic procedure, it is important to use a “no-touch” technique, as the uterine wall is innervated by both sympathetic and parasympathetic fibers. It is unnecessary to sound the uterus; the old but still common practice of sounding is uncomfortable for the patient and may provoke uterine contractions that make distention of the uterus difficult. It may also cause perforation and is simply unnecessary.

Our oral premedication regimen for HTA and Essure procedures consists of 800 mg ibuprofen (Motrin), 10 mg diazepam (Valium), and two hydrocodone/acetaminophen (Vicodin) tablets taken at home 1–2 hours before the procedure. Patients are instructed to arrive 30 minutes prior to their scheduled appointment, at which time they are given an intramuscular injection of 30 mg ketorolac (Toradol) and 0.4 mg atropine.

Toradol is a prostaglandin synthetase inhibitor and has a peripheral effect as well. Atropine is used to prevent vasovagal reactions. The patient should be warned that she may experience dry mouth, but that this is preferable to the extreme discomfort felt during a vasovagal episode.

We then administer a paracervical/intracervical block with 1% mepivacaine (Carbocaine, Polocaine), which is longer acting than lidocaine. We inject 2 mL in the anterior lip of the cervix before it is grasped with a tenaculum; we place the needle against the cervix and ask the patient to cough, which results in self-injection. We then inject 10 mL in the cervicovaginal junction on each side at 3:00 and 9:00. These injections are given superficially, just under the mucosa, to raise a weal.

We inject an additional 5 mL intracervically about 1–2 cm deep at 8:00 and 4:00, and 5 mL submucosally at 6:00 between the uterosacrals. The total amount of mepivacaine given is 37 mL, or 370 mg (the recommended maximum dose is 400 mg).

Again, it is important to leave the room for 10–15 minutes to allow the block to set properly. We recommend that the physician leave while the nurse stays to monitor the patient and help her relax.

The Essure procedure can be done with less oral anesthesia and a smaller paracervical or intracervical block than endometrial ablation requires, but because our patients tolerate our ablation anesthesia regimen so well, we use it for both procedures.

In a study of 249 endometrial ablations performed at Kaiser Permanente San Rafael over 5.5 years using the HTA system, only one procedure was discontinued because of pain, and two patients were admitted overnight for cramping and nausea. The overall success rate was 90.6%, despite 40% of our patients having submucous myomas. The only complications were four cases of postoperative endometritis, with two of those patients requiring hospitalization for intravenous antibiotics, and two cases of procedure failure due to false passages.

We have not had any adverse anesthetic reactions in our patients who have undergone HTA over the years, or in any of the thousands of other women who were given similar paracervical blocks for office gynecologic procedures.

Postprocedure recovery is rarely necessary for these level I procedures. Our nurses monitor patients' blood pressure for 10–15 minutes after the procedures are completed and ensure that patients are feeling well and are ambulatory. This monitoring is done in the procedure room. Patients who don't feel well enough to leave in that time period are brought into another exam room and are discharged when they are ready. This is very rare.

Our patients also receive written postoperative instructions that tell them to report any increase in abdominal pain, any fever, any foul-smelling discharge, and—after endometrial ablation—the absence of any discharge.

Most of the time, patients will just wave good-bye, pleased to have had their procedure done in the office.

For level II procedures, the postrecovery protocol is much more complex.

The South Carolina rule, for instance, states that monitoring in the recovery area must include both pulse oximetry and noninvasive blood pressure measurement, and that the patient must be assessed for level of consciousness, pain relief, or any untoward complication.

Most states require that the patient be monitored for at least 30 minutes and, depending on which drugs were administered, for as long as 2 hours.

Again, it is important for physicians who plan to use anything but minimal sedation in the office to know their state requirements, if any. These can usually be obtained online from the state department of health services.

A photo of a 3-mm flexible hysteroscope with other commonly used office instruments reassures patients. Courtesy Dr. Mark Glasser

A 42-year-old patient with a 4-cm type 0 myoma was treated in the office with the HTA system (preoperative view at left). The patient has been amenorrheic for more than 6 years (postprocedure view at right). Photos courtesy Dr. Mark Glasser

The Medex C-Fusor is placed around a bag of normal saline, which is used to maintain distention pressure. Courtesy Dr. Mark Glasser

This image shows paracervical block injection sites (dots) and doses of 1% mepivicaine (arrows) injected at each site. Courtesy Dr. Mark Glasser

In-Office Gynecologic Surgery, Part 2

In the last Master Class in Gynecologic Surgery, Dr. James Presthus provided the reader with an overview on in-office gynecologic surgery. Hysteroscopy, the standard of care in the diagnosis and treatment of abnormal uterine bleeding, is a procedure that lends itself especially readily to an office environment.

Dr. Presthus pointed out that the physician “can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.” He emphasized that despite the use of less anesthesia, patients routinely tolerate the procedure well.

Dr. Presthus gave us the “why” behind his recommendation that the gynecologist commit to office-based surgery.

Now, Dr. Mark Glasser provides us with the “how and what” considerations of in-office gynecologic surgery, focusing on hysteroscopy, global endometrial ablation, and the Essure tubal occlusion procedure.

Not only does Dr. Glasser make recommendations on instrumentation, he also discusses the surgical technique of hysteroscopy and the anesthesia concerns that can arise. This article is an excellent primer for those considering in-office hysteroscopy.

From 1992 until 2006, Dr. Glasser was the director of advanced gynecologic laparoscopy training for the Kaiser Northern California Region. He is a past member of the board of trustees of the AAGL and continues to serve on the national advisory committee of the AAGL and the editorial board of the Journal of Minimally Invasive Gynecology.

Nausea and vomiting are common in pregnancy and can have a significant negative effect on women's health. Approximately half of all pregnant women in the United States have nausea and vomiting in early pregnancy, and about 25% have nausea alone. Only about 25% of pregnant women are free of any such problem.

The problem presents across a broad spectrum of severity, with the most severe form being hyperemesis gravidarum, a condition characterized by persistent vomiting, weight loss greater than 5%, ketonuria, electrolyte abnormalities, hypokalemia, and dehydration; this condition usually results in the need for hospitalization, treatment with intravenous fluids, and even intravenous feeding. Approximately 1% of pregnant women have vomiting severe enough to require hospitalization.

Persistent mild nausea, however, can also be a significant problem worthy of attentive management. It is not just “morning sickness” for many of these women. Approximately 35% of women with nausea during pregnancy lose time from work, and 25% cannot function well at home throughout the day.

Nausea and vomiting can significantly impair their routines, can negatively affect their relationships with their husbands and children, and are sometimes cited as reasons for an otherwise undesired pregnancy termination.

Women who are suffering from nausea and vomiting in pregnancy frequently do not seek or receive specific therapy out of concern over safety, yet such fear is often based on misinformation and misperceptions regarding teratogenesis. Women have numerous safe and effective options, including therapy with vitamin B₆ and doxylamine, as well as ginger and other nonpharmacologic approaches, and treatment with various antiemetic drugs.

Etiology, Differential Diagnosis

Some patients can identify the triggers of their nausea and thus can avoid aggravating odors or foods. Dietary modifications include eating frequent and small meals; taking fluids between meals; eating primarily bland, dry, and high-protein foods; and avoiding fatty or spicy foods.

Discontinuing prenatal vitamin tablets containing iron also can help, as the iron can contribute to nausea. Women who are having trouble can switch to a multivitamin with no or low iron for the first trimester and can resume prenatal vitamins after 3 months, or they can switch to folic acid alone, which is all that is needed to prevent birth defects.

We must also consider other diagnoses that can cause nausea and vomiting in pregnancy, from gastroenteritis, pancreatitis, appendicitis, and other gastrointestinal disorders, to gastrourologic problems such as pyelonephritis and various metabolic disorders.

There are sometimes clues that the nausea and vomiting cannot be attributed to the pregnancy alone: Fever, abdominal pain, and headache, for instance, result from something other than the pregnancy, as do serious changes in liver enzymes, bilirubin, and amylase or lipase.

Nausea and vomiting that begin later in the pregnancy also cannot be attributed to the pregnancy itself. The problem has an early onset, usually starting at the time of the missed menstrual period. It is fully manifested by 10 weeks of gestation, and—although it usually improves as the pregnancy progresses further—the problem may persist until the placenta is delivered.

In any case, a patient who has not had any nausea in the first 3 months of her pregnancy and begins experiencing nausea and headache at 16 weeks of gestation is probably having a migraine headache.

Many believe that nausea and vomiting are related to the presence of human chorionic gonadotropin (HCG), because HCG can stimulate the ovaries to produce estrogen, and estrogen can contribute to nausea. Indeed, the start, peak, and resolution of nausea and vomiting in pregnancy correlate closely with the curve of HCG concentration. Nausea and vomiting are also more common in patients with multiple gestations and hydatidiform moles, obstetric situations in which HCG is high.

Hormonal influences do not explain, however, why some women have problems with nausea and others do not.

Over the years, some have believed that the problem is psychological, but I and many others strongly discount this belief. Any psychological problems these women have are not a cause of their nausea and vomiting, but rather are an effect.

Gastrointestinal dysmotility and Helicobacter pylori infection have been cited as other possible associations. H. pylori seropositivity has been associated with hyperemesis or serious nausea and vomiting, but data are conflicting and investigators have not studied whether the problem resolves after treatment for the infection. Ulcer disease should register as a possibility in any differential diagnosis, particularly if the woman has pain, but whether it is more broadly causative of the nausea and vomiting of pregnancy is uncertain.

There is also some evidence that the nausea and vomiting of pregnancy may be related to vitamin B₆ deficiency, and indeed, a significant number of women respond to vitamin B₆ supplementation. Overall, however, the etiology of nausea and vomiting in pregnancy are unknown.

Vitamin-Based Therapy and Doxylamine

Vitamin B₆ is a good initial therapy for women whose nausea and vomiting cannot be managed with dietary change. It has been more widely tested for safety and efficacy than has any other vitamin-based therapy for the problem, and it is inexpensive and widely available.

In a study from our group conducted many years ago, pregnant patients with nausea and vomiting were randomized to 3 days of vitamin B₆ or a placebo at a dosage of 25 mg three times a day. Half of the patients stopped vomiting, and most patients with severe nausea reported a diminution to mild or moderate nausea. Several years later, another group of investigators used 10 mg of vitamin B₆ three times a day in a larger, randomized, placebo-controlled study. After 5 days of therapy, they also documented a significant decrease in nausea.

A once-a-day, extended-release formulation of vitamin B₆ (PremesisRx) is a good first-line option. It delivers 75 mg of vitamin B₆ over 24 hours—which is easier than taking 25 mg three times a day—and contains some vitamin B12, calcium carbonate, and 1 mg of folic acid. (The level of folic acid makes the formulation a prescription therapy.)

If vitamin B₆ alone is not successful, the antihistamine doxylamine can be added in a combination similar to the formulation that was available in Bendectin from 1956 to 1983. It is estimated that Bendectin was used by more than 30 million women during this time period and, at one point, by approximately 40% of pregnant women.

Although no other agent given in pregnancy has more conclusive safety data with regard to the incidence of birth defects (more than 6,000 patients exposed to the combination have been compared with more than 6,000 controls), Bendectin was removed from the U.S. market in 1983 by the manufacturer because of lawsuits that alleged a teratogenic effect.

The combination has been continually available in Canada as Diclectin (a sustained-release formulation), and interestingly, there are significantly fewer hospitalizations for nausea and vomiting in pregnancy in Canada than in the United States.

A version of the combination can be created by combining vitamin B₆ with the over-the-counter sleep aid Unisom SleepTabs, which contains 25 mg of doxylamine per tablet. The dose of doxylamine in Bendectin was 10 mg, and two tablets were recommended at night, so one full tablet of Unisom can be taken at night, along with a half tablet in the morning and a half-tablet in the afternoon if some nausea persists and, of course, 25 mg of vitamin B₆ at each of these times of the day.

The combination of vitamin B₆ and doxylamine can bring fast and dramatic relief for many patients, leading to significant improvements in the quality of their lives. There is always concern for obstetricians that a mother will claim that a child's birth defect was caused by a drug prescribed during the first trimester, but this is unlikely to happen with the combination of vitamin B₆ and doxylamine because legal precedents already hold that the drug does not cause birth defects.

Interestingly, some studies have suggested that women who have taken multivitamins containing vitamin B₆ before pregnancy have less nausea and vomiting.

Nonpharmacologic Approaches

Ginger ale has been a traditional remedy for nausea in various populations, and among pregnant women with nausea and vomiting, ginger is the alternative therapy with the strongest evidence base. The data on ginger have accumulated to the point at which concerns about its possible adverse effects have largely dissipated, which makes it worthy of consideration as a second-line agent.

Two small, randomized, double-blind trials used 250-mg ground ginger capsules or placebo four times a day, one in 70 outpatients with nausea and vomiting and one in women who were hospitalized with hyperemesis gravidarum. Investigators of both trials reported significantly reduced nausea and reductions in vomiting among the women in the ginger groups (Obstet. Gynecol. 2001;97:577–82; Eur. J. Obstet. Gynecol. Reprod. Biol. 1990;38:19–24).

Among more recent randomized trials was one of approximately 300 women that compared ginger with vitamin B₆. Women who received identical-looking capsules three times a day of 25 mg vitamin B₆ or 350 mg ginger had similar levels of improvement in nausea and vomiting at 1 week, 2 weeks, and 3 weeks.

There were no differences in fetal outcome or congenital anomalies; the only difference was that the women taking ginger reported more heartburn and belching (Obstet. Gynecol. 2004;103:639–45).

In a literature review, a group of Italian investigators identified six double-blind, randomized, controlled trials with a total of 675 participants that met criteria for methodological quality for the evaluation of efficacy. Of these six trials, four demonstrated the superiority of ginger over placebo, and two demonstrated the equivalence of ginger with vitamin B₆.

To review safety, the investigators looked at an observational cohort study involving 187 women as well as at the randomized trials. The studies showed no significant side effects and no adverse effects on pregnancy outcome (Obstet. Gynecol. 2005;105:849).

Acupuncture is another therapy worthy of consideration and one that can be added to the treatment regimen at any time. It has now been studied in two randomized trials in pregnant women who had nausea and vomiting, and although the results do not demonstrate broad efficacy, the findings together suggest that the therapy can be worth a try (Obstet. Gynecol. 2001:97;184–8; J. Pain Symptom Manage. 2000:20;273–9).

Nerve stimulation of the P6 acupuncture point also appears to decrease the nausea and vomiting of pregnancy for some women, whereas acupressure with devices like the Sea-Band or the Bioband appears to be less effective.

Antiemetic Drugs

Ginger and vitamin B₆—alone or in combination with doxylamine—do not work for everyone. In unsuccessful cases, we can move on to try other antihistamines and, if necessary, to consider the four other categories of antiemetic drugs: phenothiazines, prokinetic agents, serotonin (5-HT3) antagonists, and corticosteroids.

With the exception of doxylamine, which is a Food and Drug Administration category A drug, none are FDA approved for use in pregnancy. The drugs are underutilized, however, largely because of misperceptions of teratogenic risk.

In a supplement to the American Journal of Obstetrics and Gynecology on nausea and vomiting in pregnancy, Dr. L.A. Magee and associates reported on an evidence-based review of the safety and effectiveness of available antiemetics. They concluded that many medications, particularly the antihistamines and phenothiazines, are safe and effective for the treatment of varying degrees of nausea and vomiting (Am. J. Obstet. Gynecol. 2002:186;S256–61).

In the same supplement, Dr. Gideon Koren addressed the issue of perceived versus true risk of medications for nausea and vomiting, and presents an algorithm for management that includes a hierarchical use of antiemetic drugs based on the strength of evidence of fetal safety (Am. J. Obstet. Gynecol. 2002:186;S248–52).

Although few studies have compared the antihistamines for nausea and vomiting in pregnancy, sedation seems to be a main difference among the various drugs, with some—such as diphenhydramine (Benadryl)—sedating more than others. In addition to doxylamine and diphenhydramine, we can consider using dimenhydrinate (Dramamine), meclizine (Antivert), hydroxyzine (Vistaril, Atarax), and cetirizine (Zyrtec).

If the antihistamines as a class are not effective, the phenothiazines are a good choice. Promethazine (Phenergan) is widely used for nausea and vomiting in pregnancy, and prochlorperazine (Compazine) and chlorpromazine (Thorazine) are other options.

Possible adverse side effects of the phenothiazines include sedation, hypotension, dry mouth, and extrapyramidal symptoms. Compazine tablets are placed inside the cheek—a formulation that is helpful for women with moderate and severe nausea—and are generally well tolerated, with less drowsiness and sedation than the antihistamines.

The phenothiazine droperidol (Inapsine) was popular for some time, but there were reports of cardiac deaths and, in 2001, the FDA issued a black box warning stating that all patients need a 12-lead ECG before, during, and after administration. This drug has, consequently, fallen out of favor.

Metoclopramide (Reglan) can help some women when other drugs have failed. It is a prokinetic agent, increasing upper gastrointestinal motility and lower esophageal sphincter tone. A review of Medicaid data showed no increased risk of birth defects in 303 newborns in Michigan born to mothers who had ingested this drug.

The serotonin (5-HT3) antagonist ondansetron (Zofran) has been one of the most heavily marketed drugs for postoperative nausea and vomiting, and from the start many women and their obstetricians used the drug as a first-line or near-first-line antiemetic choice for nausea and vomiting in pregnancy, despite its high cost and the relative paucity of information on its use in pregnancy.

Several years of use and studies of several hundred patients have increased the comfort level related to ondansetron use. In general, this drug and the serotonin antagonists dolasetron (Anzemet) and granisetron (Kytril) are now felt to be safe. All are FDA category B drugs.

Zofran comes in an oral disintegrating tablet that, like Compazine, is useful in patients who have difficulty swallowing or who do not feel they are able to drink. In a randomized trial, Zofran was compared with Phenergan and was found to have similar efficacy, but with less sedation.

Corticosteroids may not be as beneficial as many first thought—there are now conflicting data about their effectiveness—and some studies have suggested an increased risk of cleft lip and palate when these agents are used before 10 weeks' gestation. The drugs are recommended, therefore, only after 10 weeks' gestation and in cases in which other medications have failed.

Neither I nor any member of my family has any financial connections with the pharmaceutical industry.

A Fairly Common Condition

Nausea and vomiting in pregnancy are fairly common conditions. By themselves, they are neither life threatening nor threatening to the pregnancy, but they are nevertheless terribly uncomfortable, displeasing, and sometimes disabling.

Nausea and vomiting can often interfere with a patient's ability to perform household or workplace duties and can be destabilizing to a patient's life at a time when there otherwise is joy and happiness. Sometimes, nausea and vomiting can be so severe that they result in hospitalization and intravenous feeding.

For all these reasons, they cannot be overlooked.

Unfortunately, they are also mysterious. Nausea and vomiting in pregnancy are relatively uncommon in the populations of certain continents, such as Africa and Asia, but relatively common among North American women. They occur for varying lengths of time in some North American women and not at all in others. The causation, in short, is unclear and likely complicated. A number of hypotheses have been advanced, but none has been proved.

Despite the uncertainties, the frequency and effects of nausea and vomiting in pregnancy demand our attention. It therefore seems important to present a Master Class on the subject and to review the various treatments that have been tried and are available for patients who struggle with the condition.

Some of these approaches will work for our patients, and some will not. With these options before us, however, we can offer our patients the very best care.

Here to address the issue is Dr. Jennifer R. Niebyl, professor and chair of the department of obstetrics and gynecology at the University of Iowa Hospitals and Clinics, Iowa City.

Dr. Niebyl is an expert in the area of drugs and pregnancy and an expert in maternal-fetal medicine, with a special interest in nausea and vomiting in pregnancy.

Key Points

▸ Vitamin B6 and doxylamine should be first-line therapy for nausea and vomiting in pregnancy.

▸ No antiemetic has been found to have any teratogenic risk.

▸ Some alternative remedies, such as ginger and acupuncture, have been shown to be effective.

Treatments for Nausea/Vomiting

Vitamin B6

PremesisRx

Antihistamines

Doxylamine (Unisom)

Dimenhydrinate (Dramamine)

Diphenhydramine (Benadryl)

Meclizine (Antivert)

Hydroxyzine (Vistaril, Atarax)

Cetirizine (Zyrtec)

Phenothiazines

Promethazine (Phenergan)

Prochlorperazine (Compazine)

Chlorpromazine (Thorazine)

Prokinetic Agent

Metoclopramide (Reglan)

5-HT3 Receptor Antagonists

Ondansetron (Zofran)

Dolasetron (Anzemet)

Granisetron (Kytril)

Corticosteroids

Acupuncture

Ginger

Nausea and vomiting are common in pregnancy and can have a significant negative effect on women's health. Approximately half of all pregnant women in the United States have nausea and vomiting in early pregnancy, and about 25% have nausea alone. Only about 25% of pregnant women are free of any such problem.

The problem presents across a broad spectrum of severity, with the most severe form being hyperemesis gravidarum, a condition characterized by persistent vomiting, weight loss greater than 5%, ketonuria, electrolyte abnormalities, hypokalemia, and dehydration; this condition usually results in the need for hospitalization, treatment with intravenous fluids, and even intravenous feeding. Approximately 1% of pregnant women have vomiting severe enough to require hospitalization.

Persistent mild nausea, however, can also be a significant problem worthy of attentive management. It is not just “morning sickness” for many of these women. Approximately 35% of women with nausea during pregnancy lose time from work, and 25% cannot function well at home throughout the day.

Nausea and vomiting can significantly impair their routines, can negatively affect their relationships with their husbands and children, and are sometimes cited as reasons for an otherwise undesired pregnancy termination.

Women who are suffering from nausea and vomiting in pregnancy frequently do not seek or receive specific therapy out of concern over safety, yet such fear is often based on misinformation and misperceptions regarding teratogenesis. Women have numerous safe and effective options, including therapy with vitamin B₆ and doxylamine, as well as ginger and other nonpharmacologic approaches, and treatment with various antiemetic drugs.

Etiology, Differential Diagnosis

Some patients can identify the triggers of their nausea and thus can avoid aggravating odors or foods. Dietary modifications include eating frequent and small meals; taking fluids between meals; eating primarily bland, dry, and high-protein foods; and avoiding fatty or spicy foods.

Discontinuing prenatal vitamin tablets containing iron also can help, as the iron can contribute to nausea. Women who are having trouble can switch to a multivitamin with no or low iron for the first trimester and can resume prenatal vitamins after 3 months, or they can switch to folic acid alone, which is all that is needed to prevent birth defects.

We must also consider other diagnoses that can cause nausea and vomiting in pregnancy, from gastroenteritis, pancreatitis, appendicitis, and other gastrointestinal disorders, to gastrourologic problems such as pyelonephritis and various metabolic disorders.

There are sometimes clues that the nausea and vomiting cannot be attributed to the pregnancy alone: Fever, abdominal pain, and headache, for instance, result from something other than the pregnancy, as do serious changes in liver enzymes, bilirubin, and amylase or lipase.

Nausea and vomiting that begin later in the pregnancy also cannot be attributed to the pregnancy itself. The problem has an early onset, usually starting at the time of the missed menstrual period. It is fully manifested by 10 weeks of gestation, and—although it usually improves as the pregnancy progresses further—the problem may persist until the placenta is delivered.

In any case, a patient who has not had any nausea in the first 3 months of her pregnancy and begins experiencing nausea and headache at 16 weeks of gestation is probably having a migraine headache.

Many believe that nausea and vomiting are related to the presence of human chorionic gonadotropin (HCG), because HCG can stimulate the ovaries to produce estrogen, and estrogen can contribute to nausea. Indeed, the start, peak, and resolution of nausea and vomiting in pregnancy correlate closely with the curve of HCG concentration. Nausea and vomiting are also more common in patients with multiple gestations and hydatidiform moles, obstetric situations in which HCG is high.

Hormonal influences do not explain, however, why some women have problems with nausea and others do not.

Over the years, some have believed that the problem is psychological, but I and many others strongly discount this belief. Any psychological problems these women have are not a cause of their nausea and vomiting, but rather are an effect.

Gastrointestinal dysmotility and Helicobacter pylori infection have been cited as other possible associations. H. pylori seropositivity has been associated with hyperemesis or serious nausea and vomiting, but data are conflicting and investigators have not studied whether the problem resolves after treatment for the infection. Ulcer disease should register as a possibility in any differential diagnosis, particularly if the woman has pain, but whether it is more broadly causative of the nausea and vomiting of pregnancy is uncertain.

There is also some evidence that the nausea and vomiting of pregnancy may be related to vitamin B₆ deficiency, and indeed, a significant number of women respond to vitamin B₆ supplementation. Overall, however, the etiology of nausea and vomiting in pregnancy are unknown.

Vitamin-Based Therapy and Doxylamine

Vitamin B₆ is a good initial therapy for women whose nausea and vomiting cannot be managed with dietary change. It has been more widely tested for safety and efficacy than has any other vitamin-based therapy for the problem, and it is inexpensive and widely available.

In a study from our group conducted many years ago, pregnant patients with nausea and vomiting were randomized to 3 days of vitamin B₆ or a placebo at a dosage of 25 mg three times a day. Half of the patients stopped vomiting, and most patients with severe nausea reported a diminution to mild or moderate nausea. Several years later, another group of investigators used 10 mg of vitamin B₆ three times a day in a larger, randomized, placebo-controlled study. After 5 days of therapy, they also documented a significant decrease in nausea.

A once-a-day, extended-release formulation of vitamin B₆ (PremesisRx) is a good first-line option. It delivers 75 mg of vitamin B₆ over 24 hours—which is easier than taking 25 mg three times a day—and contains some vitamin B12, calcium carbonate, and 1 mg of folic acid. (The level of folic acid makes the formulation a prescription therapy.)

If vitamin B₆ alone is not successful, the antihistamine doxylamine can be added in a combination similar to the formulation that was available in Bendectin from 1956 to 1983. It is estimated that Bendectin was used by more than 30 million women during this time period and, at one point, by approximately 40% of pregnant women.

Although no other agent given in pregnancy has more conclusive safety data with regard to the incidence of birth defects (more than 6,000 patients exposed to the combination have been compared with more than 6,000 controls), Bendectin was removed from the U.S. market in 1983 by the manufacturer because of lawsuits that alleged a teratogenic effect.

The combination has been continually available in Canada as Diclectin (a sustained-release formulation), and interestingly, there are significantly fewer hospitalizations for nausea and vomiting in pregnancy in Canada than in the United States.

A version of the combination can be created by combining vitamin B₆ with the over-the-counter sleep aid Unisom SleepTabs, which contains 25 mg of doxylamine per tablet. The dose of doxylamine in Bendectin was 10 mg, and two tablets were recommended at night, so one full tablet of Unisom can be taken at night, along with a half tablet in the morning and a half-tablet in the afternoon if some nausea persists and, of course, 25 mg of vitamin B₆ at each of these times of the day.

The combination of vitamin B₆ and doxylamine can bring fast and dramatic relief for many patients, leading to significant improvements in the quality of their lives. There is always concern for obstetricians that a mother will claim that a child's birth defect was caused by a drug prescribed during the first trimester, but this is unlikely to happen with the combination of vitamin B₆ and doxylamine because legal precedents already hold that the drug does not cause birth defects.

Interestingly, some studies have suggested that women who have taken multivitamins containing vitamin B₆ before pregnancy have less nausea and vomiting.

Nonpharmacologic Approaches

Ginger ale has been a traditional remedy for nausea in various populations, and among pregnant women with nausea and vomiting, ginger is the alternative therapy with the strongest evidence base. The data on ginger have accumulated to the point at which concerns about its possible adverse effects have largely dissipated, which makes it worthy of consideration as a second-line agent.

Two small, randomized, double-blind trials used 250-mg ground ginger capsules or placebo four times a day, one in 70 outpatients with nausea and vomiting and one in women who were hospitalized with hyperemesis gravidarum. Investigators of both trials reported significantly reduced nausea and reductions in vomiting among the women in the ginger groups (Obstet. Gynecol. 2001;97:577–82; Eur. J. Obstet. Gynecol. Reprod. Biol. 1990;38:19–24).

Among more recent randomized trials was one of approximately 300 women that compared ginger with vitamin B₆. Women who received identical-looking capsules three times a day of 25 mg vitamin B₆ or 350 mg ginger had similar levels of improvement in nausea and vomiting at 1 week, 2 weeks, and 3 weeks.

There were no differences in fetal outcome or congenital anomalies; the only difference was that the women taking ginger reported more heartburn and belching (Obstet. Gynecol. 2004;103:639–45).

In a literature review, a group of Italian investigators identified six double-blind, randomized, controlled trials with a total of 675 participants that met criteria for methodological quality for the evaluation of efficacy. Of these six trials, four demonstrated the superiority of ginger over placebo, and two demonstrated the equivalence of ginger with vitamin B₆.

To review safety, the investigators looked at an observational cohort study involving 187 women as well as at the randomized trials. The studies showed no significant side effects and no adverse effects on pregnancy outcome (Obstet. Gynecol. 2005;105:849).

Acupuncture is another therapy worthy of consideration and one that can be added to the treatment regimen at any time. It has now been studied in two randomized trials in pregnant women who had nausea and vomiting, and although the results do not demonstrate broad efficacy, the findings together suggest that the therapy can be worth a try (Obstet. Gynecol. 2001:97;184–8; J. Pain Symptom Manage. 2000:20;273–9).

Nerve stimulation of the P6 acupuncture point also appears to decrease the nausea and vomiting of pregnancy for some women, whereas acupressure with devices like the Sea-Band or the Bioband appears to be less effective.

Antiemetic Drugs

Ginger and vitamin B₆—alone or in combination with doxylamine—do not work for everyone. In unsuccessful cases, we can move on to try other antihistamines and, if necessary, to consider the four other categories of antiemetic drugs: phenothiazines, prokinetic agents, serotonin (5-HT3) antagonists, and corticosteroids.

With the exception of doxylamine, which is a Food and Drug Administration category A drug, none are FDA approved for use in pregnancy. The drugs are underutilized, however, largely because of misperceptions of teratogenic risk.

In a supplement to the American Journal of Obstetrics and Gynecology on nausea and vomiting in pregnancy, Dr. L.A. Magee and associates reported on an evidence-based review of the safety and effectiveness of available antiemetics. They concluded that many medications, particularly the antihistamines and phenothiazines, are safe and effective for the treatment of varying degrees of nausea and vomiting (Am. J. Obstet. Gynecol. 2002:186;S256–61).

In the same supplement, Dr. Gideon Koren addressed the issue of perceived versus true risk of medications for nausea and vomiting, and presents an algorithm for management that includes a hierarchical use of antiemetic drugs based on the strength of evidence of fetal safety (Am. J. Obstet. Gynecol. 2002:186;S248–52).

Although few studies have compared the antihistamines for nausea and vomiting in pregnancy, sedation seems to be a main difference among the various drugs, with some—such as diphenhydramine (Benadryl)—sedating more than others. In addition to doxylamine and diphenhydramine, we can consider using dimenhydrinate (Dramamine), meclizine (Antivert), hydroxyzine (Vistaril, Atarax), and cetirizine (Zyrtec).

If the antihistamines as a class are not effective, the phenothiazines are a good choice. Promethazine (Phenergan) is widely used for nausea and vomiting in pregnancy, and prochlorperazine (Compazine) and chlorpromazine (Thorazine) are other options.

Possible adverse side effects of the phenothiazines include sedation, hypotension, dry mouth, and extrapyramidal symptoms. Compazine tablets are placed inside the cheek—a formulation that is helpful for women with moderate and severe nausea—and are generally well tolerated, with less drowsiness and sedation than the antihistamines.

The phenothiazine droperidol (Inapsine) was popular for some time, but there were reports of cardiac deaths and, in 2001, the FDA issued a black box warning stating that all patients need a 12-lead ECG before, during, and after administration. This drug has, consequently, fallen out of favor.

Metoclopramide (Reglan) can help some women when other drugs have failed. It is a prokinetic agent, increasing upper gastrointestinal motility and lower esophageal sphincter tone. A review of Medicaid data showed no increased risk of birth defects in 303 newborns in Michigan born to mothers who had ingested this drug.

The serotonin (5-HT3) antagonist ondansetron (Zofran) has been one of the most heavily marketed drugs for postoperative nausea and vomiting, and from the start many women and their obstetricians used the drug as a first-line or near-first-line antiemetic choice for nausea and vomiting in pregnancy, despite its high cost and the relative paucity of information on its use in pregnancy.

Several years of use and studies of several hundred patients have increased the comfort level related to ondansetron use. In general, this drug and the serotonin antagonists dolasetron (Anzemet) and granisetron (Kytril) are now felt to be safe. All are FDA category B drugs.

Zofran comes in an oral disintegrating tablet that, like Compazine, is useful in patients who have difficulty swallowing or who do not feel they are able to drink. In a randomized trial, Zofran was compared with Phenergan and was found to have similar efficacy, but with less sedation.

Corticosteroids may not be as beneficial as many first thought—there are now conflicting data about their effectiveness—and some studies have suggested an increased risk of cleft lip and palate when these agents are used before 10 weeks' gestation. The drugs are recommended, therefore, only after 10 weeks' gestation and in cases in which other medications have failed.

Neither I nor any member of my family has any financial connections with the pharmaceutical industry.

A Fairly Common Condition

Nausea and vomiting in pregnancy are fairly common conditions. By themselves, they are neither life threatening nor threatening to the pregnancy, but they are nevertheless terribly uncomfortable, displeasing, and sometimes disabling.

Nausea and vomiting can often interfere with a patient's ability to perform household or workplace duties and can be destabilizing to a patient's life at a time when there otherwise is joy and happiness. Sometimes, nausea and vomiting can be so severe that they result in hospitalization and intravenous feeding.

For all these reasons, they cannot be overlooked.

Unfortunately, they are also mysterious. Nausea and vomiting in pregnancy are relatively uncommon in the populations of certain continents, such as Africa and Asia, but relatively common among North American women. They occur for varying lengths of time in some North American women and not at all in others. The causation, in short, is unclear and likely complicated. A number of hypotheses have been advanced, but none has been proved.

Despite the uncertainties, the frequency and effects of nausea and vomiting in pregnancy demand our attention. It therefore seems important to present a Master Class on the subject and to review the various treatments that have been tried and are available for patients who struggle with the condition.

Some of these approaches will work for our patients, and some will not. With these options before us, however, we can offer our patients the very best care.

Here to address the issue is Dr. Jennifer R. Niebyl, professor and chair of the department of obstetrics and gynecology at the University of Iowa Hospitals and Clinics, Iowa City.

Dr. Niebyl is an expert in the area of drugs and pregnancy and an expert in maternal-fetal medicine, with a special interest in nausea and vomiting in pregnancy.

Key Points

▸ Vitamin B6 and doxylamine should be first-line therapy for nausea and vomiting in pregnancy.

▸ No antiemetic has been found to have any teratogenic risk.

▸ Some alternative remedies, such as ginger and acupuncture, have been shown to be effective.

Treatments for Nausea/Vomiting

Vitamin B6

PremesisRx

Antihistamines

Doxylamine (Unisom)

Dimenhydrinate (Dramamine)

Diphenhydramine (Benadryl)

Meclizine (Antivert)

Hydroxyzine (Vistaril, Atarax)

Cetirizine (Zyrtec)

Phenothiazines

Promethazine (Phenergan)

Prochlorperazine (Compazine)

Chlorpromazine (Thorazine)

Prokinetic Agent

Metoclopramide (Reglan)

5-HT3 Receptor Antagonists

Ondansetron (Zofran)

Dolasetron (Anzemet)

Granisetron (Kytril)

Corticosteroids

Acupuncture

Ginger

Nausea and vomiting are common in pregnancy and can have a significant negative effect on women's health. Approximately half of all pregnant women in the United States have nausea and vomiting in early pregnancy, and about 25% have nausea alone. Only about 25% of pregnant women are free of any such problem.

The problem presents across a broad spectrum of severity, with the most severe form being hyperemesis gravidarum, a condition characterized by persistent vomiting, weight loss greater than 5%, ketonuria, electrolyte abnormalities, hypokalemia, and dehydration; this condition usually results in the need for hospitalization, treatment with intravenous fluids, and even intravenous feeding. Approximately 1% of pregnant women have vomiting severe enough to require hospitalization.

Persistent mild nausea, however, can also be a significant problem worthy of attentive management. It is not just “morning sickness” for many of these women. Approximately 35% of women with nausea during pregnancy lose time from work, and 25% cannot function well at home throughout the day.

Nausea and vomiting can significantly impair their routines, can negatively affect their relationships with their husbands and children, and are sometimes cited as reasons for an otherwise undesired pregnancy termination.

Women who are suffering from nausea and vomiting in pregnancy frequently do not seek or receive specific therapy out of concern over safety, yet such fear is often based on misinformation and misperceptions regarding teratogenesis. Women have numerous safe and effective options, including therapy with vitamin B₆ and doxylamine, as well as ginger and other nonpharmacologic approaches, and treatment with various antiemetic drugs.

Etiology, Differential Diagnosis

Some patients can identify the triggers of their nausea and thus can avoid aggravating odors or foods. Dietary modifications include eating frequent and small meals; taking fluids between meals; eating primarily bland, dry, and high-protein foods; and avoiding fatty or spicy foods.

Discontinuing prenatal vitamin tablets containing iron also can help, as the iron can contribute to nausea. Women who are having trouble can switch to a multivitamin with no or low iron for the first trimester and can resume prenatal vitamins after 3 months, or they can switch to folic acid alone, which is all that is needed to prevent birth defects.

We must also consider other diagnoses that can cause nausea and vomiting in pregnancy, from gastroenteritis, pancreatitis, appendicitis, and other gastrointestinal disorders, to gastrourologic problems such as pyelonephritis and various metabolic disorders.

There are sometimes clues that the nausea and vomiting cannot be attributed to the pregnancy alone: Fever, abdominal pain, and headache, for instance, result from something other than the pregnancy, as do serious changes in liver enzymes, bilirubin, and amylase or lipase.

Nausea and vomiting that begin later in the pregnancy also cannot be attributed to the pregnancy itself. The problem has an early onset, usually starting at the time of the missed menstrual period. It is fully manifested by 10 weeks of gestation, and—although it usually improves as the pregnancy progresses further—the problem may persist until the placenta is delivered.

In any case, a patient who has not had any nausea in the first 3 months of her pregnancy and begins experiencing nausea and headache at 16 weeks of gestation is probably having a migraine headache.

Many believe that nausea and vomiting are related to the presence of human chorionic gonadotropin (HCG), because HCG can stimulate the ovaries to produce estrogen, and estrogen can contribute to nausea. Indeed, the start, peak, and resolution of nausea and vomiting in pregnancy correlate closely with the curve of HCG concentration. Nausea and vomiting are also more common in patients with multiple gestations and hydatidiform moles, obstetric situations in which HCG is high.

Hormonal influences do not explain, however, why some women have problems with nausea and others do not.

Over the years, some have believed that the problem is psychological, but I and many others strongly discount this belief. Any psychological problems these women have are not a cause of their nausea and vomiting, but rather are an effect.

Gastrointestinal dysmotility and Helicobacter pylori infection have been cited as other possible associations. H. pylori seropositivity has been associated with hyperemesis or serious nausea and vomiting, but data are conflicting and investigators have not studied whether the problem resolves after treatment for the infection. Ulcer disease should register as a possibility in any differential diagnosis, particularly if the woman has pain, but whether it is more broadly causative of the nausea and vomiting of pregnancy is uncertain.

There is also some evidence that the nausea and vomiting of pregnancy may be related to vitamin B₆ deficiency, and indeed, a significant number of women respond to vitamin B₆ supplementation. Overall, however, the etiology of nausea and vomiting in pregnancy are unknown.

Vitamin-Based Therapy and Doxylamine

Vitamin B₆ is a good initial therapy for women whose nausea and vomiting cannot be managed with dietary change. It has been more widely tested for safety and efficacy than has any other vitamin-based therapy for the problem, and it is inexpensive and widely available.

In a study from our group conducted many years ago, pregnant patients with nausea and vomiting were randomized to 3 days of vitamin B₆ or a placebo at a dosage of 25 mg three times a day. Half of the patients stopped vomiting, and most patients with severe nausea reported a diminution to mild or moderate nausea. Several years later, another group of investigators used 10 mg of vitamin B₆ three times a day in a larger, randomized, placebo-controlled study. After 5 days of therapy, they also documented a significant decrease in nausea.

A once-a-day, extended-release formulation of vitamin B₆ (PremesisRx) is a good first-line option. It delivers 75 mg of vitamin B₆ over 24 hours—which is easier than taking 25 mg three times a day—and contains some vitamin B12, calcium carbonate, and 1 mg of folic acid. (The level of folic acid makes the formulation a prescription therapy.)

If vitamin B₆ alone is not successful, the antihistamine doxylamine can be added in a combination similar to the formulation that was available in Bendectin from 1956 to 1983. It is estimated that Bendectin was used by more than 30 million women during this time period and, at one point, by approximately 40% of pregnant women.

Although no other agent given in pregnancy has more conclusive safety data with regard to the incidence of birth defects (more than 6,000 patients exposed to the combination have been compared with more than 6,000 controls), Bendectin was removed from the U.S. market in 1983 by the manufacturer because of lawsuits that alleged a teratogenic effect.

The combination has been continually available in Canada as Diclectin (a sustained-release formulation), and interestingly, there are significantly fewer hospitalizations for nausea and vomiting in pregnancy in Canada than in the United States.

A version of the combination can be created by combining vitamin B₆ with the over-the-counter sleep aid Unisom SleepTabs, which contains 25 mg of doxylamine per tablet. The dose of doxylamine in Bendectin was 10 mg, and two tablets were recommended at night, so one full tablet of Unisom can be taken at night, along with a half tablet in the morning and a half-tablet in the afternoon if some nausea persists and, of course, 25 mg of vitamin B₆ at each of these times of the day.

The combination of vitamin B₆ and doxylamine can bring fast and dramatic relief for many patients, leading to significant improvements in the quality of their lives. There is always concern for obstetricians that a mother will claim that a child's birth defect was caused by a drug prescribed during the first trimester, but this is unlikely to happen with the combination of vitamin B₆ and doxylamine because legal precedents already hold that the drug does not cause birth defects.

Interestingly, some studies have suggested that women who have taken multivitamins containing vitamin B₆ before pregnancy have less nausea and vomiting.

Nonpharmacologic Approaches

Ginger ale has been a traditional remedy for nausea in various populations, and among pregnant women with nausea and vomiting, ginger is the alternative therapy with the strongest evidence base. The data on ginger have accumulated to the point at which concerns about its possible adverse effects have largely dissipated, which makes it worthy of consideration as a second-line agent.

Two small, randomized, double-blind trials used 250-mg ground ginger capsules or placebo four times a day, one in 70 outpatients with nausea and vomiting and one in women who were hospitalized with hyperemesis gravidarum. Investigators of both trials reported significantly reduced nausea and reductions in vomiting among the women in the ginger groups (Obstet. Gynecol. 2001;97:577–82; Eur. J. Obstet. Gynecol. Reprod. Biol. 1990;38:19–24).

Among more recent randomized trials was one of approximately 300 women that compared ginger with vitamin B₆. Women who received identical-looking capsules three times a day of 25 mg vitamin B₆ or 350 mg ginger had similar levels of improvement in nausea and vomiting at 1 week, 2 weeks, and 3 weeks.

There were no differences in fetal outcome or congenital anomalies; the only difference was that the women taking ginger reported more heartburn and belching (Obstet. Gynecol. 2004;103:639–45).

In a literature review, a group of Italian investigators identified six double-blind, randomized, controlled trials with a total of 675 participants that met criteria for methodological quality for the evaluation of efficacy. Of these six trials, four demonstrated the superiority of ginger over placebo, and two demonstrated the equivalence of ginger with vitamin B₆.

To review safety, the investigators looked at an observational cohort study involving 187 women as well as at the randomized trials. The studies showed no significant side effects and no adverse effects on pregnancy outcome (Obstet. Gynecol. 2005;105:849).

Acupuncture is another therapy worthy of consideration and one that can be added to the treatment regimen at any time. It has now been studied in two randomized trials in pregnant women who had nausea and vomiting, and although the results do not demonstrate broad efficacy, the findings together suggest that the therapy can be worth a try (Obstet. Gynecol. 2001:97;184–8; J. Pain Symptom Manage. 2000:20;273–9).

Nerve stimulation of the P6 acupuncture point also appears to decrease the nausea and vomiting of pregnancy for some women, whereas acupressure with devices like the Sea-Band or the Bioband appears to be less effective.

Antiemetic Drugs

Ginger and vitamin B₆—alone or in combination with doxylamine—do not work for everyone. In unsuccessful cases, we can move on to try other antihistamines and, if necessary, to consider the four other categories of antiemetic drugs: phenothiazines, prokinetic agents, serotonin (5-HT3) antagonists, and corticosteroids.

With the exception of doxylamine, which is a Food and Drug Administration category A drug, none are FDA approved for use in pregnancy. The drugs are underutilized, however, largely because of misperceptions of teratogenic risk.

In a supplement to the American Journal of Obstetrics and Gynecology on nausea and vomiting in pregnancy, Dr. L.A. Magee and associates reported on an evidence-based review of the safety and effectiveness of available antiemetics. They concluded that many medications, particularly the antihistamines and phenothiazines, are safe and effective for the treatment of varying degrees of nausea and vomiting (Am. J. Obstet. Gynecol. 2002:186;S256–61).

In the same supplement, Dr. Gideon Koren addressed the issue of perceived versus true risk of medications for nausea and vomiting, and presents an algorithm for management that includes a hierarchical use of antiemetic drugs based on the strength of evidence of fetal safety (Am. J. Obstet. Gynecol. 2002:186;S248–52).

Although few studies have compared the antihistamines for nausea and vomiting in pregnancy, sedation seems to be a main difference among the various drugs, with some—such as diphenhydramine (Benadryl)—sedating more than others. In addition to doxylamine and diphenhydramine, we can consider using dimenhydrinate (Dramamine), meclizine (Antivert), hydroxyzine (Vistaril, Atarax), and cetirizine (Zyrtec).

If the antihistamines as a class are not effective, the phenothiazines are a good choice. Promethazine (Phenergan) is widely used for nausea and vomiting in pregnancy, and prochlorperazine (Compazine) and chlorpromazine (Thorazine) are other options.

Possible adverse side effects of the phenothiazines include sedation, hypotension, dry mouth, and extrapyramidal symptoms. Compazine tablets are placed inside the cheek—a formulation that is helpful for women with moderate and severe nausea—and are generally well tolerated, with less drowsiness and sedation than the antihistamines.

The phenothiazine droperidol (Inapsine) was popular for some time, but there were reports of cardiac deaths and, in 2001, the FDA issued a black box warning stating that all patients need a 12-lead ECG before, during, and after administration. This drug has, consequently, fallen out of favor.

Metoclopramide (Reglan) can help some women when other drugs have failed. It is a prokinetic agent, increasing upper gastrointestinal motility and lower esophageal sphincter tone. A review of Medicaid data showed no increased risk of birth defects in 303 newborns in Michigan born to mothers who had ingested this drug.

The serotonin (5-HT3) antagonist ondansetron (Zofran) has been one of the most heavily marketed drugs for postoperative nausea and vomiting, and from the start many women and their obstetricians used the drug as a first-line or near-first-line antiemetic choice for nausea and vomiting in pregnancy, despite its high cost and the relative paucity of information on its use in pregnancy.

Several years of use and studies of several hundred patients have increased the comfort level related to ondansetron use. In general, this drug and the serotonin antagonists dolasetron (Anzemet) and granisetron (Kytril) are now felt to be safe. All are FDA category B drugs.

Zofran comes in an oral disintegrating tablet that, like Compazine, is useful in patients who have difficulty swallowing or who do not feel they are able to drink. In a randomized trial, Zofran was compared with Phenergan and was found to have similar efficacy, but with less sedation.

Corticosteroids may not be as beneficial as many first thought—there are now conflicting data about their effectiveness—and some studies have suggested an increased risk of cleft lip and palate when these agents are used before 10 weeks' gestation. The drugs are recommended, therefore, only after 10 weeks' gestation and in cases in which other medications have failed.

Neither I nor any member of my family has any financial connections with the pharmaceutical industry.

A Fairly Common Condition

Nausea and vomiting in pregnancy are fairly common conditions. By themselves, they are neither life threatening nor threatening to the pregnancy, but they are nevertheless terribly uncomfortable, displeasing, and sometimes disabling.

Nausea and vomiting can often interfere with a patient's ability to perform household or workplace duties and can be destabilizing to a patient's life at a time when there otherwise is joy and happiness. Sometimes, nausea and vomiting can be so severe that they result in hospitalization and intravenous feeding.

For all these reasons, they cannot be overlooked.

Unfortunately, they are also mysterious. Nausea and vomiting in pregnancy are relatively uncommon in the populations of certain continents, such as Africa and Asia, but relatively common among North American women. They occur for varying lengths of time in some North American women and not at all in others. The causation, in short, is unclear and likely complicated. A number of hypotheses have been advanced, but none has been proved.

Despite the uncertainties, the frequency and effects of nausea and vomiting in pregnancy demand our attention. It therefore seems important to present a Master Class on the subject and to review the various treatments that have been tried and are available for patients who struggle with the condition.

Some of these approaches will work for our patients, and some will not. With these options before us, however, we can offer our patients the very best care.

Here to address the issue is Dr. Jennifer R. Niebyl, professor and chair of the department of obstetrics and gynecology at the University of Iowa Hospitals and Clinics, Iowa City.

Dr. Niebyl is an expert in the area of drugs and pregnancy and an expert in maternal-fetal medicine, with a special interest in nausea and vomiting in pregnancy.

Key Points

▸ Vitamin B6 and doxylamine should be first-line therapy for nausea and vomiting in pregnancy.

▸ No antiemetic has been found to have any teratogenic risk.

▸ Some alternative remedies, such as ginger and acupuncture, have been shown to be effective.

Treatments for Nausea/Vomiting

Vitamin B6

PremesisRx

Antihistamines

Doxylamine (Unisom)

Dimenhydrinate (Dramamine)

Diphenhydramine (Benadryl)

Meclizine (Antivert)

Hydroxyzine (Vistaril, Atarax)

Cetirizine (Zyrtec)

Phenothiazines

Promethazine (Phenergan)

Prochlorperazine (Compazine)

Chlorpromazine (Thorazine)

Prokinetic Agent

Metoclopramide (Reglan)

5-HT3 Receptor Antagonists

Ondansetron (Zofran)

Dolasetron (Anzemet)

Granisetron (Kytril)

Corticosteroids

Acupuncture

Ginger