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ERAS program cuts complications after radical cystectomy
NEW YORK – Prior to October 2014, urology patients undergoing radical cystectomy at a 950-bed, tertiary care hospital experienced postoperative morbidity at a relative high rate, according to NSQIP data.
“Despite improvements in surgical techniques and perioperative care protocols, the rate of the overall morbidity for radical cystectomy was higher than we would like to see,” said Tracey Hong, RN, BScN, of the Clinical Quality and Patient Safety Department at Vancouver (B.C.) General Hospital. “We took this as an opportunity to improve our patient outcomes and experience.”
Vancouver General joined the American College of Surgeons National Surgical Improvement Quality Program (ACS NSQIP) in 2011. The enhanced recovery after surgery (ERAS) perioperative protocol the institution adopted in late 2014 was associated with a 32% decrease in overall morbidity. The rate dropped from 31.3% in the pre-ERAS study period from May 2011 to September 2014, to 21.1% after implementation, from October 2014 to September 2016, according to a study Ms. Hong presented at the American College of Surgeons Quality and Safety Conference.
The investigators compared outcomes between all 92 people undergoing elective radical cystectomy during the first time period to 152 consecutive patients treated under the ERAS protocol. Median length of stay decreased from 8 days before ERAS to 7 days after, a significant difference (P less than .05).
The researchers also assessed outcomes based on how adherent clinicians were to 12 key elements of the 26-item ERAS initiative. These elements included preoperative counseling, preoperative anesthesia consultation, and carbohydrate loading on the morning of surgery. Intraoperatively, they tracked normothermia, use of multimodal anesthesia, use of goal-directed fluid therapy using a monitor, timely antibiotics, and adequate postoperative nausea and vomiting prophylaxis. The four postoperative key measures were mobilization at least once by postoperative day 0, full fluids and mobilization twice on postoperative day 1, and starting solid food by postoperative day 4.
A total 52% of the ERAS cases were associated with 75% or greater adherence to these 12 key items. Adherence with the intraoperative fluid therapy and all the postoperative elements proved to be the most challenging, Ms. Hong said.
The more adherent cases experienced a lower overall postoperative morbidity rate, 15.2%, compared with 27.4% among the less adherent group. The 15.2% morbidity among the more adherent cases also compared favorably with the 31.1% rate for cases prior to ERAS adoption.
“We will continue working on improving compliance,” Ms. Hong said. “We need to increase adherence to goal-directed fluid therapy and the postoperative components,” Ms. Hong said.
Three main strategies remain essential to the ongoing success of the ERAS program, Ms. Hong said. Empowering patients to be active participants and to engage in their own health outcomes is one. “Second, we involve a multidisciplinary team at an early stage so they take ownership and get engaged in the program,” she said. “Last but not least, we continue to measure the outcomes in 100% of cases.”
Continuous auditing and sharing results with the team on a regular basis will be necessary to maintain engagement in the ERAS protocol going forward, Ms. Hong added. “Tenacity is vital.”
Ms. Hong had no relevant financial disclosures.
NEW YORK – Prior to October 2014, urology patients undergoing radical cystectomy at a 950-bed, tertiary care hospital experienced postoperative morbidity at a relative high rate, according to NSQIP data.
“Despite improvements in surgical techniques and perioperative care protocols, the rate of the overall morbidity for radical cystectomy was higher than we would like to see,” said Tracey Hong, RN, BScN, of the Clinical Quality and Patient Safety Department at Vancouver (B.C.) General Hospital. “We took this as an opportunity to improve our patient outcomes and experience.”
Vancouver General joined the American College of Surgeons National Surgical Improvement Quality Program (ACS NSQIP) in 2011. The enhanced recovery after surgery (ERAS) perioperative protocol the institution adopted in late 2014 was associated with a 32% decrease in overall morbidity. The rate dropped from 31.3% in the pre-ERAS study period from May 2011 to September 2014, to 21.1% after implementation, from October 2014 to September 2016, according to a study Ms. Hong presented at the American College of Surgeons Quality and Safety Conference.
The investigators compared outcomes between all 92 people undergoing elective radical cystectomy during the first time period to 152 consecutive patients treated under the ERAS protocol. Median length of stay decreased from 8 days before ERAS to 7 days after, a significant difference (P less than .05).
The researchers also assessed outcomes based on how adherent clinicians were to 12 key elements of the 26-item ERAS initiative. These elements included preoperative counseling, preoperative anesthesia consultation, and carbohydrate loading on the morning of surgery. Intraoperatively, they tracked normothermia, use of multimodal anesthesia, use of goal-directed fluid therapy using a monitor, timely antibiotics, and adequate postoperative nausea and vomiting prophylaxis. The four postoperative key measures were mobilization at least once by postoperative day 0, full fluids and mobilization twice on postoperative day 1, and starting solid food by postoperative day 4.
A total 52% of the ERAS cases were associated with 75% or greater adherence to these 12 key items. Adherence with the intraoperative fluid therapy and all the postoperative elements proved to be the most challenging, Ms. Hong said.
The more adherent cases experienced a lower overall postoperative morbidity rate, 15.2%, compared with 27.4% among the less adherent group. The 15.2% morbidity among the more adherent cases also compared favorably with the 31.1% rate for cases prior to ERAS adoption.
“We will continue working on improving compliance,” Ms. Hong said. “We need to increase adherence to goal-directed fluid therapy and the postoperative components,” Ms. Hong said.
Three main strategies remain essential to the ongoing success of the ERAS program, Ms. Hong said. Empowering patients to be active participants and to engage in their own health outcomes is one. “Second, we involve a multidisciplinary team at an early stage so they take ownership and get engaged in the program,” she said. “Last but not least, we continue to measure the outcomes in 100% of cases.”
Continuous auditing and sharing results with the team on a regular basis will be necessary to maintain engagement in the ERAS protocol going forward, Ms. Hong added. “Tenacity is vital.”
Ms. Hong had no relevant financial disclosures.
NEW YORK – Prior to October 2014, urology patients undergoing radical cystectomy at a 950-bed, tertiary care hospital experienced postoperative morbidity at a relative high rate, according to NSQIP data.
“Despite improvements in surgical techniques and perioperative care protocols, the rate of the overall morbidity for radical cystectomy was higher than we would like to see,” said Tracey Hong, RN, BScN, of the Clinical Quality and Patient Safety Department at Vancouver (B.C.) General Hospital. “We took this as an opportunity to improve our patient outcomes and experience.”
Vancouver General joined the American College of Surgeons National Surgical Improvement Quality Program (ACS NSQIP) in 2011. The enhanced recovery after surgery (ERAS) perioperative protocol the institution adopted in late 2014 was associated with a 32% decrease in overall morbidity. The rate dropped from 31.3% in the pre-ERAS study period from May 2011 to September 2014, to 21.1% after implementation, from October 2014 to September 2016, according to a study Ms. Hong presented at the American College of Surgeons Quality and Safety Conference.
The investigators compared outcomes between all 92 people undergoing elective radical cystectomy during the first time period to 152 consecutive patients treated under the ERAS protocol. Median length of stay decreased from 8 days before ERAS to 7 days after, a significant difference (P less than .05).
The researchers also assessed outcomes based on how adherent clinicians were to 12 key elements of the 26-item ERAS initiative. These elements included preoperative counseling, preoperative anesthesia consultation, and carbohydrate loading on the morning of surgery. Intraoperatively, they tracked normothermia, use of multimodal anesthesia, use of goal-directed fluid therapy using a monitor, timely antibiotics, and adequate postoperative nausea and vomiting prophylaxis. The four postoperative key measures were mobilization at least once by postoperative day 0, full fluids and mobilization twice on postoperative day 1, and starting solid food by postoperative day 4.
A total 52% of the ERAS cases were associated with 75% or greater adherence to these 12 key items. Adherence with the intraoperative fluid therapy and all the postoperative elements proved to be the most challenging, Ms. Hong said.
The more adherent cases experienced a lower overall postoperative morbidity rate, 15.2%, compared with 27.4% among the less adherent group. The 15.2% morbidity among the more adherent cases also compared favorably with the 31.1% rate for cases prior to ERAS adoption.
“We will continue working on improving compliance,” Ms. Hong said. “We need to increase adherence to goal-directed fluid therapy and the postoperative components,” Ms. Hong said.
Three main strategies remain essential to the ongoing success of the ERAS program, Ms. Hong said. Empowering patients to be active participants and to engage in their own health outcomes is one. “Second, we involve a multidisciplinary team at an early stage so they take ownership and get engaged in the program,” she said. “Last but not least, we continue to measure the outcomes in 100% of cases.”
Continuous auditing and sharing results with the team on a regular basis will be necessary to maintain engagement in the ERAS protocol going forward, Ms. Hong added. “Tenacity is vital.”
Ms. Hong had no relevant financial disclosures.
AT THE ACS QUALITY & SAFETY CONFERENCE
Key clinical point: An enhanced recovery after surgery protocol can reduce postoperative morbidity after radical cystectomy.
Major finding: Investigators report a 32% decrease in overall morbidity after adoption of ERAS pathways.
Data source: Comparison between 92 patients before and 152 patients after implementation of ERAS protocol.
Disclosures: Tracey Hong, BScN, had no relevant financial disclosures.
Should convicted sex offender get penile prosthetic implant?
SAN DIEGO – Should a man with a distant history of pedophilia be allowed to get a penile prosthetic implant to treat his erectile dysfunction? Mental health professionals at a Veterans Affairs medical center in San Diego recently faced this question and decided the risk was too great. They denied his request.
“This kind of dilemma occurs throughout all health systems, and it’s very challenging. It obviously puts the physician in a very ethically challenging situation,” said Kristin Beizai, MD, a psychiatrist and coauthor of a case report presented at the annual meeting of the American Psychiatric Association.
Yash B. Joshi, MD, PhD, and Dr. Beizai, both psychiatrists at the University of California, San Diego, and the VA San Diego Healthcare System, reported the penile prosthetic implant case in a poster at APA.
According to them, a married veteran sought treatment for erectile dysfunction (ED) from VA hospital urologists after oral treatment had failed. The elderly man, who had been imprisoned for 3 years some 25-30 years previously, sought a penile prosthetic implant – an alternative to treatments for ED when drugs have failed. Other options include self-injections and vacuum devices.
Men with the implants trigger erections by squeezing a pump in the scrotum that allows fluid to flow from a reservoir into the cylinder.
The man had been imprisoned in his 40s for 3 years because of a single incident of sexually abusing a toddler. According to the case report, his primary care doctors previously had offered him ED treatments “without acknowledging this history in their clinical-decision making process.”
A psychologist determined the man to be at low risk of committing a sexual offense again and cleared him for an implant. But his urologists requested an ethics consultation, which was provided by a team that included representatives from the fields of psychiatry, internal medicine, nursing, and social work.
“The ethics team determined that the most appropriate course of action hinged on a thorough and individualized risk-benefit assessment to determine if providing the treatment was ethically justifiable,” Dr. Beizai said in an interview.
An on-site psychologist and an outside expert evaluated the patient using a tool known as the Violence Risk Assessment Instrument–Sexual and determined the man was at moderate to severe risk of committing a sexual offense again.
“It was also discovered that the patient never completed treatment for pedophilia in the community as previously recommended,” the psychiatrists reported. “He was offered a plan for reevaluation and rehabilitation by subspecialists but declined this option.”
The man subsequently died of natural causes.
Dr. Beizai said those kinds of cases present numerous challenges. “This case involves surgery/urology, but this is an issue with primary care as well, and they likely do not have the time, resources, or protocol to address fully, particularly when legal information may be withheld and there are confidentiality issues.”
In regard to a risk-benefit analysis, she said, “a general mental health practitioner may not be comfortable completing this kind of assessment, and there may be an indication to refer to a forensic psychiatrist or psychologist. But this can be an expensive and scarce resource.”
There’s also the potential for political storms if the news gets out that a convicted sex offender received ED treatment. News reports in the mid-2000s about this kind of care persuaded several states to ban government payments for ED treatment for convicted sex offenders, and Medicaid funding was eliminated.
Two researchers who study pedophilia said in an interview that these decisions are far from simple and must take several factors into account.
Fred S. Berlin, MD, PhD, director of the Sexual Behavior Consultation Unit, and associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, said a sexual offense background isn’t necessarily enough of a reason to deny ED treatment to a patient. Important factors for decision making, he said, include the nature of the previous offenses (such as whether they involved penile penetration, or the use of drugs or alcohol) and the state of an offender’s current relationship.
He added that it’s important to understand that the lack of functioning genitals isn’t a barrier to sexual abuse. “There shouldn’t be a narrow focus on the capacity of the penis to have an erection,” he said.
Treatment for ED in convicted sex offenders can be helpful in some cases, said Richard B. Krueger, MD, an associate clinical professor of psychiatry at Columbia University, New York, and medical director of the Sexual Behavior Clinic at New York State Psychiatric Institute. “The general sense is that it would be a benefit to enable an appropriate, peer-related relationship with a spouse, significant other, or adults,” Dr. Krueger said.
Red flags regarding ED treatment in sex offenders, he said, include high scores on predictive tests, a history of extreme sadism or sociopathy, and challenges regarding monitoring of the offender.
Dr. Beizai, Dr. Joshi, Dr. Krueger, and Dr. Berlin reported no relevant disclosures.
[polldaddy:9767052]
SAN DIEGO – Should a man with a distant history of pedophilia be allowed to get a penile prosthetic implant to treat his erectile dysfunction? Mental health professionals at a Veterans Affairs medical center in San Diego recently faced this question and decided the risk was too great. They denied his request.
“This kind of dilemma occurs throughout all health systems, and it’s very challenging. It obviously puts the physician in a very ethically challenging situation,” said Kristin Beizai, MD, a psychiatrist and coauthor of a case report presented at the annual meeting of the American Psychiatric Association.
Yash B. Joshi, MD, PhD, and Dr. Beizai, both psychiatrists at the University of California, San Diego, and the VA San Diego Healthcare System, reported the penile prosthetic implant case in a poster at APA.
According to them, a married veteran sought treatment for erectile dysfunction (ED) from VA hospital urologists after oral treatment had failed. The elderly man, who had been imprisoned for 3 years some 25-30 years previously, sought a penile prosthetic implant – an alternative to treatments for ED when drugs have failed. Other options include self-injections and vacuum devices.
Men with the implants trigger erections by squeezing a pump in the scrotum that allows fluid to flow from a reservoir into the cylinder.
The man had been imprisoned in his 40s for 3 years because of a single incident of sexually abusing a toddler. According to the case report, his primary care doctors previously had offered him ED treatments “without acknowledging this history in their clinical-decision making process.”
A psychologist determined the man to be at low risk of committing a sexual offense again and cleared him for an implant. But his urologists requested an ethics consultation, which was provided by a team that included representatives from the fields of psychiatry, internal medicine, nursing, and social work.
“The ethics team determined that the most appropriate course of action hinged on a thorough and individualized risk-benefit assessment to determine if providing the treatment was ethically justifiable,” Dr. Beizai said in an interview.
An on-site psychologist and an outside expert evaluated the patient using a tool known as the Violence Risk Assessment Instrument–Sexual and determined the man was at moderate to severe risk of committing a sexual offense again.
“It was also discovered that the patient never completed treatment for pedophilia in the community as previously recommended,” the psychiatrists reported. “He was offered a plan for reevaluation and rehabilitation by subspecialists but declined this option.”
The man subsequently died of natural causes.
Dr. Beizai said those kinds of cases present numerous challenges. “This case involves surgery/urology, but this is an issue with primary care as well, and they likely do not have the time, resources, or protocol to address fully, particularly when legal information may be withheld and there are confidentiality issues.”
In regard to a risk-benefit analysis, she said, “a general mental health practitioner may not be comfortable completing this kind of assessment, and there may be an indication to refer to a forensic psychiatrist or psychologist. But this can be an expensive and scarce resource.”
There’s also the potential for political storms if the news gets out that a convicted sex offender received ED treatment. News reports in the mid-2000s about this kind of care persuaded several states to ban government payments for ED treatment for convicted sex offenders, and Medicaid funding was eliminated.
Two researchers who study pedophilia said in an interview that these decisions are far from simple and must take several factors into account.
Fred S. Berlin, MD, PhD, director of the Sexual Behavior Consultation Unit, and associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, said a sexual offense background isn’t necessarily enough of a reason to deny ED treatment to a patient. Important factors for decision making, he said, include the nature of the previous offenses (such as whether they involved penile penetration, or the use of drugs or alcohol) and the state of an offender’s current relationship.
He added that it’s important to understand that the lack of functioning genitals isn’t a barrier to sexual abuse. “There shouldn’t be a narrow focus on the capacity of the penis to have an erection,” he said.
Treatment for ED in convicted sex offenders can be helpful in some cases, said Richard B. Krueger, MD, an associate clinical professor of psychiatry at Columbia University, New York, and medical director of the Sexual Behavior Clinic at New York State Psychiatric Institute. “The general sense is that it would be a benefit to enable an appropriate, peer-related relationship with a spouse, significant other, or adults,” Dr. Krueger said.
Red flags regarding ED treatment in sex offenders, he said, include high scores on predictive tests, a history of extreme sadism or sociopathy, and challenges regarding monitoring of the offender.
Dr. Beizai, Dr. Joshi, Dr. Krueger, and Dr. Berlin reported no relevant disclosures.
[polldaddy:9767052]
SAN DIEGO – Should a man with a distant history of pedophilia be allowed to get a penile prosthetic implant to treat his erectile dysfunction? Mental health professionals at a Veterans Affairs medical center in San Diego recently faced this question and decided the risk was too great. They denied his request.
“This kind of dilemma occurs throughout all health systems, and it’s very challenging. It obviously puts the physician in a very ethically challenging situation,” said Kristin Beizai, MD, a psychiatrist and coauthor of a case report presented at the annual meeting of the American Psychiatric Association.
Yash B. Joshi, MD, PhD, and Dr. Beizai, both psychiatrists at the University of California, San Diego, and the VA San Diego Healthcare System, reported the penile prosthetic implant case in a poster at APA.
According to them, a married veteran sought treatment for erectile dysfunction (ED) from VA hospital urologists after oral treatment had failed. The elderly man, who had been imprisoned for 3 years some 25-30 years previously, sought a penile prosthetic implant – an alternative to treatments for ED when drugs have failed. Other options include self-injections and vacuum devices.
Men with the implants trigger erections by squeezing a pump in the scrotum that allows fluid to flow from a reservoir into the cylinder.
The man had been imprisoned in his 40s for 3 years because of a single incident of sexually abusing a toddler. According to the case report, his primary care doctors previously had offered him ED treatments “without acknowledging this history in their clinical-decision making process.”
A psychologist determined the man to be at low risk of committing a sexual offense again and cleared him for an implant. But his urologists requested an ethics consultation, which was provided by a team that included representatives from the fields of psychiatry, internal medicine, nursing, and social work.
“The ethics team determined that the most appropriate course of action hinged on a thorough and individualized risk-benefit assessment to determine if providing the treatment was ethically justifiable,” Dr. Beizai said in an interview.
An on-site psychologist and an outside expert evaluated the patient using a tool known as the Violence Risk Assessment Instrument–Sexual and determined the man was at moderate to severe risk of committing a sexual offense again.
“It was also discovered that the patient never completed treatment for pedophilia in the community as previously recommended,” the psychiatrists reported. “He was offered a plan for reevaluation and rehabilitation by subspecialists but declined this option.”
The man subsequently died of natural causes.
Dr. Beizai said those kinds of cases present numerous challenges. “This case involves surgery/urology, but this is an issue with primary care as well, and they likely do not have the time, resources, or protocol to address fully, particularly when legal information may be withheld and there are confidentiality issues.”
In regard to a risk-benefit analysis, she said, “a general mental health practitioner may not be comfortable completing this kind of assessment, and there may be an indication to refer to a forensic psychiatrist or psychologist. But this can be an expensive and scarce resource.”
There’s also the potential for political storms if the news gets out that a convicted sex offender received ED treatment. News reports in the mid-2000s about this kind of care persuaded several states to ban government payments for ED treatment for convicted sex offenders, and Medicaid funding was eliminated.
Two researchers who study pedophilia said in an interview that these decisions are far from simple and must take several factors into account.
Fred S. Berlin, MD, PhD, director of the Sexual Behavior Consultation Unit, and associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, said a sexual offense background isn’t necessarily enough of a reason to deny ED treatment to a patient. Important factors for decision making, he said, include the nature of the previous offenses (such as whether they involved penile penetration, or the use of drugs or alcohol) and the state of an offender’s current relationship.
He added that it’s important to understand that the lack of functioning genitals isn’t a barrier to sexual abuse. “There shouldn’t be a narrow focus on the capacity of the penis to have an erection,” he said.
Treatment for ED in convicted sex offenders can be helpful in some cases, said Richard B. Krueger, MD, an associate clinical professor of psychiatry at Columbia University, New York, and medical director of the Sexual Behavior Clinic at New York State Psychiatric Institute. “The general sense is that it would be a benefit to enable an appropriate, peer-related relationship with a spouse, significant other, or adults,” Dr. Krueger said.
Red flags regarding ED treatment in sex offenders, he said, include high scores on predictive tests, a history of extreme sadism or sociopathy, and challenges regarding monitoring of the offender.
Dr. Beizai, Dr. Joshi, Dr. Krueger, and Dr. Berlin reported no relevant disclosures.
[polldaddy:9767052]
AT APA
Registry helps track pelvic organ prolapse outcomes in the U.S.
DENVER – Catherine Bradley, MD, said during a presentation at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“This is a unique collaborative registry created in response to U.S. industry requirements. There are many benefits to using this approach, but also many challenges. It’s a work in progress,” said Dr. Bradley, of the University of Iowa, Iowa City. She chairs the American Urogynecologic Society Research Council, which helps oversee the registry.
The purpose of the PFDR is to fulfill requirements from the Food and Drug Administration for postmarketing studies of the vaginal mesh procedure, to give surgeons a pelvic organ prolapse treatment database to track individual and aggregate outcomes for research and quality improvement purposes, and to create a framework for future clinical studies, according to Dr. Bradley.
As such, the PFDR comprises two interrelated registries, Dr. Bradley noted. The PFDR-I includes industry-sponsored studies, while the PFDR-R is the independent research registry of the American Urogynecologic Society. The PFDR previously included a third quality improvement registry, which in January 2016 was moved to a separate platform called AQUIRE.
The PFDR-I is tracking 1,620 patients who underwent 1,386 procedures for pelvic organ prolapse as part of four studies sponsored by three manufacturers, according to Dr. Bradley. The PFDR-R, for its part, has eight active sites and has enrolled 179 patients with pelvic organ prolapse, 154 of whom underwent mesh surgery and 25 of whom received vaginal pessaries, she said.
The PFDR-R is voluntary and has faced some barriers in the 10 months since its launch, Dr. Bradley said. Participation increases workload for physicians as well as data entry personnel, and patients must provide informed consent to be entered into the registry. But the benefits of participating are also substantial, she emphasized. The PFDR-R will enable surgeons to track their own outcomes in terms of caseload, anatomic outcomes, symptoms and quality of life, and adverse events. They can download their own data, compare their outcomes to others as part of highly granular benchmarking initiatives, and propose and conduct studies of the entire registry.
The PFDR is supported by ACell, ASTORA Women’s Health, Boston Scientific, and Coloplast. Dr. Bradley reported having no conflicts of interest.
DENVER – Catherine Bradley, MD, said during a presentation at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“This is a unique collaborative registry created in response to U.S. industry requirements. There are many benefits to using this approach, but also many challenges. It’s a work in progress,” said Dr. Bradley, of the University of Iowa, Iowa City. She chairs the American Urogynecologic Society Research Council, which helps oversee the registry.
The purpose of the PFDR is to fulfill requirements from the Food and Drug Administration for postmarketing studies of the vaginal mesh procedure, to give surgeons a pelvic organ prolapse treatment database to track individual and aggregate outcomes for research and quality improvement purposes, and to create a framework for future clinical studies, according to Dr. Bradley.
As such, the PFDR comprises two interrelated registries, Dr. Bradley noted. The PFDR-I includes industry-sponsored studies, while the PFDR-R is the independent research registry of the American Urogynecologic Society. The PFDR previously included a third quality improvement registry, which in January 2016 was moved to a separate platform called AQUIRE.
The PFDR-I is tracking 1,620 patients who underwent 1,386 procedures for pelvic organ prolapse as part of four studies sponsored by three manufacturers, according to Dr. Bradley. The PFDR-R, for its part, has eight active sites and has enrolled 179 patients with pelvic organ prolapse, 154 of whom underwent mesh surgery and 25 of whom received vaginal pessaries, she said.
The PFDR-R is voluntary and has faced some barriers in the 10 months since its launch, Dr. Bradley said. Participation increases workload for physicians as well as data entry personnel, and patients must provide informed consent to be entered into the registry. But the benefits of participating are also substantial, she emphasized. The PFDR-R will enable surgeons to track their own outcomes in terms of caseload, anatomic outcomes, symptoms and quality of life, and adverse events. They can download their own data, compare their outcomes to others as part of highly granular benchmarking initiatives, and propose and conduct studies of the entire registry.
The PFDR is supported by ACell, ASTORA Women’s Health, Boston Scientific, and Coloplast. Dr. Bradley reported having no conflicts of interest.
DENVER – Catherine Bradley, MD, said during a presentation at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“This is a unique collaborative registry created in response to U.S. industry requirements. There are many benefits to using this approach, but also many challenges. It’s a work in progress,” said Dr. Bradley, of the University of Iowa, Iowa City. She chairs the American Urogynecologic Society Research Council, which helps oversee the registry.
The purpose of the PFDR is to fulfill requirements from the Food and Drug Administration for postmarketing studies of the vaginal mesh procedure, to give surgeons a pelvic organ prolapse treatment database to track individual and aggregate outcomes for research and quality improvement purposes, and to create a framework for future clinical studies, according to Dr. Bradley.
As such, the PFDR comprises two interrelated registries, Dr. Bradley noted. The PFDR-I includes industry-sponsored studies, while the PFDR-R is the independent research registry of the American Urogynecologic Society. The PFDR previously included a third quality improvement registry, which in January 2016 was moved to a separate platform called AQUIRE.
The PFDR-I is tracking 1,620 patients who underwent 1,386 procedures for pelvic organ prolapse as part of four studies sponsored by three manufacturers, according to Dr. Bradley. The PFDR-R, for its part, has eight active sites and has enrolled 179 patients with pelvic organ prolapse, 154 of whom underwent mesh surgery and 25 of whom received vaginal pessaries, she said.
The PFDR-R is voluntary and has faced some barriers in the 10 months since its launch, Dr. Bradley said. Participation increases workload for physicians as well as data entry personnel, and patients must provide informed consent to be entered into the registry. But the benefits of participating are also substantial, she emphasized. The PFDR-R will enable surgeons to track their own outcomes in terms of caseload, anatomic outcomes, symptoms and quality of life, and adverse events. They can download their own data, compare their outcomes to others as part of highly granular benchmarking initiatives, and propose and conduct studies of the entire registry.
The PFDR is supported by ACell, ASTORA Women’s Health, Boston Scientific, and Coloplast. Dr. Bradley reported having no conflicts of interest.
AT PFD WEEK 2016
POP severity not linked to risk of de novo stress urinary incontinence
DENVER – Surgical correction of severe pelvic organ prolapse (POP) is no more likely to lead to stress urinary incontinence than is correction of less severe POP, suggest findings from a retrospective study of 206 patients at a tertiary care center.
But a baseline complaint of stress urinary incontinence (SUI) prior to surgery, despite a negative SUI evaluation, was associated with an increased risk, Alexandriah Alas, MD, and her colleagues at the Cleveland Clinic Florida in Weston wrote in a poster presented at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“We recommend counseling patients with a negative evaluation that there is up to a 10.6% risk of developing de novo SUI,” the researchers wrote.
Past studies have linked surgical correction of POP with a 16%-51% increase in risk of de novo SUI, but have not examined whether severe prolapse adds to that risk. The researchers reviewed records from patients who underwent surgical POP correction at their center between 2003 and 2013, excluding those with objective evidence of SUI at baseline or a history of incontinence surgery. They included patients with a baseline subjective complaint of SUI, as long as it was not the primary presenting complaint.
A total of 48 (23%) patients had massive POP – that is, a POP-Q score of at least 3 at points Ba, Bp, or C – and 158 patients had less massive POP, the researchers wrote. In all, 22 patients (10.6%) developed de novo SUI. Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).
Women with massive POP tended to be older and had a higher incidence of hypertension than those with less severe POP. After controlling for these differences, a baseline complaint of SUI was the strongest predictor of de novo SUI, increasing the odds of this outcome more than fivefold (adjusted odds ratio, 5.5; 95% confidence interval, 1.4-23.9). Two other factors trended toward statistical significance in this multivariable model – a baseline complaint of mixed urinary incontinence and a longer POP-Q point D value (-9.5 instead of -7.5).
Among women with no baseline complaint of SUI, the incidence of de novo SUI was 6.3%. Significant predictors of de novo SUI in this subgroup included longer total vaginal length (10.5 cm vs. 9.5 cm, P = .003) and urinary leaks, even if they occurred about every other day as compared to not at all (P = .02).
The researchers did not report information on funding sources or financial disclosures.
DENVER – Surgical correction of severe pelvic organ prolapse (POP) is no more likely to lead to stress urinary incontinence than is correction of less severe POP, suggest findings from a retrospective study of 206 patients at a tertiary care center.
But a baseline complaint of stress urinary incontinence (SUI) prior to surgery, despite a negative SUI evaluation, was associated with an increased risk, Alexandriah Alas, MD, and her colleagues at the Cleveland Clinic Florida in Weston wrote in a poster presented at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“We recommend counseling patients with a negative evaluation that there is up to a 10.6% risk of developing de novo SUI,” the researchers wrote.
Past studies have linked surgical correction of POP with a 16%-51% increase in risk of de novo SUI, but have not examined whether severe prolapse adds to that risk. The researchers reviewed records from patients who underwent surgical POP correction at their center between 2003 and 2013, excluding those with objective evidence of SUI at baseline or a history of incontinence surgery. They included patients with a baseline subjective complaint of SUI, as long as it was not the primary presenting complaint.
A total of 48 (23%) patients had massive POP – that is, a POP-Q score of at least 3 at points Ba, Bp, or C – and 158 patients had less massive POP, the researchers wrote. In all, 22 patients (10.6%) developed de novo SUI. Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).
Women with massive POP tended to be older and had a higher incidence of hypertension than those with less severe POP. After controlling for these differences, a baseline complaint of SUI was the strongest predictor of de novo SUI, increasing the odds of this outcome more than fivefold (adjusted odds ratio, 5.5; 95% confidence interval, 1.4-23.9). Two other factors trended toward statistical significance in this multivariable model – a baseline complaint of mixed urinary incontinence and a longer POP-Q point D value (-9.5 instead of -7.5).
Among women with no baseline complaint of SUI, the incidence of de novo SUI was 6.3%. Significant predictors of de novo SUI in this subgroup included longer total vaginal length (10.5 cm vs. 9.5 cm, P = .003) and urinary leaks, even if they occurred about every other day as compared to not at all (P = .02).
The researchers did not report information on funding sources or financial disclosures.
DENVER – Surgical correction of severe pelvic organ prolapse (POP) is no more likely to lead to stress urinary incontinence than is correction of less severe POP, suggest findings from a retrospective study of 206 patients at a tertiary care center.
But a baseline complaint of stress urinary incontinence (SUI) prior to surgery, despite a negative SUI evaluation, was associated with an increased risk, Alexandriah Alas, MD, and her colleagues at the Cleveland Clinic Florida in Weston wrote in a poster presented at Pelvic Floor Disorders Week, sponsored by the American Urogynecologic Society.
“We recommend counseling patients with a negative evaluation that there is up to a 10.6% risk of developing de novo SUI,” the researchers wrote.
Past studies have linked surgical correction of POP with a 16%-51% increase in risk of de novo SUI, but have not examined whether severe prolapse adds to that risk. The researchers reviewed records from patients who underwent surgical POP correction at their center between 2003 and 2013, excluding those with objective evidence of SUI at baseline or a history of incontinence surgery. They included patients with a baseline subjective complaint of SUI, as long as it was not the primary presenting complaint.
A total of 48 (23%) patients had massive POP – that is, a POP-Q score of at least 3 at points Ba, Bp, or C – and 158 patients had less massive POP, the researchers wrote. In all, 22 patients (10.6%) developed de novo SUI. Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).
Women with massive POP tended to be older and had a higher incidence of hypertension than those with less severe POP. After controlling for these differences, a baseline complaint of SUI was the strongest predictor of de novo SUI, increasing the odds of this outcome more than fivefold (adjusted odds ratio, 5.5; 95% confidence interval, 1.4-23.9). Two other factors trended toward statistical significance in this multivariable model – a baseline complaint of mixed urinary incontinence and a longer POP-Q point D value (-9.5 instead of -7.5).
Among women with no baseline complaint of SUI, the incidence of de novo SUI was 6.3%. Significant predictors of de novo SUI in this subgroup included longer total vaginal length (10.5 cm vs. 9.5 cm, P = .003) and urinary leaks, even if they occurred about every other day as compared to not at all (P = .02).
The researchers did not report information on funding sources or financial disclosures.
AT PFD WEEK 2016
Key clinical point:
Major finding: Postsurgical rates of de novo SUI were 12.5% among women with massive POP and 10.6% among women with less severe POP (P = .6).
Data source: A single-center retrospective study of 206 patients who underwent surgical correction of POP and had no objective evidence of SUI at baseline.
Disclosures: The researchers did not report information on funding sources or financial disclosures.
Absorbable suture performs well in sacrocolpopexy with mesh
DENVER – Using absorbable polydioxanone suture during laparoscopic sacrocolpopexy was associated with a mesh erosion rate of just 1.6%, according to a single-center, 1-year prospective study of 64 patients.
That is substantially less than typical erosion rates of about 5% when permanent suture is used, Danielle Taylor, DO, of Akron (Ohio ) General Medical Center said at Pelvic Floor Disorders Week sponsored by the American Urogynecologic Society.
The researchers observed no anatomic failures or suture extrusions, and patients reported significant postoperative improvements on several validated measures of quality of life.
“Larger samples and longer follow-up may be needed,” said Dr. Taylor. “But our study suggests that permanent, nondissolving suture material may not be necessary for sacrocolpopexy.”
Sacrocolpopexy with mesh usually involves using nonabsorbable suture to attach its anterior and posterior arms to the vaginal mucosa. Instead, Dr. Taylor and colleagues used 90-day delayed absorbable 2.0 V-Loc (Covidien) suture during laparoscopic sacrocolpopexy for patients with baseline Pelvic Organ Prolapse Quantification (POP-Q) scores of at least 2 and symptomatic uterovaginal prolapse.
Two permanent Gore-Tex sutures were also placed at the apex of the cervix in each of the 64 patients, said Dr. Taylor, a urogynecology fellow at the University of Massachusetts, Worcester, who worked on the study as a resident at the Cleveland Clinic Akron General, in Ohio. She and her colleagues rechecked patients at postoperative weeks 2 and 6, and at months 6 and 12. They lost two patients to follow-up, both after week 2.
At baseline, 37 patients (58%) were in stage II pelvic organ prolapse, 27% were in stage III, and 14% were in stage IV. At 6 months after surgery, 85% had no detectable prolapse, 8% had stage I, and 6% had stage II. At 1 year, 82% remained in pelvic organ prolapse stage 0 and the rest were in stage I or II. All stage II patients remained asymptomatic, Dr. Taylor said.
At baseline, the median value for POP-Q point C was -3 (range, –8 to +6). At 6 months and 1 year later, the median value had improved to –8, and patients ranged between –10 and –8.
Quality of life surveys of 54 patients reflected these outcomes, Dr. Taylor said. A year after surgery, average scores on the Pelvic Floor Distress Index (PFDI) dropped by 67 points, from 103 to 35 (P less than .0001). Likewise, average scores on the Pelvic Floor Impact Questionnaire (PFIQ) dropped by 29 points (P less than .0001), and scores on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) indicated a significant decrease in the effects of pelvic organ prolapse on sexual functioning (P = .008).
In addition to a single case of mesh erosion, one patient developed postoperative ileus and one experienced small bowel obstruction, both of which resolved, Dr. Taylor reported. The researchers aim to continue the study with longer follow-up intervals and detailed analyses of postoperative pain.
Dr. Taylor reported no funding sources and had no disclosures. One coauthor disclosed ties to Coloplast Corp.
DENVER – Using absorbable polydioxanone suture during laparoscopic sacrocolpopexy was associated with a mesh erosion rate of just 1.6%, according to a single-center, 1-year prospective study of 64 patients.
That is substantially less than typical erosion rates of about 5% when permanent suture is used, Danielle Taylor, DO, of Akron (Ohio ) General Medical Center said at Pelvic Floor Disorders Week sponsored by the American Urogynecologic Society.
The researchers observed no anatomic failures or suture extrusions, and patients reported significant postoperative improvements on several validated measures of quality of life.
“Larger samples and longer follow-up may be needed,” said Dr. Taylor. “But our study suggests that permanent, nondissolving suture material may not be necessary for sacrocolpopexy.”
Sacrocolpopexy with mesh usually involves using nonabsorbable suture to attach its anterior and posterior arms to the vaginal mucosa. Instead, Dr. Taylor and colleagues used 90-day delayed absorbable 2.0 V-Loc (Covidien) suture during laparoscopic sacrocolpopexy for patients with baseline Pelvic Organ Prolapse Quantification (POP-Q) scores of at least 2 and symptomatic uterovaginal prolapse.
Two permanent Gore-Tex sutures were also placed at the apex of the cervix in each of the 64 patients, said Dr. Taylor, a urogynecology fellow at the University of Massachusetts, Worcester, who worked on the study as a resident at the Cleveland Clinic Akron General, in Ohio. She and her colleagues rechecked patients at postoperative weeks 2 and 6, and at months 6 and 12. They lost two patients to follow-up, both after week 2.
At baseline, 37 patients (58%) were in stage II pelvic organ prolapse, 27% were in stage III, and 14% were in stage IV. At 6 months after surgery, 85% had no detectable prolapse, 8% had stage I, and 6% had stage II. At 1 year, 82% remained in pelvic organ prolapse stage 0 and the rest were in stage I or II. All stage II patients remained asymptomatic, Dr. Taylor said.
At baseline, the median value for POP-Q point C was -3 (range, –8 to +6). At 6 months and 1 year later, the median value had improved to –8, and patients ranged between –10 and –8.
Quality of life surveys of 54 patients reflected these outcomes, Dr. Taylor said. A year after surgery, average scores on the Pelvic Floor Distress Index (PFDI) dropped by 67 points, from 103 to 35 (P less than .0001). Likewise, average scores on the Pelvic Floor Impact Questionnaire (PFIQ) dropped by 29 points (P less than .0001), and scores on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) indicated a significant decrease in the effects of pelvic organ prolapse on sexual functioning (P = .008).
In addition to a single case of mesh erosion, one patient developed postoperative ileus and one experienced small bowel obstruction, both of which resolved, Dr. Taylor reported. The researchers aim to continue the study with longer follow-up intervals and detailed analyses of postoperative pain.
Dr. Taylor reported no funding sources and had no disclosures. One coauthor disclosed ties to Coloplast Corp.
DENVER – Using absorbable polydioxanone suture during laparoscopic sacrocolpopexy was associated with a mesh erosion rate of just 1.6%, according to a single-center, 1-year prospective study of 64 patients.
That is substantially less than typical erosion rates of about 5% when permanent suture is used, Danielle Taylor, DO, of Akron (Ohio ) General Medical Center said at Pelvic Floor Disorders Week sponsored by the American Urogynecologic Society.
The researchers observed no anatomic failures or suture extrusions, and patients reported significant postoperative improvements on several validated measures of quality of life.
“Larger samples and longer follow-up may be needed,” said Dr. Taylor. “But our study suggests that permanent, nondissolving suture material may not be necessary for sacrocolpopexy.”
Sacrocolpopexy with mesh usually involves using nonabsorbable suture to attach its anterior and posterior arms to the vaginal mucosa. Instead, Dr. Taylor and colleagues used 90-day delayed absorbable 2.0 V-Loc (Covidien) suture during laparoscopic sacrocolpopexy for patients with baseline Pelvic Organ Prolapse Quantification (POP-Q) scores of at least 2 and symptomatic uterovaginal prolapse.
Two permanent Gore-Tex sutures were also placed at the apex of the cervix in each of the 64 patients, said Dr. Taylor, a urogynecology fellow at the University of Massachusetts, Worcester, who worked on the study as a resident at the Cleveland Clinic Akron General, in Ohio. She and her colleagues rechecked patients at postoperative weeks 2 and 6, and at months 6 and 12. They lost two patients to follow-up, both after week 2.
At baseline, 37 patients (58%) were in stage II pelvic organ prolapse, 27% were in stage III, and 14% were in stage IV. At 6 months after surgery, 85% had no detectable prolapse, 8% had stage I, and 6% had stage II. At 1 year, 82% remained in pelvic organ prolapse stage 0 and the rest were in stage I or II. All stage II patients remained asymptomatic, Dr. Taylor said.
At baseline, the median value for POP-Q point C was -3 (range, –8 to +6). At 6 months and 1 year later, the median value had improved to –8, and patients ranged between –10 and –8.
Quality of life surveys of 54 patients reflected these outcomes, Dr. Taylor said. A year after surgery, average scores on the Pelvic Floor Distress Index (PFDI) dropped by 67 points, from 103 to 35 (P less than .0001). Likewise, average scores on the Pelvic Floor Impact Questionnaire (PFIQ) dropped by 29 points (P less than .0001), and scores on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) indicated a significant decrease in the effects of pelvic organ prolapse on sexual functioning (P = .008).
In addition to a single case of mesh erosion, one patient developed postoperative ileus and one experienced small bowel obstruction, both of which resolved, Dr. Taylor reported. The researchers aim to continue the study with longer follow-up intervals and detailed analyses of postoperative pain.
Dr. Taylor reported no funding sources and had no disclosures. One coauthor disclosed ties to Coloplast Corp.
Key clinical point:
Major finding: When 90-day delayed absorbable polydioxanone suture was used, the mesh erosion rate was 1.6%. There were no anatomic failures or cases of suture extrusion.
Data source: A single-center prospective case series of 64 patients.
Disclosures: Dr. Taylor reported having no financial disclosures. One coauthor reported ties to Coloplast Corp.
Most people who undergo gender reassignment surgery appreciate the results
ORLANDO – Gender reassignment surgery is the most extreme step for those transgender individuals who wish to complete the transformation to the opposite sex. While many transgender people do not opt to take this step, it may be an option for people who still have gender dysphoria after a thorough diagnostic work-up by a mental health professional, hormonal treatment, and having lived in the desired gender role as a “real-life test.”
Dr. Stan Monstrey, of Ghent University Hospital, Belgium, is an experienced gender reassignment surgeon and reported at the annual meeting of the American Academy of Clinical Endocrinology that between 1995 and 2005, he saw about 20-30 new patients a year. But now, he said, “We operate on a weekly basis between a minimum of three and sometimes six or seven transsexuals, so ... in our practice, probably between 90% and 95% are still going the whole way, still want what was called initially binary surgery.”
Transwomen: Male to female
The transformation procedure for male to female begins with feminizing aesthetic procedures, such as reducing the Adam’s apple (laryngeal prominence of the thyroid cartilage) and chin, frontal boss of the forehead, and possibly other facial work such as rhinoplasty. “Sometimes minor changes can have a huge effect on the face of the patient,” Dr. Monstrey said. “This is becoming, in our opinion, increasingly important for transwomen.”
Then, in about 75% of cases, Dr. Monstrey performs at least two surgeries under the same anesthesia – breast augmentation and perineal transformation. He said even after years of hormone therapy, most such patients have only a limited amount of breast tissue but want more prominent breasts. Implants can be placed behind or in front of the pectoralis muscle via inframammary, transaxillary, or occasionally periareolar approaches. Results are immediate, and complications are rare.
Another technique, which has become very popular over the past 5-10 years, is lipofilling to fill defects and depressions in the breasts. Stem cells contained in the fat may help soften scars. But when faced with a patient who had a BRCA1 mutation, the surgeons would not use lipofilling, fearing the potential for breast cancer, and would use prostheses instead (J Sex Med. 2014 Oct;11:2496-9). Still, questions remain about even using hormone treatments in such a patient.
Dr. Monstrey mentioned that in Belgium, breast augmentation for transwomen is considered reconstructive surgery and is always reimbursed whereas it is considered aesthetic surgery and never reimbursed for non-transwomen who want larger breasts. (For transmen, breast amputation is similarly reimbursed.)
The second operation is genital transformation. Basically, the interior of the penis is removed and the skin is invaginated to form a vagina of 8-18.5 cm and a scrotal flap, along with castration and removal of the penile bulb erectile tissue (corpus spongiosum) posteriorly. It is important to protect the rectal wall, which is not very strong. The foreskin becomes the new clitoral hood and inner side of the labia minora, and the clitoris is formed by reducing and transposing the penile glans. If the patient had a small penis and not enough tissue for the reconstruction, skin flaps from various other sites can be used.
Among more than 1,200 patients, 92% could achieve orgasm. Rectovaginal fistulas occurred in 4 patients, 19 needed repositioning of the urethra, 21 needed an operation to lengthen the vagina, and 95 needed aesthetic correction of the vulva. Dr. Monstrey said many patients have asked him when they should tell their new boyfriends about their transformation, meaning that the surgery was quite convincing even with penetrative sex.
If the first operation does not work, another technique is to use an isolated piece of colon or sigmoid bowel, which has been performed completely laparoscopically by a very skilled gastroenterologic surgeon at the hospital in Ghent.
Speaking to a roomful of endocrinologists, Dr. Monstrey told them, “I’ll be the first one to agree with you that indeed puberty blockers are a very good thing. However, we as surgeons are not so enthusiastic about them because … it is impossible to create a normal vagina” because of a lack of available tissue from the underdeveloped penis.
Transmen: Female to male
“Transmen react much better to hormonal therapy than do transwomen,” he said. “If they hide their breasts they really look like men. The disadvantage is that the surgical treatment is much more complex.” The most important operation for them is subcutaneous mastectomy and male contouring. A small, semiareolar incision leaves almost no scar. Most patients still require excision of redundant skin of the breasts.
Phalloplasty is a complex operation aimed at giving the patient an aesthetic phallus, a normal scrotum, the ability to void while standing, and to perform sexual intercourse, all while protecting erogenous sensation, with minimal morbidity and mortality. Dr. Monstrey reported that he has performed 600-700 phalloplasties.
The most common technique has been to use a free vascularized flap from another bodily site with the artery, vein, and nerves to reconnect at the phalloplasty site. Because the skin is very thin on the inner forearm, it is often used and allows forming an inner tube for the urethra and an outer tube for the penis. The surgery may have to be done in three or four stages for the best results. From pictures that Dr. Monstrey showed, it was obvious that the constructed penises were not absolutely natural in appearance, but he said most patients were “rather happy” with them, despite many of these patients being quite demanding. A scrotum is constructed from transposition of the labia minora.
Unfortunately, voiding while standing is often a problem, with 197 out of 562 patients (35%) having a fistula and urine leakage, but this issue frequently corrects itself. “More difficult to treat are the strictures with stenosis, which can be a problem voiding,” he said (occurring in 78/562). Other complications were 5 complete and 43 partial flap failures, 4 cases of compression syndrome, 58 cases of delayed wound healing, and 15 cases of transient ischemia. Flap failures occurred mainly in smokers, “so we don’t operate on smokers anymore,” he said.
One year after the constructive surgery, a penile prosthesis is implanted for those who want it, allowing sexual intercourse. Most individuals had orgasmic function, not because of reconnected nerves in the flap, but, Dr. Monstrey said he believes, because the clitoris, placed beneath the phallus, is denuded and stimulated during sexual activity. He said the problem is that the prostheses are usually intended for elderly men “who have sex a couple of times a month and who have a normal anatomy.” Young transmen may engage in more sexual activity, “so we have a lot of problems with exposure [of the prosthesis], infection, technical defects, and so on,” he said.
A technique gaining popularity is to use a skin flap from the groin area to make a urethra and one from the thigh to construct a penis. Although a penile transplant has recently been performed for a patient who had lost his penis to cancer, transplants are not being considered at this point, both for surgical technical reasons and because of a need for lifelong immunosuppressive drugs.
Proper referrals and counseling
The World Professional Association for Transgender Health in its Standard of Care guidelines 7 recommends one mental health professional referral for the breast surgery and two such referrals for genital surgery. The issue of possible parenthood should be discussed with patients, along with early counseling about fertility options. The age of majority and consent in different countries is important. Dr. Monstrey said genital surgery may be possible before the age of 18 years if all members of a multidisciplinary team of health professionals agree on a case by case basis that the adolescent can understand the risks, benefits, and alternatives to the surgery with the same degree of competence as someone 18 years of age or older.
Dr. Monstrey reported having no financial disclosures.
ORLANDO – Gender reassignment surgery is the most extreme step for those transgender individuals who wish to complete the transformation to the opposite sex. While many transgender people do not opt to take this step, it may be an option for people who still have gender dysphoria after a thorough diagnostic work-up by a mental health professional, hormonal treatment, and having lived in the desired gender role as a “real-life test.”
Dr. Stan Monstrey, of Ghent University Hospital, Belgium, is an experienced gender reassignment surgeon and reported at the annual meeting of the American Academy of Clinical Endocrinology that between 1995 and 2005, he saw about 20-30 new patients a year. But now, he said, “We operate on a weekly basis between a minimum of three and sometimes six or seven transsexuals, so ... in our practice, probably between 90% and 95% are still going the whole way, still want what was called initially binary surgery.”
Transwomen: Male to female
The transformation procedure for male to female begins with feminizing aesthetic procedures, such as reducing the Adam’s apple (laryngeal prominence of the thyroid cartilage) and chin, frontal boss of the forehead, and possibly other facial work such as rhinoplasty. “Sometimes minor changes can have a huge effect on the face of the patient,” Dr. Monstrey said. “This is becoming, in our opinion, increasingly important for transwomen.”
Then, in about 75% of cases, Dr. Monstrey performs at least two surgeries under the same anesthesia – breast augmentation and perineal transformation. He said even after years of hormone therapy, most such patients have only a limited amount of breast tissue but want more prominent breasts. Implants can be placed behind or in front of the pectoralis muscle via inframammary, transaxillary, or occasionally periareolar approaches. Results are immediate, and complications are rare.
Another technique, which has become very popular over the past 5-10 years, is lipofilling to fill defects and depressions in the breasts. Stem cells contained in the fat may help soften scars. But when faced with a patient who had a BRCA1 mutation, the surgeons would not use lipofilling, fearing the potential for breast cancer, and would use prostheses instead (J Sex Med. 2014 Oct;11:2496-9). Still, questions remain about even using hormone treatments in such a patient.
Dr. Monstrey mentioned that in Belgium, breast augmentation for transwomen is considered reconstructive surgery and is always reimbursed whereas it is considered aesthetic surgery and never reimbursed for non-transwomen who want larger breasts. (For transmen, breast amputation is similarly reimbursed.)
The second operation is genital transformation. Basically, the interior of the penis is removed and the skin is invaginated to form a vagina of 8-18.5 cm and a scrotal flap, along with castration and removal of the penile bulb erectile tissue (corpus spongiosum) posteriorly. It is important to protect the rectal wall, which is not very strong. The foreskin becomes the new clitoral hood and inner side of the labia minora, and the clitoris is formed by reducing and transposing the penile glans. If the patient had a small penis and not enough tissue for the reconstruction, skin flaps from various other sites can be used.
Among more than 1,200 patients, 92% could achieve orgasm. Rectovaginal fistulas occurred in 4 patients, 19 needed repositioning of the urethra, 21 needed an operation to lengthen the vagina, and 95 needed aesthetic correction of the vulva. Dr. Monstrey said many patients have asked him when they should tell their new boyfriends about their transformation, meaning that the surgery was quite convincing even with penetrative sex.
If the first operation does not work, another technique is to use an isolated piece of colon or sigmoid bowel, which has been performed completely laparoscopically by a very skilled gastroenterologic surgeon at the hospital in Ghent.
Speaking to a roomful of endocrinologists, Dr. Monstrey told them, “I’ll be the first one to agree with you that indeed puberty blockers are a very good thing. However, we as surgeons are not so enthusiastic about them because … it is impossible to create a normal vagina” because of a lack of available tissue from the underdeveloped penis.
Transmen: Female to male
“Transmen react much better to hormonal therapy than do transwomen,” he said. “If they hide their breasts they really look like men. The disadvantage is that the surgical treatment is much more complex.” The most important operation for them is subcutaneous mastectomy and male contouring. A small, semiareolar incision leaves almost no scar. Most patients still require excision of redundant skin of the breasts.
Phalloplasty is a complex operation aimed at giving the patient an aesthetic phallus, a normal scrotum, the ability to void while standing, and to perform sexual intercourse, all while protecting erogenous sensation, with minimal morbidity and mortality. Dr. Monstrey reported that he has performed 600-700 phalloplasties.
The most common technique has been to use a free vascularized flap from another bodily site with the artery, vein, and nerves to reconnect at the phalloplasty site. Because the skin is very thin on the inner forearm, it is often used and allows forming an inner tube for the urethra and an outer tube for the penis. The surgery may have to be done in three or four stages for the best results. From pictures that Dr. Monstrey showed, it was obvious that the constructed penises were not absolutely natural in appearance, but he said most patients were “rather happy” with them, despite many of these patients being quite demanding. A scrotum is constructed from transposition of the labia minora.
Unfortunately, voiding while standing is often a problem, with 197 out of 562 patients (35%) having a fistula and urine leakage, but this issue frequently corrects itself. “More difficult to treat are the strictures with stenosis, which can be a problem voiding,” he said (occurring in 78/562). Other complications were 5 complete and 43 partial flap failures, 4 cases of compression syndrome, 58 cases of delayed wound healing, and 15 cases of transient ischemia. Flap failures occurred mainly in smokers, “so we don’t operate on smokers anymore,” he said.
One year after the constructive surgery, a penile prosthesis is implanted for those who want it, allowing sexual intercourse. Most individuals had orgasmic function, not because of reconnected nerves in the flap, but, Dr. Monstrey said he believes, because the clitoris, placed beneath the phallus, is denuded and stimulated during sexual activity. He said the problem is that the prostheses are usually intended for elderly men “who have sex a couple of times a month and who have a normal anatomy.” Young transmen may engage in more sexual activity, “so we have a lot of problems with exposure [of the prosthesis], infection, technical defects, and so on,” he said.
A technique gaining popularity is to use a skin flap from the groin area to make a urethra and one from the thigh to construct a penis. Although a penile transplant has recently been performed for a patient who had lost his penis to cancer, transplants are not being considered at this point, both for surgical technical reasons and because of a need for lifelong immunosuppressive drugs.
Proper referrals and counseling
The World Professional Association for Transgender Health in its Standard of Care guidelines 7 recommends one mental health professional referral for the breast surgery and two such referrals for genital surgery. The issue of possible parenthood should be discussed with patients, along with early counseling about fertility options. The age of majority and consent in different countries is important. Dr. Monstrey said genital surgery may be possible before the age of 18 years if all members of a multidisciplinary team of health professionals agree on a case by case basis that the adolescent can understand the risks, benefits, and alternatives to the surgery with the same degree of competence as someone 18 years of age or older.
Dr. Monstrey reported having no financial disclosures.
ORLANDO – Gender reassignment surgery is the most extreme step for those transgender individuals who wish to complete the transformation to the opposite sex. While many transgender people do not opt to take this step, it may be an option for people who still have gender dysphoria after a thorough diagnostic work-up by a mental health professional, hormonal treatment, and having lived in the desired gender role as a “real-life test.”
Dr. Stan Monstrey, of Ghent University Hospital, Belgium, is an experienced gender reassignment surgeon and reported at the annual meeting of the American Academy of Clinical Endocrinology that between 1995 and 2005, he saw about 20-30 new patients a year. But now, he said, “We operate on a weekly basis between a minimum of three and sometimes six or seven transsexuals, so ... in our practice, probably between 90% and 95% are still going the whole way, still want what was called initially binary surgery.”
Transwomen: Male to female
The transformation procedure for male to female begins with feminizing aesthetic procedures, such as reducing the Adam’s apple (laryngeal prominence of the thyroid cartilage) and chin, frontal boss of the forehead, and possibly other facial work such as rhinoplasty. “Sometimes minor changes can have a huge effect on the face of the patient,” Dr. Monstrey said. “This is becoming, in our opinion, increasingly important for transwomen.”
Then, in about 75% of cases, Dr. Monstrey performs at least two surgeries under the same anesthesia – breast augmentation and perineal transformation. He said even after years of hormone therapy, most such patients have only a limited amount of breast tissue but want more prominent breasts. Implants can be placed behind or in front of the pectoralis muscle via inframammary, transaxillary, or occasionally periareolar approaches. Results are immediate, and complications are rare.
Another technique, which has become very popular over the past 5-10 years, is lipofilling to fill defects and depressions in the breasts. Stem cells contained in the fat may help soften scars. But when faced with a patient who had a BRCA1 mutation, the surgeons would not use lipofilling, fearing the potential for breast cancer, and would use prostheses instead (J Sex Med. 2014 Oct;11:2496-9). Still, questions remain about even using hormone treatments in such a patient.
Dr. Monstrey mentioned that in Belgium, breast augmentation for transwomen is considered reconstructive surgery and is always reimbursed whereas it is considered aesthetic surgery and never reimbursed for non-transwomen who want larger breasts. (For transmen, breast amputation is similarly reimbursed.)
The second operation is genital transformation. Basically, the interior of the penis is removed and the skin is invaginated to form a vagina of 8-18.5 cm and a scrotal flap, along with castration and removal of the penile bulb erectile tissue (corpus spongiosum) posteriorly. It is important to protect the rectal wall, which is not very strong. The foreskin becomes the new clitoral hood and inner side of the labia minora, and the clitoris is formed by reducing and transposing the penile glans. If the patient had a small penis and not enough tissue for the reconstruction, skin flaps from various other sites can be used.
Among more than 1,200 patients, 92% could achieve orgasm. Rectovaginal fistulas occurred in 4 patients, 19 needed repositioning of the urethra, 21 needed an operation to lengthen the vagina, and 95 needed aesthetic correction of the vulva. Dr. Monstrey said many patients have asked him when they should tell their new boyfriends about their transformation, meaning that the surgery was quite convincing even with penetrative sex.
If the first operation does not work, another technique is to use an isolated piece of colon or sigmoid bowel, which has been performed completely laparoscopically by a very skilled gastroenterologic surgeon at the hospital in Ghent.
Speaking to a roomful of endocrinologists, Dr. Monstrey told them, “I’ll be the first one to agree with you that indeed puberty blockers are a very good thing. However, we as surgeons are not so enthusiastic about them because … it is impossible to create a normal vagina” because of a lack of available tissue from the underdeveloped penis.
Transmen: Female to male
“Transmen react much better to hormonal therapy than do transwomen,” he said. “If they hide their breasts they really look like men. The disadvantage is that the surgical treatment is much more complex.” The most important operation for them is subcutaneous mastectomy and male contouring. A small, semiareolar incision leaves almost no scar. Most patients still require excision of redundant skin of the breasts.
Phalloplasty is a complex operation aimed at giving the patient an aesthetic phallus, a normal scrotum, the ability to void while standing, and to perform sexual intercourse, all while protecting erogenous sensation, with minimal morbidity and mortality. Dr. Monstrey reported that he has performed 600-700 phalloplasties.
The most common technique has been to use a free vascularized flap from another bodily site with the artery, vein, and nerves to reconnect at the phalloplasty site. Because the skin is very thin on the inner forearm, it is often used and allows forming an inner tube for the urethra and an outer tube for the penis. The surgery may have to be done in three or four stages for the best results. From pictures that Dr. Monstrey showed, it was obvious that the constructed penises were not absolutely natural in appearance, but he said most patients were “rather happy” with them, despite many of these patients being quite demanding. A scrotum is constructed from transposition of the labia minora.
Unfortunately, voiding while standing is often a problem, with 197 out of 562 patients (35%) having a fistula and urine leakage, but this issue frequently corrects itself. “More difficult to treat are the strictures with stenosis, which can be a problem voiding,” he said (occurring in 78/562). Other complications were 5 complete and 43 partial flap failures, 4 cases of compression syndrome, 58 cases of delayed wound healing, and 15 cases of transient ischemia. Flap failures occurred mainly in smokers, “so we don’t operate on smokers anymore,” he said.
One year after the constructive surgery, a penile prosthesis is implanted for those who want it, allowing sexual intercourse. Most individuals had orgasmic function, not because of reconnected nerves in the flap, but, Dr. Monstrey said he believes, because the clitoris, placed beneath the phallus, is denuded and stimulated during sexual activity. He said the problem is that the prostheses are usually intended for elderly men “who have sex a couple of times a month and who have a normal anatomy.” Young transmen may engage in more sexual activity, “so we have a lot of problems with exposure [of the prosthesis], infection, technical defects, and so on,” he said.
A technique gaining popularity is to use a skin flap from the groin area to make a urethra and one from the thigh to construct a penis. Although a penile transplant has recently been performed for a patient who had lost his penis to cancer, transplants are not being considered at this point, both for surgical technical reasons and because of a need for lifelong immunosuppressive drugs.
Proper referrals and counseling
The World Professional Association for Transgender Health in its Standard of Care guidelines 7 recommends one mental health professional referral for the breast surgery and two such referrals for genital surgery. The issue of possible parenthood should be discussed with patients, along with early counseling about fertility options. The age of majority and consent in different countries is important. Dr. Monstrey said genital surgery may be possible before the age of 18 years if all members of a multidisciplinary team of health professionals agree on a case by case basis that the adolescent can understand the risks, benefits, and alternatives to the surgery with the same degree of competence as someone 18 years of age or older.
Dr. Monstrey reported having no financial disclosures.
AACE 2016
Androgen deprivation therapy linked to depression
Men on androgen deprivation therapy for prostate cancer are at significantly increased risk for depression, a risk that increases with duration of therapy, investigators report.
A review of Surveillance, Epidemiology, and End Results (SEER) Medicare data on nearly 79,000 men older than 65 years with a diagnosis of prostate cancer showed that those who received androgen deprivation therapy (ADT) had a 23% increased risk for depression, compared with men who were not on ADT, reported Kathryn T. Dinh of Harvard Medical School, Boston, and her colleagues.
“We observed a significantly increased risk of depression and inpatient psychiatric treatment in men treated with ADT for prostate cancer, as well as a duration-response effect such that more ADT was linked to an increasing risk of depression and inpatient and outpatient psychiatric treatment. The possible psychiatric effects of ADT should be recognized by physicians and discussed with patients before initiating treatment,” they wrote (J Clin Oncol. 2016 Apr 11. doi: 10.1200/JCO.2015.64.1969).
Although ADT has been identified in some studies as a risk factor for clinical depression, evidence for such a relationship has been spotty, the investigators said, prompting them to conduct a population-based retrospective study to get a better handle on the issue.
They reviewed SEER Medicare data on 78,552 men older than 65 years with a diagnosis of stage I-III prostate cancer treated with ADT from 1992 through 2006, excluding from the sample those patients who had a psychiatric diagnosis within the past 12 months.
Ms. Dinh and her associates found that the 33,882 patients (43%) who received ADT had a significantly higher 3-year cumulative incidence of depression than patients who did not have ADT (7.1% vs. 5.2%, P less than .001), and a significantly higher proportion had either inpatient psychiatric treatment (2.8% vs. 1.9%, P less than .001) or outpatient psychiatric therapy (3.4% vs. 2.5%, P less than .001).
In proportional hazard models controlling for demographic and clinical factors, receipt of ADT was associated with adjusted hazard ratios of 1.23 for depression and 1.29 (P less than .001 for both) for inpatient psychiatric treatment. There was no significant increase in risk for outpatient psychiatric treatment in this analysis, however.
In addition, the longer patients that were on ADT, the greater the risk for depression. The risk of depression was 12% for patients treated for 6 months or less, 26% for those on ADT for 7-11 months, and 37% for those on ADT for at least 1 year.
“The impact of ADT on depression may plausibly occur via deregulation of neurochemicals, such as serotonin, in addition to the well-described physical effects,” Ms. Dinh and her associates wrote.
Side effects of ADT that can impair quality of life also may contribute to clinical depression, they noted.
The study was supported by charitable grants and internal institutional sources. One investigator reported consulting or advisory roles with Medivation, GenomeDx, and Ferring. Three of the other ten coauthors also reported financial disclosures.
Men on androgen deprivation therapy for prostate cancer are at significantly increased risk for depression, a risk that increases with duration of therapy, investigators report.
A review of Surveillance, Epidemiology, and End Results (SEER) Medicare data on nearly 79,000 men older than 65 years with a diagnosis of prostate cancer showed that those who received androgen deprivation therapy (ADT) had a 23% increased risk for depression, compared with men who were not on ADT, reported Kathryn T. Dinh of Harvard Medical School, Boston, and her colleagues.
“We observed a significantly increased risk of depression and inpatient psychiatric treatment in men treated with ADT for prostate cancer, as well as a duration-response effect such that more ADT was linked to an increasing risk of depression and inpatient and outpatient psychiatric treatment. The possible psychiatric effects of ADT should be recognized by physicians and discussed with patients before initiating treatment,” they wrote (J Clin Oncol. 2016 Apr 11. doi: 10.1200/JCO.2015.64.1969).
Although ADT has been identified in some studies as a risk factor for clinical depression, evidence for such a relationship has been spotty, the investigators said, prompting them to conduct a population-based retrospective study to get a better handle on the issue.
They reviewed SEER Medicare data on 78,552 men older than 65 years with a diagnosis of stage I-III prostate cancer treated with ADT from 1992 through 2006, excluding from the sample those patients who had a psychiatric diagnosis within the past 12 months.
Ms. Dinh and her associates found that the 33,882 patients (43%) who received ADT had a significantly higher 3-year cumulative incidence of depression than patients who did not have ADT (7.1% vs. 5.2%, P less than .001), and a significantly higher proportion had either inpatient psychiatric treatment (2.8% vs. 1.9%, P less than .001) or outpatient psychiatric therapy (3.4% vs. 2.5%, P less than .001).
In proportional hazard models controlling for demographic and clinical factors, receipt of ADT was associated with adjusted hazard ratios of 1.23 for depression and 1.29 (P less than .001 for both) for inpatient psychiatric treatment. There was no significant increase in risk for outpatient psychiatric treatment in this analysis, however.
In addition, the longer patients that were on ADT, the greater the risk for depression. The risk of depression was 12% for patients treated for 6 months or less, 26% for those on ADT for 7-11 months, and 37% for those on ADT for at least 1 year.
“The impact of ADT on depression may plausibly occur via deregulation of neurochemicals, such as serotonin, in addition to the well-described physical effects,” Ms. Dinh and her associates wrote.
Side effects of ADT that can impair quality of life also may contribute to clinical depression, they noted.
The study was supported by charitable grants and internal institutional sources. One investigator reported consulting or advisory roles with Medivation, GenomeDx, and Ferring. Three of the other ten coauthors also reported financial disclosures.
Men on androgen deprivation therapy for prostate cancer are at significantly increased risk for depression, a risk that increases with duration of therapy, investigators report.
A review of Surveillance, Epidemiology, and End Results (SEER) Medicare data on nearly 79,000 men older than 65 years with a diagnosis of prostate cancer showed that those who received androgen deprivation therapy (ADT) had a 23% increased risk for depression, compared with men who were not on ADT, reported Kathryn T. Dinh of Harvard Medical School, Boston, and her colleagues.
“We observed a significantly increased risk of depression and inpatient psychiatric treatment in men treated with ADT for prostate cancer, as well as a duration-response effect such that more ADT was linked to an increasing risk of depression and inpatient and outpatient psychiatric treatment. The possible psychiatric effects of ADT should be recognized by physicians and discussed with patients before initiating treatment,” they wrote (J Clin Oncol. 2016 Apr 11. doi: 10.1200/JCO.2015.64.1969).
Although ADT has been identified in some studies as a risk factor for clinical depression, evidence for such a relationship has been spotty, the investigators said, prompting them to conduct a population-based retrospective study to get a better handle on the issue.
They reviewed SEER Medicare data on 78,552 men older than 65 years with a diagnosis of stage I-III prostate cancer treated with ADT from 1992 through 2006, excluding from the sample those patients who had a psychiatric diagnosis within the past 12 months.
Ms. Dinh and her associates found that the 33,882 patients (43%) who received ADT had a significantly higher 3-year cumulative incidence of depression than patients who did not have ADT (7.1% vs. 5.2%, P less than .001), and a significantly higher proportion had either inpatient psychiatric treatment (2.8% vs. 1.9%, P less than .001) or outpatient psychiatric therapy (3.4% vs. 2.5%, P less than .001).
In proportional hazard models controlling for demographic and clinical factors, receipt of ADT was associated with adjusted hazard ratios of 1.23 for depression and 1.29 (P less than .001 for both) for inpatient psychiatric treatment. There was no significant increase in risk for outpatient psychiatric treatment in this analysis, however.
In addition, the longer patients that were on ADT, the greater the risk for depression. The risk of depression was 12% for patients treated for 6 months or less, 26% for those on ADT for 7-11 months, and 37% for those on ADT for at least 1 year.
“The impact of ADT on depression may plausibly occur via deregulation of neurochemicals, such as serotonin, in addition to the well-described physical effects,” Ms. Dinh and her associates wrote.
Side effects of ADT that can impair quality of life also may contribute to clinical depression, they noted.
The study was supported by charitable grants and internal institutional sources. One investigator reported consulting or advisory roles with Medivation, GenomeDx, and Ferring. Three of the other ten coauthors also reported financial disclosures.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Androgen deprivation therapy for prostate cancer is associated with increased risk for clinical depression.
Major finding: Men who received androgen deprivation therapy (ADT) had a 23% increased risk for depression compared with men who were not on ADT.
Data source: Review of SEER Medicare data on 78,552 men with stage I-III prostate cancer.
Disclosures: The study was supported by charitable grants and internal institutional sources. One investigator reported consulting or advisory roles with Medivation, GenomeDx, and Ferring. Three of the other ten coauthors also reported financial disclosures.
PSA screens could be cost effective if low-risk cases went untreated
Given current treatment practices, prostate-specific antigen (PSA) screening is not cost effective unless performed every 4 years in men aged 55-69 years, and with a biopsy threshold of 10.0 ng/mL, researchers reported online in JAMA Oncology.
But several less conservative testing strategies could be cost effective if patients with Gleason scores under 7 and clinical T2a stage cancer or lower are not treated unless they clinically progress, said Joshua A. Roth, Ph.D., of Fred Hutchinson Cancer Research Center in Seattle and his associates.
The study has “clear implications for the future of PSA screening in the United States,” the investigators wrote (JAMA Oncol. Mar 24. doi: 10.1001/jamaoncol.2015.6275). “Rather than stopping PSA screening, as recommended by the U.S. Preventive Services Task Force, implementation of strategies that extend the screening interval and/or use higher PSA biopsy thresholds have the potential to preserve substantial benefit, while controlling harm and costs.”
The investigators constructed a hypothetical group of men in the United States who underwent 18 different PSA screening strategies starting at age 40. Under the current treatment paradigm, PSA screening increased years of life by 3%-6%, with a cost of $7,335-$21,649 for each extra year of life. Quality years of life rose only if the strategy included a narrower age range for testing or a biopsy threshold of 10.0 ng/mL.
If the more selective treatment model was used, screening 55- to 69-year-old men every 4 years and using a PSA biopsy threshold of 3.0 ng/mL was not only potentially cost effective, but also increased quality years of life. The same was true for quadrennial screening of men aged 50-74 years with a biopsy threshold of 4.0 ng/mL.
“Our work adds to a growing consensus that highly conservative use of the PSA test and biopsy referral is necessary if PSA screening is to be cost effective,” the researchers concluded. Less frequent screening and stricter biopsy criteria for biopsy were most likely to make screening cost effective, especially if physicians do not immediately treat low-risk cases, they added.
The study was supported by the National Cancer Institute, the Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality. The investigators had no disclosures.
This study forces us to change the debate from “Should we screen?” to “How can we get physicians to follow best practice?” I have heard it said that the professional, financial, and malpractice incentives to screen and then treat low-risk cancer are too overwhelming to allow for significant practice change. But this is clearly disconfirmed by the literature. Use of active surveillance for low-risk prostate cancer has increased fourfold in the past few years; PSA testing in older men has also fallen recently. Rates of unnecessary treatment still remain much too high (about 60%) as does screening of older men (about 35% for those aged 75 years and older). More work needs to be done, and much more change needs to happen.
![]() |
Andrew J. Vickers, Ph.D. |
Based on these results, if we follow the literature on how to screen with PSA and which screen-detected prostate cancers to treat, we will likely do more good than harm. If we simply carry on with common practice – screening older men, aggressively treating low-risk disease – then we should call for PSA screening to end.
Andrew J. Vickers, Ph.D., is at Memorial Sloan Kettering Cancer Center, New York. He reported being named on a patent application for a statistical method to detect prostate cancer; receiving royalties from sales of the test; and having stock options in OPKO Health, which commercialized the test. These comments are from his editorial (JAMA Oncol. 2016 Mar 24 doi: 10.1001/jamaoncol.2015.6276).
This study forces us to change the debate from “Should we screen?” to “How can we get physicians to follow best practice?” I have heard it said that the professional, financial, and malpractice incentives to screen and then treat low-risk cancer are too overwhelming to allow for significant practice change. But this is clearly disconfirmed by the literature. Use of active surveillance for low-risk prostate cancer has increased fourfold in the past few years; PSA testing in older men has also fallen recently. Rates of unnecessary treatment still remain much too high (about 60%) as does screening of older men (about 35% for those aged 75 years and older). More work needs to be done, and much more change needs to happen.
![]() |
Andrew J. Vickers, Ph.D. |
Based on these results, if we follow the literature on how to screen with PSA and which screen-detected prostate cancers to treat, we will likely do more good than harm. If we simply carry on with common practice – screening older men, aggressively treating low-risk disease – then we should call for PSA screening to end.
Andrew J. Vickers, Ph.D., is at Memorial Sloan Kettering Cancer Center, New York. He reported being named on a patent application for a statistical method to detect prostate cancer; receiving royalties from sales of the test; and having stock options in OPKO Health, which commercialized the test. These comments are from his editorial (JAMA Oncol. 2016 Mar 24 doi: 10.1001/jamaoncol.2015.6276).
This study forces us to change the debate from “Should we screen?” to “How can we get physicians to follow best practice?” I have heard it said that the professional, financial, and malpractice incentives to screen and then treat low-risk cancer are too overwhelming to allow for significant practice change. But this is clearly disconfirmed by the literature. Use of active surveillance for low-risk prostate cancer has increased fourfold in the past few years; PSA testing in older men has also fallen recently. Rates of unnecessary treatment still remain much too high (about 60%) as does screening of older men (about 35% for those aged 75 years and older). More work needs to be done, and much more change needs to happen.
![]() |
Andrew J. Vickers, Ph.D. |
Based on these results, if we follow the literature on how to screen with PSA and which screen-detected prostate cancers to treat, we will likely do more good than harm. If we simply carry on with common practice – screening older men, aggressively treating low-risk disease – then we should call for PSA screening to end.
Andrew J. Vickers, Ph.D., is at Memorial Sloan Kettering Cancer Center, New York. He reported being named on a patent application for a statistical method to detect prostate cancer; receiving royalties from sales of the test; and having stock options in OPKO Health, which commercialized the test. These comments are from his editorial (JAMA Oncol. 2016 Mar 24 doi: 10.1001/jamaoncol.2015.6276).
Given current treatment practices, prostate-specific antigen (PSA) screening is not cost effective unless performed every 4 years in men aged 55-69 years, and with a biopsy threshold of 10.0 ng/mL, researchers reported online in JAMA Oncology.
But several less conservative testing strategies could be cost effective if patients with Gleason scores under 7 and clinical T2a stage cancer or lower are not treated unless they clinically progress, said Joshua A. Roth, Ph.D., of Fred Hutchinson Cancer Research Center in Seattle and his associates.
The study has “clear implications for the future of PSA screening in the United States,” the investigators wrote (JAMA Oncol. Mar 24. doi: 10.1001/jamaoncol.2015.6275). “Rather than stopping PSA screening, as recommended by the U.S. Preventive Services Task Force, implementation of strategies that extend the screening interval and/or use higher PSA biopsy thresholds have the potential to preserve substantial benefit, while controlling harm and costs.”
The investigators constructed a hypothetical group of men in the United States who underwent 18 different PSA screening strategies starting at age 40. Under the current treatment paradigm, PSA screening increased years of life by 3%-6%, with a cost of $7,335-$21,649 for each extra year of life. Quality years of life rose only if the strategy included a narrower age range for testing or a biopsy threshold of 10.0 ng/mL.
If the more selective treatment model was used, screening 55- to 69-year-old men every 4 years and using a PSA biopsy threshold of 3.0 ng/mL was not only potentially cost effective, but also increased quality years of life. The same was true for quadrennial screening of men aged 50-74 years with a biopsy threshold of 4.0 ng/mL.
“Our work adds to a growing consensus that highly conservative use of the PSA test and biopsy referral is necessary if PSA screening is to be cost effective,” the researchers concluded. Less frequent screening and stricter biopsy criteria for biopsy were most likely to make screening cost effective, especially if physicians do not immediately treat low-risk cases, they added.
The study was supported by the National Cancer Institute, the Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality. The investigators had no disclosures.
Given current treatment practices, prostate-specific antigen (PSA) screening is not cost effective unless performed every 4 years in men aged 55-69 years, and with a biopsy threshold of 10.0 ng/mL, researchers reported online in JAMA Oncology.
But several less conservative testing strategies could be cost effective if patients with Gleason scores under 7 and clinical T2a stage cancer or lower are not treated unless they clinically progress, said Joshua A. Roth, Ph.D., of Fred Hutchinson Cancer Research Center in Seattle and his associates.
The study has “clear implications for the future of PSA screening in the United States,” the investigators wrote (JAMA Oncol. Mar 24. doi: 10.1001/jamaoncol.2015.6275). “Rather than stopping PSA screening, as recommended by the U.S. Preventive Services Task Force, implementation of strategies that extend the screening interval and/or use higher PSA biopsy thresholds have the potential to preserve substantial benefit, while controlling harm and costs.”
The investigators constructed a hypothetical group of men in the United States who underwent 18 different PSA screening strategies starting at age 40. Under the current treatment paradigm, PSA screening increased years of life by 3%-6%, with a cost of $7,335-$21,649 for each extra year of life. Quality years of life rose only if the strategy included a narrower age range for testing or a biopsy threshold of 10.0 ng/mL.
If the more selective treatment model was used, screening 55- to 69-year-old men every 4 years and using a PSA biopsy threshold of 3.0 ng/mL was not only potentially cost effective, but also increased quality years of life. The same was true for quadrennial screening of men aged 50-74 years with a biopsy threshold of 4.0 ng/mL.
“Our work adds to a growing consensus that highly conservative use of the PSA test and biopsy referral is necessary if PSA screening is to be cost effective,” the researchers concluded. Less frequent screening and stricter biopsy criteria for biopsy were most likely to make screening cost effective, especially if physicians do not immediately treat low-risk cases, they added.
The study was supported by the National Cancer Institute, the Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality. The investigators had no disclosures.
FROM JAMA ONCOLOGY
Key clinical point: A modeling study found that screening for prostate-specific antigen could be cost effective if low-risk cases are not treated unless they progress.
Major finding: Screening 55- to 69-year-old men every 4 years and using a PSA biopsy threshold of 3.0 ng/mL was potentially cost effective and also increased quality years of life. The same was true for quadrennial screening of men aged 50-74 years with a biopsy threshold of 4.0 ng/mL.
Data source: A microsimulation model of prostate cancer incidence and mortality.
Disclosures: The study was supported by the National Cancer Institute, the Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality. The investigators had no disclosures.
Flu vaccination found safe in surgical patients
Immunizing surgical patients against seasonal influenza before they are discharged from the hospital appears safe and is a sound strategy for expanding vaccine coverage, especially among people at high risk, according to a report published online March 14 in Annals of Internal Medicine.
All health care contacts, including hospitalizations, are considered excellent opportunities for influenza vaccination, and current recommendations advise that eligible inpatients receive the immunization before discharge. However, surgical patients don’t often get the flu vaccine before they leave the hospital, likely because of concerns that potential adverse effects like fever and myalgia could be falsely attributed to surgical complications. This would lead to unnecessary patient evaluations and could interfere with postsurgical care, said Sara Y. Tartof, Ph.D., and her associates in the department of research and evaluation, Kaiser Permanente Southern California, Pasadena.
“Although this concern is understandable, few clinical data support it,” they noted.
“To provide clinical evidence that would either substantiate or refute” these concerns about perioperative flu vaccination, the investigators analyzed data in the electronic health records for 81,647 surgeries. All the study participants were deemed eligible for flu vaccination. They were socioeconomically and ethnically diverse, ranged in age from 6 months to 106 years, and underwent surgery at 14 hospitals during three consecutive flu seasons. Operations included general, cardiac, eye, dermatologic, ENT, neurologic, ob.gyn., oral/maxillofacial, orthopedic, plastic, podiatric, urologic, and vascular procedures.
Patients received a flu vaccine in 6,420 hospital stays for surgery – only 15% of 42,777 eligible hospitalizations – usually on the day of discharge. (The remaining 38,870 patients either had been vaccinated before hospital admission or were vaccinated more than a week after discharge and were not included in further analyses.)
Compared with eligible patients who didn’t receive a flu vaccine during hospitalization for surgery, those who did showed no increased risk for subsequent inpatient visits, ED visits, or clinical work-ups for infection. Patients who received the flu vaccine before discharge showed a minimally increased risk for outpatient visits during the week following hospitalization, but this was considered unlikely “to translate into substantial clinical impact,” especially when balanced against the benefit of immunization, Dr. Tartof and her associates said (Ann Intern Med. 2016 Mar 14. doi: 10.7326/M15-1667).
Giving the flu vaccine during a surgical hospitalization “is an opportunity to protect a high-risk population,” because surgery patients tend to be of an age, and to have comorbid conditions, that raise their risk for flu complications. In addition, previous research has reported that 39%-46% of adults hospitalized for influenza-related disease in a given year had been hospitalized during the preceding autumn, indicating that recent hospitalization also raises the risk for flu complications, the investigators said.
“Our data support the rationale for increasing vaccination rates among surgical inpatients,” they said.
This study was funded by the U.S. Centers for Disease Control and Prevention through the Vaccine Safety Datalink program. Dr. Tartof reported receiving grants from Merck outside of this work; two of her associates reported receiving grants from Novartis and GlaxoSmithKline outside of this work.
Immunizing surgical patients against seasonal influenza before they are discharged from the hospital appears safe and is a sound strategy for expanding vaccine coverage, especially among people at high risk, according to a report published online March 14 in Annals of Internal Medicine.
All health care contacts, including hospitalizations, are considered excellent opportunities for influenza vaccination, and current recommendations advise that eligible inpatients receive the immunization before discharge. However, surgical patients don’t often get the flu vaccine before they leave the hospital, likely because of concerns that potential adverse effects like fever and myalgia could be falsely attributed to surgical complications. This would lead to unnecessary patient evaluations and could interfere with postsurgical care, said Sara Y. Tartof, Ph.D., and her associates in the department of research and evaluation, Kaiser Permanente Southern California, Pasadena.
“Although this concern is understandable, few clinical data support it,” they noted.
“To provide clinical evidence that would either substantiate or refute” these concerns about perioperative flu vaccination, the investigators analyzed data in the electronic health records for 81,647 surgeries. All the study participants were deemed eligible for flu vaccination. They were socioeconomically and ethnically diverse, ranged in age from 6 months to 106 years, and underwent surgery at 14 hospitals during three consecutive flu seasons. Operations included general, cardiac, eye, dermatologic, ENT, neurologic, ob.gyn., oral/maxillofacial, orthopedic, plastic, podiatric, urologic, and vascular procedures.
Patients received a flu vaccine in 6,420 hospital stays for surgery – only 15% of 42,777 eligible hospitalizations – usually on the day of discharge. (The remaining 38,870 patients either had been vaccinated before hospital admission or were vaccinated more than a week after discharge and were not included in further analyses.)
Compared with eligible patients who didn’t receive a flu vaccine during hospitalization for surgery, those who did showed no increased risk for subsequent inpatient visits, ED visits, or clinical work-ups for infection. Patients who received the flu vaccine before discharge showed a minimally increased risk for outpatient visits during the week following hospitalization, but this was considered unlikely “to translate into substantial clinical impact,” especially when balanced against the benefit of immunization, Dr. Tartof and her associates said (Ann Intern Med. 2016 Mar 14. doi: 10.7326/M15-1667).
Giving the flu vaccine during a surgical hospitalization “is an opportunity to protect a high-risk population,” because surgery patients tend to be of an age, and to have comorbid conditions, that raise their risk for flu complications. In addition, previous research has reported that 39%-46% of adults hospitalized for influenza-related disease in a given year had been hospitalized during the preceding autumn, indicating that recent hospitalization also raises the risk for flu complications, the investigators said.
“Our data support the rationale for increasing vaccination rates among surgical inpatients,” they said.
This study was funded by the U.S. Centers for Disease Control and Prevention through the Vaccine Safety Datalink program. Dr. Tartof reported receiving grants from Merck outside of this work; two of her associates reported receiving grants from Novartis and GlaxoSmithKline outside of this work.
Immunizing surgical patients against seasonal influenza before they are discharged from the hospital appears safe and is a sound strategy for expanding vaccine coverage, especially among people at high risk, according to a report published online March 14 in Annals of Internal Medicine.
All health care contacts, including hospitalizations, are considered excellent opportunities for influenza vaccination, and current recommendations advise that eligible inpatients receive the immunization before discharge. However, surgical patients don’t often get the flu vaccine before they leave the hospital, likely because of concerns that potential adverse effects like fever and myalgia could be falsely attributed to surgical complications. This would lead to unnecessary patient evaluations and could interfere with postsurgical care, said Sara Y. Tartof, Ph.D., and her associates in the department of research and evaluation, Kaiser Permanente Southern California, Pasadena.
“Although this concern is understandable, few clinical data support it,” they noted.
“To provide clinical evidence that would either substantiate or refute” these concerns about perioperative flu vaccination, the investigators analyzed data in the electronic health records for 81,647 surgeries. All the study participants were deemed eligible for flu vaccination. They were socioeconomically and ethnically diverse, ranged in age from 6 months to 106 years, and underwent surgery at 14 hospitals during three consecutive flu seasons. Operations included general, cardiac, eye, dermatologic, ENT, neurologic, ob.gyn., oral/maxillofacial, orthopedic, plastic, podiatric, urologic, and vascular procedures.
Patients received a flu vaccine in 6,420 hospital stays for surgery – only 15% of 42,777 eligible hospitalizations – usually on the day of discharge. (The remaining 38,870 patients either had been vaccinated before hospital admission or were vaccinated more than a week after discharge and were not included in further analyses.)
Compared with eligible patients who didn’t receive a flu vaccine during hospitalization for surgery, those who did showed no increased risk for subsequent inpatient visits, ED visits, or clinical work-ups for infection. Patients who received the flu vaccine before discharge showed a minimally increased risk for outpatient visits during the week following hospitalization, but this was considered unlikely “to translate into substantial clinical impact,” especially when balanced against the benefit of immunization, Dr. Tartof and her associates said (Ann Intern Med. 2016 Mar 14. doi: 10.7326/M15-1667).
Giving the flu vaccine during a surgical hospitalization “is an opportunity to protect a high-risk population,” because surgery patients tend to be of an age, and to have comorbid conditions, that raise their risk for flu complications. In addition, previous research has reported that 39%-46% of adults hospitalized for influenza-related disease in a given year had been hospitalized during the preceding autumn, indicating that recent hospitalization also raises the risk for flu complications, the investigators said.
“Our data support the rationale for increasing vaccination rates among surgical inpatients,” they said.
This study was funded by the U.S. Centers for Disease Control and Prevention through the Vaccine Safety Datalink program. Dr. Tartof reported receiving grants from Merck outside of this work; two of her associates reported receiving grants from Novartis and GlaxoSmithKline outside of this work.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point: Immunizing surgical patients against seasonal influenza before they leave the hospital appears safe.
Major finding: Patients received a flu vaccine in only 6,420 hospital stays for surgery, comprising only 15% of the patient hospitalizations that were eligible.
Data source: A retrospective cohort study involving 81,647 surgeries at 14 California hospitals during three consecutive flu seasons.
Disclosures: This study was funded by the U.S. Centers for Disease Control and Prevention through the Vaccine Safety Datalink program. Dr. Tartof reported receiving grants from Merck outside of this work; two of her associates reported receiving grants from Novartis and GlaxoSmithKline outside of this work.
Self-assessed mental health scores tied to radical cystectomy complications
Patients with bladder cancer and low scores on self-assessed mental health testing had more high-grade complications after radical cystectomy than their peers with better scores, even though their physical health was comparable, according to research published in the Journal of Urology.
The retrospective study mirrors past work linking preoperative mental disorders to adverse outcomes after major abdominal surgery, bariatric surgery, cardiac surgery, and kidney transplantation, said Dr. Pranav Sharma and his associates at Moffitt Cancer Center in Tampa. This study is the first to examine the association for bladder cancer patients who undergo radical cystectomy, according to the researchers.
They examined 30-day rates of Clavien grade IIIa or greater complications among 274 patients who filled out the Short Form 12 self-assessment of health status less than 6 months before surgery as part of a “new patient” questionnaire (J Urol. 2015. doi:10.1016/j.juro.2015.07.095). This included only 58% of radical cystectomy patients treated at Moffitt, and these patients had higher rates of positive soft-tissue margins and more aggressive pathology than did radical cystectomy patients who did not fill out the SF-12, the researchers said.
In all, 17% of patients experienced at least one high-grade complication within 30 days of their surgery. The median mental health composite score among patients with high-grade complications was 44.8 on a 100-point scale – significantly lower than the 49.8 score for patients who did not experience 30-day high-grade complications (P = .004). Physical composite scores did not significantly differ among patients who did and did not experience 30-day high-grade complications (median, 39.2 for patients with complications vs. 43.8 for those without; P = .06), the investigators said.
A model that incorporated known risk factors for postoperative complications – including age, body mass index, age-adjusted Charlson Comorbidity Index, American Society of Anesthesiologists score, preoperative albumin, and pathologic tumor stage – was not significantly linked with 30-day high-grade complications, even after including the SF-12 physical composite score (P = .14), Dr. Sharma and his associates reported. The association, however, became significant after they added the mental health composite score to the model (odds ratio, 0.96; 95% confidence interval, 0.93-0.99; P = .01).
“Although there is responder subjectivity associated with survey-based health-related [quality of life] measures, this finding suggests that measuring baseline mental health before surgery may provide additional information that can improve the risk stratification of patients undergoing radical cystectomy,” they wrote.
The study might have lacked statistical power to detect some associations, and the small sample size precluded the researchers from testing associations between self-reported health and specific types of complications, they noted. Also, “since we evaluated patients retrospectively, only a non-causal association between preoperative SF-12 mental composite score and high-grade 30-day complications after radical cystectomy can be suggested,” they cautioned.
The research was partly supported by the Collaborative Data Services Core at the H. Lee Moffitt Cancer Center & Research Institute. The investigators declared no conflicts of interest.
Patients with bladder cancer and low scores on self-assessed mental health testing had more high-grade complications after radical cystectomy than their peers with better scores, even though their physical health was comparable, according to research published in the Journal of Urology.
The retrospective study mirrors past work linking preoperative mental disorders to adverse outcomes after major abdominal surgery, bariatric surgery, cardiac surgery, and kidney transplantation, said Dr. Pranav Sharma and his associates at Moffitt Cancer Center in Tampa. This study is the first to examine the association for bladder cancer patients who undergo radical cystectomy, according to the researchers.
They examined 30-day rates of Clavien grade IIIa or greater complications among 274 patients who filled out the Short Form 12 self-assessment of health status less than 6 months before surgery as part of a “new patient” questionnaire (J Urol. 2015. doi:10.1016/j.juro.2015.07.095). This included only 58% of radical cystectomy patients treated at Moffitt, and these patients had higher rates of positive soft-tissue margins and more aggressive pathology than did radical cystectomy patients who did not fill out the SF-12, the researchers said.
In all, 17% of patients experienced at least one high-grade complication within 30 days of their surgery. The median mental health composite score among patients with high-grade complications was 44.8 on a 100-point scale – significantly lower than the 49.8 score for patients who did not experience 30-day high-grade complications (P = .004). Physical composite scores did not significantly differ among patients who did and did not experience 30-day high-grade complications (median, 39.2 for patients with complications vs. 43.8 for those without; P = .06), the investigators said.
A model that incorporated known risk factors for postoperative complications – including age, body mass index, age-adjusted Charlson Comorbidity Index, American Society of Anesthesiologists score, preoperative albumin, and pathologic tumor stage – was not significantly linked with 30-day high-grade complications, even after including the SF-12 physical composite score (P = .14), Dr. Sharma and his associates reported. The association, however, became significant after they added the mental health composite score to the model (odds ratio, 0.96; 95% confidence interval, 0.93-0.99; P = .01).
“Although there is responder subjectivity associated with survey-based health-related [quality of life] measures, this finding suggests that measuring baseline mental health before surgery may provide additional information that can improve the risk stratification of patients undergoing radical cystectomy,” they wrote.
The study might have lacked statistical power to detect some associations, and the small sample size precluded the researchers from testing associations between self-reported health and specific types of complications, they noted. Also, “since we evaluated patients retrospectively, only a non-causal association between preoperative SF-12 mental composite score and high-grade 30-day complications after radical cystectomy can be suggested,” they cautioned.
The research was partly supported by the Collaborative Data Services Core at the H. Lee Moffitt Cancer Center & Research Institute. The investigators declared no conflicts of interest.
Patients with bladder cancer and low scores on self-assessed mental health testing had more high-grade complications after radical cystectomy than their peers with better scores, even though their physical health was comparable, according to research published in the Journal of Urology.
The retrospective study mirrors past work linking preoperative mental disorders to adverse outcomes after major abdominal surgery, bariatric surgery, cardiac surgery, and kidney transplantation, said Dr. Pranav Sharma and his associates at Moffitt Cancer Center in Tampa. This study is the first to examine the association for bladder cancer patients who undergo radical cystectomy, according to the researchers.
They examined 30-day rates of Clavien grade IIIa or greater complications among 274 patients who filled out the Short Form 12 self-assessment of health status less than 6 months before surgery as part of a “new patient” questionnaire (J Urol. 2015. doi:10.1016/j.juro.2015.07.095). This included only 58% of radical cystectomy patients treated at Moffitt, and these patients had higher rates of positive soft-tissue margins and more aggressive pathology than did radical cystectomy patients who did not fill out the SF-12, the researchers said.
In all, 17% of patients experienced at least one high-grade complication within 30 days of their surgery. The median mental health composite score among patients with high-grade complications was 44.8 on a 100-point scale – significantly lower than the 49.8 score for patients who did not experience 30-day high-grade complications (P = .004). Physical composite scores did not significantly differ among patients who did and did not experience 30-day high-grade complications (median, 39.2 for patients with complications vs. 43.8 for those without; P = .06), the investigators said.
A model that incorporated known risk factors for postoperative complications – including age, body mass index, age-adjusted Charlson Comorbidity Index, American Society of Anesthesiologists score, preoperative albumin, and pathologic tumor stage – was not significantly linked with 30-day high-grade complications, even after including the SF-12 physical composite score (P = .14), Dr. Sharma and his associates reported. The association, however, became significant after they added the mental health composite score to the model (odds ratio, 0.96; 95% confidence interval, 0.93-0.99; P = .01).
“Although there is responder subjectivity associated with survey-based health-related [quality of life] measures, this finding suggests that measuring baseline mental health before surgery may provide additional information that can improve the risk stratification of patients undergoing radical cystectomy,” they wrote.
The study might have lacked statistical power to detect some associations, and the small sample size precluded the researchers from testing associations between self-reported health and specific types of complications, they noted. Also, “since we evaluated patients retrospectively, only a non-causal association between preoperative SF-12 mental composite score and high-grade 30-day complications after radical cystectomy can be suggested,” they cautioned.
The research was partly supported by the Collaborative Data Services Core at the H. Lee Moffitt Cancer Center & Research Institute. The investigators declared no conflicts of interest.
FROM THE JOURNAL OF UROLOGY
Key clinical point: Measuring baseline mental health before surgery may provide additional information that can improve the risk stratification of patients undergoing radical cystectomy.
Major finding: The median mental health composite score among patients with high-grade complications was 44.8 on a 100-point scale – significantly lower than the 49.8 median score for patients with no 30-day high-grade complications (P = .004).
Data source: Single-center retrospective study of patients who completed the Short Form 12 less than 6 months before undergoing surgery.
Disclosures: The research was partly supported by the Collaborative Data Services Core at the H. Lee Moffitt Cancer Center and Research Institute. The investigators declared no conflicts of interest.