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LGBTQ students would get new protections under Biden plan

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Tue, 02/14/2023 - 12:59

On the 50th anniversary of Title IX’s inception, the Biden administration has proposed changes to the law that would protect transgender students and assault survivors on college and university campuses.

With these changes, the protections provided by Title IX – a civil rights law that prohibits sex-based discrimination in schools that receive federal funding – would now be extended to students who identify as trans. The update would ensure that government-funded schools make proper accommodations for a trans student population, such as allowing students to use bathrooms and other facilities that align with their gender identity, and enforcing the use of students’ correct pronouns.

The revisions also seek to undo amendments made to the law by Betsy DeVos, who was secretary of education during the Trump presidency, which strengthened due process protections for students accused of sexual assault and narrowed the definition of sexual harassment. These rules “weakened protections for survivors of sexual assault and diminished the promise of an education free from discrimination,” the Biden administration said.



“Our proposed changes will allow us to continue that progress and ensure all our nation’s students – no matter where they live, who they are, or whom they love – can learn, grow, and thrive in school,” Education Secretary Miguel Cardona, PhD, said in a news release. “We welcome public comment on these critical regulations so we can further the Biden-Harris Administration’s mission of creating educational environments free from sex discrimination and sexual violence.”

The revisions will go through a long period of public comment before they are set into law. Still, the proposed changes mark a way forward for trans students who are not explicitly protected under Title IX, and they offer solace to assault survivors who may have felt discouraged to come forward and report under Ms. DeVos’s rules.

“The proposed regulations reflect the [Education] Department’s commitment to give full effect to Title IX, ensuring that no person experiences sex discrimination in education, and that school procedures for addressing complaints of sex discrimination, including sexual violence and other forms of sex-based harassment, are clear, effective, and fair to all involved,” said Catherine Lhamon, JD, assistant secretary for the Education Department’s Office Of Civil Rights.

More specific rules about transgender students’ participation in school sports are still to come.

A version of this article first appeared on WebMD.com.

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On the 50th anniversary of Title IX’s inception, the Biden administration has proposed changes to the law that would protect transgender students and assault survivors on college and university campuses.

With these changes, the protections provided by Title IX – a civil rights law that prohibits sex-based discrimination in schools that receive federal funding – would now be extended to students who identify as trans. The update would ensure that government-funded schools make proper accommodations for a trans student population, such as allowing students to use bathrooms and other facilities that align with their gender identity, and enforcing the use of students’ correct pronouns.

The revisions also seek to undo amendments made to the law by Betsy DeVos, who was secretary of education during the Trump presidency, which strengthened due process protections for students accused of sexual assault and narrowed the definition of sexual harassment. These rules “weakened protections for survivors of sexual assault and diminished the promise of an education free from discrimination,” the Biden administration said.



“Our proposed changes will allow us to continue that progress and ensure all our nation’s students – no matter where they live, who they are, or whom they love – can learn, grow, and thrive in school,” Education Secretary Miguel Cardona, PhD, said in a news release. “We welcome public comment on these critical regulations so we can further the Biden-Harris Administration’s mission of creating educational environments free from sex discrimination and sexual violence.”

The revisions will go through a long period of public comment before they are set into law. Still, the proposed changes mark a way forward for trans students who are not explicitly protected under Title IX, and they offer solace to assault survivors who may have felt discouraged to come forward and report under Ms. DeVos’s rules.

“The proposed regulations reflect the [Education] Department’s commitment to give full effect to Title IX, ensuring that no person experiences sex discrimination in education, and that school procedures for addressing complaints of sex discrimination, including sexual violence and other forms of sex-based harassment, are clear, effective, and fair to all involved,” said Catherine Lhamon, JD, assistant secretary for the Education Department’s Office Of Civil Rights.

More specific rules about transgender students’ participation in school sports are still to come.

A version of this article first appeared on WebMD.com.

On the 50th anniversary of Title IX’s inception, the Biden administration has proposed changes to the law that would protect transgender students and assault survivors on college and university campuses.

With these changes, the protections provided by Title IX – a civil rights law that prohibits sex-based discrimination in schools that receive federal funding – would now be extended to students who identify as trans. The update would ensure that government-funded schools make proper accommodations for a trans student population, such as allowing students to use bathrooms and other facilities that align with their gender identity, and enforcing the use of students’ correct pronouns.

The revisions also seek to undo amendments made to the law by Betsy DeVos, who was secretary of education during the Trump presidency, which strengthened due process protections for students accused of sexual assault and narrowed the definition of sexual harassment. These rules “weakened protections for survivors of sexual assault and diminished the promise of an education free from discrimination,” the Biden administration said.



“Our proposed changes will allow us to continue that progress and ensure all our nation’s students – no matter where they live, who they are, or whom they love – can learn, grow, and thrive in school,” Education Secretary Miguel Cardona, PhD, said in a news release. “We welcome public comment on these critical regulations so we can further the Biden-Harris Administration’s mission of creating educational environments free from sex discrimination and sexual violence.”

The revisions will go through a long period of public comment before they are set into law. Still, the proposed changes mark a way forward for trans students who are not explicitly protected under Title IX, and they offer solace to assault survivors who may have felt discouraged to come forward and report under Ms. DeVos’s rules.

“The proposed regulations reflect the [Education] Department’s commitment to give full effect to Title IX, ensuring that no person experiences sex discrimination in education, and that school procedures for addressing complaints of sex discrimination, including sexual violence and other forms of sex-based harassment, are clear, effective, and fair to all involved,” said Catherine Lhamon, JD, assistant secretary for the Education Department’s Office Of Civil Rights.

More specific rules about transgender students’ participation in school sports are still to come.

A version of this article first appeared on WebMD.com.

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Deaths rare in tonsillectomy, but some children at more risk

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Tue, 02/14/2023 - 12:59

It’s rare for a child to die after a tonsillectomy, but children who die are more likely to have a complex chronic condition such as cerebral palsy or Down syndrome, according to a retrospective cohort study published in JAMA.

“Among children undergoing tonsillectomy, the rate of postoperative death was 7 per 100,000 operations overall, [but] among children with complex chronic conditions, the rate of postoperative death was 117 per 100,000 operations, representing 44% of overall deaths,” write researchers at the University of Wisconsin–Madison. “These findings may inform decisionmaking for pediatric tonsillectomy.”

The rate of death in children after tonsillectomy has been uncertain, the authors write. Specific mortality rates for children at increased risk for complications, including those under 3 years old and those with sleep-disordered breathing or complex chronic conditions, have not been available.

To learn how likely children undergoing tonsillectomy are to die after their surgery, as well as which children are most at risk, lead study author M. Bruce Edmonson, MD, MPH, department of pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, and his colleagues drew data from five states, including ambulatory surgery, inpatient, and emergency department discharge data sets provided by the Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality for California, Florida, Maryland, New York, and Wisconsin.

Participants included 504,262 patients under 21 years of age whose discharge records linked their inpatient or outpatient tonsillectomy, with or without adenoidectomy, with at least 90 days of follow-up.

In a longitudinal analysis, the research team investigated postoperative death within 30 days or during a surgical stay lasting over 30 days. They calculated postoperative mortality per 100,000 operations, both overall and classified by age group, sleep-disordered breathing, and complex chronic conditions.

The 504,262 children ranged in age from 0 to 20 years and underwent a total of 505,182 tonsillectomies. Of these, 10.1% were performed in children aged under 3 years, 28.9% in children with sleep-disordered breathing, and 2.8% in those with complex chronic conditions.

The 36 linked postoperative deaths occurred between 2 and 20.5 days after surgical admission, and 19 (53%) of the deaths occurred after surgical discharge.

The unadjusted mortality rate was 7.04 (95% confidence interval, 4.97-9.98) deaths per 100,000 procedures. In multivariable models, children younger than 3 years and children with sleep-disordered breathing were not significantly more likely to die.

But children with complex chronic conditions were significantly more likely to die than were children without those conditions (117.22 vs. 3.87 deaths per 100,000 procedures, respectively).

Children with complex chronic conditions underwent only 2.8% of all tonsillectomies, but they accounted for 44% of postoperative deaths. Most deaths linked with complex chronic conditions occurred among children with neurologic, neuromuscular, congenital, or genetic disorders.
 

Findings can help providers advise patients and their families about tonsillectomy risks

Kavita Dedhia, MD, MSHP, attending otolaryngologist, Division of Otolaryngology, Children’s Hospital of Philadelphia, Pennsylvania, told this news organization that she was not surprised by the findings.

“This study suggests that mortality is an extremely rare complication of tonsillectomy, and that children with complex medical conditions are at highest risk,” Dr. Dedhia, who was not involved in the study, said in an email.

“Due to their underlying comorbidities, medically fragile children are considered to be at higher risk while undergoing anesthesia and surgical procedures,” she added.

Dr. Dedhia noted that nonpatient factors the study did not explore may have affected the mortality rates, including each hospital’s experience with managing children with complex medical conditions, as well as whether the hospitals were tertiary care facilities, and pediatric or adult hospitals.

She would like to know what hospital or practice characteristics may have contributed to the mortality risk and whether increased mortality in these patients is limited to tonsillectomy or is also found with other surgical procedures.

“The strength of this study is that it is large and multi-regional and that it informs providers about patient factors impacting mortality in pediatric tonsillectomy,” Dr. Dedhia said. “This study arms surgeons with data to discuss mortality risk with the families of medically complex children undergoing tonsillectomy.”

The study authors and Dr. Dedhia report no relevant financial relationships. Funding information was not provided.

A version of this article first appeared on Medscape.com.

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It’s rare for a child to die after a tonsillectomy, but children who die are more likely to have a complex chronic condition such as cerebral palsy or Down syndrome, according to a retrospective cohort study published in JAMA.

“Among children undergoing tonsillectomy, the rate of postoperative death was 7 per 100,000 operations overall, [but] among children with complex chronic conditions, the rate of postoperative death was 117 per 100,000 operations, representing 44% of overall deaths,” write researchers at the University of Wisconsin–Madison. “These findings may inform decisionmaking for pediatric tonsillectomy.”

The rate of death in children after tonsillectomy has been uncertain, the authors write. Specific mortality rates for children at increased risk for complications, including those under 3 years old and those with sleep-disordered breathing or complex chronic conditions, have not been available.

To learn how likely children undergoing tonsillectomy are to die after their surgery, as well as which children are most at risk, lead study author M. Bruce Edmonson, MD, MPH, department of pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, and his colleagues drew data from five states, including ambulatory surgery, inpatient, and emergency department discharge data sets provided by the Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality for California, Florida, Maryland, New York, and Wisconsin.

Participants included 504,262 patients under 21 years of age whose discharge records linked their inpatient or outpatient tonsillectomy, with or without adenoidectomy, with at least 90 days of follow-up.

In a longitudinal analysis, the research team investigated postoperative death within 30 days or during a surgical stay lasting over 30 days. They calculated postoperative mortality per 100,000 operations, both overall and classified by age group, sleep-disordered breathing, and complex chronic conditions.

The 504,262 children ranged in age from 0 to 20 years and underwent a total of 505,182 tonsillectomies. Of these, 10.1% were performed in children aged under 3 years, 28.9% in children with sleep-disordered breathing, and 2.8% in those with complex chronic conditions.

The 36 linked postoperative deaths occurred between 2 and 20.5 days after surgical admission, and 19 (53%) of the deaths occurred after surgical discharge.

The unadjusted mortality rate was 7.04 (95% confidence interval, 4.97-9.98) deaths per 100,000 procedures. In multivariable models, children younger than 3 years and children with sleep-disordered breathing were not significantly more likely to die.

But children with complex chronic conditions were significantly more likely to die than were children without those conditions (117.22 vs. 3.87 deaths per 100,000 procedures, respectively).

Children with complex chronic conditions underwent only 2.8% of all tonsillectomies, but they accounted for 44% of postoperative deaths. Most deaths linked with complex chronic conditions occurred among children with neurologic, neuromuscular, congenital, or genetic disorders.
 

Findings can help providers advise patients and their families about tonsillectomy risks

Kavita Dedhia, MD, MSHP, attending otolaryngologist, Division of Otolaryngology, Children’s Hospital of Philadelphia, Pennsylvania, told this news organization that she was not surprised by the findings.

“This study suggests that mortality is an extremely rare complication of tonsillectomy, and that children with complex medical conditions are at highest risk,” Dr. Dedhia, who was not involved in the study, said in an email.

“Due to their underlying comorbidities, medically fragile children are considered to be at higher risk while undergoing anesthesia and surgical procedures,” she added.

Dr. Dedhia noted that nonpatient factors the study did not explore may have affected the mortality rates, including each hospital’s experience with managing children with complex medical conditions, as well as whether the hospitals were tertiary care facilities, and pediatric or adult hospitals.

She would like to know what hospital or practice characteristics may have contributed to the mortality risk and whether increased mortality in these patients is limited to tonsillectomy or is also found with other surgical procedures.

“The strength of this study is that it is large and multi-regional and that it informs providers about patient factors impacting mortality in pediatric tonsillectomy,” Dr. Dedhia said. “This study arms surgeons with data to discuss mortality risk with the families of medically complex children undergoing tonsillectomy.”

The study authors and Dr. Dedhia report no relevant financial relationships. Funding information was not provided.

A version of this article first appeared on Medscape.com.

It’s rare for a child to die after a tonsillectomy, but children who die are more likely to have a complex chronic condition such as cerebral palsy or Down syndrome, according to a retrospective cohort study published in JAMA.

“Among children undergoing tonsillectomy, the rate of postoperative death was 7 per 100,000 operations overall, [but] among children with complex chronic conditions, the rate of postoperative death was 117 per 100,000 operations, representing 44% of overall deaths,” write researchers at the University of Wisconsin–Madison. “These findings may inform decisionmaking for pediatric tonsillectomy.”

The rate of death in children after tonsillectomy has been uncertain, the authors write. Specific mortality rates for children at increased risk for complications, including those under 3 years old and those with sleep-disordered breathing or complex chronic conditions, have not been available.

To learn how likely children undergoing tonsillectomy are to die after their surgery, as well as which children are most at risk, lead study author M. Bruce Edmonson, MD, MPH, department of pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, and his colleagues drew data from five states, including ambulatory surgery, inpatient, and emergency department discharge data sets provided by the Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality for California, Florida, Maryland, New York, and Wisconsin.

Participants included 504,262 patients under 21 years of age whose discharge records linked their inpatient or outpatient tonsillectomy, with or without adenoidectomy, with at least 90 days of follow-up.

In a longitudinal analysis, the research team investigated postoperative death within 30 days or during a surgical stay lasting over 30 days. They calculated postoperative mortality per 100,000 operations, both overall and classified by age group, sleep-disordered breathing, and complex chronic conditions.

The 504,262 children ranged in age from 0 to 20 years and underwent a total of 505,182 tonsillectomies. Of these, 10.1% were performed in children aged under 3 years, 28.9% in children with sleep-disordered breathing, and 2.8% in those with complex chronic conditions.

The 36 linked postoperative deaths occurred between 2 and 20.5 days after surgical admission, and 19 (53%) of the deaths occurred after surgical discharge.

The unadjusted mortality rate was 7.04 (95% confidence interval, 4.97-9.98) deaths per 100,000 procedures. In multivariable models, children younger than 3 years and children with sleep-disordered breathing were not significantly more likely to die.

But children with complex chronic conditions were significantly more likely to die than were children without those conditions (117.22 vs. 3.87 deaths per 100,000 procedures, respectively).

Children with complex chronic conditions underwent only 2.8% of all tonsillectomies, but they accounted for 44% of postoperative deaths. Most deaths linked with complex chronic conditions occurred among children with neurologic, neuromuscular, congenital, or genetic disorders.
 

Findings can help providers advise patients and their families about tonsillectomy risks

Kavita Dedhia, MD, MSHP, attending otolaryngologist, Division of Otolaryngology, Children’s Hospital of Philadelphia, Pennsylvania, told this news organization that she was not surprised by the findings.

“This study suggests that mortality is an extremely rare complication of tonsillectomy, and that children with complex medical conditions are at highest risk,” Dr. Dedhia, who was not involved in the study, said in an email.

“Due to their underlying comorbidities, medically fragile children are considered to be at higher risk while undergoing anesthesia and surgical procedures,” she added.

Dr. Dedhia noted that nonpatient factors the study did not explore may have affected the mortality rates, including each hospital’s experience with managing children with complex medical conditions, as well as whether the hospitals were tertiary care facilities, and pediatric or adult hospitals.

She would like to know what hospital or practice characteristics may have contributed to the mortality risk and whether increased mortality in these patients is limited to tonsillectomy or is also found with other surgical procedures.

“The strength of this study is that it is large and multi-regional and that it informs providers about patient factors impacting mortality in pediatric tonsillectomy,” Dr. Dedhia said. “This study arms surgeons with data to discuss mortality risk with the families of medically complex children undergoing tonsillectomy.”

The study authors and Dr. Dedhia report no relevant financial relationships. Funding information was not provided.

A version of this article first appeared on Medscape.com.

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Care gaps common after anal sphincter injuries from childbirth

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Wed, 08/17/2022 - 14:02

Postpartum complications may go unrecognized in women who incur anal sphincter injuries during childbirth, a review of electronic medical records at one academic health system suggests.

In the first 3 months after delivery, few patients with an obstetric anal sphincter injury (OASI) had documented pelvic floor problems, compared with higher rates documented in medical literature, the researchers found.

“Lack of identified pelvic floor dysfunction in this population differs from the incidence in previously published data and may reflect lack of identification by obstetric providers,” the researchers reported. The findings “highlight a gap in health care that, when addressed, could significantly improve postpartum quality of life.”

The findings are scheduled to be presented at the annual scientific meeting of the American Urogynecologic Society and International Urogynecological Association.

Anal sphincter injuries occur in about 4.4% of vaginal deliveries and are the most common cause of anal incontinence in women of reproductive age.

For the new study, researchers reviewed records of 287 women who underwent a vaginal birth that resulted in an anal sphincter injury at five Ohio hospitals affiliated with Cleveland Clinic from 2013 to 2015.

Of those who met eligibility criteria, 209 (72.8%) were White, 262 (91.3%) were non-Hispanic, and 249 (86.8%) were aged 20-34 years. Most had an epidural (92%), did not require a blood transfusion (97.9%), did not develop a vaginal hematoma (98.9%), and did not have their injury repaired in an operating room (97.2%), the researchers reported.

Among pelvic floor disorders, urinary incontinence was not reported in 96% of patients, fecal incontinence was not reported in 97.1%, and pelvic organ prolapse was not reported in 99.3%. Most had no recorded complications from their lacerations (87.8%) or postpartum depression (92%), the researchers found.

However, a 2015 study found that, 12 weeks after delivery, women with OASIs commonly reported symptoms of incontinence, with 26% reporting urinary stress incontinence, 21.4% urinary urgency incontinence, 59% anal incontinence, and 15% fecal incontinence.

Depression was also seldom identified despite higher risk of mood disorders among women with OASI, the researchers found.

The team also examined interpregnancy intervals, defined as the time between a woman’s first vaginal delivery and conception of a subsequent pregnancy. Of 178 women for whom data were available, the median interval was 26.4 months (95% confidence interval, 23.7-29.9), similar to the median for births nationally.

Lead researcher Alexandra Nutaitis, DO, a resident in obstetrics and gynecology at Cleveland Clinic Akron General, said in an interview that it’s unclear whether physicians did not inquire about symptoms or didn’t record them. She noted that anal sphincter injuries are a “stigmatized topic.”
 

Not asked, not told

Carolyn Swenson, MD, an associate professor in urogynecology at the University of Utah, Salt Lake City, said physicians in the study may have relied on patients to bring up their symptoms rather than using questionnaires to screen for problems.

“What we know is that if you don’t ask women about pelvic floor disorders, they often don’t tell you that they are experiencing symptoms,” said Dr. Swenson, who was not involved in the new research.

Dr. Swenson called for validated questionnaires to assess pelvic floor symptoms in postpartum patients.

Regarding interpregnancy intervals, Dr. Nutaitis said she would be surprised if women who experienced an OASI didn’t delay having another child longer than women who did not undergo that physical and psychological trauma – but other factors such as societal pressures may override any reluctance to proceed with another pregnancy.

Dr. Swenson said it’s possible that a subgroup of women who have severe complications, such as those with a fourth-degree tear, might put off having another child. However, more research is needed to find out, she said.

Dr. Nutaitis and Dr. Swenson disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Postpartum complications may go unrecognized in women who incur anal sphincter injuries during childbirth, a review of electronic medical records at one academic health system suggests.

In the first 3 months after delivery, few patients with an obstetric anal sphincter injury (OASI) had documented pelvic floor problems, compared with higher rates documented in medical literature, the researchers found.

“Lack of identified pelvic floor dysfunction in this population differs from the incidence in previously published data and may reflect lack of identification by obstetric providers,” the researchers reported. The findings “highlight a gap in health care that, when addressed, could significantly improve postpartum quality of life.”

The findings are scheduled to be presented at the annual scientific meeting of the American Urogynecologic Society and International Urogynecological Association.

Anal sphincter injuries occur in about 4.4% of vaginal deliveries and are the most common cause of anal incontinence in women of reproductive age.

For the new study, researchers reviewed records of 287 women who underwent a vaginal birth that resulted in an anal sphincter injury at five Ohio hospitals affiliated with Cleveland Clinic from 2013 to 2015.

Of those who met eligibility criteria, 209 (72.8%) were White, 262 (91.3%) were non-Hispanic, and 249 (86.8%) were aged 20-34 years. Most had an epidural (92%), did not require a blood transfusion (97.9%), did not develop a vaginal hematoma (98.9%), and did not have their injury repaired in an operating room (97.2%), the researchers reported.

Among pelvic floor disorders, urinary incontinence was not reported in 96% of patients, fecal incontinence was not reported in 97.1%, and pelvic organ prolapse was not reported in 99.3%. Most had no recorded complications from their lacerations (87.8%) or postpartum depression (92%), the researchers found.

However, a 2015 study found that, 12 weeks after delivery, women with OASIs commonly reported symptoms of incontinence, with 26% reporting urinary stress incontinence, 21.4% urinary urgency incontinence, 59% anal incontinence, and 15% fecal incontinence.

Depression was also seldom identified despite higher risk of mood disorders among women with OASI, the researchers found.

The team also examined interpregnancy intervals, defined as the time between a woman’s first vaginal delivery and conception of a subsequent pregnancy. Of 178 women for whom data were available, the median interval was 26.4 months (95% confidence interval, 23.7-29.9), similar to the median for births nationally.

Lead researcher Alexandra Nutaitis, DO, a resident in obstetrics and gynecology at Cleveland Clinic Akron General, said in an interview that it’s unclear whether physicians did not inquire about symptoms or didn’t record them. She noted that anal sphincter injuries are a “stigmatized topic.”
 

Not asked, not told

Carolyn Swenson, MD, an associate professor in urogynecology at the University of Utah, Salt Lake City, said physicians in the study may have relied on patients to bring up their symptoms rather than using questionnaires to screen for problems.

“What we know is that if you don’t ask women about pelvic floor disorders, they often don’t tell you that they are experiencing symptoms,” said Dr. Swenson, who was not involved in the new research.

Dr. Swenson called for validated questionnaires to assess pelvic floor symptoms in postpartum patients.

Regarding interpregnancy intervals, Dr. Nutaitis said she would be surprised if women who experienced an OASI didn’t delay having another child longer than women who did not undergo that physical and psychological trauma – but other factors such as societal pressures may override any reluctance to proceed with another pregnancy.

Dr. Swenson said it’s possible that a subgroup of women who have severe complications, such as those with a fourth-degree tear, might put off having another child. However, more research is needed to find out, she said.

Dr. Nutaitis and Dr. Swenson disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Postpartum complications may go unrecognized in women who incur anal sphincter injuries during childbirth, a review of electronic medical records at one academic health system suggests.

In the first 3 months after delivery, few patients with an obstetric anal sphincter injury (OASI) had documented pelvic floor problems, compared with higher rates documented in medical literature, the researchers found.

“Lack of identified pelvic floor dysfunction in this population differs from the incidence in previously published data and may reflect lack of identification by obstetric providers,” the researchers reported. The findings “highlight a gap in health care that, when addressed, could significantly improve postpartum quality of life.”

The findings are scheduled to be presented at the annual scientific meeting of the American Urogynecologic Society and International Urogynecological Association.

Anal sphincter injuries occur in about 4.4% of vaginal deliveries and are the most common cause of anal incontinence in women of reproductive age.

For the new study, researchers reviewed records of 287 women who underwent a vaginal birth that resulted in an anal sphincter injury at five Ohio hospitals affiliated with Cleveland Clinic from 2013 to 2015.

Of those who met eligibility criteria, 209 (72.8%) were White, 262 (91.3%) were non-Hispanic, and 249 (86.8%) were aged 20-34 years. Most had an epidural (92%), did not require a blood transfusion (97.9%), did not develop a vaginal hematoma (98.9%), and did not have their injury repaired in an operating room (97.2%), the researchers reported.

Among pelvic floor disorders, urinary incontinence was not reported in 96% of patients, fecal incontinence was not reported in 97.1%, and pelvic organ prolapse was not reported in 99.3%. Most had no recorded complications from their lacerations (87.8%) or postpartum depression (92%), the researchers found.

However, a 2015 study found that, 12 weeks after delivery, women with OASIs commonly reported symptoms of incontinence, with 26% reporting urinary stress incontinence, 21.4% urinary urgency incontinence, 59% anal incontinence, and 15% fecal incontinence.

Depression was also seldom identified despite higher risk of mood disorders among women with OASI, the researchers found.

The team also examined interpregnancy intervals, defined as the time between a woman’s first vaginal delivery and conception of a subsequent pregnancy. Of 178 women for whom data were available, the median interval was 26.4 months (95% confidence interval, 23.7-29.9), similar to the median for births nationally.

Lead researcher Alexandra Nutaitis, DO, a resident in obstetrics and gynecology at Cleveland Clinic Akron General, said in an interview that it’s unclear whether physicians did not inquire about symptoms or didn’t record them. She noted that anal sphincter injuries are a “stigmatized topic.”
 

Not asked, not told

Carolyn Swenson, MD, an associate professor in urogynecology at the University of Utah, Salt Lake City, said physicians in the study may have relied on patients to bring up their symptoms rather than using questionnaires to screen for problems.

“What we know is that if you don’t ask women about pelvic floor disorders, they often don’t tell you that they are experiencing symptoms,” said Dr. Swenson, who was not involved in the new research.

Dr. Swenson called for validated questionnaires to assess pelvic floor symptoms in postpartum patients.

Regarding interpregnancy intervals, Dr. Nutaitis said she would be surprised if women who experienced an OASI didn’t delay having another child longer than women who did not undergo that physical and psychological trauma – but other factors such as societal pressures may override any reluctance to proceed with another pregnancy.

Dr. Swenson said it’s possible that a subgroup of women who have severe complications, such as those with a fourth-degree tear, might put off having another child. However, more research is needed to find out, she said.

Dr. Nutaitis and Dr. Swenson disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Surgeons may underestimate recovery from incontinence operation

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Tue, 06/14/2022 - 10:21

Surgeons may significantly underestimate how long it will take women to return to normal activities following sling surgery to correct stress urinary incontinence, a new study has found.

The researchers found that just over 40% of women reported returning to work and other normal activities within 2 weeks of having undergone midurethral sling procedures – a much less optimistic forecast than what surgeons typically provide in these cases.

“This is in contrast to a published survey of physicians that showed the majority of surgeons suggested patients return to work within 2 weeks,” Rui Wang, MD, a fellow in female pelvic medicine and reconstructive surgery at Hartford Hospital, Conn., said in an interview.

Dr. Wang referred to a published survey of 135 physicians that was conducted at a 2018 meeting of the Society of Gynecologic Surgeons. In that survey, 88% of respondents indicated that patients could return to sedentary work within 2 weeks after undergoing sling surgery. Most recommended longer waits before returning to manual labor.

The authors of the survey noted a lack of consensus guidelines and wide variations in recommendations for postoperative restrictions after minimally invasive gynecologic and pelvic reconstructive surgery, which the researchers called a “largely unstudied field.”

Dr. Wang said, “The majority of patients may need more than 2 weeks to return to work and normal activities even following minimally invasive outpatient surgeries such as midurethral sling.”

Dr. Wang is scheduled to present the findings June 18 at the annual meeting of the American Urogynecologic Society.

For the new study, Dr. Wang and a colleague examined how patients answered questions about their activity levels during recovery after sling procedures. The patients were enrolled in the Trial of Mid-Urethral Slings (TOMUS), a randomized controlled trial that compared two types of midurethral slings used for the treatment of stress urinary incontinence: the retropubic midurethral mesh sling and the transobturator midurethral sling. Results of the trial were published in 2010.

Of 597 women enrolled in TOMUS, 441 were included in the new analysis. Patients who underwent another surgery at the same time as their sling procedure were excluded from the analysis.

As part of the trial, patients were asked how many paid workdays they took off after surgery; whether they had returned to full normal activities of daily life, including work, if applicable; and how much time it took for them to fully return to normal activities of daily life, including work.

The researchers found that 183 (41.5%) returned to normal activities within 2 weeks of the procedure. Among those patients, the median recovery time was 6 days. Within 6 weeks of surgery, 308 (70%) had returned to normal activities, including work. After 6 months, 407 (98.3%) were back to their normal routines, the study showed.

Multivariate regression analysis yielded no factor that predicted the timing of returning to normal activity and work. Nor did the researchers observe any significant differences in failure rates and adverse outcomes between patients who returned within 2 weeks or after 2 weeks.
 

Essential information for patient planning

Dr. Wang said she expects that the findings will help physicians in counseling patients and setting postoperative recovery expectations. “For patients planning elective surgery, one of the most important quality-of-life issues is the time they will need to take off from work and recover,” she said.

Although most patients needed more than 2 weeks to recover, the median paid time off after surgery was 4 days. “Many patients would have taken unpaid days off or used vacation time for their postoperative recovery,” Dr. Wang said.

She added that more research is needed to explore whether that discrepancy disproportionately affects women in jobs with fewer employee benefits. “We did not find that age, race/ethnicity, marital status, occupation, symptom severity, and duration of surgery significantly predicted the timing of return to work or normal activities,” she said. “But are there other factors, such as geographic location, insurance status, [or] income, that may affect this timing?”

Sarah Boyd, MD, an assistant professor in the Division of Female Pelvic Medicine and Reconstructive Surgery at Penn State College of Medicine, Hershey, said the new findings add concrete information that can guide patients in planning their recovery.

“Previously, surgeons could only provide general estimates to these patients based on the experience of their patients,” Dr. Boyd, who was not involved in the study, told this news organization.

The analysis has not been published in a peer-reviewed journal, and Dr. Boyd said that the findings may not pertain to all individuals who undergo midurethral sling procedures, such as people who have had prior surgery for incontinence or those who undergo surgery for other pelvic floor disorders at the same time.

Dr. Wang and Dr. Boyd reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Surgeons may significantly underestimate how long it will take women to return to normal activities following sling surgery to correct stress urinary incontinence, a new study has found.

The researchers found that just over 40% of women reported returning to work and other normal activities within 2 weeks of having undergone midurethral sling procedures – a much less optimistic forecast than what surgeons typically provide in these cases.

“This is in contrast to a published survey of physicians that showed the majority of surgeons suggested patients return to work within 2 weeks,” Rui Wang, MD, a fellow in female pelvic medicine and reconstructive surgery at Hartford Hospital, Conn., said in an interview.

Dr. Wang referred to a published survey of 135 physicians that was conducted at a 2018 meeting of the Society of Gynecologic Surgeons. In that survey, 88% of respondents indicated that patients could return to sedentary work within 2 weeks after undergoing sling surgery. Most recommended longer waits before returning to manual labor.

The authors of the survey noted a lack of consensus guidelines and wide variations in recommendations for postoperative restrictions after minimally invasive gynecologic and pelvic reconstructive surgery, which the researchers called a “largely unstudied field.”

Dr. Wang said, “The majority of patients may need more than 2 weeks to return to work and normal activities even following minimally invasive outpatient surgeries such as midurethral sling.”

Dr. Wang is scheduled to present the findings June 18 at the annual meeting of the American Urogynecologic Society.

For the new study, Dr. Wang and a colleague examined how patients answered questions about their activity levels during recovery after sling procedures. The patients were enrolled in the Trial of Mid-Urethral Slings (TOMUS), a randomized controlled trial that compared two types of midurethral slings used for the treatment of stress urinary incontinence: the retropubic midurethral mesh sling and the transobturator midurethral sling. Results of the trial were published in 2010.

Of 597 women enrolled in TOMUS, 441 were included in the new analysis. Patients who underwent another surgery at the same time as their sling procedure were excluded from the analysis.

As part of the trial, patients were asked how many paid workdays they took off after surgery; whether they had returned to full normal activities of daily life, including work, if applicable; and how much time it took for them to fully return to normal activities of daily life, including work.

The researchers found that 183 (41.5%) returned to normal activities within 2 weeks of the procedure. Among those patients, the median recovery time was 6 days. Within 6 weeks of surgery, 308 (70%) had returned to normal activities, including work. After 6 months, 407 (98.3%) were back to their normal routines, the study showed.

Multivariate regression analysis yielded no factor that predicted the timing of returning to normal activity and work. Nor did the researchers observe any significant differences in failure rates and adverse outcomes between patients who returned within 2 weeks or after 2 weeks.
 

Essential information for patient planning

Dr. Wang said she expects that the findings will help physicians in counseling patients and setting postoperative recovery expectations. “For patients planning elective surgery, one of the most important quality-of-life issues is the time they will need to take off from work and recover,” she said.

Although most patients needed more than 2 weeks to recover, the median paid time off after surgery was 4 days. “Many patients would have taken unpaid days off or used vacation time for their postoperative recovery,” Dr. Wang said.

She added that more research is needed to explore whether that discrepancy disproportionately affects women in jobs with fewer employee benefits. “We did not find that age, race/ethnicity, marital status, occupation, symptom severity, and duration of surgery significantly predicted the timing of return to work or normal activities,” she said. “But are there other factors, such as geographic location, insurance status, [or] income, that may affect this timing?”

Sarah Boyd, MD, an assistant professor in the Division of Female Pelvic Medicine and Reconstructive Surgery at Penn State College of Medicine, Hershey, said the new findings add concrete information that can guide patients in planning their recovery.

“Previously, surgeons could only provide general estimates to these patients based on the experience of their patients,” Dr. Boyd, who was not involved in the study, told this news organization.

The analysis has not been published in a peer-reviewed journal, and Dr. Boyd said that the findings may not pertain to all individuals who undergo midurethral sling procedures, such as people who have had prior surgery for incontinence or those who undergo surgery for other pelvic floor disorders at the same time.

Dr. Wang and Dr. Boyd reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Surgeons may significantly underestimate how long it will take women to return to normal activities following sling surgery to correct stress urinary incontinence, a new study has found.

The researchers found that just over 40% of women reported returning to work and other normal activities within 2 weeks of having undergone midurethral sling procedures – a much less optimistic forecast than what surgeons typically provide in these cases.

“This is in contrast to a published survey of physicians that showed the majority of surgeons suggested patients return to work within 2 weeks,” Rui Wang, MD, a fellow in female pelvic medicine and reconstructive surgery at Hartford Hospital, Conn., said in an interview.

Dr. Wang referred to a published survey of 135 physicians that was conducted at a 2018 meeting of the Society of Gynecologic Surgeons. In that survey, 88% of respondents indicated that patients could return to sedentary work within 2 weeks after undergoing sling surgery. Most recommended longer waits before returning to manual labor.

The authors of the survey noted a lack of consensus guidelines and wide variations in recommendations for postoperative restrictions after minimally invasive gynecologic and pelvic reconstructive surgery, which the researchers called a “largely unstudied field.”

Dr. Wang said, “The majority of patients may need more than 2 weeks to return to work and normal activities even following minimally invasive outpatient surgeries such as midurethral sling.”

Dr. Wang is scheduled to present the findings June 18 at the annual meeting of the American Urogynecologic Society.

For the new study, Dr. Wang and a colleague examined how patients answered questions about their activity levels during recovery after sling procedures. The patients were enrolled in the Trial of Mid-Urethral Slings (TOMUS), a randomized controlled trial that compared two types of midurethral slings used for the treatment of stress urinary incontinence: the retropubic midurethral mesh sling and the transobturator midurethral sling. Results of the trial were published in 2010.

Of 597 women enrolled in TOMUS, 441 were included in the new analysis. Patients who underwent another surgery at the same time as their sling procedure were excluded from the analysis.

As part of the trial, patients were asked how many paid workdays they took off after surgery; whether they had returned to full normal activities of daily life, including work, if applicable; and how much time it took for them to fully return to normal activities of daily life, including work.

The researchers found that 183 (41.5%) returned to normal activities within 2 weeks of the procedure. Among those patients, the median recovery time was 6 days. Within 6 weeks of surgery, 308 (70%) had returned to normal activities, including work. After 6 months, 407 (98.3%) were back to their normal routines, the study showed.

Multivariate regression analysis yielded no factor that predicted the timing of returning to normal activity and work. Nor did the researchers observe any significant differences in failure rates and adverse outcomes between patients who returned within 2 weeks or after 2 weeks.
 

Essential information for patient planning

Dr. Wang said she expects that the findings will help physicians in counseling patients and setting postoperative recovery expectations. “For patients planning elective surgery, one of the most important quality-of-life issues is the time they will need to take off from work and recover,” she said.

Although most patients needed more than 2 weeks to recover, the median paid time off after surgery was 4 days. “Many patients would have taken unpaid days off or used vacation time for their postoperative recovery,” Dr. Wang said.

She added that more research is needed to explore whether that discrepancy disproportionately affects women in jobs with fewer employee benefits. “We did not find that age, race/ethnicity, marital status, occupation, symptom severity, and duration of surgery significantly predicted the timing of return to work or normal activities,” she said. “But are there other factors, such as geographic location, insurance status, [or] income, that may affect this timing?”

Sarah Boyd, MD, an assistant professor in the Division of Female Pelvic Medicine and Reconstructive Surgery at Penn State College of Medicine, Hershey, said the new findings add concrete information that can guide patients in planning their recovery.

“Previously, surgeons could only provide general estimates to these patients based on the experience of their patients,” Dr. Boyd, who was not involved in the study, told this news organization.

The analysis has not been published in a peer-reviewed journal, and Dr. Boyd said that the findings may not pertain to all individuals who undergo midurethral sling procedures, such as people who have had prior surgery for incontinence or those who undergo surgery for other pelvic floor disorders at the same time.

Dr. Wang and Dr. Boyd reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Challenges and innovations in training gyn surgeons

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Obstetrics and gynecology (ObGyn) is a surgical specialty, yet the training of ObGyn residents differs significantly from that of residents in other surgical specialties. In addition to attaining competency in both the distinct but related fields of obstetrics and gynecology, ObGyn residents have their training condensed into 4 years rather than the 5 years’ training of many other surgical specialties. This limits the time dedicated to gynecologic surgery, currently 18 to 20 months in most programs, and has been exacerbated by tighter duty-hour restrictions.1

Additionally, with increasing demand for minimally invasive procedures, residents are expected to attain competency in a growing breadth of gynecologic procedures in a patient population with increasing morbidity, and they may have less autonomy to do so in an increasingly litigious environment.2 Furthermore, annual hysterectomy cases are declining, from about 680,000 in 2002 to 430,000 in 2010,3 and these declining rates are seen in the low case numbers of recent graduates.4

Training time, procedure complexity

With less time to master a growing body of increasingly complex procedures, is the profession adequately training gynecologic surgeons? Many gynecologic surgeons are concerned that the answer is no and that significant shifts in resident training are needed to generate safe and competent gynecologic surgeons. These training deficits represent a deficiency in the quality of care for women specifically, and thus the inattention to training gynecologic surgeons should be considered a health care disparity.

The concern over insufficient attention to gynecologic surgical training is not new, nor are proposed solutions, with many physicians citing the above concerns.5-9 In 2018, the Accreditation Council for Graduate Medical Education (ACGME) case minimums for hysterectomy increased to 85 from 70 hysterectomies, with a shift toward minimally invasive hysterectomy.10 Otherwise, minimal national changes have been made in this century to training gynecologic surgeons.

Tracking as an option

Many critics of current ObGyn training argue that obstetrics and gynecology, while related, have significantly different pathologies, surgical approaches, and skill sets and thus warrant the option to track toward obstetrics or gynecology after attaining limited core skill set in residency. In 2010, the Carnegie Foundation for the Advancement of Teaching called for the need for increased individualization opportunities in graduate medical education, citing that minimal changes have been made to medical education since the Flexner Report a century prior.11

Notably, tracking has been implemented with success at Cleveland Clinic, where residents are given 5 to 10 weeks of time allotted to their specific fields of interest, while still meeting minimum ACGME requirements and, in some cases, exceeding hysterectomy minimums by as much as 500%.12 Tracking is viewed positively by a majority of program directors.13 See the box below for Dr. Ferrando’s experience on tracking at the Cleveland Clinic.

 

Simulation training

Other educators advocate for maximizing preparedness for the operating room by using high-fidelity simulation.14,15 Simulation allows for the acquisition of basic technical skills needed for surgery as well as for repetition not easily achieved in the current surgical environment. Additionally, it provides lower-level learners the opportunity to acquire basic skills in a safe setting, thereby enhancing the ability to participate meaningfully on arrival in the operating room.16

In 2018, the American Board of Obstetrics and Gynecology added the Fundamentals of Laparoscopic Surgery certification as a new requirement for board certification.17 Laparoscopic and robotic surgery simulators allow trainees to develop coordination and specific skills, like knot tying and suturing. Additionally, models are available with varying levels of fidelity for vaginal and abdominal hysterectomy.18-20 See the box below for Dr. Miyazaki’s experience in developing the Miya Model trainer for vaginal surgery simulation.

Structured feedback

Finally, if a resident has limited exposure to a specific procedure, maximizing the preparation and feedback for each procedure is paramount. However, surgeons receive minimal formal training in teaching trainees, which leads to inconsistent and underutilized feedback.21 Specific structured feedback models have been implemented with success in the general surgery literature, including the SHARP (Set learning objectives, How did it go, Address concerns, Review learning points, Plan ahead) and BID (Briefing, Intraoperative, Debriefing) models.22,23

Reimbursement reform

While surgical reimbursement is not directly tied to resident education, decreased reimbursement to women’s health pathology and procedures has the downstream effect of decreasing the funds available for ObGyn departments to invest in research and education. Additionally, “suboptimal mastery or maintenance of appropriate surgical skills results in procedural inefficiencies that compound surgical cost.”5 Providers and payors alike should therefore be motivated to improve funding in order to improve adequate training of gynecologic surgeons. Payment reform is necessary to equally value women’s health procedures but also can ensure that gynecologic surgeons have the funds needed to train a competent next generation of ObGyn physicians. ●

Key takeaways
  • Residents and fellows have significant constraints that limit adequate training in gynecologic surgery. In a panel discussion at the 48th annual meeting of the Society of Gynecologic Surgeons, Drs. Zimmerman, Ferrando, and Miyazaki spoke about potential solutions.
  • Allowing residents to track toward obstetric or gynecologic subspecialties may improve surgical volume of trainees who aim for a future career in gynecologic surgery.
  • Simulation has demonstrated efficacy in enabling residents to prepare and improve their technical skills for specific procedures prior to entering the operating room.

 

 

Cleveland Clinic’s tracking innovation

Cecile A. Ferrando, MD, MPH

In his 2013 presidential address at the opening ceremony of the 42nd AAGL Global Congress on Minimally Invasive Gynecology, Javier Magrina, MD, asked the audience, “Isn’t it time to separate the O from the G?”7 Since that address, this catchy question has been posed several times, and it continues to be a topic of interest to many ObGyn educators seeking to innovate the curriculum and to better train our next generation’s gynecologic surgeons.

Several concerns have been raised about the current traditional 4-year residency training program, which has been impacted by the reduction of training hours due to duty-hour rules in the setting of decreased surgical volume and new technologies used to perform surgery. While other surgical specialties have begun to innovate their pathways for trainees, ObGyn has been a little slower to make a significant transition in its approach to training.

In 2012, Cleveland Clinic decided to lead the way in innovation regarding residency training. At its inception, the curriculum was designed to allow “tracking blocks” through each academic year to allow residents to gain additional experience in their specialty of choice. The program was carefully designed to assure that residents would achieve all 28 of the core obstetrics and gynecology milestones while still allowing for curricular flexibility.

Currently, residents are given autonomy to design their own tracking blocks with an assigned mentor for the rotation. Allowing residents to spend more time in their specialty of choice permits them to fine-tune skills that a standard curriculum may not have afforded the opportunity to home in on. It also allows residents to gain exposure to specialties that are not part of the core program, such as vulvar health, breast health and surgery, and gender affirmation surgery.

The Cleveland Clinic experience has been successful thus far. Importantly, preliminary data show that the tracking program does not interfere with the overall case number necessary for graduation. Residents also have succeeded in their postgraduation pursuits, including those who chose to specialize in general obstetrics and gynecology.

Cleveland Clinic is no longer the only program to incorporate tracking into its curriculum. This innovation is likely to become more standard as medical education in ObGyn evolves. We have not yet “separated the O from the G” completely in our specialty. However, thought leaders in our field are recognizing the need to better prepare our trainees, and this flexibility in mindset is bound to lead to a paradigm that may become the new standard for our specialty.

Acknowledgments: John E. Jelovsek, MD, the first Program Director of the Cleveland Clinic Residency in Obstetrics & Gynecology, who was responsible for creating the tracking program; and Vicki Reed, MD, the current Program Director, who has continued to innovate the program.

 

 

The Miya Model (developer Douglas Miyazaki, MD) supports training in basic and full surgical procedures

The Miya Model (Miyazaki Enterprises LLC) is a multiprocedural vaginal surgery simulator born from the need for standardized, scalable training in response to reductions in the average surgical case volume per resident. The Miya Model supports various basic procedures, such as pelvic exams and dilation and curettage, as well as full surgical procedures, including anterior and posterior colporrhaphy, midurethral and retropubic slings, cystoscopy, and vaginal hysterectomy. Training with the Miya Model moves resident surgical education from the operating room to any simulation lab or office-based setting. With rapidly declining resident surgical case volumes, there is an even stronger need to provide additional training outside of the operating room theater. Creation and development of the Miya Model were fueled by a desire to create a safer and more efficient method to educate residents without the risk of patient harm.

Miyazaki Enterprises has taken the Miya Model from a vision on paper to a standardized, commercially available product to help support resident and physician education. The Miya Model has undergone numerous rounds of waterfall and agile development, validity testing, and the creation of internal and external processes to achieve this vision. It serves as an example that ideas originating from significant demonstrated market need can be successfully created and deployed by a physician.

 

References
  1. Espey E, Ogburn T, Puscheck E. Impact of duty hour limitations on resident and student education in obstetrics and gynecology. J Reprod Med. 2007;52:345-348.
  2. Pulliam SJ, Berkowitz LR. Smaller pieces of the hysterectomy pie: current challenges in resident surgical education. Obstet Gynecol. 2009;113(2 pt 1):395-398. doi: 10.1097/AOG.0b013e3181955011.
  3. Wright JD, Herzog TJ, Tsui J, et al. Nationwide trends in the performance of inpatient hysterectomy in the United States. Obstet Gynecol. 2013;122(2 pt 1):233-241. doi: 10.1097/AOG.0b013e318299a6cf.
  4. Cadish LA, Kropat G, Muffly TM. Hysterectomy volume among recent obstetrics and gynecology residency graduates. Female Pelvic Med Reconstr Surg. 2021;27:382-387. doi: 10.1097/SPV.0000000000000879.
  5. Podratz KC. Gynecologic surgery: an imperiled ballet. Presidential address. Am J Obstet Gynecol. 1998;178:1229-1234. doi: 10.1016/ s0002-9378(98)70327-8.
  6. Bissonnette JM, Gabbe SG, Hammond CB, et al. Restructuring residency training in obstetrics and gynecology. Am J Obstet Gynecol. 1999;180(3 pt 1):516-518. doi: 10.1016/s0002-9378(99)70246-2.
  7. Magrina JF. Isn’t it time to separate the O from the G? J Minim Invasive Gynecol. 2014;21:501-503. doi: 10.1016/j.jmig.2014.01.022.
  8. Merrill JA. Needed changes in obstetric-gynecologic training. Obstet Gynecol Surv. 1994;49:1-2.
  9. Lauer JK, Advincula AP. The future of the gynecologic surgeon: rationale for and steps toward subspecialization of complex gynecologic surgery. J Minim Invasive Gynecol. 2021;28:726-729. doi: 10.1016/j.jmig.2020.12.031.
  10. Hall EF, Raker CA, Hampton BS. Variability in gynecologic case volume of obstetrician-gynecologist residents graduating from 2009 to 2017. Am J Obstet Gynecol. 2020;222:617.e1-617.e8. doi: 10.1016/j .ajog.2019.11.1258.
  11. Irby DM, Cooke M, O’Brien BC. Calls for reform of medical education by the Carnegie Foundation for the Advancement of Teaching: 1910 and 2010. Acad Med. 2010;85:220-227. doi: 10.1097 /ACM.0b013e3181c88449.
  12. Reed VR, Emery J, Farrell RM, et al. Tracking—a flexible obstetrics and gynecology residency curriculum. Obstet Gynecol. 2019;134(suppl 1):29s-33s. doi: 10.1097/AOG.0000000000003464.
  13. Hariton E, Freret TS, Nitecki R, et al. Program director perceptions of subspecialty tracking in obstetrics and gynecology residency. J Grad Med Educ. 2018;10:665-670. doi: 10.4300/JGME-D-18-00096.1.
  14. Azadi S, Green IC, Arnold A, et al. Robotic surgery: the impact of simulation and other innovative platforms on performance and training. J Minim Invasive Gynecol. 2021;28:490-495. doi: 10.1016/j .jmig.2020.12.001.
  15. Wohlrab K, Jelovsek JE, Myers D. Incorporating simulation into gynecologic surgical training. Am J Obstet Gynecol. 2017;217:522-526. doi: 10.1016/j.ajog.2017.05.017.
  16. Chen CC, Green IC, Colbert-Getz JM, et al. Warm-up on a simulator improves residents’ performance in laparoscopic surgery: a randomized trial. Int Urogynecol J. 2013;24:1615-1622. doi: 10.1007 /s00192-013-2066-2.
  17. Fundamentals of Laparoscopic Surgery. ABOG announces new eligibility requirement for board certification. January 23, 2018. Accessed May 12, 2022. https://www.flsprogram.org/news/abog -announces-new-eligibility-requirement-board-certification/.
  18. Zoorob D, Frenn R, Moffitt M, et al. Multi-institutional validation of a vaginal hysterectomy simulation model for resident training. J Minim Invasive Gynecol. 2021;28:1490-1496.e1. doi: 10.1016/j .jmig.2020.12.006.
  19. Barrier BF, Thompson AB, McCullough MW, et al. A novel and inexpensive vaginal hysterectomy simulator. Simul Healthc. 2012;7:374-379. doi: 10.1097/SIH.0b013e318266d0c6.
  20. Stickrath E, Alston M. A novel abdominal hysterectomy simulator and its impact on obstetrics and gynecology residents’ surgical confidence. MedEdPORTAL. 2017;13:10636. doi: 10.15766/mep_2374-8265.10636.
  21. McKendy KM, Watanabe Y, Lee L, et al. Perioperative feedback in surgical training: a systematic review. Am J Surg. 2017;214:117-126. doi: 10.1016/j.amjsurg.2016.12.014.
  22. Ahmed M, Arora S, Russ S, et al. Operation debrief: a SHARP improvement in performance feedback in the operating room. Ann Surg. 2013;258:958-963. doi: 10.1097/SLA.0b013e31828c88fc.
  23. Anderson CI, Gupta RN, Larson JR, et al. Impact of objectively assessing surgeons’ teaching on effective perioperative instructional behaviors. JAMA Surg. 2013;148:915-922. doi: 10.1001/jamasurg.2013.2144.
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Author and Disclosure Information

Mary V. Baker, MD, MBA 
Fellow, Female Pelvic Medicine and  
Reconstructive Surgery 
Division of Urogynecology 
Vanderbilt University Medical Center 
Nashville, Tennessee 

Brandy M. Butler, MD 
Fellow, Female Pelvic Medicine and  
Reconstructive Surgery 
Division of Urogynecology 
Vanderbilt University Medical Center 
Nashville, Tennessee 

Shivani M. Murarka, MD 
Fellow, Female Pelvic Medicine and  
Reconstructive Surgery 
Division of Urogynecology 
Vanderbilt University Medical Center 
Nashville, Tennessee 

Cecile A. Ferrando, MD, MPH 
Associate Professor 
Obstetrics and Gynecology Subspecialty Care  
for Women’s Health 
Women’s Health Institute 
Cleveland Clinic 
Cleveland, Ohio 

Douglas W. Miyazaki, MD 
Department of Obstetrics and Gynecology 
Novant Health 
Pelvic Health Center 
Winston-Salem, North Carolina 
President, Miyazaki Enterprises LLC 
Greensboro, North Carolina 

Carl W. Zimmerman, MD 
Frances and John C. Burch Chair in Obstetrics  
and Gynecology 
Division of Urogynecology 
Vanderbilt University School of Medicine 
Nashville, Tennessee

 

Dr. Ferrando reports receiving authorship royalties from UpToDate, Inc. Dr. Miyazaki reports being a speaker for Coloplast and the President of Miyazaki Enterprises LLC. The other authors report no financial relationships relevant to this article.

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Mary V. Baker, MD, MBA 
Fellow, Female Pelvic Medicine and  
Reconstructive Surgery 
Division of Urogynecology 
Vanderbilt University Medical Center 
Nashville, Tennessee 

Brandy M. Butler, MD 
Fellow, Female Pelvic Medicine and  
Reconstructive Surgery 
Division of Urogynecology 
Vanderbilt University Medical Center 
Nashville, Tennessee 

Shivani M. Murarka, MD 
Fellow, Female Pelvic Medicine and  
Reconstructive Surgery 
Division of Urogynecology 
Vanderbilt University Medical Center 
Nashville, Tennessee 

Cecile A. Ferrando, MD, MPH 
Associate Professor 
Obstetrics and Gynecology Subspecialty Care  
for Women’s Health 
Women’s Health Institute 
Cleveland Clinic 
Cleveland, Ohio 

Douglas W. Miyazaki, MD 
Department of Obstetrics and Gynecology 
Novant Health 
Pelvic Health Center 
Winston-Salem, North Carolina 
President, Miyazaki Enterprises LLC 
Greensboro, North Carolina 

Carl W. Zimmerman, MD 
Frances and John C. Burch Chair in Obstetrics  
and Gynecology 
Division of Urogynecology 
Vanderbilt University School of Medicine 
Nashville, Tennessee

 

Dr. Ferrando reports receiving authorship royalties from UpToDate, Inc. Dr. Miyazaki reports being a speaker for Coloplast and the President of Miyazaki Enterprises LLC. The other authors report no financial relationships relevant to this article.

Author and Disclosure Information

Mary V. Baker, MD, MBA 
Fellow, Female Pelvic Medicine and  
Reconstructive Surgery 
Division of Urogynecology 
Vanderbilt University Medical Center 
Nashville, Tennessee 

Brandy M. Butler, MD 
Fellow, Female Pelvic Medicine and  
Reconstructive Surgery 
Division of Urogynecology 
Vanderbilt University Medical Center 
Nashville, Tennessee 

Shivani M. Murarka, MD 
Fellow, Female Pelvic Medicine and  
Reconstructive Surgery 
Division of Urogynecology 
Vanderbilt University Medical Center 
Nashville, Tennessee 

Cecile A. Ferrando, MD, MPH 
Associate Professor 
Obstetrics and Gynecology Subspecialty Care  
for Women’s Health 
Women’s Health Institute 
Cleveland Clinic 
Cleveland, Ohio 

Douglas W. Miyazaki, MD 
Department of Obstetrics and Gynecology 
Novant Health 
Pelvic Health Center 
Winston-Salem, North Carolina 
President, Miyazaki Enterprises LLC 
Greensboro, North Carolina 

Carl W. Zimmerman, MD 
Frances and John C. Burch Chair in Obstetrics  
and Gynecology 
Division of Urogynecology 
Vanderbilt University School of Medicine 
Nashville, Tennessee

 

Dr. Ferrando reports receiving authorship royalties from UpToDate, Inc. Dr. Miyazaki reports being a speaker for Coloplast and the President of Miyazaki Enterprises LLC. The other authors report no financial relationships relevant to this article.

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Article PDF

 

 

Obstetrics and gynecology (ObGyn) is a surgical specialty, yet the training of ObGyn residents differs significantly from that of residents in other surgical specialties. In addition to attaining competency in both the distinct but related fields of obstetrics and gynecology, ObGyn residents have their training condensed into 4 years rather than the 5 years’ training of many other surgical specialties. This limits the time dedicated to gynecologic surgery, currently 18 to 20 months in most programs, and has been exacerbated by tighter duty-hour restrictions.1

Additionally, with increasing demand for minimally invasive procedures, residents are expected to attain competency in a growing breadth of gynecologic procedures in a patient population with increasing morbidity, and they may have less autonomy to do so in an increasingly litigious environment.2 Furthermore, annual hysterectomy cases are declining, from about 680,000 in 2002 to 430,000 in 2010,3 and these declining rates are seen in the low case numbers of recent graduates.4

Training time, procedure complexity

With less time to master a growing body of increasingly complex procedures, is the profession adequately training gynecologic surgeons? Many gynecologic surgeons are concerned that the answer is no and that significant shifts in resident training are needed to generate safe and competent gynecologic surgeons. These training deficits represent a deficiency in the quality of care for women specifically, and thus the inattention to training gynecologic surgeons should be considered a health care disparity.

The concern over insufficient attention to gynecologic surgical training is not new, nor are proposed solutions, with many physicians citing the above concerns.5-9 In 2018, the Accreditation Council for Graduate Medical Education (ACGME) case minimums for hysterectomy increased to 85 from 70 hysterectomies, with a shift toward minimally invasive hysterectomy.10 Otherwise, minimal national changes have been made in this century to training gynecologic surgeons.

Tracking as an option

Many critics of current ObGyn training argue that obstetrics and gynecology, while related, have significantly different pathologies, surgical approaches, and skill sets and thus warrant the option to track toward obstetrics or gynecology after attaining limited core skill set in residency. In 2010, the Carnegie Foundation for the Advancement of Teaching called for the need for increased individualization opportunities in graduate medical education, citing that minimal changes have been made to medical education since the Flexner Report a century prior.11

Notably, tracking has been implemented with success at Cleveland Clinic, where residents are given 5 to 10 weeks of time allotted to their specific fields of interest, while still meeting minimum ACGME requirements and, in some cases, exceeding hysterectomy minimums by as much as 500%.12 Tracking is viewed positively by a majority of program directors.13 See the box below for Dr. Ferrando’s experience on tracking at the Cleveland Clinic.

 

Simulation training

Other educators advocate for maximizing preparedness for the operating room by using high-fidelity simulation.14,15 Simulation allows for the acquisition of basic technical skills needed for surgery as well as for repetition not easily achieved in the current surgical environment. Additionally, it provides lower-level learners the opportunity to acquire basic skills in a safe setting, thereby enhancing the ability to participate meaningfully on arrival in the operating room.16

In 2018, the American Board of Obstetrics and Gynecology added the Fundamentals of Laparoscopic Surgery certification as a new requirement for board certification.17 Laparoscopic and robotic surgery simulators allow trainees to develop coordination and specific skills, like knot tying and suturing. Additionally, models are available with varying levels of fidelity for vaginal and abdominal hysterectomy.18-20 See the box below for Dr. Miyazaki’s experience in developing the Miya Model trainer for vaginal surgery simulation.

Structured feedback

Finally, if a resident has limited exposure to a specific procedure, maximizing the preparation and feedback for each procedure is paramount. However, surgeons receive minimal formal training in teaching trainees, which leads to inconsistent and underutilized feedback.21 Specific structured feedback models have been implemented with success in the general surgery literature, including the SHARP (Set learning objectives, How did it go, Address concerns, Review learning points, Plan ahead) and BID (Briefing, Intraoperative, Debriefing) models.22,23

Reimbursement reform

While surgical reimbursement is not directly tied to resident education, decreased reimbursement to women’s health pathology and procedures has the downstream effect of decreasing the funds available for ObGyn departments to invest in research and education. Additionally, “suboptimal mastery or maintenance of appropriate surgical skills results in procedural inefficiencies that compound surgical cost.”5 Providers and payors alike should therefore be motivated to improve funding in order to improve adequate training of gynecologic surgeons. Payment reform is necessary to equally value women’s health procedures but also can ensure that gynecologic surgeons have the funds needed to train a competent next generation of ObGyn physicians. ●

Key takeaways
  • Residents and fellows have significant constraints that limit adequate training in gynecologic surgery. In a panel discussion at the 48th annual meeting of the Society of Gynecologic Surgeons, Drs. Zimmerman, Ferrando, and Miyazaki spoke about potential solutions.
  • Allowing residents to track toward obstetric or gynecologic subspecialties may improve surgical volume of trainees who aim for a future career in gynecologic surgery.
  • Simulation has demonstrated efficacy in enabling residents to prepare and improve their technical skills for specific procedures prior to entering the operating room.

 

 

Cleveland Clinic’s tracking innovation

Cecile A. Ferrando, MD, MPH

In his 2013 presidential address at the opening ceremony of the 42nd AAGL Global Congress on Minimally Invasive Gynecology, Javier Magrina, MD, asked the audience, “Isn’t it time to separate the O from the G?”7 Since that address, this catchy question has been posed several times, and it continues to be a topic of interest to many ObGyn educators seeking to innovate the curriculum and to better train our next generation’s gynecologic surgeons.

Several concerns have been raised about the current traditional 4-year residency training program, which has been impacted by the reduction of training hours due to duty-hour rules in the setting of decreased surgical volume and new technologies used to perform surgery. While other surgical specialties have begun to innovate their pathways for trainees, ObGyn has been a little slower to make a significant transition in its approach to training.

In 2012, Cleveland Clinic decided to lead the way in innovation regarding residency training. At its inception, the curriculum was designed to allow “tracking blocks” through each academic year to allow residents to gain additional experience in their specialty of choice. The program was carefully designed to assure that residents would achieve all 28 of the core obstetrics and gynecology milestones while still allowing for curricular flexibility.

Currently, residents are given autonomy to design their own tracking blocks with an assigned mentor for the rotation. Allowing residents to spend more time in their specialty of choice permits them to fine-tune skills that a standard curriculum may not have afforded the opportunity to home in on. It also allows residents to gain exposure to specialties that are not part of the core program, such as vulvar health, breast health and surgery, and gender affirmation surgery.

The Cleveland Clinic experience has been successful thus far. Importantly, preliminary data show that the tracking program does not interfere with the overall case number necessary for graduation. Residents also have succeeded in their postgraduation pursuits, including those who chose to specialize in general obstetrics and gynecology.

Cleveland Clinic is no longer the only program to incorporate tracking into its curriculum. This innovation is likely to become more standard as medical education in ObGyn evolves. We have not yet “separated the O from the G” completely in our specialty. However, thought leaders in our field are recognizing the need to better prepare our trainees, and this flexibility in mindset is bound to lead to a paradigm that may become the new standard for our specialty.

Acknowledgments: John E. Jelovsek, MD, the first Program Director of the Cleveland Clinic Residency in Obstetrics & Gynecology, who was responsible for creating the tracking program; and Vicki Reed, MD, the current Program Director, who has continued to innovate the program.

 

 

The Miya Model (developer Douglas Miyazaki, MD) supports training in basic and full surgical procedures

The Miya Model (Miyazaki Enterprises LLC) is a multiprocedural vaginal surgery simulator born from the need for standardized, scalable training in response to reductions in the average surgical case volume per resident. The Miya Model supports various basic procedures, such as pelvic exams and dilation and curettage, as well as full surgical procedures, including anterior and posterior colporrhaphy, midurethral and retropubic slings, cystoscopy, and vaginal hysterectomy. Training with the Miya Model moves resident surgical education from the operating room to any simulation lab or office-based setting. With rapidly declining resident surgical case volumes, there is an even stronger need to provide additional training outside of the operating room theater. Creation and development of the Miya Model were fueled by a desire to create a safer and more efficient method to educate residents without the risk of patient harm.

Miyazaki Enterprises has taken the Miya Model from a vision on paper to a standardized, commercially available product to help support resident and physician education. The Miya Model has undergone numerous rounds of waterfall and agile development, validity testing, and the creation of internal and external processes to achieve this vision. It serves as an example that ideas originating from significant demonstrated market need can be successfully created and deployed by a physician.

 

 

 

Obstetrics and gynecology (ObGyn) is a surgical specialty, yet the training of ObGyn residents differs significantly from that of residents in other surgical specialties. In addition to attaining competency in both the distinct but related fields of obstetrics and gynecology, ObGyn residents have their training condensed into 4 years rather than the 5 years’ training of many other surgical specialties. This limits the time dedicated to gynecologic surgery, currently 18 to 20 months in most programs, and has been exacerbated by tighter duty-hour restrictions.1

Additionally, with increasing demand for minimally invasive procedures, residents are expected to attain competency in a growing breadth of gynecologic procedures in a patient population with increasing morbidity, and they may have less autonomy to do so in an increasingly litigious environment.2 Furthermore, annual hysterectomy cases are declining, from about 680,000 in 2002 to 430,000 in 2010,3 and these declining rates are seen in the low case numbers of recent graduates.4

Training time, procedure complexity

With less time to master a growing body of increasingly complex procedures, is the profession adequately training gynecologic surgeons? Many gynecologic surgeons are concerned that the answer is no and that significant shifts in resident training are needed to generate safe and competent gynecologic surgeons. These training deficits represent a deficiency in the quality of care for women specifically, and thus the inattention to training gynecologic surgeons should be considered a health care disparity.

The concern over insufficient attention to gynecologic surgical training is not new, nor are proposed solutions, with many physicians citing the above concerns.5-9 In 2018, the Accreditation Council for Graduate Medical Education (ACGME) case minimums for hysterectomy increased to 85 from 70 hysterectomies, with a shift toward minimally invasive hysterectomy.10 Otherwise, minimal national changes have been made in this century to training gynecologic surgeons.

Tracking as an option

Many critics of current ObGyn training argue that obstetrics and gynecology, while related, have significantly different pathologies, surgical approaches, and skill sets and thus warrant the option to track toward obstetrics or gynecology after attaining limited core skill set in residency. In 2010, the Carnegie Foundation for the Advancement of Teaching called for the need for increased individualization opportunities in graduate medical education, citing that minimal changes have been made to medical education since the Flexner Report a century prior.11

Notably, tracking has been implemented with success at Cleveland Clinic, where residents are given 5 to 10 weeks of time allotted to their specific fields of interest, while still meeting minimum ACGME requirements and, in some cases, exceeding hysterectomy minimums by as much as 500%.12 Tracking is viewed positively by a majority of program directors.13 See the box below for Dr. Ferrando’s experience on tracking at the Cleveland Clinic.

 

Simulation training

Other educators advocate for maximizing preparedness for the operating room by using high-fidelity simulation.14,15 Simulation allows for the acquisition of basic technical skills needed for surgery as well as for repetition not easily achieved in the current surgical environment. Additionally, it provides lower-level learners the opportunity to acquire basic skills in a safe setting, thereby enhancing the ability to participate meaningfully on arrival in the operating room.16

In 2018, the American Board of Obstetrics and Gynecology added the Fundamentals of Laparoscopic Surgery certification as a new requirement for board certification.17 Laparoscopic and robotic surgery simulators allow trainees to develop coordination and specific skills, like knot tying and suturing. Additionally, models are available with varying levels of fidelity for vaginal and abdominal hysterectomy.18-20 See the box below for Dr. Miyazaki’s experience in developing the Miya Model trainer for vaginal surgery simulation.

Structured feedback

Finally, if a resident has limited exposure to a specific procedure, maximizing the preparation and feedback for each procedure is paramount. However, surgeons receive minimal formal training in teaching trainees, which leads to inconsistent and underutilized feedback.21 Specific structured feedback models have been implemented with success in the general surgery literature, including the SHARP (Set learning objectives, How did it go, Address concerns, Review learning points, Plan ahead) and BID (Briefing, Intraoperative, Debriefing) models.22,23

Reimbursement reform

While surgical reimbursement is not directly tied to resident education, decreased reimbursement to women’s health pathology and procedures has the downstream effect of decreasing the funds available for ObGyn departments to invest in research and education. Additionally, “suboptimal mastery or maintenance of appropriate surgical skills results in procedural inefficiencies that compound surgical cost.”5 Providers and payors alike should therefore be motivated to improve funding in order to improve adequate training of gynecologic surgeons. Payment reform is necessary to equally value women’s health procedures but also can ensure that gynecologic surgeons have the funds needed to train a competent next generation of ObGyn physicians. ●

Key takeaways
  • Residents and fellows have significant constraints that limit adequate training in gynecologic surgery. In a panel discussion at the 48th annual meeting of the Society of Gynecologic Surgeons, Drs. Zimmerman, Ferrando, and Miyazaki spoke about potential solutions.
  • Allowing residents to track toward obstetric or gynecologic subspecialties may improve surgical volume of trainees who aim for a future career in gynecologic surgery.
  • Simulation has demonstrated efficacy in enabling residents to prepare and improve their technical skills for specific procedures prior to entering the operating room.

 

 

Cleveland Clinic’s tracking innovation

Cecile A. Ferrando, MD, MPH

In his 2013 presidential address at the opening ceremony of the 42nd AAGL Global Congress on Minimally Invasive Gynecology, Javier Magrina, MD, asked the audience, “Isn’t it time to separate the O from the G?”7 Since that address, this catchy question has been posed several times, and it continues to be a topic of interest to many ObGyn educators seeking to innovate the curriculum and to better train our next generation’s gynecologic surgeons.

Several concerns have been raised about the current traditional 4-year residency training program, which has been impacted by the reduction of training hours due to duty-hour rules in the setting of decreased surgical volume and new technologies used to perform surgery. While other surgical specialties have begun to innovate their pathways for trainees, ObGyn has been a little slower to make a significant transition in its approach to training.

In 2012, Cleveland Clinic decided to lead the way in innovation regarding residency training. At its inception, the curriculum was designed to allow “tracking blocks” through each academic year to allow residents to gain additional experience in their specialty of choice. The program was carefully designed to assure that residents would achieve all 28 of the core obstetrics and gynecology milestones while still allowing for curricular flexibility.

Currently, residents are given autonomy to design their own tracking blocks with an assigned mentor for the rotation. Allowing residents to spend more time in their specialty of choice permits them to fine-tune skills that a standard curriculum may not have afforded the opportunity to home in on. It also allows residents to gain exposure to specialties that are not part of the core program, such as vulvar health, breast health and surgery, and gender affirmation surgery.

The Cleveland Clinic experience has been successful thus far. Importantly, preliminary data show that the tracking program does not interfere with the overall case number necessary for graduation. Residents also have succeeded in their postgraduation pursuits, including those who chose to specialize in general obstetrics and gynecology.

Cleveland Clinic is no longer the only program to incorporate tracking into its curriculum. This innovation is likely to become more standard as medical education in ObGyn evolves. We have not yet “separated the O from the G” completely in our specialty. However, thought leaders in our field are recognizing the need to better prepare our trainees, and this flexibility in mindset is bound to lead to a paradigm that may become the new standard for our specialty.

Acknowledgments: John E. Jelovsek, MD, the first Program Director of the Cleveland Clinic Residency in Obstetrics & Gynecology, who was responsible for creating the tracking program; and Vicki Reed, MD, the current Program Director, who has continued to innovate the program.

 

 

The Miya Model (developer Douglas Miyazaki, MD) supports training in basic and full surgical procedures

The Miya Model (Miyazaki Enterprises LLC) is a multiprocedural vaginal surgery simulator born from the need for standardized, scalable training in response to reductions in the average surgical case volume per resident. The Miya Model supports various basic procedures, such as pelvic exams and dilation and curettage, as well as full surgical procedures, including anterior and posterior colporrhaphy, midurethral and retropubic slings, cystoscopy, and vaginal hysterectomy. Training with the Miya Model moves resident surgical education from the operating room to any simulation lab or office-based setting. With rapidly declining resident surgical case volumes, there is an even stronger need to provide additional training outside of the operating room theater. Creation and development of the Miya Model were fueled by a desire to create a safer and more efficient method to educate residents without the risk of patient harm.

Miyazaki Enterprises has taken the Miya Model from a vision on paper to a standardized, commercially available product to help support resident and physician education. The Miya Model has undergone numerous rounds of waterfall and agile development, validity testing, and the creation of internal and external processes to achieve this vision. It serves as an example that ideas originating from significant demonstrated market need can be successfully created and deployed by a physician.

 

References
  1. Espey E, Ogburn T, Puscheck E. Impact of duty hour limitations on resident and student education in obstetrics and gynecology. J Reprod Med. 2007;52:345-348.
  2. Pulliam SJ, Berkowitz LR. Smaller pieces of the hysterectomy pie: current challenges in resident surgical education. Obstet Gynecol. 2009;113(2 pt 1):395-398. doi: 10.1097/AOG.0b013e3181955011.
  3. Wright JD, Herzog TJ, Tsui J, et al. Nationwide trends in the performance of inpatient hysterectomy in the United States. Obstet Gynecol. 2013;122(2 pt 1):233-241. doi: 10.1097/AOG.0b013e318299a6cf.
  4. Cadish LA, Kropat G, Muffly TM. Hysterectomy volume among recent obstetrics and gynecology residency graduates. Female Pelvic Med Reconstr Surg. 2021;27:382-387. doi: 10.1097/SPV.0000000000000879.
  5. Podratz KC. Gynecologic surgery: an imperiled ballet. Presidential address. Am J Obstet Gynecol. 1998;178:1229-1234. doi: 10.1016/ s0002-9378(98)70327-8.
  6. Bissonnette JM, Gabbe SG, Hammond CB, et al. Restructuring residency training in obstetrics and gynecology. Am J Obstet Gynecol. 1999;180(3 pt 1):516-518. doi: 10.1016/s0002-9378(99)70246-2.
  7. Magrina JF. Isn’t it time to separate the O from the G? J Minim Invasive Gynecol. 2014;21:501-503. doi: 10.1016/j.jmig.2014.01.022.
  8. Merrill JA. Needed changes in obstetric-gynecologic training. Obstet Gynecol Surv. 1994;49:1-2.
  9. Lauer JK, Advincula AP. The future of the gynecologic surgeon: rationale for and steps toward subspecialization of complex gynecologic surgery. J Minim Invasive Gynecol. 2021;28:726-729. doi: 10.1016/j.jmig.2020.12.031.
  10. Hall EF, Raker CA, Hampton BS. Variability in gynecologic case volume of obstetrician-gynecologist residents graduating from 2009 to 2017. Am J Obstet Gynecol. 2020;222:617.e1-617.e8. doi: 10.1016/j .ajog.2019.11.1258.
  11. Irby DM, Cooke M, O’Brien BC. Calls for reform of medical education by the Carnegie Foundation for the Advancement of Teaching: 1910 and 2010. Acad Med. 2010;85:220-227. doi: 10.1097 /ACM.0b013e3181c88449.
  12. Reed VR, Emery J, Farrell RM, et al. Tracking—a flexible obstetrics and gynecology residency curriculum. Obstet Gynecol. 2019;134(suppl 1):29s-33s. doi: 10.1097/AOG.0000000000003464.
  13. Hariton E, Freret TS, Nitecki R, et al. Program director perceptions of subspecialty tracking in obstetrics and gynecology residency. J Grad Med Educ. 2018;10:665-670. doi: 10.4300/JGME-D-18-00096.1.
  14. Azadi S, Green IC, Arnold A, et al. Robotic surgery: the impact of simulation and other innovative platforms on performance and training. J Minim Invasive Gynecol. 2021;28:490-495. doi: 10.1016/j .jmig.2020.12.001.
  15. Wohlrab K, Jelovsek JE, Myers D. Incorporating simulation into gynecologic surgical training. Am J Obstet Gynecol. 2017;217:522-526. doi: 10.1016/j.ajog.2017.05.017.
  16. Chen CC, Green IC, Colbert-Getz JM, et al. Warm-up on a simulator improves residents’ performance in laparoscopic surgery: a randomized trial. Int Urogynecol J. 2013;24:1615-1622. doi: 10.1007 /s00192-013-2066-2.
  17. Fundamentals of Laparoscopic Surgery. ABOG announces new eligibility requirement for board certification. January 23, 2018. Accessed May 12, 2022. https://www.flsprogram.org/news/abog -announces-new-eligibility-requirement-board-certification/.
  18. Zoorob D, Frenn R, Moffitt M, et al. Multi-institutional validation of a vaginal hysterectomy simulation model for resident training. J Minim Invasive Gynecol. 2021;28:1490-1496.e1. doi: 10.1016/j .jmig.2020.12.006.
  19. Barrier BF, Thompson AB, McCullough MW, et al. A novel and inexpensive vaginal hysterectomy simulator. Simul Healthc. 2012;7:374-379. doi: 10.1097/SIH.0b013e318266d0c6.
  20. Stickrath E, Alston M. A novel abdominal hysterectomy simulator and its impact on obstetrics and gynecology residents’ surgical confidence. MedEdPORTAL. 2017;13:10636. doi: 10.15766/mep_2374-8265.10636.
  21. McKendy KM, Watanabe Y, Lee L, et al. Perioperative feedback in surgical training: a systematic review. Am J Surg. 2017;214:117-126. doi: 10.1016/j.amjsurg.2016.12.014.
  22. Ahmed M, Arora S, Russ S, et al. Operation debrief: a SHARP improvement in performance feedback in the operating room. Ann Surg. 2013;258:958-963. doi: 10.1097/SLA.0b013e31828c88fc.
  23. Anderson CI, Gupta RN, Larson JR, et al. Impact of objectively assessing surgeons’ teaching on effective perioperative instructional behaviors. JAMA Surg. 2013;148:915-922. doi: 10.1001/jamasurg.2013.2144.
References
  1. Espey E, Ogburn T, Puscheck E. Impact of duty hour limitations on resident and student education in obstetrics and gynecology. J Reprod Med. 2007;52:345-348.
  2. Pulliam SJ, Berkowitz LR. Smaller pieces of the hysterectomy pie: current challenges in resident surgical education. Obstet Gynecol. 2009;113(2 pt 1):395-398. doi: 10.1097/AOG.0b013e3181955011.
  3. Wright JD, Herzog TJ, Tsui J, et al. Nationwide trends in the performance of inpatient hysterectomy in the United States. Obstet Gynecol. 2013;122(2 pt 1):233-241. doi: 10.1097/AOG.0b013e318299a6cf.
  4. Cadish LA, Kropat G, Muffly TM. Hysterectomy volume among recent obstetrics and gynecology residency graduates. Female Pelvic Med Reconstr Surg. 2021;27:382-387. doi: 10.1097/SPV.0000000000000879.
  5. Podratz KC. Gynecologic surgery: an imperiled ballet. Presidential address. Am J Obstet Gynecol. 1998;178:1229-1234. doi: 10.1016/ s0002-9378(98)70327-8.
  6. Bissonnette JM, Gabbe SG, Hammond CB, et al. Restructuring residency training in obstetrics and gynecology. Am J Obstet Gynecol. 1999;180(3 pt 1):516-518. doi: 10.1016/s0002-9378(99)70246-2.
  7. Magrina JF. Isn’t it time to separate the O from the G? J Minim Invasive Gynecol. 2014;21:501-503. doi: 10.1016/j.jmig.2014.01.022.
  8. Merrill JA. Needed changes in obstetric-gynecologic training. Obstet Gynecol Surv. 1994;49:1-2.
  9. Lauer JK, Advincula AP. The future of the gynecologic surgeon: rationale for and steps toward subspecialization of complex gynecologic surgery. J Minim Invasive Gynecol. 2021;28:726-729. doi: 10.1016/j.jmig.2020.12.031.
  10. Hall EF, Raker CA, Hampton BS. Variability in gynecologic case volume of obstetrician-gynecologist residents graduating from 2009 to 2017. Am J Obstet Gynecol. 2020;222:617.e1-617.e8. doi: 10.1016/j .ajog.2019.11.1258.
  11. Irby DM, Cooke M, O’Brien BC. Calls for reform of medical education by the Carnegie Foundation for the Advancement of Teaching: 1910 and 2010. Acad Med. 2010;85:220-227. doi: 10.1097 /ACM.0b013e3181c88449.
  12. Reed VR, Emery J, Farrell RM, et al. Tracking—a flexible obstetrics and gynecology residency curriculum. Obstet Gynecol. 2019;134(suppl 1):29s-33s. doi: 10.1097/AOG.0000000000003464.
  13. Hariton E, Freret TS, Nitecki R, et al. Program director perceptions of subspecialty tracking in obstetrics and gynecology residency. J Grad Med Educ. 2018;10:665-670. doi: 10.4300/JGME-D-18-00096.1.
  14. Azadi S, Green IC, Arnold A, et al. Robotic surgery: the impact of simulation and other innovative platforms on performance and training. J Minim Invasive Gynecol. 2021;28:490-495. doi: 10.1016/j .jmig.2020.12.001.
  15. Wohlrab K, Jelovsek JE, Myers D. Incorporating simulation into gynecologic surgical training. Am J Obstet Gynecol. 2017;217:522-526. doi: 10.1016/j.ajog.2017.05.017.
  16. Chen CC, Green IC, Colbert-Getz JM, et al. Warm-up on a simulator improves residents’ performance in laparoscopic surgery: a randomized trial. Int Urogynecol J. 2013;24:1615-1622. doi: 10.1007 /s00192-013-2066-2.
  17. Fundamentals of Laparoscopic Surgery. ABOG announces new eligibility requirement for board certification. January 23, 2018. Accessed May 12, 2022. https://www.flsprogram.org/news/abog -announces-new-eligibility-requirement-board-certification/.
  18. Zoorob D, Frenn R, Moffitt M, et al. Multi-institutional validation of a vaginal hysterectomy simulation model for resident training. J Minim Invasive Gynecol. 2021;28:1490-1496.e1. doi: 10.1016/j .jmig.2020.12.006.
  19. Barrier BF, Thompson AB, McCullough MW, et al. A novel and inexpensive vaginal hysterectomy simulator. Simul Healthc. 2012;7:374-379. doi: 10.1097/SIH.0b013e318266d0c6.
  20. Stickrath E, Alston M. A novel abdominal hysterectomy simulator and its impact on obstetrics and gynecology residents’ surgical confidence. MedEdPORTAL. 2017;13:10636. doi: 10.15766/mep_2374-8265.10636.
  21. McKendy KM, Watanabe Y, Lee L, et al. Perioperative feedback in surgical training: a systematic review. Am J Surg. 2017;214:117-126. doi: 10.1016/j.amjsurg.2016.12.014.
  22. Ahmed M, Arora S, Russ S, et al. Operation debrief: a SHARP improvement in performance feedback in the operating room. Ann Surg. 2013;258:958-963. doi: 10.1097/SLA.0b013e31828c88fc.
  23. Anderson CI, Gupta RN, Larson JR, et al. Impact of objectively assessing surgeons’ teaching on effective perioperative instructional behaviors. JAMA Surg. 2013;148:915-922. doi: 10.1001/jamasurg.2013.2144.
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Vesicovaginal and rectovaginal fistulas from obstetric-related causes: Diagnosis and management

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Fri, 09/02/2022 - 12:18

 

 

Although rare in the United States and more common in low-resource countries, fistulas due to obstructed labor do occur. In developed countries, other obstetric causes for fistula are usually surgery, trauma, or infection related. An abnormal communication between organs—be it the urethra, bladder, ureter, uterus, cervix, or rectum—can develop1 and lead to vesicovaginal fistula (VVF), urethrovaginal fistula (FIGURE 1), vesicocervical fistula, vesicouterine fistula, ureterovaginal fistula (FIGURE 2), and rectovaginal fistula (RVF). Other nonobstetric causes include gynecologic surgery, radiation, malignancy, and congenital malformations.

During labor, hypoxia, subsequent ischemia, and pressure necrosis contribute to fistula formation. Injury sustained during a cesarean delivery (CD) or cesarean hysterectomy can lead to fistula formation; at times, however, complications are unavoidable given the nature of the pathologic condition that the patient presents with.

VVF and RVF have a devastating impact on a woman’s quality of life as they lead to significant morbidity and short- and long-term psychological distress. The fistula may not be recognized at the time of injury. The presenting signs and symptoms may be intermittent and confusing. Immediate surgical intervention may not be possible due to ongoing inflammation or infection. Recovery often is prolonged. As there is significant concomitant postpartum anxiety and depression, patients with fistula often require psychosocial support and counseling. After repair, there is still a risk for recurrence and voiding dysfunction.

 

Fistula signs and symptoms and evaluation

In cases of VVF, patients present with continuing large or small volume urinary incontinence. Depending on the time to diagnosis, patients may have calculi formation, prolapse, scarring, external perineal dermatitis, perineal nerve injury, and even motor weakness. Cyclic hematuria may be seen in vesicouterine fistulas.2

Multiple classification systems for diagnosis and staging of VVF have been suggested.3,4 A classification system for RVF was published by Tsang and colleagues.5 All these classification systems have attempted to characterize fistulas in terms of level of surgical complexity for repair, providing a guideline for preoperative assessment. These classification systems do not translate into prediction regarding outcomes.

Evaluation of pelvic fistula from the urinary tract starts with a thorough history that includes onset, duration, and description of leakage (continuous, intermittent, or positional) and whether there is concomitant stress and urge incontinence. A detailed obstetric history, including circumstances around the mode of delivery, underlying risk factors, and psychosocial history, should be obtained.

The pelvic examination with a plastic speculum and adequate lighting should assess the external perineum for dermatitis; bulbocavernosus and anal reflexes; and the vagina for length, caliber, level of scarring, and any prolapse. For VVFs, the location, size, and number of the fistula tracts can be visualized and confirmed with a retrograde fill of the bladder via a Foley catheter with saline or water mixed with methylene blue or any other blue dye (FIGURE 3). If a ureterovaginal fistula is suspected, the patient can simultaneously be given oral phenazopyridine and a tampon inserted within the vagina; the patient can then ambulate, and re-examination of the end of the tampon can reveal orange staining. The bladder meanwhile is retrograde filled with blue dye, with no blue staining of the tampon.



For RVF, history taking should include the onset, duration, and description of leakage, and the external anal sphincter should be assessed, with careful examination of the distal vagina at the vestibule as this is the most common location for RVF (fistula in ano). Patients may describe vaginal flatus and sometimes only brownish discharge, which can be intermittent, leading to an incorrect diagnosis of vaginitis that is treated repeatedly without success.

There is no consensus regarding optimal imaging for the assessment of VVF. Imaging used for diagnosis of VVF includes a voiding cystogram with opacification of the vagina after filling the bladder with contrast if there is a fistula. A cystoscopy can evaluate for calculi, retained suture, level of inflammation, and location of the ureters in relation to the fistula. Renal ultrasonography is of limited use. Intravenous pyelography can miss lesions by the trigone. In general, a computed tomography (CT) urogram and magnetic resonance imaging (MRI) with bladder contrast are more sensitive.

In the diagnosis of RVF, contrast vaginoscopy, double contrast barium enema, CT scan with contrast, and MRI can be used. MRI is more sensitive.6 A high index of suspicion is required based on the patient’s history as these imaging modalities do not always confirm RVF despite patient’s clear history of leakage. When the history is convincing, a thorough rectovaginal exam under anesthesia may be imperative. If rectal trauma is present, endoanal ultrasonography can delineate external and internal anal sphincter defects.

Prolonged Foley catheter placement after obstetric injury can lead to successful closure of a VVF. Prior to surgical intervention, assessing if there is possible ureteral involvement and use of intraoperative ureteral stents is a consideration. The route of surgery can be vaginal, abdominal, combined abdominal-vaginal, laparoscopic, or robotic.7 The robotic approach is increasingly utilized.8,9 However, the general consensus among fistula surgeons is that the vaginal approach should be considered first.

Continue to: Surgical repair...

 

 

Surgical repair

VVF repair. Factors that influence successful repair of VVF include the size and number of fistula, location, degree of scarring, bladder capacity, and urethral length.

Surgical technique requires wide mobilization and adequate exposure. The fistula tract can be delineated and manipulated with a pediatric Foley catheter, ureteral stent, or even a ureteral guidewire to aid in dissection (FIGURE 4). Intraoperative visualization of the ureters, including stenting, often is needed. The fistulous track is excised depending on the level of scarring. Closure of the bladder uroepithelium for the first layer is with absorbable interrupted 3-0 or 2-0 sutures in a tension-free closure. The bladder is then evaluated with a retrograde fill with saline and methylene blue to ensure a watertight closure for the first layer. If the first layer is not watertight, the second layer closure will not compensate and the fistula will persist. Particular attention is paid to the angles of the fistula at the first layer closure to prevent recurrence of the fistula at the angles. A running second layer with absorbable 2-0 suture is done. At times, a Martius flap or an omental J flap can be used to provide an additional layer for support and to increase vascularity.10 The patient is sent home with a Foley catheter for drainage for 10 to 14 days.11 Antibiotics are not needed postoperatively for VVF surgery.12

CT cystogram or retrograde cystogram is usually done to evaluate closure of the fistula prior to removal of the Foley catheter; retrograde fill with contrast directly into the bladder with 300 mL is sufficient (FIGURE 5). Patients are advised to refrain from sexual activity for a minimum of 6 weeks, but depending on the level of complexity and scarring, this can be up to 12 weeks.



The success rate in general is in the 95% range. Patients with successful closure of VVF are at risk for urge incontinence due to decreased bladder capacity, stress incontinence especially if the continence mechanism or urethra is involved, vaginal scarring, dyspareunia, and infertility.13 In general, sexual function improves after surgical repair.

RVF repair. Prior to surgical repair of RVF, the integrity of the external anal sphincter must be determined. If it is not involved, a vertical incision is made in the posterior vaginal wall, the vaginal epithelium is separated from the vaginal muscularis, and the fistula tract is identified. After complete wide mobilization of the tissue surrounding the tract, it is excised. The rectal wall is repaired with 3-0 or 4-0 absorbable interrupted sutures; a second layer and if possible even a third layer and finally the vaginal epithelium are all closed with 2-0 absorbable interrupted sutures.

If the sphincter complex is involved, the dissection involves an inverted U incision separating the vaginal wall from the rectum. The fistula tract is excised, the rectal wall is closed, and the internal anal sphincter is identified and reapproximated with interrupted absorbable 2-0 or 0 sutures. The disrupted external sphincter is then reapproximated with 2-0 or 0 sutures, and finally the transverse perineal and bulbocavernosus muscles are brought together with Lembert 0 sutures prior to closure of the external skin. Perioperative antibiotics have been shown to improve success rates in the correction of RVF.5 In patients with sphincter trauma and known RVF, outcomes with a sphincteroplasty are better, compared with endorectal advancement flaps. The patient is discharged with a bowel regimen and dietary precautions that aim for daily soft bowel movements.

After surgical treatment of fistulas, patients benefit from pelvic floor physical therapy that focuses on pelvic floor strengthening. Incorporating the habit of Kegel exercises after every void, timed (scheduled) bladder voiding, and avoidance of straining with urination or defecation should be emphasized.

Continue to: CASE 1 Pregnant woman with rectal bleeding...

 

 

CASE 1 Pregnant woman with rectal bleeding

A 37-year-old woman at 36 3/7 weeks’ gestation presented with acute rectal bleeding and pain. This was found to result from a catastrophic rupture of a pelvic arteriovenous malformation that caused an 11 x 7 x 9.5 cm size inferior pelvic hematoma and a full-thickness rectal tear at the dentate line. During examination under anesthesia, the baby was delivered by a stat CD due to breech presentation and a prolonged fetal heart rate deceleration. The patient underwent embolization of the right middle rectal artery and right internal iliac artery by a radiologic intervention. Further bleeding required surgical intervention for evacuation of about 1,000 mL of hematoma, repair of the rectal tear, and laparoscopic diverting loop ileostomy. In total, the patient received 8 U of packed red blood cells, 6 U of fresh frozen plasma, 5 L of crystalloid solution, and 2 g of tranexamic acid. The patient reported increased foul-smelling vaginal discharge, bedside exam suggested possible fistulous tract, and on postoperative day 16, an exam under anesthesia by Urogynecology confirmed a rectovaginal fistula in the right mid vagina. After 2 months of observation to allow resolution of inflammation, successful excision of the fistula tract and repair of RVF using the above-mentioned technique was accomplished.

CASE 2 Patient with VVF after cesarean hysterectomy

A 40-year-old (G6P2222) patient underwent cesarean hysterectomy for placenta percreta and uterine rupture at 24 weeks’ gestation. Intraoperatively, there were right ureteral ligation and posterior bladder wall cystotomies. The right ureter was reimplanted in the right upper posterior wall and the cystostomies were closed. As the patient had continuous urinary leakage postoperatively, a CT urogram was obtained, which showed left ureteral obstruction and VVF. Urinary incontinence persisted despite bilateral robotic ureteral reimplantation with omental flap by the urology team. Percutaneous nephrostomy tubes were placed bilaterally. The patient underwent additional imaging studies, including MRI, with findings of VVF and possible ureterovaginal fistula.

On referral to Urogynecology, the patient underwent cystoscopy with antegrade pyelogram, and the bilateral ureteroneocystostomy orifices had 5 French open-ended ureteral stents placed. A 10 French pediatric Foley catheter was inserted intravaginally into the bladder through the VVF. Via the vaginal approach, cervical remnant and skin bridges overlying the VVF were excised. The scarred fistula tract was excised with a circumferential incision. Horizontal interrupted Lembert sutures with 3-0 absorbable suture were used to reapproximate the first layer, which was confirmed to be watertight on testing with retrograde fill. Second-layer closure was completed with horizontal mattress 2-0 absorbable sutures, followed by a third-layer closure done in similar fashion. Fibrin glue was then placed. The vaginal epithelium was closed with 2-0 absorbable suture. Percutaneous nephrostomy tubes were removed. Postoperatively, the patient had a CT cystogram with no leak and no incontinence, but she developed urgency, which was controlled with timed voids and oxybutynin. 

References
  1. Adler AJ, Ronsmans C, Calvert C, et al. Estimating the presence of obstetric fistula: a systematic review and meta-analysis BMC Pregnancy Childbirth. 2013;13:246.
  2. Battacharjee S, Kohli UA, Sood A, et al. Vesicouterine fistula: Youssef’s syndrome. Med J Armed Forces India. 2015;71(suppl 1):S175-S177. doi: 10.1016/j.mjafi.2013.11.006.
  3. Waaldijk K. Step-by-Step Surgery of Vesicovaginal Fistulas. Campion Press; 1994.
  4.  Goh, JTW. A new classification for female genital tract fistula. Aust N Z J Ob Gynecol. 2004:44:502-504.
  5. Tsang CB, Rothenberger DA. Rectovaginal fistulas: therapeutic options. Surg Clin North Am. 1997;77:95-114.
  6. Champagne BJ, McGee MF. Rectovaginal fistula. Surg Clin North Am. 2010;90:69-82.
  7. Bodner-Adler B, Hanzal E, Pablik E, et al. Management of vesicovaginal fistulas in women following benign gynecologic surgery: a systematic review and meta-analysis. PLoS One. 2017;12:e0171554.
  8. Randazzo M, Lengauer L, Rochat CH, et al. Best practices in robotic-assisted repair of vesicovaginal fistula: a consensus report from the European Association of Urology Robotic Urology Section Scientific Working Group for Reconstructive Urology. Eur Urol. 2020;78: 432-442.
  9. Miklos JR, Moore RD, Chinthakanan O. Laparoscopic and robotic assisted vesicovaginal fistula repair: a systematic review of the literature. J Minim Invasive Gynecol. 2015:22:727-736.
  10. Hancock B. Practical Obstetric Fistula Surgery. Royal Society of Medicine Press; 2009.
  11. Nardos R, Menber B, Browning A. Outcome of obstetric fistula repair after 10-day versus 14-day Foley catheterization. Int J Gynaecol 0bstet. 2012;118:21-23.
  12. Tomlinson AJ, Thornton JG. A randomized controlled trial of antibiotic prophylaxis for vesico-vaginal fistula repair. Br J Obstet Gynaecol. 2005;105:397-399.
  13. Bengtson AM, Kopp D, Tang JH, et al. Identifying patients with vesicovaginal fistula at high risk of urinary incontinence after surgery. Obstet Gynecol. 2016;128:945-953.
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Division Head, Female Pelvic Medicine and  
Reconstructive Surgery and Section of  
Minimally Invasive Gynecology & Robotics 
Cooper Medical School of Rowan University 
Cooper University Health Care 
Camden, New Jersey

 

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Department of Obstetrics and Gynecology 
Division Head, Female Pelvic Medicine and  
Reconstructive Surgery and Section of  
Minimally Invasive Gynecology & Robotics 
Cooper Medical School of Rowan University 
Cooper University Health Care 
Camden, New Jersey

 

Dr. Mama reports receiving grant or research support from and serving as a speaker for AbbVie.

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Saifuddin T. Mama, MD, MPH 

Associate Professor 
Department of Obstetrics and Gynecology 
Division Head, Female Pelvic Medicine and  
Reconstructive Surgery and Section of  
Minimally Invasive Gynecology & Robotics 
Cooper Medical School of Rowan University 
Cooper University Health Care 
Camden, New Jersey

 

Dr. Mama reports receiving grant or research support from and serving as a speaker for AbbVie.

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Article PDF

 

 

Although rare in the United States and more common in low-resource countries, fistulas due to obstructed labor do occur. In developed countries, other obstetric causes for fistula are usually surgery, trauma, or infection related. An abnormal communication between organs—be it the urethra, bladder, ureter, uterus, cervix, or rectum—can develop1 and lead to vesicovaginal fistula (VVF), urethrovaginal fistula (FIGURE 1), vesicocervical fistula, vesicouterine fistula, ureterovaginal fistula (FIGURE 2), and rectovaginal fistula (RVF). Other nonobstetric causes include gynecologic surgery, radiation, malignancy, and congenital malformations.

During labor, hypoxia, subsequent ischemia, and pressure necrosis contribute to fistula formation. Injury sustained during a cesarean delivery (CD) or cesarean hysterectomy can lead to fistula formation; at times, however, complications are unavoidable given the nature of the pathologic condition that the patient presents with.

VVF and RVF have a devastating impact on a woman’s quality of life as they lead to significant morbidity and short- and long-term psychological distress. The fistula may not be recognized at the time of injury. The presenting signs and symptoms may be intermittent and confusing. Immediate surgical intervention may not be possible due to ongoing inflammation or infection. Recovery often is prolonged. As there is significant concomitant postpartum anxiety and depression, patients with fistula often require psychosocial support and counseling. After repair, there is still a risk for recurrence and voiding dysfunction.

 

Fistula signs and symptoms and evaluation

In cases of VVF, patients present with continuing large or small volume urinary incontinence. Depending on the time to diagnosis, patients may have calculi formation, prolapse, scarring, external perineal dermatitis, perineal nerve injury, and even motor weakness. Cyclic hematuria may be seen in vesicouterine fistulas.2

Multiple classification systems for diagnosis and staging of VVF have been suggested.3,4 A classification system for RVF was published by Tsang and colleagues.5 All these classification systems have attempted to characterize fistulas in terms of level of surgical complexity for repair, providing a guideline for preoperative assessment. These classification systems do not translate into prediction regarding outcomes.

Evaluation of pelvic fistula from the urinary tract starts with a thorough history that includes onset, duration, and description of leakage (continuous, intermittent, or positional) and whether there is concomitant stress and urge incontinence. A detailed obstetric history, including circumstances around the mode of delivery, underlying risk factors, and psychosocial history, should be obtained.

The pelvic examination with a plastic speculum and adequate lighting should assess the external perineum for dermatitis; bulbocavernosus and anal reflexes; and the vagina for length, caliber, level of scarring, and any prolapse. For VVFs, the location, size, and number of the fistula tracts can be visualized and confirmed with a retrograde fill of the bladder via a Foley catheter with saline or water mixed with methylene blue or any other blue dye (FIGURE 3). If a ureterovaginal fistula is suspected, the patient can simultaneously be given oral phenazopyridine and a tampon inserted within the vagina; the patient can then ambulate, and re-examination of the end of the tampon can reveal orange staining. The bladder meanwhile is retrograde filled with blue dye, with no blue staining of the tampon.



For RVF, history taking should include the onset, duration, and description of leakage, and the external anal sphincter should be assessed, with careful examination of the distal vagina at the vestibule as this is the most common location for RVF (fistula in ano). Patients may describe vaginal flatus and sometimes only brownish discharge, which can be intermittent, leading to an incorrect diagnosis of vaginitis that is treated repeatedly without success.

There is no consensus regarding optimal imaging for the assessment of VVF. Imaging used for diagnosis of VVF includes a voiding cystogram with opacification of the vagina after filling the bladder with contrast if there is a fistula. A cystoscopy can evaluate for calculi, retained suture, level of inflammation, and location of the ureters in relation to the fistula. Renal ultrasonography is of limited use. Intravenous pyelography can miss lesions by the trigone. In general, a computed tomography (CT) urogram and magnetic resonance imaging (MRI) with bladder contrast are more sensitive.

In the diagnosis of RVF, contrast vaginoscopy, double contrast barium enema, CT scan with contrast, and MRI can be used. MRI is more sensitive.6 A high index of suspicion is required based on the patient’s history as these imaging modalities do not always confirm RVF despite patient’s clear history of leakage. When the history is convincing, a thorough rectovaginal exam under anesthesia may be imperative. If rectal trauma is present, endoanal ultrasonography can delineate external and internal anal sphincter defects.

Prolonged Foley catheter placement after obstetric injury can lead to successful closure of a VVF. Prior to surgical intervention, assessing if there is possible ureteral involvement and use of intraoperative ureteral stents is a consideration. The route of surgery can be vaginal, abdominal, combined abdominal-vaginal, laparoscopic, or robotic.7 The robotic approach is increasingly utilized.8,9 However, the general consensus among fistula surgeons is that the vaginal approach should be considered first.

Continue to: Surgical repair...

 

 

Surgical repair

VVF repair. Factors that influence successful repair of VVF include the size and number of fistula, location, degree of scarring, bladder capacity, and urethral length.

Surgical technique requires wide mobilization and adequate exposure. The fistula tract can be delineated and manipulated with a pediatric Foley catheter, ureteral stent, or even a ureteral guidewire to aid in dissection (FIGURE 4). Intraoperative visualization of the ureters, including stenting, often is needed. The fistulous track is excised depending on the level of scarring. Closure of the bladder uroepithelium for the first layer is with absorbable interrupted 3-0 or 2-0 sutures in a tension-free closure. The bladder is then evaluated with a retrograde fill with saline and methylene blue to ensure a watertight closure for the first layer. If the first layer is not watertight, the second layer closure will not compensate and the fistula will persist. Particular attention is paid to the angles of the fistula at the first layer closure to prevent recurrence of the fistula at the angles. A running second layer with absorbable 2-0 suture is done. At times, a Martius flap or an omental J flap can be used to provide an additional layer for support and to increase vascularity.10 The patient is sent home with a Foley catheter for drainage for 10 to 14 days.11 Antibiotics are not needed postoperatively for VVF surgery.12

CT cystogram or retrograde cystogram is usually done to evaluate closure of the fistula prior to removal of the Foley catheter; retrograde fill with contrast directly into the bladder with 300 mL is sufficient (FIGURE 5). Patients are advised to refrain from sexual activity for a minimum of 6 weeks, but depending on the level of complexity and scarring, this can be up to 12 weeks.



The success rate in general is in the 95% range. Patients with successful closure of VVF are at risk for urge incontinence due to decreased bladder capacity, stress incontinence especially if the continence mechanism or urethra is involved, vaginal scarring, dyspareunia, and infertility.13 In general, sexual function improves after surgical repair.

RVF repair. Prior to surgical repair of RVF, the integrity of the external anal sphincter must be determined. If it is not involved, a vertical incision is made in the posterior vaginal wall, the vaginal epithelium is separated from the vaginal muscularis, and the fistula tract is identified. After complete wide mobilization of the tissue surrounding the tract, it is excised. The rectal wall is repaired with 3-0 or 4-0 absorbable interrupted sutures; a second layer and if possible even a third layer and finally the vaginal epithelium are all closed with 2-0 absorbable interrupted sutures.

If the sphincter complex is involved, the dissection involves an inverted U incision separating the vaginal wall from the rectum. The fistula tract is excised, the rectal wall is closed, and the internal anal sphincter is identified and reapproximated with interrupted absorbable 2-0 or 0 sutures. The disrupted external sphincter is then reapproximated with 2-0 or 0 sutures, and finally the transverse perineal and bulbocavernosus muscles are brought together with Lembert 0 sutures prior to closure of the external skin. Perioperative antibiotics have been shown to improve success rates in the correction of RVF.5 In patients with sphincter trauma and known RVF, outcomes with a sphincteroplasty are better, compared with endorectal advancement flaps. The patient is discharged with a bowel regimen and dietary precautions that aim for daily soft bowel movements.

After surgical treatment of fistulas, patients benefit from pelvic floor physical therapy that focuses on pelvic floor strengthening. Incorporating the habit of Kegel exercises after every void, timed (scheduled) bladder voiding, and avoidance of straining with urination or defecation should be emphasized.

Continue to: CASE 1 Pregnant woman with rectal bleeding...

 

 

CASE 1 Pregnant woman with rectal bleeding

A 37-year-old woman at 36 3/7 weeks’ gestation presented with acute rectal bleeding and pain. This was found to result from a catastrophic rupture of a pelvic arteriovenous malformation that caused an 11 x 7 x 9.5 cm size inferior pelvic hematoma and a full-thickness rectal tear at the dentate line. During examination under anesthesia, the baby was delivered by a stat CD due to breech presentation and a prolonged fetal heart rate deceleration. The patient underwent embolization of the right middle rectal artery and right internal iliac artery by a radiologic intervention. Further bleeding required surgical intervention for evacuation of about 1,000 mL of hematoma, repair of the rectal tear, and laparoscopic diverting loop ileostomy. In total, the patient received 8 U of packed red blood cells, 6 U of fresh frozen plasma, 5 L of crystalloid solution, and 2 g of tranexamic acid. The patient reported increased foul-smelling vaginal discharge, bedside exam suggested possible fistulous tract, and on postoperative day 16, an exam under anesthesia by Urogynecology confirmed a rectovaginal fistula in the right mid vagina. After 2 months of observation to allow resolution of inflammation, successful excision of the fistula tract and repair of RVF using the above-mentioned technique was accomplished.

CASE 2 Patient with VVF after cesarean hysterectomy

A 40-year-old (G6P2222) patient underwent cesarean hysterectomy for placenta percreta and uterine rupture at 24 weeks’ gestation. Intraoperatively, there were right ureteral ligation and posterior bladder wall cystotomies. The right ureter was reimplanted in the right upper posterior wall and the cystostomies were closed. As the patient had continuous urinary leakage postoperatively, a CT urogram was obtained, which showed left ureteral obstruction and VVF. Urinary incontinence persisted despite bilateral robotic ureteral reimplantation with omental flap by the urology team. Percutaneous nephrostomy tubes were placed bilaterally. The patient underwent additional imaging studies, including MRI, with findings of VVF and possible ureterovaginal fistula.

On referral to Urogynecology, the patient underwent cystoscopy with antegrade pyelogram, and the bilateral ureteroneocystostomy orifices had 5 French open-ended ureteral stents placed. A 10 French pediatric Foley catheter was inserted intravaginally into the bladder through the VVF. Via the vaginal approach, cervical remnant and skin bridges overlying the VVF were excised. The scarred fistula tract was excised with a circumferential incision. Horizontal interrupted Lembert sutures with 3-0 absorbable suture were used to reapproximate the first layer, which was confirmed to be watertight on testing with retrograde fill. Second-layer closure was completed with horizontal mattress 2-0 absorbable sutures, followed by a third-layer closure done in similar fashion. Fibrin glue was then placed. The vaginal epithelium was closed with 2-0 absorbable suture. Percutaneous nephrostomy tubes were removed. Postoperatively, the patient had a CT cystogram with no leak and no incontinence, but she developed urgency, which was controlled with timed voids and oxybutynin. 

 

 

Although rare in the United States and more common in low-resource countries, fistulas due to obstructed labor do occur. In developed countries, other obstetric causes for fistula are usually surgery, trauma, or infection related. An abnormal communication between organs—be it the urethra, bladder, ureter, uterus, cervix, or rectum—can develop1 and lead to vesicovaginal fistula (VVF), urethrovaginal fistula (FIGURE 1), vesicocervical fistula, vesicouterine fistula, ureterovaginal fistula (FIGURE 2), and rectovaginal fistula (RVF). Other nonobstetric causes include gynecologic surgery, radiation, malignancy, and congenital malformations.

During labor, hypoxia, subsequent ischemia, and pressure necrosis contribute to fistula formation. Injury sustained during a cesarean delivery (CD) or cesarean hysterectomy can lead to fistula formation; at times, however, complications are unavoidable given the nature of the pathologic condition that the patient presents with.

VVF and RVF have a devastating impact on a woman’s quality of life as they lead to significant morbidity and short- and long-term psychological distress. The fistula may not be recognized at the time of injury. The presenting signs and symptoms may be intermittent and confusing. Immediate surgical intervention may not be possible due to ongoing inflammation or infection. Recovery often is prolonged. As there is significant concomitant postpartum anxiety and depression, patients with fistula often require psychosocial support and counseling. After repair, there is still a risk for recurrence and voiding dysfunction.

 

Fistula signs and symptoms and evaluation

In cases of VVF, patients present with continuing large or small volume urinary incontinence. Depending on the time to diagnosis, patients may have calculi formation, prolapse, scarring, external perineal dermatitis, perineal nerve injury, and even motor weakness. Cyclic hematuria may be seen in vesicouterine fistulas.2

Multiple classification systems for diagnosis and staging of VVF have been suggested.3,4 A classification system for RVF was published by Tsang and colleagues.5 All these classification systems have attempted to characterize fistulas in terms of level of surgical complexity for repair, providing a guideline for preoperative assessment. These classification systems do not translate into prediction regarding outcomes.

Evaluation of pelvic fistula from the urinary tract starts with a thorough history that includes onset, duration, and description of leakage (continuous, intermittent, or positional) and whether there is concomitant stress and urge incontinence. A detailed obstetric history, including circumstances around the mode of delivery, underlying risk factors, and psychosocial history, should be obtained.

The pelvic examination with a plastic speculum and adequate lighting should assess the external perineum for dermatitis; bulbocavernosus and anal reflexes; and the vagina for length, caliber, level of scarring, and any prolapse. For VVFs, the location, size, and number of the fistula tracts can be visualized and confirmed with a retrograde fill of the bladder via a Foley catheter with saline or water mixed with methylene blue or any other blue dye (FIGURE 3). If a ureterovaginal fistula is suspected, the patient can simultaneously be given oral phenazopyridine and a tampon inserted within the vagina; the patient can then ambulate, and re-examination of the end of the tampon can reveal orange staining. The bladder meanwhile is retrograde filled with blue dye, with no blue staining of the tampon.



For RVF, history taking should include the onset, duration, and description of leakage, and the external anal sphincter should be assessed, with careful examination of the distal vagina at the vestibule as this is the most common location for RVF (fistula in ano). Patients may describe vaginal flatus and sometimes only brownish discharge, which can be intermittent, leading to an incorrect diagnosis of vaginitis that is treated repeatedly without success.

There is no consensus regarding optimal imaging for the assessment of VVF. Imaging used for diagnosis of VVF includes a voiding cystogram with opacification of the vagina after filling the bladder with contrast if there is a fistula. A cystoscopy can evaluate for calculi, retained suture, level of inflammation, and location of the ureters in relation to the fistula. Renal ultrasonography is of limited use. Intravenous pyelography can miss lesions by the trigone. In general, a computed tomography (CT) urogram and magnetic resonance imaging (MRI) with bladder contrast are more sensitive.

In the diagnosis of RVF, contrast vaginoscopy, double contrast barium enema, CT scan with contrast, and MRI can be used. MRI is more sensitive.6 A high index of suspicion is required based on the patient’s history as these imaging modalities do not always confirm RVF despite patient’s clear history of leakage. When the history is convincing, a thorough rectovaginal exam under anesthesia may be imperative. If rectal trauma is present, endoanal ultrasonography can delineate external and internal anal sphincter defects.

Prolonged Foley catheter placement after obstetric injury can lead to successful closure of a VVF. Prior to surgical intervention, assessing if there is possible ureteral involvement and use of intraoperative ureteral stents is a consideration. The route of surgery can be vaginal, abdominal, combined abdominal-vaginal, laparoscopic, or robotic.7 The robotic approach is increasingly utilized.8,9 However, the general consensus among fistula surgeons is that the vaginal approach should be considered first.

Continue to: Surgical repair...

 

 

Surgical repair

VVF repair. Factors that influence successful repair of VVF include the size and number of fistula, location, degree of scarring, bladder capacity, and urethral length.

Surgical technique requires wide mobilization and adequate exposure. The fistula tract can be delineated and manipulated with a pediatric Foley catheter, ureteral stent, or even a ureteral guidewire to aid in dissection (FIGURE 4). Intraoperative visualization of the ureters, including stenting, often is needed. The fistulous track is excised depending on the level of scarring. Closure of the bladder uroepithelium for the first layer is with absorbable interrupted 3-0 or 2-0 sutures in a tension-free closure. The bladder is then evaluated with a retrograde fill with saline and methylene blue to ensure a watertight closure for the first layer. If the first layer is not watertight, the second layer closure will not compensate and the fistula will persist. Particular attention is paid to the angles of the fistula at the first layer closure to prevent recurrence of the fistula at the angles. A running second layer with absorbable 2-0 suture is done. At times, a Martius flap or an omental J flap can be used to provide an additional layer for support and to increase vascularity.10 The patient is sent home with a Foley catheter for drainage for 10 to 14 days.11 Antibiotics are not needed postoperatively for VVF surgery.12

CT cystogram or retrograde cystogram is usually done to evaluate closure of the fistula prior to removal of the Foley catheter; retrograde fill with contrast directly into the bladder with 300 mL is sufficient (FIGURE 5). Patients are advised to refrain from sexual activity for a minimum of 6 weeks, but depending on the level of complexity and scarring, this can be up to 12 weeks.



The success rate in general is in the 95% range. Patients with successful closure of VVF are at risk for urge incontinence due to decreased bladder capacity, stress incontinence especially if the continence mechanism or urethra is involved, vaginal scarring, dyspareunia, and infertility.13 In general, sexual function improves after surgical repair.

RVF repair. Prior to surgical repair of RVF, the integrity of the external anal sphincter must be determined. If it is not involved, a vertical incision is made in the posterior vaginal wall, the vaginal epithelium is separated from the vaginal muscularis, and the fistula tract is identified. After complete wide mobilization of the tissue surrounding the tract, it is excised. The rectal wall is repaired with 3-0 or 4-0 absorbable interrupted sutures; a second layer and if possible even a third layer and finally the vaginal epithelium are all closed with 2-0 absorbable interrupted sutures.

If the sphincter complex is involved, the dissection involves an inverted U incision separating the vaginal wall from the rectum. The fistula tract is excised, the rectal wall is closed, and the internal anal sphincter is identified and reapproximated with interrupted absorbable 2-0 or 0 sutures. The disrupted external sphincter is then reapproximated with 2-0 or 0 sutures, and finally the transverse perineal and bulbocavernosus muscles are brought together with Lembert 0 sutures prior to closure of the external skin. Perioperative antibiotics have been shown to improve success rates in the correction of RVF.5 In patients with sphincter trauma and known RVF, outcomes with a sphincteroplasty are better, compared with endorectal advancement flaps. The patient is discharged with a bowel regimen and dietary precautions that aim for daily soft bowel movements.

After surgical treatment of fistulas, patients benefit from pelvic floor physical therapy that focuses on pelvic floor strengthening. Incorporating the habit of Kegel exercises after every void, timed (scheduled) bladder voiding, and avoidance of straining with urination or defecation should be emphasized.

Continue to: CASE 1 Pregnant woman with rectal bleeding...

 

 

CASE 1 Pregnant woman with rectal bleeding

A 37-year-old woman at 36 3/7 weeks’ gestation presented with acute rectal bleeding and pain. This was found to result from a catastrophic rupture of a pelvic arteriovenous malformation that caused an 11 x 7 x 9.5 cm size inferior pelvic hematoma and a full-thickness rectal tear at the dentate line. During examination under anesthesia, the baby was delivered by a stat CD due to breech presentation and a prolonged fetal heart rate deceleration. The patient underwent embolization of the right middle rectal artery and right internal iliac artery by a radiologic intervention. Further bleeding required surgical intervention for evacuation of about 1,000 mL of hematoma, repair of the rectal tear, and laparoscopic diverting loop ileostomy. In total, the patient received 8 U of packed red blood cells, 6 U of fresh frozen plasma, 5 L of crystalloid solution, and 2 g of tranexamic acid. The patient reported increased foul-smelling vaginal discharge, bedside exam suggested possible fistulous tract, and on postoperative day 16, an exam under anesthesia by Urogynecology confirmed a rectovaginal fistula in the right mid vagina. After 2 months of observation to allow resolution of inflammation, successful excision of the fistula tract and repair of RVF using the above-mentioned technique was accomplished.

CASE 2 Patient with VVF after cesarean hysterectomy

A 40-year-old (G6P2222) patient underwent cesarean hysterectomy for placenta percreta and uterine rupture at 24 weeks’ gestation. Intraoperatively, there were right ureteral ligation and posterior bladder wall cystotomies. The right ureter was reimplanted in the right upper posterior wall and the cystostomies were closed. As the patient had continuous urinary leakage postoperatively, a CT urogram was obtained, which showed left ureteral obstruction and VVF. Urinary incontinence persisted despite bilateral robotic ureteral reimplantation with omental flap by the urology team. Percutaneous nephrostomy tubes were placed bilaterally. The patient underwent additional imaging studies, including MRI, with findings of VVF and possible ureterovaginal fistula.

On referral to Urogynecology, the patient underwent cystoscopy with antegrade pyelogram, and the bilateral ureteroneocystostomy orifices had 5 French open-ended ureteral stents placed. A 10 French pediatric Foley catheter was inserted intravaginally into the bladder through the VVF. Via the vaginal approach, cervical remnant and skin bridges overlying the VVF were excised. The scarred fistula tract was excised with a circumferential incision. Horizontal interrupted Lembert sutures with 3-0 absorbable suture were used to reapproximate the first layer, which was confirmed to be watertight on testing with retrograde fill. Second-layer closure was completed with horizontal mattress 2-0 absorbable sutures, followed by a third-layer closure done in similar fashion. Fibrin glue was then placed. The vaginal epithelium was closed with 2-0 absorbable suture. Percutaneous nephrostomy tubes were removed. Postoperatively, the patient had a CT cystogram with no leak and no incontinence, but she developed urgency, which was controlled with timed voids and oxybutynin. 

References
  1. Adler AJ, Ronsmans C, Calvert C, et al. Estimating the presence of obstetric fistula: a systematic review and meta-analysis BMC Pregnancy Childbirth. 2013;13:246.
  2. Battacharjee S, Kohli UA, Sood A, et al. Vesicouterine fistula: Youssef’s syndrome. Med J Armed Forces India. 2015;71(suppl 1):S175-S177. doi: 10.1016/j.mjafi.2013.11.006.
  3. Waaldijk K. Step-by-Step Surgery of Vesicovaginal Fistulas. Campion Press; 1994.
  4.  Goh, JTW. A new classification for female genital tract fistula. Aust N Z J Ob Gynecol. 2004:44:502-504.
  5. Tsang CB, Rothenberger DA. Rectovaginal fistulas: therapeutic options. Surg Clin North Am. 1997;77:95-114.
  6. Champagne BJ, McGee MF. Rectovaginal fistula. Surg Clin North Am. 2010;90:69-82.
  7. Bodner-Adler B, Hanzal E, Pablik E, et al. Management of vesicovaginal fistulas in women following benign gynecologic surgery: a systematic review and meta-analysis. PLoS One. 2017;12:e0171554.
  8. Randazzo M, Lengauer L, Rochat CH, et al. Best practices in robotic-assisted repair of vesicovaginal fistula: a consensus report from the European Association of Urology Robotic Urology Section Scientific Working Group for Reconstructive Urology. Eur Urol. 2020;78: 432-442.
  9. Miklos JR, Moore RD, Chinthakanan O. Laparoscopic and robotic assisted vesicovaginal fistula repair: a systematic review of the literature. J Minim Invasive Gynecol. 2015:22:727-736.
  10. Hancock B. Practical Obstetric Fistula Surgery. Royal Society of Medicine Press; 2009.
  11. Nardos R, Menber B, Browning A. Outcome of obstetric fistula repair after 10-day versus 14-day Foley catheterization. Int J Gynaecol 0bstet. 2012;118:21-23.
  12. Tomlinson AJ, Thornton JG. A randomized controlled trial of antibiotic prophylaxis for vesico-vaginal fistula repair. Br J Obstet Gynaecol. 2005;105:397-399.
  13. Bengtson AM, Kopp D, Tang JH, et al. Identifying patients with vesicovaginal fistula at high risk of urinary incontinence after surgery. Obstet Gynecol. 2016;128:945-953.
References
  1. Adler AJ, Ronsmans C, Calvert C, et al. Estimating the presence of obstetric fistula: a systematic review and meta-analysis BMC Pregnancy Childbirth. 2013;13:246.
  2. Battacharjee S, Kohli UA, Sood A, et al. Vesicouterine fistula: Youssef’s syndrome. Med J Armed Forces India. 2015;71(suppl 1):S175-S177. doi: 10.1016/j.mjafi.2013.11.006.
  3. Waaldijk K. Step-by-Step Surgery of Vesicovaginal Fistulas. Campion Press; 1994.
  4.  Goh, JTW. A new classification for female genital tract fistula. Aust N Z J Ob Gynecol. 2004:44:502-504.
  5. Tsang CB, Rothenberger DA. Rectovaginal fistulas: therapeutic options. Surg Clin North Am. 1997;77:95-114.
  6. Champagne BJ, McGee MF. Rectovaginal fistula. Surg Clin North Am. 2010;90:69-82.
  7. Bodner-Adler B, Hanzal E, Pablik E, et al. Management of vesicovaginal fistulas in women following benign gynecologic surgery: a systematic review and meta-analysis. PLoS One. 2017;12:e0171554.
  8. Randazzo M, Lengauer L, Rochat CH, et al. Best practices in robotic-assisted repair of vesicovaginal fistula: a consensus report from the European Association of Urology Robotic Urology Section Scientific Working Group for Reconstructive Urology. Eur Urol. 2020;78: 432-442.
  9. Miklos JR, Moore RD, Chinthakanan O. Laparoscopic and robotic assisted vesicovaginal fistula repair: a systematic review of the literature. J Minim Invasive Gynecol. 2015:22:727-736.
  10. Hancock B. Practical Obstetric Fistula Surgery. Royal Society of Medicine Press; 2009.
  11. Nardos R, Menber B, Browning A. Outcome of obstetric fistula repair after 10-day versus 14-day Foley catheterization. Int J Gynaecol 0bstet. 2012;118:21-23.
  12. Tomlinson AJ, Thornton JG. A randomized controlled trial of antibiotic prophylaxis for vesico-vaginal fistula repair. Br J Obstet Gynaecol. 2005;105:397-399.
  13. Bengtson AM, Kopp D, Tang JH, et al. Identifying patients with vesicovaginal fistula at high risk of urinary incontinence after surgery. Obstet Gynecol. 2016;128:945-953.
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OR safety and efficiency: Measuring and monitoring all factors—including surgical volume

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Changed
Fri, 09/02/2022 - 12:17

 

 

The operating room (OR) is a key contributor to a hospital’s profitability. It is a complex environment with ever-advancing technology. A successful surgery completed without complications within an optimal time depends not only on the surgeon’s experience, skills, and knowledge but also on numerous other structural, human, and nontechnical factors over which the surgeon has limited control.

As in any setting that deals with human life, in the OR, team dynamics, communication, and environment play a major role. Research has indicated the benefits of dedicated teams, reduced handoffs, and innovative modalities that continuously and systematically monitor potential breakdowns and propose solutions for the detected problems.

Finally, who should perform your loved one’s hysterectomy? This article also attempts to address the impact of surgeons’ and hospitals’ volume on operative outcomes with a diminishing number of hysterectomies but an increasing number of approaches.

 

Human factors in the OR

Human factors research was born as a product of the industrial revolution and mass production. It aims to optimize human experience and improve system performance by studying how humans interact with system. The aviation industry, for example, minimized errors significantly by using methods developed by human factors scientists. As another industry with no tolerance for mistakes, the health care sector followed suit. Ultimately, the goal of human factors research in health care is to improve patient safety, optimize work and environment, reduce costs, and enhance employees’ physical and mental health, engagement, comfort, and quality of life (FIGURE 1).1

Today’s OR is so complex that it is hard to understand its dynamics without human factors research. Every new OR technology is first tested in controlled and simulated environments to determine “work as imagined.” However, it is necessary to study “work as done” in the real world via direct observation, video recording, questionnaires, and semistructured interviews by an on-site multidisciplinary team. This process not only focuses on surgical skills, process efficiency, and outcomes but also monitors the entire process according to Human Factors and Ergonomics Engineering principles to explore otherwise hidden complexities and latent safety concerns. The Systems Engineering Initiative for Patient Safety (SEIPS) framework is used to study the impact of interactions between people, tasks, technologies, environment, and organization.1

Robot-assisted surgery (RAS), an increasingly popular surgical approach among gynecologic surgeons, recently has been the focus of human factors science. A robotic OR poses unique challenges: the surgeon is not scrubbed, is removed from the operating table, and controls a complex highly technologic device in a crowded and darkened room. These are ideal conditions waiting to be optimized by human factor experts. To demonstrate the importance of human factors in the OR, we review the evidence for RAS.

Continue to: Impact of flow disruptions...

 

 

Impact of flow disruptions

Flow disruptions (FDs) were found to be more common in RAS. Catchpole and colleagues identified a mean of 9.62 FDs per hour in 89 robotic procedures, including hysterectomies and sacrocolpopexies, from a variety of fields; FDs occurred more often during the docking stage, followed by the console time, and they mostly were caused by communication breakdown and lack of team familiarity.2

Surgeon experience significantly reduced FDs. Surgeons who had done more than 700 RAS cases experienced 60% fewer FDs than those who had done less than 250 cases (13 vs 8 per hour).2 A study focusing on residents’ impact on RAS outcomes found that each FD increased the total operative time by an average 2.4 minutes, with the number significantly higher when a resident was involved.3 About one-quarter of the training-related FDs were procedure-specific instructions, while one-third were related to instrument and robotic instruction. However, pauses to teach residents did not appear to create significant intraoperative delays. Expectedly, experienced surgeons could anticipate and reduce these disruptions by supporting the whole team.

Human ergonomics, turnover time, and robot-specific skills

In a study of human ergonomics in RAS, Yu and colleagues noted that bedside assistants could experience neck posture problems. Surprisingly, the console could constrain the surgeon’s neck-shoulder region.4 Studies that reported on communication problems in a robotic OR suggest that innovative forms of verbal and nonverbal communication may support successful team communication.5

On the learning curve for RAS, OR turnover time, a key value metric, has been longer. However, turnover time was reduced almost by half from 99.2 to 53.2 minutes over 3 months after concepts from motor racing pit stops were employed, including briefings, leadership, role definition, task allocation, and task sequencing. Average room-ready time also was lowered from 42.2 to 27.2 minutes.6 RAS presents new challenges with sterile instrument processing as well. A successful RAS program, therefore, has organizational needs that include the training of OR and sterile processing staff and appropriate shift management.1

In a robotic OR, not only the surgeon but also the whole team requires robot-specific skills. New training approaches to teamwork, communication, and situation awareness skills are necessary. Robotic equipment, with its data and power cables, 2 consoles, and changing movement paths, necessitate larger rooms with a specific layout.7

In a review of recordings of RAS that used a multidimensional assessment tool to measure team effectiveness and cognitive load, Sexton and colleagues identified anticipation, active team engagement, and higher familiarity scores as the best predictors of team efficiency.8 Several studies emphasized the need for a stable team, especially in the learning phase of robotic surgery.5,9,10 A dedicated robotic team reduced the operative time by 18% during robot-assisted sacrocolpopexy (RASCP).10 RASCP procedures that extended into the afternoon took significantly longer time.9 A dedicated anesthesiologist improved the preoperative time.9 Surgical team handoffs also have reduced OR efficiency.11,12

Studying the impact of human factors is paramount for safe and efficient surgery. It is especially necessary in ORs that are equipped with high technologic instruments such as those used in RAS.

 

Surgical Black Box: Using data for OR safety and efficiency

Surgical procedures account for more than 50% of medical errors in a hospital setting, many of which are preventable. Postevent analysis with traditional methods, such as “Morbidity and Mortality” meetings held many days later, misses many adverse events in the OR.13 Another challenge with ever-changing and fast-multiplying surgical approaches is the development of effective surgical skill. Reviewing video recording of surgical procedures has been proposed as an instrument for recognizing adverse events and perfecting surgical skills.Recently, an innovative data-capture platform called the OR Black Box, developed by Teodor Grantcharov, MD, PhD, and colleagues, went beyond simple audiovisual recording.14 This high technologic platform not only video records the actual surgical procedure with laparoscopic camera capture (and wearable cameras for open cases) but also monitors the entire OR environment via wide-angle cameras, utilizes sensors, and records both the patient’s and the surgeon’s physiologic parameters.

The OR Black Box generates a holistic view of the OR after synchronization, encryption, and secure storage of all inputs for further analysis by experts and software-based algorithms (FIGURE 2). Computer vision algorithms can recognize improper dissection techniques and complications, such as bleeding. Adverse events are flagged with an automated software on a procedural timeline to facilitate review of procedural steps, disruptive environmental and organizational factors, OR team technical and nontechnical skills, surgeon physiologic stress, and intraoperative errors, events, and rectification processes using validated instruments.


Artificial intelligence built into this platform can automatically extract objective, high-quality, and structured data to generate explainable insights by recognizing adverse events and procedural segments of interest for training and quality improvement and provide a foundation with objective measurements of technical and nontechnical performance for formative and summative assessment. This system, a major step up compared with retrospective review of likely biased medical records and labor-intensive multidisciplinary human observers, has the potential to increase efficiency and reduce costs by studying human factors that include clinical design, technology, and organization. OR efficiency, measured in real time objectively and thoroughly, may save time and resources.

OR Black Box platforms have already started to generate meaningful data. It is not surprising that auditory disruptions—OR doors opening, loud noises, pagers beeping, telephones ringing—were recorded almost every minute during laparoscopic procedures.15 Most technical errors occurred during dissection, resection, and reconstruction and most commonly were associated with improper estimations of force applied to tissue and distance to the target tissue during operative steps of a laparoscopic procedure.16 Another study based on this system showed that technical performance was an independent predictor of postoperative outcomes.17 The OR Black Box identified a device-related interruption in 30% of elective laparoscopic general surgery cases, most commonly in sleeve gastrectomy and oncologic gastrectomy procedures. This sophisticated surgical data recording system also demonstrated a significantly better ability to detect Veress needle injuries (12 vs 3) and near misses (47 vs 0) when compared with traditional chart review.18

Data from the OR Black Box also have been applied to better analyze nontechnical performance, including teamwork and interpersonal dynamics.19 Surgeons most commonly exhibited adept situational awareness and leadership, while the nurse team excelled at task management and situational awareness.19 Of the total care provider team studied, the surgeon and scrub nurse demonstrated the most favorable nontechnical behavior.19 Of note, continuous physiologic monitoring of the surgeon with this system revealed that surgeons under stress had 66% higher adverse events.

The OR Black Box is currently utilized at 20 institutions in North America and Europe. The data compiled from all these institutions revealed that there was a 10% decrease in intraoperative adverse events for each 10-point increase in technical skill score on a scale of 0 to 100 (unpublished data). This centralized data indicated that turnover time ranged widely between 7 and 91 minutes, with variation of cleanup time from 1 to 25 minutes and setup time from 22 to 43 minutes. Institutions can learn from each other using this platform. For example, the information about block time utilization (20%–99%) across institutions provides opportunities for system improvements.

With any revolutionary technology, it is imperative to study its effects on outcomes, training, costs, and privacy before it is widely implemented. We, obstetricians and gynecologists, are very familiar with the impact of electronic fetal monitoring, a great example of a technologic advance that did not improve perinatal outcomes but led to unintended consequences, such as higher rates of cesarean deliveries and lawsuits. Such a tool may lead to potential misrepresentation of intraoperative events unless legal aspects are clearly delineated. As exciting as it is, this disruptive technology requires further exploration with scientific vigor.

Continue to: Surgeon and hospital volume: Surgical outcomes paradigm...

 

 

Surgeon and hospital volume: Surgical outcomes paradigm

A landmark study in 1979 that showed decreased mortality in high-volume centers underscored the need for regionalization for certain surgical procedures.20 This association was further substantiated by 2 reports on 2.5 million Medicare beneficiaries that demonstrated significantly lower mortality for all 14 cardiovascular and oncologic procedures for hospitals with larger surgical volume (16% vs 4%) and high-volume surgeons for certain procedures, for example, 15% versus 5% for pancreatic resections for cancer.21,22

A similar association was found for all routes of hysterectomies performed for benign indications. Boyd and colleagues showed that gynecologists who performed fewer than 10 hysterectomies per year had a higher perioperative morbidity rate (16.5%) compared with those who did more (11.7%).23 Specific to vaginal hysterectomy, in a study of more than 6,000 women, surgeons who performed 13 procedures per year had 31% less risk of operative injury than those who did 5.5 procedures per year (2.5% vs 1.7%).24 Overall perioperative complications (5.0% vs 4.0%) and medical complications (5.7% vs 3.9%) were also reduced for higher-volume surgeons. In a cohort of approximately 8,000 women who underwent a laparoscopic hysterectomy, high-volume surgeons had a considerably lower complication rate (4.2% vs 6.2%).25

As expected, lower complication rates of high-volume surgeons led to lower resource utilization, including lower transfusion rates, less intensive care unit utilization, and shorter operative times and, in several studies, length of stay.24,25 Of note, low-volume surgeons were less likely to offer minimally invasive routes and were more likely to convert to laparotomy.26 In addition, significant cost savings have been associated with high surgical volume, which one study showed was 16% ($6,500 vs $5,600) for high-volume surgeons.26 With regard to mortality, a study of 7,800 women found that perioperative mortality increased more than 10-fold for surgeons who performed an average 1 case per year compared with all other surgeons (2.5% vs 0.2%).27

When gynecologic cancers are concerned, arguably, long-term survival outcomes may be more critical than perioperative morbidity and mortality. Higher surgeon and hospital volume are associated with improved perioperative outcomes for endometrial and cervical cancers.28 Importantly, minimally invasive hysterectomy was offered for endometrial cancer significantly more often by surgeons with high volume.28 Survival outcomes were not affected by surgeon or hospital volume, likely due to overall more favorable prognosis for endometrial cancer after treatment.

Although it is intuitive to assume that a surgeon’s skills and experience would make the most impact in procedures for ovarian cancer due to the complexity of ovarian cancer surgery, evidence on short-term outcomes has been mixed. Intriguingly, some studies reported that high-volume institutions had higher complication and readmission rates. However, evidence supports that the surgeon’s volume, and especially hospital volume, improves long-term survival for ovarian cancer, with a negative impact on immediate postoperative morbidity.29 This may suggest that a more aggressive surgical effort improves long-term survival but also can cause more perioperative complications. Further, longer survival may result not only from operative skills but also because of better care by a structured multidisciplinary team at more established high-volume cancer centers.

The association of improved outcomes with higher volume led to public reporting of hospital outcomes. Policy efforts toward regionalization have impacted surgical practice. Based on their analysis of 3.2 million Medicare patients who underwent 1 of 8 different cancer surgeries or cardiovascular operations from 1999 to 2008, Finks and colleagues demonstrated that care was concentrated to fewer hospitals over time for many of these procedures.29 This trend was noted for gynecologic cancer surgery but not for benign gynecologic surgery.

Regionalization of care limits access particularly for minority and underserved communities because of longer travel distances, logistic challenges, and financial strain. An alternative to regionalization of care is targeted quality improvement by rigorous adherence to quality guidelines at low-volume hospitals.

Is there a critical minimum volume that may be used as a requirement for surgeons to maintain their privileges and for hospitals to offer certain procedures? In 2015, minimum volume standards for a number of common procedures were proposed by Johns Hopkins Medicine and Dartmouth-Hitchcock Medical Center, such as 50 hip replacement surgeries per hospital and 25 per physician per year, and 20 pancreatectomies per hospital and 5 per surgeon per year.30 A modeling study for hysterectomy showed that a volume cut point of >1 procedure in the prior year would restrict privileges for a substantial number of surgeons performing abdominal (17.5%), robot-assisted (12.5%), laparoscopic (16.8%), and vaginal (27.6%) hysterectomies.27 This study concluded that minimum-volume standards for hysterectomy for even the lowest volume physicians would restrict a significant number of gynecologic surgeons, including many with outcomes that are better than predicted.

Therefore, while there is good evidence that favors better outcomes in the hands of high-volume surgeons in gynecology, the impact of such policies on gynecologic practice clearly warrants careful monitoring and further study. 

Key points  
  • What factors besides the surgeon’s skills influence surgical safety and efficiency?
  • Are you ready to have audio, video, and sensor-based recording of everything in the OR?
  • Who should perform your loved one’s hysterectomy? Do the surgeon’s and hospital’s volume matter?
References
  1. Catchpole K, Bisantz A, Hallbeck MS, et al. Human factors in robotic assisted surgery: lessons from studies ‘in the wild’. Appl Ergon. 2019;78:270-276.
  2. Catchpole K, Perkins C, Bresee C, et al. Safety, efficiency and learning curves in robotic surgery: a human factors analysis. Surg Endosc. 2016;30:3749-3761.
  3. Jain M, Fry BT, Hess LW, et al. Barriers to efficiency in robotic surgery: the resident effect. J Surg. Res. 2016;205:296-304.
  4. Yu D, Dural C, Morrow MM, et al. Intraoperative workload in robotic surgery assessed by wearable motion tracking sensors and questionnaires. Surg Endosc. 2017;31:877-886.
  5. Randell R, Honey S, Alvarado N, et al. Embedding robotic surgery into routine practice and impacts on communication and decision making: a review of the experience of surgical teams. Cognit Technol Work. 2016;18:423-437.
  6. Souders CP, Catchpole KR, Wood LN, et al. Reducing operating room turnover time for robotic surgery using a motor racing pit stop model. World J Surg. 2017;4:1943–1949.
  7. Ahmad N, Hussein AA, Cavuoto L, et al. Ambulatory movements, team dynamics and interactions during robot-assisted surgery. BJU Int. 2016;118:132-139.
  8. Sexton K, Johnson A, Gotsch A, et al. Anticipation, teamwork, and cognitive load: chasing efficiency during robot-assisted surgery. BMJ Qual Saf. 2018;27:148-154.
  9. Harmanli O, Solak S, Bayram A, et al. Optimizing the robotic surgery team: an operations management perspective. Int Urogynecol J. 2021;32:1379-1385.
  10. Carter-Brooks CM, Du AL, Bonidie MJ, et al. The impact of a dedicated robotic team on robotic-assisted sacrocolpopexy outcomes. Female Pelvic Med Reconstr Surg. 2018;24:13-16.
  11. Giugale LE, Sears S, Lavelle ES, et al. Evaluating the impact of intraoperative surgical team handoffs on patient outcomes. Female Pelvic Med Reconstr Surg. 2017;23:288-292.
  12. Geynisman-Tan J, Brown O, Mueller M, et al. Operating room efficiency: examining the impact of personnel handoffs. Female Pelvic Med Reconstr Surg. 2018;24:87-89.
  13. Alsubaie H, Goldenberg M, Grantcharov T. Quantifying recall bias in surgical safety: a need for a modern approach to morbidity and mortality reviews. Can J Surg. 2019;62:39-43.
  14. Goldenberg MG, Jung J, Grantcharov TP. Using data to enhance performance and improve quality and safety in surgery. JAMA Surg. 2017;152:972-973.
  15. Jung JJ, Grantcharov TP. The operating room black box: a prospective observational study of the operating room. J Am Coll Surg. 2017;225:S127-S128.
  16. Jung JJ, Jüni P, Lebovic G, et al. First-year analysis of the operating room black box study. Ann Surg. 2020;271:122-127.
  17. Jung JJ, Kashfi A, Sharma S, et al. Characterization of device-related interruptions in minimally invasive surgery: need for intraoperative data and effective mitigation strategies. Surg Endosc. 2019;33:717-723.
  18. Jung JJ, Adams-McGavin RC, Grantcharov TP. Underreporting of Veress needle injuries: comparing direct observation and chart review methods. J Surg Res. 2019;236:266-270.
  19. Fesco AB, Kuzulugil SS, Babaoglu C, et al. Relationship between intraoperative nontechnical performance and technical events in bariatric surgery. Br J Surg. 2018;105:1044-1050.
  20. Luft HS, Bunker JP, Enthoven AC. Should operations be regionalized? The empirical relation between surgical volume and mortality. N Engl J Med. 1979;301:1364-1369.
  21. Birkmeyer JD, Siewers AE, Finlayson EV, et al. Hospital volume and surgical mortality in the United States. N Engl J Med. 2002;346:1128-1137.
  22. Birkmeyer JD, Stukel TA, Siewers AE, et al. Surgeon volume and operative mortality in the United States. N Engl J Med. 2003;349:21172127.
  23. Boyd LR, Novetsky AP, Curtin JP. Effect of surgical volume on route of hysterectomy and short-term morbidity. Obstet Gynecol. 2010;116:909-915.
  24. Rogo-Gupta LJ, Lewin SN, Kim JH, et al. The effect of surgeon volume on outcomes and resource use for vaginal hysterectomy. Obstet Gynecol. 2010;116:1341-1347.
  25. Wallenstein MR, Ananth CV, Kim JH, et al. Effect of surgical volume on outcomes for laparoscopic hysterectomy for benign indications. Obstet Gynecol. 2012;119:709-716.
  26. Bretschneider CE, Frazzini Padilla P, Das D, et al. The impact of surgeon volume on perioperative adverse events in women undergoing minimally invasive hysterectomy for the large uterus. Am J Obstet Gynecol. 2018;219:490.e1-490.e8.
  27. Ruiz MP, Chen L, Hou JY, et al. Outcomes of hysterectomy performed by very low-volume surgeons. Obstet Gynecol. 2018;131:981-990.
  28. Wright JD. The volume-outcome paradigm for gynecologic surgery: clinical and policy implications. Clin Obstet Gynecol. 2020;63:252-265.
  29. Finks JF, Osborne NH, Birkmeyer JD. Trends in hospital volume and operative mortality for high risk surgery. N Engl J Med. 2011;364:21282137.
  30. Sternberg S. Hospitals move to limit low-volume surgeries. US News & World Report. May 19, 2015. www.usnews.com/news /articles/2015/05/19/hospitals-move-to-limit-low-volume-surgeries. Accessed April 19, 2022.
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Author and Disclosure Information

Oz Harmanli, MD 

Professor of Obstetrics and Gynecology and Urology 
Chief of Urogynecology and Reconstructive  
Pelvic Surgery 
Department of Obstetrics, Gynecology,  
and Reproductive Sciences
Yale School of Medicine 
New Haven, Connecticut

Kenneth Catchpole, PhD 

Professor
SmartState Endowed Chair in Clinical Practice  
and Human Factors 
Department of Anesthesia and Perioperative Medicine 
Medical University of South Carolina
Charleston, South Carolina 
 

Teodor Grancharov, MD, PhD 

Professor 
Department of Surgery 
University of Toronto 
Toronto, Ontario

Jason D. Wright, MD

Sol Goldman Associate Professor 
Department of Obstetrics and Gynecology 
Columbia University College of Physicians and Surgeons 
New York, New York

Dr. Grantcharov reports being the founder of Surgical Safety Technologies Inc, an academic startup that commercializes the OR Black Box platform. The other authors report no financial relationships relevant to this article.

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Oz Harmanli, MD 

Professor of Obstetrics and Gynecology and Urology 
Chief of Urogynecology and Reconstructive  
Pelvic Surgery 
Department of Obstetrics, Gynecology,  
and Reproductive Sciences
Yale School of Medicine 
New Haven, Connecticut

Kenneth Catchpole, PhD 

Professor
SmartState Endowed Chair in Clinical Practice  
and Human Factors 
Department of Anesthesia and Perioperative Medicine 
Medical University of South Carolina
Charleston, South Carolina 
 

Teodor Grancharov, MD, PhD 

Professor 
Department of Surgery 
University of Toronto 
Toronto, Ontario

Jason D. Wright, MD

Sol Goldman Associate Professor 
Department of Obstetrics and Gynecology 
Columbia University College of Physicians and Surgeons 
New York, New York

Dr. Grantcharov reports being the founder of Surgical Safety Technologies Inc, an academic startup that commercializes the OR Black Box platform. The other authors report no financial relationships relevant to this article.

Author and Disclosure Information

Oz Harmanli, MD 

Professor of Obstetrics and Gynecology and Urology 
Chief of Urogynecology and Reconstructive  
Pelvic Surgery 
Department of Obstetrics, Gynecology,  
and Reproductive Sciences
Yale School of Medicine 
New Haven, Connecticut

Kenneth Catchpole, PhD 

Professor
SmartState Endowed Chair in Clinical Practice  
and Human Factors 
Department of Anesthesia and Perioperative Medicine 
Medical University of South Carolina
Charleston, South Carolina 
 

Teodor Grancharov, MD, PhD 

Professor 
Department of Surgery 
University of Toronto 
Toronto, Ontario

Jason D. Wright, MD

Sol Goldman Associate Professor 
Department of Obstetrics and Gynecology 
Columbia University College of Physicians and Surgeons 
New York, New York

Dr. Grantcharov reports being the founder of Surgical Safety Technologies Inc, an academic startup that commercializes the OR Black Box platform. The other authors report no financial relationships relevant to this article.

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The operating room (OR) is a key contributor to a hospital’s profitability. It is a complex environment with ever-advancing technology. A successful surgery completed without complications within an optimal time depends not only on the surgeon’s experience, skills, and knowledge but also on numerous other structural, human, and nontechnical factors over which the surgeon has limited control.

As in any setting that deals with human life, in the OR, team dynamics, communication, and environment play a major role. Research has indicated the benefits of dedicated teams, reduced handoffs, and innovative modalities that continuously and systematically monitor potential breakdowns and propose solutions for the detected problems.

Finally, who should perform your loved one’s hysterectomy? This article also attempts to address the impact of surgeons’ and hospitals’ volume on operative outcomes with a diminishing number of hysterectomies but an increasing number of approaches.

 

Human factors in the OR

Human factors research was born as a product of the industrial revolution and mass production. It aims to optimize human experience and improve system performance by studying how humans interact with system. The aviation industry, for example, minimized errors significantly by using methods developed by human factors scientists. As another industry with no tolerance for mistakes, the health care sector followed suit. Ultimately, the goal of human factors research in health care is to improve patient safety, optimize work and environment, reduce costs, and enhance employees’ physical and mental health, engagement, comfort, and quality of life (FIGURE 1).1

Today’s OR is so complex that it is hard to understand its dynamics without human factors research. Every new OR technology is first tested in controlled and simulated environments to determine “work as imagined.” However, it is necessary to study “work as done” in the real world via direct observation, video recording, questionnaires, and semistructured interviews by an on-site multidisciplinary team. This process not only focuses on surgical skills, process efficiency, and outcomes but also monitors the entire process according to Human Factors and Ergonomics Engineering principles to explore otherwise hidden complexities and latent safety concerns. The Systems Engineering Initiative for Patient Safety (SEIPS) framework is used to study the impact of interactions between people, tasks, technologies, environment, and organization.1

Robot-assisted surgery (RAS), an increasingly popular surgical approach among gynecologic surgeons, recently has been the focus of human factors science. A robotic OR poses unique challenges: the surgeon is not scrubbed, is removed from the operating table, and controls a complex highly technologic device in a crowded and darkened room. These are ideal conditions waiting to be optimized by human factor experts. To demonstrate the importance of human factors in the OR, we review the evidence for RAS.

Continue to: Impact of flow disruptions...

 

 

Impact of flow disruptions

Flow disruptions (FDs) were found to be more common in RAS. Catchpole and colleagues identified a mean of 9.62 FDs per hour in 89 robotic procedures, including hysterectomies and sacrocolpopexies, from a variety of fields; FDs occurred more often during the docking stage, followed by the console time, and they mostly were caused by communication breakdown and lack of team familiarity.2

Surgeon experience significantly reduced FDs. Surgeons who had done more than 700 RAS cases experienced 60% fewer FDs than those who had done less than 250 cases (13 vs 8 per hour).2 A study focusing on residents’ impact on RAS outcomes found that each FD increased the total operative time by an average 2.4 minutes, with the number significantly higher when a resident was involved.3 About one-quarter of the training-related FDs were procedure-specific instructions, while one-third were related to instrument and robotic instruction. However, pauses to teach residents did not appear to create significant intraoperative delays. Expectedly, experienced surgeons could anticipate and reduce these disruptions by supporting the whole team.

Human ergonomics, turnover time, and robot-specific skills

In a study of human ergonomics in RAS, Yu and colleagues noted that bedside assistants could experience neck posture problems. Surprisingly, the console could constrain the surgeon’s neck-shoulder region.4 Studies that reported on communication problems in a robotic OR suggest that innovative forms of verbal and nonverbal communication may support successful team communication.5

On the learning curve for RAS, OR turnover time, a key value metric, has been longer. However, turnover time was reduced almost by half from 99.2 to 53.2 minutes over 3 months after concepts from motor racing pit stops were employed, including briefings, leadership, role definition, task allocation, and task sequencing. Average room-ready time also was lowered from 42.2 to 27.2 minutes.6 RAS presents new challenges with sterile instrument processing as well. A successful RAS program, therefore, has organizational needs that include the training of OR and sterile processing staff and appropriate shift management.1

In a robotic OR, not only the surgeon but also the whole team requires robot-specific skills. New training approaches to teamwork, communication, and situation awareness skills are necessary. Robotic equipment, with its data and power cables, 2 consoles, and changing movement paths, necessitate larger rooms with a specific layout.7

In a review of recordings of RAS that used a multidimensional assessment tool to measure team effectiveness and cognitive load, Sexton and colleagues identified anticipation, active team engagement, and higher familiarity scores as the best predictors of team efficiency.8 Several studies emphasized the need for a stable team, especially in the learning phase of robotic surgery.5,9,10 A dedicated robotic team reduced the operative time by 18% during robot-assisted sacrocolpopexy (RASCP).10 RASCP procedures that extended into the afternoon took significantly longer time.9 A dedicated anesthesiologist improved the preoperative time.9 Surgical team handoffs also have reduced OR efficiency.11,12

Studying the impact of human factors is paramount for safe and efficient surgery. It is especially necessary in ORs that are equipped with high technologic instruments such as those used in RAS.

 

Surgical Black Box: Using data for OR safety and efficiency

Surgical procedures account for more than 50% of medical errors in a hospital setting, many of which are preventable. Postevent analysis with traditional methods, such as “Morbidity and Mortality” meetings held many days later, misses many adverse events in the OR.13 Another challenge with ever-changing and fast-multiplying surgical approaches is the development of effective surgical skill. Reviewing video recording of surgical procedures has been proposed as an instrument for recognizing adverse events and perfecting surgical skills.Recently, an innovative data-capture platform called the OR Black Box, developed by Teodor Grantcharov, MD, PhD, and colleagues, went beyond simple audiovisual recording.14 This high technologic platform not only video records the actual surgical procedure with laparoscopic camera capture (and wearable cameras for open cases) but also monitors the entire OR environment via wide-angle cameras, utilizes sensors, and records both the patient’s and the surgeon’s physiologic parameters.

The OR Black Box generates a holistic view of the OR after synchronization, encryption, and secure storage of all inputs for further analysis by experts and software-based algorithms (FIGURE 2). Computer vision algorithms can recognize improper dissection techniques and complications, such as bleeding. Adverse events are flagged with an automated software on a procedural timeline to facilitate review of procedural steps, disruptive environmental and organizational factors, OR team technical and nontechnical skills, surgeon physiologic stress, and intraoperative errors, events, and rectification processes using validated instruments.


Artificial intelligence built into this platform can automatically extract objective, high-quality, and structured data to generate explainable insights by recognizing adverse events and procedural segments of interest for training and quality improvement and provide a foundation with objective measurements of technical and nontechnical performance for formative and summative assessment. This system, a major step up compared with retrospective review of likely biased medical records and labor-intensive multidisciplinary human observers, has the potential to increase efficiency and reduce costs by studying human factors that include clinical design, technology, and organization. OR efficiency, measured in real time objectively and thoroughly, may save time and resources.

OR Black Box platforms have already started to generate meaningful data. It is not surprising that auditory disruptions—OR doors opening, loud noises, pagers beeping, telephones ringing—were recorded almost every minute during laparoscopic procedures.15 Most technical errors occurred during dissection, resection, and reconstruction and most commonly were associated with improper estimations of force applied to tissue and distance to the target tissue during operative steps of a laparoscopic procedure.16 Another study based on this system showed that technical performance was an independent predictor of postoperative outcomes.17 The OR Black Box identified a device-related interruption in 30% of elective laparoscopic general surgery cases, most commonly in sleeve gastrectomy and oncologic gastrectomy procedures. This sophisticated surgical data recording system also demonstrated a significantly better ability to detect Veress needle injuries (12 vs 3) and near misses (47 vs 0) when compared with traditional chart review.18

Data from the OR Black Box also have been applied to better analyze nontechnical performance, including teamwork and interpersonal dynamics.19 Surgeons most commonly exhibited adept situational awareness and leadership, while the nurse team excelled at task management and situational awareness.19 Of the total care provider team studied, the surgeon and scrub nurse demonstrated the most favorable nontechnical behavior.19 Of note, continuous physiologic monitoring of the surgeon with this system revealed that surgeons under stress had 66% higher adverse events.

The OR Black Box is currently utilized at 20 institutions in North America and Europe. The data compiled from all these institutions revealed that there was a 10% decrease in intraoperative adverse events for each 10-point increase in technical skill score on a scale of 0 to 100 (unpublished data). This centralized data indicated that turnover time ranged widely between 7 and 91 minutes, with variation of cleanup time from 1 to 25 minutes and setup time from 22 to 43 minutes. Institutions can learn from each other using this platform. For example, the information about block time utilization (20%–99%) across institutions provides opportunities for system improvements.

With any revolutionary technology, it is imperative to study its effects on outcomes, training, costs, and privacy before it is widely implemented. We, obstetricians and gynecologists, are very familiar with the impact of electronic fetal monitoring, a great example of a technologic advance that did not improve perinatal outcomes but led to unintended consequences, such as higher rates of cesarean deliveries and lawsuits. Such a tool may lead to potential misrepresentation of intraoperative events unless legal aspects are clearly delineated. As exciting as it is, this disruptive technology requires further exploration with scientific vigor.

Continue to: Surgeon and hospital volume: Surgical outcomes paradigm...

 

 

Surgeon and hospital volume: Surgical outcomes paradigm

A landmark study in 1979 that showed decreased mortality in high-volume centers underscored the need for regionalization for certain surgical procedures.20 This association was further substantiated by 2 reports on 2.5 million Medicare beneficiaries that demonstrated significantly lower mortality for all 14 cardiovascular and oncologic procedures for hospitals with larger surgical volume (16% vs 4%) and high-volume surgeons for certain procedures, for example, 15% versus 5% for pancreatic resections for cancer.21,22

A similar association was found for all routes of hysterectomies performed for benign indications. Boyd and colleagues showed that gynecologists who performed fewer than 10 hysterectomies per year had a higher perioperative morbidity rate (16.5%) compared with those who did more (11.7%).23 Specific to vaginal hysterectomy, in a study of more than 6,000 women, surgeons who performed 13 procedures per year had 31% less risk of operative injury than those who did 5.5 procedures per year (2.5% vs 1.7%).24 Overall perioperative complications (5.0% vs 4.0%) and medical complications (5.7% vs 3.9%) were also reduced for higher-volume surgeons. In a cohort of approximately 8,000 women who underwent a laparoscopic hysterectomy, high-volume surgeons had a considerably lower complication rate (4.2% vs 6.2%).25

As expected, lower complication rates of high-volume surgeons led to lower resource utilization, including lower transfusion rates, less intensive care unit utilization, and shorter operative times and, in several studies, length of stay.24,25 Of note, low-volume surgeons were less likely to offer minimally invasive routes and were more likely to convert to laparotomy.26 In addition, significant cost savings have been associated with high surgical volume, which one study showed was 16% ($6,500 vs $5,600) for high-volume surgeons.26 With regard to mortality, a study of 7,800 women found that perioperative mortality increased more than 10-fold for surgeons who performed an average 1 case per year compared with all other surgeons (2.5% vs 0.2%).27

When gynecologic cancers are concerned, arguably, long-term survival outcomes may be more critical than perioperative morbidity and mortality. Higher surgeon and hospital volume are associated with improved perioperative outcomes for endometrial and cervical cancers.28 Importantly, minimally invasive hysterectomy was offered for endometrial cancer significantly more often by surgeons with high volume.28 Survival outcomes were not affected by surgeon or hospital volume, likely due to overall more favorable prognosis for endometrial cancer after treatment.

Although it is intuitive to assume that a surgeon’s skills and experience would make the most impact in procedures for ovarian cancer due to the complexity of ovarian cancer surgery, evidence on short-term outcomes has been mixed. Intriguingly, some studies reported that high-volume institutions had higher complication and readmission rates. However, evidence supports that the surgeon’s volume, and especially hospital volume, improves long-term survival for ovarian cancer, with a negative impact on immediate postoperative morbidity.29 This may suggest that a more aggressive surgical effort improves long-term survival but also can cause more perioperative complications. Further, longer survival may result not only from operative skills but also because of better care by a structured multidisciplinary team at more established high-volume cancer centers.

The association of improved outcomes with higher volume led to public reporting of hospital outcomes. Policy efforts toward regionalization have impacted surgical practice. Based on their analysis of 3.2 million Medicare patients who underwent 1 of 8 different cancer surgeries or cardiovascular operations from 1999 to 2008, Finks and colleagues demonstrated that care was concentrated to fewer hospitals over time for many of these procedures.29 This trend was noted for gynecologic cancer surgery but not for benign gynecologic surgery.

Regionalization of care limits access particularly for minority and underserved communities because of longer travel distances, logistic challenges, and financial strain. An alternative to regionalization of care is targeted quality improvement by rigorous adherence to quality guidelines at low-volume hospitals.

Is there a critical minimum volume that may be used as a requirement for surgeons to maintain their privileges and for hospitals to offer certain procedures? In 2015, minimum volume standards for a number of common procedures were proposed by Johns Hopkins Medicine and Dartmouth-Hitchcock Medical Center, such as 50 hip replacement surgeries per hospital and 25 per physician per year, and 20 pancreatectomies per hospital and 5 per surgeon per year.30 A modeling study for hysterectomy showed that a volume cut point of >1 procedure in the prior year would restrict privileges for a substantial number of surgeons performing abdominal (17.5%), robot-assisted (12.5%), laparoscopic (16.8%), and vaginal (27.6%) hysterectomies.27 This study concluded that minimum-volume standards for hysterectomy for even the lowest volume physicians would restrict a significant number of gynecologic surgeons, including many with outcomes that are better than predicted.

Therefore, while there is good evidence that favors better outcomes in the hands of high-volume surgeons in gynecology, the impact of such policies on gynecologic practice clearly warrants careful monitoring and further study. 

Key points  
  • What factors besides the surgeon’s skills influence surgical safety and efficiency?
  • Are you ready to have audio, video, and sensor-based recording of everything in the OR?
  • Who should perform your loved one’s hysterectomy? Do the surgeon’s and hospital’s volume matter?

 

 

The operating room (OR) is a key contributor to a hospital’s profitability. It is a complex environment with ever-advancing technology. A successful surgery completed without complications within an optimal time depends not only on the surgeon’s experience, skills, and knowledge but also on numerous other structural, human, and nontechnical factors over which the surgeon has limited control.

As in any setting that deals with human life, in the OR, team dynamics, communication, and environment play a major role. Research has indicated the benefits of dedicated teams, reduced handoffs, and innovative modalities that continuously and systematically monitor potential breakdowns and propose solutions for the detected problems.

Finally, who should perform your loved one’s hysterectomy? This article also attempts to address the impact of surgeons’ and hospitals’ volume on operative outcomes with a diminishing number of hysterectomies but an increasing number of approaches.

 

Human factors in the OR

Human factors research was born as a product of the industrial revolution and mass production. It aims to optimize human experience and improve system performance by studying how humans interact with system. The aviation industry, for example, minimized errors significantly by using methods developed by human factors scientists. As another industry with no tolerance for mistakes, the health care sector followed suit. Ultimately, the goal of human factors research in health care is to improve patient safety, optimize work and environment, reduce costs, and enhance employees’ physical and mental health, engagement, comfort, and quality of life (FIGURE 1).1

Today’s OR is so complex that it is hard to understand its dynamics without human factors research. Every new OR technology is first tested in controlled and simulated environments to determine “work as imagined.” However, it is necessary to study “work as done” in the real world via direct observation, video recording, questionnaires, and semistructured interviews by an on-site multidisciplinary team. This process not only focuses on surgical skills, process efficiency, and outcomes but also monitors the entire process according to Human Factors and Ergonomics Engineering principles to explore otherwise hidden complexities and latent safety concerns. The Systems Engineering Initiative for Patient Safety (SEIPS) framework is used to study the impact of interactions between people, tasks, technologies, environment, and organization.1

Robot-assisted surgery (RAS), an increasingly popular surgical approach among gynecologic surgeons, recently has been the focus of human factors science. A robotic OR poses unique challenges: the surgeon is not scrubbed, is removed from the operating table, and controls a complex highly technologic device in a crowded and darkened room. These are ideal conditions waiting to be optimized by human factor experts. To demonstrate the importance of human factors in the OR, we review the evidence for RAS.

Continue to: Impact of flow disruptions...

 

 

Impact of flow disruptions

Flow disruptions (FDs) were found to be more common in RAS. Catchpole and colleagues identified a mean of 9.62 FDs per hour in 89 robotic procedures, including hysterectomies and sacrocolpopexies, from a variety of fields; FDs occurred more often during the docking stage, followed by the console time, and they mostly were caused by communication breakdown and lack of team familiarity.2

Surgeon experience significantly reduced FDs. Surgeons who had done more than 700 RAS cases experienced 60% fewer FDs than those who had done less than 250 cases (13 vs 8 per hour).2 A study focusing on residents’ impact on RAS outcomes found that each FD increased the total operative time by an average 2.4 minutes, with the number significantly higher when a resident was involved.3 About one-quarter of the training-related FDs were procedure-specific instructions, while one-third were related to instrument and robotic instruction. However, pauses to teach residents did not appear to create significant intraoperative delays. Expectedly, experienced surgeons could anticipate and reduce these disruptions by supporting the whole team.

Human ergonomics, turnover time, and robot-specific skills

In a study of human ergonomics in RAS, Yu and colleagues noted that bedside assistants could experience neck posture problems. Surprisingly, the console could constrain the surgeon’s neck-shoulder region.4 Studies that reported on communication problems in a robotic OR suggest that innovative forms of verbal and nonverbal communication may support successful team communication.5

On the learning curve for RAS, OR turnover time, a key value metric, has been longer. However, turnover time was reduced almost by half from 99.2 to 53.2 minutes over 3 months after concepts from motor racing pit stops were employed, including briefings, leadership, role definition, task allocation, and task sequencing. Average room-ready time also was lowered from 42.2 to 27.2 minutes.6 RAS presents new challenges with sterile instrument processing as well. A successful RAS program, therefore, has organizational needs that include the training of OR and sterile processing staff and appropriate shift management.1

In a robotic OR, not only the surgeon but also the whole team requires robot-specific skills. New training approaches to teamwork, communication, and situation awareness skills are necessary. Robotic equipment, with its data and power cables, 2 consoles, and changing movement paths, necessitate larger rooms with a specific layout.7

In a review of recordings of RAS that used a multidimensional assessment tool to measure team effectiveness and cognitive load, Sexton and colleagues identified anticipation, active team engagement, and higher familiarity scores as the best predictors of team efficiency.8 Several studies emphasized the need for a stable team, especially in the learning phase of robotic surgery.5,9,10 A dedicated robotic team reduced the operative time by 18% during robot-assisted sacrocolpopexy (RASCP).10 RASCP procedures that extended into the afternoon took significantly longer time.9 A dedicated anesthesiologist improved the preoperative time.9 Surgical team handoffs also have reduced OR efficiency.11,12

Studying the impact of human factors is paramount for safe and efficient surgery. It is especially necessary in ORs that are equipped with high technologic instruments such as those used in RAS.

 

Surgical Black Box: Using data for OR safety and efficiency

Surgical procedures account for more than 50% of medical errors in a hospital setting, many of which are preventable. Postevent analysis with traditional methods, such as “Morbidity and Mortality” meetings held many days later, misses many adverse events in the OR.13 Another challenge with ever-changing and fast-multiplying surgical approaches is the development of effective surgical skill. Reviewing video recording of surgical procedures has been proposed as an instrument for recognizing adverse events and perfecting surgical skills.Recently, an innovative data-capture platform called the OR Black Box, developed by Teodor Grantcharov, MD, PhD, and colleagues, went beyond simple audiovisual recording.14 This high technologic platform not only video records the actual surgical procedure with laparoscopic camera capture (and wearable cameras for open cases) but also monitors the entire OR environment via wide-angle cameras, utilizes sensors, and records both the patient’s and the surgeon’s physiologic parameters.

The OR Black Box generates a holistic view of the OR after synchronization, encryption, and secure storage of all inputs for further analysis by experts and software-based algorithms (FIGURE 2). Computer vision algorithms can recognize improper dissection techniques and complications, such as bleeding. Adverse events are flagged with an automated software on a procedural timeline to facilitate review of procedural steps, disruptive environmental and organizational factors, OR team technical and nontechnical skills, surgeon physiologic stress, and intraoperative errors, events, and rectification processes using validated instruments.


Artificial intelligence built into this platform can automatically extract objective, high-quality, and structured data to generate explainable insights by recognizing adverse events and procedural segments of interest for training and quality improvement and provide a foundation with objective measurements of technical and nontechnical performance for formative and summative assessment. This system, a major step up compared with retrospective review of likely biased medical records and labor-intensive multidisciplinary human observers, has the potential to increase efficiency and reduce costs by studying human factors that include clinical design, technology, and organization. OR efficiency, measured in real time objectively and thoroughly, may save time and resources.

OR Black Box platforms have already started to generate meaningful data. It is not surprising that auditory disruptions—OR doors opening, loud noises, pagers beeping, telephones ringing—were recorded almost every minute during laparoscopic procedures.15 Most technical errors occurred during dissection, resection, and reconstruction and most commonly were associated with improper estimations of force applied to tissue and distance to the target tissue during operative steps of a laparoscopic procedure.16 Another study based on this system showed that technical performance was an independent predictor of postoperative outcomes.17 The OR Black Box identified a device-related interruption in 30% of elective laparoscopic general surgery cases, most commonly in sleeve gastrectomy and oncologic gastrectomy procedures. This sophisticated surgical data recording system also demonstrated a significantly better ability to detect Veress needle injuries (12 vs 3) and near misses (47 vs 0) when compared with traditional chart review.18

Data from the OR Black Box also have been applied to better analyze nontechnical performance, including teamwork and interpersonal dynamics.19 Surgeons most commonly exhibited adept situational awareness and leadership, while the nurse team excelled at task management and situational awareness.19 Of the total care provider team studied, the surgeon and scrub nurse demonstrated the most favorable nontechnical behavior.19 Of note, continuous physiologic monitoring of the surgeon with this system revealed that surgeons under stress had 66% higher adverse events.

The OR Black Box is currently utilized at 20 institutions in North America and Europe. The data compiled from all these institutions revealed that there was a 10% decrease in intraoperative adverse events for each 10-point increase in technical skill score on a scale of 0 to 100 (unpublished data). This centralized data indicated that turnover time ranged widely between 7 and 91 minutes, with variation of cleanup time from 1 to 25 minutes and setup time from 22 to 43 minutes. Institutions can learn from each other using this platform. For example, the information about block time utilization (20%–99%) across institutions provides opportunities for system improvements.

With any revolutionary technology, it is imperative to study its effects on outcomes, training, costs, and privacy before it is widely implemented. We, obstetricians and gynecologists, are very familiar with the impact of electronic fetal monitoring, a great example of a technologic advance that did not improve perinatal outcomes but led to unintended consequences, such as higher rates of cesarean deliveries and lawsuits. Such a tool may lead to potential misrepresentation of intraoperative events unless legal aspects are clearly delineated. As exciting as it is, this disruptive technology requires further exploration with scientific vigor.

Continue to: Surgeon and hospital volume: Surgical outcomes paradigm...

 

 

Surgeon and hospital volume: Surgical outcomes paradigm

A landmark study in 1979 that showed decreased mortality in high-volume centers underscored the need for regionalization for certain surgical procedures.20 This association was further substantiated by 2 reports on 2.5 million Medicare beneficiaries that demonstrated significantly lower mortality for all 14 cardiovascular and oncologic procedures for hospitals with larger surgical volume (16% vs 4%) and high-volume surgeons for certain procedures, for example, 15% versus 5% for pancreatic resections for cancer.21,22

A similar association was found for all routes of hysterectomies performed for benign indications. Boyd and colleagues showed that gynecologists who performed fewer than 10 hysterectomies per year had a higher perioperative morbidity rate (16.5%) compared with those who did more (11.7%).23 Specific to vaginal hysterectomy, in a study of more than 6,000 women, surgeons who performed 13 procedures per year had 31% less risk of operative injury than those who did 5.5 procedures per year (2.5% vs 1.7%).24 Overall perioperative complications (5.0% vs 4.0%) and medical complications (5.7% vs 3.9%) were also reduced for higher-volume surgeons. In a cohort of approximately 8,000 women who underwent a laparoscopic hysterectomy, high-volume surgeons had a considerably lower complication rate (4.2% vs 6.2%).25

As expected, lower complication rates of high-volume surgeons led to lower resource utilization, including lower transfusion rates, less intensive care unit utilization, and shorter operative times and, in several studies, length of stay.24,25 Of note, low-volume surgeons were less likely to offer minimally invasive routes and were more likely to convert to laparotomy.26 In addition, significant cost savings have been associated with high surgical volume, which one study showed was 16% ($6,500 vs $5,600) for high-volume surgeons.26 With regard to mortality, a study of 7,800 women found that perioperative mortality increased more than 10-fold for surgeons who performed an average 1 case per year compared with all other surgeons (2.5% vs 0.2%).27

When gynecologic cancers are concerned, arguably, long-term survival outcomes may be more critical than perioperative morbidity and mortality. Higher surgeon and hospital volume are associated with improved perioperative outcomes for endometrial and cervical cancers.28 Importantly, minimally invasive hysterectomy was offered for endometrial cancer significantly more often by surgeons with high volume.28 Survival outcomes were not affected by surgeon or hospital volume, likely due to overall more favorable prognosis for endometrial cancer after treatment.

Although it is intuitive to assume that a surgeon’s skills and experience would make the most impact in procedures for ovarian cancer due to the complexity of ovarian cancer surgery, evidence on short-term outcomes has been mixed. Intriguingly, some studies reported that high-volume institutions had higher complication and readmission rates. However, evidence supports that the surgeon’s volume, and especially hospital volume, improves long-term survival for ovarian cancer, with a negative impact on immediate postoperative morbidity.29 This may suggest that a more aggressive surgical effort improves long-term survival but also can cause more perioperative complications. Further, longer survival may result not only from operative skills but also because of better care by a structured multidisciplinary team at more established high-volume cancer centers.

The association of improved outcomes with higher volume led to public reporting of hospital outcomes. Policy efforts toward regionalization have impacted surgical practice. Based on their analysis of 3.2 million Medicare patients who underwent 1 of 8 different cancer surgeries or cardiovascular operations from 1999 to 2008, Finks and colleagues demonstrated that care was concentrated to fewer hospitals over time for many of these procedures.29 This trend was noted for gynecologic cancer surgery but not for benign gynecologic surgery.

Regionalization of care limits access particularly for minority and underserved communities because of longer travel distances, logistic challenges, and financial strain. An alternative to regionalization of care is targeted quality improvement by rigorous adherence to quality guidelines at low-volume hospitals.

Is there a critical minimum volume that may be used as a requirement for surgeons to maintain their privileges and for hospitals to offer certain procedures? In 2015, minimum volume standards for a number of common procedures were proposed by Johns Hopkins Medicine and Dartmouth-Hitchcock Medical Center, such as 50 hip replacement surgeries per hospital and 25 per physician per year, and 20 pancreatectomies per hospital and 5 per surgeon per year.30 A modeling study for hysterectomy showed that a volume cut point of >1 procedure in the prior year would restrict privileges for a substantial number of surgeons performing abdominal (17.5%), robot-assisted (12.5%), laparoscopic (16.8%), and vaginal (27.6%) hysterectomies.27 This study concluded that minimum-volume standards for hysterectomy for even the lowest volume physicians would restrict a significant number of gynecologic surgeons, including many with outcomes that are better than predicted.

Therefore, while there is good evidence that favors better outcomes in the hands of high-volume surgeons in gynecology, the impact of such policies on gynecologic practice clearly warrants careful monitoring and further study. 

Key points  
  • What factors besides the surgeon’s skills influence surgical safety and efficiency?
  • Are you ready to have audio, video, and sensor-based recording of everything in the OR?
  • Who should perform your loved one’s hysterectomy? Do the surgeon’s and hospital’s volume matter?
References
  1. Catchpole K, Bisantz A, Hallbeck MS, et al. Human factors in robotic assisted surgery: lessons from studies ‘in the wild’. Appl Ergon. 2019;78:270-276.
  2. Catchpole K, Perkins C, Bresee C, et al. Safety, efficiency and learning curves in robotic surgery: a human factors analysis. Surg Endosc. 2016;30:3749-3761.
  3. Jain M, Fry BT, Hess LW, et al. Barriers to efficiency in robotic surgery: the resident effect. J Surg. Res. 2016;205:296-304.
  4. Yu D, Dural C, Morrow MM, et al. Intraoperative workload in robotic surgery assessed by wearable motion tracking sensors and questionnaires. Surg Endosc. 2017;31:877-886.
  5. Randell R, Honey S, Alvarado N, et al. Embedding robotic surgery into routine practice and impacts on communication and decision making: a review of the experience of surgical teams. Cognit Technol Work. 2016;18:423-437.
  6. Souders CP, Catchpole KR, Wood LN, et al. Reducing operating room turnover time for robotic surgery using a motor racing pit stop model. World J Surg. 2017;4:1943–1949.
  7. Ahmad N, Hussein AA, Cavuoto L, et al. Ambulatory movements, team dynamics and interactions during robot-assisted surgery. BJU Int. 2016;118:132-139.
  8. Sexton K, Johnson A, Gotsch A, et al. Anticipation, teamwork, and cognitive load: chasing efficiency during robot-assisted surgery. BMJ Qual Saf. 2018;27:148-154.
  9. Harmanli O, Solak S, Bayram A, et al. Optimizing the robotic surgery team: an operations management perspective. Int Urogynecol J. 2021;32:1379-1385.
  10. Carter-Brooks CM, Du AL, Bonidie MJ, et al. The impact of a dedicated robotic team on robotic-assisted sacrocolpopexy outcomes. Female Pelvic Med Reconstr Surg. 2018;24:13-16.
  11. Giugale LE, Sears S, Lavelle ES, et al. Evaluating the impact of intraoperative surgical team handoffs on patient outcomes. Female Pelvic Med Reconstr Surg. 2017;23:288-292.
  12. Geynisman-Tan J, Brown O, Mueller M, et al. Operating room efficiency: examining the impact of personnel handoffs. Female Pelvic Med Reconstr Surg. 2018;24:87-89.
  13. Alsubaie H, Goldenberg M, Grantcharov T. Quantifying recall bias in surgical safety: a need for a modern approach to morbidity and mortality reviews. Can J Surg. 2019;62:39-43.
  14. Goldenberg MG, Jung J, Grantcharov TP. Using data to enhance performance and improve quality and safety in surgery. JAMA Surg. 2017;152:972-973.
  15. Jung JJ, Grantcharov TP. The operating room black box: a prospective observational study of the operating room. J Am Coll Surg. 2017;225:S127-S128.
  16. Jung JJ, Jüni P, Lebovic G, et al. First-year analysis of the operating room black box study. Ann Surg. 2020;271:122-127.
  17. Jung JJ, Kashfi A, Sharma S, et al. Characterization of device-related interruptions in minimally invasive surgery: need for intraoperative data and effective mitigation strategies. Surg Endosc. 2019;33:717-723.
  18. Jung JJ, Adams-McGavin RC, Grantcharov TP. Underreporting of Veress needle injuries: comparing direct observation and chart review methods. J Surg Res. 2019;236:266-270.
  19. Fesco AB, Kuzulugil SS, Babaoglu C, et al. Relationship between intraoperative nontechnical performance and technical events in bariatric surgery. Br J Surg. 2018;105:1044-1050.
  20. Luft HS, Bunker JP, Enthoven AC. Should operations be regionalized? The empirical relation between surgical volume and mortality. N Engl J Med. 1979;301:1364-1369.
  21. Birkmeyer JD, Siewers AE, Finlayson EV, et al. Hospital volume and surgical mortality in the United States. N Engl J Med. 2002;346:1128-1137.
  22. Birkmeyer JD, Stukel TA, Siewers AE, et al. Surgeon volume and operative mortality in the United States. N Engl J Med. 2003;349:21172127.
  23. Boyd LR, Novetsky AP, Curtin JP. Effect of surgical volume on route of hysterectomy and short-term morbidity. Obstet Gynecol. 2010;116:909-915.
  24. Rogo-Gupta LJ, Lewin SN, Kim JH, et al. The effect of surgeon volume on outcomes and resource use for vaginal hysterectomy. Obstet Gynecol. 2010;116:1341-1347.
  25. Wallenstein MR, Ananth CV, Kim JH, et al. Effect of surgical volume on outcomes for laparoscopic hysterectomy for benign indications. Obstet Gynecol. 2012;119:709-716.
  26. Bretschneider CE, Frazzini Padilla P, Das D, et al. The impact of surgeon volume on perioperative adverse events in women undergoing minimally invasive hysterectomy for the large uterus. Am J Obstet Gynecol. 2018;219:490.e1-490.e8.
  27. Ruiz MP, Chen L, Hou JY, et al. Outcomes of hysterectomy performed by very low-volume surgeons. Obstet Gynecol. 2018;131:981-990.
  28. Wright JD. The volume-outcome paradigm for gynecologic surgery: clinical and policy implications. Clin Obstet Gynecol. 2020;63:252-265.
  29. Finks JF, Osborne NH, Birkmeyer JD. Trends in hospital volume and operative mortality for high risk surgery. N Engl J Med. 2011;364:21282137.
  30. Sternberg S. Hospitals move to limit low-volume surgeries. US News & World Report. May 19, 2015. www.usnews.com/news /articles/2015/05/19/hospitals-move-to-limit-low-volume-surgeries. Accessed April 19, 2022.
References
  1. Catchpole K, Bisantz A, Hallbeck MS, et al. Human factors in robotic assisted surgery: lessons from studies ‘in the wild’. Appl Ergon. 2019;78:270-276.
  2. Catchpole K, Perkins C, Bresee C, et al. Safety, efficiency and learning curves in robotic surgery: a human factors analysis. Surg Endosc. 2016;30:3749-3761.
  3. Jain M, Fry BT, Hess LW, et al. Barriers to efficiency in robotic surgery: the resident effect. J Surg. Res. 2016;205:296-304.
  4. Yu D, Dural C, Morrow MM, et al. Intraoperative workload in robotic surgery assessed by wearable motion tracking sensors and questionnaires. Surg Endosc. 2017;31:877-886.
  5. Randell R, Honey S, Alvarado N, et al. Embedding robotic surgery into routine practice and impacts on communication and decision making: a review of the experience of surgical teams. Cognit Technol Work. 2016;18:423-437.
  6. Souders CP, Catchpole KR, Wood LN, et al. Reducing operating room turnover time for robotic surgery using a motor racing pit stop model. World J Surg. 2017;4:1943–1949.
  7. Ahmad N, Hussein AA, Cavuoto L, et al. Ambulatory movements, team dynamics and interactions during robot-assisted surgery. BJU Int. 2016;118:132-139.
  8. Sexton K, Johnson A, Gotsch A, et al. Anticipation, teamwork, and cognitive load: chasing efficiency during robot-assisted surgery. BMJ Qual Saf. 2018;27:148-154.
  9. Harmanli O, Solak S, Bayram A, et al. Optimizing the robotic surgery team: an operations management perspective. Int Urogynecol J. 2021;32:1379-1385.
  10. Carter-Brooks CM, Du AL, Bonidie MJ, et al. The impact of a dedicated robotic team on robotic-assisted sacrocolpopexy outcomes. Female Pelvic Med Reconstr Surg. 2018;24:13-16.
  11. Giugale LE, Sears S, Lavelle ES, et al. Evaluating the impact of intraoperative surgical team handoffs on patient outcomes. Female Pelvic Med Reconstr Surg. 2017;23:288-292.
  12. Geynisman-Tan J, Brown O, Mueller M, et al. Operating room efficiency: examining the impact of personnel handoffs. Female Pelvic Med Reconstr Surg. 2018;24:87-89.
  13. Alsubaie H, Goldenberg M, Grantcharov T. Quantifying recall bias in surgical safety: a need for a modern approach to morbidity and mortality reviews. Can J Surg. 2019;62:39-43.
  14. Goldenberg MG, Jung J, Grantcharov TP. Using data to enhance performance and improve quality and safety in surgery. JAMA Surg. 2017;152:972-973.
  15. Jung JJ, Grantcharov TP. The operating room black box: a prospective observational study of the operating room. J Am Coll Surg. 2017;225:S127-S128.
  16. Jung JJ, Jüni P, Lebovic G, et al. First-year analysis of the operating room black box study. Ann Surg. 2020;271:122-127.
  17. Jung JJ, Kashfi A, Sharma S, et al. Characterization of device-related interruptions in minimally invasive surgery: need for intraoperative data and effective mitigation strategies. Surg Endosc. 2019;33:717-723.
  18. Jung JJ, Adams-McGavin RC, Grantcharov TP. Underreporting of Veress needle injuries: comparing direct observation and chart review methods. J Surg Res. 2019;236:266-270.
  19. Fesco AB, Kuzulugil SS, Babaoglu C, et al. Relationship between intraoperative nontechnical performance and technical events in bariatric surgery. Br J Surg. 2018;105:1044-1050.
  20. Luft HS, Bunker JP, Enthoven AC. Should operations be regionalized? The empirical relation between surgical volume and mortality. N Engl J Med. 1979;301:1364-1369.
  21. Birkmeyer JD, Siewers AE, Finlayson EV, et al. Hospital volume and surgical mortality in the United States. N Engl J Med. 2002;346:1128-1137.
  22. Birkmeyer JD, Stukel TA, Siewers AE, et al. Surgeon volume and operative mortality in the United States. N Engl J Med. 2003;349:21172127.
  23. Boyd LR, Novetsky AP, Curtin JP. Effect of surgical volume on route of hysterectomy and short-term morbidity. Obstet Gynecol. 2010;116:909-915.
  24. Rogo-Gupta LJ, Lewin SN, Kim JH, et al. The effect of surgeon volume on outcomes and resource use for vaginal hysterectomy. Obstet Gynecol. 2010;116:1341-1347.
  25. Wallenstein MR, Ananth CV, Kim JH, et al. Effect of surgical volume on outcomes for laparoscopic hysterectomy for benign indications. Obstet Gynecol. 2012;119:709-716.
  26. Bretschneider CE, Frazzini Padilla P, Das D, et al. The impact of surgeon volume on perioperative adverse events in women undergoing minimally invasive hysterectomy for the large uterus. Am J Obstet Gynecol. 2018;219:490.e1-490.e8.
  27. Ruiz MP, Chen L, Hou JY, et al. Outcomes of hysterectomy performed by very low-volume surgeons. Obstet Gynecol. 2018;131:981-990.
  28. Wright JD. The volume-outcome paradigm for gynecologic surgery: clinical and policy implications. Clin Obstet Gynecol. 2020;63:252-265.
  29. Finks JF, Osborne NH, Birkmeyer JD. Trends in hospital volume and operative mortality for high risk surgery. N Engl J Med. 2011;364:21282137.
  30. Sternberg S. Hospitals move to limit low-volume surgeries. US News & World Report. May 19, 2015. www.usnews.com/news /articles/2015/05/19/hospitals-move-to-limit-low-volume-surgeries. Accessed April 19, 2022.
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Steps to minimize morbidity from unanticipated placenta accreta spectrum

Article Type
Changed
Tue, 06/14/2022 - 13:10

 

 

CASE Placenta accreta spectrum following uncomplicated vaginal delivery

Imagine you are an obstetric hospitalist taking call at a level II maternal level of care hospital. Your patient is a 35-year-old woman, gravida 2, para 1, with a past history of retained placenta requiring dilation and curettage and intravenous antibiotics for endomyometritis. This is an in vitro fertilization pregnancy that has progressed normally, and the patient labored spontaneously at 38 weeks’ gestation. Following an uncomplicated vaginal delivery, the placenta has not delivered, and you attempt a manual placental extraction after a 40-minute third stage. While there is epidural analgesia and you can reach the uterine fundus, you are unable to create a separation plane between the placenta and uterus.

What do you do next?

Placenta accreta spectrum (PAS) includes a broad range of clinical scenarios with abnormal placental attachment as their common denominator. The condition has classically been defined pathologically, with chorionic villi attaching directly to the myometrium (“accreta”) or extending more deeply into the myometrium (“increta”) or attaching to surrounding tissues and structures (“percreta”).1 It is most commonly encountered in patients with low placental implantation on a prior cesarean section scar; indeed, placenta previa, particularly with a history of cesarean delivery, is the strongest risk factor for the development of PAS.2 In addition to abnormal placental attachment, these placental attachments are often hypervascular and can lead to catastrophic hemorrhage if not managed appropriately. For this reason, patients with sonographic or radiologic signs of PAS should be referred to specialized centers for further workup, counseling, and delivery planning.3

Although delivery at a specialized PAS center has been associated with improved patient outcomes,4 not all patients with PAS will be identified in the antepartum period. Ultrasonography may miss up to 40% to 50% of PAS cases, particularly when the sonologist has not been advised to look for the condition,5 and not all patients with PAS will have a previa implanted in a prior cesarean scar. A recent study found that these patients with nonprevia PAS were identified by imaging less than 40% of the time and were significantly less likely to be managed by a specialized team of clinicians.6 Thus, it falls upon every obstetric care provider to be aware of this diagnosis, promptly recognize its unanticipated presentations, and have a plan to optimize patient safety.

Step 1: Recognition

While PAS is classically defined as a pathologic condition, no clinician has the luxury of histology in the delivery room. Researchers have variously defined PAS clinically, with the common trait of abnormal placental adherence.7-9 The TABLE compares published definitions that have been used in the literature. While some definitions include hemorrhage, no clinician wants to induce significant hemorrhage to confirm their patient’s diagnosis. Thus, practically, the clinical PAS diagnosis comes down to abnormal placental attachment: If it is apparent that some or all of the placenta will not separate from the uterine wall with digital manipulation or careful curettage, then PAS should be suspected, and appropriate steps should be taken before further removal attempts.

At cesarean delivery, the PAS diagnosis may be aided by visual cues. With placenta previa, the lower uterine segment may bulge and take on a bluish hue, distinctly different from the upper healthy myometrium. PAS may also manifest with neovascularization, particularly behind the bladder. As with vaginal births, the placenta will fail to separate after the delivery, and controlled traction on the umbilical cord can produce a “dimple sign,” or visible myometrial retraction at the site of implantation (FIGURE 1). Finally, if the diagnosis is still in doubt, attempts to gently form a cleavage plane between the placenta and myometrium will be unsuccessful if PAS is present.8

Step 2: Initial management—pause, plan

Most importantly, do not attempt to forcibly remove the placenta. It can be left attached to the uterus until appropriate resources are secured. Efforts to forcibly remove an adherent placenta may well lead to major hemorrhage, and thus it falls on the patient’s care team to pause and plan for PAS care at this point. FIGURE 2 displays an algorithm for patient management. Further steps depend primarily on whether or not the patient is already hemorrhaging. In a stable situation, the patient should be counseled regarding the abnormal findings and the suspected PAS diagnosis. This includes the possibility of further procedures, blood transfusion, and hysterectomy. Local resources, including nursing, anesthesia, and the blood bank, should be notified about the situation and for the potential to call in specialized services. If on-site experienced specialists are not available, then patient transfer to a PAS specialty center should be strongly considered. While awaiting additional help or transport, the patient requires close monitoring for gross and physiologic signs of hemorrhage. If pursued, transport to a PAS specialty center should be expedited.

If the patient is already hemorrhaging or unstable, then appropriate local resources must be activated. At a minimum, this requires an obstetrician and anesthesiologist at the bedside and activation of hemorrhage protocols (eg, a massive transfusion protocol). If blood products are unavailable, consider whether they can be transported from other nearby blood banks, and start that process promptly. Next, contact backup services. Based on local resources and clinical severity, this may include maternal-fetal medicine specialists, pelvic surgeons, general and trauma surgeons, intensivists, interventional radiologists, and transfusion specialists. Even if the patient cannot be safely transferred to another hospital, the obstetrician can call an outside PAS specialist to discuss next steps in care and begin transfer plans, assuming the patient can be stabilized. Based on the Maternal Levels of Care definitions published by the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine,10 patients with PAS should be managed at level III or level IV centers. However, delivery units at every level of maternal care should have a protocol for securing local help and reaching an appropriate consultant if a PAS case is encountered. Know which center in your area specializes in PAS so that when an unanticipated case arises, you know who to call.

Continue to: Step 3: Ultimate management—mobilize and prepare for bleeding...

 

 

Step 3: Ultimate management—mobilize and prepare for bleeding

If diagnosis occurs intraoperatively at a PAS specialty center, or if safe transport is not possible, then the team should mobilize for the possibility of hysterectomy and prepare for massive bleeding, which can occur regardless of the treatment chosen. Many patients require or will opt for hysterectomy. For example, a patient who has finished childbearing may consent to a hysterectomy upon hearing she likely has PAS. In patients with suspected PAS who are actively hemorrhaging or are unstable, hysterectomy is required.

Uterine conservation may be considered in stable patients who strongly desire future childbearing or uterine retention. This often requires leaving densely adherent placental tissue in situ and thus requires thorough counseling regarding the risks of delayed hemorrhage, infection, and emergent hysterectomy.11 This may not be desirable or safe for some patients, so informed consent is crucial. In such cases, we strongly recommend consultation with a PAS specialist, even if that requires immediate control of the placental blood supply (such as with arterial embolization), and transfer to a PAS specialty center.

 

Clinical scenarios

Vaginal delivery

The patient in the opening case was never expected to have PAS given her normal placental location and absence of a uterine scar. Even though she had some possible PAS risk factors (past retained placenta with instrumentation and in vitro fertilization), her absolute risk for the condition was low. Nevertheless, inability to create a separation plane should be considered PAS until proven otherwise. Although at this point many obstetricians would move to an operating room for uterine curettage, we recommend that the care team pause and put measures in place for possible PAS and hemorrhage. This involves notification of the blood bank, crossmatching of blood products, alerting the anesthesia team, and having a clear plan in place should a major hemorrhage ensue. This may involve use of balloon tamponade, activation of an interventional radiology team, or possible laparotomy with arterial ligations or hysterectomy. Avoidance of a prolonged third stage should be balanced against the need for preparation with these cases.

It is important for clinicians to bear in mind, and communicate to the patient, that hysterectomy is the standard of care for PAS. Significant delays in performing an indicated hysterectomy can lead to coagulopathy and patient instability. Timeliness is key; we find that delays in the decision to perform an indicated hysterectomy are often at the root of the cause for worsened morbidity in patients with unanticipated PAS. With an unscarred uterus and no placenta previa, a postpartum hysterectomy can be performed by many obstetrician-gynecologists experienced in this abdominal procedure.

Cesarean delivery

Undiagnosed PAS may present at cesarean delivery with or without placenta previa and a prior uterine scar. With this combination, PAS is often visually apparent upon opening the abdominal cavity (TABLE and FIGURE 1). Such surgical findings call for a clinical pause, as further actions at this point can lead to catastrophic hemorrhage. The obstetrician should consider a series of questions:

1. Are appropriate surgical and transfusion resources immediately available? If yes, they should be notified in case they are needed urgently. If not, then the obstetrician should ask whether the delivery must occur now.

2. Is this a scheduled delivery with a stable patient and fetus? If so, then closing the abdominal incision, monitoring the patient and fetus, and either transferring the patient to a PAS center or awaiting appropriate local specialists may be a lifesaving step.

3. Is immediate delivery required? If the fetus must be delivered, then it is imperative to create a hysterotomy out of the way of the placenta. Disrupting the adherent placenta with either an incision or manual manipulation may trigger a massive hemorrhage and should be avoided. This may require rectus muscle transection or creating a “T” incision on the skin to reach the uterine fundus and creating a hysterotomy over the top or even the back of the uterus. Once the fetus is delivered and lack of uterine hemorrhage confirmed (both abdominally and vaginally), the hysterotomy and abdomen can be closed with anticipation of urgent patient transfer to a PAS team or center.

4. Is the patient hemorrhaging? If the patient is hemorrhaging and closure is not an option, then recruitment of local emergent surgical teams is warranted, even if that requires packing the abdomen until an appropriate surgeon can arrive.

Diagnosis at cesarean delivery requires expedited and complex patient counseling. A patient who is unstable or hemorrhaging needs to be told that hysterectomy is lifesaving in this situation. For patients who are stable, it may be appropriate to close the abdomen and leave the placenta in situ, perform comprehensive counseling, and assess the possibility of transfer to a specialty center.

Summary

All obstetric care providers should be familiar with the clinical presentation of undiagnosed accreta spectrum. While hemorrhage is often part of the diagnosis, recognition of abnormal placental adherence and PAS-focused management should ideally be undertaken before this occurs. Once PAS is suspected, avoidance of further placental disruption may save significant morbidity, even if that means leaving the placenta attached until appropriate resources can be obtained. A local protocol for consultation, emergency transfer, and deployment of local resources should be part of every delivery unit’s emergency preparedness plan.

CASE Outcome

This patient is stabilized, with an adherent, retained placenta and no signs of hemorrhage. You administer uterotonics and notify your anesthesiologist and backup obstetrician that you have a likely case of accreta spectrum. A second intravenous line is placed, and blood products are crossmatched. The closest level III hospital is called, and they accept your patient for transfer. There, she is counseled about PAS, and she expresses no desire for future childbearing. After again confirming no placental separation in the operating room, the patient is moved immediately to perform laparotomy and total abdominal hysterectomy through a Pfannenstiel incision. She does not require a blood transfusion, and the pathology returns with grade I placenta accreta spectrum. ●

References

 

  1. American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. Obstetric Care Consensus No. 7: placenta accreta spectrum. Obstet Gynecol. 2018; 132:e259-e275. doi:10.1097/AOG.0000000000002983.
  2. Carusi DA. The placenta accreta spectrum: epidemiology and risk factors. Clin Obstet Gynecol. 2018;61:733-742. doi:10.1097/GRF.0000000000000391.
  3. Silver RM, Fox KA, Barton JR, et al. Center of excellence for placenta accreta. Am J Obstet Gynecol. 2015;212:561-568. doi:10.1016/j.ajog.2014.11.018.
  4. Shamshirsaz AA, Fox KA, Salmanian B, et al. Maternal morbidity in patients with morbidly adherent placenta treated with and without a standardized multidisciplinary approach. Am J Obstet Gynecol. 2015;212:218.e1-9. doi:10.1016/j.ajog.2014.08.019.
  5. Bowman ZS, Eller AG, Kennedy AM, et al. Accuracy of ultrasound for the prediction of placenta accreta. Am J Obstet Gynecol. 2014;211:177.e1-7. doi:10.1016/j.ajog.2014.03.029.
  6. Carusi DA, Fox KA, Lyell DJ, et al. Placenta accreta spectrum without placenta previa. Obstet Gynecol. 2020;136:458-465. doi:10.1097/AOG.0000000000003970.
  7. Kayem G, Seco A, Beucher G, et al. Clinical profiles of placenta accreta spectrum: the PACCRETA population-based study. BJOG. 2021;128:1646-1655. doi:10.1111/1471-0528.16647.
  8. Jauniaux E, Ayres-de-Campos D, Langhoff-Roos J, et al. FIGO classification for the clinical diagnosis of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2019;146:20-24. doi:10.1002/ijgo.12761.
  9. Collins SL, Alemdar B, van Beekhuizen HJ, et al. Evidence-based guidelines for the management of abnormally invasive placenta: recommendations from the International Society for Abnormally Invasive Placenta. Am J Obstet Gynecol. 2019;220(6):511-526. doi:10.1016/j.ajog.2019.02.054.
  10. American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. Obstetric care consensus. No. 7: placenta accreta spectrum. Obstet Gynecol. 2018;132:e259-e275. doi: 10.1097/AOG.0000000000002983.
  11. Sentilhes L, Kayem G, Silver RM. Conservative management of placenta accreta spectrum. Clin Obstet Gynecol. 2018; 61(4):783-794. doi:10.1097/GRF.0000000000000395.
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Author and Disclosure Information

Dr. Carusi is Director of Surgical Obstetrics and Placental Abnormalities and Associate Professor, Harvard Medical School, Boston, Massachusetts.

Dr. Einerson is Director, Utah Placenta Accreta Program, and Assistant Professor, Division of Maternal-Fetal Medicine, University of Utah Health, Salt Lake City.

The authors report no financial relationships related to this article.

 

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Dr. Carusi is Director of Surgical Obstetrics and Placental Abnormalities and Associate Professor, Harvard Medical School, Boston, Massachusetts.

Dr. Einerson is Director, Utah Placenta Accreta Program, and Assistant Professor, Division of Maternal-Fetal Medicine, University of Utah Health, Salt Lake City.

The authors report no financial relationships related to this article.

 

Author and Disclosure Information

Dr. Carusi is Director of Surgical Obstetrics and Placental Abnormalities and Associate Professor, Harvard Medical School, Boston, Massachusetts.

Dr. Einerson is Director, Utah Placenta Accreta Program, and Assistant Professor, Division of Maternal-Fetal Medicine, University of Utah Health, Salt Lake City.

The authors report no financial relationships related to this article.

 

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CASE Placenta accreta spectrum following uncomplicated vaginal delivery

Imagine you are an obstetric hospitalist taking call at a level II maternal level of care hospital. Your patient is a 35-year-old woman, gravida 2, para 1, with a past history of retained placenta requiring dilation and curettage and intravenous antibiotics for endomyometritis. This is an in vitro fertilization pregnancy that has progressed normally, and the patient labored spontaneously at 38 weeks’ gestation. Following an uncomplicated vaginal delivery, the placenta has not delivered, and you attempt a manual placental extraction after a 40-minute third stage. While there is epidural analgesia and you can reach the uterine fundus, you are unable to create a separation plane between the placenta and uterus.

What do you do next?

Placenta accreta spectrum (PAS) includes a broad range of clinical scenarios with abnormal placental attachment as their common denominator. The condition has classically been defined pathologically, with chorionic villi attaching directly to the myometrium (“accreta”) or extending more deeply into the myometrium (“increta”) or attaching to surrounding tissues and structures (“percreta”).1 It is most commonly encountered in patients with low placental implantation on a prior cesarean section scar; indeed, placenta previa, particularly with a history of cesarean delivery, is the strongest risk factor for the development of PAS.2 In addition to abnormal placental attachment, these placental attachments are often hypervascular and can lead to catastrophic hemorrhage if not managed appropriately. For this reason, patients with sonographic or radiologic signs of PAS should be referred to specialized centers for further workup, counseling, and delivery planning.3

Although delivery at a specialized PAS center has been associated with improved patient outcomes,4 not all patients with PAS will be identified in the antepartum period. Ultrasonography may miss up to 40% to 50% of PAS cases, particularly when the sonologist has not been advised to look for the condition,5 and not all patients with PAS will have a previa implanted in a prior cesarean scar. A recent study found that these patients with nonprevia PAS were identified by imaging less than 40% of the time and were significantly less likely to be managed by a specialized team of clinicians.6 Thus, it falls upon every obstetric care provider to be aware of this diagnosis, promptly recognize its unanticipated presentations, and have a plan to optimize patient safety.

Step 1: Recognition

While PAS is classically defined as a pathologic condition, no clinician has the luxury of histology in the delivery room. Researchers have variously defined PAS clinically, with the common trait of abnormal placental adherence.7-9 The TABLE compares published definitions that have been used in the literature. While some definitions include hemorrhage, no clinician wants to induce significant hemorrhage to confirm their patient’s diagnosis. Thus, practically, the clinical PAS diagnosis comes down to abnormal placental attachment: If it is apparent that some or all of the placenta will not separate from the uterine wall with digital manipulation or careful curettage, then PAS should be suspected, and appropriate steps should be taken before further removal attempts.

At cesarean delivery, the PAS diagnosis may be aided by visual cues. With placenta previa, the lower uterine segment may bulge and take on a bluish hue, distinctly different from the upper healthy myometrium. PAS may also manifest with neovascularization, particularly behind the bladder. As with vaginal births, the placenta will fail to separate after the delivery, and controlled traction on the umbilical cord can produce a “dimple sign,” or visible myometrial retraction at the site of implantation (FIGURE 1). Finally, if the diagnosis is still in doubt, attempts to gently form a cleavage plane between the placenta and myometrium will be unsuccessful if PAS is present.8

Step 2: Initial management—pause, plan

Most importantly, do not attempt to forcibly remove the placenta. It can be left attached to the uterus until appropriate resources are secured. Efforts to forcibly remove an adherent placenta may well lead to major hemorrhage, and thus it falls on the patient’s care team to pause and plan for PAS care at this point. FIGURE 2 displays an algorithm for patient management. Further steps depend primarily on whether or not the patient is already hemorrhaging. In a stable situation, the patient should be counseled regarding the abnormal findings and the suspected PAS diagnosis. This includes the possibility of further procedures, blood transfusion, and hysterectomy. Local resources, including nursing, anesthesia, and the blood bank, should be notified about the situation and for the potential to call in specialized services. If on-site experienced specialists are not available, then patient transfer to a PAS specialty center should be strongly considered. While awaiting additional help or transport, the patient requires close monitoring for gross and physiologic signs of hemorrhage. If pursued, transport to a PAS specialty center should be expedited.

If the patient is already hemorrhaging or unstable, then appropriate local resources must be activated. At a minimum, this requires an obstetrician and anesthesiologist at the bedside and activation of hemorrhage protocols (eg, a massive transfusion protocol). If blood products are unavailable, consider whether they can be transported from other nearby blood banks, and start that process promptly. Next, contact backup services. Based on local resources and clinical severity, this may include maternal-fetal medicine specialists, pelvic surgeons, general and trauma surgeons, intensivists, interventional radiologists, and transfusion specialists. Even if the patient cannot be safely transferred to another hospital, the obstetrician can call an outside PAS specialist to discuss next steps in care and begin transfer plans, assuming the patient can be stabilized. Based on the Maternal Levels of Care definitions published by the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine,10 patients with PAS should be managed at level III or level IV centers. However, delivery units at every level of maternal care should have a protocol for securing local help and reaching an appropriate consultant if a PAS case is encountered. Know which center in your area specializes in PAS so that when an unanticipated case arises, you know who to call.

Continue to: Step 3: Ultimate management—mobilize and prepare for bleeding...

 

 

Step 3: Ultimate management—mobilize and prepare for bleeding

If diagnosis occurs intraoperatively at a PAS specialty center, or if safe transport is not possible, then the team should mobilize for the possibility of hysterectomy and prepare for massive bleeding, which can occur regardless of the treatment chosen. Many patients require or will opt for hysterectomy. For example, a patient who has finished childbearing may consent to a hysterectomy upon hearing she likely has PAS. In patients with suspected PAS who are actively hemorrhaging or are unstable, hysterectomy is required.

Uterine conservation may be considered in stable patients who strongly desire future childbearing or uterine retention. This often requires leaving densely adherent placental tissue in situ and thus requires thorough counseling regarding the risks of delayed hemorrhage, infection, and emergent hysterectomy.11 This may not be desirable or safe for some patients, so informed consent is crucial. In such cases, we strongly recommend consultation with a PAS specialist, even if that requires immediate control of the placental blood supply (such as with arterial embolization), and transfer to a PAS specialty center.

 

Clinical scenarios

Vaginal delivery

The patient in the opening case was never expected to have PAS given her normal placental location and absence of a uterine scar. Even though she had some possible PAS risk factors (past retained placenta with instrumentation and in vitro fertilization), her absolute risk for the condition was low. Nevertheless, inability to create a separation plane should be considered PAS until proven otherwise. Although at this point many obstetricians would move to an operating room for uterine curettage, we recommend that the care team pause and put measures in place for possible PAS and hemorrhage. This involves notification of the blood bank, crossmatching of blood products, alerting the anesthesia team, and having a clear plan in place should a major hemorrhage ensue. This may involve use of balloon tamponade, activation of an interventional radiology team, or possible laparotomy with arterial ligations or hysterectomy. Avoidance of a prolonged third stage should be balanced against the need for preparation with these cases.

It is important for clinicians to bear in mind, and communicate to the patient, that hysterectomy is the standard of care for PAS. Significant delays in performing an indicated hysterectomy can lead to coagulopathy and patient instability. Timeliness is key; we find that delays in the decision to perform an indicated hysterectomy are often at the root of the cause for worsened morbidity in patients with unanticipated PAS. With an unscarred uterus and no placenta previa, a postpartum hysterectomy can be performed by many obstetrician-gynecologists experienced in this abdominal procedure.

Cesarean delivery

Undiagnosed PAS may present at cesarean delivery with or without placenta previa and a prior uterine scar. With this combination, PAS is often visually apparent upon opening the abdominal cavity (TABLE and FIGURE 1). Such surgical findings call for a clinical pause, as further actions at this point can lead to catastrophic hemorrhage. The obstetrician should consider a series of questions:

1. Are appropriate surgical and transfusion resources immediately available? If yes, they should be notified in case they are needed urgently. If not, then the obstetrician should ask whether the delivery must occur now.

2. Is this a scheduled delivery with a stable patient and fetus? If so, then closing the abdominal incision, monitoring the patient and fetus, and either transferring the patient to a PAS center or awaiting appropriate local specialists may be a lifesaving step.

3. Is immediate delivery required? If the fetus must be delivered, then it is imperative to create a hysterotomy out of the way of the placenta. Disrupting the adherent placenta with either an incision or manual manipulation may trigger a massive hemorrhage and should be avoided. This may require rectus muscle transection or creating a “T” incision on the skin to reach the uterine fundus and creating a hysterotomy over the top or even the back of the uterus. Once the fetus is delivered and lack of uterine hemorrhage confirmed (both abdominally and vaginally), the hysterotomy and abdomen can be closed with anticipation of urgent patient transfer to a PAS team or center.

4. Is the patient hemorrhaging? If the patient is hemorrhaging and closure is not an option, then recruitment of local emergent surgical teams is warranted, even if that requires packing the abdomen until an appropriate surgeon can arrive.

Diagnosis at cesarean delivery requires expedited and complex patient counseling. A patient who is unstable or hemorrhaging needs to be told that hysterectomy is lifesaving in this situation. For patients who are stable, it may be appropriate to close the abdomen and leave the placenta in situ, perform comprehensive counseling, and assess the possibility of transfer to a specialty center.

Summary

All obstetric care providers should be familiar with the clinical presentation of undiagnosed accreta spectrum. While hemorrhage is often part of the diagnosis, recognition of abnormal placental adherence and PAS-focused management should ideally be undertaken before this occurs. Once PAS is suspected, avoidance of further placental disruption may save significant morbidity, even if that means leaving the placenta attached until appropriate resources can be obtained. A local protocol for consultation, emergency transfer, and deployment of local resources should be part of every delivery unit’s emergency preparedness plan.

CASE Outcome

This patient is stabilized, with an adherent, retained placenta and no signs of hemorrhage. You administer uterotonics and notify your anesthesiologist and backup obstetrician that you have a likely case of accreta spectrum. A second intravenous line is placed, and blood products are crossmatched. The closest level III hospital is called, and they accept your patient for transfer. There, she is counseled about PAS, and she expresses no desire for future childbearing. After again confirming no placental separation in the operating room, the patient is moved immediately to perform laparotomy and total abdominal hysterectomy through a Pfannenstiel incision. She does not require a blood transfusion, and the pathology returns with grade I placenta accreta spectrum. ●

 

 

CASE Placenta accreta spectrum following uncomplicated vaginal delivery

Imagine you are an obstetric hospitalist taking call at a level II maternal level of care hospital. Your patient is a 35-year-old woman, gravida 2, para 1, with a past history of retained placenta requiring dilation and curettage and intravenous antibiotics for endomyometritis. This is an in vitro fertilization pregnancy that has progressed normally, and the patient labored spontaneously at 38 weeks’ gestation. Following an uncomplicated vaginal delivery, the placenta has not delivered, and you attempt a manual placental extraction after a 40-minute third stage. While there is epidural analgesia and you can reach the uterine fundus, you are unable to create a separation plane between the placenta and uterus.

What do you do next?

Placenta accreta spectrum (PAS) includes a broad range of clinical scenarios with abnormal placental attachment as their common denominator. The condition has classically been defined pathologically, with chorionic villi attaching directly to the myometrium (“accreta”) or extending more deeply into the myometrium (“increta”) or attaching to surrounding tissues and structures (“percreta”).1 It is most commonly encountered in patients with low placental implantation on a prior cesarean section scar; indeed, placenta previa, particularly with a history of cesarean delivery, is the strongest risk factor for the development of PAS.2 In addition to abnormal placental attachment, these placental attachments are often hypervascular and can lead to catastrophic hemorrhage if not managed appropriately. For this reason, patients with sonographic or radiologic signs of PAS should be referred to specialized centers for further workup, counseling, and delivery planning.3

Although delivery at a specialized PAS center has been associated with improved patient outcomes,4 not all patients with PAS will be identified in the antepartum period. Ultrasonography may miss up to 40% to 50% of PAS cases, particularly when the sonologist has not been advised to look for the condition,5 and not all patients with PAS will have a previa implanted in a prior cesarean scar. A recent study found that these patients with nonprevia PAS were identified by imaging less than 40% of the time and were significantly less likely to be managed by a specialized team of clinicians.6 Thus, it falls upon every obstetric care provider to be aware of this diagnosis, promptly recognize its unanticipated presentations, and have a plan to optimize patient safety.

Step 1: Recognition

While PAS is classically defined as a pathologic condition, no clinician has the luxury of histology in the delivery room. Researchers have variously defined PAS clinically, with the common trait of abnormal placental adherence.7-9 The TABLE compares published definitions that have been used in the literature. While some definitions include hemorrhage, no clinician wants to induce significant hemorrhage to confirm their patient’s diagnosis. Thus, practically, the clinical PAS diagnosis comes down to abnormal placental attachment: If it is apparent that some or all of the placenta will not separate from the uterine wall with digital manipulation or careful curettage, then PAS should be suspected, and appropriate steps should be taken before further removal attempts.

At cesarean delivery, the PAS diagnosis may be aided by visual cues. With placenta previa, the lower uterine segment may bulge and take on a bluish hue, distinctly different from the upper healthy myometrium. PAS may also manifest with neovascularization, particularly behind the bladder. As with vaginal births, the placenta will fail to separate after the delivery, and controlled traction on the umbilical cord can produce a “dimple sign,” or visible myometrial retraction at the site of implantation (FIGURE 1). Finally, if the diagnosis is still in doubt, attempts to gently form a cleavage plane between the placenta and myometrium will be unsuccessful if PAS is present.8

Step 2: Initial management—pause, plan

Most importantly, do not attempt to forcibly remove the placenta. It can be left attached to the uterus until appropriate resources are secured. Efforts to forcibly remove an adherent placenta may well lead to major hemorrhage, and thus it falls on the patient’s care team to pause and plan for PAS care at this point. FIGURE 2 displays an algorithm for patient management. Further steps depend primarily on whether or not the patient is already hemorrhaging. In a stable situation, the patient should be counseled regarding the abnormal findings and the suspected PAS diagnosis. This includes the possibility of further procedures, blood transfusion, and hysterectomy. Local resources, including nursing, anesthesia, and the blood bank, should be notified about the situation and for the potential to call in specialized services. If on-site experienced specialists are not available, then patient transfer to a PAS specialty center should be strongly considered. While awaiting additional help or transport, the patient requires close monitoring for gross and physiologic signs of hemorrhage. If pursued, transport to a PAS specialty center should be expedited.

If the patient is already hemorrhaging or unstable, then appropriate local resources must be activated. At a minimum, this requires an obstetrician and anesthesiologist at the bedside and activation of hemorrhage protocols (eg, a massive transfusion protocol). If blood products are unavailable, consider whether they can be transported from other nearby blood banks, and start that process promptly. Next, contact backup services. Based on local resources and clinical severity, this may include maternal-fetal medicine specialists, pelvic surgeons, general and trauma surgeons, intensivists, interventional radiologists, and transfusion specialists. Even if the patient cannot be safely transferred to another hospital, the obstetrician can call an outside PAS specialist to discuss next steps in care and begin transfer plans, assuming the patient can be stabilized. Based on the Maternal Levels of Care definitions published by the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine,10 patients with PAS should be managed at level III or level IV centers. However, delivery units at every level of maternal care should have a protocol for securing local help and reaching an appropriate consultant if a PAS case is encountered. Know which center in your area specializes in PAS so that when an unanticipated case arises, you know who to call.

Continue to: Step 3: Ultimate management—mobilize and prepare for bleeding...

 

 

Step 3: Ultimate management—mobilize and prepare for bleeding

If diagnosis occurs intraoperatively at a PAS specialty center, or if safe transport is not possible, then the team should mobilize for the possibility of hysterectomy and prepare for massive bleeding, which can occur regardless of the treatment chosen. Many patients require or will opt for hysterectomy. For example, a patient who has finished childbearing may consent to a hysterectomy upon hearing she likely has PAS. In patients with suspected PAS who are actively hemorrhaging or are unstable, hysterectomy is required.

Uterine conservation may be considered in stable patients who strongly desire future childbearing or uterine retention. This often requires leaving densely adherent placental tissue in situ and thus requires thorough counseling regarding the risks of delayed hemorrhage, infection, and emergent hysterectomy.11 This may not be desirable or safe for some patients, so informed consent is crucial. In such cases, we strongly recommend consultation with a PAS specialist, even if that requires immediate control of the placental blood supply (such as with arterial embolization), and transfer to a PAS specialty center.

 

Clinical scenarios

Vaginal delivery

The patient in the opening case was never expected to have PAS given her normal placental location and absence of a uterine scar. Even though she had some possible PAS risk factors (past retained placenta with instrumentation and in vitro fertilization), her absolute risk for the condition was low. Nevertheless, inability to create a separation plane should be considered PAS until proven otherwise. Although at this point many obstetricians would move to an operating room for uterine curettage, we recommend that the care team pause and put measures in place for possible PAS and hemorrhage. This involves notification of the blood bank, crossmatching of blood products, alerting the anesthesia team, and having a clear plan in place should a major hemorrhage ensue. This may involve use of balloon tamponade, activation of an interventional radiology team, or possible laparotomy with arterial ligations or hysterectomy. Avoidance of a prolonged third stage should be balanced against the need for preparation with these cases.

It is important for clinicians to bear in mind, and communicate to the patient, that hysterectomy is the standard of care for PAS. Significant delays in performing an indicated hysterectomy can lead to coagulopathy and patient instability. Timeliness is key; we find that delays in the decision to perform an indicated hysterectomy are often at the root of the cause for worsened morbidity in patients with unanticipated PAS. With an unscarred uterus and no placenta previa, a postpartum hysterectomy can be performed by many obstetrician-gynecologists experienced in this abdominal procedure.

Cesarean delivery

Undiagnosed PAS may present at cesarean delivery with or without placenta previa and a prior uterine scar. With this combination, PAS is often visually apparent upon opening the abdominal cavity (TABLE and FIGURE 1). Such surgical findings call for a clinical pause, as further actions at this point can lead to catastrophic hemorrhage. The obstetrician should consider a series of questions:

1. Are appropriate surgical and transfusion resources immediately available? If yes, they should be notified in case they are needed urgently. If not, then the obstetrician should ask whether the delivery must occur now.

2. Is this a scheduled delivery with a stable patient and fetus? If so, then closing the abdominal incision, monitoring the patient and fetus, and either transferring the patient to a PAS center or awaiting appropriate local specialists may be a lifesaving step.

3. Is immediate delivery required? If the fetus must be delivered, then it is imperative to create a hysterotomy out of the way of the placenta. Disrupting the adherent placenta with either an incision or manual manipulation may trigger a massive hemorrhage and should be avoided. This may require rectus muscle transection or creating a “T” incision on the skin to reach the uterine fundus and creating a hysterotomy over the top or even the back of the uterus. Once the fetus is delivered and lack of uterine hemorrhage confirmed (both abdominally and vaginally), the hysterotomy and abdomen can be closed with anticipation of urgent patient transfer to a PAS team or center.

4. Is the patient hemorrhaging? If the patient is hemorrhaging and closure is not an option, then recruitment of local emergent surgical teams is warranted, even if that requires packing the abdomen until an appropriate surgeon can arrive.

Diagnosis at cesarean delivery requires expedited and complex patient counseling. A patient who is unstable or hemorrhaging needs to be told that hysterectomy is lifesaving in this situation. For patients who are stable, it may be appropriate to close the abdomen and leave the placenta in situ, perform comprehensive counseling, and assess the possibility of transfer to a specialty center.

Summary

All obstetric care providers should be familiar with the clinical presentation of undiagnosed accreta spectrum. While hemorrhage is often part of the diagnosis, recognition of abnormal placental adherence and PAS-focused management should ideally be undertaken before this occurs. Once PAS is suspected, avoidance of further placental disruption may save significant morbidity, even if that means leaving the placenta attached until appropriate resources can be obtained. A local protocol for consultation, emergency transfer, and deployment of local resources should be part of every delivery unit’s emergency preparedness plan.

CASE Outcome

This patient is stabilized, with an adherent, retained placenta and no signs of hemorrhage. You administer uterotonics and notify your anesthesiologist and backup obstetrician that you have a likely case of accreta spectrum. A second intravenous line is placed, and blood products are crossmatched. The closest level III hospital is called, and they accept your patient for transfer. There, she is counseled about PAS, and she expresses no desire for future childbearing. After again confirming no placental separation in the operating room, the patient is moved immediately to perform laparotomy and total abdominal hysterectomy through a Pfannenstiel incision. She does not require a blood transfusion, and the pathology returns with grade I placenta accreta spectrum. ●

References

 

  1. American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. Obstetric Care Consensus No. 7: placenta accreta spectrum. Obstet Gynecol. 2018; 132:e259-e275. doi:10.1097/AOG.0000000000002983.
  2. Carusi DA. The placenta accreta spectrum: epidemiology and risk factors. Clin Obstet Gynecol. 2018;61:733-742. doi:10.1097/GRF.0000000000000391.
  3. Silver RM, Fox KA, Barton JR, et al. Center of excellence for placenta accreta. Am J Obstet Gynecol. 2015;212:561-568. doi:10.1016/j.ajog.2014.11.018.
  4. Shamshirsaz AA, Fox KA, Salmanian B, et al. Maternal morbidity in patients with morbidly adherent placenta treated with and without a standardized multidisciplinary approach. Am J Obstet Gynecol. 2015;212:218.e1-9. doi:10.1016/j.ajog.2014.08.019.
  5. Bowman ZS, Eller AG, Kennedy AM, et al. Accuracy of ultrasound for the prediction of placenta accreta. Am J Obstet Gynecol. 2014;211:177.e1-7. doi:10.1016/j.ajog.2014.03.029.
  6. Carusi DA, Fox KA, Lyell DJ, et al. Placenta accreta spectrum without placenta previa. Obstet Gynecol. 2020;136:458-465. doi:10.1097/AOG.0000000000003970.
  7. Kayem G, Seco A, Beucher G, et al. Clinical profiles of placenta accreta spectrum: the PACCRETA population-based study. BJOG. 2021;128:1646-1655. doi:10.1111/1471-0528.16647.
  8. Jauniaux E, Ayres-de-Campos D, Langhoff-Roos J, et al. FIGO classification for the clinical diagnosis of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2019;146:20-24. doi:10.1002/ijgo.12761.
  9. Collins SL, Alemdar B, van Beekhuizen HJ, et al. Evidence-based guidelines for the management of abnormally invasive placenta: recommendations from the International Society for Abnormally Invasive Placenta. Am J Obstet Gynecol. 2019;220(6):511-526. doi:10.1016/j.ajog.2019.02.054.
  10. American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. Obstetric care consensus. No. 7: placenta accreta spectrum. Obstet Gynecol. 2018;132:e259-e275. doi: 10.1097/AOG.0000000000002983.
  11. Sentilhes L, Kayem G, Silver RM. Conservative management of placenta accreta spectrum. Clin Obstet Gynecol. 2018; 61(4):783-794. doi:10.1097/GRF.0000000000000395.
References

 

  1. American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine. Obstetric Care Consensus No. 7: placenta accreta spectrum. Obstet Gynecol. 2018; 132:e259-e275. doi:10.1097/AOG.0000000000002983.
  2. Carusi DA. The placenta accreta spectrum: epidemiology and risk factors. Clin Obstet Gynecol. 2018;61:733-742. doi:10.1097/GRF.0000000000000391.
  3. Silver RM, Fox KA, Barton JR, et al. Center of excellence for placenta accreta. Am J Obstet Gynecol. 2015;212:561-568. doi:10.1016/j.ajog.2014.11.018.
  4. Shamshirsaz AA, Fox KA, Salmanian B, et al. Maternal morbidity in patients with morbidly adherent placenta treated with and without a standardized multidisciplinary approach. Am J Obstet Gynecol. 2015;212:218.e1-9. doi:10.1016/j.ajog.2014.08.019.
  5. Bowman ZS, Eller AG, Kennedy AM, et al. Accuracy of ultrasound for the prediction of placenta accreta. Am J Obstet Gynecol. 2014;211:177.e1-7. doi:10.1016/j.ajog.2014.03.029.
  6. Carusi DA, Fox KA, Lyell DJ, et al. Placenta accreta spectrum without placenta previa. Obstet Gynecol. 2020;136:458-465. doi:10.1097/AOG.0000000000003970.
  7. Kayem G, Seco A, Beucher G, et al. Clinical profiles of placenta accreta spectrum: the PACCRETA population-based study. BJOG. 2021;128:1646-1655. doi:10.1111/1471-0528.16647.
  8. Jauniaux E, Ayres-de-Campos D, Langhoff-Roos J, et al. FIGO classification for the clinical diagnosis of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2019;146:20-24. doi:10.1002/ijgo.12761.
  9. Collins SL, Alemdar B, van Beekhuizen HJ, et al. Evidence-based guidelines for the management of abnormally invasive placenta: recommendations from the International Society for Abnormally Invasive Placenta. Am J Obstet Gynecol. 2019;220(6):511-526. doi:10.1016/j.ajog.2019.02.054.
  10. American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. Obstetric care consensus. No. 7: placenta accreta spectrum. Obstet Gynecol. 2018;132:e259-e275. doi: 10.1097/AOG.0000000000002983.
  11. Sentilhes L, Kayem G, Silver RM. Conservative management of placenta accreta spectrum. Clin Obstet Gynecol. 2018; 61(4):783-794. doi:10.1097/GRF.0000000000000395.
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Women are not being warned that anesthetic may reduce birth pill efficacy

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The effectiveness of hormonal contraceptives, including the pill and mini-pill, may be compromised by sugammadex, a drug widely used in anesthesia for reversing neuromuscular blockade induced by rocuronium or vecuronium.

Yet women are not routinely informed that the drug may make their contraception less effective, delegates at Euroanaesthesia, the annual meeting of the European Society of Anaesthesiology and Intensive Care in Milan were told.

New research presented at the meeting supports the authors’ experience that “robust methods for identifying at-risk patients and informing them of the associated risk of contraceptive failures is not common practice across anesthetic departments within the United Kingdom, and likely further afield.”

This is according to a survey of almost 150 anesthetic professionals, including consultants, junior doctors, and physician assistants, working at University College London Hospitals NHS Foundation Trust.

Dr. Neha Passi, Dr. Matt Oliver, and colleagues at the trust’s department of anesthesiology sent out a seven-question survey to their 150 colleagues and received 82 responses, 94% of which claimed awareness of the risk of contraceptive failure with sugammadex. However, 70% of the respondents admitted that they do not routinely discuss this with patients who have received the drug.
 

Risk with all forms of hormonal contraceptive

Yet current guidance is to inform women of child-bearing age that they have received the drug and, because of increased risk of contraceptive failure, advise those taking oral hormonal contraceptives to follow the missed pill advice in the leaflet that comes with their contraceptives. It also counsels that clinicians should advise women using other types of hormonal contraceptive to use an additional nonhormonal means of contraception for 7 days.

The study authors also carried out a retrospective audit of sugammadex use in the trust and reported that during the 6 weeks covered by the audit, 234 patients were administered sugammadex of whom 65 (28%) were women of childbearing age. Of these, 17 had a medical history that meant they weren’t at risk of pregnancy, but the other 48 should have received advice on the risks of contraceptive failure – however there was no record in the medical notes of such advice having been given for any of the at-risk 48 women.

While sugammadex is the only anesthetic drug known to have this effect, it is recognized to interact with progesterone and so may reduce the effectiveness of hormonal contraceptives, including the progesterone-only pill, combined pill, vaginal rings, implants, and intrauterine devices.

Dr. Passi said: “It is concerning that we are so seldom informing patients of the risk of contraceptive failure following sugammadex use.

“Use of sugammadex is expected to rise as it becomes cheaper in the future, and ensuring that women receiving this medicine are aware it may increase their risk of unwanted pregnancy must be a priority.”

She added: “It is important to note, however, that most patients receiving an anesthetic do not need a muscle relaxant and that sugammadex is one of several drugs available to reverse muscle relaxation.”

Dr. Oliver said: “We only studied one hospital trust but we expect the results to be similar in elsewhere in the U.K.”

In response to their findings, the study’s authors have created patient information leaflets and letters and programmed the trust’s electronic patient record system to identify “at-risk” patients and deliver electronic prompts to the anesthetists caring for them in the perioperative period.

A version of this article first appeared on Medscape UK.

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The effectiveness of hormonal contraceptives, including the pill and mini-pill, may be compromised by sugammadex, a drug widely used in anesthesia for reversing neuromuscular blockade induced by rocuronium or vecuronium.

Yet women are not routinely informed that the drug may make their contraception less effective, delegates at Euroanaesthesia, the annual meeting of the European Society of Anaesthesiology and Intensive Care in Milan were told.

New research presented at the meeting supports the authors’ experience that “robust methods for identifying at-risk patients and informing them of the associated risk of contraceptive failures is not common practice across anesthetic departments within the United Kingdom, and likely further afield.”

This is according to a survey of almost 150 anesthetic professionals, including consultants, junior doctors, and physician assistants, working at University College London Hospitals NHS Foundation Trust.

Dr. Neha Passi, Dr. Matt Oliver, and colleagues at the trust’s department of anesthesiology sent out a seven-question survey to their 150 colleagues and received 82 responses, 94% of which claimed awareness of the risk of contraceptive failure with sugammadex. However, 70% of the respondents admitted that they do not routinely discuss this with patients who have received the drug.
 

Risk with all forms of hormonal contraceptive

Yet current guidance is to inform women of child-bearing age that they have received the drug and, because of increased risk of contraceptive failure, advise those taking oral hormonal contraceptives to follow the missed pill advice in the leaflet that comes with their contraceptives. It also counsels that clinicians should advise women using other types of hormonal contraceptive to use an additional nonhormonal means of contraception for 7 days.

The study authors also carried out a retrospective audit of sugammadex use in the trust and reported that during the 6 weeks covered by the audit, 234 patients were administered sugammadex of whom 65 (28%) were women of childbearing age. Of these, 17 had a medical history that meant they weren’t at risk of pregnancy, but the other 48 should have received advice on the risks of contraceptive failure – however there was no record in the medical notes of such advice having been given for any of the at-risk 48 women.

While sugammadex is the only anesthetic drug known to have this effect, it is recognized to interact with progesterone and so may reduce the effectiveness of hormonal contraceptives, including the progesterone-only pill, combined pill, vaginal rings, implants, and intrauterine devices.

Dr. Passi said: “It is concerning that we are so seldom informing patients of the risk of contraceptive failure following sugammadex use.

“Use of sugammadex is expected to rise as it becomes cheaper in the future, and ensuring that women receiving this medicine are aware it may increase their risk of unwanted pregnancy must be a priority.”

She added: “It is important to note, however, that most patients receiving an anesthetic do not need a muscle relaxant and that sugammadex is one of several drugs available to reverse muscle relaxation.”

Dr. Oliver said: “We only studied one hospital trust but we expect the results to be similar in elsewhere in the U.K.”

In response to their findings, the study’s authors have created patient information leaflets and letters and programmed the trust’s electronic patient record system to identify “at-risk” patients and deliver electronic prompts to the anesthetists caring for them in the perioperative period.

A version of this article first appeared on Medscape UK.

The effectiveness of hormonal contraceptives, including the pill and mini-pill, may be compromised by sugammadex, a drug widely used in anesthesia for reversing neuromuscular blockade induced by rocuronium or vecuronium.

Yet women are not routinely informed that the drug may make their contraception less effective, delegates at Euroanaesthesia, the annual meeting of the European Society of Anaesthesiology and Intensive Care in Milan were told.

New research presented at the meeting supports the authors’ experience that “robust methods for identifying at-risk patients and informing them of the associated risk of contraceptive failures is not common practice across anesthetic departments within the United Kingdom, and likely further afield.”

This is according to a survey of almost 150 anesthetic professionals, including consultants, junior doctors, and physician assistants, working at University College London Hospitals NHS Foundation Trust.

Dr. Neha Passi, Dr. Matt Oliver, and colleagues at the trust’s department of anesthesiology sent out a seven-question survey to their 150 colleagues and received 82 responses, 94% of which claimed awareness of the risk of contraceptive failure with sugammadex. However, 70% of the respondents admitted that they do not routinely discuss this with patients who have received the drug.
 

Risk with all forms of hormonal contraceptive

Yet current guidance is to inform women of child-bearing age that they have received the drug and, because of increased risk of contraceptive failure, advise those taking oral hormonal contraceptives to follow the missed pill advice in the leaflet that comes with their contraceptives. It also counsels that clinicians should advise women using other types of hormonal contraceptive to use an additional nonhormonal means of contraception for 7 days.

The study authors also carried out a retrospective audit of sugammadex use in the trust and reported that during the 6 weeks covered by the audit, 234 patients were administered sugammadex of whom 65 (28%) were women of childbearing age. Of these, 17 had a medical history that meant they weren’t at risk of pregnancy, but the other 48 should have received advice on the risks of contraceptive failure – however there was no record in the medical notes of such advice having been given for any of the at-risk 48 women.

While sugammadex is the only anesthetic drug known to have this effect, it is recognized to interact with progesterone and so may reduce the effectiveness of hormonal contraceptives, including the progesterone-only pill, combined pill, vaginal rings, implants, and intrauterine devices.

Dr. Passi said: “It is concerning that we are so seldom informing patients of the risk of contraceptive failure following sugammadex use.

“Use of sugammadex is expected to rise as it becomes cheaper in the future, and ensuring that women receiving this medicine are aware it may increase their risk of unwanted pregnancy must be a priority.”

She added: “It is important to note, however, that most patients receiving an anesthetic do not need a muscle relaxant and that sugammadex is one of several drugs available to reverse muscle relaxation.”

Dr. Oliver said: “We only studied one hospital trust but we expect the results to be similar in elsewhere in the U.K.”

In response to their findings, the study’s authors have created patient information leaflets and letters and programmed the trust’s electronic patient record system to identify “at-risk” patients and deliver electronic prompts to the anesthetists caring for them in the perioperative period.

A version of this article first appeared on Medscape UK.

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Müllerian anomalies: Operative considerations

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Dr. Lee is Program Director, Minimally Invasive Gynecologic Surgery, UPMC Magee-Womens Hospital, Pittsburgh, Pennsylvania.

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