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Detransition, baby: Examining factors leading to ‘detransitioning’ and regret in the transgender community
Over the holiday season I had the pleasure of finally reading the national bestseller, Detransition, Baby. On the surface, the story depicts the complex relationships between Reese, a transgender woman who strongly desires a family, her ex-wife, Ames – a transgender woman who detransitioned to live as a cisgender man – and Ames’ cisgender female partner, who is unexpectedly pregnant with his child. The story delves much deeper than the relationships between these characters, as it exceptionally articulates many of the emotional intricacies of the transgender experience and addresses one of the most taboo topics in the transgender community – detransitioning and regret.
The terms “transition” and “detransition” have fallen out of favor in the vernacular of the transgender population as they incorrectly imply that gender identity is contingent upon gender-affirmation processes.1,2 More importantly, the terms “detransition” and regret are not synonymous. Conflating these terms has undermined the intrinsic nature of gender identity, which has resulted in political and legal consequences seeking to limit or outright ban care for transgender patients.
As a gender-affirming surgeon, one of the most common questions I get asked is the rate of regret patients have after their surgeries. While I have no issue answering the question when it is presented, I do not hesitate to point out some of the problematic subtext inherent in such inquiries. Within the line of questioning, many often comment, “It’s so permanent,” “I can’t believe people can do this to their bodies,” or “How sure are patients before undergoing these surgeries?” While these comments and queries can be downright offensive, they seem to stem from the difficulty people have comprehending gender dysphoria and the painstaking steps people take to affirm their identity. The implication of these comments also reveals a more deep-seated issue – general distrust of individual bodily autonomy, personal identity, and choice.
For the obstetrician-gynecologist, understanding the concept of autonomous, patient-centered decision-making should be second nature, as we face a similar line of interrogation when discussing abortion, contraception, and pregnancy. No other field faces this level of scrutiny when it comes to defending a patient’s bodily autonomy. For example, given the history of reproductive injustice with tubal ligation procedures, the American College of Obstetricians and Gynecologists has issued clear guidelines regarding counseling of women while acknowledging the tenuous history of these procedures with minority subgroups. According to their committee opinion, ethical counseling for such a permanent procedure involves understanding the content of information presented to the patient, how that information is conveyed, and self-reflection on the part of the provider.3 The approach to counseling and understanding gender-affirming care is no different.
I want to be clear that regret after gender-affirming surgery is rare, occurring in 0%-3.8% of patients.4-6 In a separate study, 91% of patients expressed significant improvement in quality of life after surgery.7 However, what is disheartening about patients who experience surgical regret is that it originates from continued difficulty from the transition process itself and ongoing discrimination – even though the patient’s physical characteristics match their gender identity.4-6 Similarly, in another survey which examined 17,151 participants who had pursued gender affirmation (broadly defined), approximately 2,242 (13.1%) reported a history of detransition.2 Among these adults, the vast majority (82.5%), cited external factors such as school harassment, sexual violence, family pressure, and social stigma as reasons for detransitioning.2 Other associated factors included male sex assigned at birth, nonbinary gender identity, bisexual orientation, and having an unsupportive family.2
When Ames is explaining his “detransition” to his cisfemale partner, he states: “I got sick of living as trans …[sic]… I am trans, but I don’t need to do trans.”8 While there is still more research needed to further understand detransitioning and surgical regret, these few studies demonstrate a heart-breaking reality – in many aspects of our society it is still extremely difficult to live as a transgender person.
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa. She did not report any disclosures.
References
1. National LGBTQIA+ Health Education Center, A program of the Fenway Institute: LGBTQIA+ glossary of terms for health care teams. 2020. Available at www.lgbtqiahealtheducation.org/wp-content/uploads/2020/10/Glossary-2020.08.30.pdf. Accessed Dec. 30, 2021.
2. Turban JL et al. LGBT Health 2021;8(4):273-80.
3. Sterilization of women: Ethical issues and considerations. Committee Opinion No. 695. American College of Obstetricians and Gynecologists. Obstet Gynecol 2017;129:e109-16.
4. Ruppin U, Pfafflin F. Arch Sex Behav. 2015;44:1321-9.
5. Lawrence AA. Arch Sex Behav. 2003;32:299-315.
6. Landen M et al. Acta Psychiatr Scand. 1998;97:284-9.
7. Papdopulos NA et al. J Sex Med. 2017;14(5):721-30.
8. Peters T. Detransition, Baby. New York: Penguin Random House, 2021.
Over the holiday season I had the pleasure of finally reading the national bestseller, Detransition, Baby. On the surface, the story depicts the complex relationships between Reese, a transgender woman who strongly desires a family, her ex-wife, Ames – a transgender woman who detransitioned to live as a cisgender man – and Ames’ cisgender female partner, who is unexpectedly pregnant with his child. The story delves much deeper than the relationships between these characters, as it exceptionally articulates many of the emotional intricacies of the transgender experience and addresses one of the most taboo topics in the transgender community – detransitioning and regret.
The terms “transition” and “detransition” have fallen out of favor in the vernacular of the transgender population as they incorrectly imply that gender identity is contingent upon gender-affirmation processes.1,2 More importantly, the terms “detransition” and regret are not synonymous. Conflating these terms has undermined the intrinsic nature of gender identity, which has resulted in political and legal consequences seeking to limit or outright ban care for transgender patients.
As a gender-affirming surgeon, one of the most common questions I get asked is the rate of regret patients have after their surgeries. While I have no issue answering the question when it is presented, I do not hesitate to point out some of the problematic subtext inherent in such inquiries. Within the line of questioning, many often comment, “It’s so permanent,” “I can’t believe people can do this to their bodies,” or “How sure are patients before undergoing these surgeries?” While these comments and queries can be downright offensive, they seem to stem from the difficulty people have comprehending gender dysphoria and the painstaking steps people take to affirm their identity. The implication of these comments also reveals a more deep-seated issue – general distrust of individual bodily autonomy, personal identity, and choice.
For the obstetrician-gynecologist, understanding the concept of autonomous, patient-centered decision-making should be second nature, as we face a similar line of interrogation when discussing abortion, contraception, and pregnancy. No other field faces this level of scrutiny when it comes to defending a patient’s bodily autonomy. For example, given the history of reproductive injustice with tubal ligation procedures, the American College of Obstetricians and Gynecologists has issued clear guidelines regarding counseling of women while acknowledging the tenuous history of these procedures with minority subgroups. According to their committee opinion, ethical counseling for such a permanent procedure involves understanding the content of information presented to the patient, how that information is conveyed, and self-reflection on the part of the provider.3 The approach to counseling and understanding gender-affirming care is no different.
I want to be clear that regret after gender-affirming surgery is rare, occurring in 0%-3.8% of patients.4-6 In a separate study, 91% of patients expressed significant improvement in quality of life after surgery.7 However, what is disheartening about patients who experience surgical regret is that it originates from continued difficulty from the transition process itself and ongoing discrimination – even though the patient’s physical characteristics match their gender identity.4-6 Similarly, in another survey which examined 17,151 participants who had pursued gender affirmation (broadly defined), approximately 2,242 (13.1%) reported a history of detransition.2 Among these adults, the vast majority (82.5%), cited external factors such as school harassment, sexual violence, family pressure, and social stigma as reasons for detransitioning.2 Other associated factors included male sex assigned at birth, nonbinary gender identity, bisexual orientation, and having an unsupportive family.2
When Ames is explaining his “detransition” to his cisfemale partner, he states: “I got sick of living as trans …[sic]… I am trans, but I don’t need to do trans.”8 While there is still more research needed to further understand detransitioning and surgical regret, these few studies demonstrate a heart-breaking reality – in many aspects of our society it is still extremely difficult to live as a transgender person.
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa. She did not report any disclosures.
References
1. National LGBTQIA+ Health Education Center, A program of the Fenway Institute: LGBTQIA+ glossary of terms for health care teams. 2020. Available at www.lgbtqiahealtheducation.org/wp-content/uploads/2020/10/Glossary-2020.08.30.pdf. Accessed Dec. 30, 2021.
2. Turban JL et al. LGBT Health 2021;8(4):273-80.
3. Sterilization of women: Ethical issues and considerations. Committee Opinion No. 695. American College of Obstetricians and Gynecologists. Obstet Gynecol 2017;129:e109-16.
4. Ruppin U, Pfafflin F. Arch Sex Behav. 2015;44:1321-9.
5. Lawrence AA. Arch Sex Behav. 2003;32:299-315.
6. Landen M et al. Acta Psychiatr Scand. 1998;97:284-9.
7. Papdopulos NA et al. J Sex Med. 2017;14(5):721-30.
8. Peters T. Detransition, Baby. New York: Penguin Random House, 2021.
Over the holiday season I had the pleasure of finally reading the national bestseller, Detransition, Baby. On the surface, the story depicts the complex relationships between Reese, a transgender woman who strongly desires a family, her ex-wife, Ames – a transgender woman who detransitioned to live as a cisgender man – and Ames’ cisgender female partner, who is unexpectedly pregnant with his child. The story delves much deeper than the relationships between these characters, as it exceptionally articulates many of the emotional intricacies of the transgender experience and addresses one of the most taboo topics in the transgender community – detransitioning and regret.
The terms “transition” and “detransition” have fallen out of favor in the vernacular of the transgender population as they incorrectly imply that gender identity is contingent upon gender-affirmation processes.1,2 More importantly, the terms “detransition” and regret are not synonymous. Conflating these terms has undermined the intrinsic nature of gender identity, which has resulted in political and legal consequences seeking to limit or outright ban care for transgender patients.
As a gender-affirming surgeon, one of the most common questions I get asked is the rate of regret patients have after their surgeries. While I have no issue answering the question when it is presented, I do not hesitate to point out some of the problematic subtext inherent in such inquiries. Within the line of questioning, many often comment, “It’s so permanent,” “I can’t believe people can do this to their bodies,” or “How sure are patients before undergoing these surgeries?” While these comments and queries can be downright offensive, they seem to stem from the difficulty people have comprehending gender dysphoria and the painstaking steps people take to affirm their identity. The implication of these comments also reveals a more deep-seated issue – general distrust of individual bodily autonomy, personal identity, and choice.
For the obstetrician-gynecologist, understanding the concept of autonomous, patient-centered decision-making should be second nature, as we face a similar line of interrogation when discussing abortion, contraception, and pregnancy. No other field faces this level of scrutiny when it comes to defending a patient’s bodily autonomy. For example, given the history of reproductive injustice with tubal ligation procedures, the American College of Obstetricians and Gynecologists has issued clear guidelines regarding counseling of women while acknowledging the tenuous history of these procedures with minority subgroups. According to their committee opinion, ethical counseling for such a permanent procedure involves understanding the content of information presented to the patient, how that information is conveyed, and self-reflection on the part of the provider.3 The approach to counseling and understanding gender-affirming care is no different.
I want to be clear that regret after gender-affirming surgery is rare, occurring in 0%-3.8% of patients.4-6 In a separate study, 91% of patients expressed significant improvement in quality of life after surgery.7 However, what is disheartening about patients who experience surgical regret is that it originates from continued difficulty from the transition process itself and ongoing discrimination – even though the patient’s physical characteristics match their gender identity.4-6 Similarly, in another survey which examined 17,151 participants who had pursued gender affirmation (broadly defined), approximately 2,242 (13.1%) reported a history of detransition.2 Among these adults, the vast majority (82.5%), cited external factors such as school harassment, sexual violence, family pressure, and social stigma as reasons for detransitioning.2 Other associated factors included male sex assigned at birth, nonbinary gender identity, bisexual orientation, and having an unsupportive family.2
When Ames is explaining his “detransition” to his cisfemale partner, he states: “I got sick of living as trans …[sic]… I am trans, but I don’t need to do trans.”8 While there is still more research needed to further understand detransitioning and surgical regret, these few studies demonstrate a heart-breaking reality – in many aspects of our society it is still extremely difficult to live as a transgender person.
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa. She did not report any disclosures.
References
1. National LGBTQIA+ Health Education Center, A program of the Fenway Institute: LGBTQIA+ glossary of terms for health care teams. 2020. Available at www.lgbtqiahealtheducation.org/wp-content/uploads/2020/10/Glossary-2020.08.30.pdf. Accessed Dec. 30, 2021.
2. Turban JL et al. LGBT Health 2021;8(4):273-80.
3. Sterilization of women: Ethical issues and considerations. Committee Opinion No. 695. American College of Obstetricians and Gynecologists. Obstet Gynecol 2017;129:e109-16.
4. Ruppin U, Pfafflin F. Arch Sex Behav. 2015;44:1321-9.
5. Lawrence AA. Arch Sex Behav. 2003;32:299-315.
6. Landen M et al. Acta Psychiatr Scand. 1998;97:284-9.
7. Papdopulos NA et al. J Sex Med. 2017;14(5):721-30.
8. Peters T. Detransition, Baby. New York: Penguin Random House, 2021.
Racial disparities found in treatment of tubal pregnancies
Black and Latina women are more likely to have an open surgery compared with a minimally invasive procedure to treat ectopic pregnancy, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.
The researchers found that Black and Latina women had 50% lesser odds of undergoing laparoscopic surgery, a minimally invasive procedure, compared to their White peers.
“We see these disparities in minority populations, [especially in] women with regard to so many other aspects of [gynecologic] surgery,” study author Alexandra Huttler, MD, said in an interview. “The fact that these disparities exist [in the treatment of tubal pregnancies] was unfortunately not surprising to us.”
Dr. Huttler and her team analyzed data from the American College of Surgeons’ National Surgical Quality Improvement Program, which followed more than 9,000 patients who had undergone surgical management of a tubal ectopic pregnancy between 2010 and 2019. Of the group, 85% underwent laparoscopic surgery while 14% had open surgery, which requires a longer recovery time.
The proportion of cases performed laparoscopically increased from 81% in 2010 to 91% in 2019. However, a disproportionate number of Black and Latina women underwent open surgery to treat ectopic pregnancies during this time. Because they are more invasive, open surgeries are associated with longer operative times, hospital stays, and increased complications, Dr. Huttler said. They are typically associated with more pain and patients are more likely to be admitted to the hospital for postoperative care.
On the other hand, minimally invasive surgeries are associated with decreased operative time, “less recovery and less pain,” Dr. Huttler explained.
The researchers also looked at trends of the related surgical procedure salpingectomy, which is surgical removal of one or both fallopian tubes versus salpingostomy, a surgical unblocking of the tube. Of the group, 91% underwent salpingectomy and 9% underwent salpingostomy.
Researchers found that Black and Latina women had 78% and 54% greater odds, respectively, of receiving a salpingectomy. However, the clinical significance of these findings are unclear because there are “many factors” that are patient and case specific, Dr. Huttler said.
The study is important and adds to a litany of studies that have shown that women of color do not receive optimal care, said Ruben Alvero, MD, who was not involved in the study.
“Women of color in general have seen compromises in their care at many levels in the system,” Dr. Alvero, professor of obstetrics and gynecology at Stanford (Calif.) University, said in an interview. “We really have to do a massive overhaul of how we treat women of color so they get the same level of treatment that all other populations receive.”
While the factors contributing to these health disparities can be complicated, Dr. Alvero said that one reason for this multivariate discrepancy could be that Black and Latina women tend to seek care at, or only have access to, underresourced hospitals.
Dr. Huttler said she hopes her findings prompt further discussion of these disparities.
“There really are disparities at all levels of care here and figuring out what the root of this is certainly requires further research,” Dr. Huttler said.
The experts interviewed disclosed no conflicts on interests.
Black and Latina women are more likely to have an open surgery compared with a minimally invasive procedure to treat ectopic pregnancy, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.
The researchers found that Black and Latina women had 50% lesser odds of undergoing laparoscopic surgery, a minimally invasive procedure, compared to their White peers.
“We see these disparities in minority populations, [especially in] women with regard to so many other aspects of [gynecologic] surgery,” study author Alexandra Huttler, MD, said in an interview. “The fact that these disparities exist [in the treatment of tubal pregnancies] was unfortunately not surprising to us.”
Dr. Huttler and her team analyzed data from the American College of Surgeons’ National Surgical Quality Improvement Program, which followed more than 9,000 patients who had undergone surgical management of a tubal ectopic pregnancy between 2010 and 2019. Of the group, 85% underwent laparoscopic surgery while 14% had open surgery, which requires a longer recovery time.
The proportion of cases performed laparoscopically increased from 81% in 2010 to 91% in 2019. However, a disproportionate number of Black and Latina women underwent open surgery to treat ectopic pregnancies during this time. Because they are more invasive, open surgeries are associated with longer operative times, hospital stays, and increased complications, Dr. Huttler said. They are typically associated with more pain and patients are more likely to be admitted to the hospital for postoperative care.
On the other hand, minimally invasive surgeries are associated with decreased operative time, “less recovery and less pain,” Dr. Huttler explained.
The researchers also looked at trends of the related surgical procedure salpingectomy, which is surgical removal of one or both fallopian tubes versus salpingostomy, a surgical unblocking of the tube. Of the group, 91% underwent salpingectomy and 9% underwent salpingostomy.
Researchers found that Black and Latina women had 78% and 54% greater odds, respectively, of receiving a salpingectomy. However, the clinical significance of these findings are unclear because there are “many factors” that are patient and case specific, Dr. Huttler said.
The study is important and adds to a litany of studies that have shown that women of color do not receive optimal care, said Ruben Alvero, MD, who was not involved in the study.
“Women of color in general have seen compromises in their care at many levels in the system,” Dr. Alvero, professor of obstetrics and gynecology at Stanford (Calif.) University, said in an interview. “We really have to do a massive overhaul of how we treat women of color so they get the same level of treatment that all other populations receive.”
While the factors contributing to these health disparities can be complicated, Dr. Alvero said that one reason for this multivariate discrepancy could be that Black and Latina women tend to seek care at, or only have access to, underresourced hospitals.
Dr. Huttler said she hopes her findings prompt further discussion of these disparities.
“There really are disparities at all levels of care here and figuring out what the root of this is certainly requires further research,” Dr. Huttler said.
The experts interviewed disclosed no conflicts on interests.
Black and Latina women are more likely to have an open surgery compared with a minimally invasive procedure to treat ectopic pregnancy, according to research presented at the American Society for Reproductive Medicine’s 2021 meeting.
The researchers found that Black and Latina women had 50% lesser odds of undergoing laparoscopic surgery, a minimally invasive procedure, compared to their White peers.
“We see these disparities in minority populations, [especially in] women with regard to so many other aspects of [gynecologic] surgery,” study author Alexandra Huttler, MD, said in an interview. “The fact that these disparities exist [in the treatment of tubal pregnancies] was unfortunately not surprising to us.”
Dr. Huttler and her team analyzed data from the American College of Surgeons’ National Surgical Quality Improvement Program, which followed more than 9,000 patients who had undergone surgical management of a tubal ectopic pregnancy between 2010 and 2019. Of the group, 85% underwent laparoscopic surgery while 14% had open surgery, which requires a longer recovery time.
The proportion of cases performed laparoscopically increased from 81% in 2010 to 91% in 2019. However, a disproportionate number of Black and Latina women underwent open surgery to treat ectopic pregnancies during this time. Because they are more invasive, open surgeries are associated with longer operative times, hospital stays, and increased complications, Dr. Huttler said. They are typically associated with more pain and patients are more likely to be admitted to the hospital for postoperative care.
On the other hand, minimally invasive surgeries are associated with decreased operative time, “less recovery and less pain,” Dr. Huttler explained.
The researchers also looked at trends of the related surgical procedure salpingectomy, which is surgical removal of one or both fallopian tubes versus salpingostomy, a surgical unblocking of the tube. Of the group, 91% underwent salpingectomy and 9% underwent salpingostomy.
Researchers found that Black and Latina women had 78% and 54% greater odds, respectively, of receiving a salpingectomy. However, the clinical significance of these findings are unclear because there are “many factors” that are patient and case specific, Dr. Huttler said.
The study is important and adds to a litany of studies that have shown that women of color do not receive optimal care, said Ruben Alvero, MD, who was not involved in the study.
“Women of color in general have seen compromises in their care at many levels in the system,” Dr. Alvero, professor of obstetrics and gynecology at Stanford (Calif.) University, said in an interview. “We really have to do a massive overhaul of how we treat women of color so they get the same level of treatment that all other populations receive.”
While the factors contributing to these health disparities can be complicated, Dr. Alvero said that one reason for this multivariate discrepancy could be that Black and Latina women tend to seek care at, or only have access to, underresourced hospitals.
Dr. Huttler said she hopes her findings prompt further discussion of these disparities.
“There really are disparities at all levels of care here and figuring out what the root of this is certainly requires further research,” Dr. Huttler said.
The experts interviewed disclosed no conflicts on interests.
FROM ASRM 2021
MDs doing wrong-site surgery: Why is it still happening?
In July 2021, University Hospitals, in Cleveland, announced that its staff had transplanted a kidney into the wrong patient. Although the patient who received the kidney was recovering well, the patient who was supposed to have received the kidney was skipped over. As a result of the error, two employees were placed on administrative leave and the incident was being investigated, the hospital announced.
In April 2020, an interventional radiologist at Boca Raton Regional Hospital, in Boca Raton, Fla., was sued for allegedly placing a stent into the wrong kidney of an 80-year-old patient. Using fluoroscopic guidance, the doctor removed an old stent from the right side but incorrectly replaced it with a new stent on the left side, according to an interview conducted by this news organization with the patient’s lawyers at Searcy Law, in West Palm Beach.
“The problem is that it is so rare that doctors don’t focus on it,” says Mary R. Kwaan, MD, a colorectal surgeon at UCLA Medical Center, Los Angeles.
A 2006 study in which Kwaan was the lead author concluded that there was one wrong-site surgery for every 112,994 surgeries. Those mistakes can add up. A 2006 study estimated that 25 to 52 wrong-site surgeries were performed each week in the United States.
“Many surgeons don’t think it can happen to them, so they don’t take extra precautions,” says David Mayer, MD, executive director of the MedStar Institute for Quality and Safety, in Washington, DC. “When they make a wrong-site error, usually the first thing they say is, ‘I never thought this would happen to me,’ ” he says.
Wrong-site surgeries are considered sentinel events -- the worst kinds of medical errors. The Sullivan Group, a patient safety consultancy based in Colorado, reports that in 2013, 2.7% of patients who were involved in wrong-site surgeries died and 41% experienced some type of permanent injury. The mean malpractice payment was $127,000.
Some malpractice payments are much higher. In 2013, a Maryland ob.gyn paid a $1.42 million malpractice award for removing the wrong ovary from a woman in 2009. In 2017, a Pennsylvania urologist paid $870,000 for removing the wrong testicle from a man in 2013.
Wrong-site surgery often involves experienced surgeons
One might think that wrong-site surgeries usually involve younger or less-experienced surgeons, but that’s not the case; two thirds of the surgeons who perform wrong-site surgeries are in their 40s and 50s, compared with fewer than 25% younger than 40.
In a rather chilling statistic, in a 2013 survey, 12.4% of doctors who were involved in sentinel events in general had claims for more than one event.
These errors are more common in certain specialties. In a study reported in the Journal of Neurology, Neurosurgery and Spine, 25% of orthopedic surgeons reported performing at least one wrong-site surgery during their career.
Within orthopedics, spine surgery is ground zero for wrong-site surgery. “Finding the site in spine surgery can be more difficult than in common left-right orthopedic procedures,” says Joseph A. Bosco III, a New York City orthopedist.
A 2007 study found that 25% of neurosurgeons had performed wrong-site surgeries. In Missouri in 2013, for example, a 53-year-old patient who was scheduled to undergo a left-sided craniotomy bypass allegedly underwent a right-sided craniotomy and was unable to speak after surgery.
Wrong-site surgeries are also performed by general surgeons, urologists, cardiologists, otolaryngologists, and ophthalmologists. A 2021 lawsuit accused a Tampa urologist of removing the patient’s wrong testicle. And a 2019 lawsuit accused a Chicago ophthalmologist of operating on the wrong eye to remove a cyst.
It’s not just the surgeon’s mistake
Mistakes are not only made by the surgeon in the operating room (OR). They can be made by staff when scheduling a surgery, radiologists and pathologists when writing their reports for surgery, and by team members in the OR.
Many people are prone to confusing left and right. A 2020 study found that 14.9% of people had difficulty distinguishing left from right; other studies have shown higher rates. Distractions increase the likelihood of mistakes. In a 2015 study, background noise in a hospital ward made it more difficult for medical students to make left-right judgments.
OR personnel can be confused when patients are turned around. “To operate on the back of someone’s leg, the surgeon may turn the patient from supine to prone, and so left becomes right,” says Samuel C. Seiden, MD, an anesthesiologist in Roseville, Calif., who has studied wrong-site surgery.
Operative site markings that are drawn on the skin can be rubbed off when surgical prep is applied, and markings aren’t usually possible for procedures such as spine surgeries. Surgical draping can make it harder to distinguish the patient’s left and right, and a busy surgeon relying on memory may confuse cases and perform wrong-patient surgery.
A push to eliminate wrong-site surgery
In 2004, the Joint Commission, which accredits hospitals and many surgery centers, decided to do something about wrong-site surgery and related surgical errors. It released a universal protocol, which requires hospitals to take three steps to prevent errors: perform preoperative verification that is based on patient care documents; mark the operative site; and take a time-out just before surgery, during which the team should consider whether a mistake is about to be made.
Two years after the Joint Commission published its protocol, Dr. Seiden led a study to determine what effect it had had. The investigators found that wrong-site cases had decreased by only about one third. Preventing wrong-site surgery “turns out to be more complicated to eradicate than anybody thought,” Mark Chassin, MD, president of the Joint Commission, stated a few years later.
Why did the protocol have only a limited effect? Dr. Seiden says that it has been hard to change doctors’ traditional attitudes against standardization. “Some have had an attitude that checklists are for dummies, but that is changing,” he says.
For instance, some surgical teams were not paying attention during time-outs. “The time-out should be like the invocation of the National Anthem,” an orthopedic surgeon from Iowa wrote. “All other activities should stop.”
Even had surgeons followed the universal protocol, about one third of wrong-site surgeries would not have been identified, according to Dr. Kwaan’s study, which was published in the same year as Dr. Seiden’s. As an example, when the wrong kidney was removed at Methodist Hospital, in St. Louis Park, Minn., the hospital said it was following a protocol set by the Minnesota Hospital Association.
Redoubling efforts
In 2009, the Joint Commission decided to take another tack. It encouraged hospitals to make root-cause analyses not only of wrong-site surgeries but also of near misses, which are much more plentiful. It used the insights gained to change surgical routines and protocols.
The Safe Surgery Project, a collaboration between the Joint Commission’s Center for Transforming Healthcare and eight hospitals and surgery centers, reduced the number of errors and near misses by 46% in the scheduling area, 63% in pre-op, and 51% in the OR area.
From that project, the center developed the Targeted Solutions Tool, which basically uses the same methodology that the project used. The center told this news organization that 79 healthcare organizations have used the tool and have reduced the number of errors and near misses by 56% in scheduling, 24% in pre-op, and 48% in the OR.
For this approach to work, however, surgical teams must report their errors to the hospital, which had not been done before. A 2008 study by the Office of the Inspector General of the U.S. Department of Health and Human Services found that surgical staff did not report 86% of adverse events to their hospitals. Reasons given included lack of time, fear of punitive action, and skepticism that reporting would do any good.
Unlike some other adverse events, it’s hard to keep wrong-site surgeries secret from patients, because they can usually see the scars from it, but some surgeons invent ways to cover it up from patients, too, Dr. Mayer says. One wrong-side hernia repair was corrected in mid operation. Afterward, the surgeon told the patient that he had found another hernia on the other side and had fixed that one, too.
Changing the culture
Reformers argue that wrong-site surgeries can be prevented by changing the culture of the hospital or surgery center. “We have to think of wrong-site surgeries as a failure of the system, not of the individual,” says Ron Savrin, MD, a general surgeon in Chagrin Falls, Ohio, who is a surgery subject matter expert for the Sullivan Group. “It should never be only up to one individual to stop an error from occurring.”
Seeing oneself as part of a team can reduce errors. Although other people can introduce errors that make a person look bad, they can also stop the errors that might otherwise have occurred. Punishing individuals for making errors does little good in stopping errors.
“It’s human nature to want to punish somebody for making a mistake, and it’s hard to change that mentality,” Dr. Savrin says. He recalls that when he was a resident, “the morbidity and mortality conferences could be very difficult for anyone who made a mistake, but I think that attitude is changing.”
Studies have found wide variation in the number of wrong-site surgeries among hospitals. A recent Pennsylvania study found an average of one wrong-site surgery or near miss per hospital per year, but about one third of hospitals did not report any.
Wrong-site surgeries are often concentrated in certain hospitals -- even prestigious teaching hospitals are not immune. A decade ago, Rhode Island Hospital had five wrong-site surgeries in 2 years, and Boston’s Beth Israel Deaconess Medical Center had three wrong-spine surgeries within 2 months.
Other ways to reduce errors
Dr. Seiden thinks reform efforts should take a page from his own specialty. Anesthesiology has developed a variety of forcing functions, which are simple changes in technology that can stop errors. An example is the use of a valve that will not deliver a drug unless certain steps are followed.
The StartBox System, a new way to prevent surgical errors, delivers the surgery blade only after all safety information has been provided. Tested by 11 orthopedic surgeons performing 487 procedures, the system identified 17 near misses.
Another approach is to film time-outs so as to enforce compliance with protocols and help with root-cause analyses. NYU-Langone Medical Center, in New York City, not only films the time-out but also grades OR teams on compliance, says Dr. Bosco, who is vice chair of clinical affairs in the department of orthopedic surgery at the hospital.
In addition, more states are requiring hospitals to report adverse events, including wrong-site surgeries. According to the National Academy for State Health Policy, 28 states require the reporting of adverse events. However, only six states identify facilities in public reports; 16 states publish only aggregate data; and five states do not report error data to the public.
The goal is zero errors
Are there fewer wrong-site surgeries now? “My sense is that surgeons, hospitals, and surgery centers are taking wrong-site errors more seriously,” Dr. Savrin says.
Because reported information is spotty and no major studies on incidence have been conducted in recent years, “we don’t have a clear idea,” he says, “but my best guess is that the rate is declining.
“Absolute zero preventable errors has to be our goal,” Dr. Savrin says “We might not get there, but we can’t stop trying.”
A version of this article first appeared on Medscape.com.
In July 2021, University Hospitals, in Cleveland, announced that its staff had transplanted a kidney into the wrong patient. Although the patient who received the kidney was recovering well, the patient who was supposed to have received the kidney was skipped over. As a result of the error, two employees were placed on administrative leave and the incident was being investigated, the hospital announced.
In April 2020, an interventional radiologist at Boca Raton Regional Hospital, in Boca Raton, Fla., was sued for allegedly placing a stent into the wrong kidney of an 80-year-old patient. Using fluoroscopic guidance, the doctor removed an old stent from the right side but incorrectly replaced it with a new stent on the left side, according to an interview conducted by this news organization with the patient’s lawyers at Searcy Law, in West Palm Beach.
“The problem is that it is so rare that doctors don’t focus on it,” says Mary R. Kwaan, MD, a colorectal surgeon at UCLA Medical Center, Los Angeles.
A 2006 study in which Kwaan was the lead author concluded that there was one wrong-site surgery for every 112,994 surgeries. Those mistakes can add up. A 2006 study estimated that 25 to 52 wrong-site surgeries were performed each week in the United States.
“Many surgeons don’t think it can happen to them, so they don’t take extra precautions,” says David Mayer, MD, executive director of the MedStar Institute for Quality and Safety, in Washington, DC. “When they make a wrong-site error, usually the first thing they say is, ‘I never thought this would happen to me,’ ” he says.
Wrong-site surgeries are considered sentinel events -- the worst kinds of medical errors. The Sullivan Group, a patient safety consultancy based in Colorado, reports that in 2013, 2.7% of patients who were involved in wrong-site surgeries died and 41% experienced some type of permanent injury. The mean malpractice payment was $127,000.
Some malpractice payments are much higher. In 2013, a Maryland ob.gyn paid a $1.42 million malpractice award for removing the wrong ovary from a woman in 2009. In 2017, a Pennsylvania urologist paid $870,000 for removing the wrong testicle from a man in 2013.
Wrong-site surgery often involves experienced surgeons
One might think that wrong-site surgeries usually involve younger or less-experienced surgeons, but that’s not the case; two thirds of the surgeons who perform wrong-site surgeries are in their 40s and 50s, compared with fewer than 25% younger than 40.
In a rather chilling statistic, in a 2013 survey, 12.4% of doctors who were involved in sentinel events in general had claims for more than one event.
These errors are more common in certain specialties. In a study reported in the Journal of Neurology, Neurosurgery and Spine, 25% of orthopedic surgeons reported performing at least one wrong-site surgery during their career.
Within orthopedics, spine surgery is ground zero for wrong-site surgery. “Finding the site in spine surgery can be more difficult than in common left-right orthopedic procedures,” says Joseph A. Bosco III, a New York City orthopedist.
A 2007 study found that 25% of neurosurgeons had performed wrong-site surgeries. In Missouri in 2013, for example, a 53-year-old patient who was scheduled to undergo a left-sided craniotomy bypass allegedly underwent a right-sided craniotomy and was unable to speak after surgery.
Wrong-site surgeries are also performed by general surgeons, urologists, cardiologists, otolaryngologists, and ophthalmologists. A 2021 lawsuit accused a Tampa urologist of removing the patient’s wrong testicle. And a 2019 lawsuit accused a Chicago ophthalmologist of operating on the wrong eye to remove a cyst.
It’s not just the surgeon’s mistake
Mistakes are not only made by the surgeon in the operating room (OR). They can be made by staff when scheduling a surgery, radiologists and pathologists when writing their reports for surgery, and by team members in the OR.
Many people are prone to confusing left and right. A 2020 study found that 14.9% of people had difficulty distinguishing left from right; other studies have shown higher rates. Distractions increase the likelihood of mistakes. In a 2015 study, background noise in a hospital ward made it more difficult for medical students to make left-right judgments.
OR personnel can be confused when patients are turned around. “To operate on the back of someone’s leg, the surgeon may turn the patient from supine to prone, and so left becomes right,” says Samuel C. Seiden, MD, an anesthesiologist in Roseville, Calif., who has studied wrong-site surgery.
Operative site markings that are drawn on the skin can be rubbed off when surgical prep is applied, and markings aren’t usually possible for procedures such as spine surgeries. Surgical draping can make it harder to distinguish the patient’s left and right, and a busy surgeon relying on memory may confuse cases and perform wrong-patient surgery.
A push to eliminate wrong-site surgery
In 2004, the Joint Commission, which accredits hospitals and many surgery centers, decided to do something about wrong-site surgery and related surgical errors. It released a universal protocol, which requires hospitals to take three steps to prevent errors: perform preoperative verification that is based on patient care documents; mark the operative site; and take a time-out just before surgery, during which the team should consider whether a mistake is about to be made.
Two years after the Joint Commission published its protocol, Dr. Seiden led a study to determine what effect it had had. The investigators found that wrong-site cases had decreased by only about one third. Preventing wrong-site surgery “turns out to be more complicated to eradicate than anybody thought,” Mark Chassin, MD, president of the Joint Commission, stated a few years later.
Why did the protocol have only a limited effect? Dr. Seiden says that it has been hard to change doctors’ traditional attitudes against standardization. “Some have had an attitude that checklists are for dummies, but that is changing,” he says.
For instance, some surgical teams were not paying attention during time-outs. “The time-out should be like the invocation of the National Anthem,” an orthopedic surgeon from Iowa wrote. “All other activities should stop.”
Even had surgeons followed the universal protocol, about one third of wrong-site surgeries would not have been identified, according to Dr. Kwaan’s study, which was published in the same year as Dr. Seiden’s. As an example, when the wrong kidney was removed at Methodist Hospital, in St. Louis Park, Minn., the hospital said it was following a protocol set by the Minnesota Hospital Association.
Redoubling efforts
In 2009, the Joint Commission decided to take another tack. It encouraged hospitals to make root-cause analyses not only of wrong-site surgeries but also of near misses, which are much more plentiful. It used the insights gained to change surgical routines and protocols.
The Safe Surgery Project, a collaboration between the Joint Commission’s Center for Transforming Healthcare and eight hospitals and surgery centers, reduced the number of errors and near misses by 46% in the scheduling area, 63% in pre-op, and 51% in the OR area.
From that project, the center developed the Targeted Solutions Tool, which basically uses the same methodology that the project used. The center told this news organization that 79 healthcare organizations have used the tool and have reduced the number of errors and near misses by 56% in scheduling, 24% in pre-op, and 48% in the OR.
For this approach to work, however, surgical teams must report their errors to the hospital, which had not been done before. A 2008 study by the Office of the Inspector General of the U.S. Department of Health and Human Services found that surgical staff did not report 86% of adverse events to their hospitals. Reasons given included lack of time, fear of punitive action, and skepticism that reporting would do any good.
Unlike some other adverse events, it’s hard to keep wrong-site surgeries secret from patients, because they can usually see the scars from it, but some surgeons invent ways to cover it up from patients, too, Dr. Mayer says. One wrong-side hernia repair was corrected in mid operation. Afterward, the surgeon told the patient that he had found another hernia on the other side and had fixed that one, too.
Changing the culture
Reformers argue that wrong-site surgeries can be prevented by changing the culture of the hospital or surgery center. “We have to think of wrong-site surgeries as a failure of the system, not of the individual,” says Ron Savrin, MD, a general surgeon in Chagrin Falls, Ohio, who is a surgery subject matter expert for the Sullivan Group. “It should never be only up to one individual to stop an error from occurring.”
Seeing oneself as part of a team can reduce errors. Although other people can introduce errors that make a person look bad, they can also stop the errors that might otherwise have occurred. Punishing individuals for making errors does little good in stopping errors.
“It’s human nature to want to punish somebody for making a mistake, and it’s hard to change that mentality,” Dr. Savrin says. He recalls that when he was a resident, “the morbidity and mortality conferences could be very difficult for anyone who made a mistake, but I think that attitude is changing.”
Studies have found wide variation in the number of wrong-site surgeries among hospitals. A recent Pennsylvania study found an average of one wrong-site surgery or near miss per hospital per year, but about one third of hospitals did not report any.
Wrong-site surgeries are often concentrated in certain hospitals -- even prestigious teaching hospitals are not immune. A decade ago, Rhode Island Hospital had five wrong-site surgeries in 2 years, and Boston’s Beth Israel Deaconess Medical Center had three wrong-spine surgeries within 2 months.
Other ways to reduce errors
Dr. Seiden thinks reform efforts should take a page from his own specialty. Anesthesiology has developed a variety of forcing functions, which are simple changes in technology that can stop errors. An example is the use of a valve that will not deliver a drug unless certain steps are followed.
The StartBox System, a new way to prevent surgical errors, delivers the surgery blade only after all safety information has been provided. Tested by 11 orthopedic surgeons performing 487 procedures, the system identified 17 near misses.
Another approach is to film time-outs so as to enforce compliance with protocols and help with root-cause analyses. NYU-Langone Medical Center, in New York City, not only films the time-out but also grades OR teams on compliance, says Dr. Bosco, who is vice chair of clinical affairs in the department of orthopedic surgery at the hospital.
In addition, more states are requiring hospitals to report adverse events, including wrong-site surgeries. According to the National Academy for State Health Policy, 28 states require the reporting of adverse events. However, only six states identify facilities in public reports; 16 states publish only aggregate data; and five states do not report error data to the public.
The goal is zero errors
Are there fewer wrong-site surgeries now? “My sense is that surgeons, hospitals, and surgery centers are taking wrong-site errors more seriously,” Dr. Savrin says.
Because reported information is spotty and no major studies on incidence have been conducted in recent years, “we don’t have a clear idea,” he says, “but my best guess is that the rate is declining.
“Absolute zero preventable errors has to be our goal,” Dr. Savrin says “We might not get there, but we can’t stop trying.”
A version of this article first appeared on Medscape.com.
In July 2021, University Hospitals, in Cleveland, announced that its staff had transplanted a kidney into the wrong patient. Although the patient who received the kidney was recovering well, the patient who was supposed to have received the kidney was skipped over. As a result of the error, two employees were placed on administrative leave and the incident was being investigated, the hospital announced.
In April 2020, an interventional radiologist at Boca Raton Regional Hospital, in Boca Raton, Fla., was sued for allegedly placing a stent into the wrong kidney of an 80-year-old patient. Using fluoroscopic guidance, the doctor removed an old stent from the right side but incorrectly replaced it with a new stent on the left side, according to an interview conducted by this news organization with the patient’s lawyers at Searcy Law, in West Palm Beach.
“The problem is that it is so rare that doctors don’t focus on it,” says Mary R. Kwaan, MD, a colorectal surgeon at UCLA Medical Center, Los Angeles.
A 2006 study in which Kwaan was the lead author concluded that there was one wrong-site surgery for every 112,994 surgeries. Those mistakes can add up. A 2006 study estimated that 25 to 52 wrong-site surgeries were performed each week in the United States.
“Many surgeons don’t think it can happen to them, so they don’t take extra precautions,” says David Mayer, MD, executive director of the MedStar Institute for Quality and Safety, in Washington, DC. “When they make a wrong-site error, usually the first thing they say is, ‘I never thought this would happen to me,’ ” he says.
Wrong-site surgeries are considered sentinel events -- the worst kinds of medical errors. The Sullivan Group, a patient safety consultancy based in Colorado, reports that in 2013, 2.7% of patients who were involved in wrong-site surgeries died and 41% experienced some type of permanent injury. The mean malpractice payment was $127,000.
Some malpractice payments are much higher. In 2013, a Maryland ob.gyn paid a $1.42 million malpractice award for removing the wrong ovary from a woman in 2009. In 2017, a Pennsylvania urologist paid $870,000 for removing the wrong testicle from a man in 2013.
Wrong-site surgery often involves experienced surgeons
One might think that wrong-site surgeries usually involve younger or less-experienced surgeons, but that’s not the case; two thirds of the surgeons who perform wrong-site surgeries are in their 40s and 50s, compared with fewer than 25% younger than 40.
In a rather chilling statistic, in a 2013 survey, 12.4% of doctors who were involved in sentinel events in general had claims for more than one event.
These errors are more common in certain specialties. In a study reported in the Journal of Neurology, Neurosurgery and Spine, 25% of orthopedic surgeons reported performing at least one wrong-site surgery during their career.
Within orthopedics, spine surgery is ground zero for wrong-site surgery. “Finding the site in spine surgery can be more difficult than in common left-right orthopedic procedures,” says Joseph A. Bosco III, a New York City orthopedist.
A 2007 study found that 25% of neurosurgeons had performed wrong-site surgeries. In Missouri in 2013, for example, a 53-year-old patient who was scheduled to undergo a left-sided craniotomy bypass allegedly underwent a right-sided craniotomy and was unable to speak after surgery.
Wrong-site surgeries are also performed by general surgeons, urologists, cardiologists, otolaryngologists, and ophthalmologists. A 2021 lawsuit accused a Tampa urologist of removing the patient’s wrong testicle. And a 2019 lawsuit accused a Chicago ophthalmologist of operating on the wrong eye to remove a cyst.
It’s not just the surgeon’s mistake
Mistakes are not only made by the surgeon in the operating room (OR). They can be made by staff when scheduling a surgery, radiologists and pathologists when writing their reports for surgery, and by team members in the OR.
Many people are prone to confusing left and right. A 2020 study found that 14.9% of people had difficulty distinguishing left from right; other studies have shown higher rates. Distractions increase the likelihood of mistakes. In a 2015 study, background noise in a hospital ward made it more difficult for medical students to make left-right judgments.
OR personnel can be confused when patients are turned around. “To operate on the back of someone’s leg, the surgeon may turn the patient from supine to prone, and so left becomes right,” says Samuel C. Seiden, MD, an anesthesiologist in Roseville, Calif., who has studied wrong-site surgery.
Operative site markings that are drawn on the skin can be rubbed off when surgical prep is applied, and markings aren’t usually possible for procedures such as spine surgeries. Surgical draping can make it harder to distinguish the patient’s left and right, and a busy surgeon relying on memory may confuse cases and perform wrong-patient surgery.
A push to eliminate wrong-site surgery
In 2004, the Joint Commission, which accredits hospitals and many surgery centers, decided to do something about wrong-site surgery and related surgical errors. It released a universal protocol, which requires hospitals to take three steps to prevent errors: perform preoperative verification that is based on patient care documents; mark the operative site; and take a time-out just before surgery, during which the team should consider whether a mistake is about to be made.
Two years after the Joint Commission published its protocol, Dr. Seiden led a study to determine what effect it had had. The investigators found that wrong-site cases had decreased by only about one third. Preventing wrong-site surgery “turns out to be more complicated to eradicate than anybody thought,” Mark Chassin, MD, president of the Joint Commission, stated a few years later.
Why did the protocol have only a limited effect? Dr. Seiden says that it has been hard to change doctors’ traditional attitudes against standardization. “Some have had an attitude that checklists are for dummies, but that is changing,” he says.
For instance, some surgical teams were not paying attention during time-outs. “The time-out should be like the invocation of the National Anthem,” an orthopedic surgeon from Iowa wrote. “All other activities should stop.”
Even had surgeons followed the universal protocol, about one third of wrong-site surgeries would not have been identified, according to Dr. Kwaan’s study, which was published in the same year as Dr. Seiden’s. As an example, when the wrong kidney was removed at Methodist Hospital, in St. Louis Park, Minn., the hospital said it was following a protocol set by the Minnesota Hospital Association.
Redoubling efforts
In 2009, the Joint Commission decided to take another tack. It encouraged hospitals to make root-cause analyses not only of wrong-site surgeries but also of near misses, which are much more plentiful. It used the insights gained to change surgical routines and protocols.
The Safe Surgery Project, a collaboration between the Joint Commission’s Center for Transforming Healthcare and eight hospitals and surgery centers, reduced the number of errors and near misses by 46% in the scheduling area, 63% in pre-op, and 51% in the OR area.
From that project, the center developed the Targeted Solutions Tool, which basically uses the same methodology that the project used. The center told this news organization that 79 healthcare organizations have used the tool and have reduced the number of errors and near misses by 56% in scheduling, 24% in pre-op, and 48% in the OR.
For this approach to work, however, surgical teams must report their errors to the hospital, which had not been done before. A 2008 study by the Office of the Inspector General of the U.S. Department of Health and Human Services found that surgical staff did not report 86% of adverse events to their hospitals. Reasons given included lack of time, fear of punitive action, and skepticism that reporting would do any good.
Unlike some other adverse events, it’s hard to keep wrong-site surgeries secret from patients, because they can usually see the scars from it, but some surgeons invent ways to cover it up from patients, too, Dr. Mayer says. One wrong-side hernia repair was corrected in mid operation. Afterward, the surgeon told the patient that he had found another hernia on the other side and had fixed that one, too.
Changing the culture
Reformers argue that wrong-site surgeries can be prevented by changing the culture of the hospital or surgery center. “We have to think of wrong-site surgeries as a failure of the system, not of the individual,” says Ron Savrin, MD, a general surgeon in Chagrin Falls, Ohio, who is a surgery subject matter expert for the Sullivan Group. “It should never be only up to one individual to stop an error from occurring.”
Seeing oneself as part of a team can reduce errors. Although other people can introduce errors that make a person look bad, they can also stop the errors that might otherwise have occurred. Punishing individuals for making errors does little good in stopping errors.
“It’s human nature to want to punish somebody for making a mistake, and it’s hard to change that mentality,” Dr. Savrin says. He recalls that when he was a resident, “the morbidity and mortality conferences could be very difficult for anyone who made a mistake, but I think that attitude is changing.”
Studies have found wide variation in the number of wrong-site surgeries among hospitals. A recent Pennsylvania study found an average of one wrong-site surgery or near miss per hospital per year, but about one third of hospitals did not report any.
Wrong-site surgeries are often concentrated in certain hospitals -- even prestigious teaching hospitals are not immune. A decade ago, Rhode Island Hospital had five wrong-site surgeries in 2 years, and Boston’s Beth Israel Deaconess Medical Center had three wrong-spine surgeries within 2 months.
Other ways to reduce errors
Dr. Seiden thinks reform efforts should take a page from his own specialty. Anesthesiology has developed a variety of forcing functions, which are simple changes in technology that can stop errors. An example is the use of a valve that will not deliver a drug unless certain steps are followed.
The StartBox System, a new way to prevent surgical errors, delivers the surgery blade only after all safety information has been provided. Tested by 11 orthopedic surgeons performing 487 procedures, the system identified 17 near misses.
Another approach is to film time-outs so as to enforce compliance with protocols and help with root-cause analyses. NYU-Langone Medical Center, in New York City, not only films the time-out but also grades OR teams on compliance, says Dr. Bosco, who is vice chair of clinical affairs in the department of orthopedic surgery at the hospital.
In addition, more states are requiring hospitals to report adverse events, including wrong-site surgeries. According to the National Academy for State Health Policy, 28 states require the reporting of adverse events. However, only six states identify facilities in public reports; 16 states publish only aggregate data; and five states do not report error data to the public.
The goal is zero errors
Are there fewer wrong-site surgeries now? “My sense is that surgeons, hospitals, and surgery centers are taking wrong-site errors more seriously,” Dr. Savrin says.
Because reported information is spotty and no major studies on incidence have been conducted in recent years, “we don’t have a clear idea,” he says, “but my best guess is that the rate is declining.
“Absolute zero preventable errors has to be our goal,” Dr. Savrin says “We might not get there, but we can’t stop trying.”
A version of this article first appeared on Medscape.com.
Pelvic floor dysfunction imaging: New guidelines provide recommendations
New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.
“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.
“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”
MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.
However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.
Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.
To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.
However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.
The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.
“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.
One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.
“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.
Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”
“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.
Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.
And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.
“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.
The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.
However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.
Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.
“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.
“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”
In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.
The authors of the guidelines have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.
“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.
“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”
MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.
However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.
Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.
To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.
However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.
The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.
“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.
One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.
“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.
Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”
“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.
Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.
And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.
“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.
The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.
However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.
Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.
“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.
“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”
In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.
The authors of the guidelines have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.
“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.
“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”
MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.
However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.
Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.
To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.
However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.
The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.
“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.
One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.
“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.
Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”
“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.
Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.
And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.
“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.
The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.
However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.
Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.
“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.
“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”
In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.
The authors of the guidelines have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
How physicians can provide better care to transgender patients
People who identify as transgender experience many health disparities, in addition to lack of access to quality care. The most commonly cited barrier is the lack of providers who are knowledgeable about transgender health care, according to past surveys.
Even those who do seek care often have unpleasant experiences. A 2015 survey conducted by the National Center for Transgender Equality found that 33% of those who saw a health care provider reported at least one unfavorable experience related to being transgender, such as being verbally harassed or refused treatment because of their gender identity. In fact, 23% of those surveyed say they did not seek health care they needed in the past year because of fear of being mistreated as a transgender person.
This interview has been edited for length and clarity.
Question: Surveys have shown that many people who identify as transgender will seek only transition care, not primary or preventive care. Why is that?
Dr. Brandt: My answer is multifactorial. Transgender patients do seek primary care – just not as readily. There’s a lot of misconceptions about health care needs for the LGBT community in general. For example, lesbian or bisexual women may be not as well informed about the need for Pap smears compared with their heterosexual counterparts. These misconceptions are further exacerbated in the transgender community.
The fact that a lot of patients seek only transition-related care, but not preventive services, such as primary care and gynecologic care, is also related to fears of discrimination and lack of education of providers. These patients are afraid when they walk into an office that they will be misgendered or their physician won’t be familiar with their health care needs.
What can clinics and clinicians do to create a safe and welcoming environment?
Dr. Brandt: It starts with educating office staff about terminology and gender identities.
A key feature of our EHR is the sexual orientation and gender identity platform, which asks questions about a patient’s gender identity, sexual orientation, sex assigned at birth, and organ inventory. These data are then found in the patient information tab and are just as relevant as their insurance status, age, and date of birth.
There are many ways a doctor’s office can signal to patients that they are inclusive. They can hang LGBTQ-friendly flags or symbols or a sign saying, “We have an anti-discrimination policy” in the waiting room. A welcoming environment can also be achieved by revising patient questionnaires or forms so that they aren’t gender-specific or binary.
Given that the patient may have limited contact with a primary care clinician, how do you prioritize what you address during the visit?
Dr. Brandt: Similar to cisgender patients, it depends initially on the age of the patient and the reason for the visit. The priorities of an otherwise healthy transgender patient in their 20s are going to be largely the same as for a cisgender patient of the same age. As patients age in the primary care world, you’re addressing more issues, such as colorectal screening, lipid disorders, and mammograms, and that doesn’t change. For the most part, the problems that you address should be specific for that age group.
It becomes more complicated when you add in factors such as hormone therapy and whether patients have had any type of gender-affirming surgery. Those things can change the usual recommendations for screening or risk assessment. We try to figure out what routine health maintenance and cancer screening a patient needs based on age and risk factors, in addition to hormone status and surgical state.
Do you think that many physicians are educated about the care of underserved populations such as transgender patients?
Dr. Brandt: Yes and no. We are definitely getting better at it. For example, the American College of Obstetricians and Gynecologists published a committee opinion highlighting transgender care. So organizations are starting to prioritize these populations and recognize that they are, in fact, underserved and they have special health care needs.
However, the knowledge gaps are still pretty big. I get calls daily from providers asking questions about how to manage patients on hormones, or how to examine a patient who has undergone a vaginoplasty. I hear a lot of horror stories from transgender patients who had their hormones stopped for absurd and medically misinformed reasons.
But I definitely think it’s getting better and it’s being addressed at all levels – the medical school level, the residency level, and the attending level. It just takes time to inform people and for people to get used to the health care needs of these patients.
What should physicians keep in mind when treating patients who identify as transgender?
Dr. Brandt: First and foremost, understanding the terminology and the difference between gender identity, sex, and sexual orientation. Being familiar with that language and being able to speak that language very comfortably and not being awkward about it is a really important thing for primary care physicians and indeed any physician who treats transgender patients.
Physicians should also be aware that any underserved population has higher rates of mental health issues, such as depression and anxiety. Obviously, that goes along with being underserved and the stigma and the disparities that exist for these patients. Having providers educate themselves about what those disparities are and how they impact a patient’s daily life and health is paramount to knowing how to treat patients.
What are your top health concerns for these patients and how do you address them?
Dr. Brandt: I think mental health and safety is probably the number one for me. About 41% of transgender adults have attempted suicide. That number is roughly 51% in transgender youth. That is an astonishing number. These patients have much higher rates of domestic violence, intimate partner violence, and sexual assault, especially trans women and trans women of color. So understanding those statistics is huge.
Obesity, smoking, and substance abuse are my next three. Again, those are things that should be addressed at any visit, regardless of the gender identity or sexual orientation of the patient, but those rates are particularly high in this population.
Fertility and long-term care for patients should be addressed. Many patients who identify as transgender are told they can’t have a family. As a primary care physician, you may see a patient before they are seen by an ob.gyn. or surgeon. Talking about what a patient’s long-term life goals are with fertility and family planning, and what that looks like for them, is a big thing for me. Other providers may not feel that’s a concern, but I believe it should be discussed before initiation of hormone therapy, which can significantly impact fertility in some patients.
Are there nuances to the physical examination that primary care physicians should be aware of when dealing with transmasculine patients vs. transfeminine patients?
Dr. Brandt: Absolutely. And this interview can’t cover the scope of those nuances. An example that comes to mind is the genital exam. For transgender women who have undergone a vaginoplasty, the pelvic exam can be very affirming. Whereas for transgender men, a gynecologic exam can significantly exacerbate dysphoria and there are ways to conduct the exam to limit this discomfort and avoid creating a traumatic experience for the patient. It’s important to be aware that the genital exam, or any type of genitourinary exam, can be either affirming or not affirming.
Sexually transmitted infections are up in the general population, and the trans population is at even higher risk. What should physicians think about when they assess this risk?
Dr. Brandt: It’s really important for primary care clinicians and for gynecologists to learn to be comfortable talking about sexual practices, because what people do behind closed doors is really a key to how to counsel patients about safe sex.
People are well aware of the need to have safe sex. However, depending on the type of sex that you’re having, what body parts go where, what is truly safe can vary and people may not know, for example, to wear a condom when sex toys are involved or that a transgender male on testosterone can become pregnant during penile-vaginal intercourse. Providers really should be very educated on the array of sexual practices that people have and how to counsel them about those. They should know how to ask patients the gender identity of their sexual partners, the sexual orientation of their partners, and what parts go where during sex.
Providers should also talk to patients about PrEP [pre-exposure prophylaxis], whether they identify as cisgender or transgender. My trans patients tend to be a lot more educated about PrEP than other patients. It’s something that many of the residents, even in a standard gynecologic clinic, for example, don’t talk to cisgender patients about because of the stigma surrounding HIV. Many providers still think that the only people who are at risk for HIV are men who have sex with men. And while those rates are higher in some populations, depending on sexual practices, those aren’t the only patients who qualify for PrEP.
Overall, in order to counsel patients about STIs and safe sexual practices, providers should learn to be comfortable talking about sex.
Do you have any strategies on how to make the appointment more successful in addressing those issues?
Dr. Brandt: Bedside manner is a hard thing to teach, and comfort in talking about sex, gender identity, and sexual orientation can vary – but there are a lot of continuing medical education courses that physicians can utilize through the World Professional Association for Transgender Health.
If providers start to notice an influx of patients who identify as transgender or if they want to start seeing transgender patients, it’s really important for them to have that training before they start interacting with patients. In all of medicine, we sort of learn as we go, but this patient population has been subjected to discrimination, violence, error, and misgendering. They have dealt with providers who didn’t understand their health care needs. While this field is evolving, knowing how to appropriately address a patient (using their correct name, pronouns, etc.) is an absolute must.
That needs to be part of a provider’s routine vernacular and not something that they sort of stumble through. You can scare a patient away as soon as they walk into the office with an uneducated front desk staff and things that are seen in the office. Seeking out those educational tools, being aware of your own deficits as a provider and the educational needs of your office, and addressing those needs is really key.
A version of this article first appeared on Medscape.com.
People who identify as transgender experience many health disparities, in addition to lack of access to quality care. The most commonly cited barrier is the lack of providers who are knowledgeable about transgender health care, according to past surveys.
Even those who do seek care often have unpleasant experiences. A 2015 survey conducted by the National Center for Transgender Equality found that 33% of those who saw a health care provider reported at least one unfavorable experience related to being transgender, such as being verbally harassed or refused treatment because of their gender identity. In fact, 23% of those surveyed say they did not seek health care they needed in the past year because of fear of being mistreated as a transgender person.
This interview has been edited for length and clarity.
Question: Surveys have shown that many people who identify as transgender will seek only transition care, not primary or preventive care. Why is that?
Dr. Brandt: My answer is multifactorial. Transgender patients do seek primary care – just not as readily. There’s a lot of misconceptions about health care needs for the LGBT community in general. For example, lesbian or bisexual women may be not as well informed about the need for Pap smears compared with their heterosexual counterparts. These misconceptions are further exacerbated in the transgender community.
The fact that a lot of patients seek only transition-related care, but not preventive services, such as primary care and gynecologic care, is also related to fears of discrimination and lack of education of providers. These patients are afraid when they walk into an office that they will be misgendered or their physician won’t be familiar with their health care needs.
What can clinics and clinicians do to create a safe and welcoming environment?
Dr. Brandt: It starts with educating office staff about terminology and gender identities.
A key feature of our EHR is the sexual orientation and gender identity platform, which asks questions about a patient’s gender identity, sexual orientation, sex assigned at birth, and organ inventory. These data are then found in the patient information tab and are just as relevant as their insurance status, age, and date of birth.
There are many ways a doctor’s office can signal to patients that they are inclusive. They can hang LGBTQ-friendly flags or symbols or a sign saying, “We have an anti-discrimination policy” in the waiting room. A welcoming environment can also be achieved by revising patient questionnaires or forms so that they aren’t gender-specific or binary.
Given that the patient may have limited contact with a primary care clinician, how do you prioritize what you address during the visit?
Dr. Brandt: Similar to cisgender patients, it depends initially on the age of the patient and the reason for the visit. The priorities of an otherwise healthy transgender patient in their 20s are going to be largely the same as for a cisgender patient of the same age. As patients age in the primary care world, you’re addressing more issues, such as colorectal screening, lipid disorders, and mammograms, and that doesn’t change. For the most part, the problems that you address should be specific for that age group.
It becomes more complicated when you add in factors such as hormone therapy and whether patients have had any type of gender-affirming surgery. Those things can change the usual recommendations for screening or risk assessment. We try to figure out what routine health maintenance and cancer screening a patient needs based on age and risk factors, in addition to hormone status and surgical state.
Do you think that many physicians are educated about the care of underserved populations such as transgender patients?
Dr. Brandt: Yes and no. We are definitely getting better at it. For example, the American College of Obstetricians and Gynecologists published a committee opinion highlighting transgender care. So organizations are starting to prioritize these populations and recognize that they are, in fact, underserved and they have special health care needs.
However, the knowledge gaps are still pretty big. I get calls daily from providers asking questions about how to manage patients on hormones, or how to examine a patient who has undergone a vaginoplasty. I hear a lot of horror stories from transgender patients who had their hormones stopped for absurd and medically misinformed reasons.
But I definitely think it’s getting better and it’s being addressed at all levels – the medical school level, the residency level, and the attending level. It just takes time to inform people and for people to get used to the health care needs of these patients.
What should physicians keep in mind when treating patients who identify as transgender?
Dr. Brandt: First and foremost, understanding the terminology and the difference between gender identity, sex, and sexual orientation. Being familiar with that language and being able to speak that language very comfortably and not being awkward about it is a really important thing for primary care physicians and indeed any physician who treats transgender patients.
Physicians should also be aware that any underserved population has higher rates of mental health issues, such as depression and anxiety. Obviously, that goes along with being underserved and the stigma and the disparities that exist for these patients. Having providers educate themselves about what those disparities are and how they impact a patient’s daily life and health is paramount to knowing how to treat patients.
What are your top health concerns for these patients and how do you address them?
Dr. Brandt: I think mental health and safety is probably the number one for me. About 41% of transgender adults have attempted suicide. That number is roughly 51% in transgender youth. That is an astonishing number. These patients have much higher rates of domestic violence, intimate partner violence, and sexual assault, especially trans women and trans women of color. So understanding those statistics is huge.
Obesity, smoking, and substance abuse are my next three. Again, those are things that should be addressed at any visit, regardless of the gender identity or sexual orientation of the patient, but those rates are particularly high in this population.
Fertility and long-term care for patients should be addressed. Many patients who identify as transgender are told they can’t have a family. As a primary care physician, you may see a patient before they are seen by an ob.gyn. or surgeon. Talking about what a patient’s long-term life goals are with fertility and family planning, and what that looks like for them, is a big thing for me. Other providers may not feel that’s a concern, but I believe it should be discussed before initiation of hormone therapy, which can significantly impact fertility in some patients.
Are there nuances to the physical examination that primary care physicians should be aware of when dealing with transmasculine patients vs. transfeminine patients?
Dr. Brandt: Absolutely. And this interview can’t cover the scope of those nuances. An example that comes to mind is the genital exam. For transgender women who have undergone a vaginoplasty, the pelvic exam can be very affirming. Whereas for transgender men, a gynecologic exam can significantly exacerbate dysphoria and there are ways to conduct the exam to limit this discomfort and avoid creating a traumatic experience for the patient. It’s important to be aware that the genital exam, or any type of genitourinary exam, can be either affirming or not affirming.
Sexually transmitted infections are up in the general population, and the trans population is at even higher risk. What should physicians think about when they assess this risk?
Dr. Brandt: It’s really important for primary care clinicians and for gynecologists to learn to be comfortable talking about sexual practices, because what people do behind closed doors is really a key to how to counsel patients about safe sex.
People are well aware of the need to have safe sex. However, depending on the type of sex that you’re having, what body parts go where, what is truly safe can vary and people may not know, for example, to wear a condom when sex toys are involved or that a transgender male on testosterone can become pregnant during penile-vaginal intercourse. Providers really should be very educated on the array of sexual practices that people have and how to counsel them about those. They should know how to ask patients the gender identity of their sexual partners, the sexual orientation of their partners, and what parts go where during sex.
Providers should also talk to patients about PrEP [pre-exposure prophylaxis], whether they identify as cisgender or transgender. My trans patients tend to be a lot more educated about PrEP than other patients. It’s something that many of the residents, even in a standard gynecologic clinic, for example, don’t talk to cisgender patients about because of the stigma surrounding HIV. Many providers still think that the only people who are at risk for HIV are men who have sex with men. And while those rates are higher in some populations, depending on sexual practices, those aren’t the only patients who qualify for PrEP.
Overall, in order to counsel patients about STIs and safe sexual practices, providers should learn to be comfortable talking about sex.
Do you have any strategies on how to make the appointment more successful in addressing those issues?
Dr. Brandt: Bedside manner is a hard thing to teach, and comfort in talking about sex, gender identity, and sexual orientation can vary – but there are a lot of continuing medical education courses that physicians can utilize through the World Professional Association for Transgender Health.
If providers start to notice an influx of patients who identify as transgender or if they want to start seeing transgender patients, it’s really important for them to have that training before they start interacting with patients. In all of medicine, we sort of learn as we go, but this patient population has been subjected to discrimination, violence, error, and misgendering. They have dealt with providers who didn’t understand their health care needs. While this field is evolving, knowing how to appropriately address a patient (using their correct name, pronouns, etc.) is an absolute must.
That needs to be part of a provider’s routine vernacular and not something that they sort of stumble through. You can scare a patient away as soon as they walk into the office with an uneducated front desk staff and things that are seen in the office. Seeking out those educational tools, being aware of your own deficits as a provider and the educational needs of your office, and addressing those needs is really key.
A version of this article first appeared on Medscape.com.
People who identify as transgender experience many health disparities, in addition to lack of access to quality care. The most commonly cited barrier is the lack of providers who are knowledgeable about transgender health care, according to past surveys.
Even those who do seek care often have unpleasant experiences. A 2015 survey conducted by the National Center for Transgender Equality found that 33% of those who saw a health care provider reported at least one unfavorable experience related to being transgender, such as being verbally harassed or refused treatment because of their gender identity. In fact, 23% of those surveyed say they did not seek health care they needed in the past year because of fear of being mistreated as a transgender person.
This interview has been edited for length and clarity.
Question: Surveys have shown that many people who identify as transgender will seek only transition care, not primary or preventive care. Why is that?
Dr. Brandt: My answer is multifactorial. Transgender patients do seek primary care – just not as readily. There’s a lot of misconceptions about health care needs for the LGBT community in general. For example, lesbian or bisexual women may be not as well informed about the need for Pap smears compared with their heterosexual counterparts. These misconceptions are further exacerbated in the transgender community.
The fact that a lot of patients seek only transition-related care, but not preventive services, such as primary care and gynecologic care, is also related to fears of discrimination and lack of education of providers. These patients are afraid when they walk into an office that they will be misgendered or their physician won’t be familiar with their health care needs.
What can clinics and clinicians do to create a safe and welcoming environment?
Dr. Brandt: It starts with educating office staff about terminology and gender identities.
A key feature of our EHR is the sexual orientation and gender identity platform, which asks questions about a patient’s gender identity, sexual orientation, sex assigned at birth, and organ inventory. These data are then found in the patient information tab and are just as relevant as their insurance status, age, and date of birth.
There are many ways a doctor’s office can signal to patients that they are inclusive. They can hang LGBTQ-friendly flags or symbols or a sign saying, “We have an anti-discrimination policy” in the waiting room. A welcoming environment can also be achieved by revising patient questionnaires or forms so that they aren’t gender-specific or binary.
Given that the patient may have limited contact with a primary care clinician, how do you prioritize what you address during the visit?
Dr. Brandt: Similar to cisgender patients, it depends initially on the age of the patient and the reason for the visit. The priorities of an otherwise healthy transgender patient in their 20s are going to be largely the same as for a cisgender patient of the same age. As patients age in the primary care world, you’re addressing more issues, such as colorectal screening, lipid disorders, and mammograms, and that doesn’t change. For the most part, the problems that you address should be specific for that age group.
It becomes more complicated when you add in factors such as hormone therapy and whether patients have had any type of gender-affirming surgery. Those things can change the usual recommendations for screening or risk assessment. We try to figure out what routine health maintenance and cancer screening a patient needs based on age and risk factors, in addition to hormone status and surgical state.
Do you think that many physicians are educated about the care of underserved populations such as transgender patients?
Dr. Brandt: Yes and no. We are definitely getting better at it. For example, the American College of Obstetricians and Gynecologists published a committee opinion highlighting transgender care. So organizations are starting to prioritize these populations and recognize that they are, in fact, underserved and they have special health care needs.
However, the knowledge gaps are still pretty big. I get calls daily from providers asking questions about how to manage patients on hormones, or how to examine a patient who has undergone a vaginoplasty. I hear a lot of horror stories from transgender patients who had their hormones stopped for absurd and medically misinformed reasons.
But I definitely think it’s getting better and it’s being addressed at all levels – the medical school level, the residency level, and the attending level. It just takes time to inform people and for people to get used to the health care needs of these patients.
What should physicians keep in mind when treating patients who identify as transgender?
Dr. Brandt: First and foremost, understanding the terminology and the difference between gender identity, sex, and sexual orientation. Being familiar with that language and being able to speak that language very comfortably and not being awkward about it is a really important thing for primary care physicians and indeed any physician who treats transgender patients.
Physicians should also be aware that any underserved population has higher rates of mental health issues, such as depression and anxiety. Obviously, that goes along with being underserved and the stigma and the disparities that exist for these patients. Having providers educate themselves about what those disparities are and how they impact a patient’s daily life and health is paramount to knowing how to treat patients.
What are your top health concerns for these patients and how do you address them?
Dr. Brandt: I think mental health and safety is probably the number one for me. About 41% of transgender adults have attempted suicide. That number is roughly 51% in transgender youth. That is an astonishing number. These patients have much higher rates of domestic violence, intimate partner violence, and sexual assault, especially trans women and trans women of color. So understanding those statistics is huge.
Obesity, smoking, and substance abuse are my next three. Again, those are things that should be addressed at any visit, regardless of the gender identity or sexual orientation of the patient, but those rates are particularly high in this population.
Fertility and long-term care for patients should be addressed. Many patients who identify as transgender are told they can’t have a family. As a primary care physician, you may see a patient before they are seen by an ob.gyn. or surgeon. Talking about what a patient’s long-term life goals are with fertility and family planning, and what that looks like for them, is a big thing for me. Other providers may not feel that’s a concern, but I believe it should be discussed before initiation of hormone therapy, which can significantly impact fertility in some patients.
Are there nuances to the physical examination that primary care physicians should be aware of when dealing with transmasculine patients vs. transfeminine patients?
Dr. Brandt: Absolutely. And this interview can’t cover the scope of those nuances. An example that comes to mind is the genital exam. For transgender women who have undergone a vaginoplasty, the pelvic exam can be very affirming. Whereas for transgender men, a gynecologic exam can significantly exacerbate dysphoria and there are ways to conduct the exam to limit this discomfort and avoid creating a traumatic experience for the patient. It’s important to be aware that the genital exam, or any type of genitourinary exam, can be either affirming or not affirming.
Sexually transmitted infections are up in the general population, and the trans population is at even higher risk. What should physicians think about when they assess this risk?
Dr. Brandt: It’s really important for primary care clinicians and for gynecologists to learn to be comfortable talking about sexual practices, because what people do behind closed doors is really a key to how to counsel patients about safe sex.
People are well aware of the need to have safe sex. However, depending on the type of sex that you’re having, what body parts go where, what is truly safe can vary and people may not know, for example, to wear a condom when sex toys are involved or that a transgender male on testosterone can become pregnant during penile-vaginal intercourse. Providers really should be very educated on the array of sexual practices that people have and how to counsel them about those. They should know how to ask patients the gender identity of their sexual partners, the sexual orientation of their partners, and what parts go where during sex.
Providers should also talk to patients about PrEP [pre-exposure prophylaxis], whether they identify as cisgender or transgender. My trans patients tend to be a lot more educated about PrEP than other patients. It’s something that many of the residents, even in a standard gynecologic clinic, for example, don’t talk to cisgender patients about because of the stigma surrounding HIV. Many providers still think that the only people who are at risk for HIV are men who have sex with men. And while those rates are higher in some populations, depending on sexual practices, those aren’t the only patients who qualify for PrEP.
Overall, in order to counsel patients about STIs and safe sexual practices, providers should learn to be comfortable talking about sex.
Do you have any strategies on how to make the appointment more successful in addressing those issues?
Dr. Brandt: Bedside manner is a hard thing to teach, and comfort in talking about sex, gender identity, and sexual orientation can vary – but there are a lot of continuing medical education courses that physicians can utilize through the World Professional Association for Transgender Health.
If providers start to notice an influx of patients who identify as transgender or if they want to start seeing transgender patients, it’s really important for them to have that training before they start interacting with patients. In all of medicine, we sort of learn as we go, but this patient population has been subjected to discrimination, violence, error, and misgendering. They have dealt with providers who didn’t understand their health care needs. While this field is evolving, knowing how to appropriately address a patient (using their correct name, pronouns, etc.) is an absolute must.
That needs to be part of a provider’s routine vernacular and not something that they sort of stumble through. You can scare a patient away as soon as they walk into the office with an uneducated front desk staff and things that are seen in the office. Seeking out those educational tools, being aware of your own deficits as a provider and the educational needs of your office, and addressing those needs is really key.
A version of this article first appeared on Medscape.com.
Frailty screening should be routine in endometrial cancer surgery
Endometrial cancer patients should be screened for frailty before hysterectomies, and frail patients should be counseled thoroughly about their increased risk for poor outcomes, according to a review of 144,809 cases in the Nationwide Readmissions Database.
Overall, 1.8% of the women were frail according to the Johns Hopkins Adjusted Clinical Groups (ACG) frailty indicator, which characterizes patients as frail or not based on diagnostic codes in a range of areas, including abnormal weight loss, dementia, urinary or fecal incontinence, difficulty walking, inadequate social support, and other matters.
Frailty was associated with an almost fourfold increased risk of intensive care after surgery; a more than twofold risk of inpatient mortality, and a 59% increased risk of something other than routine discharge to home. Frail patients were 33% more likely to be readmitted within 30 days and 21% more likely to be readmitted within 90 days, and they had a higher risk of dying on readmission. Hospital costs and lengths of stay were higher for frail women, according to the report, which was published online in Gynecologic Oncology.
The findings were adjusted for patient, hospital, and clinical factors, and the readmission outcomes were unchanged when limited to patients who had minimally invasive surgery.
Frailty is a well-known risk factor for poor surgical outcomes, so it “comes as little surprise” that it was associated with worse outcomes in hysterectomies for endometrial cancer. Even so, “frailty is oftentimes not screened for in oncology clinics” leading to “a large number of potentially unrecognized frail patients who are recommended to undergo surgery,” said investigators led by Tiffany Sia, MD, an obstetrics and gynecology resident at Columbia University, New York.
“We believe that each potential patient’s frailty status should be assessed during the preoperative period ... frail patients should be counseled regarding these risks in the perioperative setting,” Dr. Sia said in an interview.
“Researchers and clinicians have adopted the scoring instrument that corresponds best with the data they have available,” but “lack of a widely recognized gold standard or easily utilized diagnostic tool makes frailty rather difficult to formally assess in a clinical setting,” she said.
The investigators found a “surprisingly high rate” of frail patients (82%) who underwent total abdominal hysterectomies compared to less invasive options, with 16.5% undergoing extended procedures. The reason is unknown because stage, tumor grade, and histology – factors that likely influenced decision making – were not captured in the analysis.
However, almost half of the frail subjects were 70 years or older, and increasing age is associated with more aggressive tumor characteristics and worse prognosis.
The team said future research should integrate screening instruments into routine clinic workflow, but there have been a number of roadblocks. Current screening instruments are “cumbersome to use and difficult to implement ... as they typically require measurement of a frailty phenotype such as a timed up-and-go test or grip strength and require numerous patient surveys,” they added.
Proposed screening tools include the Frailty Index, Memorial Sloan Kettering–Frailty Index, Hopkins’ frailty indicator, and the Vulnerable Elders Survey, but no preferred method has emerged, and each scale captures different subpopulations of frailty and differs in its prognostic ability.
There was no external funding, and Dr. Sia didn’t have any disclosures.
Endometrial cancer patients should be screened for frailty before hysterectomies, and frail patients should be counseled thoroughly about their increased risk for poor outcomes, according to a review of 144,809 cases in the Nationwide Readmissions Database.
Overall, 1.8% of the women were frail according to the Johns Hopkins Adjusted Clinical Groups (ACG) frailty indicator, which characterizes patients as frail or not based on diagnostic codes in a range of areas, including abnormal weight loss, dementia, urinary or fecal incontinence, difficulty walking, inadequate social support, and other matters.
Frailty was associated with an almost fourfold increased risk of intensive care after surgery; a more than twofold risk of inpatient mortality, and a 59% increased risk of something other than routine discharge to home. Frail patients were 33% more likely to be readmitted within 30 days and 21% more likely to be readmitted within 90 days, and they had a higher risk of dying on readmission. Hospital costs and lengths of stay were higher for frail women, according to the report, which was published online in Gynecologic Oncology.
The findings were adjusted for patient, hospital, and clinical factors, and the readmission outcomes were unchanged when limited to patients who had minimally invasive surgery.
Frailty is a well-known risk factor for poor surgical outcomes, so it “comes as little surprise” that it was associated with worse outcomes in hysterectomies for endometrial cancer. Even so, “frailty is oftentimes not screened for in oncology clinics” leading to “a large number of potentially unrecognized frail patients who are recommended to undergo surgery,” said investigators led by Tiffany Sia, MD, an obstetrics and gynecology resident at Columbia University, New York.
“We believe that each potential patient’s frailty status should be assessed during the preoperative period ... frail patients should be counseled regarding these risks in the perioperative setting,” Dr. Sia said in an interview.
“Researchers and clinicians have adopted the scoring instrument that corresponds best with the data they have available,” but “lack of a widely recognized gold standard or easily utilized diagnostic tool makes frailty rather difficult to formally assess in a clinical setting,” she said.
The investigators found a “surprisingly high rate” of frail patients (82%) who underwent total abdominal hysterectomies compared to less invasive options, with 16.5% undergoing extended procedures. The reason is unknown because stage, tumor grade, and histology – factors that likely influenced decision making – were not captured in the analysis.
However, almost half of the frail subjects were 70 years or older, and increasing age is associated with more aggressive tumor characteristics and worse prognosis.
The team said future research should integrate screening instruments into routine clinic workflow, but there have been a number of roadblocks. Current screening instruments are “cumbersome to use and difficult to implement ... as they typically require measurement of a frailty phenotype such as a timed up-and-go test or grip strength and require numerous patient surveys,” they added.
Proposed screening tools include the Frailty Index, Memorial Sloan Kettering–Frailty Index, Hopkins’ frailty indicator, and the Vulnerable Elders Survey, but no preferred method has emerged, and each scale captures different subpopulations of frailty and differs in its prognostic ability.
There was no external funding, and Dr. Sia didn’t have any disclosures.
Endometrial cancer patients should be screened for frailty before hysterectomies, and frail patients should be counseled thoroughly about their increased risk for poor outcomes, according to a review of 144,809 cases in the Nationwide Readmissions Database.
Overall, 1.8% of the women were frail according to the Johns Hopkins Adjusted Clinical Groups (ACG) frailty indicator, which characterizes patients as frail or not based on diagnostic codes in a range of areas, including abnormal weight loss, dementia, urinary or fecal incontinence, difficulty walking, inadequate social support, and other matters.
Frailty was associated with an almost fourfold increased risk of intensive care after surgery; a more than twofold risk of inpatient mortality, and a 59% increased risk of something other than routine discharge to home. Frail patients were 33% more likely to be readmitted within 30 days and 21% more likely to be readmitted within 90 days, and they had a higher risk of dying on readmission. Hospital costs and lengths of stay were higher for frail women, according to the report, which was published online in Gynecologic Oncology.
The findings were adjusted for patient, hospital, and clinical factors, and the readmission outcomes were unchanged when limited to patients who had minimally invasive surgery.
Frailty is a well-known risk factor for poor surgical outcomes, so it “comes as little surprise” that it was associated with worse outcomes in hysterectomies for endometrial cancer. Even so, “frailty is oftentimes not screened for in oncology clinics” leading to “a large number of potentially unrecognized frail patients who are recommended to undergo surgery,” said investigators led by Tiffany Sia, MD, an obstetrics and gynecology resident at Columbia University, New York.
“We believe that each potential patient’s frailty status should be assessed during the preoperative period ... frail patients should be counseled regarding these risks in the perioperative setting,” Dr. Sia said in an interview.
“Researchers and clinicians have adopted the scoring instrument that corresponds best with the data they have available,” but “lack of a widely recognized gold standard or easily utilized diagnostic tool makes frailty rather difficult to formally assess in a clinical setting,” she said.
The investigators found a “surprisingly high rate” of frail patients (82%) who underwent total abdominal hysterectomies compared to less invasive options, with 16.5% undergoing extended procedures. The reason is unknown because stage, tumor grade, and histology – factors that likely influenced decision making – were not captured in the analysis.
However, almost half of the frail subjects were 70 years or older, and increasing age is associated with more aggressive tumor characteristics and worse prognosis.
The team said future research should integrate screening instruments into routine clinic workflow, but there have been a number of roadblocks. Current screening instruments are “cumbersome to use and difficult to implement ... as they typically require measurement of a frailty phenotype such as a timed up-and-go test or grip strength and require numerous patient surveys,” they added.
Proposed screening tools include the Frailty Index, Memorial Sloan Kettering–Frailty Index, Hopkins’ frailty indicator, and the Vulnerable Elders Survey, but no preferred method has emerged, and each scale captures different subpopulations of frailty and differs in its prognostic ability.
There was no external funding, and Dr. Sia didn’t have any disclosures.
FROM GYNECOLOGIC ONCOLOGY
FDA supports robotic device as hysterectomy helper
Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.
The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.
The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.
RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.
“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.
The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.
The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.
“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.
The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.
Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.
Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.
The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.
The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.
RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.
“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.
The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.
The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.
“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.
The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.
Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.
Surgeons have a new tool for use in benign hysterectomies with the Food & Drug Administration’s authorization for marketing of the Hominis Surgical System, a robotic-assisted surgical device. The marketing authorization was granted to Memic Innovative Surgery.
The FDA reviewed the device through the De Novo classification review process, a regulatory pathway for low- to moderate-risk devices of a new type.
The robotically assisted surgical device (RASD) is designed to facilitate transvaginal hysterectomy procedures and salpingo-oophorectomy procedures in patients without cancer.
RASDs are not robots and require human control, but they allow a surgeon to use computer technology to control and move surgical instruments inserted through incisions or orifices. “RASD technology facilitates performing minimally invasive surgery and complex tasks in confined areas inside the body,” according to an FDA press release announcing the authorization.
“The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures,” Binita Ashar, MD, of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health, said in the press release. The device represents another minimally invasive option for noncancerous conditions requiring gynecologic surgery.
The FDA also is establishing controls to ensure safety and effectiveness for RASDs, including labeling and performance testing requirements. “When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type,” according to the press release.
The Hominis Surgical System involves the use of minimally invasive surgical instruments inserted through the vagina. A video camera is inserted laparoscopically through an abdominal incision; the camera allows the surgeon to visualize the instruments inside the patient.
“The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device,” according to the press release.
The FDA reviewed data from a clinical study of 30 patients aged 37-79 years who underwent transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions.
Observed adverse events included minor blood loss, urinary tract infection and delayed healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy, according to the FDA. However, all 30 procedures were completed with no need for conversion to an open or other procedure.
Prophylactic NPWT may not improve complication rate after gynecologic surgery
Use of prophylactic negative pressure wound therapy may not be appropriate in surgical cases where women undergo a laparotomy for presumed gynecologic malignancy, according to recent research in Obstetrics & Gynecology.
“The results of our randomized trial do not support the routine use of prophylactic negative pressure wound therapy at the time of laparotomy incision closure in women who are undergoing surgery for gynecologic malignancies or in morbidly obese women who are undergoing laparotomy for benign indications,” Mario M. Leitao Jr., MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues wrote.
Dr. Leitao and colleagues randomized 663 patients, stratified by body mass index (BMI) after skin closure, to receive negative pressure wound therapy (NPWT) or standard gauze after undergoing a laparotomy for gynecological surgery between March 2016 and August 2019. Patients in the study were aged a median 61 years with a median BMI of 26 kg/m2, but 32 patients with a BMI of 40 or higher who underwent a laparotomy for gynecologic surgery regardless of indication were also included in the study. Most women (80%-82%) were undergoing surgery to treat ovary, fallopian tube, or peritoneal cancer. The most common medical comorbidities in both groups were hypertension (34%-35%) and diabetes (8%-14%). Information on race of patients was not included in the baseline characteristics for the study.
In total, 505 patients were available for evaluation after surgery, which consisted of 254 patients in the NPWT group and 251 patients in the standard gauze group, with 495 patients (98%) having a malignant indication. The researchers examined the incidence of wound complication up to 30 days after surgery.
The results showed a similar rate of wound complications in the NPWT group (44 patients; 17.3%), compared with the group receiving standard gauze (41 patients; 16.3%), with an absolute risk difference between groups of 1% (90% confidence interval, –4.5 to 6.5%; P = .77). Nearly all patients who developed wound complications in both NPWT (92%) and standard gauze (95%) groups had the wound complication diagnosis occur after discharge from the hospital. Dr. Leitao and colleagues noted similarities between groups with regard to wound complications, with most patients having grade 1 complications, and said there were no instances of patients requiring surgery for complications. Among patients in the NPWT group, 33 patients developed skin blistering, compared with 3 patients in the standard gauze group (13% vs. 1.2%; P < .001). After an interim analysis consisting of 444 patients, the study was halted because of “low probability of showing a difference between the two groups at the end of the study.”
The analysis of patients with a BMI of 40 or higher showed 7 of 15 patients (47%) developed wound complications in the NPWT group and 6 of 17 patients (35%) in the standard gauze group (P = .51). In post hoc analyses, the researchers found a median BMI of 26 (range, 17-60) was significantly associated with not developing a wound complication, compared with a BMI of 32 (range, 17-56) (P < .001), and that 41% of patients with a BMI of at least 40 experienced wound complications, compared with 15% of patients with a BMI of less than 40 (P < .001). There was an independent association between developing a wound complication and increasing BMI, according to a multivariate analysis (adjusted odds ratio, 1.10; 95% CI, 1.06-1.14).
Applicability of results unclear for patients with higher BMI
Sarah M. Temkin, MD, a gynecologic oncologist who was not involved with the study, said in an interview that the results by Dr. Leitao and colleagues answer the question of whether patients undergoing surgery for gynecologic malignancy require NPWT, but raised questions about patient selection in the study.
“I think it’s hard to take data from this type of high-end surgical practice and apply it to the general population,” she said, who noted the median BMI of 26 for patients included in the study. A study that included only patients with a BMI of 40 or higher “would have made these results more applicable.”
The low rate of wound complications in the study could potentially be explained by patient selection, Dr. Temkin explained. She cited her own retrospective study from 2016 that showed a wound complication rate of 27.3% for patients receiving prophylactic NPWT where the BMI for the group was 41.29, compared with a complication rate of 19.7% for patients receiving standard care who had a BMI of 30.67.
“It’s hard to cross-trial compare, but that’s significantly higher than what they saw in this prospective study, and I would say that’s a difference with the patient population,” she said. “I think the question of how to reduce surgical-site infections and wound complications in the heavy patient with comorbidities is still unanswered.”
The question is important because patients with a higher BMI and medical comorbidities “still need cancer surgery and methods to reduce the morbidity of that surgery,” Dr. Temkin said. “I think this is an unmet need.”
This study was funded in part by a support grant from the National Institutes of Health/National Cancer Institute Cancer Center, and KCI/Acelity provided part of the study protocol. Nine authors reported personal and institutional relationships in the form of personal fees, grants, stock ownership, consultancies, and speaker’s bureau positions with AstraZeneca, Biom’Up, Bovie Medical, C Surgeries, CMR, ConMed, Covidien, Ethicon, GlaxoSmithKline, GRAIL, Intuitive Surgical, JNJ, Medtronic, Merck, Mylan, Olympus, Stryker/Novadaq, TransEnterix, UpToDate, and Verthermia. Dr. Temkin reported no relevant financial disclosures.
Use of prophylactic negative pressure wound therapy may not be appropriate in surgical cases where women undergo a laparotomy for presumed gynecologic malignancy, according to recent research in Obstetrics & Gynecology.
“The results of our randomized trial do not support the routine use of prophylactic negative pressure wound therapy at the time of laparotomy incision closure in women who are undergoing surgery for gynecologic malignancies or in morbidly obese women who are undergoing laparotomy for benign indications,” Mario M. Leitao Jr., MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues wrote.
Dr. Leitao and colleagues randomized 663 patients, stratified by body mass index (BMI) after skin closure, to receive negative pressure wound therapy (NPWT) or standard gauze after undergoing a laparotomy for gynecological surgery between March 2016 and August 2019. Patients in the study were aged a median 61 years with a median BMI of 26 kg/m2, but 32 patients with a BMI of 40 or higher who underwent a laparotomy for gynecologic surgery regardless of indication were also included in the study. Most women (80%-82%) were undergoing surgery to treat ovary, fallopian tube, or peritoneal cancer. The most common medical comorbidities in both groups were hypertension (34%-35%) and diabetes (8%-14%). Information on race of patients was not included in the baseline characteristics for the study.
In total, 505 patients were available for evaluation after surgery, which consisted of 254 patients in the NPWT group and 251 patients in the standard gauze group, with 495 patients (98%) having a malignant indication. The researchers examined the incidence of wound complication up to 30 days after surgery.
The results showed a similar rate of wound complications in the NPWT group (44 patients; 17.3%), compared with the group receiving standard gauze (41 patients; 16.3%), with an absolute risk difference between groups of 1% (90% confidence interval, –4.5 to 6.5%; P = .77). Nearly all patients who developed wound complications in both NPWT (92%) and standard gauze (95%) groups had the wound complication diagnosis occur after discharge from the hospital. Dr. Leitao and colleagues noted similarities between groups with regard to wound complications, with most patients having grade 1 complications, and said there were no instances of patients requiring surgery for complications. Among patients in the NPWT group, 33 patients developed skin blistering, compared with 3 patients in the standard gauze group (13% vs. 1.2%; P < .001). After an interim analysis consisting of 444 patients, the study was halted because of “low probability of showing a difference between the two groups at the end of the study.”
The analysis of patients with a BMI of 40 or higher showed 7 of 15 patients (47%) developed wound complications in the NPWT group and 6 of 17 patients (35%) in the standard gauze group (P = .51). In post hoc analyses, the researchers found a median BMI of 26 (range, 17-60) was significantly associated with not developing a wound complication, compared with a BMI of 32 (range, 17-56) (P < .001), and that 41% of patients with a BMI of at least 40 experienced wound complications, compared with 15% of patients with a BMI of less than 40 (P < .001). There was an independent association between developing a wound complication and increasing BMI, according to a multivariate analysis (adjusted odds ratio, 1.10; 95% CI, 1.06-1.14).
Applicability of results unclear for patients with higher BMI
Sarah M. Temkin, MD, a gynecologic oncologist who was not involved with the study, said in an interview that the results by Dr. Leitao and colleagues answer the question of whether patients undergoing surgery for gynecologic malignancy require NPWT, but raised questions about patient selection in the study.
“I think it’s hard to take data from this type of high-end surgical practice and apply it to the general population,” she said, who noted the median BMI of 26 for patients included in the study. A study that included only patients with a BMI of 40 or higher “would have made these results more applicable.”
The low rate of wound complications in the study could potentially be explained by patient selection, Dr. Temkin explained. She cited her own retrospective study from 2016 that showed a wound complication rate of 27.3% for patients receiving prophylactic NPWT where the BMI for the group was 41.29, compared with a complication rate of 19.7% for patients receiving standard care who had a BMI of 30.67.
“It’s hard to cross-trial compare, but that’s significantly higher than what they saw in this prospective study, and I would say that’s a difference with the patient population,” she said. “I think the question of how to reduce surgical-site infections and wound complications in the heavy patient with comorbidities is still unanswered.”
The question is important because patients with a higher BMI and medical comorbidities “still need cancer surgery and methods to reduce the morbidity of that surgery,” Dr. Temkin said. “I think this is an unmet need.”
This study was funded in part by a support grant from the National Institutes of Health/National Cancer Institute Cancer Center, and KCI/Acelity provided part of the study protocol. Nine authors reported personal and institutional relationships in the form of personal fees, grants, stock ownership, consultancies, and speaker’s bureau positions with AstraZeneca, Biom’Up, Bovie Medical, C Surgeries, CMR, ConMed, Covidien, Ethicon, GlaxoSmithKline, GRAIL, Intuitive Surgical, JNJ, Medtronic, Merck, Mylan, Olympus, Stryker/Novadaq, TransEnterix, UpToDate, and Verthermia. Dr. Temkin reported no relevant financial disclosures.
Use of prophylactic negative pressure wound therapy may not be appropriate in surgical cases where women undergo a laparotomy for presumed gynecologic malignancy, according to recent research in Obstetrics & Gynecology.
“The results of our randomized trial do not support the routine use of prophylactic negative pressure wound therapy at the time of laparotomy incision closure in women who are undergoing surgery for gynecologic malignancies or in morbidly obese women who are undergoing laparotomy for benign indications,” Mario M. Leitao Jr., MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues wrote.
Dr. Leitao and colleagues randomized 663 patients, stratified by body mass index (BMI) after skin closure, to receive negative pressure wound therapy (NPWT) or standard gauze after undergoing a laparotomy for gynecological surgery between March 2016 and August 2019. Patients in the study were aged a median 61 years with a median BMI of 26 kg/m2, but 32 patients with a BMI of 40 or higher who underwent a laparotomy for gynecologic surgery regardless of indication were also included in the study. Most women (80%-82%) were undergoing surgery to treat ovary, fallopian tube, or peritoneal cancer. The most common medical comorbidities in both groups were hypertension (34%-35%) and diabetes (8%-14%). Information on race of patients was not included in the baseline characteristics for the study.
In total, 505 patients were available for evaluation after surgery, which consisted of 254 patients in the NPWT group and 251 patients in the standard gauze group, with 495 patients (98%) having a malignant indication. The researchers examined the incidence of wound complication up to 30 days after surgery.
The results showed a similar rate of wound complications in the NPWT group (44 patients; 17.3%), compared with the group receiving standard gauze (41 patients; 16.3%), with an absolute risk difference between groups of 1% (90% confidence interval, –4.5 to 6.5%; P = .77). Nearly all patients who developed wound complications in both NPWT (92%) and standard gauze (95%) groups had the wound complication diagnosis occur after discharge from the hospital. Dr. Leitao and colleagues noted similarities between groups with regard to wound complications, with most patients having grade 1 complications, and said there were no instances of patients requiring surgery for complications. Among patients in the NPWT group, 33 patients developed skin blistering, compared with 3 patients in the standard gauze group (13% vs. 1.2%; P < .001). After an interim analysis consisting of 444 patients, the study was halted because of “low probability of showing a difference between the two groups at the end of the study.”
The analysis of patients with a BMI of 40 or higher showed 7 of 15 patients (47%) developed wound complications in the NPWT group and 6 of 17 patients (35%) in the standard gauze group (P = .51). In post hoc analyses, the researchers found a median BMI of 26 (range, 17-60) was significantly associated with not developing a wound complication, compared with a BMI of 32 (range, 17-56) (P < .001), and that 41% of patients with a BMI of at least 40 experienced wound complications, compared with 15% of patients with a BMI of less than 40 (P < .001). There was an independent association between developing a wound complication and increasing BMI, according to a multivariate analysis (adjusted odds ratio, 1.10; 95% CI, 1.06-1.14).
Applicability of results unclear for patients with higher BMI
Sarah M. Temkin, MD, a gynecologic oncologist who was not involved with the study, said in an interview that the results by Dr. Leitao and colleagues answer the question of whether patients undergoing surgery for gynecologic malignancy require NPWT, but raised questions about patient selection in the study.
“I think it’s hard to take data from this type of high-end surgical practice and apply it to the general population,” she said, who noted the median BMI of 26 for patients included in the study. A study that included only patients with a BMI of 40 or higher “would have made these results more applicable.”
The low rate of wound complications in the study could potentially be explained by patient selection, Dr. Temkin explained. She cited her own retrospective study from 2016 that showed a wound complication rate of 27.3% for patients receiving prophylactic NPWT where the BMI for the group was 41.29, compared with a complication rate of 19.7% for patients receiving standard care who had a BMI of 30.67.
“It’s hard to cross-trial compare, but that’s significantly higher than what they saw in this prospective study, and I would say that’s a difference with the patient population,” she said. “I think the question of how to reduce surgical-site infections and wound complications in the heavy patient with comorbidities is still unanswered.”
The question is important because patients with a higher BMI and medical comorbidities “still need cancer surgery and methods to reduce the morbidity of that surgery,” Dr. Temkin said. “I think this is an unmet need.”
This study was funded in part by a support grant from the National Institutes of Health/National Cancer Institute Cancer Center, and KCI/Acelity provided part of the study protocol. Nine authors reported personal and institutional relationships in the form of personal fees, grants, stock ownership, consultancies, and speaker’s bureau positions with AstraZeneca, Biom’Up, Bovie Medical, C Surgeries, CMR, ConMed, Covidien, Ethicon, GlaxoSmithKline, GRAIL, Intuitive Surgical, JNJ, Medtronic, Merck, Mylan, Olympus, Stryker/Novadaq, TransEnterix, UpToDate, and Verthermia. Dr. Temkin reported no relevant financial disclosures.
FROM OBSTETRICS & GYNECOLOGY
FDA finalizes guidance for power morcellators in gynecologic surgery
The agency noted that physicians should conduct a thorough preoperative screening and that the devices should only be used for hysterectomies and myomectomies. Clinicians should not use the devices in cases involving uterine malignancy or suspected uterine malignancy.
In addition, clinicians should not use morcellators to remove uterine tissue containing suspected fibroids in women older than 50 years or who are postmenopausal. Nor should the devices be used for women who are “candidates for removal of tissue (en bloc) through the vagina or via a minilaparotomy incision,” the agency said.
The safety communication, which was issued on Dec. 29, 2020, updates previous guidance from February 2020. The updated recommendations are consistent with final labeling guidance for laparoscopic power morcellators, also issued by the FDA on Dec. 29.
Risk of disease spread
Prior evidence suggests that use of uncontained power morcellators in women with malignant uterine tissue can spread disease.
Even among women who do not have malignant uterine tissue, containment is important. The agency noted an association between uncontained power morcellation and the spread of benign uterine tissue, such as parasitic myomas and disseminated peritoneal leiomyomatosis, which could require additional surgeries.
In 2016, the FDA approved the PneumoLiner, a containment system for isolating uterine tissue that is not suspected of containing cancer.
“While unsuspected cancer can occur at any age, the prevalence of unsuspected cancer in women undergoing hysterectomy for fibroids increases with age such that the benefit-risk profile of using [laparoscopic power morcellators] is worse in older women when compared to younger women,” according to the new labeling guidance. “Also, the surgical technique of en bloc tissue removal eliminates the need to perform morcellation, thereby reducing the risk of iatrogenic dissemination and upstaging of an occult sarcoma. A thorough preoperative screening should be conducted; however, it is important to note that no screening procedure that can reliably detect sarcoma preoperatively has been identified.”
“The FDA will continue to review the latest data and scientific literature on laparoscopic power morcellation, including gathering real-world evidence from patients, providers and others, and encouraging innovation to better detect uterine cancer and develop containment systems for gynecologic surgery,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a news release. “The FDA seeks to ensure women and their health care providers are fully informed when considering laparoscopic power morcellators for gynecologic surgeries.”
A version of this article first appeared on Medscape.com.
The agency noted that physicians should conduct a thorough preoperative screening and that the devices should only be used for hysterectomies and myomectomies. Clinicians should not use the devices in cases involving uterine malignancy or suspected uterine malignancy.
In addition, clinicians should not use morcellators to remove uterine tissue containing suspected fibroids in women older than 50 years or who are postmenopausal. Nor should the devices be used for women who are “candidates for removal of tissue (en bloc) through the vagina or via a minilaparotomy incision,” the agency said.
The safety communication, which was issued on Dec. 29, 2020, updates previous guidance from February 2020. The updated recommendations are consistent with final labeling guidance for laparoscopic power morcellators, also issued by the FDA on Dec. 29.
Risk of disease spread
Prior evidence suggests that use of uncontained power morcellators in women with malignant uterine tissue can spread disease.
Even among women who do not have malignant uterine tissue, containment is important. The agency noted an association between uncontained power morcellation and the spread of benign uterine tissue, such as parasitic myomas and disseminated peritoneal leiomyomatosis, which could require additional surgeries.
In 2016, the FDA approved the PneumoLiner, a containment system for isolating uterine tissue that is not suspected of containing cancer.
“While unsuspected cancer can occur at any age, the prevalence of unsuspected cancer in women undergoing hysterectomy for fibroids increases with age such that the benefit-risk profile of using [laparoscopic power morcellators] is worse in older women when compared to younger women,” according to the new labeling guidance. “Also, the surgical technique of en bloc tissue removal eliminates the need to perform morcellation, thereby reducing the risk of iatrogenic dissemination and upstaging of an occult sarcoma. A thorough preoperative screening should be conducted; however, it is important to note that no screening procedure that can reliably detect sarcoma preoperatively has been identified.”
“The FDA will continue to review the latest data and scientific literature on laparoscopic power morcellation, including gathering real-world evidence from patients, providers and others, and encouraging innovation to better detect uterine cancer and develop containment systems for gynecologic surgery,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a news release. “The FDA seeks to ensure women and their health care providers are fully informed when considering laparoscopic power morcellators for gynecologic surgeries.”
A version of this article first appeared on Medscape.com.
The agency noted that physicians should conduct a thorough preoperative screening and that the devices should only be used for hysterectomies and myomectomies. Clinicians should not use the devices in cases involving uterine malignancy or suspected uterine malignancy.
In addition, clinicians should not use morcellators to remove uterine tissue containing suspected fibroids in women older than 50 years or who are postmenopausal. Nor should the devices be used for women who are “candidates for removal of tissue (en bloc) through the vagina or via a minilaparotomy incision,” the agency said.
The safety communication, which was issued on Dec. 29, 2020, updates previous guidance from February 2020. The updated recommendations are consistent with final labeling guidance for laparoscopic power morcellators, also issued by the FDA on Dec. 29.
Risk of disease spread
Prior evidence suggests that use of uncontained power morcellators in women with malignant uterine tissue can spread disease.
Even among women who do not have malignant uterine tissue, containment is important. The agency noted an association between uncontained power morcellation and the spread of benign uterine tissue, such as parasitic myomas and disseminated peritoneal leiomyomatosis, which could require additional surgeries.
In 2016, the FDA approved the PneumoLiner, a containment system for isolating uterine tissue that is not suspected of containing cancer.
“While unsuspected cancer can occur at any age, the prevalence of unsuspected cancer in women undergoing hysterectomy for fibroids increases with age such that the benefit-risk profile of using [laparoscopic power morcellators] is worse in older women when compared to younger women,” according to the new labeling guidance. “Also, the surgical technique of en bloc tissue removal eliminates the need to perform morcellation, thereby reducing the risk of iatrogenic dissemination and upstaging of an occult sarcoma. A thorough preoperative screening should be conducted; however, it is important to note that no screening procedure that can reliably detect sarcoma preoperatively has been identified.”
“The FDA will continue to review the latest data and scientific literature on laparoscopic power morcellation, including gathering real-world evidence from patients, providers and others, and encouraging innovation to better detect uterine cancer and develop containment systems for gynecologic surgery,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a news release. “The FDA seeks to ensure women and their health care providers are fully informed when considering laparoscopic power morcellators for gynecologic surgeries.”
A version of this article first appeared on Medscape.com.
Cervical cancer recurrence patterns differ after laparoscopic and open hysterectomy
When cervical cancer recurs after radical hysterectomy, the likelihood of recurrence at certain sites and the timing of recurrence may be associated with the surgical approach, according to a retrospective study.
according to a propensity-matched analysis of data from 105 patients with recurrence.
And recurrence in the pelvic cavity and peritoneal carcinomatosis were more common after laparoscopic hysterectomy than after open surgery. Overall survival was similar between the groups, however.
The different patterns of recurrence may relate to dissemination of the disease during colpotomy, but the reasons are unknown, study author Giorgio Bogani, MD, PhD, said at the meeting sponsored by AAGL.
To examine patterns of recurrence after laparoscopic and open abdominal radical hysterectomy for cervical cancer, Dr. Bogani of the department of gynecologic surgery at the National Cancer Institute in Milan and colleagues analyzed data from patients with cervical cancer who developed recurrence after surgery at two oncologic referral centers between 1990 and 2018 (Int J Gynecol Cancer. 2020 Jul. doi: 10.1136/ijgc-2020-001381).
The investigators applied a propensity-matching algorithm to reduce possible confounding factors. They matched 35 patients who had recurrence after laparoscopic hysterectomy to 70 patients who had recurrence after open surgery. The groups had similar baseline characteristics.
As in the Laparoscopic Approach to Cervical Cancer (LACC) trial, patients who had minimally invasive surgery were more likely to have a worse disease-free survival, compared with patients who had open surgery, Dr. Bogani said. Patients who underwent laparoscopic radical hysterectomy had a median progression-free survival of 8 months, whereas patients who underwent open abdominal procedures had a median progression-free survival of 15.8 months.
Although vaginal, lymphatic, and distant recurrences were similar between the groups, a greater percentage of patients in the laparoscopic hysterectomy group had recurrence in the pelvic cavity (74% vs. 34%) and peritoneal carcinomatosis (17% vs. 1.5%).
The LACC trial, which found significantly lower disease-free and overall survival with laparoscopic hysterectomy, sent a “shockwave through the gynecologic oncology community” when it was published in 2018, said Masoud Azodi, MD, in a discussion following Dr. Bogani’s presentation.
Researchers have raised questions about that trial’s design and validity, noted Dr. Azodi, director of minimally invasive and robotic surgery at Yale University in New Haven, Conn.
It could be that local recurrences are attributable to surgical technique, rather than to the minimally invasive approach in itself, Dr. Azodi said. Prior studies of laparoscopic hysterectomy for cervical cancer had indicated better surgical outcomes and equivalent oncologic results, relative to open surgery.
Before the LACC trial, Dr. Bogani used the minimally invasive approach for almost all surgeries. Since then, he has performed open surgeries. If he were to use a minimally invasive approach now, it would be in the context of a clinical trial, Dr. Bogani said.
Dr. Bogani and Dr. Azodi had no relevant financial disclosures.
SOURCE: Bogani G et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.069.
When cervical cancer recurs after radical hysterectomy, the likelihood of recurrence at certain sites and the timing of recurrence may be associated with the surgical approach, according to a retrospective study.
according to a propensity-matched analysis of data from 105 patients with recurrence.
And recurrence in the pelvic cavity and peritoneal carcinomatosis were more common after laparoscopic hysterectomy than after open surgery. Overall survival was similar between the groups, however.
The different patterns of recurrence may relate to dissemination of the disease during colpotomy, but the reasons are unknown, study author Giorgio Bogani, MD, PhD, said at the meeting sponsored by AAGL.
To examine patterns of recurrence after laparoscopic and open abdominal radical hysterectomy for cervical cancer, Dr. Bogani of the department of gynecologic surgery at the National Cancer Institute in Milan and colleagues analyzed data from patients with cervical cancer who developed recurrence after surgery at two oncologic referral centers between 1990 and 2018 (Int J Gynecol Cancer. 2020 Jul. doi: 10.1136/ijgc-2020-001381).
The investigators applied a propensity-matching algorithm to reduce possible confounding factors. They matched 35 patients who had recurrence after laparoscopic hysterectomy to 70 patients who had recurrence after open surgery. The groups had similar baseline characteristics.
As in the Laparoscopic Approach to Cervical Cancer (LACC) trial, patients who had minimally invasive surgery were more likely to have a worse disease-free survival, compared with patients who had open surgery, Dr. Bogani said. Patients who underwent laparoscopic radical hysterectomy had a median progression-free survival of 8 months, whereas patients who underwent open abdominal procedures had a median progression-free survival of 15.8 months.
Although vaginal, lymphatic, and distant recurrences were similar between the groups, a greater percentage of patients in the laparoscopic hysterectomy group had recurrence in the pelvic cavity (74% vs. 34%) and peritoneal carcinomatosis (17% vs. 1.5%).
The LACC trial, which found significantly lower disease-free and overall survival with laparoscopic hysterectomy, sent a “shockwave through the gynecologic oncology community” when it was published in 2018, said Masoud Azodi, MD, in a discussion following Dr. Bogani’s presentation.
Researchers have raised questions about that trial’s design and validity, noted Dr. Azodi, director of minimally invasive and robotic surgery at Yale University in New Haven, Conn.
It could be that local recurrences are attributable to surgical technique, rather than to the minimally invasive approach in itself, Dr. Azodi said. Prior studies of laparoscopic hysterectomy for cervical cancer had indicated better surgical outcomes and equivalent oncologic results, relative to open surgery.
Before the LACC trial, Dr. Bogani used the minimally invasive approach for almost all surgeries. Since then, he has performed open surgeries. If he were to use a minimally invasive approach now, it would be in the context of a clinical trial, Dr. Bogani said.
Dr. Bogani and Dr. Azodi had no relevant financial disclosures.
SOURCE: Bogani G et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.069.
When cervical cancer recurs after radical hysterectomy, the likelihood of recurrence at certain sites and the timing of recurrence may be associated with the surgical approach, according to a retrospective study.
according to a propensity-matched analysis of data from 105 patients with recurrence.
And recurrence in the pelvic cavity and peritoneal carcinomatosis were more common after laparoscopic hysterectomy than after open surgery. Overall survival was similar between the groups, however.
The different patterns of recurrence may relate to dissemination of the disease during colpotomy, but the reasons are unknown, study author Giorgio Bogani, MD, PhD, said at the meeting sponsored by AAGL.
To examine patterns of recurrence after laparoscopic and open abdominal radical hysterectomy for cervical cancer, Dr. Bogani of the department of gynecologic surgery at the National Cancer Institute in Milan and colleagues analyzed data from patients with cervical cancer who developed recurrence after surgery at two oncologic referral centers between 1990 and 2018 (Int J Gynecol Cancer. 2020 Jul. doi: 10.1136/ijgc-2020-001381).
The investigators applied a propensity-matching algorithm to reduce possible confounding factors. They matched 35 patients who had recurrence after laparoscopic hysterectomy to 70 patients who had recurrence after open surgery. The groups had similar baseline characteristics.
As in the Laparoscopic Approach to Cervical Cancer (LACC) trial, patients who had minimally invasive surgery were more likely to have a worse disease-free survival, compared with patients who had open surgery, Dr. Bogani said. Patients who underwent laparoscopic radical hysterectomy had a median progression-free survival of 8 months, whereas patients who underwent open abdominal procedures had a median progression-free survival of 15.8 months.
Although vaginal, lymphatic, and distant recurrences were similar between the groups, a greater percentage of patients in the laparoscopic hysterectomy group had recurrence in the pelvic cavity (74% vs. 34%) and peritoneal carcinomatosis (17% vs. 1.5%).
The LACC trial, which found significantly lower disease-free and overall survival with laparoscopic hysterectomy, sent a “shockwave through the gynecologic oncology community” when it was published in 2018, said Masoud Azodi, MD, in a discussion following Dr. Bogani’s presentation.
Researchers have raised questions about that trial’s design and validity, noted Dr. Azodi, director of minimally invasive and robotic surgery at Yale University in New Haven, Conn.
It could be that local recurrences are attributable to surgical technique, rather than to the minimally invasive approach in itself, Dr. Azodi said. Prior studies of laparoscopic hysterectomy for cervical cancer had indicated better surgical outcomes and equivalent oncologic results, relative to open surgery.
Before the LACC trial, Dr. Bogani used the minimally invasive approach for almost all surgeries. Since then, he has performed open surgeries. If he were to use a minimally invasive approach now, it would be in the context of a clinical trial, Dr. Bogani said.
Dr. Bogani and Dr. Azodi had no relevant financial disclosures.
SOURCE: Bogani G et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.069.
FROM AAGL GLOBAL CONGRESS
