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Surgery for adhesive small-bowel obstruction linked with lower risk of recurrence

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Thu, 10/29/2020 - 15:33

Background: Guidelines recommend nonoperative monitoring for aSBO; however, long-term association of operative versus nonoperative management and aSBO recurrence is poorly understood.

Study design: Longitudinal, retrospective cohort.

Setting: Hospitals in Ontario.

Synopsis: Administrative data for 2005-2014 was used to identify 27,904 adults hospitalized for an initial episode of aSBO who did not have known inflammatory bowel disease, history of radiotherapy, malignancy, ileus, impaction, or anatomical obstruction. Approximately 22% of patients were managed surgically during the index admission. Patients were followed for a median of 3.6 years. Overall, 19.6% of patients experienced at least one admission for recurrence of aSBO during the study period. With each recurrence, the probability of subsequent recurrence increased, the time between episodes decreased, and the probability of being treated surgically decreased.

Patients were then matched into operative (n = 6,160) and nonoperative (n = 6,160) cohorts based on a propensity score which incorporated comorbidity burden, age, gender, and socioeconomic status. Patients who underwent operative management during their index admission for aSBO had a lower overall risk of recurrence compared to patients managed nonoperatively (13.0% vs. 21.3%; P less than .001). Operative intervention was associated with lower hazards of recurrence even when accounting for death. Additionally, surgical intervention after any episode was associated with a significantly lower risk of recurrence, compared with nonoperative management.

Bottom line: Contrary to surgical dogma, surgical intervention is associated with reduced risk of recurrent aSBO in patients without complicating factors. Hospitalists should consider recurrence risk when managing these patients nonoperatively.

Citation: Behman R et al. Association of surgical intervention for adhesive small-bowel obstruction with the risk of recurrence. JAMA Surg. 2019 May 1;154(5):413-20.

Dr. Liu is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.

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Background: Guidelines recommend nonoperative monitoring for aSBO; however, long-term association of operative versus nonoperative management and aSBO recurrence is poorly understood.

Study design: Longitudinal, retrospective cohort.

Setting: Hospitals in Ontario.

Synopsis: Administrative data for 2005-2014 was used to identify 27,904 adults hospitalized for an initial episode of aSBO who did not have known inflammatory bowel disease, history of radiotherapy, malignancy, ileus, impaction, or anatomical obstruction. Approximately 22% of patients were managed surgically during the index admission. Patients were followed for a median of 3.6 years. Overall, 19.6% of patients experienced at least one admission for recurrence of aSBO during the study period. With each recurrence, the probability of subsequent recurrence increased, the time between episodes decreased, and the probability of being treated surgically decreased.

Patients were then matched into operative (n = 6,160) and nonoperative (n = 6,160) cohorts based on a propensity score which incorporated comorbidity burden, age, gender, and socioeconomic status. Patients who underwent operative management during their index admission for aSBO had a lower overall risk of recurrence compared to patients managed nonoperatively (13.0% vs. 21.3%; P less than .001). Operative intervention was associated with lower hazards of recurrence even when accounting for death. Additionally, surgical intervention after any episode was associated with a significantly lower risk of recurrence, compared with nonoperative management.

Bottom line: Contrary to surgical dogma, surgical intervention is associated with reduced risk of recurrent aSBO in patients without complicating factors. Hospitalists should consider recurrence risk when managing these patients nonoperatively.

Citation: Behman R et al. Association of surgical intervention for adhesive small-bowel obstruction with the risk of recurrence. JAMA Surg. 2019 May 1;154(5):413-20.

Dr. Liu is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.

Background: Guidelines recommend nonoperative monitoring for aSBO; however, long-term association of operative versus nonoperative management and aSBO recurrence is poorly understood.

Study design: Longitudinal, retrospective cohort.

Setting: Hospitals in Ontario.

Synopsis: Administrative data for 2005-2014 was used to identify 27,904 adults hospitalized for an initial episode of aSBO who did not have known inflammatory bowel disease, history of radiotherapy, malignancy, ileus, impaction, or anatomical obstruction. Approximately 22% of patients were managed surgically during the index admission. Patients were followed for a median of 3.6 years. Overall, 19.6% of patients experienced at least one admission for recurrence of aSBO during the study period. With each recurrence, the probability of subsequent recurrence increased, the time between episodes decreased, and the probability of being treated surgically decreased.

Patients were then matched into operative (n = 6,160) and nonoperative (n = 6,160) cohorts based on a propensity score which incorporated comorbidity burden, age, gender, and socioeconomic status. Patients who underwent operative management during their index admission for aSBO had a lower overall risk of recurrence compared to patients managed nonoperatively (13.0% vs. 21.3%; P less than .001). Operative intervention was associated with lower hazards of recurrence even when accounting for death. Additionally, surgical intervention after any episode was associated with a significantly lower risk of recurrence, compared with nonoperative management.

Bottom line: Contrary to surgical dogma, surgical intervention is associated with reduced risk of recurrent aSBO in patients without complicating factors. Hospitalists should consider recurrence risk when managing these patients nonoperatively.

Citation: Behman R et al. Association of surgical intervention for adhesive small-bowel obstruction with the risk of recurrence. JAMA Surg. 2019 May 1;154(5):413-20.

Dr. Liu is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.

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Chinese American families suffer discrimination related to COVID-19

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Tue, 02/14/2023 - 13:00

 

Half of Chinese American parents and their children report having experienced an in-person episode of racial discrimination related to the COVID-19 pandemic, according to results from a survey study.

In the United States, where public officials continue to refer to SARS-CoV-2 as the “China virus” and have often sought to draw attention to its origins in Wuhan, China, “the associations between discrimination triggered by the racialization of this acute public health crisis and mental health are unknown,” Charissa S.L. Cheah, PhD, of the University of Maryland, Baltimore County, and colleagues wrote.

For their research published Oct. 29 in Pediatrics, Dr. Cheah and colleagues recruited a cohort of 543 Chinese American parents of school-age children, and 230 of their children aged 10-18 years, to complete online surveys between mid-March and late May 2020. Parents in the cohort were largely foreign born, with all identifying as ethnically Chinese, while their children were mostly U.S. born.
 

Evidence of discrimination against Chinese Americans

Half of parents and their children (51% of parents and 50% of youth) reported experiencing at least one in-person incident of direct discrimination (assessed using questions derived from a validated scale of racial aggression) related to the pandemic. Dr. Cheah and colleagues also reported a high incidence of direct discrimination online (32% of parents and 46% of youth). Additionally, the researchers measured reports of vicarious or indirect discrimination – such as hearing jokes or disparaging remarks about one’s ethnic group – which they used a different adapted scale to capture. More than three-quarters of the cohort reported such experiences.

The experiences of discrimination likely bore on the mental health of both parents and youth. Using a series of instruments designed to measure overall psychological well-being as well as symptoms of depression, anxiety, and certain emotional and behavioral outcomes, Dr. Cheah and colleagues reported significant negative associations between direct online or in-person discrimination and psychological health. For parents and children alike, anxiety and depressive symptoms were positively associated with all varieties of discrimination experiences measured in the study.

About a fifth of the youth in the study were deemed, based on the symptom scales used in the study, to have an elevated risk of clinically significant mental health problems, higher than the 10%-15% that would be expected for these age groups in the United States.

“This study revealed that a high percentage of Chinese American parents and their children personally experienced or witnessed anti-Chinese or anti–Asian American racial discrimination both online and in person due to the COVID-19 pandemic,” the investigators wrote. “Most respondents reported directly experiencing or witnessing racial discrimination against other Chinese or Asian American individuals due to COVID-19 at least once.”

Dr. Cheah and colleagues noted that their cross-sectional study did not lend itself to causal interpretations and was vulnerable to certain types of reporting bias. Nonetheless, they argued, as the pandemic continues, “pediatricians should be sensitive to the potential mental health needs of Chinese American youth and their parents related to various forms of racism, in addition to other stressors, as the foundations of perceptions of racial-ethnic discrimination and their consequences may be set during this period.”
 

 

 

COVID-19 didn’t only bring infection

In an accompanying editorial, Tina L. Cheng, MD, of Johns Hopkins University, Baltimore, and her daughter Alison M. Conca-Cheng, a medical student at Brown University, Providence, R.I., remarked that the study’s findings were consistent with recent research that found “4 in 10 Americans reported that it has become more common since COVID-19 for people to express racist views about Asian Americans,” and also described an increase in complaints of discriminatory experiences by Asian Americans.

In this context, a link to poor mental health “should be no surprise,” Dr. Cheng and Ms. Conca-Cheng argued, and urged pediatricians to consult the American Academy of Pediatrics’ 2019 policy statement on racism and on child and adolescent health. “It calls for us to optimize clinical practice, improve workforce development and professional education, strengthen research, and deploy systems through community engagement, advocacy, and public policy.”

David Rettew, MD, a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington, called the study’s main points “clear and disturbing.”

“While it is difficult to find much in the way here of a silver lining, these alarming reports have helped people working in health care and mental health to understand racism as another form of trauma and abuse which, like other types, can have real negative effects on health,” Dr. Rettew said in an interview. “The more we as mental health professions ask about racism and offer resources for people who have experienced it, just as we would people who have endured other types of trauma, the more we can help people heal. That said, it would be better just to stop this from happening in the first place.”

Dr. Cheah and colleagues’ study was supported by a National Science Foundation grant. The investigators disclosed no conflicts of interest. Dr. Cheng and Ms. Conca-Cheng disclosed no financial conflicts of interest related to their editorial. Dr. Rettew said he had no relevant financial disclosures.

SOURCE: Cheah CSL et al. Pediatrics. 2020;146(5):e2020021816.

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Half of Chinese American parents and their children report having experienced an in-person episode of racial discrimination related to the COVID-19 pandemic, according to results from a survey study.

In the United States, where public officials continue to refer to SARS-CoV-2 as the “China virus” and have often sought to draw attention to its origins in Wuhan, China, “the associations between discrimination triggered by the racialization of this acute public health crisis and mental health are unknown,” Charissa S.L. Cheah, PhD, of the University of Maryland, Baltimore County, and colleagues wrote.

For their research published Oct. 29 in Pediatrics, Dr. Cheah and colleagues recruited a cohort of 543 Chinese American parents of school-age children, and 230 of their children aged 10-18 years, to complete online surveys between mid-March and late May 2020. Parents in the cohort were largely foreign born, with all identifying as ethnically Chinese, while their children were mostly U.S. born.
 

Evidence of discrimination against Chinese Americans

Half of parents and their children (51% of parents and 50% of youth) reported experiencing at least one in-person incident of direct discrimination (assessed using questions derived from a validated scale of racial aggression) related to the pandemic. Dr. Cheah and colleagues also reported a high incidence of direct discrimination online (32% of parents and 46% of youth). Additionally, the researchers measured reports of vicarious or indirect discrimination – such as hearing jokes or disparaging remarks about one’s ethnic group – which they used a different adapted scale to capture. More than three-quarters of the cohort reported such experiences.

The experiences of discrimination likely bore on the mental health of both parents and youth. Using a series of instruments designed to measure overall psychological well-being as well as symptoms of depression, anxiety, and certain emotional and behavioral outcomes, Dr. Cheah and colleagues reported significant negative associations between direct online or in-person discrimination and psychological health. For parents and children alike, anxiety and depressive symptoms were positively associated with all varieties of discrimination experiences measured in the study.

About a fifth of the youth in the study were deemed, based on the symptom scales used in the study, to have an elevated risk of clinically significant mental health problems, higher than the 10%-15% that would be expected for these age groups in the United States.

“This study revealed that a high percentage of Chinese American parents and their children personally experienced or witnessed anti-Chinese or anti–Asian American racial discrimination both online and in person due to the COVID-19 pandemic,” the investigators wrote. “Most respondents reported directly experiencing or witnessing racial discrimination against other Chinese or Asian American individuals due to COVID-19 at least once.”

Dr. Cheah and colleagues noted that their cross-sectional study did not lend itself to causal interpretations and was vulnerable to certain types of reporting bias. Nonetheless, they argued, as the pandemic continues, “pediatricians should be sensitive to the potential mental health needs of Chinese American youth and their parents related to various forms of racism, in addition to other stressors, as the foundations of perceptions of racial-ethnic discrimination and their consequences may be set during this period.”
 

 

 

COVID-19 didn’t only bring infection

In an accompanying editorial, Tina L. Cheng, MD, of Johns Hopkins University, Baltimore, and her daughter Alison M. Conca-Cheng, a medical student at Brown University, Providence, R.I., remarked that the study’s findings were consistent with recent research that found “4 in 10 Americans reported that it has become more common since COVID-19 for people to express racist views about Asian Americans,” and also described an increase in complaints of discriminatory experiences by Asian Americans.

In this context, a link to poor mental health “should be no surprise,” Dr. Cheng and Ms. Conca-Cheng argued, and urged pediatricians to consult the American Academy of Pediatrics’ 2019 policy statement on racism and on child and adolescent health. “It calls for us to optimize clinical practice, improve workforce development and professional education, strengthen research, and deploy systems through community engagement, advocacy, and public policy.”

David Rettew, MD, a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington, called the study’s main points “clear and disturbing.”

“While it is difficult to find much in the way here of a silver lining, these alarming reports have helped people working in health care and mental health to understand racism as another form of trauma and abuse which, like other types, can have real negative effects on health,” Dr. Rettew said in an interview. “The more we as mental health professions ask about racism and offer resources for people who have experienced it, just as we would people who have endured other types of trauma, the more we can help people heal. That said, it would be better just to stop this from happening in the first place.”

Dr. Cheah and colleagues’ study was supported by a National Science Foundation grant. The investigators disclosed no conflicts of interest. Dr. Cheng and Ms. Conca-Cheng disclosed no financial conflicts of interest related to their editorial. Dr. Rettew said he had no relevant financial disclosures.

SOURCE: Cheah CSL et al. Pediatrics. 2020;146(5):e2020021816.

 

Half of Chinese American parents and their children report having experienced an in-person episode of racial discrimination related to the COVID-19 pandemic, according to results from a survey study.

In the United States, where public officials continue to refer to SARS-CoV-2 as the “China virus” and have often sought to draw attention to its origins in Wuhan, China, “the associations between discrimination triggered by the racialization of this acute public health crisis and mental health are unknown,” Charissa S.L. Cheah, PhD, of the University of Maryland, Baltimore County, and colleagues wrote.

For their research published Oct. 29 in Pediatrics, Dr. Cheah and colleagues recruited a cohort of 543 Chinese American parents of school-age children, and 230 of their children aged 10-18 years, to complete online surveys between mid-March and late May 2020. Parents in the cohort were largely foreign born, with all identifying as ethnically Chinese, while their children were mostly U.S. born.
 

Evidence of discrimination against Chinese Americans

Half of parents and their children (51% of parents and 50% of youth) reported experiencing at least one in-person incident of direct discrimination (assessed using questions derived from a validated scale of racial aggression) related to the pandemic. Dr. Cheah and colleagues also reported a high incidence of direct discrimination online (32% of parents and 46% of youth). Additionally, the researchers measured reports of vicarious or indirect discrimination – such as hearing jokes or disparaging remarks about one’s ethnic group – which they used a different adapted scale to capture. More than three-quarters of the cohort reported such experiences.

The experiences of discrimination likely bore on the mental health of both parents and youth. Using a series of instruments designed to measure overall psychological well-being as well as symptoms of depression, anxiety, and certain emotional and behavioral outcomes, Dr. Cheah and colleagues reported significant negative associations between direct online or in-person discrimination and psychological health. For parents and children alike, anxiety and depressive symptoms were positively associated with all varieties of discrimination experiences measured in the study.

About a fifth of the youth in the study were deemed, based on the symptom scales used in the study, to have an elevated risk of clinically significant mental health problems, higher than the 10%-15% that would be expected for these age groups in the United States.

“This study revealed that a high percentage of Chinese American parents and their children personally experienced or witnessed anti-Chinese or anti–Asian American racial discrimination both online and in person due to the COVID-19 pandemic,” the investigators wrote. “Most respondents reported directly experiencing or witnessing racial discrimination against other Chinese or Asian American individuals due to COVID-19 at least once.”

Dr. Cheah and colleagues noted that their cross-sectional study did not lend itself to causal interpretations and was vulnerable to certain types of reporting bias. Nonetheless, they argued, as the pandemic continues, “pediatricians should be sensitive to the potential mental health needs of Chinese American youth and their parents related to various forms of racism, in addition to other stressors, as the foundations of perceptions of racial-ethnic discrimination and their consequences may be set during this period.”
 

 

 

COVID-19 didn’t only bring infection

In an accompanying editorial, Tina L. Cheng, MD, of Johns Hopkins University, Baltimore, and her daughter Alison M. Conca-Cheng, a medical student at Brown University, Providence, R.I., remarked that the study’s findings were consistent with recent research that found “4 in 10 Americans reported that it has become more common since COVID-19 for people to express racist views about Asian Americans,” and also described an increase in complaints of discriminatory experiences by Asian Americans.

In this context, a link to poor mental health “should be no surprise,” Dr. Cheng and Ms. Conca-Cheng argued, and urged pediatricians to consult the American Academy of Pediatrics’ 2019 policy statement on racism and on child and adolescent health. “It calls for us to optimize clinical practice, improve workforce development and professional education, strengthen research, and deploy systems through community engagement, advocacy, and public policy.”

David Rettew, MD, a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington, called the study’s main points “clear and disturbing.”

“While it is difficult to find much in the way here of a silver lining, these alarming reports have helped people working in health care and mental health to understand racism as another form of trauma and abuse which, like other types, can have real negative effects on health,” Dr. Rettew said in an interview. “The more we as mental health professions ask about racism and offer resources for people who have experienced it, just as we would people who have endured other types of trauma, the more we can help people heal. That said, it would be better just to stop this from happening in the first place.”

Dr. Cheah and colleagues’ study was supported by a National Science Foundation grant. The investigators disclosed no conflicts of interest. Dr. Cheng and Ms. Conca-Cheng disclosed no financial conflicts of interest related to their editorial. Dr. Rettew said he had no relevant financial disclosures.

SOURCE: Cheah CSL et al. Pediatrics. 2020;146(5):e2020021816.

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Are uterine manipulators safe for gynecologic cancer surgery?

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Wed, 10/28/2020 - 12:07

Over the past 4 decades there has been increasing use of minimally invasive surgery (MIS) for gynecologic cancer, particularly endometrial and cervical cancers. Uterine manipulators are a device inserted into the uterine cavity during MIS approaches to aid in directing the uterus within the pelvis, facilitating access to the uterine blood supply, defining the cardinal ligaments, lateralizing the ureters, and delineating the cervicovaginal junction. However, concerns have been raised regarding whether these devices are safe to use when the uterine corpus or cervix contains cancer.

Dr. Emma C. Rossi

In 2018, the LACC trial was published and demonstrated decreased survival for patients with cervical cancer who had undergone radical hysterectomy via a minimally invasive route.1 Several hypotheses were proposed to explain this finding including possible tumor disruption from use of a uterine manipulator. Regrettably, this study did not document manipulator use, and therefore its influence on outcomes could not be measured. However, since that time there has been honed interest into the potential negative influence of uterine manipulators on endometrial and cervical cancer surgery.

Uterine manipulators typically are inserted through the uterine cervix and reside in the endometrial cavity. It is often an inflated balloon which stabilizes the device within the cavity. Hypotheses for how they may contribute to the spread of malignancy include the massage of endometrial tumor from the pressure of the inflated balloon, facilitation of tumor dissemination through cervical lymphatics or vasculature as the manipulator traverses or punctures a cervical cancer, and possibly perforation of the uterine cavity during placement of the manipulator, and in doing so, contaminating the peritoneal cavity with endometrial or cervical cancer cells that have been dragged through with the device.

Interestingly, uterine manipulator placement is not the only time during which endometrial or cervical cancers may be disturbed prior to resection. Many diagnostic procedures such as cervical excisional procedures (loop electrosurgical excision procedure and conizations) or hysteroscopic resections cause significant intentional disruption of tumor. In the case of hysteroscopy for endometrial cancer, endometrial cancer cells have been detected in the peritoneal washings of endometrial cancer patients who have undergone this procedure, however, no worse outcomes have been associated when hysteroscopy was included as part of the diagnostic work-up, suggesting that more than simply efflux into the peritoneal cavity is necessary for those tumor cells to have metastatic potential.2

Indeed the data is mixed regarding oncologic outcomes with uterine manipulator use, especially for endometrial cancer. In one recent study the outcomes of 951 patients with endometrial cancer from seven Italian centers were evaluated.3 There was no difference in recurrence rates or disease-specific survival between the 579 patients in whom manipulators were used and the 372 patients in which surgery was performed without manipulators. More recently a Spanish study reported retrospectively on 2,661 patients at 15 centers and determined that use of a uterine manipulator (two-thirds of the cohort) was associated with a hazard ratio of 1.74 (95% confidence interval, 1.07-2.83) for risk of death.4 Unfortunately, in this study there were substantial differences between sites that used manipulators and those that did not. Additionally, while one would expect different patterns of recurrence if the manipulator was introducing a unique mechanism for metastasis, this was not observed between the manipulator and nonmanipulator arms. Finally, the groups were intrinsically different with respect to important risk factors such as lymphovascular space invasion, which might have contributed to the observed outcomes. It is important to recognize that, in both the LAP-2 and LACE trials, minimally invasive hysterectomy for endometrial cancer had been shown to have noninferior survival outcomes, compared with open hysterectomy.5,6 While these large randomized, controlled trials did not capture uterine manipulator usage, presumably it was utilized in at least some or most cases, and without apparent significant negative effect.

In cervical cancer, there is more competing data raising concern regarding manipulator use. The SUCCOR study was completed in 2020 and included a retrospective evaluation of 1,272 patients who had undergone open or MIS radical hysterectomy for early stage cervical cancer across 126 European centers during 2013-2014.7 They were able to evaluate for variables, such as uterine manipulator use. While they found that recurrence was higher for patients who had MIS hysterectomy, the HR (2.07) was similar to the HR for recurrence (2.76) among those who had uterine manipulator use. Conversely, the hazard ratio for recurrence following MIS radical hysterectomy without a manipulator was comparable with the superior rates seen with open surgery. This study was retrospective and therefore is largely hypothesis generating, however it does raise the question of whether the technique of MIS radical hysterectomy can be performed safely if particular steps, such as avoidance of a uterine manipulator, are followed. We await definitive results from prospective trials to determine this.

As mentioned earlier, the uterine manipulator is an important safety and feasibility tool for MIS hysterectomy. When not utilized, surgeons may need to add additional ports and instrumentation to maneuver the uterus and may have difficulty completing hysterectomy via a MIS approach for obese patients. There are additional urologic safety concerns when uterine elevation and cervicovaginal delineation is missing. Therefore, surgeons should consider use of the uterine manipulator on a case-by-case basis, potentially avoiding its use when it is not felt to be of benefit. While the wealth of prospective data suggests that manipulators are most likely safe in hysterectomy for endometrial cancer, they should be avoided if a minimally invasive approach to cervical cancer is employed.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no conflicts of interest to report. Email her at [email protected].

References

1. N Engl J Med. 2018 Nov 15. doi: 10.1056/NEJMoa1806395.

2. Fertil Steril. 2011 Oct. doi: 10.1016/j.fertnstert.2011.07.1146.

3. Am J Obstet Gynecol. 2017 Jun. doi: 10.1016/j.ajog.2017.01.027.

4. Am J Obstet Gynecol. 2020 Jul 18. doi: 10.1016/j.ajog.2020.07.025.

5. J Clin Oncol. 2009 Nov 10. doi: 10.1200/JCO.2009.22.3248.

6. JAMA. 2017 Mar 28. doi: 10.1001/jama.2017.2068.

7. Int J Gynecol Cancer. 2020. doi: 10.1136/ijgc-2020-001506.

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Over the past 4 decades there has been increasing use of minimally invasive surgery (MIS) for gynecologic cancer, particularly endometrial and cervical cancers. Uterine manipulators are a device inserted into the uterine cavity during MIS approaches to aid in directing the uterus within the pelvis, facilitating access to the uterine blood supply, defining the cardinal ligaments, lateralizing the ureters, and delineating the cervicovaginal junction. However, concerns have been raised regarding whether these devices are safe to use when the uterine corpus or cervix contains cancer.

Dr. Emma C. Rossi

In 2018, the LACC trial was published and demonstrated decreased survival for patients with cervical cancer who had undergone radical hysterectomy via a minimally invasive route.1 Several hypotheses were proposed to explain this finding including possible tumor disruption from use of a uterine manipulator. Regrettably, this study did not document manipulator use, and therefore its influence on outcomes could not be measured. However, since that time there has been honed interest into the potential negative influence of uterine manipulators on endometrial and cervical cancer surgery.

Uterine manipulators typically are inserted through the uterine cervix and reside in the endometrial cavity. It is often an inflated balloon which stabilizes the device within the cavity. Hypotheses for how they may contribute to the spread of malignancy include the massage of endometrial tumor from the pressure of the inflated balloon, facilitation of tumor dissemination through cervical lymphatics or vasculature as the manipulator traverses or punctures a cervical cancer, and possibly perforation of the uterine cavity during placement of the manipulator, and in doing so, contaminating the peritoneal cavity with endometrial or cervical cancer cells that have been dragged through with the device.

Interestingly, uterine manipulator placement is not the only time during which endometrial or cervical cancers may be disturbed prior to resection. Many diagnostic procedures such as cervical excisional procedures (loop electrosurgical excision procedure and conizations) or hysteroscopic resections cause significant intentional disruption of tumor. In the case of hysteroscopy for endometrial cancer, endometrial cancer cells have been detected in the peritoneal washings of endometrial cancer patients who have undergone this procedure, however, no worse outcomes have been associated when hysteroscopy was included as part of the diagnostic work-up, suggesting that more than simply efflux into the peritoneal cavity is necessary for those tumor cells to have metastatic potential.2

Indeed the data is mixed regarding oncologic outcomes with uterine manipulator use, especially for endometrial cancer. In one recent study the outcomes of 951 patients with endometrial cancer from seven Italian centers were evaluated.3 There was no difference in recurrence rates or disease-specific survival between the 579 patients in whom manipulators were used and the 372 patients in which surgery was performed without manipulators. More recently a Spanish study reported retrospectively on 2,661 patients at 15 centers and determined that use of a uterine manipulator (two-thirds of the cohort) was associated with a hazard ratio of 1.74 (95% confidence interval, 1.07-2.83) for risk of death.4 Unfortunately, in this study there were substantial differences between sites that used manipulators and those that did not. Additionally, while one would expect different patterns of recurrence if the manipulator was introducing a unique mechanism for metastasis, this was not observed between the manipulator and nonmanipulator arms. Finally, the groups were intrinsically different with respect to important risk factors such as lymphovascular space invasion, which might have contributed to the observed outcomes. It is important to recognize that, in both the LAP-2 and LACE trials, minimally invasive hysterectomy for endometrial cancer had been shown to have noninferior survival outcomes, compared with open hysterectomy.5,6 While these large randomized, controlled trials did not capture uterine manipulator usage, presumably it was utilized in at least some or most cases, and without apparent significant negative effect.

In cervical cancer, there is more competing data raising concern regarding manipulator use. The SUCCOR study was completed in 2020 and included a retrospective evaluation of 1,272 patients who had undergone open or MIS radical hysterectomy for early stage cervical cancer across 126 European centers during 2013-2014.7 They were able to evaluate for variables, such as uterine manipulator use. While they found that recurrence was higher for patients who had MIS hysterectomy, the HR (2.07) was similar to the HR for recurrence (2.76) among those who had uterine manipulator use. Conversely, the hazard ratio for recurrence following MIS radical hysterectomy without a manipulator was comparable with the superior rates seen with open surgery. This study was retrospective and therefore is largely hypothesis generating, however it does raise the question of whether the technique of MIS radical hysterectomy can be performed safely if particular steps, such as avoidance of a uterine manipulator, are followed. We await definitive results from prospective trials to determine this.

As mentioned earlier, the uterine manipulator is an important safety and feasibility tool for MIS hysterectomy. When not utilized, surgeons may need to add additional ports and instrumentation to maneuver the uterus and may have difficulty completing hysterectomy via a MIS approach for obese patients. There are additional urologic safety concerns when uterine elevation and cervicovaginal delineation is missing. Therefore, surgeons should consider use of the uterine manipulator on a case-by-case basis, potentially avoiding its use when it is not felt to be of benefit. While the wealth of prospective data suggests that manipulators are most likely safe in hysterectomy for endometrial cancer, they should be avoided if a minimally invasive approach to cervical cancer is employed.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no conflicts of interest to report. Email her at [email protected].

References

1. N Engl J Med. 2018 Nov 15. doi: 10.1056/NEJMoa1806395.

2. Fertil Steril. 2011 Oct. doi: 10.1016/j.fertnstert.2011.07.1146.

3. Am J Obstet Gynecol. 2017 Jun. doi: 10.1016/j.ajog.2017.01.027.

4. Am J Obstet Gynecol. 2020 Jul 18. doi: 10.1016/j.ajog.2020.07.025.

5. J Clin Oncol. 2009 Nov 10. doi: 10.1200/JCO.2009.22.3248.

6. JAMA. 2017 Mar 28. doi: 10.1001/jama.2017.2068.

7. Int J Gynecol Cancer. 2020. doi: 10.1136/ijgc-2020-001506.

Over the past 4 decades there has been increasing use of minimally invasive surgery (MIS) for gynecologic cancer, particularly endometrial and cervical cancers. Uterine manipulators are a device inserted into the uterine cavity during MIS approaches to aid in directing the uterus within the pelvis, facilitating access to the uterine blood supply, defining the cardinal ligaments, lateralizing the ureters, and delineating the cervicovaginal junction. However, concerns have been raised regarding whether these devices are safe to use when the uterine corpus or cervix contains cancer.

Dr. Emma C. Rossi

In 2018, the LACC trial was published and demonstrated decreased survival for patients with cervical cancer who had undergone radical hysterectomy via a minimally invasive route.1 Several hypotheses were proposed to explain this finding including possible tumor disruption from use of a uterine manipulator. Regrettably, this study did not document manipulator use, and therefore its influence on outcomes could not be measured. However, since that time there has been honed interest into the potential negative influence of uterine manipulators on endometrial and cervical cancer surgery.

Uterine manipulators typically are inserted through the uterine cervix and reside in the endometrial cavity. It is often an inflated balloon which stabilizes the device within the cavity. Hypotheses for how they may contribute to the spread of malignancy include the massage of endometrial tumor from the pressure of the inflated balloon, facilitation of tumor dissemination through cervical lymphatics or vasculature as the manipulator traverses or punctures a cervical cancer, and possibly perforation of the uterine cavity during placement of the manipulator, and in doing so, contaminating the peritoneal cavity with endometrial or cervical cancer cells that have been dragged through with the device.

Interestingly, uterine manipulator placement is not the only time during which endometrial or cervical cancers may be disturbed prior to resection. Many diagnostic procedures such as cervical excisional procedures (loop electrosurgical excision procedure and conizations) or hysteroscopic resections cause significant intentional disruption of tumor. In the case of hysteroscopy for endometrial cancer, endometrial cancer cells have been detected in the peritoneal washings of endometrial cancer patients who have undergone this procedure, however, no worse outcomes have been associated when hysteroscopy was included as part of the diagnostic work-up, suggesting that more than simply efflux into the peritoneal cavity is necessary for those tumor cells to have metastatic potential.2

Indeed the data is mixed regarding oncologic outcomes with uterine manipulator use, especially for endometrial cancer. In one recent study the outcomes of 951 patients with endometrial cancer from seven Italian centers were evaluated.3 There was no difference in recurrence rates or disease-specific survival between the 579 patients in whom manipulators were used and the 372 patients in which surgery was performed without manipulators. More recently a Spanish study reported retrospectively on 2,661 patients at 15 centers and determined that use of a uterine manipulator (two-thirds of the cohort) was associated with a hazard ratio of 1.74 (95% confidence interval, 1.07-2.83) for risk of death.4 Unfortunately, in this study there were substantial differences between sites that used manipulators and those that did not. Additionally, while one would expect different patterns of recurrence if the manipulator was introducing a unique mechanism for metastasis, this was not observed between the manipulator and nonmanipulator arms. Finally, the groups were intrinsically different with respect to important risk factors such as lymphovascular space invasion, which might have contributed to the observed outcomes. It is important to recognize that, in both the LAP-2 and LACE trials, minimally invasive hysterectomy for endometrial cancer had been shown to have noninferior survival outcomes, compared with open hysterectomy.5,6 While these large randomized, controlled trials did not capture uterine manipulator usage, presumably it was utilized in at least some or most cases, and without apparent significant negative effect.

In cervical cancer, there is more competing data raising concern regarding manipulator use. The SUCCOR study was completed in 2020 and included a retrospective evaluation of 1,272 patients who had undergone open or MIS radical hysterectomy for early stage cervical cancer across 126 European centers during 2013-2014.7 They were able to evaluate for variables, such as uterine manipulator use. While they found that recurrence was higher for patients who had MIS hysterectomy, the HR (2.07) was similar to the HR for recurrence (2.76) among those who had uterine manipulator use. Conversely, the hazard ratio for recurrence following MIS radical hysterectomy without a manipulator was comparable with the superior rates seen with open surgery. This study was retrospective and therefore is largely hypothesis generating, however it does raise the question of whether the technique of MIS radical hysterectomy can be performed safely if particular steps, such as avoidance of a uterine manipulator, are followed. We await definitive results from prospective trials to determine this.

As mentioned earlier, the uterine manipulator is an important safety and feasibility tool for MIS hysterectomy. When not utilized, surgeons may need to add additional ports and instrumentation to maneuver the uterus and may have difficulty completing hysterectomy via a MIS approach for obese patients. There are additional urologic safety concerns when uterine elevation and cervicovaginal delineation is missing. Therefore, surgeons should consider use of the uterine manipulator on a case-by-case basis, potentially avoiding its use when it is not felt to be of benefit. While the wealth of prospective data suggests that manipulators are most likely safe in hysterectomy for endometrial cancer, they should be avoided if a minimally invasive approach to cervical cancer is employed.

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no conflicts of interest to report. Email her at [email protected].

References

1. N Engl J Med. 2018 Nov 15. doi: 10.1056/NEJMoa1806395.

2. Fertil Steril. 2011 Oct. doi: 10.1016/j.fertnstert.2011.07.1146.

3. Am J Obstet Gynecol. 2017 Jun. doi: 10.1016/j.ajog.2017.01.027.

4. Am J Obstet Gynecol. 2020 Jul 18. doi: 10.1016/j.ajog.2020.07.025.

5. J Clin Oncol. 2009 Nov 10. doi: 10.1200/JCO.2009.22.3248.

6. JAMA. 2017 Mar 28. doi: 10.1001/jama.2017.2068.

7. Int J Gynecol Cancer. 2020. doi: 10.1136/ijgc-2020-001506.

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POP surgeries not tied to decreased sexual functioning

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Sexual activity and function improve or at least are maintained following pelvic organ prolapse surgery, Danielle D. Antosh, MD, of the Houston Methodist Hospital and colleagues reported in a systematic review of prospective comparative studies on pelvic organ prolapse surgery, which was published in Obstetrics & Gynecology.

In a preliminary search of 3,124 citations, Dr. Antosh and her colleagues, who are members of the Society of Gynecologic Surgeons Systematic Review Group responsible for the study, identified and accepted 74 articles representing 67 original studies. Ten of these were ancillary studies with different reported outcomes or follow-up times, and 44 were randomized control trials. They compared the pre- and postoperative effects of pelvic organ prolapse (POP) surgery on sexual function for changes in sexual activity and function across eight different prolapse surgery categories: mixed native tissue repairs, anterior repair, posterior repair, uterosacral ligament suspension, sacrospinous ligament suspension, transvaginal mesh, biologic grafts, and sacrocolpopexy. In only three categories – posterior repair, transvaginal mesh, and biological grafts – postoperative changes in sexual function scores were similar or remained unchanged. In all other categories, total sexual function scores improved. Dyspareunia was lower after surgery for all prolapse surgery types.


“Although sexual function improves in the majority of women, it is important to note that a small proportion of women can develop de novo (new onset) dyspareunia after surgery. The rate of this ranges from 0%-9% for prolapse surgeries. However, there is limited data on posterior repairs,” Dr. Antosh said in a later interview.* 
 

POP surgeries positively impact sexual function, dyspareunia outcomes

The researchers determined that there is “moderate to high quality data” supporting the influence of POP on sexual activity and function. They also observed a lower prevalence of dyspareunia postoperatively across all surgery types, compared with baseline. Additionally, no decrease in sexual function was reported across surgical categories; in fact, sexual activity and function improved or stayed the same after POP surgery in this review.

Across most POP surgery groups, Dr. Antosh and colleagues found that with the exception of the sacrospinous ligament suspension, transvaginal mesh, and sacrocolpopexy groups, the rate of postoperative sexual activity was modestly higher. Several studies attributed this finding to a lack of partner or partner-related issues. Another 16 studies (7.7%) cited pain as the primary factor for postoperative sexual inactivity.

Few studies included in the review “reported both preoperative and postoperative rates of sexual activity and dyspareunia, and no study reported patient-level changes in sexual activity or dyspareunia (except occasionally, for de novo activity or dyspareunia),” Dr. Antosh and associates clarified. As a result, they concluded that their findings are based primarily on qualitative comparisons of events reported pre- and postoperatively from different but overlapping sets of studies.

The finding that the prevalence of dyspareunia decreased following all types of POP surgery is consistent with previous reviews. Because the studies did not account for minimally important differences in sexual function scores, it is important to consider this when interpreting results of the review. Dr. Antosh and colleagues also noted that some studies did not define dyspareunia, and those that did frequently used measures that were not validated. They also were unable to identify the persistence of dyspareunia following surgery as this was not recorded in the literature.
 

Menopausal status and other considerations

Also worth noting, the mean age of women in the studies were postmenopausal, yet the “studies did not stratify sexual function outcomes based on premenopause compared with postmenopause status.”

The researchers advised that future studies using validated definitions of sexual activity, function, and dyspareunia, as well as reporting both their preoperative and postoperative measures would do much to improve the quality of research reported.

It is widely recognized that women with pelvic floor disorders experience a high rate of sexual dysfunction, so the need to achieve optimum outcomes that at least maintain if not improve sexual function postoperatively should be of key concern when planning POP surgery for patients, they cautioned. Previous studies have observed that women experiencing POP rated the need for improved sexual function second only to resolved bulge symptoms and improvement in overall function. The women also classified sexual dysfunction in the same category of adversity as having chronic pain or having to be admitted to an intensive care unit.
 

Study provides preoperative counseling help

Dr. David M. Jaspan

David M. Jaspan, DO, chairman of the department of obstetrics and gynecology and Natasha Abdullah, MD, obstetrics and gynecology resident, both of Einstein Medical Center, Philadelphia, collaboratively commented on the study findings: “This review provides physicians with data to add to the preoperative counseling for patients undergoing pelvic organ prolapse surgery.”

In particular, they noted that, while the article “is a review of previous literature, Table 1 provides an opportunity for physicians to share with their patients the important answers to their concerns surrounding postoperative sexual activity, dyspareunia, and total changes in sexual function scores based on the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire 12 (PISQ-12).” 

Noting the clinical usefulness of the questionnaire, they added: “The PISQ-12 is a validated and reliable short form that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse and predicts PISQ-31 scores. It was developed from the data of 99 of 182 women surveyed to create the long form (PISQ-31); 46 patients were recruited for further validation. Test-retest reliability was checked with a subset of 20 patients. All subsets regression analysis with R greater than 0.92 identified 12 items that predicted PISQ-31 scores. The PISQ-12 covers three domains of function: Behavioral/Emotive, Physical, and Partner-Related.”

Because ob.gyns. are trained to recognize the “multifactorial reasons (age, partner relationship, other health conditions etc.) that surround sexual activity,” Dr. Jaspan and Dr. Abdullah cautioned against prematurely concluding that the lower sexual activity score is directly related to POP surgery. 

Dr. Natasha Abdullah

“Because sexual function is such an important postsurgical outcome for patients, this article provides significant preoperative counseling data for patients on all POP repair options,” they observed. “No surgical option worsens sexual function. The article concludes that individually validated definitions of sexual activity, function, and dyspareunia in a measuring instrument would improve the quality of data for future studies.”

The study authors reported no relevant financial disclosures. Although no direct funding was provided by the Society of Gynecologic Surgeons, they did provide meeting space, oversight, stipends for expert and statistical support, and aid in disseminating findings. Dr. Abdullah and Dr. Jaspan had no relevant financial disclosures.
 

SOURCE: Antosh DD et al. Obstet Gynecol. 2020. doi: 10.1097/AOG.0000000000004125.

*This article was updated on 10/28.

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Sexual activity and function improve or at least are maintained following pelvic organ prolapse surgery, Danielle D. Antosh, MD, of the Houston Methodist Hospital and colleagues reported in a systematic review of prospective comparative studies on pelvic organ prolapse surgery, which was published in Obstetrics & Gynecology.

In a preliminary search of 3,124 citations, Dr. Antosh and her colleagues, who are members of the Society of Gynecologic Surgeons Systematic Review Group responsible for the study, identified and accepted 74 articles representing 67 original studies. Ten of these were ancillary studies with different reported outcomes or follow-up times, and 44 were randomized control trials. They compared the pre- and postoperative effects of pelvic organ prolapse (POP) surgery on sexual function for changes in sexual activity and function across eight different prolapse surgery categories: mixed native tissue repairs, anterior repair, posterior repair, uterosacral ligament suspension, sacrospinous ligament suspension, transvaginal mesh, biologic grafts, and sacrocolpopexy. In only three categories – posterior repair, transvaginal mesh, and biological grafts – postoperative changes in sexual function scores were similar or remained unchanged. In all other categories, total sexual function scores improved. Dyspareunia was lower after surgery for all prolapse surgery types.


“Although sexual function improves in the majority of women, it is important to note that a small proportion of women can develop de novo (new onset) dyspareunia after surgery. The rate of this ranges from 0%-9% for prolapse surgeries. However, there is limited data on posterior repairs,” Dr. Antosh said in a later interview.* 
 

POP surgeries positively impact sexual function, dyspareunia outcomes

The researchers determined that there is “moderate to high quality data” supporting the influence of POP on sexual activity and function. They also observed a lower prevalence of dyspareunia postoperatively across all surgery types, compared with baseline. Additionally, no decrease in sexual function was reported across surgical categories; in fact, sexual activity and function improved or stayed the same after POP surgery in this review.

Across most POP surgery groups, Dr. Antosh and colleagues found that with the exception of the sacrospinous ligament suspension, transvaginal mesh, and sacrocolpopexy groups, the rate of postoperative sexual activity was modestly higher. Several studies attributed this finding to a lack of partner or partner-related issues. Another 16 studies (7.7%) cited pain as the primary factor for postoperative sexual inactivity.

Few studies included in the review “reported both preoperative and postoperative rates of sexual activity and dyspareunia, and no study reported patient-level changes in sexual activity or dyspareunia (except occasionally, for de novo activity or dyspareunia),” Dr. Antosh and associates clarified. As a result, they concluded that their findings are based primarily on qualitative comparisons of events reported pre- and postoperatively from different but overlapping sets of studies.

The finding that the prevalence of dyspareunia decreased following all types of POP surgery is consistent with previous reviews. Because the studies did not account for minimally important differences in sexual function scores, it is important to consider this when interpreting results of the review. Dr. Antosh and colleagues also noted that some studies did not define dyspareunia, and those that did frequently used measures that were not validated. They also were unable to identify the persistence of dyspareunia following surgery as this was not recorded in the literature.
 

Menopausal status and other considerations

Also worth noting, the mean age of women in the studies were postmenopausal, yet the “studies did not stratify sexual function outcomes based on premenopause compared with postmenopause status.”

The researchers advised that future studies using validated definitions of sexual activity, function, and dyspareunia, as well as reporting both their preoperative and postoperative measures would do much to improve the quality of research reported.

It is widely recognized that women with pelvic floor disorders experience a high rate of sexual dysfunction, so the need to achieve optimum outcomes that at least maintain if not improve sexual function postoperatively should be of key concern when planning POP surgery for patients, they cautioned. Previous studies have observed that women experiencing POP rated the need for improved sexual function second only to resolved bulge symptoms and improvement in overall function. The women also classified sexual dysfunction in the same category of adversity as having chronic pain or having to be admitted to an intensive care unit.
 

Study provides preoperative counseling help

Dr. David M. Jaspan

David M. Jaspan, DO, chairman of the department of obstetrics and gynecology and Natasha Abdullah, MD, obstetrics and gynecology resident, both of Einstein Medical Center, Philadelphia, collaboratively commented on the study findings: “This review provides physicians with data to add to the preoperative counseling for patients undergoing pelvic organ prolapse surgery.”

In particular, they noted that, while the article “is a review of previous literature, Table 1 provides an opportunity for physicians to share with their patients the important answers to their concerns surrounding postoperative sexual activity, dyspareunia, and total changes in sexual function scores based on the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire 12 (PISQ-12).” 

Noting the clinical usefulness of the questionnaire, they added: “The PISQ-12 is a validated and reliable short form that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse and predicts PISQ-31 scores. It was developed from the data of 99 of 182 women surveyed to create the long form (PISQ-31); 46 patients were recruited for further validation. Test-retest reliability was checked with a subset of 20 patients. All subsets regression analysis with R greater than 0.92 identified 12 items that predicted PISQ-31 scores. The PISQ-12 covers three domains of function: Behavioral/Emotive, Physical, and Partner-Related.”

Because ob.gyns. are trained to recognize the “multifactorial reasons (age, partner relationship, other health conditions etc.) that surround sexual activity,” Dr. Jaspan and Dr. Abdullah cautioned against prematurely concluding that the lower sexual activity score is directly related to POP surgery. 

Dr. Natasha Abdullah

“Because sexual function is such an important postsurgical outcome for patients, this article provides significant preoperative counseling data for patients on all POP repair options,” they observed. “No surgical option worsens sexual function. The article concludes that individually validated definitions of sexual activity, function, and dyspareunia in a measuring instrument would improve the quality of data for future studies.”

The study authors reported no relevant financial disclosures. Although no direct funding was provided by the Society of Gynecologic Surgeons, they did provide meeting space, oversight, stipends for expert and statistical support, and aid in disseminating findings. Dr. Abdullah and Dr. Jaspan had no relevant financial disclosures.
 

SOURCE: Antosh DD et al. Obstet Gynecol. 2020. doi: 10.1097/AOG.0000000000004125.

*This article was updated on 10/28.

Sexual activity and function improve or at least are maintained following pelvic organ prolapse surgery, Danielle D. Antosh, MD, of the Houston Methodist Hospital and colleagues reported in a systematic review of prospective comparative studies on pelvic organ prolapse surgery, which was published in Obstetrics & Gynecology.

In a preliminary search of 3,124 citations, Dr. Antosh and her colleagues, who are members of the Society of Gynecologic Surgeons Systematic Review Group responsible for the study, identified and accepted 74 articles representing 67 original studies. Ten of these were ancillary studies with different reported outcomes or follow-up times, and 44 were randomized control trials. They compared the pre- and postoperative effects of pelvic organ prolapse (POP) surgery on sexual function for changes in sexual activity and function across eight different prolapse surgery categories: mixed native tissue repairs, anterior repair, posterior repair, uterosacral ligament suspension, sacrospinous ligament suspension, transvaginal mesh, biologic grafts, and sacrocolpopexy. In only three categories – posterior repair, transvaginal mesh, and biological grafts – postoperative changes in sexual function scores were similar or remained unchanged. In all other categories, total sexual function scores improved. Dyspareunia was lower after surgery for all prolapse surgery types.


“Although sexual function improves in the majority of women, it is important to note that a small proportion of women can develop de novo (new onset) dyspareunia after surgery. The rate of this ranges from 0%-9% for prolapse surgeries. However, there is limited data on posterior repairs,” Dr. Antosh said in a later interview.* 
 

POP surgeries positively impact sexual function, dyspareunia outcomes

The researchers determined that there is “moderate to high quality data” supporting the influence of POP on sexual activity and function. They also observed a lower prevalence of dyspareunia postoperatively across all surgery types, compared with baseline. Additionally, no decrease in sexual function was reported across surgical categories; in fact, sexual activity and function improved or stayed the same after POP surgery in this review.

Across most POP surgery groups, Dr. Antosh and colleagues found that with the exception of the sacrospinous ligament suspension, transvaginal mesh, and sacrocolpopexy groups, the rate of postoperative sexual activity was modestly higher. Several studies attributed this finding to a lack of partner or partner-related issues. Another 16 studies (7.7%) cited pain as the primary factor for postoperative sexual inactivity.

Few studies included in the review “reported both preoperative and postoperative rates of sexual activity and dyspareunia, and no study reported patient-level changes in sexual activity or dyspareunia (except occasionally, for de novo activity or dyspareunia),” Dr. Antosh and associates clarified. As a result, they concluded that their findings are based primarily on qualitative comparisons of events reported pre- and postoperatively from different but overlapping sets of studies.

The finding that the prevalence of dyspareunia decreased following all types of POP surgery is consistent with previous reviews. Because the studies did not account for minimally important differences in sexual function scores, it is important to consider this when interpreting results of the review. Dr. Antosh and colleagues also noted that some studies did not define dyspareunia, and those that did frequently used measures that were not validated. They also were unable to identify the persistence of dyspareunia following surgery as this was not recorded in the literature.
 

Menopausal status and other considerations

Also worth noting, the mean age of women in the studies were postmenopausal, yet the “studies did not stratify sexual function outcomes based on premenopause compared with postmenopause status.”

The researchers advised that future studies using validated definitions of sexual activity, function, and dyspareunia, as well as reporting both their preoperative and postoperative measures would do much to improve the quality of research reported.

It is widely recognized that women with pelvic floor disorders experience a high rate of sexual dysfunction, so the need to achieve optimum outcomes that at least maintain if not improve sexual function postoperatively should be of key concern when planning POP surgery for patients, they cautioned. Previous studies have observed that women experiencing POP rated the need for improved sexual function second only to resolved bulge symptoms and improvement in overall function. The women also classified sexual dysfunction in the same category of adversity as having chronic pain or having to be admitted to an intensive care unit.
 

Study provides preoperative counseling help

Dr. David M. Jaspan

David M. Jaspan, DO, chairman of the department of obstetrics and gynecology and Natasha Abdullah, MD, obstetrics and gynecology resident, both of Einstein Medical Center, Philadelphia, collaboratively commented on the study findings: “This review provides physicians with data to add to the preoperative counseling for patients undergoing pelvic organ prolapse surgery.”

In particular, they noted that, while the article “is a review of previous literature, Table 1 provides an opportunity for physicians to share with their patients the important answers to their concerns surrounding postoperative sexual activity, dyspareunia, and total changes in sexual function scores based on the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire 12 (PISQ-12).” 

Noting the clinical usefulness of the questionnaire, they added: “The PISQ-12 is a validated and reliable short form that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse and predicts PISQ-31 scores. It was developed from the data of 99 of 182 women surveyed to create the long form (PISQ-31); 46 patients were recruited for further validation. Test-retest reliability was checked with a subset of 20 patients. All subsets regression analysis with R greater than 0.92 identified 12 items that predicted PISQ-31 scores. The PISQ-12 covers three domains of function: Behavioral/Emotive, Physical, and Partner-Related.”

Because ob.gyns. are trained to recognize the “multifactorial reasons (age, partner relationship, other health conditions etc.) that surround sexual activity,” Dr. Jaspan and Dr. Abdullah cautioned against prematurely concluding that the lower sexual activity score is directly related to POP surgery. 

Dr. Natasha Abdullah

“Because sexual function is such an important postsurgical outcome for patients, this article provides significant preoperative counseling data for patients on all POP repair options,” they observed. “No surgical option worsens sexual function. The article concludes that individually validated definitions of sexual activity, function, and dyspareunia in a measuring instrument would improve the quality of data for future studies.”

The study authors reported no relevant financial disclosures. Although no direct funding was provided by the Society of Gynecologic Surgeons, they did provide meeting space, oversight, stipends for expert and statistical support, and aid in disseminating findings. Dr. Abdullah and Dr. Jaspan had no relevant financial disclosures.
 

SOURCE: Antosh DD et al. Obstet Gynecol. 2020. doi: 10.1097/AOG.0000000000004125.

*This article was updated on 10/28.

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When should students resume sports after a COVID-19 diagnosis?

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Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

A teenager wears a face mask
Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

Dr. Susannah Briskin

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

 

 



Mitigating risk

Dr. David T. Bernhardt

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

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Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

A teenager wears a face mask
Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

Dr. Susannah Briskin

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

 

 



Mitigating risk

Dr. David T. Bernhardt

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.

A teenager wears a face mask
Canberk Sezer/Getty Images

There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.

“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”

Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
 

Limited data

Dr. Susannah Briskin

The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.

Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.

“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”

Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.

“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.

Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”

Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”

 

 



Mitigating risk

Dr. David T. Bernhardt

COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”

When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”

If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.

Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.

Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”

Dr. Bernhardt had no relevant disclosures.

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Two-stage surgery to reduce ovarian cancer risk piques interest

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“Many physicians would assume that prevention of cancer, especially cancer as serious as ovarian cancer, trumps all other decision making, but when we really listen to high-risk women, they want to have options,” Karen Lu, MD, chair of gynecologic oncology and reproductive medicine at MD Anderson Cancer Center, Houston, Texas, told Medscape Medical News.

She was commenting on the findings from a UK survey conducted among women at an increased risk for ovarian cancer (OC), some of whom had already undergone salpingo-oophorectomy (RRSO), a standard risk-reducing surgery that involves removal of fallopian tubes and ovaries.

The survey found that these women were just as likely to consider an alternative two-stage surgical approach in which the fallopian tubes are removed but removal of the ovaries is delayed ― risk-reducing early salpingectomy with delayed oophorectomy (RRESDO).

In the survey, women were asked which option they would theorectically prefer. At present, the two-step surgery is recommended only within the context of a research trial (several of which are ongoing).

The UK survey was published online August 16 in the British Journal of Obstetrics and Gynaecology.

It found that premenopausal women concerned about the sexual dysfunction that can occur after RRSO were most likely to embrace the two-step surgery option.

The likelihood of finding this option acceptable was nearly three times higher among this subgroup of patients (odds ratio [RR], 2.9). It was more than five times higher among patients who had already undergone RRSO and had experienced sexual dysfunction after the surgery (OR, 5.3), the authors report.

These findings largely mirror those from a 2014 survey of US women, which set the stage for the Women Choosing Surgical Prevention (WISP) study.

The WISP investigators, led by Lu, are assessing quality-of-life outcomes related to sexual function with RRESDO vs RRSO.

Final results from the WISP study and from a similar Dutch study, TUBA, which is evaluating RRESDO’s effects on menopause-related quality of life, are anticipated in late 2020 or early 2021.

The investigators from both the WISP and the TUBA trials are planning a joint trial to evaluate the safety and efficacy of RRESDO, Lu told Medscape Medical News.

The PROTECTOR study, in the United Kingdom, is currently enrolling patients. Like WISP, its primary endpoint will be quality-of-life measures related to sexual function. The PROTECTOR trial will offer the option of RRESDO to the “large proportion of eligible women” who are interested in this two-stage approach, as evidenced by the UK survey, said Faiza Gaba, MBB, first author on the survey results. Gaba is affiliated with the Wolfson Institute of Preventive Medicine at the Queen Mary University of London and the Department of Gynaecological Oncology at St Bartholomew’s Hospital, London, United Kingdom.

Survey findings

The 39-item survey was offered from October 2017 to June 2019 at multiple clinics in the United Kingdom and to members of a support group for BRCA gene carriers. Of the 683 respondents, 346 had undergone RRSO and 337 had not. Those who had not were significantly younger (38.3 years vs 51.5 years); 262 were premenopausal.

Overall, 88.8% of the premenopausal and 95.2% of the postmenopausal women who had undergone RRSO were satisfied with their decision, but, respectively, 9.4% and 1.2% of these women regretted their decision.

More than half (55.3%) said they would consider participating in a study offering RRESDO, 20.2% said they wouldn’t consider it, and 24% weren’t sure.

Among the premenopausal respondents who had not undergone RRSO, 69.1% said they would consider it, and 30.9% said they would not.

Those wanting to delay hot flashes were five times more likely to find RRESDO acceptable (OR, 5.0).

Willingness to undergo RRESDO in a trial setting was also higher among those who considered it acceptable to undergo two surgeries (OR, 444.1), to undergo interval monitoring between surgeries (OR, 59.0), to have uncertainty about the level of OC risk reduction with RRESDO (OR, 14.6), and to potentially experience interval OC between the two surgeries (OR, 9.6).

Notably, 74.1% of the premenopausal RRSO patients used hormone replacement therapy (HRT), and most said it reduced symptoms of vaginal dryness. HRT use was not significantly associated with satisfaction or regret regarding decisions to undergo RRSO, the authors found.

Rather, the high regret rates among premenopausal women who underwent RRSO were driven largely by certain symptoms. Regret was highest among those who experienced night sweats (OR, 13.8), sleep disturbance (OR, 18.8), sexual dysfunction (OR, 5.3), or urinary incontinence (OR 17.2). More of those women than those who did not experience these symptoms said they regretted their decision (OR, 6.4) and that RRSO did them a lot of harm (OR, 3.9). These women were also significantly more likely to say they would have opted for RRESDO instead of RRSO had they been given the option, whereas those with hot flashes, osteoporosis, or fatigue after RRSO were less likely, retrospectively, to choose RRESDO.

The findings suggest “there is a range of tolerability and acceptability of various symptoms among women which affects surgical decision making,” the authors comment.

RRSO remains the gold standard for OC risk reduction, but about 10% of premenopausal women regret having undergone RRSO, mainly because of the menopausal sequelae, they note.

RRESDO could offer an alternative for relatively young women who wish to delay the onset of menopause, they suggest.

The approach is supported by evidence that most high-grade, serous OC originates in the fallopian tubes, meaning delayed oophorectomy with RRESDO may have a favorable risk-benefit profile for those wishing to avoid surgical menopause.

Preliminary reports from WISP and TUBA were presented at the annual meeting of the Society of Gynecologic Oncology in 2019. These initial results showed, as expected, that menopausal symptoms were worse with RRSO. This was true even among those who used HRT, WISP lead investigator Lu told Medscape Medical News.

She applauded the work by Gaba and colleagues, saying that the survey shows that women appreciate having options.

“It’s quite a daunting dilemma” for a woman at high risk but who is without cancer ― a “previvor” ― to be told that the standard-of-care recommendation is to undergo surgical menopause years earlier than would occur naturally, Lu added.

However, it is most important to know whether a given approach is safe and effective, and that’s where the joint international study planned by her team and the TUBA study investigators comes in.

“Acceptability is important; showing the impact on menopausal symptoms and sexual function is important,” she said. “But ultimately, we really need to know that [RRESDO] protects women from ovarian cancer.”

The UK survey was funded by a grant from Rosetrees Trust. Gaba and Lu have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

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“Many physicians would assume that prevention of cancer, especially cancer as serious as ovarian cancer, trumps all other decision making, but when we really listen to high-risk women, they want to have options,” Karen Lu, MD, chair of gynecologic oncology and reproductive medicine at MD Anderson Cancer Center, Houston, Texas, told Medscape Medical News.

She was commenting on the findings from a UK survey conducted among women at an increased risk for ovarian cancer (OC), some of whom had already undergone salpingo-oophorectomy (RRSO), a standard risk-reducing surgery that involves removal of fallopian tubes and ovaries.

The survey found that these women were just as likely to consider an alternative two-stage surgical approach in which the fallopian tubes are removed but removal of the ovaries is delayed ― risk-reducing early salpingectomy with delayed oophorectomy (RRESDO).

In the survey, women were asked which option they would theorectically prefer. At present, the two-step surgery is recommended only within the context of a research trial (several of which are ongoing).

The UK survey was published online August 16 in the British Journal of Obstetrics and Gynaecology.

It found that premenopausal women concerned about the sexual dysfunction that can occur after RRSO were most likely to embrace the two-step surgery option.

The likelihood of finding this option acceptable was nearly three times higher among this subgroup of patients (odds ratio [RR], 2.9). It was more than five times higher among patients who had already undergone RRSO and had experienced sexual dysfunction after the surgery (OR, 5.3), the authors report.

These findings largely mirror those from a 2014 survey of US women, which set the stage for the Women Choosing Surgical Prevention (WISP) study.

The WISP investigators, led by Lu, are assessing quality-of-life outcomes related to sexual function with RRESDO vs RRSO.

Final results from the WISP study and from a similar Dutch study, TUBA, which is evaluating RRESDO’s effects on menopause-related quality of life, are anticipated in late 2020 or early 2021.

The investigators from both the WISP and the TUBA trials are planning a joint trial to evaluate the safety and efficacy of RRESDO, Lu told Medscape Medical News.

The PROTECTOR study, in the United Kingdom, is currently enrolling patients. Like WISP, its primary endpoint will be quality-of-life measures related to sexual function. The PROTECTOR trial will offer the option of RRESDO to the “large proportion of eligible women” who are interested in this two-stage approach, as evidenced by the UK survey, said Faiza Gaba, MBB, first author on the survey results. Gaba is affiliated with the Wolfson Institute of Preventive Medicine at the Queen Mary University of London and the Department of Gynaecological Oncology at St Bartholomew’s Hospital, London, United Kingdom.

Survey findings

The 39-item survey was offered from October 2017 to June 2019 at multiple clinics in the United Kingdom and to members of a support group for BRCA gene carriers. Of the 683 respondents, 346 had undergone RRSO and 337 had not. Those who had not were significantly younger (38.3 years vs 51.5 years); 262 were premenopausal.

Overall, 88.8% of the premenopausal and 95.2% of the postmenopausal women who had undergone RRSO were satisfied with their decision, but, respectively, 9.4% and 1.2% of these women regretted their decision.

More than half (55.3%) said they would consider participating in a study offering RRESDO, 20.2% said they wouldn’t consider it, and 24% weren’t sure.

Among the premenopausal respondents who had not undergone RRSO, 69.1% said they would consider it, and 30.9% said they would not.

Those wanting to delay hot flashes were five times more likely to find RRESDO acceptable (OR, 5.0).

Willingness to undergo RRESDO in a trial setting was also higher among those who considered it acceptable to undergo two surgeries (OR, 444.1), to undergo interval monitoring between surgeries (OR, 59.0), to have uncertainty about the level of OC risk reduction with RRESDO (OR, 14.6), and to potentially experience interval OC between the two surgeries (OR, 9.6).

Notably, 74.1% of the premenopausal RRSO patients used hormone replacement therapy (HRT), and most said it reduced symptoms of vaginal dryness. HRT use was not significantly associated with satisfaction or regret regarding decisions to undergo RRSO, the authors found.

Rather, the high regret rates among premenopausal women who underwent RRSO were driven largely by certain symptoms. Regret was highest among those who experienced night sweats (OR, 13.8), sleep disturbance (OR, 18.8), sexual dysfunction (OR, 5.3), or urinary incontinence (OR 17.2). More of those women than those who did not experience these symptoms said they regretted their decision (OR, 6.4) and that RRSO did them a lot of harm (OR, 3.9). These women were also significantly more likely to say they would have opted for RRESDO instead of RRSO had they been given the option, whereas those with hot flashes, osteoporosis, or fatigue after RRSO were less likely, retrospectively, to choose RRESDO.

The findings suggest “there is a range of tolerability and acceptability of various symptoms among women which affects surgical decision making,” the authors comment.

RRSO remains the gold standard for OC risk reduction, but about 10% of premenopausal women regret having undergone RRSO, mainly because of the menopausal sequelae, they note.

RRESDO could offer an alternative for relatively young women who wish to delay the onset of menopause, they suggest.

The approach is supported by evidence that most high-grade, serous OC originates in the fallopian tubes, meaning delayed oophorectomy with RRESDO may have a favorable risk-benefit profile for those wishing to avoid surgical menopause.

Preliminary reports from WISP and TUBA were presented at the annual meeting of the Society of Gynecologic Oncology in 2019. These initial results showed, as expected, that menopausal symptoms were worse with RRSO. This was true even among those who used HRT, WISP lead investigator Lu told Medscape Medical News.

She applauded the work by Gaba and colleagues, saying that the survey shows that women appreciate having options.

“It’s quite a daunting dilemma” for a woman at high risk but who is without cancer ― a “previvor” ― to be told that the standard-of-care recommendation is to undergo surgical menopause years earlier than would occur naturally, Lu added.

However, it is most important to know whether a given approach is safe and effective, and that’s where the joint international study planned by her team and the TUBA study investigators comes in.

“Acceptability is important; showing the impact on menopausal symptoms and sexual function is important,” she said. “But ultimately, we really need to know that [RRESDO] protects women from ovarian cancer.”

The UK survey was funded by a grant from Rosetrees Trust. Gaba and Lu have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

“Many physicians would assume that prevention of cancer, especially cancer as serious as ovarian cancer, trumps all other decision making, but when we really listen to high-risk women, they want to have options,” Karen Lu, MD, chair of gynecologic oncology and reproductive medicine at MD Anderson Cancer Center, Houston, Texas, told Medscape Medical News.

She was commenting on the findings from a UK survey conducted among women at an increased risk for ovarian cancer (OC), some of whom had already undergone salpingo-oophorectomy (RRSO), a standard risk-reducing surgery that involves removal of fallopian tubes and ovaries.

The survey found that these women were just as likely to consider an alternative two-stage surgical approach in which the fallopian tubes are removed but removal of the ovaries is delayed ― risk-reducing early salpingectomy with delayed oophorectomy (RRESDO).

In the survey, women were asked which option they would theorectically prefer. At present, the two-step surgery is recommended only within the context of a research trial (several of which are ongoing).

The UK survey was published online August 16 in the British Journal of Obstetrics and Gynaecology.

It found that premenopausal women concerned about the sexual dysfunction that can occur after RRSO were most likely to embrace the two-step surgery option.

The likelihood of finding this option acceptable was nearly three times higher among this subgroup of patients (odds ratio [RR], 2.9). It was more than five times higher among patients who had already undergone RRSO and had experienced sexual dysfunction after the surgery (OR, 5.3), the authors report.

These findings largely mirror those from a 2014 survey of US women, which set the stage for the Women Choosing Surgical Prevention (WISP) study.

The WISP investigators, led by Lu, are assessing quality-of-life outcomes related to sexual function with RRESDO vs RRSO.

Final results from the WISP study and from a similar Dutch study, TUBA, which is evaluating RRESDO’s effects on menopause-related quality of life, are anticipated in late 2020 or early 2021.

The investigators from both the WISP and the TUBA trials are planning a joint trial to evaluate the safety and efficacy of RRESDO, Lu told Medscape Medical News.

The PROTECTOR study, in the United Kingdom, is currently enrolling patients. Like WISP, its primary endpoint will be quality-of-life measures related to sexual function. The PROTECTOR trial will offer the option of RRESDO to the “large proportion of eligible women” who are interested in this two-stage approach, as evidenced by the UK survey, said Faiza Gaba, MBB, first author on the survey results. Gaba is affiliated with the Wolfson Institute of Preventive Medicine at the Queen Mary University of London and the Department of Gynaecological Oncology at St Bartholomew’s Hospital, London, United Kingdom.

Survey findings

The 39-item survey was offered from October 2017 to June 2019 at multiple clinics in the United Kingdom and to members of a support group for BRCA gene carriers. Of the 683 respondents, 346 had undergone RRSO and 337 had not. Those who had not were significantly younger (38.3 years vs 51.5 years); 262 were premenopausal.

Overall, 88.8% of the premenopausal and 95.2% of the postmenopausal women who had undergone RRSO were satisfied with their decision, but, respectively, 9.4% and 1.2% of these women regretted their decision.

More than half (55.3%) said they would consider participating in a study offering RRESDO, 20.2% said they wouldn’t consider it, and 24% weren’t sure.

Among the premenopausal respondents who had not undergone RRSO, 69.1% said they would consider it, and 30.9% said they would not.

Those wanting to delay hot flashes were five times more likely to find RRESDO acceptable (OR, 5.0).

Willingness to undergo RRESDO in a trial setting was also higher among those who considered it acceptable to undergo two surgeries (OR, 444.1), to undergo interval monitoring between surgeries (OR, 59.0), to have uncertainty about the level of OC risk reduction with RRESDO (OR, 14.6), and to potentially experience interval OC between the two surgeries (OR, 9.6).

Notably, 74.1% of the premenopausal RRSO patients used hormone replacement therapy (HRT), and most said it reduced symptoms of vaginal dryness. HRT use was not significantly associated with satisfaction or regret regarding decisions to undergo RRSO, the authors found.

Rather, the high regret rates among premenopausal women who underwent RRSO were driven largely by certain symptoms. Regret was highest among those who experienced night sweats (OR, 13.8), sleep disturbance (OR, 18.8), sexual dysfunction (OR, 5.3), or urinary incontinence (OR 17.2). More of those women than those who did not experience these symptoms said they regretted their decision (OR, 6.4) and that RRSO did them a lot of harm (OR, 3.9). These women were also significantly more likely to say they would have opted for RRESDO instead of RRSO had they been given the option, whereas those with hot flashes, osteoporosis, or fatigue after RRSO were less likely, retrospectively, to choose RRESDO.

The findings suggest “there is a range of tolerability and acceptability of various symptoms among women which affects surgical decision making,” the authors comment.

RRSO remains the gold standard for OC risk reduction, but about 10% of premenopausal women regret having undergone RRSO, mainly because of the menopausal sequelae, they note.

RRESDO could offer an alternative for relatively young women who wish to delay the onset of menopause, they suggest.

The approach is supported by evidence that most high-grade, serous OC originates in the fallopian tubes, meaning delayed oophorectomy with RRESDO may have a favorable risk-benefit profile for those wishing to avoid surgical menopause.

Preliminary reports from WISP and TUBA were presented at the annual meeting of the Society of Gynecologic Oncology in 2019. These initial results showed, as expected, that menopausal symptoms were worse with RRSO. This was true even among those who used HRT, WISP lead investigator Lu told Medscape Medical News.

She applauded the work by Gaba and colleagues, saying that the survey shows that women appreciate having options.

“It’s quite a daunting dilemma” for a woman at high risk but who is without cancer ― a “previvor” ― to be told that the standard-of-care recommendation is to undergo surgical menopause years earlier than would occur naturally, Lu added.

However, it is most important to know whether a given approach is safe and effective, and that’s where the joint international study planned by her team and the TUBA study investigators comes in.

“Acceptability is important; showing the impact on menopausal symptoms and sexual function is important,” she said. “But ultimately, we really need to know that [RRESDO] protects women from ovarian cancer.”

The UK survey was funded by a grant from Rosetrees Trust. Gaba and Lu have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

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Laparoscopic specimen retrieval bags in gyn surgery: Expert guidance on selection

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The use of minimally invasive gynecologic surgery (MIGS) has grown rapidly over the past 20 years. MIGS, which includes vaginal hysterectomy and laparoscopic hysterectomy, is safe and has fewer complications and a more rapid recovery period than open abdominal surgery.1,2 In 2005, the role of MIGS was expanded further when the US Food and Drug Administration (FDA) approved robot-assisted surgery for the performance of gynecologic procedures.3 As knowledge and experience in the safe performance of MIGS progresses, the rates for MIGS procedures have skyrocketed and continue to grow. Between 2007 and 2010, laparoscopic hysterectomy rates rose from 23.5% to 30.5%, while robot-assisted laparoscopic hysterectomy rates increased from 0.5% to 9.5%, representing 40% of all hysterectomies.4 Due to the benefits of minimally invasive surgery over open abdominal surgery, patient and physician preference for minimally invasive procedures has grown significantly in popularity.1,5

Because incisions are small in minimally invasive surgery, surgeons have been challenged with removing large specimens through incisions that are much smaller than the presenting pathology. One approach is to use a specimen retrieval bag for specimen extraction. Once the dissection is completed, the specimen is placed within the retrieval bag for removal, thus minimizing exposure of the specimen and its contents to the abdominopelvic cavity and incision.

The use of specimen retrieval devices has been advocated to prevent infection, avoid spillage into the peritoneal cavity, and minimize the risk of port-site metastases in cases of potentially cancerous specimens. Devices include affordable and readily available products, such as nonpowdered gloves, and commercially produced bags.6

While the use of specimen containment systems for tissue extraction has been well described in gynecology, the available systems vary widely in construction, size, durability, and shape, potentially leading to confusion and suboptimal bag selection during surgery.7 In this article, we review the most common laparoscopic bags available in the United States, provide an overview of bag characteristics, offer practice guidelines for bag selection, and review bag terminology to highlight important concepts for bag selection.

Controversy spurs change

In April 2014, the FDA warned against the use of power morcellation for specimen removal during minimally invasive surgery, citing a prevalence of 1 in 352 unsuspected uterine sarcomas and 1 in 498 unsuspected uterine leiomyosarcomas among women undergoing hysterectomy or myomectomy for presumed benign leiomyoma.8 Since then, the risk of occult uterine sarcomas, including leiomyosarcoma, in women undergoing surgery for benign gynecologic indications has been determined to be much lower.

Nonetheless, the clinical importance of contained specimen removal was clearly highlighted and the role of specimen retrieval bags soared to the forefront. Open power morcellation is no longer commonly practiced, and national societies such as the American Association of Gynecologic Laparoscopists (AAGL), the Society of Gynecologic Oncology (SGO), and the American College of Obstetricians and Gynecologists (ACOG) recommend that containment systems be used for safer specimen retrieval during gynecologic surgery.9-11 After the specimen is placed inside the containment system (typically a specimen bag), the surgeon may deliver the bag through a vaginal colpotomy or through a slightly extended laparoscopic incision to remove bulky specimens using cold-cutting extraction techniques.12-15

Continue to: Know the pathology’s characteristics...

 

 

Know the pathology’s characteristics

In most cases, based on imaging studies and physical examination, surgeons have a good idea of what to expect before proceeding with surgery. The 2 most common characteristics used for surgical planning are the specimen size (dimensions) and the tissue type (solid, cystic, soft tissue, or mixed). The mass size can range from less than 1 cm to larger than a 20-week sized fibroid uterus. Assessing the specimen in 3 dimensions is important. Tissue type also is a consideration, as soft and squishy masses, such as ovarian cysts, are easier to deflate and manipulate within the bag compared with solid or calcified tumors, such as a large fibroid uterus or a large dermoid with solid components.

Specimen shape also is a critical determinant for bag selection. Most specimen retrieval bags are tapered to varying degrees, and some have an irregular shape. Long tubular structures, such as fallopian tubes that are composed of soft tissue, fit easily into most bags regardless of bag shape or extent of bag taper, whereas the round shape of a bulky myoma may render certain bags ineffective even if the bag’s entrance accommodates the greatest diameter of the myoma. Often, a round mass will not fully fit into a bag because there is a poor fit between the mass’s shape and the bag’s shape and taper. (We discuss the concept of a poor “fit” below.) Knowing the pathology before starting a procedure can help optimize bag selection, streamline operative flow, and reduce waste.

Overview of laparoscopic bag characteristics and clinical applications

The TABLE lists the most common laparoscopic bags available for purchase in the United States. Details include the trocar size, manufacturer, product name, mouth diameter, volume, bag shape, construction material, and best clinical application.

The following are terms used to refer to the components of a laparoscopic retrieval bag:

  • Mouth diameter: diameter at the entrance of a fully opened bag (FIGURE 1)
  • Bag volume: the total volume a bag can accommodate when completely full
  • Bag rim: characteristics of the rim of the bag when opened (that is, rigid vs soft rim, complete vs partial rim mechanism to hold the bag open) (FIGURE 2)
  • Bag shape: the shape of the bag when it is fully opened (square shaped vs cone shaped vs curved bag shape) (FIGURE 2)
  • Bag taper (severity and type): extent the bag is tapered from the rim of the bag’s entrance to the base of the bag; categorized by taper severity (minimal, gradual, or steep taper) and type (continuous taper or curved taper) (FIGURE 3)
  • Ball fit: the maximum spherical specimen size that completely fits into a bag and allows it to cinch closed (FIGURE 4)
  • Bag strength: durability of a bag when placed on tension during specimen extraction (weak, moderate, or extremely durable).

Continue to: Mouth diameter...

 

 

Mouth diameter

Bag manufacturers often differentiate bag sizes by indicating “volume” in milliliters. Bag volume, however, offers little clinical value to surgeons, as pelvic mass dimensions are usually measured in centimeters on imaging. Rather, an important characteristic for bag selection is the diameter of the rim of the bag when it is fully opened—the so-called bag mouth diameter. For a specimen to fit, the 2 dimensions of the specimen must be smaller than the dimensions of the bag entrance.

Notably, the number often linked to the specimen bag—as, for example, in the 10-mm Endo Catch bag (Covidien/Medtronic)— describes the width of the shaft of the bag before it is opened rather than the mouth diameter of the opened bag. The number actually correlates with the trocar size necessary for bag insertion rather than with the specimen size that can fit into the bag. Therefore, a 10-mm Endo Catch bag cannot fit a 10-cm mass, but rather requires a trocar size of 10 mm or greater for insertion of the bag. Fully opened, the mouth diameters of the 10-mm Endo Catch bag are roughly 6 cm x 7 cm, which allows for delivery of a 6-cm mass.

Because 2 bags that use the same trocar size for insertion may have vastly differing bag dimensions, the surgeon must know the bag mouth diameters when selecting a bag to remove the presenting pathology. For example, the Inzii 12 (Applied Medical) laparoscopic bag has mouth diameters of 9.7 cm × 13.0 cm, whereas the Anchor TRSROBO-12 (ConMed) has mouth diameters of 6.7 cm × 7.6 cm (TABLE). Although both bags can be inserted through a 12-mm trocar, both bags cannot fit the same size mass for removal.

Shape and taper

Laparoscopic bags come in various shapes (curved, cone, or square shaped), with varying levels of bag taper (steep, gradual, or no taper) (FIGURES 2 and 3). While taper has little impact on long and skinny specimens, taper may hinder successful bagging of bulky or spherical specimens.

Each bag has different grades of taper regardless of mouth diameter or trocar size. For round masses, the steeper the taper, the smaller the mass that can comfortably fit within the bag. This concept is connected to the idea of “ball fit,” explained below.

In addition, bag shape may affect what mass size can fit into the bag. An irregularly shaped curved bag or a bag with a steep taper may be well suited for removal of multiple specimens of varying sizes or soft masses that are malleable enough to conform to the bag’s shape (such as a ruptured ovarian cyst). Alternatively, a square-shaped bag or a bag with minimal taper would better accommodate a round mass.

Ball fit

When thinking about large circular masses, such as myomas or ovarian cysts, one must consider the ball fit. This refers to the maximum spherical size of the specimen that fits completely within a bag while allowing the bag to cinch closed. Generally, this is an estimation that factors in the bag shape, extent of the bag taper, bag mouth diameter, and specimen shape and tissue type. At times, although a mass can fit through the bag’s mouth diameter, a steep taper may prevent the mass from being fully bagged and limit closure of the bag (FIGURE 4).

Curved bags like the Anchor TRSVATS-15 (ConMed), which have a very narrow bottom, are prone to a limited ball fit, and thus the bag mouth diameter will not correlate with the largest mass size that can be fitted within the bag. Therefore, if using a steeply tapered bag for removal of large round masses, do not rely on the bag’s mouth diameter for bag selection. The surgeon must visualize the ball fit within the bag, taking into account the specimen size and shape, bag shape, and bag taper. In these scenarios, using the diameter of the midportion of the opened bag may better reflect the mass size that can fit into that bag.

Bag strength

Bag strength depends on the material used for bag construction. Most laparoscopic bags in the United States are made of 3 different materials: polyurethane, polypropylene, and ripstop nylon.

Polyurethane and polypropylene are synthetic plastic polymers; in bag form they are stretchy and, under extreme force, may tear. They are best used for bagging fluid-filled cysts or soft pliable masses that will not require extensive bag or tissue handling, such as extraction of large leiomyomas. Polyurethane and polypropylene bags are more susceptible to puncture with sharp laparoscopic instruments or scalpels, and care must be taken to avoid accidentally cutting the bag during tissue extraction.

Alternatively, bags made of ripstop nylon are favored for their bag strength. Ripstop nylon is a synthetic fabric that is woven together in a crosshatch pattern that makes it resistant to tearing and ripping. It was developed originally during World War II as a replacement for silk parachutes. Modern applications include its use in sails, kites, and high-quality camping equipment. This material has a favorable strength-to-weight ratio, and, in case of a tear, it is less prone to extension of the tear. For surgical applications, these bags are best used for bagging specimens that will require a lot of bag manipulation and tissue extraction. However, the ripstop fabric takes up more space in the incision than polyurethane or polypropylene, leaving the surgeon with less space for tissue extraction. Thus, as a tradeoff for bag strength, the surgeon may need to extend the incision a little, and a small self-retracting wound retractor may be necessary to allow visibility for safe tissue extraction when using a ripstop nylon bag compared with others.

Continue to: Trocar selection is important...

 

 

Trocar selection is important

While considering bag selection, the surgeon also must consider trocar selection to allow for laparoscopic insertion of the bag. Trocar size for bag selection refers to the minimum trocar diameter needed to insert the laparoscopic bag. Most bags are designed to fit into a laparoscopic trocar or into the skin incision that previously housed the trocar. Trocar size does not directly correlate with bag mouth diameter; for example, a 10-mm laparoscopic bag that can be inserted through a 10- or 12-mm trocar size cannot fit a 10-cm mass (see the mouth diameter section above).

A tip to maximize operating room (OR) efficiency is to start off with a larger trocar, such as a 12-mm trocar, if it is known that a laparoscopic bag with a 12-mm trocar size will be used, rather than starting with a 5-mm trocar and upsizing the port site incision. This saves time and offers intraoperative flexibility, allowing for the use of larger instruments and quicker insufflation.

Furthermore, if the specimen has a solid component and tissue extraction is anticipated, consider starting off with a large trocar, one that is larger than the bag’s trocar size since the incision likely will be extended. For example, even if a myoma will fit within a 10-mm laparoscopic bag made of ripstop nylon, using a 15-mm trocar rather than a 10-mm trocar may be considered since the skin and fascial incisions will need to be extended to allow for cold-cut tissue extraction. Starting with the larger 15-mm trocar may offer surgical advantages, such as direct needle delivery of larger needles for myometrial closure after myomectomy or direct removal of smaller myomas through the trocar to avoid bagging multiple specimens.

Putting it all together

To optimize efficiency in the OR for specimen removal, we recommend streamlining OR flow and reducing waste by first considering the specimen size, tissue type, bag shape, and trocar selection. Choose a bag by taking into account the bag mouth diameter and the amount of taper you will need to obtain an appropriate ball fit. If the tissue type is soft and pliable, consider a polyurethane or polypropylene bag and the smallest bag size possible, even if it has a narrow bag shape and taper.

However, if the tissue type is solid, the shape is round, and the mass is large (requiring extensive tissue extraction for removal), consider a bag made of ripstop nylon and factor in the bag shape as well as the bag taper. Using a bag without a steep taper may allow a better fit.

After choosing a laparoscopic bag, select the appropriate trocars necessary for completion of the surgery. Consider starting off with a larger trocar rather than spending the time to upsize a trocar if you plan to use a large bag or intend to extend the trocar incision for a contained tissue extraction. These tips will help optimize efficiency, reduce equipment wastage, and prevent intra-abdominal spillage.

Keep in mind that all procedures, including specimen removal using containment systems, have inherent risks. For example, visualization of the mass within the bag and visualization of vital structures may be hindered by bulkiness of the bag or specimen. There is also a risk of bag compromise and leakage, whether through manipulation of the bag or puncture during specimen extraction. Lastly, even though removing a specimen within a containment system minimizes spillage and reports of in-bag cold-knife tissue extraction in women with histologically proven endometrial cancer have suggested that it is safe, laparoscopic bags have not been proven to prevent the dissemination of malignant tissue fragments.16,17

Overall, the inherent risks of specimen extraction during minimally invasive surgery are far outweighed by the well-established advantages of laparoscopic surgery, which carries lower risks of surgical complications such as bleeding and infection, shorter hospital stay, and quicker recovery time compared to laparotomy. There is no doubt minimally invasive surgery offers many benefits.

In summary, for best bag selection, it is equally important to know the characteristics of the pathology as it is to know the features of the specimen retrieval systems available at your institution. Understanding both the pathology and the equipment available will allow the surgeon to make the best surgical decisions for the case. ●

References
  1. Desai VB, Wright JD, Lin H, et al. Laparoscopic hysterectomy route, resource use, and outcomes: change after power morcellation warning. Obstet Gynecol. 2019;134:227-238.
  2. American College of Obstetricians and Gynecologists. ACOG committee opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009;114:1156-1158.
  3. Liu H, Lu D, Wang L, et al. Robotic surgery for benign gynecological disease. Cochrane Database Syst Rev. 2012;2:CD008978.
  4. Wright JD, Herzog TJ, Tsui J, et al. Nationwide trends in the performance of inpatient hysterectomy in the United States. Obstet Gynecol. 2013;122(2 pt 1):233-241.
  5. Turner LC, Shepherd JP, Wang L, et al. Hysterectomy surgery trends: a more accurate depiction of the last decade? Am J Obstet Gynecol. 2013;208:277.e1-7.
  6. Holme JB, Mortensen FV. A powder-free surgical glove bag for retraction of the gallbladder during laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2005;15:209-211.
  7. Siedhoff MT, Cohen SL. Tissue extraction techniques for leiomyomas and uteri during minimally invasive surgery. Obstet Gynecol. 2017;130:1251-1260.
  8. US Food and Drug Administration. Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. April 17, 2014. https://wayback .archive-it.org/7993/20170722215731/https:/www.fda.gov /MedicalDevices/Safety/AlertsandNotices/ucm393576.htm. Accessed September 22, 2020.
  9. AAGL. AAGL practice report: morcellation during uterine tissue extraction. J Minim Invasive Gynecol. 2014;21:517-530.
  10. American College of Obstetricians and Gynecologists. ACOG committee opinion No. 770: uterine morcellation for presumed leiomyomas. Obstet Gynecol. 2019;133:e238-e248.
  11. Society of Gynecologic Oncology website. SGO position statement: morcellation. December 1, 2013. https://www .sgo.org/newsroom/position-statements-2/morcellation/. Accessed September 22, 2020.
  12. Advincula AP, Truong MD. ExCITE: minimally invasive tissue extraction made simple with simulation. OBG Manag. 2015;27(12):40-45.
  13. Solima E, Scagnelli G, Austoni V, et al. Vaginal uterine morcellation within a specimen containment system: a study of bag integrity. J Minim Invasive Gynecol. 2015;22:1244-1246.
  14. Ghezzi F, Casarin J, De Francesco G, et al. Transvaginal contained tissue extraction after laparoscopic myomectomy: a cohort study. BJOG. 2018;125:367-373.
  15. Dotson S, Landa A, Ehrisman J, et al. Safety and feasibility of contained uterine morcellation in women undergoing laparoscopic hysterectomy. Gynecol Oncol Res Pract. 2018;5:8.
  16. Favero G, Miglino G, Köhler C, et al. Vaginal morcellation inside protective pouch: a safe strategy for uterine extration in cases of bulky endometrial cancers: operative and oncological safety of the method. J Minim Invasive Gynecol. 2015;22:938-943.
  17. Montella F, Riboni F, Cosma S, et al. A safe method of vaginal longitudinal morcellation of bulky uterus with endometrial cancer in a bag at laparoscopy. Surg Endosc. 2014;28:1949-1953.
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Dr. Hur is an Assistant Professor of Obstetrics and Gynecology, Columbia University Irving Medical Center and New York Presbyterian Hospital.

The authors report no financial relationships relevant to this article.

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The authors report no financial relationships relevant to this article.

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The use of minimally invasive gynecologic surgery (MIGS) has grown rapidly over the past 20 years. MIGS, which includes vaginal hysterectomy and laparoscopic hysterectomy, is safe and has fewer complications and a more rapid recovery period than open abdominal surgery.1,2 In 2005, the role of MIGS was expanded further when the US Food and Drug Administration (FDA) approved robot-assisted surgery for the performance of gynecologic procedures.3 As knowledge and experience in the safe performance of MIGS progresses, the rates for MIGS procedures have skyrocketed and continue to grow. Between 2007 and 2010, laparoscopic hysterectomy rates rose from 23.5% to 30.5%, while robot-assisted laparoscopic hysterectomy rates increased from 0.5% to 9.5%, representing 40% of all hysterectomies.4 Due to the benefits of minimally invasive surgery over open abdominal surgery, patient and physician preference for minimally invasive procedures has grown significantly in popularity.1,5

Because incisions are small in minimally invasive surgery, surgeons have been challenged with removing large specimens through incisions that are much smaller than the presenting pathology. One approach is to use a specimen retrieval bag for specimen extraction. Once the dissection is completed, the specimen is placed within the retrieval bag for removal, thus minimizing exposure of the specimen and its contents to the abdominopelvic cavity and incision.

The use of specimen retrieval devices has been advocated to prevent infection, avoid spillage into the peritoneal cavity, and minimize the risk of port-site metastases in cases of potentially cancerous specimens. Devices include affordable and readily available products, such as nonpowdered gloves, and commercially produced bags.6

While the use of specimen containment systems for tissue extraction has been well described in gynecology, the available systems vary widely in construction, size, durability, and shape, potentially leading to confusion and suboptimal bag selection during surgery.7 In this article, we review the most common laparoscopic bags available in the United States, provide an overview of bag characteristics, offer practice guidelines for bag selection, and review bag terminology to highlight important concepts for bag selection.

Controversy spurs change

In April 2014, the FDA warned against the use of power morcellation for specimen removal during minimally invasive surgery, citing a prevalence of 1 in 352 unsuspected uterine sarcomas and 1 in 498 unsuspected uterine leiomyosarcomas among women undergoing hysterectomy or myomectomy for presumed benign leiomyoma.8 Since then, the risk of occult uterine sarcomas, including leiomyosarcoma, in women undergoing surgery for benign gynecologic indications has been determined to be much lower.

Nonetheless, the clinical importance of contained specimen removal was clearly highlighted and the role of specimen retrieval bags soared to the forefront. Open power morcellation is no longer commonly practiced, and national societies such as the American Association of Gynecologic Laparoscopists (AAGL), the Society of Gynecologic Oncology (SGO), and the American College of Obstetricians and Gynecologists (ACOG) recommend that containment systems be used for safer specimen retrieval during gynecologic surgery.9-11 After the specimen is placed inside the containment system (typically a specimen bag), the surgeon may deliver the bag through a vaginal colpotomy or through a slightly extended laparoscopic incision to remove bulky specimens using cold-cutting extraction techniques.12-15

Continue to: Know the pathology’s characteristics...

 

 

Know the pathology’s characteristics

In most cases, based on imaging studies and physical examination, surgeons have a good idea of what to expect before proceeding with surgery. The 2 most common characteristics used for surgical planning are the specimen size (dimensions) and the tissue type (solid, cystic, soft tissue, or mixed). The mass size can range from less than 1 cm to larger than a 20-week sized fibroid uterus. Assessing the specimen in 3 dimensions is important. Tissue type also is a consideration, as soft and squishy masses, such as ovarian cysts, are easier to deflate and manipulate within the bag compared with solid or calcified tumors, such as a large fibroid uterus or a large dermoid with solid components.

Specimen shape also is a critical determinant for bag selection. Most specimen retrieval bags are tapered to varying degrees, and some have an irregular shape. Long tubular structures, such as fallopian tubes that are composed of soft tissue, fit easily into most bags regardless of bag shape or extent of bag taper, whereas the round shape of a bulky myoma may render certain bags ineffective even if the bag’s entrance accommodates the greatest diameter of the myoma. Often, a round mass will not fully fit into a bag because there is a poor fit between the mass’s shape and the bag’s shape and taper. (We discuss the concept of a poor “fit” below.) Knowing the pathology before starting a procedure can help optimize bag selection, streamline operative flow, and reduce waste.

Overview of laparoscopic bag characteristics and clinical applications

The TABLE lists the most common laparoscopic bags available for purchase in the United States. Details include the trocar size, manufacturer, product name, mouth diameter, volume, bag shape, construction material, and best clinical application.

The following are terms used to refer to the components of a laparoscopic retrieval bag:

  • Mouth diameter: diameter at the entrance of a fully opened bag (FIGURE 1)
  • Bag volume: the total volume a bag can accommodate when completely full
  • Bag rim: characteristics of the rim of the bag when opened (that is, rigid vs soft rim, complete vs partial rim mechanism to hold the bag open) (FIGURE 2)
  • Bag shape: the shape of the bag when it is fully opened (square shaped vs cone shaped vs curved bag shape) (FIGURE 2)
  • Bag taper (severity and type): extent the bag is tapered from the rim of the bag’s entrance to the base of the bag; categorized by taper severity (minimal, gradual, or steep taper) and type (continuous taper or curved taper) (FIGURE 3)
  • Ball fit: the maximum spherical specimen size that completely fits into a bag and allows it to cinch closed (FIGURE 4)
  • Bag strength: durability of a bag when placed on tension during specimen extraction (weak, moderate, or extremely durable).

Continue to: Mouth diameter...

 

 

Mouth diameter

Bag manufacturers often differentiate bag sizes by indicating “volume” in milliliters. Bag volume, however, offers little clinical value to surgeons, as pelvic mass dimensions are usually measured in centimeters on imaging. Rather, an important characteristic for bag selection is the diameter of the rim of the bag when it is fully opened—the so-called bag mouth diameter. For a specimen to fit, the 2 dimensions of the specimen must be smaller than the dimensions of the bag entrance.

Notably, the number often linked to the specimen bag—as, for example, in the 10-mm Endo Catch bag (Covidien/Medtronic)— describes the width of the shaft of the bag before it is opened rather than the mouth diameter of the opened bag. The number actually correlates with the trocar size necessary for bag insertion rather than with the specimen size that can fit into the bag. Therefore, a 10-mm Endo Catch bag cannot fit a 10-cm mass, but rather requires a trocar size of 10 mm or greater for insertion of the bag. Fully opened, the mouth diameters of the 10-mm Endo Catch bag are roughly 6 cm x 7 cm, which allows for delivery of a 6-cm mass.

Because 2 bags that use the same trocar size for insertion may have vastly differing bag dimensions, the surgeon must know the bag mouth diameters when selecting a bag to remove the presenting pathology. For example, the Inzii 12 (Applied Medical) laparoscopic bag has mouth diameters of 9.7 cm × 13.0 cm, whereas the Anchor TRSROBO-12 (ConMed) has mouth diameters of 6.7 cm × 7.6 cm (TABLE). Although both bags can be inserted through a 12-mm trocar, both bags cannot fit the same size mass for removal.

Shape and taper

Laparoscopic bags come in various shapes (curved, cone, or square shaped), with varying levels of bag taper (steep, gradual, or no taper) (FIGURES 2 and 3). While taper has little impact on long and skinny specimens, taper may hinder successful bagging of bulky or spherical specimens.

Each bag has different grades of taper regardless of mouth diameter or trocar size. For round masses, the steeper the taper, the smaller the mass that can comfortably fit within the bag. This concept is connected to the idea of “ball fit,” explained below.

In addition, bag shape may affect what mass size can fit into the bag. An irregularly shaped curved bag or a bag with a steep taper may be well suited for removal of multiple specimens of varying sizes or soft masses that are malleable enough to conform to the bag’s shape (such as a ruptured ovarian cyst). Alternatively, a square-shaped bag or a bag with minimal taper would better accommodate a round mass.

Ball fit

When thinking about large circular masses, such as myomas or ovarian cysts, one must consider the ball fit. This refers to the maximum spherical size of the specimen that fits completely within a bag while allowing the bag to cinch closed. Generally, this is an estimation that factors in the bag shape, extent of the bag taper, bag mouth diameter, and specimen shape and tissue type. At times, although a mass can fit through the bag’s mouth diameter, a steep taper may prevent the mass from being fully bagged and limit closure of the bag (FIGURE 4).

Curved bags like the Anchor TRSVATS-15 (ConMed), which have a very narrow bottom, are prone to a limited ball fit, and thus the bag mouth diameter will not correlate with the largest mass size that can be fitted within the bag. Therefore, if using a steeply tapered bag for removal of large round masses, do not rely on the bag’s mouth diameter for bag selection. The surgeon must visualize the ball fit within the bag, taking into account the specimen size and shape, bag shape, and bag taper. In these scenarios, using the diameter of the midportion of the opened bag may better reflect the mass size that can fit into that bag.

Bag strength

Bag strength depends on the material used for bag construction. Most laparoscopic bags in the United States are made of 3 different materials: polyurethane, polypropylene, and ripstop nylon.

Polyurethane and polypropylene are synthetic plastic polymers; in bag form they are stretchy and, under extreme force, may tear. They are best used for bagging fluid-filled cysts or soft pliable masses that will not require extensive bag or tissue handling, such as extraction of large leiomyomas. Polyurethane and polypropylene bags are more susceptible to puncture with sharp laparoscopic instruments or scalpels, and care must be taken to avoid accidentally cutting the bag during tissue extraction.

Alternatively, bags made of ripstop nylon are favored for their bag strength. Ripstop nylon is a synthetic fabric that is woven together in a crosshatch pattern that makes it resistant to tearing and ripping. It was developed originally during World War II as a replacement for silk parachutes. Modern applications include its use in sails, kites, and high-quality camping equipment. This material has a favorable strength-to-weight ratio, and, in case of a tear, it is less prone to extension of the tear. For surgical applications, these bags are best used for bagging specimens that will require a lot of bag manipulation and tissue extraction. However, the ripstop fabric takes up more space in the incision than polyurethane or polypropylene, leaving the surgeon with less space for tissue extraction. Thus, as a tradeoff for bag strength, the surgeon may need to extend the incision a little, and a small self-retracting wound retractor may be necessary to allow visibility for safe tissue extraction when using a ripstop nylon bag compared with others.

Continue to: Trocar selection is important...

 

 

Trocar selection is important

While considering bag selection, the surgeon also must consider trocar selection to allow for laparoscopic insertion of the bag. Trocar size for bag selection refers to the minimum trocar diameter needed to insert the laparoscopic bag. Most bags are designed to fit into a laparoscopic trocar or into the skin incision that previously housed the trocar. Trocar size does not directly correlate with bag mouth diameter; for example, a 10-mm laparoscopic bag that can be inserted through a 10- or 12-mm trocar size cannot fit a 10-cm mass (see the mouth diameter section above).

A tip to maximize operating room (OR) efficiency is to start off with a larger trocar, such as a 12-mm trocar, if it is known that a laparoscopic bag with a 12-mm trocar size will be used, rather than starting with a 5-mm trocar and upsizing the port site incision. This saves time and offers intraoperative flexibility, allowing for the use of larger instruments and quicker insufflation.

Furthermore, if the specimen has a solid component and tissue extraction is anticipated, consider starting off with a large trocar, one that is larger than the bag’s trocar size since the incision likely will be extended. For example, even if a myoma will fit within a 10-mm laparoscopic bag made of ripstop nylon, using a 15-mm trocar rather than a 10-mm trocar may be considered since the skin and fascial incisions will need to be extended to allow for cold-cut tissue extraction. Starting with the larger 15-mm trocar may offer surgical advantages, such as direct needle delivery of larger needles for myometrial closure after myomectomy or direct removal of smaller myomas through the trocar to avoid bagging multiple specimens.

Putting it all together

To optimize efficiency in the OR for specimen removal, we recommend streamlining OR flow and reducing waste by first considering the specimen size, tissue type, bag shape, and trocar selection. Choose a bag by taking into account the bag mouth diameter and the amount of taper you will need to obtain an appropriate ball fit. If the tissue type is soft and pliable, consider a polyurethane or polypropylene bag and the smallest bag size possible, even if it has a narrow bag shape and taper.

However, if the tissue type is solid, the shape is round, and the mass is large (requiring extensive tissue extraction for removal), consider a bag made of ripstop nylon and factor in the bag shape as well as the bag taper. Using a bag without a steep taper may allow a better fit.

After choosing a laparoscopic bag, select the appropriate trocars necessary for completion of the surgery. Consider starting off with a larger trocar rather than spending the time to upsize a trocar if you plan to use a large bag or intend to extend the trocar incision for a contained tissue extraction. These tips will help optimize efficiency, reduce equipment wastage, and prevent intra-abdominal spillage.

Keep in mind that all procedures, including specimen removal using containment systems, have inherent risks. For example, visualization of the mass within the bag and visualization of vital structures may be hindered by bulkiness of the bag or specimen. There is also a risk of bag compromise and leakage, whether through manipulation of the bag or puncture during specimen extraction. Lastly, even though removing a specimen within a containment system minimizes spillage and reports of in-bag cold-knife tissue extraction in women with histologically proven endometrial cancer have suggested that it is safe, laparoscopic bags have not been proven to prevent the dissemination of malignant tissue fragments.16,17

Overall, the inherent risks of specimen extraction during minimally invasive surgery are far outweighed by the well-established advantages of laparoscopic surgery, which carries lower risks of surgical complications such as bleeding and infection, shorter hospital stay, and quicker recovery time compared to laparotomy. There is no doubt minimally invasive surgery offers many benefits.

In summary, for best bag selection, it is equally important to know the characteristics of the pathology as it is to know the features of the specimen retrieval systems available at your institution. Understanding both the pathology and the equipment available will allow the surgeon to make the best surgical decisions for the case. ●

The use of minimally invasive gynecologic surgery (MIGS) has grown rapidly over the past 20 years. MIGS, which includes vaginal hysterectomy and laparoscopic hysterectomy, is safe and has fewer complications and a more rapid recovery period than open abdominal surgery.1,2 In 2005, the role of MIGS was expanded further when the US Food and Drug Administration (FDA) approved robot-assisted surgery for the performance of gynecologic procedures.3 As knowledge and experience in the safe performance of MIGS progresses, the rates for MIGS procedures have skyrocketed and continue to grow. Between 2007 and 2010, laparoscopic hysterectomy rates rose from 23.5% to 30.5%, while robot-assisted laparoscopic hysterectomy rates increased from 0.5% to 9.5%, representing 40% of all hysterectomies.4 Due to the benefits of minimally invasive surgery over open abdominal surgery, patient and physician preference for minimally invasive procedures has grown significantly in popularity.1,5

Because incisions are small in minimally invasive surgery, surgeons have been challenged with removing large specimens through incisions that are much smaller than the presenting pathology. One approach is to use a specimen retrieval bag for specimen extraction. Once the dissection is completed, the specimen is placed within the retrieval bag for removal, thus minimizing exposure of the specimen and its contents to the abdominopelvic cavity and incision.

The use of specimen retrieval devices has been advocated to prevent infection, avoid spillage into the peritoneal cavity, and minimize the risk of port-site metastases in cases of potentially cancerous specimens. Devices include affordable and readily available products, such as nonpowdered gloves, and commercially produced bags.6

While the use of specimen containment systems for tissue extraction has been well described in gynecology, the available systems vary widely in construction, size, durability, and shape, potentially leading to confusion and suboptimal bag selection during surgery.7 In this article, we review the most common laparoscopic bags available in the United States, provide an overview of bag characteristics, offer practice guidelines for bag selection, and review bag terminology to highlight important concepts for bag selection.

Controversy spurs change

In April 2014, the FDA warned against the use of power morcellation for specimen removal during minimally invasive surgery, citing a prevalence of 1 in 352 unsuspected uterine sarcomas and 1 in 498 unsuspected uterine leiomyosarcomas among women undergoing hysterectomy or myomectomy for presumed benign leiomyoma.8 Since then, the risk of occult uterine sarcomas, including leiomyosarcoma, in women undergoing surgery for benign gynecologic indications has been determined to be much lower.

Nonetheless, the clinical importance of contained specimen removal was clearly highlighted and the role of specimen retrieval bags soared to the forefront. Open power morcellation is no longer commonly practiced, and national societies such as the American Association of Gynecologic Laparoscopists (AAGL), the Society of Gynecologic Oncology (SGO), and the American College of Obstetricians and Gynecologists (ACOG) recommend that containment systems be used for safer specimen retrieval during gynecologic surgery.9-11 After the specimen is placed inside the containment system (typically a specimen bag), the surgeon may deliver the bag through a vaginal colpotomy or through a slightly extended laparoscopic incision to remove bulky specimens using cold-cutting extraction techniques.12-15

Continue to: Know the pathology’s characteristics...

 

 

Know the pathology’s characteristics

In most cases, based on imaging studies and physical examination, surgeons have a good idea of what to expect before proceeding with surgery. The 2 most common characteristics used for surgical planning are the specimen size (dimensions) and the tissue type (solid, cystic, soft tissue, or mixed). The mass size can range from less than 1 cm to larger than a 20-week sized fibroid uterus. Assessing the specimen in 3 dimensions is important. Tissue type also is a consideration, as soft and squishy masses, such as ovarian cysts, are easier to deflate and manipulate within the bag compared with solid or calcified tumors, such as a large fibroid uterus or a large dermoid with solid components.

Specimen shape also is a critical determinant for bag selection. Most specimen retrieval bags are tapered to varying degrees, and some have an irregular shape. Long tubular structures, such as fallopian tubes that are composed of soft tissue, fit easily into most bags regardless of bag shape or extent of bag taper, whereas the round shape of a bulky myoma may render certain bags ineffective even if the bag’s entrance accommodates the greatest diameter of the myoma. Often, a round mass will not fully fit into a bag because there is a poor fit between the mass’s shape and the bag’s shape and taper. (We discuss the concept of a poor “fit” below.) Knowing the pathology before starting a procedure can help optimize bag selection, streamline operative flow, and reduce waste.

Overview of laparoscopic bag characteristics and clinical applications

The TABLE lists the most common laparoscopic bags available for purchase in the United States. Details include the trocar size, manufacturer, product name, mouth diameter, volume, bag shape, construction material, and best clinical application.

The following are terms used to refer to the components of a laparoscopic retrieval bag:

  • Mouth diameter: diameter at the entrance of a fully opened bag (FIGURE 1)
  • Bag volume: the total volume a bag can accommodate when completely full
  • Bag rim: characteristics of the rim of the bag when opened (that is, rigid vs soft rim, complete vs partial rim mechanism to hold the bag open) (FIGURE 2)
  • Bag shape: the shape of the bag when it is fully opened (square shaped vs cone shaped vs curved bag shape) (FIGURE 2)
  • Bag taper (severity and type): extent the bag is tapered from the rim of the bag’s entrance to the base of the bag; categorized by taper severity (minimal, gradual, or steep taper) and type (continuous taper or curved taper) (FIGURE 3)
  • Ball fit: the maximum spherical specimen size that completely fits into a bag and allows it to cinch closed (FIGURE 4)
  • Bag strength: durability of a bag when placed on tension during specimen extraction (weak, moderate, or extremely durable).

Continue to: Mouth diameter...

 

 

Mouth diameter

Bag manufacturers often differentiate bag sizes by indicating “volume” in milliliters. Bag volume, however, offers little clinical value to surgeons, as pelvic mass dimensions are usually measured in centimeters on imaging. Rather, an important characteristic for bag selection is the diameter of the rim of the bag when it is fully opened—the so-called bag mouth diameter. For a specimen to fit, the 2 dimensions of the specimen must be smaller than the dimensions of the bag entrance.

Notably, the number often linked to the specimen bag—as, for example, in the 10-mm Endo Catch bag (Covidien/Medtronic)— describes the width of the shaft of the bag before it is opened rather than the mouth diameter of the opened bag. The number actually correlates with the trocar size necessary for bag insertion rather than with the specimen size that can fit into the bag. Therefore, a 10-mm Endo Catch bag cannot fit a 10-cm mass, but rather requires a trocar size of 10 mm or greater for insertion of the bag. Fully opened, the mouth diameters of the 10-mm Endo Catch bag are roughly 6 cm x 7 cm, which allows for delivery of a 6-cm mass.

Because 2 bags that use the same trocar size for insertion may have vastly differing bag dimensions, the surgeon must know the bag mouth diameters when selecting a bag to remove the presenting pathology. For example, the Inzii 12 (Applied Medical) laparoscopic bag has mouth diameters of 9.7 cm × 13.0 cm, whereas the Anchor TRSROBO-12 (ConMed) has mouth diameters of 6.7 cm × 7.6 cm (TABLE). Although both bags can be inserted through a 12-mm trocar, both bags cannot fit the same size mass for removal.

Shape and taper

Laparoscopic bags come in various shapes (curved, cone, or square shaped), with varying levels of bag taper (steep, gradual, or no taper) (FIGURES 2 and 3). While taper has little impact on long and skinny specimens, taper may hinder successful bagging of bulky or spherical specimens.

Each bag has different grades of taper regardless of mouth diameter or trocar size. For round masses, the steeper the taper, the smaller the mass that can comfortably fit within the bag. This concept is connected to the idea of “ball fit,” explained below.

In addition, bag shape may affect what mass size can fit into the bag. An irregularly shaped curved bag or a bag with a steep taper may be well suited for removal of multiple specimens of varying sizes or soft masses that are malleable enough to conform to the bag’s shape (such as a ruptured ovarian cyst). Alternatively, a square-shaped bag or a bag with minimal taper would better accommodate a round mass.

Ball fit

When thinking about large circular masses, such as myomas or ovarian cysts, one must consider the ball fit. This refers to the maximum spherical size of the specimen that fits completely within a bag while allowing the bag to cinch closed. Generally, this is an estimation that factors in the bag shape, extent of the bag taper, bag mouth diameter, and specimen shape and tissue type. At times, although a mass can fit through the bag’s mouth diameter, a steep taper may prevent the mass from being fully bagged and limit closure of the bag (FIGURE 4).

Curved bags like the Anchor TRSVATS-15 (ConMed), which have a very narrow bottom, are prone to a limited ball fit, and thus the bag mouth diameter will not correlate with the largest mass size that can be fitted within the bag. Therefore, if using a steeply tapered bag for removal of large round masses, do not rely on the bag’s mouth diameter for bag selection. The surgeon must visualize the ball fit within the bag, taking into account the specimen size and shape, bag shape, and bag taper. In these scenarios, using the diameter of the midportion of the opened bag may better reflect the mass size that can fit into that bag.

Bag strength

Bag strength depends on the material used for bag construction. Most laparoscopic bags in the United States are made of 3 different materials: polyurethane, polypropylene, and ripstop nylon.

Polyurethane and polypropylene are synthetic plastic polymers; in bag form they are stretchy and, under extreme force, may tear. They are best used for bagging fluid-filled cysts or soft pliable masses that will not require extensive bag or tissue handling, such as extraction of large leiomyomas. Polyurethane and polypropylene bags are more susceptible to puncture with sharp laparoscopic instruments or scalpels, and care must be taken to avoid accidentally cutting the bag during tissue extraction.

Alternatively, bags made of ripstop nylon are favored for their bag strength. Ripstop nylon is a synthetic fabric that is woven together in a crosshatch pattern that makes it resistant to tearing and ripping. It was developed originally during World War II as a replacement for silk parachutes. Modern applications include its use in sails, kites, and high-quality camping equipment. This material has a favorable strength-to-weight ratio, and, in case of a tear, it is less prone to extension of the tear. For surgical applications, these bags are best used for bagging specimens that will require a lot of bag manipulation and tissue extraction. However, the ripstop fabric takes up more space in the incision than polyurethane or polypropylene, leaving the surgeon with less space for tissue extraction. Thus, as a tradeoff for bag strength, the surgeon may need to extend the incision a little, and a small self-retracting wound retractor may be necessary to allow visibility for safe tissue extraction when using a ripstop nylon bag compared with others.

Continue to: Trocar selection is important...

 

 

Trocar selection is important

While considering bag selection, the surgeon also must consider trocar selection to allow for laparoscopic insertion of the bag. Trocar size for bag selection refers to the minimum trocar diameter needed to insert the laparoscopic bag. Most bags are designed to fit into a laparoscopic trocar or into the skin incision that previously housed the trocar. Trocar size does not directly correlate with bag mouth diameter; for example, a 10-mm laparoscopic bag that can be inserted through a 10- or 12-mm trocar size cannot fit a 10-cm mass (see the mouth diameter section above).

A tip to maximize operating room (OR) efficiency is to start off with a larger trocar, such as a 12-mm trocar, if it is known that a laparoscopic bag with a 12-mm trocar size will be used, rather than starting with a 5-mm trocar and upsizing the port site incision. This saves time and offers intraoperative flexibility, allowing for the use of larger instruments and quicker insufflation.

Furthermore, if the specimen has a solid component and tissue extraction is anticipated, consider starting off with a large trocar, one that is larger than the bag’s trocar size since the incision likely will be extended. For example, even if a myoma will fit within a 10-mm laparoscopic bag made of ripstop nylon, using a 15-mm trocar rather than a 10-mm trocar may be considered since the skin and fascial incisions will need to be extended to allow for cold-cut tissue extraction. Starting with the larger 15-mm trocar may offer surgical advantages, such as direct needle delivery of larger needles for myometrial closure after myomectomy or direct removal of smaller myomas through the trocar to avoid bagging multiple specimens.

Putting it all together

To optimize efficiency in the OR for specimen removal, we recommend streamlining OR flow and reducing waste by first considering the specimen size, tissue type, bag shape, and trocar selection. Choose a bag by taking into account the bag mouth diameter and the amount of taper you will need to obtain an appropriate ball fit. If the tissue type is soft and pliable, consider a polyurethane or polypropylene bag and the smallest bag size possible, even if it has a narrow bag shape and taper.

However, if the tissue type is solid, the shape is round, and the mass is large (requiring extensive tissue extraction for removal), consider a bag made of ripstop nylon and factor in the bag shape as well as the bag taper. Using a bag without a steep taper may allow a better fit.

After choosing a laparoscopic bag, select the appropriate trocars necessary for completion of the surgery. Consider starting off with a larger trocar rather than spending the time to upsize a trocar if you plan to use a large bag or intend to extend the trocar incision for a contained tissue extraction. These tips will help optimize efficiency, reduce equipment wastage, and prevent intra-abdominal spillage.

Keep in mind that all procedures, including specimen removal using containment systems, have inherent risks. For example, visualization of the mass within the bag and visualization of vital structures may be hindered by bulkiness of the bag or specimen. There is also a risk of bag compromise and leakage, whether through manipulation of the bag or puncture during specimen extraction. Lastly, even though removing a specimen within a containment system minimizes spillage and reports of in-bag cold-knife tissue extraction in women with histologically proven endometrial cancer have suggested that it is safe, laparoscopic bags have not been proven to prevent the dissemination of malignant tissue fragments.16,17

Overall, the inherent risks of specimen extraction during minimally invasive surgery are far outweighed by the well-established advantages of laparoscopic surgery, which carries lower risks of surgical complications such as bleeding and infection, shorter hospital stay, and quicker recovery time compared to laparotomy. There is no doubt minimally invasive surgery offers many benefits.

In summary, for best bag selection, it is equally important to know the characteristics of the pathology as it is to know the features of the specimen retrieval systems available at your institution. Understanding both the pathology and the equipment available will allow the surgeon to make the best surgical decisions for the case. ●

References
  1. Desai VB, Wright JD, Lin H, et al. Laparoscopic hysterectomy route, resource use, and outcomes: change after power morcellation warning. Obstet Gynecol. 2019;134:227-238.
  2. American College of Obstetricians and Gynecologists. ACOG committee opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009;114:1156-1158.
  3. Liu H, Lu D, Wang L, et al. Robotic surgery for benign gynecological disease. Cochrane Database Syst Rev. 2012;2:CD008978.
  4. Wright JD, Herzog TJ, Tsui J, et al. Nationwide trends in the performance of inpatient hysterectomy in the United States. Obstet Gynecol. 2013;122(2 pt 1):233-241.
  5. Turner LC, Shepherd JP, Wang L, et al. Hysterectomy surgery trends: a more accurate depiction of the last decade? Am J Obstet Gynecol. 2013;208:277.e1-7.
  6. Holme JB, Mortensen FV. A powder-free surgical glove bag for retraction of the gallbladder during laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2005;15:209-211.
  7. Siedhoff MT, Cohen SL. Tissue extraction techniques for leiomyomas and uteri during minimally invasive surgery. Obstet Gynecol. 2017;130:1251-1260.
  8. US Food and Drug Administration. Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. April 17, 2014. https://wayback .archive-it.org/7993/20170722215731/https:/www.fda.gov /MedicalDevices/Safety/AlertsandNotices/ucm393576.htm. Accessed September 22, 2020.
  9. AAGL. AAGL practice report: morcellation during uterine tissue extraction. J Minim Invasive Gynecol. 2014;21:517-530.
  10. American College of Obstetricians and Gynecologists. ACOG committee opinion No. 770: uterine morcellation for presumed leiomyomas. Obstet Gynecol. 2019;133:e238-e248.
  11. Society of Gynecologic Oncology website. SGO position statement: morcellation. December 1, 2013. https://www .sgo.org/newsroom/position-statements-2/morcellation/. Accessed September 22, 2020.
  12. Advincula AP, Truong MD. ExCITE: minimally invasive tissue extraction made simple with simulation. OBG Manag. 2015;27(12):40-45.
  13. Solima E, Scagnelli G, Austoni V, et al. Vaginal uterine morcellation within a specimen containment system: a study of bag integrity. J Minim Invasive Gynecol. 2015;22:1244-1246.
  14. Ghezzi F, Casarin J, De Francesco G, et al. Transvaginal contained tissue extraction after laparoscopic myomectomy: a cohort study. BJOG. 2018;125:367-373.
  15. Dotson S, Landa A, Ehrisman J, et al. Safety and feasibility of contained uterine morcellation in women undergoing laparoscopic hysterectomy. Gynecol Oncol Res Pract. 2018;5:8.
  16. Favero G, Miglino G, Köhler C, et al. Vaginal morcellation inside protective pouch: a safe strategy for uterine extration in cases of bulky endometrial cancers: operative and oncological safety of the method. J Minim Invasive Gynecol. 2015;22:938-943.
  17. Montella F, Riboni F, Cosma S, et al. A safe method of vaginal longitudinal morcellation of bulky uterus with endometrial cancer in a bag at laparoscopy. Surg Endosc. 2014;28:1949-1953.
References
  1. Desai VB, Wright JD, Lin H, et al. Laparoscopic hysterectomy route, resource use, and outcomes: change after power morcellation warning. Obstet Gynecol. 2019;134:227-238.
  2. American College of Obstetricians and Gynecologists. ACOG committee opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009;114:1156-1158.
  3. Liu H, Lu D, Wang L, et al. Robotic surgery for benign gynecological disease. Cochrane Database Syst Rev. 2012;2:CD008978.
  4. Wright JD, Herzog TJ, Tsui J, et al. Nationwide trends in the performance of inpatient hysterectomy in the United States. Obstet Gynecol. 2013;122(2 pt 1):233-241.
  5. Turner LC, Shepherd JP, Wang L, et al. Hysterectomy surgery trends: a more accurate depiction of the last decade? Am J Obstet Gynecol. 2013;208:277.e1-7.
  6. Holme JB, Mortensen FV. A powder-free surgical glove bag for retraction of the gallbladder during laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2005;15:209-211.
  7. Siedhoff MT, Cohen SL. Tissue extraction techniques for leiomyomas and uteri during minimally invasive surgery. Obstet Gynecol. 2017;130:1251-1260.
  8. US Food and Drug Administration. Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. April 17, 2014. https://wayback .archive-it.org/7993/20170722215731/https:/www.fda.gov /MedicalDevices/Safety/AlertsandNotices/ucm393576.htm. Accessed September 22, 2020.
  9. AAGL. AAGL practice report: morcellation during uterine tissue extraction. J Minim Invasive Gynecol. 2014;21:517-530.
  10. American College of Obstetricians and Gynecologists. ACOG committee opinion No. 770: uterine morcellation for presumed leiomyomas. Obstet Gynecol. 2019;133:e238-e248.
  11. Society of Gynecologic Oncology website. SGO position statement: morcellation. December 1, 2013. https://www .sgo.org/newsroom/position-statements-2/morcellation/. Accessed September 22, 2020.
  12. Advincula AP, Truong MD. ExCITE: minimally invasive tissue extraction made simple with simulation. OBG Manag. 2015;27(12):40-45.
  13. Solima E, Scagnelli G, Austoni V, et al. Vaginal uterine morcellation within a specimen containment system: a study of bag integrity. J Minim Invasive Gynecol. 2015;22:1244-1246.
  14. Ghezzi F, Casarin J, De Francesco G, et al. Transvaginal contained tissue extraction after laparoscopic myomectomy: a cohort study. BJOG. 2018;125:367-373.
  15. Dotson S, Landa A, Ehrisman J, et al. Safety and feasibility of contained uterine morcellation in women undergoing laparoscopic hysterectomy. Gynecol Oncol Res Pract. 2018;5:8.
  16. Favero G, Miglino G, Köhler C, et al. Vaginal morcellation inside protective pouch: a safe strategy for uterine extration in cases of bulky endometrial cancers: operative and oncological safety of the method. J Minim Invasive Gynecol. 2015;22:938-943.
  17. Montella F, Riboni F, Cosma S, et al. A safe method of vaginal longitudinal morcellation of bulky uterus with endometrial cancer in a bag at laparoscopy. Surg Endosc. 2014;28:1949-1953.
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Fourteen-day sports hiatus recommended for children after COVID-19

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Changed
Tue, 02/14/2023 - 13:00

 

Children should not return to sports for 14 days after exposure to COVID-19, and those with moderate symptoms should undergo an electrocardiogram before returning, according to the American Academy of Pediatrics.

The recommendations, which update the academy’s July 23 guidance, stem from new concerns that the disease can cause myocarditis, said Susannah Briskin, MD, a pediatric sports medicine specialist at Rainbow Babies and Children’s Hospital in Cleveland.

“There has been emerging evidence about cases of myocarditis occurring in athletes, including athletes who are asymptomatic with COVID-19,” she said in an interview.

The update aligns the AAP recommendations with those from the American College of Cardiologists, she added.

Recent imaging studies have turned up signs of myocarditis in athletes recovering from mild or asymptomatic cases of COVID-19 and have prompted calls for clearer guidelines about imaging studies and return to play.

Viral myocarditis poses a risk to athletes because it can lead to potentially fatal arrhythmias, Dr. Briskin said.

Although children benefit from participating in sports, these activities also put them at risk of contracting COVID-19 and spreading it to others, the guidance noted.

To balance the risks and benefits, the academy proposed guidelines that vary depending on the severity of the presentation.

In the first category are patients with a severe presentation (hypotension, arrhythmias, need for intubation or extracorporeal membrane oxygenation support, kidney or cardiac failure) or with multisystem inflammatory syndrome. Clinicians should treat these patients as though they have myocarditis. Patients should be restricted from engaging in sports and other exercise for 3-6 months, the guidance stated.

The primary care physician and “appropriate pediatric medical subspecialist, preferably in consultation with a pediatric cardiologist,” should clear them before they return to activities. In examining patients for return to play, clinicians should focus on cardiac symptoms, including chest pain, shortness of breath, fatigue, palpitations, or syncope, the guidance said.

In another category are patients with cardiac symptoms, those with concerning findings on examination, and those with moderate symptoms of COVID-19, including prolonged fever. These patients should undergo an ECG and possibly be referred to a pediatric cardiologist, the guidelines said. These symptoms must be absent for at least 14 days before these patients can return to sports, and the athletes should obtain clearance from their primary care physicians before they resume.

In a third category are patients who have been infected with SARS-CoV-2 or who have had close contact with someone who was infected but who have not themselves experienced symptoms. These athletes should refrain from sports for at least 14 days, the guidelines said.

Children who don’t fall into any of these categories should not be tested for the virus or antibodies to it before participation in sports, the academy said.

The guidelines don’t vary depending on the sport. But the academy has issued separate guidance for parents and guardians to help them evaluate the risk for COVID-19 transmission by sport.

Athletes participating in “sports that have greater amount of contact time or proximity to people would be at higher risk for contracting COVID-19,” Dr. Briskin said. “But I think that’s all fairly common sense, given the recommendations for non–sport-related activity just in terms of social distancing and masking.”

The new guidance called on sports organizers to minimize contact by, for example, modifying drills and conditioning. It recommended that athletes wear masks except during vigorous exercise or when participating in water sports, as well as in other circumstances in which the mask could become a safety hazard.

They also recommended using handwashing stations or hand sanitizer, avoiding contact with shared surfaces, and avoiding small rooms and areas with poor ventilation.

Dr. Briskin disclosed no relevant financial relationships.

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

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Children should not return to sports for 14 days after exposure to COVID-19, and those with moderate symptoms should undergo an electrocardiogram before returning, according to the American Academy of Pediatrics.

The recommendations, which update the academy’s July 23 guidance, stem from new concerns that the disease can cause myocarditis, said Susannah Briskin, MD, a pediatric sports medicine specialist at Rainbow Babies and Children’s Hospital in Cleveland.

“There has been emerging evidence about cases of myocarditis occurring in athletes, including athletes who are asymptomatic with COVID-19,” she said in an interview.

The update aligns the AAP recommendations with those from the American College of Cardiologists, she added.

Recent imaging studies have turned up signs of myocarditis in athletes recovering from mild or asymptomatic cases of COVID-19 and have prompted calls for clearer guidelines about imaging studies and return to play.

Viral myocarditis poses a risk to athletes because it can lead to potentially fatal arrhythmias, Dr. Briskin said.

Although children benefit from participating in sports, these activities also put them at risk of contracting COVID-19 and spreading it to others, the guidance noted.

To balance the risks and benefits, the academy proposed guidelines that vary depending on the severity of the presentation.

In the first category are patients with a severe presentation (hypotension, arrhythmias, need for intubation or extracorporeal membrane oxygenation support, kidney or cardiac failure) or with multisystem inflammatory syndrome. Clinicians should treat these patients as though they have myocarditis. Patients should be restricted from engaging in sports and other exercise for 3-6 months, the guidance stated.

The primary care physician and “appropriate pediatric medical subspecialist, preferably in consultation with a pediatric cardiologist,” should clear them before they return to activities. In examining patients for return to play, clinicians should focus on cardiac symptoms, including chest pain, shortness of breath, fatigue, palpitations, or syncope, the guidance said.

In another category are patients with cardiac symptoms, those with concerning findings on examination, and those with moderate symptoms of COVID-19, including prolonged fever. These patients should undergo an ECG and possibly be referred to a pediatric cardiologist, the guidelines said. These symptoms must be absent for at least 14 days before these patients can return to sports, and the athletes should obtain clearance from their primary care physicians before they resume.

In a third category are patients who have been infected with SARS-CoV-2 or who have had close contact with someone who was infected but who have not themselves experienced symptoms. These athletes should refrain from sports for at least 14 days, the guidelines said.

Children who don’t fall into any of these categories should not be tested for the virus or antibodies to it before participation in sports, the academy said.

The guidelines don’t vary depending on the sport. But the academy has issued separate guidance for parents and guardians to help them evaluate the risk for COVID-19 transmission by sport.

Athletes participating in “sports that have greater amount of contact time or proximity to people would be at higher risk for contracting COVID-19,” Dr. Briskin said. “But I think that’s all fairly common sense, given the recommendations for non–sport-related activity just in terms of social distancing and masking.”

The new guidance called on sports organizers to minimize contact by, for example, modifying drills and conditioning. It recommended that athletes wear masks except during vigorous exercise or when participating in water sports, as well as in other circumstances in which the mask could become a safety hazard.

They also recommended using handwashing stations or hand sanitizer, avoiding contact with shared surfaces, and avoiding small rooms and areas with poor ventilation.

Dr. Briskin disclosed no relevant financial relationships.

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

 

Children should not return to sports for 14 days after exposure to COVID-19, and those with moderate symptoms should undergo an electrocardiogram before returning, according to the American Academy of Pediatrics.

The recommendations, which update the academy’s July 23 guidance, stem from new concerns that the disease can cause myocarditis, said Susannah Briskin, MD, a pediatric sports medicine specialist at Rainbow Babies and Children’s Hospital in Cleveland.

“There has been emerging evidence about cases of myocarditis occurring in athletes, including athletes who are asymptomatic with COVID-19,” she said in an interview.

The update aligns the AAP recommendations with those from the American College of Cardiologists, she added.

Recent imaging studies have turned up signs of myocarditis in athletes recovering from mild or asymptomatic cases of COVID-19 and have prompted calls for clearer guidelines about imaging studies and return to play.

Viral myocarditis poses a risk to athletes because it can lead to potentially fatal arrhythmias, Dr. Briskin said.

Although children benefit from participating in sports, these activities also put them at risk of contracting COVID-19 and spreading it to others, the guidance noted.

To balance the risks and benefits, the academy proposed guidelines that vary depending on the severity of the presentation.

In the first category are patients with a severe presentation (hypotension, arrhythmias, need for intubation or extracorporeal membrane oxygenation support, kidney or cardiac failure) or with multisystem inflammatory syndrome. Clinicians should treat these patients as though they have myocarditis. Patients should be restricted from engaging in sports and other exercise for 3-6 months, the guidance stated.

The primary care physician and “appropriate pediatric medical subspecialist, preferably in consultation with a pediatric cardiologist,” should clear them before they return to activities. In examining patients for return to play, clinicians should focus on cardiac symptoms, including chest pain, shortness of breath, fatigue, palpitations, or syncope, the guidance said.

In another category are patients with cardiac symptoms, those with concerning findings on examination, and those with moderate symptoms of COVID-19, including prolonged fever. These patients should undergo an ECG and possibly be referred to a pediatric cardiologist, the guidelines said. These symptoms must be absent for at least 14 days before these patients can return to sports, and the athletes should obtain clearance from their primary care physicians before they resume.

In a third category are patients who have been infected with SARS-CoV-2 or who have had close contact with someone who was infected but who have not themselves experienced symptoms. These athletes should refrain from sports for at least 14 days, the guidelines said.

Children who don’t fall into any of these categories should not be tested for the virus or antibodies to it before participation in sports, the academy said.

The guidelines don’t vary depending on the sport. But the academy has issued separate guidance for parents and guardians to help them evaluate the risk for COVID-19 transmission by sport.

Athletes participating in “sports that have greater amount of contact time or proximity to people would be at higher risk for contracting COVID-19,” Dr. Briskin said. “But I think that’s all fairly common sense, given the recommendations for non–sport-related activity just in terms of social distancing and masking.”

The new guidance called on sports organizers to minimize contact by, for example, modifying drills and conditioning. It recommended that athletes wear masks except during vigorous exercise or when participating in water sports, as well as in other circumstances in which the mask could become a safety hazard.

They also recommended using handwashing stations or hand sanitizer, avoiding contact with shared surfaces, and avoiding small rooms and areas with poor ventilation.

Dr. Briskin disclosed no relevant financial relationships.

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

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Access to care: A nurse practitioner’s plea

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Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Candice Baxendale

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

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Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Candice Baxendale

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Candice Baxendale

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

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Learning about “No”

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To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

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].

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To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

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].

To say that the pandemic has dropped us into uncharted territory is an understatement of unmeasurable proportions. Every day we learn more about it, and every day that new information brings us new challenges. COVID-19 is playing by its own set of rules. To keep pace with it societies have been forced to adapt to them, and members of those societies have had to realize that these new rules must be obeyed or be prepared to suffer the consequences.

BananaStock/Thinkstock

I’m not sure exactly when it happened but gradually over my 7 and a half decades on this planet it appears that following the rules and understanding the value of “No” have become concepts to be ignored and left to gather dust in the attics and basements of our society. The tug of war between well-considered rules and the often misinterpreted concept of freedom has been ebbing and flowing since Eve plucked a forbidden apple off that tree.

In some parts of the world, the twin skills of saying and responding to “No” have become lost arts. I think it is not by chance that, of the four books I have written for parents, the one titled “How to Say No to Your Toddler” has become the most widely distributed, having been translated into Italian, Polish, and Russian. It is only slightly comforting to learn that at least some parents understand that creating rules can be important, but realize they aren’t quite sure how go about it.

As it has become clear that social distancing and mask wearing are associated with curtailing the spread of COVID-19, state and local governments have had to bone up on their long-forgotten No-saying skills. This relearning process has been particularly painful for school administrators who may have been warned that “You’ll never be able to get first and second graders to wear masks” or that “College students just won’t obey the rules.”

Both of these cautions are based on observations by educators with years of experience and certainly have a ring of truth to them. But could it be that these pessimistic predictions reflect a society in which parents and educators have lost the talent for crafting sensible rules and linking them to enforceable and rational consequences?

As colleges throughout the country have reopened using a variety of learning and residential strategies, there have been numerous incidents that validate the gloomy predictions of student misbehavior. Smaller schools seem to be having less difficulty, which is not surprising given their relative ease in fostering a sense of community. Many schools have been forced to rollback their plans for in-person learning because students have failed to follow some very simple but unpopular rules.

Dr. William G. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years.
Dr. William G. Wilkoff

In a swift and decisive response to student misbehavior, Northeastern University in Boston dismissed 11 first-year students and will not refund their tuition when officials discovered a prohibited social gathering in one of the resident facilities (“Northeastern Dismisses 11 Students for Gathering in Violation of COVID-19 Policies,” by Ian Thomsen, News at Northwestern). This response seemed to have come as a surprise to many students and parents around the country who have become accustomed a diet of warnings and minor sanctions.

Whether this action by Northeastern will trigger similar responses by other universities remains to be seen. But we can hope that it sets an example of how learning about “No” can be an important part of one’s education.
 

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].

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