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When Childhood Cancer Survivors Face Sexual Challenges
Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.
This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.
Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.
The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
Characteristics and Mechanisms
Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.
As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.
Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.
Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects.
Sexual Function in CCS
A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.
The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.
Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.
In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.
The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
Factors Influencing Sexual Function
The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.
Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.
Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.
Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.
The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.
Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.
Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.
Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.
This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.
Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.
The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
Characteristics and Mechanisms
Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.
As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.
Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.
Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects.
Sexual Function in CCS
A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.
The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.
Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.
In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.
The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
Factors Influencing Sexual Function
The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.
Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.
Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.
Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.
The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.
Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.
Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.
Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Childhood cancers represent a diverse group of neoplasms, and thanks to advances in treatment, survival rates have improved significantly. Today, more than 80%-85% of children diagnosed with cancer in developed countries survive into adulthood.
This increase in survival has brought new challenges, however. Compared with the general population, childhood cancer survivors (CCS) are at a notably higher risk for early mortality, developing secondary cancers, and experiencing various long-term clinical and psychosocial issues stemming from their disease or its treatment.
Long-term follow-up care for CCS is a complex and evolving field. Despite ongoing efforts to establish global and national guidelines, current evidence indicates that the care and management of these patients remain suboptimal.
The disruptions caused by cancer and its treatment can interfere with normal physiological and psychological development, leading to issues with sexual function. This aspect of health is critical as it influences not just physical well-being but also psychosocial, developmental, and emotional health.
Characteristics and Mechanisms
Sexual functioning encompasses the physiological and psychological aspects of sexual behavior, including desire, arousal, orgasm, sexual pleasure, and overall satisfaction.
As CCS reach adolescence or adulthood, they often face sexual and reproductive issues, particularly as they enter romantic relationships.
Sexual functioning is a complex process that relies on the interaction of various factors, including physiological health, psychosexual development, romantic relationships, body image, and desire.
Despite its importance, the impact of childhood cancer on sexual function is often overlooked, even though cancer and its treatments can have lifelong effects.
Sexual Function in CCS
A recent review aimed to summarize the existing research on sexual function among CCS, highlighting assessment tools, key stages of psychosexual development, common sexual problems, and the prevalence of sexual dysfunction.
The review study included 22 studies published between 2000 and 2022, comprising two qualitative, six cohort, and 14 cross-sectional studies.
Most CCS reached all key stages of psychosexual development at an average age of 29.8 years. Although some milestones were achieved later than is typical, many survivors felt they reached these stages at the appropriate time. Sexual initiation was less common among those who had undergone intensive neurotoxic treatments, such as those diagnosed with brain tumors or leukemia in childhood.
In a cross-sectional study of CCS aged 17-39 years, about one third had never engaged in sexual intercourse, 41.4% reported never experiencing sexual attraction, 44.8% were dissatisfied with their sex lives, and many rarely felt sexually attractive to others. Another study found that common issues among CCS included a lack of interest in sex (30%), difficulty enjoying sex (24%), and difficulty becoming aroused (23%). However, comparing and analyzing these problems was challenging due to the lack of standardized assessment criteria.
The prevalence of sexual dysfunction among CCS ranged from 12.3% to 46.5%. For males, the prevalence ranged from 12.3% to 54.0%, while for females, it ranged from 19.9% to 57.0%.
Factors Influencing Sexual Function
The review identified the following four categories of factors influencing sexual function in CCS: Demographic, treatment-related, psychological, and physiological.
Demographic factors: Gender, age, education level, relationship status, income level, and race all play roles in sexual function.
Female survivors reported more severe sexual dysfunction and poorer sexual health than did male survivors. Age at cancer diagnosis, age at evaluation, and the time since diagnosis were closely linked to sexual experiences. Patients diagnosed with cancer during childhood tended to report better sexual function than those diagnosed during adolescence.
Treatment-related factors: The type of cancer and intensity of treatment, along with surgical history, were significant factors. Surgeries involving the spinal cord or sympathetic nerves, as well as a history of prostate or pelvic surgery, were strongly associated with erectile dysfunction in men. In women, pelvic surgeries and treatments to the pelvic area were commonly linked to sexual dysfunction.
The association between treatment intensity and sexual function was noted across several studies, although the results were not always consistent. For example, testicular radiation above 10 Gy was positively correlated with sexual dysfunction. Women who underwent more intensive treatments were more likely to report issues in multiple areas of sexual function, while men in this group were less likely to have children.
Among female CCS, certain types of cancer, such as germ cell tumors, renal tumors, and leukemia, present a higher risk for sexual dysfunction. Women who had CNS tumors in childhood frequently reported problems like difficulty in sexual arousal, low sexual satisfaction, infrequent sexual activity, and fewer sexual partners, compared with survivors of other cancers. Survivors of acute lymphoblastic leukemia and those who underwent hematopoietic stem cell transplantation (HSCT) also showed varying degrees of impaired sexual function, compared with the general population. The HSCT group showed significant testicular damage, including reduced testicular volumes, low testosterone levels, and low sperm counts.
Psychological factors: These factors, such as emotional distress, play a significant role in sexual dysfunction among CCS. Symptoms like anxiety, nervousness during sexual activity, and depression are commonly reported by those with sexual dysfunction. The connection between body image and sexual function is complex. Many CCS with sexual dysfunction express concern about how others, particularly their partners, perceived their altered body image due to cancer and its treatment.
Physiological factors: In male CCS, low serum testosterone levels and low lean muscle mass are linked to an increased risk for sexual dysfunction. Treatments involving alkylating agents or testicular radiation, and surgery or radiotherapy targeting the genitourinary organs or the hypothalamic-pituitary region, can lead to various physiological and endocrine disorders, contributing to sexual dysfunction. Despite these risks, there is a lack of research evaluating sexual function through the lens of the hypothalamic-pituitary-gonadal axis and neuroendocrine pathways.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Uterus Transplants in Women With Uterine-Factor Infertility Show High Rate of Live Births
TOPLINE:
Uterus transplants in women with absolute uterine-factor infertility resulted in a 70% success rate of women later giving birth.
METHODOLOGY:
- The study included 20 women with uterine-factor infertility, a condition in which women do not have a uterus or have one that is not functional; each patient had at least one functioning ovary and uterine abnormalities.
- All patients underwent womb transplantation at a large US specialized care center between 2016 and 2019.
- The transplant was performed using grafts from 18 living donors and two deceased donors.
- Patients received anti-rejection medication until the transplanted uterus was removed following one or two live births or graft failure.
- Researchers measured uterus graft survival and subsequent live births.
TAKEAWAY:
- Out of the 20 participants, 14 (70%) had successful uterus transplants and all 14 gave birth to at least one healthy infant.
- Half of the successful pregnancies had complications, which included gestational hypertension (14%), cervical insufficiency (14%), and preterm labor (14%).
- None of the 16 live-born infants had congenital malformations, and no developmental delays were observed as of May 2024.
- Four of the 18 living donors experienced grade 3 complications, including ureteral obstruction and thermal injury to the ureters.
IN PRACTICE:
“Uterus transplant was technically feasible and was associated with a high live birth rate following successful graft survival,” wrote the authors of the study. “Adverse events were common, with medical and surgical risks affecting recipients as well as donors.”
SOURCE:
The study was led by Giuliano Testa, MD, MBA, of Baylor University Medical Center in Dallas, Texas, and was published online in JAMA Network.
LIMITATIONS:
The findings are based on data from a single center. The sample size was small. The high cost of uterus transplants limits generalizability.
DISCLOSURES:
No disclosures were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Uterus transplants in women with absolute uterine-factor infertility resulted in a 70% success rate of women later giving birth.
METHODOLOGY:
- The study included 20 women with uterine-factor infertility, a condition in which women do not have a uterus or have one that is not functional; each patient had at least one functioning ovary and uterine abnormalities.
- All patients underwent womb transplantation at a large US specialized care center between 2016 and 2019.
- The transplant was performed using grafts from 18 living donors and two deceased donors.
- Patients received anti-rejection medication until the transplanted uterus was removed following one or two live births or graft failure.
- Researchers measured uterus graft survival and subsequent live births.
TAKEAWAY:
- Out of the 20 participants, 14 (70%) had successful uterus transplants and all 14 gave birth to at least one healthy infant.
- Half of the successful pregnancies had complications, which included gestational hypertension (14%), cervical insufficiency (14%), and preterm labor (14%).
- None of the 16 live-born infants had congenital malformations, and no developmental delays were observed as of May 2024.
- Four of the 18 living donors experienced grade 3 complications, including ureteral obstruction and thermal injury to the ureters.
IN PRACTICE:
“Uterus transplant was technically feasible and was associated with a high live birth rate following successful graft survival,” wrote the authors of the study. “Adverse events were common, with medical and surgical risks affecting recipients as well as donors.”
SOURCE:
The study was led by Giuliano Testa, MD, MBA, of Baylor University Medical Center in Dallas, Texas, and was published online in JAMA Network.
LIMITATIONS:
The findings are based on data from a single center. The sample size was small. The high cost of uterus transplants limits generalizability.
DISCLOSURES:
No disclosures were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Uterus transplants in women with absolute uterine-factor infertility resulted in a 70% success rate of women later giving birth.
METHODOLOGY:
- The study included 20 women with uterine-factor infertility, a condition in which women do not have a uterus or have one that is not functional; each patient had at least one functioning ovary and uterine abnormalities.
- All patients underwent womb transplantation at a large US specialized care center between 2016 and 2019.
- The transplant was performed using grafts from 18 living donors and two deceased donors.
- Patients received anti-rejection medication until the transplanted uterus was removed following one or two live births or graft failure.
- Researchers measured uterus graft survival and subsequent live births.
TAKEAWAY:
- Out of the 20 participants, 14 (70%) had successful uterus transplants and all 14 gave birth to at least one healthy infant.
- Half of the successful pregnancies had complications, which included gestational hypertension (14%), cervical insufficiency (14%), and preterm labor (14%).
- None of the 16 live-born infants had congenital malformations, and no developmental delays were observed as of May 2024.
- Four of the 18 living donors experienced grade 3 complications, including ureteral obstruction and thermal injury to the ureters.
IN PRACTICE:
“Uterus transplant was technically feasible and was associated with a high live birth rate following successful graft survival,” wrote the authors of the study. “Adverse events were common, with medical and surgical risks affecting recipients as well as donors.”
SOURCE:
The study was led by Giuliano Testa, MD, MBA, of Baylor University Medical Center in Dallas, Texas, and was published online in JAMA Network.
LIMITATIONS:
The findings are based on data from a single center. The sample size was small. The high cost of uterus transplants limits generalizability.
DISCLOSURES:
No disclosures were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
How Common Is Pediatric Emergency Mistriage?
multicenter retrospective study published in JAMA Pediatrics. Researchers also identified gender, age, race, ethnicity, and comorbidity disparities in those who were undertriaged.
, according to aThe researchers found that only 34.1% of visits were correctly triaged while 58.5% were overtriaged and 7.4% were undertriaged. The findings were based on analysis of more than 1 million pediatric emergency visits over a 5-year period that used the Emergency Severity Index (ESI) version 4 for triage.
“The ESI had poor sensitivity in identifying a critically ill pediatric patient, and undertriage occurred in 1 in 14 children,” wrote Dana R. Sax, MD, a senior emergency physician at The Permanente Medical Group in northern California, and her colleagues.
“More than 90% of pediatric visits were assigned a mid to low triage acuity category, and actual resource use and care intensity frequently did not align with ESI predictions,” the authors wrote. “Our findings highlight an opportunity to improve triage for pediatric patients to mitigate critical undertriage, optimize resource decisions, standardize processes across time and setting, and promote more equitable care.”
The authors added that the study findings are currently being used by the Permanente system “to develop standardized triage education across centers to improve early identification of high-risk patients.”
Disparities in Emergency Care
The results underscore the need for more work to address disparities in emergency care, wrote Warren D. Frankenberger, PhD, RN, a nurse scientist at Children’s Hospital of Philadelphia, and two colleagues in an accompanying editorial.
“Decisions in triage can have significant downstream effects on subsequent care during the ED visit,” they wrote in their editorial. “Given that the triage process in most instances is fully executed by nurses, nurse researchers are in a key position to evaluate these and other covariates to influence further improvements in triage.” They suggested that use of clinical decision support tools and artificial intelligence (AI) may improve the triage process, albeit with the caveat that AI often relies on models with pre-existing historical bias that may perpetuate structural inequalities.
Study Methodology
The researchers analyzed 1,016,816 pediatric visits at 21 emergency departments in Kaiser Permanente Northern California between January 2016 and December 2020. The patients were an average 7 years old, and 47% were female. The researchers excluded visits that lacked ESI data or had incomplete ED time variables as well as those with patients who left against medical advice, were not seen, or were transferred from another ED.
The study relied on novel definitions of ESI undertriage and overtriage developed through a modified Delphi process by a team of four emergency physicians, one pediatric emergency physician, two emergency nurses, and one pediatric ICU physician. The definition involved comparing ESI levels to the clinical outcomes and resource use.
Resources included laboratory analysis, electrocardiography, radiography, CT, MRI, diagnostic ultrasonography (not point of care), angiography, IV fluids, and IV, intramuscular, or nebulized medications. Resources did not include “oral medications, tetanus immunizations, point-of-care testing, history and physical examination, saline or heparin lock, prescription refills, simple wound care, crutches, splints, and slings.”
Level 1 events were those requiring time-sensitive, critical intervention, including high-risk sepsis. Level 2 events included most level 1 events that occurred after the first hour (except operating room admission or hospital transfer) as well as respiratory therapy, toxicology consult, lumbar puncture, suicidality as chief concern, at least 2 doses of albuterol or continuous albuterol nebulization, a skeletal survey x-ray order, and medical social work consult with an ED length of stay of at least 2 hours. Level 3 events included IV mediation order, any CT order, OR admission or hospital transfer after one hour, or any pediatric hospitalist consult.
Analyzing the ED Visits
Overtriaged cases were ESI level 1 or 2 cases in which fewer than 2 resources were used; level 3 cases where fewer than 2 resources were used and no level 1 or 2 events occurred; and level 4 cases where no resources were used.
Undertriaged cases were defined as the following:
- ESI level 5 cases where any resource was used and any level 1, 2, or 3 events occurred.
- Level 4 cases where more than 1 resource was used and any level 1, 2, or 3 events occurred.
- Level 3 cases where any level 1 event occurred, more than one level 2 event occurred, or any level 2 event occurred and more than one additional ED resource type was used.
- Level 2 cases where any level 1 event occurred.
About half the visits (51%) were assigned ESI 3, which was the category with the highest proportion of mistriage. After adjusting for study facility and triage vital signs, the researchers found that children age 6 and older were more likely to be undertriaged than those younger than 6, particularly those age 15 and older (relative risk [RR], 1.36).
Undertriage was also modestly more likely with male patients (female patients’ RR, 0.93), patients with comorbidities (RR, 1.11-1.2), patients who arrived by ambulance (RR, 1.04), and patients who were Asian (RR, 1.10), Black (RR, 1.05), or Hispanic (RR, 1.04). Undertriage became gradually less likely with each additional year in the study period, with an RR of 0.89 in 2019 and 2020.
Among the study’s limitations were use of ESI version 4, instead of the currently used 5, and the omission of common procedures from the outcome definition that “may systematically bias the analysis toward overtriage,” the editorial noted. The authors also did not include pain as a variable in the analysis, which can often indicate patient acuity.
Further, this study was unable to include covariates identified in other research that may influence clinical decision-making, such as “the presenting illness or injury, children with complex medical needs, and language proficiency,” Dr. Frankenberger and colleagues wrote. “Furthermore, environmental stressors, such as ED volume and crowding, can influence how a nurse prioritizes care and may increase bias in decision-making and/or increase practice variability.”
The study was funded by the Kaiser Permanente Northern California (KPNC) Community Health program. One author had consulting payments from CSL Behring and Abbott Point-of-Care, and six of the authors have received grant funding from the KPNC Community Health program. The editorial authors reported no conflicts of interest.
multicenter retrospective study published in JAMA Pediatrics. Researchers also identified gender, age, race, ethnicity, and comorbidity disparities in those who were undertriaged.
, according to aThe researchers found that only 34.1% of visits were correctly triaged while 58.5% were overtriaged and 7.4% were undertriaged. The findings were based on analysis of more than 1 million pediatric emergency visits over a 5-year period that used the Emergency Severity Index (ESI) version 4 for triage.
“The ESI had poor sensitivity in identifying a critically ill pediatric patient, and undertriage occurred in 1 in 14 children,” wrote Dana R. Sax, MD, a senior emergency physician at The Permanente Medical Group in northern California, and her colleagues.
“More than 90% of pediatric visits were assigned a mid to low triage acuity category, and actual resource use and care intensity frequently did not align with ESI predictions,” the authors wrote. “Our findings highlight an opportunity to improve triage for pediatric patients to mitigate critical undertriage, optimize resource decisions, standardize processes across time and setting, and promote more equitable care.”
The authors added that the study findings are currently being used by the Permanente system “to develop standardized triage education across centers to improve early identification of high-risk patients.”
Disparities in Emergency Care
The results underscore the need for more work to address disparities in emergency care, wrote Warren D. Frankenberger, PhD, RN, a nurse scientist at Children’s Hospital of Philadelphia, and two colleagues in an accompanying editorial.
“Decisions in triage can have significant downstream effects on subsequent care during the ED visit,” they wrote in their editorial. “Given that the triage process in most instances is fully executed by nurses, nurse researchers are in a key position to evaluate these and other covariates to influence further improvements in triage.” They suggested that use of clinical decision support tools and artificial intelligence (AI) may improve the triage process, albeit with the caveat that AI often relies on models with pre-existing historical bias that may perpetuate structural inequalities.
Study Methodology
The researchers analyzed 1,016,816 pediatric visits at 21 emergency departments in Kaiser Permanente Northern California between January 2016 and December 2020. The patients were an average 7 years old, and 47% were female. The researchers excluded visits that lacked ESI data or had incomplete ED time variables as well as those with patients who left against medical advice, were not seen, or were transferred from another ED.
The study relied on novel definitions of ESI undertriage and overtriage developed through a modified Delphi process by a team of four emergency physicians, one pediatric emergency physician, two emergency nurses, and one pediatric ICU physician. The definition involved comparing ESI levels to the clinical outcomes and resource use.
Resources included laboratory analysis, electrocardiography, radiography, CT, MRI, diagnostic ultrasonography (not point of care), angiography, IV fluids, and IV, intramuscular, or nebulized medications. Resources did not include “oral medications, tetanus immunizations, point-of-care testing, history and physical examination, saline or heparin lock, prescription refills, simple wound care, crutches, splints, and slings.”
Level 1 events were those requiring time-sensitive, critical intervention, including high-risk sepsis. Level 2 events included most level 1 events that occurred after the first hour (except operating room admission or hospital transfer) as well as respiratory therapy, toxicology consult, lumbar puncture, suicidality as chief concern, at least 2 doses of albuterol or continuous albuterol nebulization, a skeletal survey x-ray order, and medical social work consult with an ED length of stay of at least 2 hours. Level 3 events included IV mediation order, any CT order, OR admission or hospital transfer after one hour, or any pediatric hospitalist consult.
Analyzing the ED Visits
Overtriaged cases were ESI level 1 or 2 cases in which fewer than 2 resources were used; level 3 cases where fewer than 2 resources were used and no level 1 or 2 events occurred; and level 4 cases where no resources were used.
Undertriaged cases were defined as the following:
- ESI level 5 cases where any resource was used and any level 1, 2, or 3 events occurred.
- Level 4 cases where more than 1 resource was used and any level 1, 2, or 3 events occurred.
- Level 3 cases where any level 1 event occurred, more than one level 2 event occurred, or any level 2 event occurred and more than one additional ED resource type was used.
- Level 2 cases where any level 1 event occurred.
About half the visits (51%) were assigned ESI 3, which was the category with the highest proportion of mistriage. After adjusting for study facility and triage vital signs, the researchers found that children age 6 and older were more likely to be undertriaged than those younger than 6, particularly those age 15 and older (relative risk [RR], 1.36).
Undertriage was also modestly more likely with male patients (female patients’ RR, 0.93), patients with comorbidities (RR, 1.11-1.2), patients who arrived by ambulance (RR, 1.04), and patients who were Asian (RR, 1.10), Black (RR, 1.05), or Hispanic (RR, 1.04). Undertriage became gradually less likely with each additional year in the study period, with an RR of 0.89 in 2019 and 2020.
Among the study’s limitations were use of ESI version 4, instead of the currently used 5, and the omission of common procedures from the outcome definition that “may systematically bias the analysis toward overtriage,” the editorial noted. The authors also did not include pain as a variable in the analysis, which can often indicate patient acuity.
Further, this study was unable to include covariates identified in other research that may influence clinical decision-making, such as “the presenting illness or injury, children with complex medical needs, and language proficiency,” Dr. Frankenberger and colleagues wrote. “Furthermore, environmental stressors, such as ED volume and crowding, can influence how a nurse prioritizes care and may increase bias in decision-making and/or increase practice variability.”
The study was funded by the Kaiser Permanente Northern California (KPNC) Community Health program. One author had consulting payments from CSL Behring and Abbott Point-of-Care, and six of the authors have received grant funding from the KPNC Community Health program. The editorial authors reported no conflicts of interest.
multicenter retrospective study published in JAMA Pediatrics. Researchers also identified gender, age, race, ethnicity, and comorbidity disparities in those who were undertriaged.
, according to aThe researchers found that only 34.1% of visits were correctly triaged while 58.5% were overtriaged and 7.4% were undertriaged. The findings were based on analysis of more than 1 million pediatric emergency visits over a 5-year period that used the Emergency Severity Index (ESI) version 4 for triage.
“The ESI had poor sensitivity in identifying a critically ill pediatric patient, and undertriage occurred in 1 in 14 children,” wrote Dana R. Sax, MD, a senior emergency physician at The Permanente Medical Group in northern California, and her colleagues.
“More than 90% of pediatric visits were assigned a mid to low triage acuity category, and actual resource use and care intensity frequently did not align with ESI predictions,” the authors wrote. “Our findings highlight an opportunity to improve triage for pediatric patients to mitigate critical undertriage, optimize resource decisions, standardize processes across time and setting, and promote more equitable care.”
The authors added that the study findings are currently being used by the Permanente system “to develop standardized triage education across centers to improve early identification of high-risk patients.”
Disparities in Emergency Care
The results underscore the need for more work to address disparities in emergency care, wrote Warren D. Frankenberger, PhD, RN, a nurse scientist at Children’s Hospital of Philadelphia, and two colleagues in an accompanying editorial.
“Decisions in triage can have significant downstream effects on subsequent care during the ED visit,” they wrote in their editorial. “Given that the triage process in most instances is fully executed by nurses, nurse researchers are in a key position to evaluate these and other covariates to influence further improvements in triage.” They suggested that use of clinical decision support tools and artificial intelligence (AI) may improve the triage process, albeit with the caveat that AI often relies on models with pre-existing historical bias that may perpetuate structural inequalities.
Study Methodology
The researchers analyzed 1,016,816 pediatric visits at 21 emergency departments in Kaiser Permanente Northern California between January 2016 and December 2020. The patients were an average 7 years old, and 47% were female. The researchers excluded visits that lacked ESI data or had incomplete ED time variables as well as those with patients who left against medical advice, were not seen, or were transferred from another ED.
The study relied on novel definitions of ESI undertriage and overtriage developed through a modified Delphi process by a team of four emergency physicians, one pediatric emergency physician, two emergency nurses, and one pediatric ICU physician. The definition involved comparing ESI levels to the clinical outcomes and resource use.
Resources included laboratory analysis, electrocardiography, radiography, CT, MRI, diagnostic ultrasonography (not point of care), angiography, IV fluids, and IV, intramuscular, or nebulized medications. Resources did not include “oral medications, tetanus immunizations, point-of-care testing, history and physical examination, saline or heparin lock, prescription refills, simple wound care, crutches, splints, and slings.”
Level 1 events were those requiring time-sensitive, critical intervention, including high-risk sepsis. Level 2 events included most level 1 events that occurred after the first hour (except operating room admission or hospital transfer) as well as respiratory therapy, toxicology consult, lumbar puncture, suicidality as chief concern, at least 2 doses of albuterol or continuous albuterol nebulization, a skeletal survey x-ray order, and medical social work consult with an ED length of stay of at least 2 hours. Level 3 events included IV mediation order, any CT order, OR admission or hospital transfer after one hour, or any pediatric hospitalist consult.
Analyzing the ED Visits
Overtriaged cases were ESI level 1 or 2 cases in which fewer than 2 resources were used; level 3 cases where fewer than 2 resources were used and no level 1 or 2 events occurred; and level 4 cases where no resources were used.
Undertriaged cases were defined as the following:
- ESI level 5 cases where any resource was used and any level 1, 2, or 3 events occurred.
- Level 4 cases where more than 1 resource was used and any level 1, 2, or 3 events occurred.
- Level 3 cases where any level 1 event occurred, more than one level 2 event occurred, or any level 2 event occurred and more than one additional ED resource type was used.
- Level 2 cases where any level 1 event occurred.
About half the visits (51%) were assigned ESI 3, which was the category with the highest proportion of mistriage. After adjusting for study facility and triage vital signs, the researchers found that children age 6 and older were more likely to be undertriaged than those younger than 6, particularly those age 15 and older (relative risk [RR], 1.36).
Undertriage was also modestly more likely with male patients (female patients’ RR, 0.93), patients with comorbidities (RR, 1.11-1.2), patients who arrived by ambulance (RR, 1.04), and patients who were Asian (RR, 1.10), Black (RR, 1.05), or Hispanic (RR, 1.04). Undertriage became gradually less likely with each additional year in the study period, with an RR of 0.89 in 2019 and 2020.
Among the study’s limitations were use of ESI version 4, instead of the currently used 5, and the omission of common procedures from the outcome definition that “may systematically bias the analysis toward overtriage,” the editorial noted. The authors also did not include pain as a variable in the analysis, which can often indicate patient acuity.
Further, this study was unable to include covariates identified in other research that may influence clinical decision-making, such as “the presenting illness or injury, children with complex medical needs, and language proficiency,” Dr. Frankenberger and colleagues wrote. “Furthermore, environmental stressors, such as ED volume and crowding, can influence how a nurse prioritizes care and may increase bias in decision-making and/or increase practice variability.”
The study was funded by the Kaiser Permanente Northern California (KPNC) Community Health program. One author had consulting payments from CSL Behring and Abbott Point-of-Care, and six of the authors have received grant funding from the KPNC Community Health program. The editorial authors reported no conflicts of interest.
FROM JAMA PEDIATRICS
Could total mesometrial resection become a new standard treatment for cervical cancer?
These findings suggest that TMMR may be considered a primary treatment option for both early-stage and locally advanced cervical cancer confined to the Müllerian compartment, reported lead author Henrik Falconer, MD, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
What is the rationale behind TMMR?
“Current international guidelines [for cervical cancer] are primarily based on retrospective case series and a small number of outdated randomized controlled trials,” the investigators wrote in EClinicalMedicine, part of The Lancet publication platform. “The stage-dependent treatment recommendations, with surgery advised for early-stage and radiation therapy for locally advanced disease, may be considered too simplistic, suggesting that early stages of cervical cancer cannot be controlled with surgical resection alone or that locally advanced cervical cancer is inoperable.”
This mindset, they noted, overlooks the complexities of cancer spread. In contrast, TMMR and similar surgical approaches based on the cancer field model are mapped along routes of locoregional dissemination, leading to “excellent local control” in more than 600 cases at the University Hospital of Leipzig, Leipzig, Germany.
To date, however, TMMR’s adoption has been limited, and it has not been compared directly with current guideline treatments, prompting the present study.
What methods were used to compare TMMR with standard treatment?
The study compared TMMR plus therapeutic lymph node dissection (tLND) without adjuvant radiation versus standard treatment (ST) for early-stage (FIGO 2009 IB1, IIA1) and locally advanced (FIGO 2009 IB2, IIA2, IIB) cervical cancer. Standard treatment for patients with early-stage disease involved radical hysterectomy and pelvic lymphadenectomy, with adjuvant chemoradiation dependent upon final pathology. Those with locally advanced disease received definitive chemoradiation.
Data for the standard treatment group were drawn from population-based registries in Sweden, while those for the TMMR group came from the Leipzig Mesometrial Resection Study Database. The final dataset included 1,007 women treated between 2011 and 2020, with 733 undergoing standard treatment and 274 receiving TMMR.
Outcomes included RFS and OS, adjusted for clinical and tumor-related variables.
How did TMMR compare with standard treatment?
TMMR was associated with superior oncologic outcomes compared with standard treatment for early-stage cervical cancer.
Specifically, 5-year RFS was 91.2% for TMMR versus 81.8% for standard therapy (P = .002). In the adjusted analysis, TMMR was associated with a significantly lower hazard of recurrence (hazard ratio [HR], 0.39; 95% CI, 0.22–0.69) and death (HR, 0.42; 95% CI, 0.21-0.86). Also favoring TMMR, absolute difference in the risk of recurrence at 5 years was 9.4% (95% CI 3.2–15.7). In addition, 5-year OS was better in the TMMR group, at 93.3%, compared with 90.3% for standard treatment (P = .034).
Among patients with locally advanced disease, no significant differences in RFS or OS were observed.
Are these data strong enough to make TMMR the new standard treatment?
Dr. Falconer and colleagues concluded that TMMR with tLND “may replace the standard treatment approach in early-stage cervical cancer and furthermore be evaluated as an option in locally advanced cervical cancer confined to the Müllerian compartment.”
While the investigators anticipated demands for randomized controlled trials, they questioned the value of such studies, suggesting that any control arm would be “based on inconsistent or flawed concepts.”
Susan C. Modesitt, MD, director of the gynecologic oncology division of Winship Cancer Institute of Emory University, Atlanta, offered a different perspective.
“They do show encouraging data in the early stage,” Dr. Modesitt said in an interview, “but I would still want to see a randomized controlled trial, because we’ve been burned before.”
She cited the LACC trial, which dispelled strong convictions about the alleged superiority of minimally invasive radical hysterectomy.
“We thought minimally invasive was so good, and we should be doing that to everybody, but we did a trial, and we found worse outcomes,” Dr. Modesitt said. “More of those early-stage women died.”
Dr. Modesitt also pointed out the lack of safety data in the present publication.
“TMMR is a bigger procedure, so I would expect more complications,” she said, noting that rates of urinary injury, nerve injury, and readmission need to be considered alongside efficacy outcomes.
How does TMMR fit into the current treatment landscape for cervical cancer?
“This is a very niche surgery that most places don’t do,” Dr. Modesitt said.
She pointed out that “multiple variations” on the standard radical hysterectomy have been proposed in the past, such as the laterally extended endopelvic resection.
“[TMMR] is not a new concept,” she said. “It’s just a question of how radical it is.”
Instead of developing new types of radical surgery, she said, the trend in the United States is toward de-escalation of surgical treatments altogether, with greater reliance upon medical options, such as immunotherapy.
“[This study] is thought provoking, and I applaud them for doing it,” Dr. Modesitt said. “But I’m not going to go out and do that on my next patient.”
This study was supported by grants from Centre for Clinical Research Sörmland (Sweden) and Region Stockholm (Sweden). Dr. Falconer is a board member of Surgical Science.
These findings suggest that TMMR may be considered a primary treatment option for both early-stage and locally advanced cervical cancer confined to the Müllerian compartment, reported lead author Henrik Falconer, MD, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
What is the rationale behind TMMR?
“Current international guidelines [for cervical cancer] are primarily based on retrospective case series and a small number of outdated randomized controlled trials,” the investigators wrote in EClinicalMedicine, part of The Lancet publication platform. “The stage-dependent treatment recommendations, with surgery advised for early-stage and radiation therapy for locally advanced disease, may be considered too simplistic, suggesting that early stages of cervical cancer cannot be controlled with surgical resection alone or that locally advanced cervical cancer is inoperable.”
This mindset, they noted, overlooks the complexities of cancer spread. In contrast, TMMR and similar surgical approaches based on the cancer field model are mapped along routes of locoregional dissemination, leading to “excellent local control” in more than 600 cases at the University Hospital of Leipzig, Leipzig, Germany.
To date, however, TMMR’s adoption has been limited, and it has not been compared directly with current guideline treatments, prompting the present study.
What methods were used to compare TMMR with standard treatment?
The study compared TMMR plus therapeutic lymph node dissection (tLND) without adjuvant radiation versus standard treatment (ST) for early-stage (FIGO 2009 IB1, IIA1) and locally advanced (FIGO 2009 IB2, IIA2, IIB) cervical cancer. Standard treatment for patients with early-stage disease involved radical hysterectomy and pelvic lymphadenectomy, with adjuvant chemoradiation dependent upon final pathology. Those with locally advanced disease received definitive chemoradiation.
Data for the standard treatment group were drawn from population-based registries in Sweden, while those for the TMMR group came from the Leipzig Mesometrial Resection Study Database. The final dataset included 1,007 women treated between 2011 and 2020, with 733 undergoing standard treatment and 274 receiving TMMR.
Outcomes included RFS and OS, adjusted for clinical and tumor-related variables.
How did TMMR compare with standard treatment?
TMMR was associated with superior oncologic outcomes compared with standard treatment for early-stage cervical cancer.
Specifically, 5-year RFS was 91.2% for TMMR versus 81.8% for standard therapy (P = .002). In the adjusted analysis, TMMR was associated with a significantly lower hazard of recurrence (hazard ratio [HR], 0.39; 95% CI, 0.22–0.69) and death (HR, 0.42; 95% CI, 0.21-0.86). Also favoring TMMR, absolute difference in the risk of recurrence at 5 years was 9.4% (95% CI 3.2–15.7). In addition, 5-year OS was better in the TMMR group, at 93.3%, compared with 90.3% for standard treatment (P = .034).
Among patients with locally advanced disease, no significant differences in RFS or OS were observed.
Are these data strong enough to make TMMR the new standard treatment?
Dr. Falconer and colleagues concluded that TMMR with tLND “may replace the standard treatment approach in early-stage cervical cancer and furthermore be evaluated as an option in locally advanced cervical cancer confined to the Müllerian compartment.”
While the investigators anticipated demands for randomized controlled trials, they questioned the value of such studies, suggesting that any control arm would be “based on inconsistent or flawed concepts.”
Susan C. Modesitt, MD, director of the gynecologic oncology division of Winship Cancer Institute of Emory University, Atlanta, offered a different perspective.
“They do show encouraging data in the early stage,” Dr. Modesitt said in an interview, “but I would still want to see a randomized controlled trial, because we’ve been burned before.”
She cited the LACC trial, which dispelled strong convictions about the alleged superiority of minimally invasive radical hysterectomy.
“We thought minimally invasive was so good, and we should be doing that to everybody, but we did a trial, and we found worse outcomes,” Dr. Modesitt said. “More of those early-stage women died.”
Dr. Modesitt also pointed out the lack of safety data in the present publication.
“TMMR is a bigger procedure, so I would expect more complications,” she said, noting that rates of urinary injury, nerve injury, and readmission need to be considered alongside efficacy outcomes.
How does TMMR fit into the current treatment landscape for cervical cancer?
“This is a very niche surgery that most places don’t do,” Dr. Modesitt said.
She pointed out that “multiple variations” on the standard radical hysterectomy have been proposed in the past, such as the laterally extended endopelvic resection.
“[TMMR] is not a new concept,” she said. “It’s just a question of how radical it is.”
Instead of developing new types of radical surgery, she said, the trend in the United States is toward de-escalation of surgical treatments altogether, with greater reliance upon medical options, such as immunotherapy.
“[This study] is thought provoking, and I applaud them for doing it,” Dr. Modesitt said. “But I’m not going to go out and do that on my next patient.”
This study was supported by grants from Centre for Clinical Research Sörmland (Sweden) and Region Stockholm (Sweden). Dr. Falconer is a board member of Surgical Science.
These findings suggest that TMMR may be considered a primary treatment option for both early-stage and locally advanced cervical cancer confined to the Müllerian compartment, reported lead author Henrik Falconer, MD, PhD, of Karolinska Institutet, Stockholm, Sweden, and colleagues.
What is the rationale behind TMMR?
“Current international guidelines [for cervical cancer] are primarily based on retrospective case series and a small number of outdated randomized controlled trials,” the investigators wrote in EClinicalMedicine, part of The Lancet publication platform. “The stage-dependent treatment recommendations, with surgery advised for early-stage and radiation therapy for locally advanced disease, may be considered too simplistic, suggesting that early stages of cervical cancer cannot be controlled with surgical resection alone or that locally advanced cervical cancer is inoperable.”
This mindset, they noted, overlooks the complexities of cancer spread. In contrast, TMMR and similar surgical approaches based on the cancer field model are mapped along routes of locoregional dissemination, leading to “excellent local control” in more than 600 cases at the University Hospital of Leipzig, Leipzig, Germany.
To date, however, TMMR’s adoption has been limited, and it has not been compared directly with current guideline treatments, prompting the present study.
What methods were used to compare TMMR with standard treatment?
The study compared TMMR plus therapeutic lymph node dissection (tLND) without adjuvant radiation versus standard treatment (ST) for early-stage (FIGO 2009 IB1, IIA1) and locally advanced (FIGO 2009 IB2, IIA2, IIB) cervical cancer. Standard treatment for patients with early-stage disease involved radical hysterectomy and pelvic lymphadenectomy, with adjuvant chemoradiation dependent upon final pathology. Those with locally advanced disease received definitive chemoradiation.
Data for the standard treatment group were drawn from population-based registries in Sweden, while those for the TMMR group came from the Leipzig Mesometrial Resection Study Database. The final dataset included 1,007 women treated between 2011 and 2020, with 733 undergoing standard treatment and 274 receiving TMMR.
Outcomes included RFS and OS, adjusted for clinical and tumor-related variables.
How did TMMR compare with standard treatment?
TMMR was associated with superior oncologic outcomes compared with standard treatment for early-stage cervical cancer.
Specifically, 5-year RFS was 91.2% for TMMR versus 81.8% for standard therapy (P = .002). In the adjusted analysis, TMMR was associated with a significantly lower hazard of recurrence (hazard ratio [HR], 0.39; 95% CI, 0.22–0.69) and death (HR, 0.42; 95% CI, 0.21-0.86). Also favoring TMMR, absolute difference in the risk of recurrence at 5 years was 9.4% (95% CI 3.2–15.7). In addition, 5-year OS was better in the TMMR group, at 93.3%, compared with 90.3% for standard treatment (P = .034).
Among patients with locally advanced disease, no significant differences in RFS or OS were observed.
Are these data strong enough to make TMMR the new standard treatment?
Dr. Falconer and colleagues concluded that TMMR with tLND “may replace the standard treatment approach in early-stage cervical cancer and furthermore be evaluated as an option in locally advanced cervical cancer confined to the Müllerian compartment.”
While the investigators anticipated demands for randomized controlled trials, they questioned the value of such studies, suggesting that any control arm would be “based on inconsistent or flawed concepts.”
Susan C. Modesitt, MD, director of the gynecologic oncology division of Winship Cancer Institute of Emory University, Atlanta, offered a different perspective.
“They do show encouraging data in the early stage,” Dr. Modesitt said in an interview, “but I would still want to see a randomized controlled trial, because we’ve been burned before.”
She cited the LACC trial, which dispelled strong convictions about the alleged superiority of minimally invasive radical hysterectomy.
“We thought minimally invasive was so good, and we should be doing that to everybody, but we did a trial, and we found worse outcomes,” Dr. Modesitt said. “More of those early-stage women died.”
Dr. Modesitt also pointed out the lack of safety data in the present publication.
“TMMR is a bigger procedure, so I would expect more complications,” she said, noting that rates of urinary injury, nerve injury, and readmission need to be considered alongside efficacy outcomes.
How does TMMR fit into the current treatment landscape for cervical cancer?
“This is a very niche surgery that most places don’t do,” Dr. Modesitt said.
She pointed out that “multiple variations” on the standard radical hysterectomy have been proposed in the past, such as the laterally extended endopelvic resection.
“[TMMR] is not a new concept,” she said. “It’s just a question of how radical it is.”
Instead of developing new types of radical surgery, she said, the trend in the United States is toward de-escalation of surgical treatments altogether, with greater reliance upon medical options, such as immunotherapy.
“[This study] is thought provoking, and I applaud them for doing it,” Dr. Modesitt said. “But I’m not going to go out and do that on my next patient.”
This study was supported by grants from Centre for Clinical Research Sörmland (Sweden) and Region Stockholm (Sweden). Dr. Falconer is a board member of Surgical Science.
FROM THE LANCET
Opioids Post T&A
I recently encountered a study that reviewed return visits of pediatric patients after undergoing adenotonsillectomy. The investigators discovered that pain-related visits were higher for patients who had received prescriptions for opioids. After the Food and Drug Administration (FDA) issued a boxed warning about the use of codeine in postoperative pediatric tonsillectomy with adenoidectomy (T&A), patients pain-related return visits declined and steroid prescriptions increased.
On the surface, this inverse relationship between opioid prescriptions and pain-related visits seems counterintuitive. This is particularly true if you believe that opioids are effective pain medications. The relationship between pain-related visits, steroid use, and the boxed warning is a bit easier to understand and most likely points to the effectiveness of the steroids.
Keeping in mind this was a single-institution study that included more than 5000 patients and more than 700 return visits, we should be careful in reading too much into these results. However, I can’t resist the temptation to use it as a springboard from which to launch a short dissertation on pain management.
First, let’s consider whether there was something about the opioids that was causing more pain for the patients. I’m not aware of any studies that suggest pain as a side effect of codeine. Nausea and vomiting, yes. And, although the investigators were focusing on pain, it may have been that the general discomfort associated with the gastrointestinal effects of the drug were lowering the patients’ pain threshold. I certainly know of many adults who have said that they now avoid opioids postoperatively because of the general sense of unwellness they have experienced during previous surgical adventures.
However, my bias leads me to focus on this question: If the patients didn’t receive opioids postoperatively, were they receiving something else that was making them less likely to arrive at the hospital or clinic complaining of pain? I assume the researchers would have told us about some new alternative miracle painkiller that was being prescribed.
As a card-carrying nihilist in good standing, I am tempted to claim that this is another example of nothing is better than most well-intentioned somethings. However, I am going to posit that these patients were receiving something that lessened their need to seek help with their pain.
Most likely that something was a thoughtful preemptive dialogue postoperatively about what they (and in most cases their parents) might expect in the way of symptoms. And ... an easy-to-reach contact point preferably with a person with whom they were familiar. And ... were scheduled to receive follow up phone calls at intervals relevant to the details of their surgery.
I know many of you are going to say, “We are already doing those things.” And, if so, you are to be commended. And, I’m sure that every outpatient postoperative manual includes all of those common-sense ingredients of good follow-up care. However, you know as well as I do that not all postoperative instructions are delivered with same degree of thoroughness nor with sufficient pauses thoughtfully delivered to make it a real dialogue. Nor is the follow-up contact person as easy to reach as promised.
I’m not sure how much we can thank the FDA boxed warning about codeine for the decrease in postoperative pain-generated visits. However, it could be that when physicians were discouraged from prescribing postoperative opioids, they may have felt the need to lean more heavily on good old-fashioned postoperative follow-up care. Instructions presented more as a dialogue and preemptive follow-up calls made with an aura of caring are well known deterrents of middle-of-the-night calls for help.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
I recently encountered a study that reviewed return visits of pediatric patients after undergoing adenotonsillectomy. The investigators discovered that pain-related visits were higher for patients who had received prescriptions for opioids. After the Food and Drug Administration (FDA) issued a boxed warning about the use of codeine in postoperative pediatric tonsillectomy with adenoidectomy (T&A), patients pain-related return visits declined and steroid prescriptions increased.
On the surface, this inverse relationship between opioid prescriptions and pain-related visits seems counterintuitive. This is particularly true if you believe that opioids are effective pain medications. The relationship between pain-related visits, steroid use, and the boxed warning is a bit easier to understand and most likely points to the effectiveness of the steroids.
Keeping in mind this was a single-institution study that included more than 5000 patients and more than 700 return visits, we should be careful in reading too much into these results. However, I can’t resist the temptation to use it as a springboard from which to launch a short dissertation on pain management.
First, let’s consider whether there was something about the opioids that was causing more pain for the patients. I’m not aware of any studies that suggest pain as a side effect of codeine. Nausea and vomiting, yes. And, although the investigators were focusing on pain, it may have been that the general discomfort associated with the gastrointestinal effects of the drug were lowering the patients’ pain threshold. I certainly know of many adults who have said that they now avoid opioids postoperatively because of the general sense of unwellness they have experienced during previous surgical adventures.
However, my bias leads me to focus on this question: If the patients didn’t receive opioids postoperatively, were they receiving something else that was making them less likely to arrive at the hospital or clinic complaining of pain? I assume the researchers would have told us about some new alternative miracle painkiller that was being prescribed.
As a card-carrying nihilist in good standing, I am tempted to claim that this is another example of nothing is better than most well-intentioned somethings. However, I am going to posit that these patients were receiving something that lessened their need to seek help with their pain.
Most likely that something was a thoughtful preemptive dialogue postoperatively about what they (and in most cases their parents) might expect in the way of symptoms. And ... an easy-to-reach contact point preferably with a person with whom they were familiar. And ... were scheduled to receive follow up phone calls at intervals relevant to the details of their surgery.
I know many of you are going to say, “We are already doing those things.” And, if so, you are to be commended. And, I’m sure that every outpatient postoperative manual includes all of those common-sense ingredients of good follow-up care. However, you know as well as I do that not all postoperative instructions are delivered with same degree of thoroughness nor with sufficient pauses thoughtfully delivered to make it a real dialogue. Nor is the follow-up contact person as easy to reach as promised.
I’m not sure how much we can thank the FDA boxed warning about codeine for the decrease in postoperative pain-generated visits. However, it could be that when physicians were discouraged from prescribing postoperative opioids, they may have felt the need to lean more heavily on good old-fashioned postoperative follow-up care. Instructions presented more as a dialogue and preemptive follow-up calls made with an aura of caring are well known deterrents of middle-of-the-night calls for help.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
I recently encountered a study that reviewed return visits of pediatric patients after undergoing adenotonsillectomy. The investigators discovered that pain-related visits were higher for patients who had received prescriptions for opioids. After the Food and Drug Administration (FDA) issued a boxed warning about the use of codeine in postoperative pediatric tonsillectomy with adenoidectomy (T&A), patients pain-related return visits declined and steroid prescriptions increased.
On the surface, this inverse relationship between opioid prescriptions and pain-related visits seems counterintuitive. This is particularly true if you believe that opioids are effective pain medications. The relationship between pain-related visits, steroid use, and the boxed warning is a bit easier to understand and most likely points to the effectiveness of the steroids.
Keeping in mind this was a single-institution study that included more than 5000 patients and more than 700 return visits, we should be careful in reading too much into these results. However, I can’t resist the temptation to use it as a springboard from which to launch a short dissertation on pain management.
First, let’s consider whether there was something about the opioids that was causing more pain for the patients. I’m not aware of any studies that suggest pain as a side effect of codeine. Nausea and vomiting, yes. And, although the investigators were focusing on pain, it may have been that the general discomfort associated with the gastrointestinal effects of the drug were lowering the patients’ pain threshold. I certainly know of many adults who have said that they now avoid opioids postoperatively because of the general sense of unwellness they have experienced during previous surgical adventures.
However, my bias leads me to focus on this question: If the patients didn’t receive opioids postoperatively, were they receiving something else that was making them less likely to arrive at the hospital or clinic complaining of pain? I assume the researchers would have told us about some new alternative miracle painkiller that was being prescribed.
As a card-carrying nihilist in good standing, I am tempted to claim that this is another example of nothing is better than most well-intentioned somethings. However, I am going to posit that these patients were receiving something that lessened their need to seek help with their pain.
Most likely that something was a thoughtful preemptive dialogue postoperatively about what they (and in most cases their parents) might expect in the way of symptoms. And ... an easy-to-reach contact point preferably with a person with whom they were familiar. And ... were scheduled to receive follow up phone calls at intervals relevant to the details of their surgery.
I know many of you are going to say, “We are already doing those things.” And, if so, you are to be commended. And, I’m sure that every outpatient postoperative manual includes all of those common-sense ingredients of good follow-up care. However, you know as well as I do that not all postoperative instructions are delivered with same degree of thoroughness nor with sufficient pauses thoughtfully delivered to make it a real dialogue. Nor is the follow-up contact person as easy to reach as promised.
I’m not sure how much we can thank the FDA boxed warning about codeine for the decrease in postoperative pain-generated visits. However, it could be that when physicians were discouraged from prescribing postoperative opioids, they may have felt the need to lean more heavily on good old-fashioned postoperative follow-up care. Instructions presented more as a dialogue and preemptive follow-up calls made with an aura of caring are well known deterrents of middle-of-the-night calls for help.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Which Surgeries Drive the Most Opioid Prescriptions in Youth?
TOPLINE:
according to a new study.
METHODOLOGY:
- The researchers analyzed national commercial and Medicaid claims from December 2020 to November 2021 in children aged 0-21 years.
- More than 200,000 procedures were included in the study.
- For each type of surgery, researchers calculated the total amount of opioids given within 3 days of discharge, measured in morphine milligram equivalents (MMEs).
TAKEAWAY:
- In children up to age 11 years, three procedures accounted for 59.1% of MMEs: Tonsillectomy and/or adenoidectomy (50.3%), open treatment of upper extremity fracture (5.3%), and removal of deep implants (3.5%).
- In patients aged 12-21 years, three procedures accounted for 33.1% of MMEs: Tonsillectomy and/or adenoidectomy (12.7%), knee arthroscopy (12.6%), and analgesia after cesarean delivery (7.8%).
- Refill rates for children were all 1% or less.
- Refill rates for adolescents ranged from 2.3% to 9.6%.
IN PRACTICE:
“Targeting these procedures in opioid stewardship initiatives could help minimize the risks of opioid prescribing while maintaining effective postoperative pain control,” the researchers wrote.
SOURCE:
The study was led by Kao-Ping Chua, MD, PhD, of the Department of Pediatrics at the University of Michigan Medical School, Ann Arbor, and was published in Pediatrics
LIMITATIONS:
The researchers analyzed opioids prescribed only after major surgeries. The sources of data used in the analysis may not fully represent all pediatric patients.
DISCLOSURES:
Dr. Chua reported consulting fees from the US Department of Justice and the Benter Foundation outside the submitted work. Other authors reported a variety of financial interests, including consulting for the pharmaceutical industry.
A version of this article first appeared on Medscape.com.
TOPLINE:
according to a new study.
METHODOLOGY:
- The researchers analyzed national commercial and Medicaid claims from December 2020 to November 2021 in children aged 0-21 years.
- More than 200,000 procedures were included in the study.
- For each type of surgery, researchers calculated the total amount of opioids given within 3 days of discharge, measured in morphine milligram equivalents (MMEs).
TAKEAWAY:
- In children up to age 11 years, three procedures accounted for 59.1% of MMEs: Tonsillectomy and/or adenoidectomy (50.3%), open treatment of upper extremity fracture (5.3%), and removal of deep implants (3.5%).
- In patients aged 12-21 years, three procedures accounted for 33.1% of MMEs: Tonsillectomy and/or adenoidectomy (12.7%), knee arthroscopy (12.6%), and analgesia after cesarean delivery (7.8%).
- Refill rates for children were all 1% or less.
- Refill rates for adolescents ranged from 2.3% to 9.6%.
IN PRACTICE:
“Targeting these procedures in opioid stewardship initiatives could help minimize the risks of opioid prescribing while maintaining effective postoperative pain control,” the researchers wrote.
SOURCE:
The study was led by Kao-Ping Chua, MD, PhD, of the Department of Pediatrics at the University of Michigan Medical School, Ann Arbor, and was published in Pediatrics
LIMITATIONS:
The researchers analyzed opioids prescribed only after major surgeries. The sources of data used in the analysis may not fully represent all pediatric patients.
DISCLOSURES:
Dr. Chua reported consulting fees from the US Department of Justice and the Benter Foundation outside the submitted work. Other authors reported a variety of financial interests, including consulting for the pharmaceutical industry.
A version of this article first appeared on Medscape.com.
TOPLINE:
according to a new study.
METHODOLOGY:
- The researchers analyzed national commercial and Medicaid claims from December 2020 to November 2021 in children aged 0-21 years.
- More than 200,000 procedures were included in the study.
- For each type of surgery, researchers calculated the total amount of opioids given within 3 days of discharge, measured in morphine milligram equivalents (MMEs).
TAKEAWAY:
- In children up to age 11 years, three procedures accounted for 59.1% of MMEs: Tonsillectomy and/or adenoidectomy (50.3%), open treatment of upper extremity fracture (5.3%), and removal of deep implants (3.5%).
- In patients aged 12-21 years, three procedures accounted for 33.1% of MMEs: Tonsillectomy and/or adenoidectomy (12.7%), knee arthroscopy (12.6%), and analgesia after cesarean delivery (7.8%).
- Refill rates for children were all 1% or less.
- Refill rates for adolescents ranged from 2.3% to 9.6%.
IN PRACTICE:
“Targeting these procedures in opioid stewardship initiatives could help minimize the risks of opioid prescribing while maintaining effective postoperative pain control,” the researchers wrote.
SOURCE:
The study was led by Kao-Ping Chua, MD, PhD, of the Department of Pediatrics at the University of Michigan Medical School, Ann Arbor, and was published in Pediatrics
LIMITATIONS:
The researchers analyzed opioids prescribed only after major surgeries. The sources of data used in the analysis may not fully represent all pediatric patients.
DISCLOSURES:
Dr. Chua reported consulting fees from the US Department of Justice and the Benter Foundation outside the submitted work. Other authors reported a variety of financial interests, including consulting for the pharmaceutical industry.
A version of this article first appeared on Medscape.com.
Which Surgery for Vaginal Vault Prolapse? No Clear Winner
TOPLINE:
Various surgical approaches to treat vaginal vault prolapse may be similarly safe and effective and can produce high rates of patient satisfaction.
METHODOLOGY:
- A randomized clinical trial at nine sites in the United States included 360 women with vaginal vault prolapse after hysterectomy (average age, 66 years).
- The women were randomly assigned to undergo native tissue repair (transvaginal repair using the sacrospinous or uterosacral ligament), sacrocolpopexy (mesh repair placed abdominally via open or minimally invasive surgery), or transvaginal mesh repair.
TAKEAWAY:
- At 36 months, a composite measure of treatment failure — based on the need for retreatment, the presence of symptoms, or prolapse beyond the hymen — had occurred in 28% of the women who received sacrocolpopexy, 29% who received transvaginal mesh, and 43% who underwent native tissue repair.
- Sacrocolpopexy was superior to native tissue repair for treatment success (adjusted hazard ratio, 0.57; P = .01), and transvaginal mesh was noninferior to sacrocolpopexy, the researchers found.
- All of the surgical approaches were associated with high rates of treatment satisfaction and improved quality of life and sexual function.
- Adverse events and mesh complications were uncommon.
IN PRACTICE:
“All approaches were associated with high treatment satisfaction; improved symptoms, quality of life, and sexual function; and low rates of regret,” the authors of the study wrote. “As such, clinicians counseling patients with prolapse can discuss the ramifications of each approach and engage in shared, individualized decision-making.”
SOURCE:
The study was led by Shawn A. Menefee, MD, Kaiser Permanente San Diego in San Diego, California. It was published online in JAMA Surgery.
LIMITATIONS:
The US Food and Drug Administration in April 2019 banned transvaginal mesh for pelvic organ prolapse because of concerns about complications such as exposure and erosion. Five trial participants who had been assigned to receive transvaginal mesh but had not yet received it at that time were rerandomized to one of the other surgical approaches.
DISCLOSURES:
The study was supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health. Researchers disclosed consulting for companies that market medical devices.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Various surgical approaches to treat vaginal vault prolapse may be similarly safe and effective and can produce high rates of patient satisfaction.
METHODOLOGY:
- A randomized clinical trial at nine sites in the United States included 360 women with vaginal vault prolapse after hysterectomy (average age, 66 years).
- The women were randomly assigned to undergo native tissue repair (transvaginal repair using the sacrospinous or uterosacral ligament), sacrocolpopexy (mesh repair placed abdominally via open or minimally invasive surgery), or transvaginal mesh repair.
TAKEAWAY:
- At 36 months, a composite measure of treatment failure — based on the need for retreatment, the presence of symptoms, or prolapse beyond the hymen — had occurred in 28% of the women who received sacrocolpopexy, 29% who received transvaginal mesh, and 43% who underwent native tissue repair.
- Sacrocolpopexy was superior to native tissue repair for treatment success (adjusted hazard ratio, 0.57; P = .01), and transvaginal mesh was noninferior to sacrocolpopexy, the researchers found.
- All of the surgical approaches were associated with high rates of treatment satisfaction and improved quality of life and sexual function.
- Adverse events and mesh complications were uncommon.
IN PRACTICE:
“All approaches were associated with high treatment satisfaction; improved symptoms, quality of life, and sexual function; and low rates of regret,” the authors of the study wrote. “As such, clinicians counseling patients with prolapse can discuss the ramifications of each approach and engage in shared, individualized decision-making.”
SOURCE:
The study was led by Shawn A. Menefee, MD, Kaiser Permanente San Diego in San Diego, California. It was published online in JAMA Surgery.
LIMITATIONS:
The US Food and Drug Administration in April 2019 banned transvaginal mesh for pelvic organ prolapse because of concerns about complications such as exposure and erosion. Five trial participants who had been assigned to receive transvaginal mesh but had not yet received it at that time were rerandomized to one of the other surgical approaches.
DISCLOSURES:
The study was supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health. Researchers disclosed consulting for companies that market medical devices.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Various surgical approaches to treat vaginal vault prolapse may be similarly safe and effective and can produce high rates of patient satisfaction.
METHODOLOGY:
- A randomized clinical trial at nine sites in the United States included 360 women with vaginal vault prolapse after hysterectomy (average age, 66 years).
- The women were randomly assigned to undergo native tissue repair (transvaginal repair using the sacrospinous or uterosacral ligament), sacrocolpopexy (mesh repair placed abdominally via open or minimally invasive surgery), or transvaginal mesh repair.
TAKEAWAY:
- At 36 months, a composite measure of treatment failure — based on the need for retreatment, the presence of symptoms, or prolapse beyond the hymen — had occurred in 28% of the women who received sacrocolpopexy, 29% who received transvaginal mesh, and 43% who underwent native tissue repair.
- Sacrocolpopexy was superior to native tissue repair for treatment success (adjusted hazard ratio, 0.57; P = .01), and transvaginal mesh was noninferior to sacrocolpopexy, the researchers found.
- All of the surgical approaches were associated with high rates of treatment satisfaction and improved quality of life and sexual function.
- Adverse events and mesh complications were uncommon.
IN PRACTICE:
“All approaches were associated with high treatment satisfaction; improved symptoms, quality of life, and sexual function; and low rates of regret,” the authors of the study wrote. “As such, clinicians counseling patients with prolapse can discuss the ramifications of each approach and engage in shared, individualized decision-making.”
SOURCE:
The study was led by Shawn A. Menefee, MD, Kaiser Permanente San Diego in San Diego, California. It was published online in JAMA Surgery.
LIMITATIONS:
The US Food and Drug Administration in April 2019 banned transvaginal mesh for pelvic organ prolapse because of concerns about complications such as exposure and erosion. Five trial participants who had been assigned to receive transvaginal mesh but had not yet received it at that time were rerandomized to one of the other surgical approaches.
DISCLOSURES:
The study was supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institutes of Health Office of Research on Women’s Health. Researchers disclosed consulting for companies that market medical devices.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Myomectomy best for avoiding reintervention after fibroid procedures
Reintervention rates after uterus-preserving surgery for leiomyomata were lowest after vaginal myomectomy, the most frequent among four therapeutic approaches, a large cohort study reported.
Accounting for censoring, the 7-year reintervention risk for vaginal myomectomy was 20.6%, followed by uterine artery embolization (26%), endometrial ablation (35.5%), and hysteroscopic myomectomy (37%).
Hysterectomies accounted for 63.2% of reinterventions according to lead author Susanna D. Mitro, PhD, a research scientist in the Division of Research and Department of Obstetrics and Gynecology at Kaiser Permanente Northern California, Oakland, and colleagues.
Risk did not vary by body mass index, race/ethnicity, or Neighborhood Deprivation Index, but did vary for some procedures by age and parity,
These findings generally align with earlier research and “illustrate clinically meaningful long-term differences in reintervention rates after a first uterus-preserving treatment for leiomyomas,” the researchers wrote in Obstetrics & Gynecology.
The Study
In a cohort of 10,324 patients ages 18-50, 19.9% were Asian, 21.2% Black, 21.3% Hispanic, and 32.5% White, with 5.2% of other races and ethnicities. The most affected age groups were 41-45 and 46-50 years. All participants underwent a first uterus-preserving procedure after leiomyoma diagnosis according to 2009-2021 electronic health records at Kaiser Permanente Northern California.
Reintervention referred to a second uterus-preserving procedure or hysterectomy. Median follow-up was 3.8 years (interquartile range, 1.8-7.4 years), and the proportions of index procedures were as follows: 18% (1857) for hysteroscopic myomectomy; 16.2% (1669) for uterine artery embolization; 21.4% (2211) for endometrial ablations; and 44.4% (4,587) for myomectomy.
Reintervention rates were higher in younger patients after uterine artery embolization, with patients ages 18-35 at the index procedure having 1.4-3.7 times greater reintervention rates than patients ages 46-50 years. Reintervention rates for hysteroscopic myomectomy varied by parity, with multiparous patients at 35% greater risk than their nulliparous counterparts.
On the age issue, the authors note that symptom recurrence may be less common in older patients, perhaps because of the onset of menopause. “Alternatively, findings may be explained by age-specific care strategies: Older patients experiencing symptom recurrence may prefer to wait until the onset of menopause rather than pursuing another surgical treatment,” they wrote.
A recent study with 7 years’ follow-up reported a 2.4 times greater risk of hysterectomy after uterine artery embolization versus myomectomy. Reintervention rates may be lower after myomectomy because otherwise asymptomatic patients pursue myomectomy to treat infertility, the authors wrote. Alternatively, myomectomy may more completely remove leiomyomas.
These common benign tumors take a toll on healthcare resources, in 2012 costing up to $9.4 billion annually (in 2010 dollars) for related surgeries, medications, and procedures. Leiomyomas are reportedly the most frequent reason for hysterectomy.
Robust data on the optimal therapeutic approach to fibroids have been sparse, however, with a 2017 comparative-effectiveness review from the Agency for Healthcare Research and Quality reporting that evidence on leiomyoma treatments was insufficient to guide clinical care. Few well-conducted trials of leiomyoma treatment have directly compared different treatment options, the authors noted.
The rate of myomectomy is reported to be 9.2 per 10,000 woman-years in Black women and 1.3 per 10,000 woman years in White women, and the recurrence rate after myomectomy can be as great as 60% when patients are followed up to 5 years.
The authors said their findings “may be a reference to discuss expectations for treatment outcomes when choosing initial uterus-preserving treatment for leiomyomas, especially for patients receiving treatment years before the likely onset of menopause.”
This research was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health. Coauthor Dr. Lauren Wise is a paid consultant for AbbVie and has received in-kind donations from Swiss Precision Diagnostics and Kindara.com; she has also received payment from the Gates Foundation.
Reintervention rates after uterus-preserving surgery for leiomyomata were lowest after vaginal myomectomy, the most frequent among four therapeutic approaches, a large cohort study reported.
Accounting for censoring, the 7-year reintervention risk for vaginal myomectomy was 20.6%, followed by uterine artery embolization (26%), endometrial ablation (35.5%), and hysteroscopic myomectomy (37%).
Hysterectomies accounted for 63.2% of reinterventions according to lead author Susanna D. Mitro, PhD, a research scientist in the Division of Research and Department of Obstetrics and Gynecology at Kaiser Permanente Northern California, Oakland, and colleagues.
Risk did not vary by body mass index, race/ethnicity, or Neighborhood Deprivation Index, but did vary for some procedures by age and parity,
These findings generally align with earlier research and “illustrate clinically meaningful long-term differences in reintervention rates after a first uterus-preserving treatment for leiomyomas,” the researchers wrote in Obstetrics & Gynecology.
The Study
In a cohort of 10,324 patients ages 18-50, 19.9% were Asian, 21.2% Black, 21.3% Hispanic, and 32.5% White, with 5.2% of other races and ethnicities. The most affected age groups were 41-45 and 46-50 years. All participants underwent a first uterus-preserving procedure after leiomyoma diagnosis according to 2009-2021 electronic health records at Kaiser Permanente Northern California.
Reintervention referred to a second uterus-preserving procedure or hysterectomy. Median follow-up was 3.8 years (interquartile range, 1.8-7.4 years), and the proportions of index procedures were as follows: 18% (1857) for hysteroscopic myomectomy; 16.2% (1669) for uterine artery embolization; 21.4% (2211) for endometrial ablations; and 44.4% (4,587) for myomectomy.
Reintervention rates were higher in younger patients after uterine artery embolization, with patients ages 18-35 at the index procedure having 1.4-3.7 times greater reintervention rates than patients ages 46-50 years. Reintervention rates for hysteroscopic myomectomy varied by parity, with multiparous patients at 35% greater risk than their nulliparous counterparts.
On the age issue, the authors note that symptom recurrence may be less common in older patients, perhaps because of the onset of menopause. “Alternatively, findings may be explained by age-specific care strategies: Older patients experiencing symptom recurrence may prefer to wait until the onset of menopause rather than pursuing another surgical treatment,” they wrote.
A recent study with 7 years’ follow-up reported a 2.4 times greater risk of hysterectomy after uterine artery embolization versus myomectomy. Reintervention rates may be lower after myomectomy because otherwise asymptomatic patients pursue myomectomy to treat infertility, the authors wrote. Alternatively, myomectomy may more completely remove leiomyomas.
These common benign tumors take a toll on healthcare resources, in 2012 costing up to $9.4 billion annually (in 2010 dollars) for related surgeries, medications, and procedures. Leiomyomas are reportedly the most frequent reason for hysterectomy.
Robust data on the optimal therapeutic approach to fibroids have been sparse, however, with a 2017 comparative-effectiveness review from the Agency for Healthcare Research and Quality reporting that evidence on leiomyoma treatments was insufficient to guide clinical care. Few well-conducted trials of leiomyoma treatment have directly compared different treatment options, the authors noted.
The rate of myomectomy is reported to be 9.2 per 10,000 woman-years in Black women and 1.3 per 10,000 woman years in White women, and the recurrence rate after myomectomy can be as great as 60% when patients are followed up to 5 years.
The authors said their findings “may be a reference to discuss expectations for treatment outcomes when choosing initial uterus-preserving treatment for leiomyomas, especially for patients receiving treatment years before the likely onset of menopause.”
This research was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health. Coauthor Dr. Lauren Wise is a paid consultant for AbbVie and has received in-kind donations from Swiss Precision Diagnostics and Kindara.com; she has also received payment from the Gates Foundation.
Reintervention rates after uterus-preserving surgery for leiomyomata were lowest after vaginal myomectomy, the most frequent among four therapeutic approaches, a large cohort study reported.
Accounting for censoring, the 7-year reintervention risk for vaginal myomectomy was 20.6%, followed by uterine artery embolization (26%), endometrial ablation (35.5%), and hysteroscopic myomectomy (37%).
Hysterectomies accounted for 63.2% of reinterventions according to lead author Susanna D. Mitro, PhD, a research scientist in the Division of Research and Department of Obstetrics and Gynecology at Kaiser Permanente Northern California, Oakland, and colleagues.
Risk did not vary by body mass index, race/ethnicity, or Neighborhood Deprivation Index, but did vary for some procedures by age and parity,
These findings generally align with earlier research and “illustrate clinically meaningful long-term differences in reintervention rates after a first uterus-preserving treatment for leiomyomas,” the researchers wrote in Obstetrics & Gynecology.
The Study
In a cohort of 10,324 patients ages 18-50, 19.9% were Asian, 21.2% Black, 21.3% Hispanic, and 32.5% White, with 5.2% of other races and ethnicities. The most affected age groups were 41-45 and 46-50 years. All participants underwent a first uterus-preserving procedure after leiomyoma diagnosis according to 2009-2021 electronic health records at Kaiser Permanente Northern California.
Reintervention referred to a second uterus-preserving procedure or hysterectomy. Median follow-up was 3.8 years (interquartile range, 1.8-7.4 years), and the proportions of index procedures were as follows: 18% (1857) for hysteroscopic myomectomy; 16.2% (1669) for uterine artery embolization; 21.4% (2211) for endometrial ablations; and 44.4% (4,587) for myomectomy.
Reintervention rates were higher in younger patients after uterine artery embolization, with patients ages 18-35 at the index procedure having 1.4-3.7 times greater reintervention rates than patients ages 46-50 years. Reintervention rates for hysteroscopic myomectomy varied by parity, with multiparous patients at 35% greater risk than their nulliparous counterparts.
On the age issue, the authors note that symptom recurrence may be less common in older patients, perhaps because of the onset of menopause. “Alternatively, findings may be explained by age-specific care strategies: Older patients experiencing symptom recurrence may prefer to wait until the onset of menopause rather than pursuing another surgical treatment,” they wrote.
A recent study with 7 years’ follow-up reported a 2.4 times greater risk of hysterectomy after uterine artery embolization versus myomectomy. Reintervention rates may be lower after myomectomy because otherwise asymptomatic patients pursue myomectomy to treat infertility, the authors wrote. Alternatively, myomectomy may more completely remove leiomyomas.
These common benign tumors take a toll on healthcare resources, in 2012 costing up to $9.4 billion annually (in 2010 dollars) for related surgeries, medications, and procedures. Leiomyomas are reportedly the most frequent reason for hysterectomy.
Robust data on the optimal therapeutic approach to fibroids have been sparse, however, with a 2017 comparative-effectiveness review from the Agency for Healthcare Research and Quality reporting that evidence on leiomyoma treatments was insufficient to guide clinical care. Few well-conducted trials of leiomyoma treatment have directly compared different treatment options, the authors noted.
The rate of myomectomy is reported to be 9.2 per 10,000 woman-years in Black women and 1.3 per 10,000 woman years in White women, and the recurrence rate after myomectomy can be as great as 60% when patients are followed up to 5 years.
The authors said their findings “may be a reference to discuss expectations for treatment outcomes when choosing initial uterus-preserving treatment for leiomyomas, especially for patients receiving treatment years before the likely onset of menopause.”
This research was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health. Coauthor Dr. Lauren Wise is a paid consultant for AbbVie and has received in-kind donations from Swiss Precision Diagnostics and Kindara.com; she has also received payment from the Gates Foundation.
FROM OBSTETRICS & GYNECOLOGY
Delaying Embryo Transfers May Benefit Patients With Endometrial Polyps
A longer time between hysteroscopic polypectomy and frozen embryo transfer may improve the odds of successful pregnancy, based on data from a new analysis presented at the annual meeting of the Society for Reproductive Investigation.
Although uterine polyps have a negative effect on pregnancy rates, data supporting a specific time interval between hysteroscopic polypectomy (HP) and frozen embryo transfer (FET) are limited, according to Audrey Messelt, MD, of Baylor College of Medicine, Houston, Texas, and colleagues.
“Hysteroscopic polypectomy is a common procedure performed before embryo transfer to optimize the receptivity of the endometrium. Currently, there is no ideal recovery time lapse between surgery and an embryo transfer,” said senior author Laura Detti, MD, professor of obstetrics and gynecology at Baylor, in an interview. “This is often the last step prior to embryo transfer, and identifying a recovery time that allows the best outcome is important.”
In a retrospective analysis, the researchers examined the effect of the time between HP and FET on pregnancy outcomes. They identified 65 patients with uterine pathology based on saline-infusion sonogram who underwent hysteroscopy and FET between June 1, 2022, and September 30, 2023.
The endometrial preparation for FET included sequential administration of oral or transdermal estradiol and intramuscular progesterone.
Overall, 46 patients were diagnosed with endometrial polyps at the time of surgery; three had endometritis, one had a uterine septum that was resected, 15 had no abnormal pathology or had normal endometrium at the time of examination. No cases of hyperplasia or malignancy were identified.
A total of 58 patients underwent FET with a single euploid embryo, four with a single untested embryo, one with a low-mosaic embryo, and two with a double-embryo transfer (one euploid and one low mosaic).
After FET, 50 patients conceived and 15 did not. Patients with ongoing pregnancies who had a history of endometrial polyps had significantly more days from surgery to FET, compared to patients with a history of polyps who failed to conceive (median 70 days vs 45 days, P = .01).
By contrast, the time between hysteroscopy and FET was similar among patients with no endometrial pathology who did and did not have ongoing pregnancies (median 45 vs 52.5 days, P = .95).
The findings were limited by the relatively small sample size and exclusion of patients with pathologies other than polyps, as well as a lack of data on age group breakdowns. However, the results suggest that patients with uterine polyps may benefit from more time between HP and FET, while patients with normal surgical findings could undergo FET sooner, the researchers concluded.
Postpolypectomy Timing May Affect Pregnancy Outcomes
“We used to think that having had the first menses from surgery would be enough recovery time for the uterine cavity, even if it was just 2 weeks,” Dr. Detti said in an interview. “This still holds true when no endometrial polyps are diagnosed in the pathological specimen; however, we learned that if endometrial polyps are removed at the time of hysteroscopy, the ideal recovery time prior to an embryo transfer should be longer,” she said.
The current study is important because approximately 15% of women are diagnosed with endometrial polyps during their reproductive years, said Mark P. Trolice, MD, professor at the University of Central Florida, Orlando, and founder/medical director of the IVF Center of Central Florida in Winter Park, in an interview.
“Abnormalities of the uterine cavity have been shown to reduce embryo implantation and increase the risk of miscarriage,” said Dr. Trolice. Although the impact of small endometrial polyps on fertility and pregnancy are uncertain, most infertility specialists recommend removal of endometrial polyps via hysteroscopic polypectomy in general and prior to IVF embryo transfer in particular, he said.
Although infertility patients are anxious to undergo embryo transfer, the current study suggests a benefit in delaying the procedure following the removal of any polyps identified during the pretransfer evaluation, Dr. Trolice said in an interview. As for additional research, “it would be helpful to know the age group breakdown of patients and if the results were consistent among all categories,” he said.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.
A longer time between hysteroscopic polypectomy and frozen embryo transfer may improve the odds of successful pregnancy, based on data from a new analysis presented at the annual meeting of the Society for Reproductive Investigation.
Although uterine polyps have a negative effect on pregnancy rates, data supporting a specific time interval between hysteroscopic polypectomy (HP) and frozen embryo transfer (FET) are limited, according to Audrey Messelt, MD, of Baylor College of Medicine, Houston, Texas, and colleagues.
“Hysteroscopic polypectomy is a common procedure performed before embryo transfer to optimize the receptivity of the endometrium. Currently, there is no ideal recovery time lapse between surgery and an embryo transfer,” said senior author Laura Detti, MD, professor of obstetrics and gynecology at Baylor, in an interview. “This is often the last step prior to embryo transfer, and identifying a recovery time that allows the best outcome is important.”
In a retrospective analysis, the researchers examined the effect of the time between HP and FET on pregnancy outcomes. They identified 65 patients with uterine pathology based on saline-infusion sonogram who underwent hysteroscopy and FET between June 1, 2022, and September 30, 2023.
The endometrial preparation for FET included sequential administration of oral or transdermal estradiol and intramuscular progesterone.
Overall, 46 patients were diagnosed with endometrial polyps at the time of surgery; three had endometritis, one had a uterine septum that was resected, 15 had no abnormal pathology or had normal endometrium at the time of examination. No cases of hyperplasia or malignancy were identified.
A total of 58 patients underwent FET with a single euploid embryo, four with a single untested embryo, one with a low-mosaic embryo, and two with a double-embryo transfer (one euploid and one low mosaic).
After FET, 50 patients conceived and 15 did not. Patients with ongoing pregnancies who had a history of endometrial polyps had significantly more days from surgery to FET, compared to patients with a history of polyps who failed to conceive (median 70 days vs 45 days, P = .01).
By contrast, the time between hysteroscopy and FET was similar among patients with no endometrial pathology who did and did not have ongoing pregnancies (median 45 vs 52.5 days, P = .95).
The findings were limited by the relatively small sample size and exclusion of patients with pathologies other than polyps, as well as a lack of data on age group breakdowns. However, the results suggest that patients with uterine polyps may benefit from more time between HP and FET, while patients with normal surgical findings could undergo FET sooner, the researchers concluded.
Postpolypectomy Timing May Affect Pregnancy Outcomes
“We used to think that having had the first menses from surgery would be enough recovery time for the uterine cavity, even if it was just 2 weeks,” Dr. Detti said in an interview. “This still holds true when no endometrial polyps are diagnosed in the pathological specimen; however, we learned that if endometrial polyps are removed at the time of hysteroscopy, the ideal recovery time prior to an embryo transfer should be longer,” she said.
The current study is important because approximately 15% of women are diagnosed with endometrial polyps during their reproductive years, said Mark P. Trolice, MD, professor at the University of Central Florida, Orlando, and founder/medical director of the IVF Center of Central Florida in Winter Park, in an interview.
“Abnormalities of the uterine cavity have been shown to reduce embryo implantation and increase the risk of miscarriage,” said Dr. Trolice. Although the impact of small endometrial polyps on fertility and pregnancy are uncertain, most infertility specialists recommend removal of endometrial polyps via hysteroscopic polypectomy in general and prior to IVF embryo transfer in particular, he said.
Although infertility patients are anxious to undergo embryo transfer, the current study suggests a benefit in delaying the procedure following the removal of any polyps identified during the pretransfer evaluation, Dr. Trolice said in an interview. As for additional research, “it would be helpful to know the age group breakdown of patients and if the results were consistent among all categories,” he said.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.
A longer time between hysteroscopic polypectomy and frozen embryo transfer may improve the odds of successful pregnancy, based on data from a new analysis presented at the annual meeting of the Society for Reproductive Investigation.
Although uterine polyps have a negative effect on pregnancy rates, data supporting a specific time interval between hysteroscopic polypectomy (HP) and frozen embryo transfer (FET) are limited, according to Audrey Messelt, MD, of Baylor College of Medicine, Houston, Texas, and colleagues.
“Hysteroscopic polypectomy is a common procedure performed before embryo transfer to optimize the receptivity of the endometrium. Currently, there is no ideal recovery time lapse between surgery and an embryo transfer,” said senior author Laura Detti, MD, professor of obstetrics and gynecology at Baylor, in an interview. “This is often the last step prior to embryo transfer, and identifying a recovery time that allows the best outcome is important.”
In a retrospective analysis, the researchers examined the effect of the time between HP and FET on pregnancy outcomes. They identified 65 patients with uterine pathology based on saline-infusion sonogram who underwent hysteroscopy and FET between June 1, 2022, and September 30, 2023.
The endometrial preparation for FET included sequential administration of oral or transdermal estradiol and intramuscular progesterone.
Overall, 46 patients were diagnosed with endometrial polyps at the time of surgery; three had endometritis, one had a uterine septum that was resected, 15 had no abnormal pathology or had normal endometrium at the time of examination. No cases of hyperplasia or malignancy were identified.
A total of 58 patients underwent FET with a single euploid embryo, four with a single untested embryo, one with a low-mosaic embryo, and two with a double-embryo transfer (one euploid and one low mosaic).
After FET, 50 patients conceived and 15 did not. Patients with ongoing pregnancies who had a history of endometrial polyps had significantly more days from surgery to FET, compared to patients with a history of polyps who failed to conceive (median 70 days vs 45 days, P = .01).
By contrast, the time between hysteroscopy and FET was similar among patients with no endometrial pathology who did and did not have ongoing pregnancies (median 45 vs 52.5 days, P = .95).
The findings were limited by the relatively small sample size and exclusion of patients with pathologies other than polyps, as well as a lack of data on age group breakdowns. However, the results suggest that patients with uterine polyps may benefit from more time between HP and FET, while patients with normal surgical findings could undergo FET sooner, the researchers concluded.
Postpolypectomy Timing May Affect Pregnancy Outcomes
“We used to think that having had the first menses from surgery would be enough recovery time for the uterine cavity, even if it was just 2 weeks,” Dr. Detti said in an interview. “This still holds true when no endometrial polyps are diagnosed in the pathological specimen; however, we learned that if endometrial polyps are removed at the time of hysteroscopy, the ideal recovery time prior to an embryo transfer should be longer,” she said.
The current study is important because approximately 15% of women are diagnosed with endometrial polyps during their reproductive years, said Mark P. Trolice, MD, professor at the University of Central Florida, Orlando, and founder/medical director of the IVF Center of Central Florida in Winter Park, in an interview.
“Abnormalities of the uterine cavity have been shown to reduce embryo implantation and increase the risk of miscarriage,” said Dr. Trolice. Although the impact of small endometrial polyps on fertility and pregnancy are uncertain, most infertility specialists recommend removal of endometrial polyps via hysteroscopic polypectomy in general and prior to IVF embryo transfer in particular, he said.
Although infertility patients are anxious to undergo embryo transfer, the current study suggests a benefit in delaying the procedure following the removal of any polyps identified during the pretransfer evaluation, Dr. Trolice said in an interview. As for additional research, “it would be helpful to know the age group breakdown of patients and if the results were consistent among all categories,” he said.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.
Minimally Invasive Cytoreductive Approach Comparable to Open Surgery for Ovarian Cancer
This was a finding of a retrospective study presented by Judy Hayek, MD, during an oral abstract session at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, in San Diego.
Among 2,412 women in the National Cancer Database with tumor-free surgical margins (R0 resections) after interval debulking surgery (IDS), the median overall survival (OS) was 46 months for those who had undergone an open procedure or minimally invasive surgery (MIS) that was converted to an open procedure. In contrast, the median OS was 51 months for patients who underwent laparoscopic or robot-assisted minimally invasive surgery, reported Dr. Hayek, a gynecologic oncology fellow at SUNY Downstate Health Sciences University in Brooklyn, New York.
“R0 resection at the time of interval debulking surgery has similar survival outcomes by minimally invasive surgery versus laparotomy, while R0 resection via laparotomy is associated with higher perioperative mortality. There is no interaction between the extent of surgery and the impact of MIS on survival,” she said during her presentation.
The session included a debate on the pros and cons of minimally invasive vs. open surgery in this population.
Growing Use of MIS
Over the last decade, minimally invasive surgery for interval debulking was shown to be safe and feasible. More recently, two studies using National Cancer Database cohorts showed that survival was similar and perioperative outcomes were better with a minimally invasive approach at the time of IDS for patients with early disease, Dr. Hayek said (Obstet Gynecol 2017 Jul;130(1):71-79; and Gynecol Oncol 2023 May:172:130-137).
Potential limitations of MIS include the absence of haptic feedback compared with open surgery, and the possibility that limited visualization of the surgical field could lead to missed residual disease and subsequent poor outcomes for patients who were presumed to have complete gross resections, she said.
Outcomes Compared
Dr. Hayek and colleagues conducted their study to evaluate survival outcomes after R0 resections by MIS or laparotomy in IDS for patients with advanced epithelial ovarian cancer.
As noted before, they looked at outcomes for 2,412 women with stage IIIC or IV cancers of all histology types who were diagnosed from 2010 through 2019. A total of 624 patients (25.9%) had minimally invasive procedures, and 1,788 (74.1%) had open surgery or MIS that had been converted to open procedures.
Of the minimally invasive procedures, 48.7% were robot-assisted, and the remainder were laparoscopic.
Over the decade of the study, the frequency of minimally invasive surgery steadily increased, from 11.9% of all procedures in 2010 to 36.5% in 2019.
Also as noted, there was no difference in median overall survival, at 46 months for open/converted procedures vs. 51 months for minimally invasive procedures.
As might be expected, the mean length of stay was shorter with the less invasive surgery: 3.3 days compared with 5.3 days with open surgery (P less than .001). In addition, 30-day and 90-day mortality rates were also lower with MIS, at 0.8% and 1.9%, respectively, compared with 1.6% and 3.5% with laparotomy (P = .006 for 30-day mortality, and .003 for 90-day).
There were also no differences in overall survival between the procedure types when the cases were stratified according to extent of surgery. Within the minimally invasive surgery groups there were no differences in median OS for patients whose surgery was performed laparoscopically or with robotic assistance.
The study was limited by a lack of data on either patient-specific tumor burden, neoadjuvant chemotherapy use, progression-free survival, cause of death, or surgical morbidity, Dr. Hayek acknowledged.
MIS Use Debatable: CON
Despite the good outcomes with minimally invasive techniques in this favorable-risk population, critics contend that MIS interval cytoreduction is too risky in the majority of cases.
In the debate portion of the session, Kara Long Roche, MD, an associate attending in the section of ovarian cancer surgery at Memorial Sloan Kettering Cancer Center in New York, argued that the potential for MIS missing residual disease is too great.
“We know from almost every retrospective and prospective study done that the volume of residual disease after debulking, whether primary or interval, is the most important prognostic factor for our patients that we can modify,” she said.
Rather than debating morbidity, mortality, or criteria for resection, “I would argue that the question we need to debate is can MIS interval debulking achieve a completeness of resection, i.e., volume of residual disease?” she said.
Dr. Roche contended that retrospective studies such as that reported by Dr. Hayek cannot adequately answer this question because of selection bias. Patients selected for MIS have better responses to neoadjuvant chemotherapy and more favorable tumor biology; and, therefore, overall survival may not be the optimal endpoint for retrospective studies.
In addition, neoadjuvant chemotherapy does not automatically preclude the need for extensive upper abdominal surgery since almost half of patients who receive neoadjuvant chemotherapy are found to have bulky upper abdominal disease at the time of debulking.
Dr. Roche especially cautioned against what she called the WNL or “We Never Looked” phenomenon, in which patients are found on open surgery and organ mobilization to have disease that was not evident on presurgical imaging.
She acknowledged that for some patients the risks of laparotomy are likely to outweigh the benefit of a radical resection, and stressed that for such patients forgoing surgery or optimizing perioperative care may be more important than the size of the incision.
MIS IDS should be the exception, not the rule. We need prospective data with appropriate endpoints. We need surgical quality control in both arms, and we need to continue to focus on surgical education and training so that our trainees can graduate doing these procedures via any approach,” she concluded.
Debate: PRO
Arguing in favor of MIS for ovarian cancer, J. Alejandro Rauh-Hain, MD, MPH, associate professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center in Houston, told attendees “the only bias I have is that I actually love doing open surgery, but I’m going to try to convince you that there is a potential role for minimally invasive surgery in the future for selected patients with ovarian cancer after neoadjuvant chemotherapy.”
He noted that several studies have convincingly shown that neoadjuvant chemotherapy does not adversely affect oncologic outcomes for patients with advanced-stage ovarian cancer, and decreases perioperative morbidity in patients who receive it, including reductions in serious adverse events, risk of stoma, and 30-day postoperative mortality.
In addition, low use of neoadjuvant chemotherapy is associated with increased risks for 90-day postoperative deaths in both low- and high surgical volume centers in the US, according to unpublished National Cancer Database data.
Dr. Rauh-Hain noted that neoadjuvant chemotherapy use has steadily increased from 2010 through 2020, and added that in 2022, 32% of interval cytoreductive surgeries in the United States were performed with a minimally invasive approach.
To get a better handle on the MIS vs. open-surgery question, Dr. Rauh-Hain and colleagues at MD Anderson and 13 other centers in the United States, Canada, and Europe are currently recruiting patients for the Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy (LANCE) trial. In this phase 3 noninferiority study, patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who have complete or partial responses and CA125 normalization after three or four cycles of neoadjuvant chemotherapy will be randomized to laparotomy or MIS, followed by adjuvant platinum- and taxane-based chemotherapy.
The study by Hayek et al. was internally supported. Dr. Hayek and Dr. Roche reported having no conflicts of interest. Dr. Rauh-Hain disclosed financial relationships with Guidepoint Consulting, and the Schlesinger Group.
This was a finding of a retrospective study presented by Judy Hayek, MD, during an oral abstract session at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, in San Diego.
Among 2,412 women in the National Cancer Database with tumor-free surgical margins (R0 resections) after interval debulking surgery (IDS), the median overall survival (OS) was 46 months for those who had undergone an open procedure or minimally invasive surgery (MIS) that was converted to an open procedure. In contrast, the median OS was 51 months for patients who underwent laparoscopic or robot-assisted minimally invasive surgery, reported Dr. Hayek, a gynecologic oncology fellow at SUNY Downstate Health Sciences University in Brooklyn, New York.
“R0 resection at the time of interval debulking surgery has similar survival outcomes by minimally invasive surgery versus laparotomy, while R0 resection via laparotomy is associated with higher perioperative mortality. There is no interaction between the extent of surgery and the impact of MIS on survival,” she said during her presentation.
The session included a debate on the pros and cons of minimally invasive vs. open surgery in this population.
Growing Use of MIS
Over the last decade, minimally invasive surgery for interval debulking was shown to be safe and feasible. More recently, two studies using National Cancer Database cohorts showed that survival was similar and perioperative outcomes were better with a minimally invasive approach at the time of IDS for patients with early disease, Dr. Hayek said (Obstet Gynecol 2017 Jul;130(1):71-79; and Gynecol Oncol 2023 May:172:130-137).
Potential limitations of MIS include the absence of haptic feedback compared with open surgery, and the possibility that limited visualization of the surgical field could lead to missed residual disease and subsequent poor outcomes for patients who were presumed to have complete gross resections, she said.
Outcomes Compared
Dr. Hayek and colleagues conducted their study to evaluate survival outcomes after R0 resections by MIS or laparotomy in IDS for patients with advanced epithelial ovarian cancer.
As noted before, they looked at outcomes for 2,412 women with stage IIIC or IV cancers of all histology types who were diagnosed from 2010 through 2019. A total of 624 patients (25.9%) had minimally invasive procedures, and 1,788 (74.1%) had open surgery or MIS that had been converted to open procedures.
Of the minimally invasive procedures, 48.7% were robot-assisted, and the remainder were laparoscopic.
Over the decade of the study, the frequency of minimally invasive surgery steadily increased, from 11.9% of all procedures in 2010 to 36.5% in 2019.
Also as noted, there was no difference in median overall survival, at 46 months for open/converted procedures vs. 51 months for minimally invasive procedures.
As might be expected, the mean length of stay was shorter with the less invasive surgery: 3.3 days compared with 5.3 days with open surgery (P less than .001). In addition, 30-day and 90-day mortality rates were also lower with MIS, at 0.8% and 1.9%, respectively, compared with 1.6% and 3.5% with laparotomy (P = .006 for 30-day mortality, and .003 for 90-day).
There were also no differences in overall survival between the procedure types when the cases were stratified according to extent of surgery. Within the minimally invasive surgery groups there were no differences in median OS for patients whose surgery was performed laparoscopically or with robotic assistance.
The study was limited by a lack of data on either patient-specific tumor burden, neoadjuvant chemotherapy use, progression-free survival, cause of death, or surgical morbidity, Dr. Hayek acknowledged.
MIS Use Debatable: CON
Despite the good outcomes with minimally invasive techniques in this favorable-risk population, critics contend that MIS interval cytoreduction is too risky in the majority of cases.
In the debate portion of the session, Kara Long Roche, MD, an associate attending in the section of ovarian cancer surgery at Memorial Sloan Kettering Cancer Center in New York, argued that the potential for MIS missing residual disease is too great.
“We know from almost every retrospective and prospective study done that the volume of residual disease after debulking, whether primary or interval, is the most important prognostic factor for our patients that we can modify,” she said.
Rather than debating morbidity, mortality, or criteria for resection, “I would argue that the question we need to debate is can MIS interval debulking achieve a completeness of resection, i.e., volume of residual disease?” she said.
Dr. Roche contended that retrospective studies such as that reported by Dr. Hayek cannot adequately answer this question because of selection bias. Patients selected for MIS have better responses to neoadjuvant chemotherapy and more favorable tumor biology; and, therefore, overall survival may not be the optimal endpoint for retrospective studies.
In addition, neoadjuvant chemotherapy does not automatically preclude the need for extensive upper abdominal surgery since almost half of patients who receive neoadjuvant chemotherapy are found to have bulky upper abdominal disease at the time of debulking.
Dr. Roche especially cautioned against what she called the WNL or “We Never Looked” phenomenon, in which patients are found on open surgery and organ mobilization to have disease that was not evident on presurgical imaging.
She acknowledged that for some patients the risks of laparotomy are likely to outweigh the benefit of a radical resection, and stressed that for such patients forgoing surgery or optimizing perioperative care may be more important than the size of the incision.
MIS IDS should be the exception, not the rule. We need prospective data with appropriate endpoints. We need surgical quality control in both arms, and we need to continue to focus on surgical education and training so that our trainees can graduate doing these procedures via any approach,” she concluded.
Debate: PRO
Arguing in favor of MIS for ovarian cancer, J. Alejandro Rauh-Hain, MD, MPH, associate professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center in Houston, told attendees “the only bias I have is that I actually love doing open surgery, but I’m going to try to convince you that there is a potential role for minimally invasive surgery in the future for selected patients with ovarian cancer after neoadjuvant chemotherapy.”
He noted that several studies have convincingly shown that neoadjuvant chemotherapy does not adversely affect oncologic outcomes for patients with advanced-stage ovarian cancer, and decreases perioperative morbidity in patients who receive it, including reductions in serious adverse events, risk of stoma, and 30-day postoperative mortality.
In addition, low use of neoadjuvant chemotherapy is associated with increased risks for 90-day postoperative deaths in both low- and high surgical volume centers in the US, according to unpublished National Cancer Database data.
Dr. Rauh-Hain noted that neoadjuvant chemotherapy use has steadily increased from 2010 through 2020, and added that in 2022, 32% of interval cytoreductive surgeries in the United States were performed with a minimally invasive approach.
To get a better handle on the MIS vs. open-surgery question, Dr. Rauh-Hain and colleagues at MD Anderson and 13 other centers in the United States, Canada, and Europe are currently recruiting patients for the Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy (LANCE) trial. In this phase 3 noninferiority study, patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who have complete or partial responses and CA125 normalization after three or four cycles of neoadjuvant chemotherapy will be randomized to laparotomy or MIS, followed by adjuvant platinum- and taxane-based chemotherapy.
The study by Hayek et al. was internally supported. Dr. Hayek and Dr. Roche reported having no conflicts of interest. Dr. Rauh-Hain disclosed financial relationships with Guidepoint Consulting, and the Schlesinger Group.
This was a finding of a retrospective study presented by Judy Hayek, MD, during an oral abstract session at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, in San Diego.
Among 2,412 women in the National Cancer Database with tumor-free surgical margins (R0 resections) after interval debulking surgery (IDS), the median overall survival (OS) was 46 months for those who had undergone an open procedure or minimally invasive surgery (MIS) that was converted to an open procedure. In contrast, the median OS was 51 months for patients who underwent laparoscopic or robot-assisted minimally invasive surgery, reported Dr. Hayek, a gynecologic oncology fellow at SUNY Downstate Health Sciences University in Brooklyn, New York.
“R0 resection at the time of interval debulking surgery has similar survival outcomes by minimally invasive surgery versus laparotomy, while R0 resection via laparotomy is associated with higher perioperative mortality. There is no interaction between the extent of surgery and the impact of MIS on survival,” she said during her presentation.
The session included a debate on the pros and cons of minimally invasive vs. open surgery in this population.
Growing Use of MIS
Over the last decade, minimally invasive surgery for interval debulking was shown to be safe and feasible. More recently, two studies using National Cancer Database cohorts showed that survival was similar and perioperative outcomes were better with a minimally invasive approach at the time of IDS for patients with early disease, Dr. Hayek said (Obstet Gynecol 2017 Jul;130(1):71-79; and Gynecol Oncol 2023 May:172:130-137).
Potential limitations of MIS include the absence of haptic feedback compared with open surgery, and the possibility that limited visualization of the surgical field could lead to missed residual disease and subsequent poor outcomes for patients who were presumed to have complete gross resections, she said.
Outcomes Compared
Dr. Hayek and colleagues conducted their study to evaluate survival outcomes after R0 resections by MIS or laparotomy in IDS for patients with advanced epithelial ovarian cancer.
As noted before, they looked at outcomes for 2,412 women with stage IIIC or IV cancers of all histology types who were diagnosed from 2010 through 2019. A total of 624 patients (25.9%) had minimally invasive procedures, and 1,788 (74.1%) had open surgery or MIS that had been converted to open procedures.
Of the minimally invasive procedures, 48.7% were robot-assisted, and the remainder were laparoscopic.
Over the decade of the study, the frequency of minimally invasive surgery steadily increased, from 11.9% of all procedures in 2010 to 36.5% in 2019.
Also as noted, there was no difference in median overall survival, at 46 months for open/converted procedures vs. 51 months for minimally invasive procedures.
As might be expected, the mean length of stay was shorter with the less invasive surgery: 3.3 days compared with 5.3 days with open surgery (P less than .001). In addition, 30-day and 90-day mortality rates were also lower with MIS, at 0.8% and 1.9%, respectively, compared with 1.6% and 3.5% with laparotomy (P = .006 for 30-day mortality, and .003 for 90-day).
There were also no differences in overall survival between the procedure types when the cases were stratified according to extent of surgery. Within the minimally invasive surgery groups there were no differences in median OS for patients whose surgery was performed laparoscopically or with robotic assistance.
The study was limited by a lack of data on either patient-specific tumor burden, neoadjuvant chemotherapy use, progression-free survival, cause of death, or surgical morbidity, Dr. Hayek acknowledged.
MIS Use Debatable: CON
Despite the good outcomes with minimally invasive techniques in this favorable-risk population, critics contend that MIS interval cytoreduction is too risky in the majority of cases.
In the debate portion of the session, Kara Long Roche, MD, an associate attending in the section of ovarian cancer surgery at Memorial Sloan Kettering Cancer Center in New York, argued that the potential for MIS missing residual disease is too great.
“We know from almost every retrospective and prospective study done that the volume of residual disease after debulking, whether primary or interval, is the most important prognostic factor for our patients that we can modify,” she said.
Rather than debating morbidity, mortality, or criteria for resection, “I would argue that the question we need to debate is can MIS interval debulking achieve a completeness of resection, i.e., volume of residual disease?” she said.
Dr. Roche contended that retrospective studies such as that reported by Dr. Hayek cannot adequately answer this question because of selection bias. Patients selected for MIS have better responses to neoadjuvant chemotherapy and more favorable tumor biology; and, therefore, overall survival may not be the optimal endpoint for retrospective studies.
In addition, neoadjuvant chemotherapy does not automatically preclude the need for extensive upper abdominal surgery since almost half of patients who receive neoadjuvant chemotherapy are found to have bulky upper abdominal disease at the time of debulking.
Dr. Roche especially cautioned against what she called the WNL or “We Never Looked” phenomenon, in which patients are found on open surgery and organ mobilization to have disease that was not evident on presurgical imaging.
She acknowledged that for some patients the risks of laparotomy are likely to outweigh the benefit of a radical resection, and stressed that for such patients forgoing surgery or optimizing perioperative care may be more important than the size of the incision.
MIS IDS should be the exception, not the rule. We need prospective data with appropriate endpoints. We need surgical quality control in both arms, and we need to continue to focus on surgical education and training so that our trainees can graduate doing these procedures via any approach,” she concluded.
Debate: PRO
Arguing in favor of MIS for ovarian cancer, J. Alejandro Rauh-Hain, MD, MPH, associate professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center in Houston, told attendees “the only bias I have is that I actually love doing open surgery, but I’m going to try to convince you that there is a potential role for minimally invasive surgery in the future for selected patients with ovarian cancer after neoadjuvant chemotherapy.”
He noted that several studies have convincingly shown that neoadjuvant chemotherapy does not adversely affect oncologic outcomes for patients with advanced-stage ovarian cancer, and decreases perioperative morbidity in patients who receive it, including reductions in serious adverse events, risk of stoma, and 30-day postoperative mortality.
In addition, low use of neoadjuvant chemotherapy is associated with increased risks for 90-day postoperative deaths in both low- and high surgical volume centers in the US, according to unpublished National Cancer Database data.
Dr. Rauh-Hain noted that neoadjuvant chemotherapy use has steadily increased from 2010 through 2020, and added that in 2022, 32% of interval cytoreductive surgeries in the United States were performed with a minimally invasive approach.
To get a better handle on the MIS vs. open-surgery question, Dr. Rauh-Hain and colleagues at MD Anderson and 13 other centers in the United States, Canada, and Europe are currently recruiting patients for the Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy (LANCE) trial. In this phase 3 noninferiority study, patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who have complete or partial responses and CA125 normalization after three or four cycles of neoadjuvant chemotherapy will be randomized to laparotomy or MIS, followed by adjuvant platinum- and taxane-based chemotherapy.
The study by Hayek et al. was internally supported. Dr. Hayek and Dr. Roche reported having no conflicts of interest. Dr. Rauh-Hain disclosed financial relationships with Guidepoint Consulting, and the Schlesinger Group.
FROM SGO 2024