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Robotic surgery boasts fewer postoperative complications in radical hysterectomy
BOSTON – Robot-assisted radical hysterectomy is just as safe, or perhaps safer, than open surgery, according to a new study that examined perioperative and postoperative outcomes with long-term follow-ups for both types of procedures.
“Robotic surgery has been expanding for the last 20 years, but still the recurrence rate with cancer patients is missing data because very few studies are published; they don’t have long-term oncologic outcomes, and if [the technology] works properly we have to put it into the literature,” M. Bilal Sert, MD, of Oslo University, said at the annual Minimally Invasive Surgery Week.
Dr. Sert and his coinvestigators identified 215 women who underwent either open or robot-assisted radical hysterectomy between November 2005 and December 2012. All of the procedures were elective and the robot-assisted operations were performed using the da Vinci robotic surgical platform. After excluding neoadjuvant cases, which totaled 19, the researchers looked at data on 196 patients (122 open radical hysterectomy cases and 74 robot-assisted radical hysterectomy cases).
On average, operating time for open radical hysterectomy was 171 minutes, versus 263 minutes for robot-assisted radical hysterectomy. However, the robotic surgery arm had lower mean estimated blood loss than the open surgery cohort: 80 milliliters versus 468 milliliters, respectively (P = .003). Follow-up time frames were shorter in the robotic surgery cohort by 6 months: 46 months reported for robotic surgery, compared with a 52-month average experienced by those in the open surgery cohort.
Both groups experienced recurrences, including 12 patients in the open surgery cohort (9.8%) and 9 patients in the robotic surgery cohort (12.1%) (P = .3), indicating a statistically insignificant difference. Similarly, rates of perioperative complications were 8% for open surgery and 11% for robotic surgery (P = .3), which was not significantly different.
However, rates of postoperative complications were 36% for open surgery and 12% for robotic surgery (P = .001), which was statistically significant.
“Based on our data, I can say that [robot-assisted radical hysterectomy] is safe, and in fact I prefer to use the robot,” Dr. Sert said at the meeting, which was held by the Society of Laparoendoscopic Surgeons. “Of course, robot-assisted surgery will not automatically make you a better surgeon, but on more complicated radical hysterectomy patients, it will help make the surgeon more precise.”
No funding source was disclosed for this study. Dr. Sert reported having no relevant financial disclosures.
BOSTON – Robot-assisted radical hysterectomy is just as safe, or perhaps safer, than open surgery, according to a new study that examined perioperative and postoperative outcomes with long-term follow-ups for both types of procedures.
“Robotic surgery has been expanding for the last 20 years, but still the recurrence rate with cancer patients is missing data because very few studies are published; they don’t have long-term oncologic outcomes, and if [the technology] works properly we have to put it into the literature,” M. Bilal Sert, MD, of Oslo University, said at the annual Minimally Invasive Surgery Week.
Dr. Sert and his coinvestigators identified 215 women who underwent either open or robot-assisted radical hysterectomy between November 2005 and December 2012. All of the procedures were elective and the robot-assisted operations were performed using the da Vinci robotic surgical platform. After excluding neoadjuvant cases, which totaled 19, the researchers looked at data on 196 patients (122 open radical hysterectomy cases and 74 robot-assisted radical hysterectomy cases).
On average, operating time for open radical hysterectomy was 171 minutes, versus 263 minutes for robot-assisted radical hysterectomy. However, the robotic surgery arm had lower mean estimated blood loss than the open surgery cohort: 80 milliliters versus 468 milliliters, respectively (P = .003). Follow-up time frames were shorter in the robotic surgery cohort by 6 months: 46 months reported for robotic surgery, compared with a 52-month average experienced by those in the open surgery cohort.
Both groups experienced recurrences, including 12 patients in the open surgery cohort (9.8%) and 9 patients in the robotic surgery cohort (12.1%) (P = .3), indicating a statistically insignificant difference. Similarly, rates of perioperative complications were 8% for open surgery and 11% for robotic surgery (P = .3), which was not significantly different.
However, rates of postoperative complications were 36% for open surgery and 12% for robotic surgery (P = .001), which was statistically significant.
“Based on our data, I can say that [robot-assisted radical hysterectomy] is safe, and in fact I prefer to use the robot,” Dr. Sert said at the meeting, which was held by the Society of Laparoendoscopic Surgeons. “Of course, robot-assisted surgery will not automatically make you a better surgeon, but on more complicated radical hysterectomy patients, it will help make the surgeon more precise.”
No funding source was disclosed for this study. Dr. Sert reported having no relevant financial disclosures.
BOSTON – Robot-assisted radical hysterectomy is just as safe, or perhaps safer, than open surgery, according to a new study that examined perioperative and postoperative outcomes with long-term follow-ups for both types of procedures.
“Robotic surgery has been expanding for the last 20 years, but still the recurrence rate with cancer patients is missing data because very few studies are published; they don’t have long-term oncologic outcomes, and if [the technology] works properly we have to put it into the literature,” M. Bilal Sert, MD, of Oslo University, said at the annual Minimally Invasive Surgery Week.
Dr. Sert and his coinvestigators identified 215 women who underwent either open or robot-assisted radical hysterectomy between November 2005 and December 2012. All of the procedures were elective and the robot-assisted operations were performed using the da Vinci robotic surgical platform. After excluding neoadjuvant cases, which totaled 19, the researchers looked at data on 196 patients (122 open radical hysterectomy cases and 74 robot-assisted radical hysterectomy cases).
On average, operating time for open radical hysterectomy was 171 minutes, versus 263 minutes for robot-assisted radical hysterectomy. However, the robotic surgery arm had lower mean estimated blood loss than the open surgery cohort: 80 milliliters versus 468 milliliters, respectively (P = .003). Follow-up time frames were shorter in the robotic surgery cohort by 6 months: 46 months reported for robotic surgery, compared with a 52-month average experienced by those in the open surgery cohort.
Both groups experienced recurrences, including 12 patients in the open surgery cohort (9.8%) and 9 patients in the robotic surgery cohort (12.1%) (P = .3), indicating a statistically insignificant difference. Similarly, rates of perioperative complications were 8% for open surgery and 11% for robotic surgery (P = .3), which was not significantly different.
However, rates of postoperative complications were 36% for open surgery and 12% for robotic surgery (P = .001), which was statistically significant.
“Based on our data, I can say that [robot-assisted radical hysterectomy] is safe, and in fact I prefer to use the robot,” Dr. Sert said at the meeting, which was held by the Society of Laparoendoscopic Surgeons. “Of course, robot-assisted surgery will not automatically make you a better surgeon, but on more complicated radical hysterectomy patients, it will help make the surgeon more precise.”
No funding source was disclosed for this study. Dr. Sert reported having no relevant financial disclosures.
Key clinical point:
Major finding: Postoperative complications were 36% for patients who underwent open radical hysterectomy, compared with 12% for those undergoing robot-assisted radical hysterectomy (P = .001).
Data source: Retrospective review of data on 215 patients who underwent open or robot-assisted radical hysterectomy between November 2005 and December 2012.
Disclosures: Dr. Sert reported having no relevant financial disclosures.
Better survival with primary surgery in stage IIIC ovarian ca
Although the use of neoadjuvant chemotherapy for treatment of women with advanced ovarian cancer has grown significantly in recent years, a new study shows that it is associated with worse overall survival for women with stage IIIC disease, compared with primary cytoreductive surgery.
Among 594 women with advanced ovarian cancer treated at one of six major comprehensive cancer centers, median overall survival (OS) for women with stage IIIC cancers treated with neoadjuvant chemotherapy (NACT) was 33 months, compared with 43 months for women treated with primary cytoreductive surgery (PCS), reported Larissa A. Meyer, MD, of the University of Texas M.D. Anderson Cancer Center in Houston, and her colleagues.
There were no significant survival differences between chemotherapy and surgery for women with stage IV disease, however, and for these patients neoadjuvant chemotherapy was associated with fewer morbidities, and may be a better therapeutic option, the investigators reported.
“Although additional biases may persist despite propensity-score matching, our results suggest that in carefully selected patients with stage IIIC disease, PCS is associated with a survival advantage, with overall low rates of surgical morbidity. In contrast, for patients with stage IV disease, our results confirm that NACT is noninferior to PCS for survival, with fewer ICU admissions and rehospitalizations, which suggests that NACT may be preferable for patients with stage IV ovarian cancer,” they wrote in the Journal of Clinical Oncology (2016. doi: 10.1200/JCO.2016.68.1239).
The increase in the use of NACT in women with advanced ovarian cancer in the United States was spurred by two randomized clinical trials, the investigators noted. The first, published in 2010 showed that survival was similar for women with stage IIIC or IV ovarian cancer treated with either neoadjuvant chemotherapy followed by interval debulking surgery or with primary surgery followed by chemotherapy. The second study, published in 2015, found that “in women with stage III or IV ovarian cancer, survival with primary chemotherapy is noninferior to primary surgery. In this study population, the researchers stated that “giving primary chemotherapy before surgery is an acceptable standard of care for women with advanced ovarian cancer.”
To see what effect these trials had on clinical practice and outcomes in the United States, the authors conducted an observational study of patients treated at six National Cancer Institute–designated cancer centers, looking at NACT use in 1,538 women diagnosed with ovarian cancer from 2003 through 2012, and at OS, morbidity, and postoperative residual disease in a propensity score–matched sample of 594 patients.
They found that for women with stage IIIC disease, NACT use increased from 16% during the period 2003-2010, to 34% during 2011-2012. For women with stage IV disease, NACT use grew from 41% to 62% during the respective time periods (P for trend for both comparisons = .001).
As noted before, median overall survival among women with stage IIIC disease in the propensity score–matched sample was significantly shorter for those treated with primary NACT vs. PCS.
For women with stage IV disease, however, there was no significant difference in OS between those treated with NACT (median 31 months) vs. those treated with PCS (median 36 months, hazard ratio 1.16, not significant).
Women with stages IIIC and IV disease who received NACT were less likely to have one or more centimeters of residual disease postoperatively and were less likely to have an ICU admission or rehospitalization (P for all comparisons = .04). However, overall survival was lower among women with stage IIIC disease who had only microscopic residual disease or residual disease measuring 1 cm or less (HR, 1.49; P = .04).
“Future studies should prospectively consider the efficacy of NACT by extent of residual disease in unselected patients,” the authors recommended.
The study was supported by grants from the National Cancer Institute and Cancer Prevention and Research Institute of Texas. Dr. Meyer and multiple coauthors disclosed honoraria, research funding, and/or advising/consulting with various pharmaceutical companies.
Although the use of neoadjuvant chemotherapy for treatment of women with advanced ovarian cancer has grown significantly in recent years, a new study shows that it is associated with worse overall survival for women with stage IIIC disease, compared with primary cytoreductive surgery.
Among 594 women with advanced ovarian cancer treated at one of six major comprehensive cancer centers, median overall survival (OS) for women with stage IIIC cancers treated with neoadjuvant chemotherapy (NACT) was 33 months, compared with 43 months for women treated with primary cytoreductive surgery (PCS), reported Larissa A. Meyer, MD, of the University of Texas M.D. Anderson Cancer Center in Houston, and her colleagues.
There were no significant survival differences between chemotherapy and surgery for women with stage IV disease, however, and for these patients neoadjuvant chemotherapy was associated with fewer morbidities, and may be a better therapeutic option, the investigators reported.
“Although additional biases may persist despite propensity-score matching, our results suggest that in carefully selected patients with stage IIIC disease, PCS is associated with a survival advantage, with overall low rates of surgical morbidity. In contrast, for patients with stage IV disease, our results confirm that NACT is noninferior to PCS for survival, with fewer ICU admissions and rehospitalizations, which suggests that NACT may be preferable for patients with stage IV ovarian cancer,” they wrote in the Journal of Clinical Oncology (2016. doi: 10.1200/JCO.2016.68.1239).
The increase in the use of NACT in women with advanced ovarian cancer in the United States was spurred by two randomized clinical trials, the investigators noted. The first, published in 2010 showed that survival was similar for women with stage IIIC or IV ovarian cancer treated with either neoadjuvant chemotherapy followed by interval debulking surgery or with primary surgery followed by chemotherapy. The second study, published in 2015, found that “in women with stage III or IV ovarian cancer, survival with primary chemotherapy is noninferior to primary surgery. In this study population, the researchers stated that “giving primary chemotherapy before surgery is an acceptable standard of care for women with advanced ovarian cancer.”
To see what effect these trials had on clinical practice and outcomes in the United States, the authors conducted an observational study of patients treated at six National Cancer Institute–designated cancer centers, looking at NACT use in 1,538 women diagnosed with ovarian cancer from 2003 through 2012, and at OS, morbidity, and postoperative residual disease in a propensity score–matched sample of 594 patients.
They found that for women with stage IIIC disease, NACT use increased from 16% during the period 2003-2010, to 34% during 2011-2012. For women with stage IV disease, NACT use grew from 41% to 62% during the respective time periods (P for trend for both comparisons = .001).
As noted before, median overall survival among women with stage IIIC disease in the propensity score–matched sample was significantly shorter for those treated with primary NACT vs. PCS.
For women with stage IV disease, however, there was no significant difference in OS between those treated with NACT (median 31 months) vs. those treated with PCS (median 36 months, hazard ratio 1.16, not significant).
Women with stages IIIC and IV disease who received NACT were less likely to have one or more centimeters of residual disease postoperatively and were less likely to have an ICU admission or rehospitalization (P for all comparisons = .04). However, overall survival was lower among women with stage IIIC disease who had only microscopic residual disease or residual disease measuring 1 cm or less (HR, 1.49; P = .04).
“Future studies should prospectively consider the efficacy of NACT by extent of residual disease in unselected patients,” the authors recommended.
The study was supported by grants from the National Cancer Institute and Cancer Prevention and Research Institute of Texas. Dr. Meyer and multiple coauthors disclosed honoraria, research funding, and/or advising/consulting with various pharmaceutical companies.
Although the use of neoadjuvant chemotherapy for treatment of women with advanced ovarian cancer has grown significantly in recent years, a new study shows that it is associated with worse overall survival for women with stage IIIC disease, compared with primary cytoreductive surgery.
Among 594 women with advanced ovarian cancer treated at one of six major comprehensive cancer centers, median overall survival (OS) for women with stage IIIC cancers treated with neoadjuvant chemotherapy (NACT) was 33 months, compared with 43 months for women treated with primary cytoreductive surgery (PCS), reported Larissa A. Meyer, MD, of the University of Texas M.D. Anderson Cancer Center in Houston, and her colleagues.
There were no significant survival differences between chemotherapy and surgery for women with stage IV disease, however, and for these patients neoadjuvant chemotherapy was associated with fewer morbidities, and may be a better therapeutic option, the investigators reported.
“Although additional biases may persist despite propensity-score matching, our results suggest that in carefully selected patients with stage IIIC disease, PCS is associated with a survival advantage, with overall low rates of surgical morbidity. In contrast, for patients with stage IV disease, our results confirm that NACT is noninferior to PCS for survival, with fewer ICU admissions and rehospitalizations, which suggests that NACT may be preferable for patients with stage IV ovarian cancer,” they wrote in the Journal of Clinical Oncology (2016. doi: 10.1200/JCO.2016.68.1239).
The increase in the use of NACT in women with advanced ovarian cancer in the United States was spurred by two randomized clinical trials, the investigators noted. The first, published in 2010 showed that survival was similar for women with stage IIIC or IV ovarian cancer treated with either neoadjuvant chemotherapy followed by interval debulking surgery or with primary surgery followed by chemotherapy. The second study, published in 2015, found that “in women with stage III or IV ovarian cancer, survival with primary chemotherapy is noninferior to primary surgery. In this study population, the researchers stated that “giving primary chemotherapy before surgery is an acceptable standard of care for women with advanced ovarian cancer.”
To see what effect these trials had on clinical practice and outcomes in the United States, the authors conducted an observational study of patients treated at six National Cancer Institute–designated cancer centers, looking at NACT use in 1,538 women diagnosed with ovarian cancer from 2003 through 2012, and at OS, morbidity, and postoperative residual disease in a propensity score–matched sample of 594 patients.
They found that for women with stage IIIC disease, NACT use increased from 16% during the period 2003-2010, to 34% during 2011-2012. For women with stage IV disease, NACT use grew from 41% to 62% during the respective time periods (P for trend for both comparisons = .001).
As noted before, median overall survival among women with stage IIIC disease in the propensity score–matched sample was significantly shorter for those treated with primary NACT vs. PCS.
For women with stage IV disease, however, there was no significant difference in OS between those treated with NACT (median 31 months) vs. those treated with PCS (median 36 months, hazard ratio 1.16, not significant).
Women with stages IIIC and IV disease who received NACT were less likely to have one or more centimeters of residual disease postoperatively and were less likely to have an ICU admission or rehospitalization (P for all comparisons = .04). However, overall survival was lower among women with stage IIIC disease who had only microscopic residual disease or residual disease measuring 1 cm or less (HR, 1.49; P = .04).
“Future studies should prospectively consider the efficacy of NACT by extent of residual disease in unselected patients,” the authors recommended.
The study was supported by grants from the National Cancer Institute and Cancer Prevention and Research Institute of Texas. Dr. Meyer and multiple coauthors disclosed honoraria, research funding, and/or advising/consulting with various pharmaceutical companies.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Neoadjuvant chemotherapy was associated with lower overall survival of stage IIIC but not stage IV ovarian cancer.
Major finding: Median OS was 33 months with neoadjuvant chemotherapy vs. 43 months with primary cytoreductive surgery.
Data source: Observational study of 1,538 patients with ovarian cancer, and propensity score–matched sample of 594 patients for clinical outcomes.
Disclosures: The study was supported by grants from the National Cancer Institute and Cancer Prevention and Research Institute of Texas. Larissa A. Meyer and multiple coauthors disclosed honoraria, research funding, and/or advising/consulting with various pharmaceutical companies.
Power morcellation dropped, abdominal hysterectomy increased after FDA warning
Electric power morcellation during hysterectomy declined sharply after the Food and Drug Administration discouraged use of the technique in April 2014 and then recommended against it for perimenopausal and postmenopausal women in November 2014. At the same time, use of abdominal hysterectomy increased, according to a new analysis.
The FDA took these actions because of concern that intraoperative morcellation could inadvertently expose healthy abdominal tissue to contamination from occult uterine malignancies. But some clinicians warned that avoiding morcellation would lead to a greater number of hysterectomies via laparotomy, with an attendant increase in surgical complications.
To assess the effect of the FDA recommendations, Jason D. Wright, MD, of the division of gynecologic oncology, Columbia University, New York, and his colleagues analyzed time trends in hysterectomy and morcellation during nine 3-month periods before and after the FDA announcements. They used information from a national database that covers more than 500 hospitals across the country, including in their analysis 203,520 women aged 18-95 years (mean age, 48 years) who underwent hysterectomy during the study period.
Among the 117,653 minimally invasive hysterectomies performed, the use of electric power morcellation rose slightly during 2013, peaking at 13.7% in the fourth quarter of that year. It then declined precipitously, to a low of 2.8% by the last 3-month period assessed, which was the first quarter of 2015. Simultaneously, the use of abdominal hysterectomy increased from 27.1% of procedures in early 2013 to 31.8% by the last 3-month period assessed, the researchers reported (JAMA 2016;316:877-8).
However, despite the increase in abdominal procedures, the complication rate did not change over time. It was 8.3% during the first quarter studied and 8.4% during the last. In fact, the rate of complications during abdominal hysterectomy also declined, from 18.4% to 17.6%. Similarly, the rate of complications during minimally invasive hysterectomy dropped from 4.4% to 4.1%, and the complication rate decreased from 4.7% to 4.2% during vaginal hysterectomy.
The researchers noted that the prevalence of uterine cancer, endometrial hyperplasia, other gynecologic cancers, and uterine tumors of indeterminate behavior were unchanged during the study period among women who underwent minimally invasive hysterectomy with power morcellation.
“The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection. However, the high rate of abnormal pathology after the warnings highlights the difficulty in the preoperative detection of uterine pathology,” the researchers wrote. “Continued caution is needed to limit the inadvertent morcellation of uterine pathology.”
The National Cancer Institute funded the study. The researchers reported having no relevant financial disclosures.
I read with interest “Trends in Use and Outcomes of Women Undergoing Hysterectomy With Electric Power Morcellation,” by Jason D. Wright and colleagues, published in JAMA. As expected, with the concerns raised by the FDA regarding electric power morcellation, there has been a statistically significant reduction in a laparoscopic approach to hysterectomy (59.2% to 56.2%) and an even more marked decrease in use of electric power morcellation (13.7% to 2.8%).
Dr. Charles E. Miller |
Interestingly, the increase in abdominal hysterectomy (27.1% to 31.8%) appears to be secondary not only to the reduction in minimally invasive gynecologic surgery, but vaginal hysterectomy as well. While the decrease in vaginal hysterectomy, is, in part, likely due to the trend away from this technique, it is probably also due to the concern of cutting up a potential sarcoma during the procedure to deliver the large fibroid uterus. This would be supported by the fact that the greatest percentage drop in vaginal hysterectomy occurred in Q1-Q2 2014 at the time the FDA issued its safety concern.
In a study by Matthew Siedhoff, MD, et al. (Am J Obstet Gynecol. 2015 May;212[5]:591.e1-8), utilizing a decision tree model, Dr. Siedhoff anticipated that severe complications would increase with conversion of a minimally invasive approach to laparotomy. While according to Wright et al., there is no increase noted in complications per se, there is no indication as to severity of complications. Thus, while overall complications have not increased, perhaps severe complications have, in fact, increased as anticipated by Siedhoff et al. Furthermore, impact on quality of life is not considered (i.e. hospitalization, convalescence at home, etc.) in this study, but is a well known difference between minimally invasive surgery and open surgery.
Charles E. Miller, MD, is a clinical associate professor at the University of Illinois, and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville and Schaumburg, Ill. Dr. Miller reported that he is working on a study with Espiner Medical Ltd. to evaluate the safety and efficacy of a bag that is utilized for contained electric power morcellation. Karl Storz is sponsoring the study.
I read with interest “Trends in Use and Outcomes of Women Undergoing Hysterectomy With Electric Power Morcellation,” by Jason D. Wright and colleagues, published in JAMA. As expected, with the concerns raised by the FDA regarding electric power morcellation, there has been a statistically significant reduction in a laparoscopic approach to hysterectomy (59.2% to 56.2%) and an even more marked decrease in use of electric power morcellation (13.7% to 2.8%).
Dr. Charles E. Miller |
Interestingly, the increase in abdominal hysterectomy (27.1% to 31.8%) appears to be secondary not only to the reduction in minimally invasive gynecologic surgery, but vaginal hysterectomy as well. While the decrease in vaginal hysterectomy, is, in part, likely due to the trend away from this technique, it is probably also due to the concern of cutting up a potential sarcoma during the procedure to deliver the large fibroid uterus. This would be supported by the fact that the greatest percentage drop in vaginal hysterectomy occurred in Q1-Q2 2014 at the time the FDA issued its safety concern.
In a study by Matthew Siedhoff, MD, et al. (Am J Obstet Gynecol. 2015 May;212[5]:591.e1-8), utilizing a decision tree model, Dr. Siedhoff anticipated that severe complications would increase with conversion of a minimally invasive approach to laparotomy. While according to Wright et al., there is no increase noted in complications per se, there is no indication as to severity of complications. Thus, while overall complications have not increased, perhaps severe complications have, in fact, increased as anticipated by Siedhoff et al. Furthermore, impact on quality of life is not considered (i.e. hospitalization, convalescence at home, etc.) in this study, but is a well known difference between minimally invasive surgery and open surgery.
Charles E. Miller, MD, is a clinical associate professor at the University of Illinois, and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville and Schaumburg, Ill. Dr. Miller reported that he is working on a study with Espiner Medical Ltd. to evaluate the safety and efficacy of a bag that is utilized for contained electric power morcellation. Karl Storz is sponsoring the study.
I read with interest “Trends in Use and Outcomes of Women Undergoing Hysterectomy With Electric Power Morcellation,” by Jason D. Wright and colleagues, published in JAMA. As expected, with the concerns raised by the FDA regarding electric power morcellation, there has been a statistically significant reduction in a laparoscopic approach to hysterectomy (59.2% to 56.2%) and an even more marked decrease in use of electric power morcellation (13.7% to 2.8%).
Dr. Charles E. Miller |
Interestingly, the increase in abdominal hysterectomy (27.1% to 31.8%) appears to be secondary not only to the reduction in minimally invasive gynecologic surgery, but vaginal hysterectomy as well. While the decrease in vaginal hysterectomy, is, in part, likely due to the trend away from this technique, it is probably also due to the concern of cutting up a potential sarcoma during the procedure to deliver the large fibroid uterus. This would be supported by the fact that the greatest percentage drop in vaginal hysterectomy occurred in Q1-Q2 2014 at the time the FDA issued its safety concern.
In a study by Matthew Siedhoff, MD, et al. (Am J Obstet Gynecol. 2015 May;212[5]:591.e1-8), utilizing a decision tree model, Dr. Siedhoff anticipated that severe complications would increase with conversion of a minimally invasive approach to laparotomy. While according to Wright et al., there is no increase noted in complications per se, there is no indication as to severity of complications. Thus, while overall complications have not increased, perhaps severe complications have, in fact, increased as anticipated by Siedhoff et al. Furthermore, impact on quality of life is not considered (i.e. hospitalization, convalescence at home, etc.) in this study, but is a well known difference between minimally invasive surgery and open surgery.
Charles E. Miller, MD, is a clinical associate professor at the University of Illinois, and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in private practice in Naperville and Schaumburg, Ill. Dr. Miller reported that he is working on a study with Espiner Medical Ltd. to evaluate the safety and efficacy of a bag that is utilized for contained electric power morcellation. Karl Storz is sponsoring the study.
Electric power morcellation during hysterectomy declined sharply after the Food and Drug Administration discouraged use of the technique in April 2014 and then recommended against it for perimenopausal and postmenopausal women in November 2014. At the same time, use of abdominal hysterectomy increased, according to a new analysis.
The FDA took these actions because of concern that intraoperative morcellation could inadvertently expose healthy abdominal tissue to contamination from occult uterine malignancies. But some clinicians warned that avoiding morcellation would lead to a greater number of hysterectomies via laparotomy, with an attendant increase in surgical complications.
To assess the effect of the FDA recommendations, Jason D. Wright, MD, of the division of gynecologic oncology, Columbia University, New York, and his colleagues analyzed time trends in hysterectomy and morcellation during nine 3-month periods before and after the FDA announcements. They used information from a national database that covers more than 500 hospitals across the country, including in their analysis 203,520 women aged 18-95 years (mean age, 48 years) who underwent hysterectomy during the study period.
Among the 117,653 minimally invasive hysterectomies performed, the use of electric power morcellation rose slightly during 2013, peaking at 13.7% in the fourth quarter of that year. It then declined precipitously, to a low of 2.8% by the last 3-month period assessed, which was the first quarter of 2015. Simultaneously, the use of abdominal hysterectomy increased from 27.1% of procedures in early 2013 to 31.8% by the last 3-month period assessed, the researchers reported (JAMA 2016;316:877-8).
However, despite the increase in abdominal procedures, the complication rate did not change over time. It was 8.3% during the first quarter studied and 8.4% during the last. In fact, the rate of complications during abdominal hysterectomy also declined, from 18.4% to 17.6%. Similarly, the rate of complications during minimally invasive hysterectomy dropped from 4.4% to 4.1%, and the complication rate decreased from 4.7% to 4.2% during vaginal hysterectomy.
The researchers noted that the prevalence of uterine cancer, endometrial hyperplasia, other gynecologic cancers, and uterine tumors of indeterminate behavior were unchanged during the study period among women who underwent minimally invasive hysterectomy with power morcellation.
“The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection. However, the high rate of abnormal pathology after the warnings highlights the difficulty in the preoperative detection of uterine pathology,” the researchers wrote. “Continued caution is needed to limit the inadvertent morcellation of uterine pathology.”
The National Cancer Institute funded the study. The researchers reported having no relevant financial disclosures.
Electric power morcellation during hysterectomy declined sharply after the Food and Drug Administration discouraged use of the technique in April 2014 and then recommended against it for perimenopausal and postmenopausal women in November 2014. At the same time, use of abdominal hysterectomy increased, according to a new analysis.
The FDA took these actions because of concern that intraoperative morcellation could inadvertently expose healthy abdominal tissue to contamination from occult uterine malignancies. But some clinicians warned that avoiding morcellation would lead to a greater number of hysterectomies via laparotomy, with an attendant increase in surgical complications.
To assess the effect of the FDA recommendations, Jason D. Wright, MD, of the division of gynecologic oncology, Columbia University, New York, and his colleagues analyzed time trends in hysterectomy and morcellation during nine 3-month periods before and after the FDA announcements. They used information from a national database that covers more than 500 hospitals across the country, including in their analysis 203,520 women aged 18-95 years (mean age, 48 years) who underwent hysterectomy during the study period.
Among the 117,653 minimally invasive hysterectomies performed, the use of electric power morcellation rose slightly during 2013, peaking at 13.7% in the fourth quarter of that year. It then declined precipitously, to a low of 2.8% by the last 3-month period assessed, which was the first quarter of 2015. Simultaneously, the use of abdominal hysterectomy increased from 27.1% of procedures in early 2013 to 31.8% by the last 3-month period assessed, the researchers reported (JAMA 2016;316:877-8).
However, despite the increase in abdominal procedures, the complication rate did not change over time. It was 8.3% during the first quarter studied and 8.4% during the last. In fact, the rate of complications during abdominal hysterectomy also declined, from 18.4% to 17.6%. Similarly, the rate of complications during minimally invasive hysterectomy dropped from 4.4% to 4.1%, and the complication rate decreased from 4.7% to 4.2% during vaginal hysterectomy.
The researchers noted that the prevalence of uterine cancer, endometrial hyperplasia, other gynecologic cancers, and uterine tumors of indeterminate behavior were unchanged during the study period among women who underwent minimally invasive hysterectomy with power morcellation.
“The FDA warnings might result in a lower prevalence of cancer among women who underwent morcellation due to greater scrutiny on patient selection. However, the high rate of abnormal pathology after the warnings highlights the difficulty in the preoperative detection of uterine pathology,” the researchers wrote. “Continued caution is needed to limit the inadvertent morcellation of uterine pathology.”
The National Cancer Institute funded the study. The researchers reported having no relevant financial disclosures.
FROM JAMA
Key clinical point: Electric power morcellation declined after the FDA recommended against using the technique during hysterectomy.
Major finding: Use of electric power morcellation peaked at 13.7% before the FDA recommendations, then declined to a low of 2.8%.
Data source: A retrospective database analysis involving 203,520 hysterectomies performed at more than 500 U.S. hospitals during 2013-2015.
Disclosures: The National Cancer Institute funded the study. The researchers reported having no relevant financial disclosures.
Women with ovarian cancer wait over a month to start treatment
SAN DIEGO – Women diagnosed with ovarian cancer waited about 38 days, on average, from the initial concerning imaging test to initiation of treatment, according to a study analyzing health care transit times at a single community hospital.
“Ovarian cancer is such a hard disease to diagnose early,” Christopher J. LaFargue, MD, lead study author, said in an interview at the annual meeting of the Society of Gynecologic Oncology. “Once it’s diagnosed, it’s imperative that women get in to see the gynecologic oncologist [and] make sure their treatment care isn’t lagged for any reason.”
In an effort to characterize the length of time between critical points in the care of women with ovarian cancer and determine the impact of patient demographics, Dr. LaFargue and his associates retrospectively evaluated the medical records of 45 women who were diagnosed with ovarian cancer at Long Beach (Calif.) Memorial Medical Center between January 2012 and May 2015.
They examined patient demographics, including preoperative CA-125. Time points of interest were first concerning imaging test, first gynecologic oncology appointment, initiation of treatment, and adjuvant therapy. They used univariate analyses to determine associations between specific patient demographics and the time intervals of interest.
Dr. LaFargue, a resident in the department of obstetrics and gynecology at the University of California, Irvine, reported that the mean age of patients was 61 years, and the mean driving distance to the hospital from the patients’ home was 11 miles. More than half of the patients were white (58%) and 62% of patients were diagnosed with stage III or IV disease. Preoperative CA-125 exceeded 200 U/mL in 62% of patients. Medicare enrollees with supplemental insurance made up less than half of the group (44%).
The researchers found that the average time from initial concerning imaging to start of treatment was about 38 days. The average time from initial imaging to the first office visit with a gynecologic oncologist was about 18 days. The time from that appointment to initial treatment was 19 days, on average. The time from the start of neoadjuvant chemotherapy to interval cytoreductive surgery was 103 days, on average.
The only factor that significantly impacted transit time was a patient’s CA-125 level. Those who had a level of 200 U/mL or greater were more likely to receive surgery or treatment quicker, compared with those who had a CA-125 level less than 200 U/mL. No other statistically significant associations between patient demographics and length of time intervals were observed.
“It would have been nice to have seen a correlation with insurance status,” Dr. LaFargue said. “That’s kind of what we were hoping for, because then you can make an argument with insurance payers that patients who have Medicare aren’t getting treated as quickly as those who have a PPO, for example.”
He acknowledged certain limitations of the study, including its small sample size, lack of outcomes data, and the fact that it was conducted in a community hospital setting.
Dr. LaFargue reported having no financial disclosures.
SAN DIEGO – Women diagnosed with ovarian cancer waited about 38 days, on average, from the initial concerning imaging test to initiation of treatment, according to a study analyzing health care transit times at a single community hospital.
“Ovarian cancer is such a hard disease to diagnose early,” Christopher J. LaFargue, MD, lead study author, said in an interview at the annual meeting of the Society of Gynecologic Oncology. “Once it’s diagnosed, it’s imperative that women get in to see the gynecologic oncologist [and] make sure their treatment care isn’t lagged for any reason.”
In an effort to characterize the length of time between critical points in the care of women with ovarian cancer and determine the impact of patient demographics, Dr. LaFargue and his associates retrospectively evaluated the medical records of 45 women who were diagnosed with ovarian cancer at Long Beach (Calif.) Memorial Medical Center between January 2012 and May 2015.
They examined patient demographics, including preoperative CA-125. Time points of interest were first concerning imaging test, first gynecologic oncology appointment, initiation of treatment, and adjuvant therapy. They used univariate analyses to determine associations between specific patient demographics and the time intervals of interest.
Dr. LaFargue, a resident in the department of obstetrics and gynecology at the University of California, Irvine, reported that the mean age of patients was 61 years, and the mean driving distance to the hospital from the patients’ home was 11 miles. More than half of the patients were white (58%) and 62% of patients were diagnosed with stage III or IV disease. Preoperative CA-125 exceeded 200 U/mL in 62% of patients. Medicare enrollees with supplemental insurance made up less than half of the group (44%).
The researchers found that the average time from initial concerning imaging to start of treatment was about 38 days. The average time from initial imaging to the first office visit with a gynecologic oncologist was about 18 days. The time from that appointment to initial treatment was 19 days, on average. The time from the start of neoadjuvant chemotherapy to interval cytoreductive surgery was 103 days, on average.
The only factor that significantly impacted transit time was a patient’s CA-125 level. Those who had a level of 200 U/mL or greater were more likely to receive surgery or treatment quicker, compared with those who had a CA-125 level less than 200 U/mL. No other statistically significant associations between patient demographics and length of time intervals were observed.
“It would have been nice to have seen a correlation with insurance status,” Dr. LaFargue said. “That’s kind of what we were hoping for, because then you can make an argument with insurance payers that patients who have Medicare aren’t getting treated as quickly as those who have a PPO, for example.”
He acknowledged certain limitations of the study, including its small sample size, lack of outcomes data, and the fact that it was conducted in a community hospital setting.
Dr. LaFargue reported having no financial disclosures.
SAN DIEGO – Women diagnosed with ovarian cancer waited about 38 days, on average, from the initial concerning imaging test to initiation of treatment, according to a study analyzing health care transit times at a single community hospital.
“Ovarian cancer is such a hard disease to diagnose early,” Christopher J. LaFargue, MD, lead study author, said in an interview at the annual meeting of the Society of Gynecologic Oncology. “Once it’s diagnosed, it’s imperative that women get in to see the gynecologic oncologist [and] make sure their treatment care isn’t lagged for any reason.”
In an effort to characterize the length of time between critical points in the care of women with ovarian cancer and determine the impact of patient demographics, Dr. LaFargue and his associates retrospectively evaluated the medical records of 45 women who were diagnosed with ovarian cancer at Long Beach (Calif.) Memorial Medical Center between January 2012 and May 2015.
They examined patient demographics, including preoperative CA-125. Time points of interest were first concerning imaging test, first gynecologic oncology appointment, initiation of treatment, and adjuvant therapy. They used univariate analyses to determine associations between specific patient demographics and the time intervals of interest.
Dr. LaFargue, a resident in the department of obstetrics and gynecology at the University of California, Irvine, reported that the mean age of patients was 61 years, and the mean driving distance to the hospital from the patients’ home was 11 miles. More than half of the patients were white (58%) and 62% of patients were diagnosed with stage III or IV disease. Preoperative CA-125 exceeded 200 U/mL in 62% of patients. Medicare enrollees with supplemental insurance made up less than half of the group (44%).
The researchers found that the average time from initial concerning imaging to start of treatment was about 38 days. The average time from initial imaging to the first office visit with a gynecologic oncologist was about 18 days. The time from that appointment to initial treatment was 19 days, on average. The time from the start of neoadjuvant chemotherapy to interval cytoreductive surgery was 103 days, on average.
The only factor that significantly impacted transit time was a patient’s CA-125 level. Those who had a level of 200 U/mL or greater were more likely to receive surgery or treatment quicker, compared with those who had a CA-125 level less than 200 U/mL. No other statistically significant associations between patient demographics and length of time intervals were observed.
“It would have been nice to have seen a correlation with insurance status,” Dr. LaFargue said. “That’s kind of what we were hoping for, because then you can make an argument with insurance payers that patients who have Medicare aren’t getting treated as quickly as those who have a PPO, for example.”
He acknowledged certain limitations of the study, including its small sample size, lack of outcomes data, and the fact that it was conducted in a community hospital setting.
Dr. LaFargue reported having no financial disclosures.
AT THE ANNUAL MEETING ON WOMEN’S CANCER
Key clinical point: Initiation of treatment for ovarian cancer following the first concerning imaging test took an average of about 38 days.
Major finding: The average time from the initial imaging test to the first visit with a gynecologic oncologist was about 18 days.
Data source: A retrospective evaluation of 45 women who were diagnosed with ovarian cancer between January 2012 and May 2015 at a community hospital.
Disclosures: Dr. LaFargue reported having no financial disclosures.
Oophorectomy cost-effective at 4% lifetime ovarian cancer risk
Premenopausal risk-reducing salpingo-oophorectomy becomes cost-effective in women who have a 4% or greater lifetime risk of ovarian cancer, according to a modeling study published online in the Journal of Medical Genetics.
The procedure, which is usually undertaken in women aged over 35 years who have completed their families, is available in the United Kingdom to women with a greater than 10% lifetime risk of ovarian cancer. However, the researchers, led by Dr. Ranjit Manchanda of Barts Cancer Institute at Queen Mary University of London, suggested that this threshold has not been tested for cost-effectiveness.
The decision analysis model evaluated lifetime costs as well as the effects of risk-reducing salpingo-oophorectomy in 40-year-old premenopausal women by comparing it with no procedure in women whose lifetime ovarian cancer risk ranged from 2%-10%. The final outcomes were development of breast cancer, ovarian cancer, and excess deaths from coronary heart disease, while cost-effectiveness was judged against the National Institute for Health and Care Excellence threshold of £20,000-£30,000 per quality-adjusted life-years (QALY).
Researchers found that premenopausal risk-reducing salpingo-oophorectomy was cost-effective in women with a 4% or greater lifetime risk of ovarian cancer, largely because of the reduction in their risk of breast cancer. At this level of risk, surgery gained 42.7 days of life-expectancy, with an incremental cost-effectiveness ratio of £19,536($26,186)/QALY.
Premenopausal risk-reducing salpingo-oophorectomy was not cost-effective at the baseline risk rate of 2%, with an incremental cost-effectiveness ratio of £46,480($62,267)/QALY and 19.9 days gain in life expectancy (J Med Genetics 2016 June 27. doi: 10.1136/jmedgenet-2016-103800).
The cost-effectiveness was predicated on the assumption of at least an 80% compliance rate with hormone therapy (HT) in women who underwent the procedure; without HT, the cost-effectiveness threshold increased to a lifetime risk of over 8.2%.
“Our results are of major significance for clinical practice and risk management in view of declining genetic testing costs and the improvements in estimating an individual’s OC risk,” the authors wrote.
“With routine clinical testing for certain moderate penetrance genes around the corner and lack of an effective OC screening programme, these findings are timely as it provides evidence supporting a surgical prevention strategy for ‘lower-risk’ (lifetime risk less than 10%) individuals,” noted Dr. Manchanda and colleagues.
They stressed that symptom levels after salpingo-oophorectomy, particularly for sexual function, were still higher even in women taking HT compared to those who hadn’t undergone salpingo-oophorectomy.
“This limitation needs to be discussed as part of informed consent for the surgical procedure and incorporated into [the risk-reducing salpingo-oophorectomy] decision-making process,” they wrote.
One author declared a financial interest in Abcodia, which has an interest in ovarian cancer screening and biomarkers for screening and risk prediction. No other conflicts of interest were declared.
Premenopausal risk-reducing salpingo-oophorectomy becomes cost-effective in women who have a 4% or greater lifetime risk of ovarian cancer, according to a modeling study published online in the Journal of Medical Genetics.
The procedure, which is usually undertaken in women aged over 35 years who have completed their families, is available in the United Kingdom to women with a greater than 10% lifetime risk of ovarian cancer. However, the researchers, led by Dr. Ranjit Manchanda of Barts Cancer Institute at Queen Mary University of London, suggested that this threshold has not been tested for cost-effectiveness.
The decision analysis model evaluated lifetime costs as well as the effects of risk-reducing salpingo-oophorectomy in 40-year-old premenopausal women by comparing it with no procedure in women whose lifetime ovarian cancer risk ranged from 2%-10%. The final outcomes were development of breast cancer, ovarian cancer, and excess deaths from coronary heart disease, while cost-effectiveness was judged against the National Institute for Health and Care Excellence threshold of £20,000-£30,000 per quality-adjusted life-years (QALY).
Researchers found that premenopausal risk-reducing salpingo-oophorectomy was cost-effective in women with a 4% or greater lifetime risk of ovarian cancer, largely because of the reduction in their risk of breast cancer. At this level of risk, surgery gained 42.7 days of life-expectancy, with an incremental cost-effectiveness ratio of £19,536($26,186)/QALY.
Premenopausal risk-reducing salpingo-oophorectomy was not cost-effective at the baseline risk rate of 2%, with an incremental cost-effectiveness ratio of £46,480($62,267)/QALY and 19.9 days gain in life expectancy (J Med Genetics 2016 June 27. doi: 10.1136/jmedgenet-2016-103800).
The cost-effectiveness was predicated on the assumption of at least an 80% compliance rate with hormone therapy (HT) in women who underwent the procedure; without HT, the cost-effectiveness threshold increased to a lifetime risk of over 8.2%.
“Our results are of major significance for clinical practice and risk management in view of declining genetic testing costs and the improvements in estimating an individual’s OC risk,” the authors wrote.
“With routine clinical testing for certain moderate penetrance genes around the corner and lack of an effective OC screening programme, these findings are timely as it provides evidence supporting a surgical prevention strategy for ‘lower-risk’ (lifetime risk less than 10%) individuals,” noted Dr. Manchanda and colleagues.
They stressed that symptom levels after salpingo-oophorectomy, particularly for sexual function, were still higher even in women taking HT compared to those who hadn’t undergone salpingo-oophorectomy.
“This limitation needs to be discussed as part of informed consent for the surgical procedure and incorporated into [the risk-reducing salpingo-oophorectomy] decision-making process,” they wrote.
One author declared a financial interest in Abcodia, which has an interest in ovarian cancer screening and biomarkers for screening and risk prediction. No other conflicts of interest were declared.
Premenopausal risk-reducing salpingo-oophorectomy becomes cost-effective in women who have a 4% or greater lifetime risk of ovarian cancer, according to a modeling study published online in the Journal of Medical Genetics.
The procedure, which is usually undertaken in women aged over 35 years who have completed their families, is available in the United Kingdom to women with a greater than 10% lifetime risk of ovarian cancer. However, the researchers, led by Dr. Ranjit Manchanda of Barts Cancer Institute at Queen Mary University of London, suggested that this threshold has not been tested for cost-effectiveness.
The decision analysis model evaluated lifetime costs as well as the effects of risk-reducing salpingo-oophorectomy in 40-year-old premenopausal women by comparing it with no procedure in women whose lifetime ovarian cancer risk ranged from 2%-10%. The final outcomes were development of breast cancer, ovarian cancer, and excess deaths from coronary heart disease, while cost-effectiveness was judged against the National Institute for Health and Care Excellence threshold of £20,000-£30,000 per quality-adjusted life-years (QALY).
Researchers found that premenopausal risk-reducing salpingo-oophorectomy was cost-effective in women with a 4% or greater lifetime risk of ovarian cancer, largely because of the reduction in their risk of breast cancer. At this level of risk, surgery gained 42.7 days of life-expectancy, with an incremental cost-effectiveness ratio of £19,536($26,186)/QALY.
Premenopausal risk-reducing salpingo-oophorectomy was not cost-effective at the baseline risk rate of 2%, with an incremental cost-effectiveness ratio of £46,480($62,267)/QALY and 19.9 days gain in life expectancy (J Med Genetics 2016 June 27. doi: 10.1136/jmedgenet-2016-103800).
The cost-effectiveness was predicated on the assumption of at least an 80% compliance rate with hormone therapy (HT) in women who underwent the procedure; without HT, the cost-effectiveness threshold increased to a lifetime risk of over 8.2%.
“Our results are of major significance for clinical practice and risk management in view of declining genetic testing costs and the improvements in estimating an individual’s OC risk,” the authors wrote.
“With routine clinical testing for certain moderate penetrance genes around the corner and lack of an effective OC screening programme, these findings are timely as it provides evidence supporting a surgical prevention strategy for ‘lower-risk’ (lifetime risk less than 10%) individuals,” noted Dr. Manchanda and colleagues.
They stressed that symptom levels after salpingo-oophorectomy, particularly for sexual function, were still higher even in women taking HT compared to those who hadn’t undergone salpingo-oophorectomy.
“This limitation needs to be discussed as part of informed consent for the surgical procedure and incorporated into [the risk-reducing salpingo-oophorectomy] decision-making process,” they wrote.
One author declared a financial interest in Abcodia, which has an interest in ovarian cancer screening and biomarkers for screening and risk prediction. No other conflicts of interest were declared.
FROM THE JOURNAL OF MEDICAL GENETICS
Key clinical point: Premenopausal risk-reducing salpingo-oophorectomy becomes cost-effective in women who have a 4% or greater lifetime risk of ovarian cancer.
Major finding: Premenopausal risk-reducing salpingo-oophorectomy in women with a 4% or greater lifetime risk of ovarian cancer gained 42.7 days of life expectancy, with an incremental cost-effectiveness ratio of £19,536($26,186)/QALY.
Data source: Decision analysis model.
Disclosures: One author declared a financial interest in Abcodia, which has an interest in ovarian cancer screening and biomarkers for screening and risk prediction. No other conflicts of interest were declared.
VIDEO: Is hysterectomy still best for complex atypical hyperplasia?
WASHINGTON – Hysterectomy has long been the first-line therapy for complex atypical endometrial hyperplasia in patients who don’t desire to preserve their fertility. Is it time to consider hormone treatment in a larger population of patients?
That’s the question that experts debated at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Amanda Nickles Fader, associate professor and director of the Kelly Gynecologic Oncology Service* at the Johns Hopkins Hospital, Baltimore, said in an interview that changing patient demographics – particularly the growing number of overweight and obese women – are driving the need to consider the use of progestin in more cases. The obesity epidemic translates into younger women developing the condition, and it creates the potential for more complications in surgery, she said. Endometrial hyperplasia is very sensitive to hormone therapy, specifically progestin agents, with 75%-90% response rates with up-front treatment, Dr. Fader added.
But Dr. David Cohn, director of the division of gynecologic oncology at the Ohio State University, Columbus, said in an interview that surgery remains the standard of care because it is curative. Hormone treatment is appropriate in selected patients, but it is currently understudied and questions remain about the duration of treatment and about the type of hormones to use, he said.
Dr. Cohn and Dr. Fader both reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @maryellenny
*Correction, 5/17/2016: An earlier version of this story misstated Dr. Fader's title.
WASHINGTON – Hysterectomy has long been the first-line therapy for complex atypical endometrial hyperplasia in patients who don’t desire to preserve their fertility. Is it time to consider hormone treatment in a larger population of patients?
That’s the question that experts debated at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Amanda Nickles Fader, associate professor and director of the Kelly Gynecologic Oncology Service* at the Johns Hopkins Hospital, Baltimore, said in an interview that changing patient demographics – particularly the growing number of overweight and obese women – are driving the need to consider the use of progestin in more cases. The obesity epidemic translates into younger women developing the condition, and it creates the potential for more complications in surgery, she said. Endometrial hyperplasia is very sensitive to hormone therapy, specifically progestin agents, with 75%-90% response rates with up-front treatment, Dr. Fader added.
But Dr. David Cohn, director of the division of gynecologic oncology at the Ohio State University, Columbus, said in an interview that surgery remains the standard of care because it is curative. Hormone treatment is appropriate in selected patients, but it is currently understudied and questions remain about the duration of treatment and about the type of hormones to use, he said.
Dr. Cohn and Dr. Fader both reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @maryellenny
*Correction, 5/17/2016: An earlier version of this story misstated Dr. Fader's title.
WASHINGTON – Hysterectomy has long been the first-line therapy for complex atypical endometrial hyperplasia in patients who don’t desire to preserve their fertility. Is it time to consider hormone treatment in a larger population of patients?
That’s the question that experts debated at the annual meeting of the American College of Obstetricians and Gynecologists.
Dr. Amanda Nickles Fader, associate professor and director of the Kelly Gynecologic Oncology Service* at the Johns Hopkins Hospital, Baltimore, said in an interview that changing patient demographics – particularly the growing number of overweight and obese women – are driving the need to consider the use of progestin in more cases. The obesity epidemic translates into younger women developing the condition, and it creates the potential for more complications in surgery, she said. Endometrial hyperplasia is very sensitive to hormone therapy, specifically progestin agents, with 75%-90% response rates with up-front treatment, Dr. Fader added.
But Dr. David Cohn, director of the division of gynecologic oncology at the Ohio State University, Columbus, said in an interview that surgery remains the standard of care because it is curative. Hormone treatment is appropriate in selected patients, but it is currently understudied and questions remain about the duration of treatment and about the type of hormones to use, he said.
Dr. Cohn and Dr. Fader both reported having no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @maryellenny
*Correction, 5/17/2016: An earlier version of this story misstated Dr. Fader's title.
EXPERT ANALYSIS FROM ACOG 2016
Training impacted performance of surgical quality measures
INDIAN WELLS, CALIF. – Surgeons with fellowship training in female pelvic medicine and reconstructive surgery were significantly more likely to perform proposed quality measures at the time of hysterectomy for pelvic organ prolapse, compared with those who lack such training, a single-center study showed.
“The Physician Quality Reporting System was instituted as part of recent health care reform, with the aim of improving the reporting of quality measures, with the overall goal of improving the quality of care provided to patients throughout all areas of medicine,” Dr. Emily Adams-Piper said at the annual scientific meeting of the Society of Gynecologic Surgeons. “While there are many types of quality measures, including outcome measures and patient satisfaction measures, process measures may be the most directly applicable for the practicing clinician, because they provide recommended actions during specific patient encounters that can guide practice.”
Dr. Adams-Piper, a resident physician in the division of urogynecology at the University of California, Irvine, and her associates set out to investigate the use of proposed quality measures at the time of hysterectomy for pelvic organ prolapse (POP) among women receiving care from Southern California Permanente Medical Group, a large HMO.
They wanted to know if training background affected the rate of performance of four different quality measures related to hysterectomy for POP: offering conservative treatment prior to the surgical treatment of POP, quantitative assessment of POP with either a Baden-Walker or a POP-Q exam, apical support procedure performed at the time of hysterectomy for prolapse, and performance of intraoperative cystoscopy.
Patients who underwent hysterectomy for POP in 2008 were eligible for the study. The researchers reviewed electronic medical records for clinical and demographic data and categorized surgeons by their level of training.
“They were considered fellowship trained if they had pursued additional formal subspecialty training in female pelvic medicine and reconstructive surgery,” Dr. Adams-Piper explained. “Surgeons were considered grandfathered if they subsequently took the FPMRS [Female Pelvic Medicine and Reconstructive Surgery] boards when they became available in 2013. Surgeons were considered generalist if they fit into neither of these two categories and completed a residency in ob.gyn.”
Chi-squared tests were used to compare demographics and performance of the proposed quality measures. Of the 662 hysterectomies performed in 2008, 328 were included in the final analysis. The mean patient age was 60 years, the mean parity was 2.9, and the mean body mass index was 27.9 kg/m2.
Overall performance of the four proposed quality measures was high, ranging from 82%-87%. More than half of quality assessments (58%) were performed with the POP-Q exam, while the majority of apical support procedures were uterosacral ligament vault suspensions (67%), followed by sacrocolpopexy (18%), McCall culdoplasty (12%), and sacrospinous ligament fixation (3%).
When categorized by training, fellowship-trained surgeons performed 133 hysterectomies, “grandfathered” surgeons performed 55, and generalist gynecologic surgeons performed 140. Fellowship-trained surgeons performed each of the four proposed quality measures more often than did grandfathered surgeons, who performed them more often than generalist gynecologic surgeons did.
Specifically, conservative treatment was offered by 94% of fellowship-trained surgeons, 87% of grandfathered surgeons, and 76% of generalist gynecologic surgeons (P = .0002). Qualitative preoperative assessment of POP was performed by 99% of fellowship-trained surgeons, 93% of grandfathered surgeons, and 73% of generalist gynecologic surgeons (three-way comparison reached statistical significance, with a P less than .0001).
Apical repair was performed by 96% of fellowship-trained surgeons, 82% of grandfathered surgeons, and 69% of generalist gynecologic surgeons (P less than .0001). Finally, cystoscopy was performed by 98% of fellowship-trained surgeons, 91% of grandfathered surgeons, and 72% of generalist gynecologic surgeons (P less than .0001).
When the researchers evaluated the cumulative performance of all measures in the same patient, fellowship-trained surgeons had the highest rates (89%, compared with 62% of grandfathered surgeons, and 39% of generalist gynecologic surgeons; P less than .0001).
“When we looked at the patient characteristics and their distribution across the surgeon training backgrounds, we found no significant differences in the age, BMI, gravidity, or parity of the subjects that underwent surgeries with the three groups,” Dr. Adams-Piper said.
She acknowledged certain limitations of the study, including the fact that it reflects clinical practice in a single health care delivery system, it relied on prior documentation, and it evaluated data from 2008.
“From this study we can conclude that perioperative practice patterns differ by surgeon training background,” she said. “However, in order for the proposed quality measures to be clinically meaningful, they must be correlated with patient-centered outcomes.”
Dr. Adams-Piper reported having no financial disclosures. The meeting was jointly sponsored by the American College of Surgeons.
INDIAN WELLS, CALIF. – Surgeons with fellowship training in female pelvic medicine and reconstructive surgery were significantly more likely to perform proposed quality measures at the time of hysterectomy for pelvic organ prolapse, compared with those who lack such training, a single-center study showed.
“The Physician Quality Reporting System was instituted as part of recent health care reform, with the aim of improving the reporting of quality measures, with the overall goal of improving the quality of care provided to patients throughout all areas of medicine,” Dr. Emily Adams-Piper said at the annual scientific meeting of the Society of Gynecologic Surgeons. “While there are many types of quality measures, including outcome measures and patient satisfaction measures, process measures may be the most directly applicable for the practicing clinician, because they provide recommended actions during specific patient encounters that can guide practice.”
Dr. Adams-Piper, a resident physician in the division of urogynecology at the University of California, Irvine, and her associates set out to investigate the use of proposed quality measures at the time of hysterectomy for pelvic organ prolapse (POP) among women receiving care from Southern California Permanente Medical Group, a large HMO.
They wanted to know if training background affected the rate of performance of four different quality measures related to hysterectomy for POP: offering conservative treatment prior to the surgical treatment of POP, quantitative assessment of POP with either a Baden-Walker or a POP-Q exam, apical support procedure performed at the time of hysterectomy for prolapse, and performance of intraoperative cystoscopy.
Patients who underwent hysterectomy for POP in 2008 were eligible for the study. The researchers reviewed electronic medical records for clinical and demographic data and categorized surgeons by their level of training.
“They were considered fellowship trained if they had pursued additional formal subspecialty training in female pelvic medicine and reconstructive surgery,” Dr. Adams-Piper explained. “Surgeons were considered grandfathered if they subsequently took the FPMRS [Female Pelvic Medicine and Reconstructive Surgery] boards when they became available in 2013. Surgeons were considered generalist if they fit into neither of these two categories and completed a residency in ob.gyn.”
Chi-squared tests were used to compare demographics and performance of the proposed quality measures. Of the 662 hysterectomies performed in 2008, 328 were included in the final analysis. The mean patient age was 60 years, the mean parity was 2.9, and the mean body mass index was 27.9 kg/m2.
Overall performance of the four proposed quality measures was high, ranging from 82%-87%. More than half of quality assessments (58%) were performed with the POP-Q exam, while the majority of apical support procedures were uterosacral ligament vault suspensions (67%), followed by sacrocolpopexy (18%), McCall culdoplasty (12%), and sacrospinous ligament fixation (3%).
When categorized by training, fellowship-trained surgeons performed 133 hysterectomies, “grandfathered” surgeons performed 55, and generalist gynecologic surgeons performed 140. Fellowship-trained surgeons performed each of the four proposed quality measures more often than did grandfathered surgeons, who performed them more often than generalist gynecologic surgeons did.
Specifically, conservative treatment was offered by 94% of fellowship-trained surgeons, 87% of grandfathered surgeons, and 76% of generalist gynecologic surgeons (P = .0002). Qualitative preoperative assessment of POP was performed by 99% of fellowship-trained surgeons, 93% of grandfathered surgeons, and 73% of generalist gynecologic surgeons (three-way comparison reached statistical significance, with a P less than .0001).
Apical repair was performed by 96% of fellowship-trained surgeons, 82% of grandfathered surgeons, and 69% of generalist gynecologic surgeons (P less than .0001). Finally, cystoscopy was performed by 98% of fellowship-trained surgeons, 91% of grandfathered surgeons, and 72% of generalist gynecologic surgeons (P less than .0001).
When the researchers evaluated the cumulative performance of all measures in the same patient, fellowship-trained surgeons had the highest rates (89%, compared with 62% of grandfathered surgeons, and 39% of generalist gynecologic surgeons; P less than .0001).
“When we looked at the patient characteristics and their distribution across the surgeon training backgrounds, we found no significant differences in the age, BMI, gravidity, or parity of the subjects that underwent surgeries with the three groups,” Dr. Adams-Piper said.
She acknowledged certain limitations of the study, including the fact that it reflects clinical practice in a single health care delivery system, it relied on prior documentation, and it evaluated data from 2008.
“From this study we can conclude that perioperative practice patterns differ by surgeon training background,” she said. “However, in order for the proposed quality measures to be clinically meaningful, they must be correlated with patient-centered outcomes.”
Dr. Adams-Piper reported having no financial disclosures. The meeting was jointly sponsored by the American College of Surgeons.
INDIAN WELLS, CALIF. – Surgeons with fellowship training in female pelvic medicine and reconstructive surgery were significantly more likely to perform proposed quality measures at the time of hysterectomy for pelvic organ prolapse, compared with those who lack such training, a single-center study showed.
“The Physician Quality Reporting System was instituted as part of recent health care reform, with the aim of improving the reporting of quality measures, with the overall goal of improving the quality of care provided to patients throughout all areas of medicine,” Dr. Emily Adams-Piper said at the annual scientific meeting of the Society of Gynecologic Surgeons. “While there are many types of quality measures, including outcome measures and patient satisfaction measures, process measures may be the most directly applicable for the practicing clinician, because they provide recommended actions during specific patient encounters that can guide practice.”
Dr. Adams-Piper, a resident physician in the division of urogynecology at the University of California, Irvine, and her associates set out to investigate the use of proposed quality measures at the time of hysterectomy for pelvic organ prolapse (POP) among women receiving care from Southern California Permanente Medical Group, a large HMO.
They wanted to know if training background affected the rate of performance of four different quality measures related to hysterectomy for POP: offering conservative treatment prior to the surgical treatment of POP, quantitative assessment of POP with either a Baden-Walker or a POP-Q exam, apical support procedure performed at the time of hysterectomy for prolapse, and performance of intraoperative cystoscopy.
Patients who underwent hysterectomy for POP in 2008 were eligible for the study. The researchers reviewed electronic medical records for clinical and demographic data and categorized surgeons by their level of training.
“They were considered fellowship trained if they had pursued additional formal subspecialty training in female pelvic medicine and reconstructive surgery,” Dr. Adams-Piper explained. “Surgeons were considered grandfathered if they subsequently took the FPMRS [Female Pelvic Medicine and Reconstructive Surgery] boards when they became available in 2013. Surgeons were considered generalist if they fit into neither of these two categories and completed a residency in ob.gyn.”
Chi-squared tests were used to compare demographics and performance of the proposed quality measures. Of the 662 hysterectomies performed in 2008, 328 were included in the final analysis. The mean patient age was 60 years, the mean parity was 2.9, and the mean body mass index was 27.9 kg/m2.
Overall performance of the four proposed quality measures was high, ranging from 82%-87%. More than half of quality assessments (58%) were performed with the POP-Q exam, while the majority of apical support procedures were uterosacral ligament vault suspensions (67%), followed by sacrocolpopexy (18%), McCall culdoplasty (12%), and sacrospinous ligament fixation (3%).
When categorized by training, fellowship-trained surgeons performed 133 hysterectomies, “grandfathered” surgeons performed 55, and generalist gynecologic surgeons performed 140. Fellowship-trained surgeons performed each of the four proposed quality measures more often than did grandfathered surgeons, who performed them more often than generalist gynecologic surgeons did.
Specifically, conservative treatment was offered by 94% of fellowship-trained surgeons, 87% of grandfathered surgeons, and 76% of generalist gynecologic surgeons (P = .0002). Qualitative preoperative assessment of POP was performed by 99% of fellowship-trained surgeons, 93% of grandfathered surgeons, and 73% of generalist gynecologic surgeons (three-way comparison reached statistical significance, with a P less than .0001).
Apical repair was performed by 96% of fellowship-trained surgeons, 82% of grandfathered surgeons, and 69% of generalist gynecologic surgeons (P less than .0001). Finally, cystoscopy was performed by 98% of fellowship-trained surgeons, 91% of grandfathered surgeons, and 72% of generalist gynecologic surgeons (P less than .0001).
When the researchers evaluated the cumulative performance of all measures in the same patient, fellowship-trained surgeons had the highest rates (89%, compared with 62% of grandfathered surgeons, and 39% of generalist gynecologic surgeons; P less than .0001).
“When we looked at the patient characteristics and their distribution across the surgeon training backgrounds, we found no significant differences in the age, BMI, gravidity, or parity of the subjects that underwent surgeries with the three groups,” Dr. Adams-Piper said.
She acknowledged certain limitations of the study, including the fact that it reflects clinical practice in a single health care delivery system, it relied on prior documentation, and it evaluated data from 2008.
“From this study we can conclude that perioperative practice patterns differ by surgeon training background,” she said. “However, in order for the proposed quality measures to be clinically meaningful, they must be correlated with patient-centered outcomes.”
Dr. Adams-Piper reported having no financial disclosures. The meeting was jointly sponsored by the American College of Surgeons.
AT SGS 2016
Key clinical point: The level of surgical training impacted performance of proposed quality measures at the time of hysterectomy for pelvic organ prolapse.
Major finding: Fellowship-trained surgeons in female pelvic medicine and reconstructive surgery were significantly more likely to perform proposed quality measures relating to hysterectomy for pelvic organ prolapse at 89%, compared with 39% of generalist gynecologic surgeons.
Data source: A review 328 hysterectomies performed in 2008 by surgeons in a Southern California HMO.
Disclosures: Dr. Adams-Piper reported having no financial disclosures.
VIDEO: ‘Improve – but do not abandon – power morcellation’
SILVER SPRING, MD. – Without power morcellation, the number of hysterectomies performed using an open approach would dramatically increase – and the combined mortality from laparoscopic hysterectomy and potential dissemination of leiomyosarcoma would be less than that of open hysterectomy, according to testimony given July 11 at a Food and Drug Administration expert panel meeting.
Dr. Jubilee Brown, director of gynecologic oncology at the Woman's Hospital of Texas, University of Texas M.D. Anderson Cancer Center, Houston, testified at the meeting on behalf of the AAGL, an association that promotes minimally invasive gynecologic surgery. She presented results of a decision analysis suggesting that if all U.S. cases were converted to open hysterectomy from laparoscopic hysterectomy (LH) with morcellation of fibroids, 17 more women each year would die from the open procedure than from the combination LH and morcellation.
"Improve – but do not abandon – power morcellation," Dr. Brown told the FDA Obstetrics and Gynecology Devices Advisory Committee. She discussed her testimony during this video interview.
Dr. Brown said she had no relevant financial conflicts of interest.
SILVER SPRING, MD. – Without power morcellation, the number of hysterectomies performed using an open approach would dramatically increase – and the combined mortality from laparoscopic hysterectomy and potential dissemination of leiomyosarcoma would be less than that of open hysterectomy, according to testimony given July 11 at a Food and Drug Administration expert panel meeting.
Dr. Jubilee Brown, director of gynecologic oncology at the Woman's Hospital of Texas, University of Texas M.D. Anderson Cancer Center, Houston, testified at the meeting on behalf of the AAGL, an association that promotes minimally invasive gynecologic surgery. She presented results of a decision analysis suggesting that if all U.S. cases were converted to open hysterectomy from laparoscopic hysterectomy (LH) with morcellation of fibroids, 17 more women each year would die from the open procedure than from the combination LH and morcellation.
"Improve – but do not abandon – power morcellation," Dr. Brown told the FDA Obstetrics and Gynecology Devices Advisory Committee. She discussed her testimony during this video interview.
Dr. Brown said she had no relevant financial conflicts of interest.
SILVER SPRING, MD. – Without power morcellation, the number of hysterectomies performed using an open approach would dramatically increase – and the combined mortality from laparoscopic hysterectomy and potential dissemination of leiomyosarcoma would be less than that of open hysterectomy, according to testimony given July 11 at a Food and Drug Administration expert panel meeting.
Dr. Jubilee Brown, director of gynecologic oncology at the Woman's Hospital of Texas, University of Texas M.D. Anderson Cancer Center, Houston, testified at the meeting on behalf of the AAGL, an association that promotes minimally invasive gynecologic surgery. She presented results of a decision analysis suggesting that if all U.S. cases were converted to open hysterectomy from laparoscopic hysterectomy (LH) with morcellation of fibroids, 17 more women each year would die from the open procedure than from the combination LH and morcellation.
"Improve – but do not abandon – power morcellation," Dr. Brown told the FDA Obstetrics and Gynecology Devices Advisory Committee. She discussed her testimony during this video interview.
Dr. Brown said she had no relevant financial conflicts of interest.
AT AN FDA ADVISORY COMMITTEE MEETING
VIDEO: Public testimony gets heated at FDA panel meeting on morcellation
SILVER SPRING, MD. – Power morcellation devices should be never used for gynecologic procedures, Dr. Hooman Noorchashm testified to a Food and Drug Administration expert panel on July ll.
He called out members of the FDA Obstetrics and Gynecology Devices Panel Advisory Committee by name, seeking to shame them into action to disallow power morcellation for suspected uterine fibroids.
"Is this a safe and logical device?" said Dr. Noorchashm, a cardiothoracic surgeon at Brigham and Women’s Hospital in Boston. "The only classification for this device is banned – unsafe, illogical, incorrect, and deadly."
Dr. Noorchashm’s wife, Dr. Amy Reed, had a hysterectomy with morcellation for suspected fibroids. Biopsy later confirmed sarcoma was present. Use of power morcellation caused tumor cells to spread, upstaging her sarcoma to stage IV.
On Twitter @denisefulton
SILVER SPRING, MD. – Power morcellation devices should be never used for gynecologic procedures, Dr. Hooman Noorchashm testified to a Food and Drug Administration expert panel on July ll.
He called out members of the FDA Obstetrics and Gynecology Devices Panel Advisory Committee by name, seeking to shame them into action to disallow power morcellation for suspected uterine fibroids.
"Is this a safe and logical device?" said Dr. Noorchashm, a cardiothoracic surgeon at Brigham and Women’s Hospital in Boston. "The only classification for this device is banned – unsafe, illogical, incorrect, and deadly."
Dr. Noorchashm’s wife, Dr. Amy Reed, had a hysterectomy with morcellation for suspected fibroids. Biopsy later confirmed sarcoma was present. Use of power morcellation caused tumor cells to spread, upstaging her sarcoma to stage IV.
On Twitter @denisefulton
SILVER SPRING, MD. – Power morcellation devices should be never used for gynecologic procedures, Dr. Hooman Noorchashm testified to a Food and Drug Administration expert panel on July ll.
He called out members of the FDA Obstetrics and Gynecology Devices Panel Advisory Committee by name, seeking to shame them into action to disallow power morcellation for suspected uterine fibroids.
"Is this a safe and logical device?" said Dr. Noorchashm, a cardiothoracic surgeon at Brigham and Women’s Hospital in Boston. "The only classification for this device is banned – unsafe, illogical, incorrect, and deadly."
Dr. Noorchashm’s wife, Dr. Amy Reed, had a hysterectomy with morcellation for suspected fibroids. Biopsy later confirmed sarcoma was present. Use of power morcellation caused tumor cells to spread, upstaging her sarcoma to stage IV.
On Twitter @denisefulton
AT AN FDA ADVISORY COMMITTEE MEETING