ACS Surgery News

SCOTTSDALE, ARIZ. – Women with asymptomatic stage 2 pelvic organ prolapse can be reassured that it rarely progresses, according to the results of a study reported at the annual meeting of the Society of Gynecologic Surgery.

Investigators led by Dr. Peggy A. Norton, chief of urogynecology and pelvic reconstructive surgery at the University of Utah in Salt Lake City, performed a secondary analysis of the 597 women undergoing surgery for stress urinary incontinence in the randomized TOMUS (Trial of Mid-Urethral Slings) study. Analyses were based on the 291 women (49%) who also had stage 2 prolapse – a group for whom the need for repair has been a gray area.

The results showed that among the 189 women who had asymptomatic prolapse and did not have concomitant repair at the time of continence surgery, just 2% experienced progression to stage 3 prolapse after 6 years of follow-up. Moreover, none underwent surgery for the prolapse during that time.

This very low rate of progression was surprising, according to Dr. Norton, and noteworthy in that these women were being rigorously followed up in a trial.

"We would conclude that surgeons may counsel women with asymptomatic stage 2 prolapse that their prolapse is unlikely to progress or even unlikely to require surgery in the next 5-7 years. Said another way, it is not necessary to perform concomitant anterior prolapse surgery for asymptomatic stage 2 anterior prolapse when performing a mid-urethral sling for stress incontinence," she said at the annual scientific meeting of the Society of Gynecologic Surgeons, jointly sponsored by the American College of Surgeons.

In additional findings, among the 47 women who had symptomatic prolapse and did have concomitant repair at the time of their continence surgery, just 6% underwent another prolapse repair during follow-up (2 at 36 months and 1 at 48 months). The women who underwent another repair typically had a repeated anterior prolapse or an apical prolapse, but the numbers were too small to definitively pin down any pattern.

Invited discussant Dr. Jeffrey Mangel, director of the division of urogynecology and pelvic reconstructive surgery at the Metrohealth Medical Center, Cleveland, noted, "This is a very common clinical scenario; we see this every week – patients who have primary stress incontinence who have some mild degree of anterior wall prolapse – and the question is how to manage that."

"This was an impressive long-term surgical follow-up," he commented. However, "the surgical bias is there; that is, we know how we counsel patients can influence what patients decide to do or not to do in response to these milder degrees of symptoms and findings on anatomy.

"Were the patients in the TOMUS trial who had concurrent prolapse surgery (or not) evenly distributed across all the study sites, and were there any differences in stress incontinence outcomes in patients who had their prolapse repaired and those who didn’t?" Dr. Mangel asked.

There were some differences in surgical intervention across institutions, as might be expected in a multicenter trial, Dr. Norton said. The results for the whole trial population at 2 years of follow-up, previously reported, showed that concomitant repair did not adversely affect continence outcomes (N. Engl. J. Med. 2010;362:2066-76). "Doing a concomitant procedure didn’t increase the number of [adverse events]; it just changed the type of [adverse events] that we saw. But it didn’t change the primary outcome for stress urinary incontinence.

"I think we would all agree it is hard to improve in an asymptomatic patient, but how, given these findings, would you counsel a patient about symptomatic stage 2 anterior wall prolapse who is a candidate for a sling procedure with regard to concurrent repair of the prolapse?" Dr. Mangel asked.

"It has to be an individual discussion between the surgeon and the patient," Dr. Norton replied. "We have always told patients, have everything repaired at the time, while we are in there anyway. I think what’s changed for me is the minute we saw these results, I was able to say to patients, if we repair this stage 2 prolapse, you have about a 6%-7% chance that over the next couple of years, we’ll have to repair it again. And it seems like for patients who don’t have any bother, that none of them go on [to need repair]. So it may be that there’s a difference in patients feeling that stage 2 prolapse that may be one of the critical issues."

The decision to perform concomitant prolapse repair in women undergoing continence surgery is typically clear-cut if the prolapse is stage 0 or 1 (no) or stage 3 or 4 (yes), according to Dr. Norton. "But it’s more difficult to counsel patients on defects that have some intermediate anatomy or intermediate levels of bother or even no bother."

The total 575 women in TOMUS underwent either a retropubic or transobturator continence procedure. Concomitant vaginal procedures to repair pelvic organ prolapse were allowed at the surgeon’s discretion after discussion with the patient.

The women were assessed at baseline and annually for 5-7 years after surgery with the Urinary Distress Inventory (UDI) and the Pelvic Organ Prolapse Quantification System (POP-Q).

About a quarter of women with stage 2 prolapse had symptoms according to responses on the UDI. As expected, 70% of those who were symptomatic, but only 15% of those who were asymptomatic, had a concomitant repair at the time of their continence surgery.

"These findings are not generalizable to women with higher stages of prolapse since we really only had sufficient power to be looking at stage 2’s," said Dr. Norton. "Also, this was a primary randomized trial of stress incontinence, and patients were not randomized to receive or not receive concomitant prolapse repair, so it really limits our ability to [control for] selection bias or surgeon bias."

Dr. Norton disclosed no relevant financial conflicts of interest.

SCOTTSDALE, ARIZ. – Women with asymptomatic stage 2 pelvic organ prolapse can be reassured that it rarely progresses, according to the results of a study reported at the annual meeting of the Society of Gynecologic Surgery.

Investigators led by Dr. Peggy A. Norton, chief of urogynecology and pelvic reconstructive surgery at the University of Utah in Salt Lake City, performed a secondary analysis of the 597 women undergoing surgery for stress urinary incontinence in the randomized TOMUS (Trial of Mid-Urethral Slings) study. Analyses were based on the 291 women (49%) who also had stage 2 prolapse – a group for whom the need for repair has been a gray area.

The results showed that among the 189 women who had asymptomatic prolapse and did not have concomitant repair at the time of continence surgery, just 2% experienced progression to stage 3 prolapse after 6 years of follow-up. Moreover, none underwent surgery for the prolapse during that time.

This very low rate of progression was surprising, according to Dr. Norton, and noteworthy in that these women were being rigorously followed up in a trial.

"We would conclude that surgeons may counsel women with asymptomatic stage 2 prolapse that their prolapse is unlikely to progress or even unlikely to require surgery in the next 5-7 years. Said another way, it is not necessary to perform concomitant anterior prolapse surgery for asymptomatic stage 2 anterior prolapse when performing a mid-urethral sling for stress incontinence," she said at the annual scientific meeting of the Society of Gynecologic Surgeons, jointly sponsored by the American College of Surgeons.

In additional findings, among the 47 women who had symptomatic prolapse and did have concomitant repair at the time of their continence surgery, just 6% underwent another prolapse repair during follow-up (2 at 36 months and 1 at 48 months). The women who underwent another repair typically had a repeated anterior prolapse or an apical prolapse, but the numbers were too small to definitively pin down any pattern.

Invited discussant Dr. Jeffrey Mangel, director of the division of urogynecology and pelvic reconstructive surgery at the Metrohealth Medical Center, Cleveland, noted, "This is a very common clinical scenario; we see this every week – patients who have primary stress incontinence who have some mild degree of anterior wall prolapse – and the question is how to manage that."

"This was an impressive long-term surgical follow-up," he commented. However, "the surgical bias is there; that is, we know how we counsel patients can influence what patients decide to do or not to do in response to these milder degrees of symptoms and findings on anatomy.

"Were the patients in the TOMUS trial who had concurrent prolapse surgery (or not) evenly distributed across all the study sites, and were there any differences in stress incontinence outcomes in patients who had their prolapse repaired and those who didn’t?" Dr. Mangel asked.

There were some differences in surgical intervention across institutions, as might be expected in a multicenter trial, Dr. Norton said. The results for the whole trial population at 2 years of follow-up, previously reported, showed that concomitant repair did not adversely affect continence outcomes (N. Engl. J. Med. 2010;362:2066-76). "Doing a concomitant procedure didn’t increase the number of [adverse events]; it just changed the type of [adverse events] that we saw. But it didn’t change the primary outcome for stress urinary incontinence.

"I think we would all agree it is hard to improve in an asymptomatic patient, but how, given these findings, would you counsel a patient about symptomatic stage 2 anterior wall prolapse who is a candidate for a sling procedure with regard to concurrent repair of the prolapse?" Dr. Mangel asked.

"It has to be an individual discussion between the surgeon and the patient," Dr. Norton replied. "We have always told patients, have everything repaired at the time, while we are in there anyway. I think what’s changed for me is the minute we saw these results, I was able to say to patients, if we repair this stage 2 prolapse, you have about a 6%-7% chance that over the next couple of years, we’ll have to repair it again. And it seems like for patients who don’t have any bother, that none of them go on [to need repair]. So it may be that there’s a difference in patients feeling that stage 2 prolapse that may be one of the critical issues."

The decision to perform concomitant prolapse repair in women undergoing continence surgery is typically clear-cut if the prolapse is stage 0 or 1 (no) or stage 3 or 4 (yes), according to Dr. Norton. "But it’s more difficult to counsel patients on defects that have some intermediate anatomy or intermediate levels of bother or even no bother."

The total 575 women in TOMUS underwent either a retropubic or transobturator continence procedure. Concomitant vaginal procedures to repair pelvic organ prolapse were allowed at the surgeon’s discretion after discussion with the patient.

The women were assessed at baseline and annually for 5-7 years after surgery with the Urinary Distress Inventory (UDI) and the Pelvic Organ Prolapse Quantification System (POP-Q).

About a quarter of women with stage 2 prolapse had symptoms according to responses on the UDI. As expected, 70% of those who were symptomatic, but only 15% of those who were asymptomatic, had a concomitant repair at the time of their continence surgery.

"These findings are not generalizable to women with higher stages of prolapse since we really only had sufficient power to be looking at stage 2’s," said Dr. Norton. "Also, this was a primary randomized trial of stress incontinence, and patients were not randomized to receive or not receive concomitant prolapse repair, so it really limits our ability to [control for] selection bias or surgeon bias."

Dr. Norton disclosed no relevant financial conflicts of interest.

SCOTTSDALE, ARIZ. – Women with asymptomatic stage 2 pelvic organ prolapse can be reassured that it rarely progresses, according to the results of a study reported at the annual meeting of the Society of Gynecologic Surgery.

Investigators led by Dr. Peggy A. Norton, chief of urogynecology and pelvic reconstructive surgery at the University of Utah in Salt Lake City, performed a secondary analysis of the 597 women undergoing surgery for stress urinary incontinence in the randomized TOMUS (Trial of Mid-Urethral Slings) study. Analyses were based on the 291 women (49%) who also had stage 2 prolapse – a group for whom the need for repair has been a gray area.

The results showed that among the 189 women who had asymptomatic prolapse and did not have concomitant repair at the time of continence surgery, just 2% experienced progression to stage 3 prolapse after 6 years of follow-up. Moreover, none underwent surgery for the prolapse during that time.

This very low rate of progression was surprising, according to Dr. Norton, and noteworthy in that these women were being rigorously followed up in a trial.

"We would conclude that surgeons may counsel women with asymptomatic stage 2 prolapse that their prolapse is unlikely to progress or even unlikely to require surgery in the next 5-7 years. Said another way, it is not necessary to perform concomitant anterior prolapse surgery for asymptomatic stage 2 anterior prolapse when performing a mid-urethral sling for stress incontinence," she said at the annual scientific meeting of the Society of Gynecologic Surgeons, jointly sponsored by the American College of Surgeons.

In additional findings, among the 47 women who had symptomatic prolapse and did have concomitant repair at the time of their continence surgery, just 6% underwent another prolapse repair during follow-up (2 at 36 months and 1 at 48 months). The women who underwent another repair typically had a repeated anterior prolapse or an apical prolapse, but the numbers were too small to definitively pin down any pattern.

Invited discussant Dr. Jeffrey Mangel, director of the division of urogynecology and pelvic reconstructive surgery at the Metrohealth Medical Center, Cleveland, noted, "This is a very common clinical scenario; we see this every week – patients who have primary stress incontinence who have some mild degree of anterior wall prolapse – and the question is how to manage that."

"This was an impressive long-term surgical follow-up," he commented. However, "the surgical bias is there; that is, we know how we counsel patients can influence what patients decide to do or not to do in response to these milder degrees of symptoms and findings on anatomy.

"Were the patients in the TOMUS trial who had concurrent prolapse surgery (or not) evenly distributed across all the study sites, and were there any differences in stress incontinence outcomes in patients who had their prolapse repaired and those who didn’t?" Dr. Mangel asked.

There were some differences in surgical intervention across institutions, as might be expected in a multicenter trial, Dr. Norton said. The results for the whole trial population at 2 years of follow-up, previously reported, showed that concomitant repair did not adversely affect continence outcomes (N. Engl. J. Med. 2010;362:2066-76). "Doing a concomitant procedure didn’t increase the number of [adverse events]; it just changed the type of [adverse events] that we saw. But it didn’t change the primary outcome for stress urinary incontinence.

"I think we would all agree it is hard to improve in an asymptomatic patient, but how, given these findings, would you counsel a patient about symptomatic stage 2 anterior wall prolapse who is a candidate for a sling procedure with regard to concurrent repair of the prolapse?" Dr. Mangel asked.

"It has to be an individual discussion between the surgeon and the patient," Dr. Norton replied. "We have always told patients, have everything repaired at the time, while we are in there anyway. I think what’s changed for me is the minute we saw these results, I was able to say to patients, if we repair this stage 2 prolapse, you have about a 6%-7% chance that over the next couple of years, we’ll have to repair it again. And it seems like for patients who don’t have any bother, that none of them go on [to need repair]. So it may be that there’s a difference in patients feeling that stage 2 prolapse that may be one of the critical issues."

The decision to perform concomitant prolapse repair in women undergoing continence surgery is typically clear-cut if the prolapse is stage 0 or 1 (no) or stage 3 or 4 (yes), according to Dr. Norton. "But it’s more difficult to counsel patients on defects that have some intermediate anatomy or intermediate levels of bother or even no bother."

The total 575 women in TOMUS underwent either a retropubic or transobturator continence procedure. Concomitant vaginal procedures to repair pelvic organ prolapse were allowed at the surgeon’s discretion after discussion with the patient.

The women were assessed at baseline and annually for 5-7 years after surgery with the Urinary Distress Inventory (UDI) and the Pelvic Organ Prolapse Quantification System (POP-Q).

About a quarter of women with stage 2 prolapse had symptoms according to responses on the UDI. As expected, 70% of those who were symptomatic, but only 15% of those who were asymptomatic, had a concomitant repair at the time of their continence surgery.

"These findings are not generalizable to women with higher stages of prolapse since we really only had sufficient power to be looking at stage 2’s," said Dr. Norton. "Also, this was a primary randomized trial of stress incontinence, and patients were not randomized to receive or not receive concomitant prolapse repair, so it really limits our ability to [control for] selection bias or surgeon bias."

Dr. Norton disclosed no relevant financial conflicts of interest.

WASHINGTON – Administration of crushed tablets of ticagrelor* may provide a way to dramatically accelerate the onset of platelet inhibition in patients with ST-elevation myocardial infarction.

In a proof-of-concept crossover study involving 36 healthy volunteers, crushing a whole 90-mg tablet of ticagrelor (Brilinta) and suspending it in 200 mL of water given orally resulted in a mean plasma ticagrelor concentration of 149 ng/mL 30 minutes post dose, compared with 34 ng/mL after a whole tablet was swallowed, Dr. Glenn F. Carlson reported at the annual meeting of the American College of Cardiology.

When the crushed tablet suspended in water was administered via nasogastric tube, the results were even more dramatic: a mean plasma ticagrelor concentration of 265 ng/mL 30 minutes post dose, or a ninefold greater mean plasma concentration compared with swallowing a whole tablet, said Dr. Carlson of AstraZeneca.

At 1 hour post dose, mean plasma concentrations of ticagrelor and its metabolite remained significantly greater with both of the crushed-tablet dosing strategies than with whole ticagrelor. However, 2 to 48 hours post dose, plasma concentrations were similar for all three drug administration strategies.

The clinical relevance of these findings lies in the well-established observation that in acute coronary syndromes – and especially in ST-elevation myocardial infarction – time is myocardium. That is, the more quickly that effective antiplatelet activity and reperfusion can be achieved, the less extensive the myocardial tissue damage, he noted.

The three modes of ticagrelor administration were found to be bioequivalent and equally safe.

The study was funded by AstraZeneca. Dr. Carlson is an employee of the company.

[email protected]

*CORRECTION, 4/29/2014: An earlier version of the article misstated the name of the drug ticagrelor.

WASHINGTON – Administration of crushed tablets of ticagrelor* may provide a way to dramatically accelerate the onset of platelet inhibition in patients with ST-elevation myocardial infarction.

In a proof-of-concept crossover study involving 36 healthy volunteers, crushing a whole 90-mg tablet of ticagrelor (Brilinta) and suspending it in 200 mL of water given orally resulted in a mean plasma ticagrelor concentration of 149 ng/mL 30 minutes post dose, compared with 34 ng/mL after a whole tablet was swallowed, Dr. Glenn F. Carlson reported at the annual meeting of the American College of Cardiology.

When the crushed tablet suspended in water was administered via nasogastric tube, the results were even more dramatic: a mean plasma ticagrelor concentration of 265 ng/mL 30 minutes post dose, or a ninefold greater mean plasma concentration compared with swallowing a whole tablet, said Dr. Carlson of AstraZeneca.

At 1 hour post dose, mean plasma concentrations of ticagrelor and its metabolite remained significantly greater with both of the crushed-tablet dosing strategies than with whole ticagrelor. However, 2 to 48 hours post dose, plasma concentrations were similar for all three drug administration strategies.

The clinical relevance of these findings lies in the well-established observation that in acute coronary syndromes – and especially in ST-elevation myocardial infarction – time is myocardium. That is, the more quickly that effective antiplatelet activity and reperfusion can be achieved, the less extensive the myocardial tissue damage, he noted.

The three modes of ticagrelor administration were found to be bioequivalent and equally safe.

The study was funded by AstraZeneca. Dr. Carlson is an employee of the company.

[email protected]

*CORRECTION, 4/29/2014: An earlier version of the article misstated the name of the drug ticagrelor.

WASHINGTON – Administration of crushed tablets of ticagrelor* may provide a way to dramatically accelerate the onset of platelet inhibition in patients with ST-elevation myocardial infarction.

In a proof-of-concept crossover study involving 36 healthy volunteers, crushing a whole 90-mg tablet of ticagrelor (Brilinta) and suspending it in 200 mL of water given orally resulted in a mean plasma ticagrelor concentration of 149 ng/mL 30 minutes post dose, compared with 34 ng/mL after a whole tablet was swallowed, Dr. Glenn F. Carlson reported at the annual meeting of the American College of Cardiology.

When the crushed tablet suspended in water was administered via nasogastric tube, the results were even more dramatic: a mean plasma ticagrelor concentration of 265 ng/mL 30 minutes post dose, or a ninefold greater mean plasma concentration compared with swallowing a whole tablet, said Dr. Carlson of AstraZeneca.

At 1 hour post dose, mean plasma concentrations of ticagrelor and its metabolite remained significantly greater with both of the crushed-tablet dosing strategies than with whole ticagrelor. However, 2 to 48 hours post dose, plasma concentrations were similar for all three drug administration strategies.

The clinical relevance of these findings lies in the well-established observation that in acute coronary syndromes – and especially in ST-elevation myocardial infarction – time is myocardium. That is, the more quickly that effective antiplatelet activity and reperfusion can be achieved, the less extensive the myocardial tissue damage, he noted.

The three modes of ticagrelor administration were found to be bioequivalent and equally safe.

The study was funded by AstraZeneca. Dr. Carlson is an employee of the company.

[email protected]

*CORRECTION, 4/29/2014: An earlier version of the article misstated the name of the drug ticagrelor.

Ingenol mebutate gel for the treatment of actinic keratosis is an effective adjunct therapy to cryosurgery, and the absence of attendant serious local reactions can increase compliance, based on data from more than 100 patients.

"By the time you do see a reaction, because the treatment time is only 2 or 3 days, the patient is done applying it, so the compliance is increased," Dr. Miriam S. Bettencourt, a community-based dermatologist in Las Vegas.

Dr. Bettencourt conducted her chart review of 135 patients "out of curiosity," she said in an interview. She found that at follow-ups of 1-4 months, nearly 100% of patients who received ingenol mebutate gel as an adjunctive therapy with cryosurgery for AK on the face had clearance rates of at least 75%. In addition, clearance of at least 75% was seen in 89% of patients treated on the scalp and 84% of patients treated on the forearms and/or hands. Most of the patients were male (88%), ranging in age from 39 to 85 years, with a median age of 70 years.

"One of the questions I had was, in a clinical practice, whether [the gel] mimics the clinical trial results that showed only a mild to moderate reaction," said Dr. Bettencourt. Common side affects of topical AK treatments include erythema, flaking, scaling, and crusting. In more extreme cases, vesicular pustulation is possible.

"I found that patients really didn’t complain of pain," said Dr. Bettencourt. "Most local skin reactions were resolved within a week." She prescribed moisturizers for patients whose reactions were moderate.

The findings were published in the March issue of the Journal of Drugs in Dermatology (J. Drugs Dermatol. 2014:13:269-73).

The results negate the common tenet that the more severe the reaction to the topical, the deeper the healing of the AK, said Dr. Bettencourt. "The degree of reaction does not correlate with the level of improvement. We used to think so, but that’s not true." The results show that the reaction can be "tolerable" and short lived despite dramatic results, she said.

The gel was approved by the Food and Drug Administration for use in the United States in early 2012 under the name Picato (LEO Pharmaceuticals). Unlike other topicals that must be applied over the course of weeks, the gel is applied for 2 or 3 days, with side effects lasting much of that time.

In addition to increased compliance, Dr. Bettencourt said she also measured whether her off-label "creativity" such as prescribing higher concentrations for the scalp and instructing patients to spread the gel over larger areas, yielded worthwhile results.

"I found that, especially for the face, you can spread the medication without jeopardizing the efficacy," said Dr. Bettencourt. However, when the gel is applied to the scalp, "You lose a little bit of the efficacy, because that’s a lot to cover using the prescribed three tubes, but you still get good results."

In addition, Dr. Bettencourt said that the gel offers cosmetic advantages over other treatments such as the topical imiquimod or photodynamic therapy because there is no hypo- or hyperpigmentation. And, because there is no photosensitivity associated with the gel, Dr. Bettencourt said she can offer it year-round.

She still prescribes other topicals, however, because not all patients’ insurance plans cover the gel. Medicare, does cover the gel, she noted, but only if the patient has a supplemental insurance policy.

While the study was unsponsored, and Dr. Bettencourt had no financial conflicts to disclose, she noted that she has shared her data with LEO Pharmaceuticals, the gel’s manufacturer. "They were thrilled, and helped me to put the results together," she said.

[email protected]

On Twitter @whitneymcknight

Ingenol mebutate gel for the treatment of actinic keratosis is an effective adjunct therapy to cryosurgery, and the absence of attendant serious local reactions can increase compliance, based on data from more than 100 patients.

"By the time you do see a reaction, because the treatment time is only 2 or 3 days, the patient is done applying it, so the compliance is increased," Dr. Miriam S. Bettencourt, a community-based dermatologist in Las Vegas.

Dr. Bettencourt conducted her chart review of 135 patients "out of curiosity," she said in an interview. She found that at follow-ups of 1-4 months, nearly 100% of patients who received ingenol mebutate gel as an adjunctive therapy with cryosurgery for AK on the face had clearance rates of at least 75%. In addition, clearance of at least 75% was seen in 89% of patients treated on the scalp and 84% of patients treated on the forearms and/or hands. Most of the patients were male (88%), ranging in age from 39 to 85 years, with a median age of 70 years.

"One of the questions I had was, in a clinical practice, whether [the gel] mimics the clinical trial results that showed only a mild to moderate reaction," said Dr. Bettencourt. Common side affects of topical AK treatments include erythema, flaking, scaling, and crusting. In more extreme cases, vesicular pustulation is possible.

"I found that patients really didn’t complain of pain," said Dr. Bettencourt. "Most local skin reactions were resolved within a week." She prescribed moisturizers for patients whose reactions were moderate.

The findings were published in the March issue of the Journal of Drugs in Dermatology (J. Drugs Dermatol. 2014:13:269-73).

The results negate the common tenet that the more severe the reaction to the topical, the deeper the healing of the AK, said Dr. Bettencourt. "The degree of reaction does not correlate with the level of improvement. We used to think so, but that’s not true." The results show that the reaction can be "tolerable" and short lived despite dramatic results, she said.

The gel was approved by the Food and Drug Administration for use in the United States in early 2012 under the name Picato (LEO Pharmaceuticals). Unlike other topicals that must be applied over the course of weeks, the gel is applied for 2 or 3 days, with side effects lasting much of that time.

In addition to increased compliance, Dr. Bettencourt said she also measured whether her off-label "creativity" such as prescribing higher concentrations for the scalp and instructing patients to spread the gel over larger areas, yielded worthwhile results.

"I found that, especially for the face, you can spread the medication without jeopardizing the efficacy," said Dr. Bettencourt. However, when the gel is applied to the scalp, "You lose a little bit of the efficacy, because that’s a lot to cover using the prescribed three tubes, but you still get good results."

In addition, Dr. Bettencourt said that the gel offers cosmetic advantages over other treatments such as the topical imiquimod or photodynamic therapy because there is no hypo- or hyperpigmentation. And, because there is no photosensitivity associated with the gel, Dr. Bettencourt said she can offer it year-round.

She still prescribes other topicals, however, because not all patients’ insurance plans cover the gel. Medicare, does cover the gel, she noted, but only if the patient has a supplemental insurance policy.

While the study was unsponsored, and Dr. Bettencourt had no financial conflicts to disclose, she noted that she has shared her data with LEO Pharmaceuticals, the gel’s manufacturer. "They were thrilled, and helped me to put the results together," she said.

[email protected]

On Twitter @whitneymcknight

Ingenol mebutate gel for the treatment of actinic keratosis is an effective adjunct therapy to cryosurgery, and the absence of attendant serious local reactions can increase compliance, based on data from more than 100 patients.

"By the time you do see a reaction, because the treatment time is only 2 or 3 days, the patient is done applying it, so the compliance is increased," Dr. Miriam S. Bettencourt, a community-based dermatologist in Las Vegas.

Dr. Bettencourt conducted her chart review of 135 patients "out of curiosity," she said in an interview. She found that at follow-ups of 1-4 months, nearly 100% of patients who received ingenol mebutate gel as an adjunctive therapy with cryosurgery for AK on the face had clearance rates of at least 75%. In addition, clearance of at least 75% was seen in 89% of patients treated on the scalp and 84% of patients treated on the forearms and/or hands. Most of the patients were male (88%), ranging in age from 39 to 85 years, with a median age of 70 years.

"One of the questions I had was, in a clinical practice, whether [the gel] mimics the clinical trial results that showed only a mild to moderate reaction," said Dr. Bettencourt. Common side affects of topical AK treatments include erythema, flaking, scaling, and crusting. In more extreme cases, vesicular pustulation is possible.

"I found that patients really didn’t complain of pain," said Dr. Bettencourt. "Most local skin reactions were resolved within a week." She prescribed moisturizers for patients whose reactions were moderate.

The findings were published in the March issue of the Journal of Drugs in Dermatology (J. Drugs Dermatol. 2014:13:269-73).

The results negate the common tenet that the more severe the reaction to the topical, the deeper the healing of the AK, said Dr. Bettencourt. "The degree of reaction does not correlate with the level of improvement. We used to think so, but that’s not true." The results show that the reaction can be "tolerable" and short lived despite dramatic results, she said.

The gel was approved by the Food and Drug Administration for use in the United States in early 2012 under the name Picato (LEO Pharmaceuticals). Unlike other topicals that must be applied over the course of weeks, the gel is applied for 2 or 3 days, with side effects lasting much of that time.

In addition to increased compliance, Dr. Bettencourt said she also measured whether her off-label "creativity" such as prescribing higher concentrations for the scalp and instructing patients to spread the gel over larger areas, yielded worthwhile results.

"I found that, especially for the face, you can spread the medication without jeopardizing the efficacy," said Dr. Bettencourt. However, when the gel is applied to the scalp, "You lose a little bit of the efficacy, because that’s a lot to cover using the prescribed three tubes, but you still get good results."

In addition, Dr. Bettencourt said that the gel offers cosmetic advantages over other treatments such as the topical imiquimod or photodynamic therapy because there is no hypo- or hyperpigmentation. And, because there is no photosensitivity associated with the gel, Dr. Bettencourt said she can offer it year-round.

She still prescribes other topicals, however, because not all patients’ insurance plans cover the gel. Medicare, does cover the gel, she noted, but only if the patient has a supplemental insurance policy.

While the study was unsponsored, and Dr. Bettencourt had no financial conflicts to disclose, she noted that she has shared her data with LEO Pharmaceuticals, the gel’s manufacturer. "They were thrilled, and helped me to put the results together," she said.

[email protected]

On Twitter @whitneymcknight

SCOTTSDALE, ARIZ. – Applying a paracervical block before laparoscopic supracervical hysterectomy improves some operative outcomes but not others, Dr. Rachel L. Barr said at the annual scientific meeting of the Society of Gynecologic Surgeons.

The 132 women undergoing scheduled ambulatory surgery for presumed benign indications were randomized evenly to receive paracervical injection of bupivacaine plus epinephrine or paracervical injection of normal saline as a placebo control, each in addition to standard anesthesia.

Overall, about one-third of women were admitted to the hospital after the surgery – the trial’s primary outcome – with no significant difference between groups, reported lead investigator Dr. Rachel L. Barr, an obstetrician-gynecologist at Mount Sinai Hospital in New York. The findings were similar when restricted to women admitted specifically for pain management.

The paracervical-block group consumed about one-tenth of a tablet less of narcotics per day after surgery. They also had significantly lower estimated blood loss, although the median value was identical at 100 mL.

"The paracervical block with bupivacaine and epinephrine before laparoscopic supracervical hysterectomy is recommended to decrease the number of postoperative narcotic tablets consumed. It has the additional benefit of decreased blood loss and was found to be safe," Dr. Barr commented. "However, it was not effective at decreasing admissions for pain control."

"My first question for the authors relates to the clinical vs. statistical significance of the estimated blood loss and its variability in measurement and whether the authors considered using hematocrit in the study design," said invited discussant Dr. Clifford Wai of the division of female pelvic medicine and reconstructive surgery, University of Texas Southwestern Medical Center, Dallas.

The attending surgeon who performed all of the hysterectomies was very experienced, which likely helped achieve fairly low estimated blood loss in general, according to Dr. Barr. "So within this population, maybe the 50-mL difference between the two groups [in interquartile ranges] may not be that clinically significant."

"However, if you were to generalize this to other surgeons who maybe don’t do quite as many laparoscopic supracervical hysterectomies or on average have a higher blood loss, there may be a role for the paracervical block in helping decrease their blood loss, and you may see a larger decrease in blood loss when using the block," she added. "In addition, I think the block can be used as a tool to reduce blood loss in cases where, based on uterine size or pathology, you might predict there would be a higher blood loss, or in patients who have a lower hematocrit to begin with and refuse transfusions; this might decrease their blood loss and improve their recovery."

The investigators did not use hematocrit because they expected many patients to go home after surgery, and they do not routinely obtain a complete blood cell count in the postanesthesia care unit unless there is a clinical indication, she said at the meeting jointly sponsored by the American College of Surgeons.

"My second question is, given the limitations of the study, do the authors feel the conclusions justify a change in clinical practice?" Dr. Wai asked.

"We do now use the paracervical block with bupivacaine and epinephrine for all of our patients prior to laparoscopic supracervical hysterectomy," Dr. Barr replied.

Session attendee Dr. William W. Hurd, professor of obstetrics and gynecology at Duke University, Durham, N.C., and director of the division of reproductive endocrinology and infertility at the Duke Fertility Center, wondered, "Do you think that tiny change in pain medication would be clinically significant?"

"I do," Dr. Barr answered. "Maybe it’s not clinically significant just looking at that one value. But when you are talking to your patients preoperatively and they are asking, ‘Doctor, am I going to be taking tons of narcotics after? Am I going to get addicted?’ I think you can reassure them that over their postoperative course they might only need to take one or two tablets instead of two or three over several days. This might not seem like a lot to us, but I think that difference is reassuring to our patients."

The investigators studied patients undergoing laparoscopic supracervical hysterectomy at Mount Sinai Hospital between 2011 and 2013.

"In designing our study, we had noted that many patients at our institution were staying overnight electively in the hospital for pain management despite otherwise being stable for discharge home following laparoscopic hysterectomy," noted Dr. Barr.

The paracervical injection was performed after intubation but before the uterine manipulator was inserted or the abdominal incision was made. Admission was defined as at least one overnight stay in the hospital.

Results showed that the paracervical block and control groups were statistically indistinguishable with respect to the overall admission rate (41% vs. 28%) and the unplanned admission rate (34% vs. 27%). In the subset with an unplanned admission, 21 women were admitted for pain management: 10 in the paracervical-block group and 11 in the control group.

Use of fentanyl and use of oxycodone while in the postanesthesia care unit did not differ significantly between groups. However, in the first 14 days after surgery, the paracervical block group consumed fewer tablets of narcotics per day (0.58 vs. 0.71) and more tablets of over-the-counter analgesics per day (1.02 vs. 0.77). Mean pain scores during the first 2 postoperative days were essentially the same.

"Maybe the patients who didn’t have the block were using narcotics more to achieve a lower pain score. That’s one way to think about it," Dr. Barr proposed.

The two groups had similar rates of perioperative outcomes such as operative time and complications. Estimated median blood loss was generally low, but significantly lower in the paracervical block group.

"Out of all 132 patients, we only had 7 patients who had a blood loss greater than or equal to 500 mL, and the largest blood loss was 900 mL. Also, there were no transfusions," she pointed out.

Three patients – two in the paracervical block group and one in the control group – developed a cervical infection after surgery. All were successfully treated with oral antibiotics.

"The hysterectomies were all supracervical so the results may not apply to total hysterectomies, and we did not control for additional procedures performed at the same time," Dr. Barr noted.

Dr. Barr disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Applying a paracervical block before laparoscopic supracervical hysterectomy improves some operative outcomes but not others, Dr. Rachel L. Barr said at the annual scientific meeting of the Society of Gynecologic Surgeons.

The 132 women undergoing scheduled ambulatory surgery for presumed benign indications were randomized evenly to receive paracervical injection of bupivacaine plus epinephrine or paracervical injection of normal saline as a placebo control, each in addition to standard anesthesia.

Overall, about one-third of women were admitted to the hospital after the surgery – the trial’s primary outcome – with no significant difference between groups, reported lead investigator Dr. Rachel L. Barr, an obstetrician-gynecologist at Mount Sinai Hospital in New York. The findings were similar when restricted to women admitted specifically for pain management.

The paracervical-block group consumed about one-tenth of a tablet less of narcotics per day after surgery. They also had significantly lower estimated blood loss, although the median value was identical at 100 mL.

"The paracervical block with bupivacaine and epinephrine before laparoscopic supracervical hysterectomy is recommended to decrease the number of postoperative narcotic tablets consumed. It has the additional benefit of decreased blood loss and was found to be safe," Dr. Barr commented. "However, it was not effective at decreasing admissions for pain control."

"My first question for the authors relates to the clinical vs. statistical significance of the estimated blood loss and its variability in measurement and whether the authors considered using hematocrit in the study design," said invited discussant Dr. Clifford Wai of the division of female pelvic medicine and reconstructive surgery, University of Texas Southwestern Medical Center, Dallas.

The attending surgeon who performed all of the hysterectomies was very experienced, which likely helped achieve fairly low estimated blood loss in general, according to Dr. Barr. "So within this population, maybe the 50-mL difference between the two groups [in interquartile ranges] may not be that clinically significant."

"However, if you were to generalize this to other surgeons who maybe don’t do quite as many laparoscopic supracervical hysterectomies or on average have a higher blood loss, there may be a role for the paracervical block in helping decrease their blood loss, and you may see a larger decrease in blood loss when using the block," she added. "In addition, I think the block can be used as a tool to reduce blood loss in cases where, based on uterine size or pathology, you might predict there would be a higher blood loss, or in patients who have a lower hematocrit to begin with and refuse transfusions; this might decrease their blood loss and improve their recovery."

The investigators did not use hematocrit because they expected many patients to go home after surgery, and they do not routinely obtain a complete blood cell count in the postanesthesia care unit unless there is a clinical indication, she said at the meeting jointly sponsored by the American College of Surgeons.

"My second question is, given the limitations of the study, do the authors feel the conclusions justify a change in clinical practice?" Dr. Wai asked.

"We do now use the paracervical block with bupivacaine and epinephrine for all of our patients prior to laparoscopic supracervical hysterectomy," Dr. Barr replied.

Session attendee Dr. William W. Hurd, professor of obstetrics and gynecology at Duke University, Durham, N.C., and director of the division of reproductive endocrinology and infertility at the Duke Fertility Center, wondered, "Do you think that tiny change in pain medication would be clinically significant?"

"I do," Dr. Barr answered. "Maybe it’s not clinically significant just looking at that one value. But when you are talking to your patients preoperatively and they are asking, ‘Doctor, am I going to be taking tons of narcotics after? Am I going to get addicted?’ I think you can reassure them that over their postoperative course they might only need to take one or two tablets instead of two or three over several days. This might not seem like a lot to us, but I think that difference is reassuring to our patients."

The investigators studied patients undergoing laparoscopic supracervical hysterectomy at Mount Sinai Hospital between 2011 and 2013.

"In designing our study, we had noted that many patients at our institution were staying overnight electively in the hospital for pain management despite otherwise being stable for discharge home following laparoscopic hysterectomy," noted Dr. Barr.

The paracervical injection was performed after intubation but before the uterine manipulator was inserted or the abdominal incision was made. Admission was defined as at least one overnight stay in the hospital.

Results showed that the paracervical block and control groups were statistically indistinguishable with respect to the overall admission rate (41% vs. 28%) and the unplanned admission rate (34% vs. 27%). In the subset with an unplanned admission, 21 women were admitted for pain management: 10 in the paracervical-block group and 11 in the control group.

Use of fentanyl and use of oxycodone while in the postanesthesia care unit did not differ significantly between groups. However, in the first 14 days after surgery, the paracervical block group consumed fewer tablets of narcotics per day (0.58 vs. 0.71) and more tablets of over-the-counter analgesics per day (1.02 vs. 0.77). Mean pain scores during the first 2 postoperative days were essentially the same.

"Maybe the patients who didn’t have the block were using narcotics more to achieve a lower pain score. That’s one way to think about it," Dr. Barr proposed.

The two groups had similar rates of perioperative outcomes such as operative time and complications. Estimated median blood loss was generally low, but significantly lower in the paracervical block group.

"Out of all 132 patients, we only had 7 patients who had a blood loss greater than or equal to 500 mL, and the largest blood loss was 900 mL. Also, there were no transfusions," she pointed out.

Three patients – two in the paracervical block group and one in the control group – developed a cervical infection after surgery. All were successfully treated with oral antibiotics.

"The hysterectomies were all supracervical so the results may not apply to total hysterectomies, and we did not control for additional procedures performed at the same time," Dr. Barr noted.

Dr. Barr disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Applying a paracervical block before laparoscopic supracervical hysterectomy improves some operative outcomes but not others, Dr. Rachel L. Barr said at the annual scientific meeting of the Society of Gynecologic Surgeons.

The 132 women undergoing scheduled ambulatory surgery for presumed benign indications were randomized evenly to receive paracervical injection of bupivacaine plus epinephrine or paracervical injection of normal saline as a placebo control, each in addition to standard anesthesia.

Overall, about one-third of women were admitted to the hospital after the surgery – the trial’s primary outcome – with no significant difference between groups, reported lead investigator Dr. Rachel L. Barr, an obstetrician-gynecologist at Mount Sinai Hospital in New York. The findings were similar when restricted to women admitted specifically for pain management.

The paracervical-block group consumed about one-tenth of a tablet less of narcotics per day after surgery. They also had significantly lower estimated blood loss, although the median value was identical at 100 mL.

"The paracervical block with bupivacaine and epinephrine before laparoscopic supracervical hysterectomy is recommended to decrease the number of postoperative narcotic tablets consumed. It has the additional benefit of decreased blood loss and was found to be safe," Dr. Barr commented. "However, it was not effective at decreasing admissions for pain control."

"My first question for the authors relates to the clinical vs. statistical significance of the estimated blood loss and its variability in measurement and whether the authors considered using hematocrit in the study design," said invited discussant Dr. Clifford Wai of the division of female pelvic medicine and reconstructive surgery, University of Texas Southwestern Medical Center, Dallas.

The attending surgeon who performed all of the hysterectomies was very experienced, which likely helped achieve fairly low estimated blood loss in general, according to Dr. Barr. "So within this population, maybe the 50-mL difference between the two groups [in interquartile ranges] may not be that clinically significant."

"However, if you were to generalize this to other surgeons who maybe don’t do quite as many laparoscopic supracervical hysterectomies or on average have a higher blood loss, there may be a role for the paracervical block in helping decrease their blood loss, and you may see a larger decrease in blood loss when using the block," she added. "In addition, I think the block can be used as a tool to reduce blood loss in cases where, based on uterine size or pathology, you might predict there would be a higher blood loss, or in patients who have a lower hematocrit to begin with and refuse transfusions; this might decrease their blood loss and improve their recovery."

The investigators did not use hematocrit because they expected many patients to go home after surgery, and they do not routinely obtain a complete blood cell count in the postanesthesia care unit unless there is a clinical indication, she said at the meeting jointly sponsored by the American College of Surgeons.

"My second question is, given the limitations of the study, do the authors feel the conclusions justify a change in clinical practice?" Dr. Wai asked.

"We do now use the paracervical block with bupivacaine and epinephrine for all of our patients prior to laparoscopic supracervical hysterectomy," Dr. Barr replied.

Session attendee Dr. William W. Hurd, professor of obstetrics and gynecology at Duke University, Durham, N.C., and director of the division of reproductive endocrinology and infertility at the Duke Fertility Center, wondered, "Do you think that tiny change in pain medication would be clinically significant?"

"I do," Dr. Barr answered. "Maybe it’s not clinically significant just looking at that one value. But when you are talking to your patients preoperatively and they are asking, ‘Doctor, am I going to be taking tons of narcotics after? Am I going to get addicted?’ I think you can reassure them that over their postoperative course they might only need to take one or two tablets instead of two or three over several days. This might not seem like a lot to us, but I think that difference is reassuring to our patients."

The investigators studied patients undergoing laparoscopic supracervical hysterectomy at Mount Sinai Hospital between 2011 and 2013.

"In designing our study, we had noted that many patients at our institution were staying overnight electively in the hospital for pain management despite otherwise being stable for discharge home following laparoscopic hysterectomy," noted Dr. Barr.

The paracervical injection was performed after intubation but before the uterine manipulator was inserted or the abdominal incision was made. Admission was defined as at least one overnight stay in the hospital.

Results showed that the paracervical block and control groups were statistically indistinguishable with respect to the overall admission rate (41% vs. 28%) and the unplanned admission rate (34% vs. 27%). In the subset with an unplanned admission, 21 women were admitted for pain management: 10 in the paracervical-block group and 11 in the control group.

Use of fentanyl and use of oxycodone while in the postanesthesia care unit did not differ significantly between groups. However, in the first 14 days after surgery, the paracervical block group consumed fewer tablets of narcotics per day (0.58 vs. 0.71) and more tablets of over-the-counter analgesics per day (1.02 vs. 0.77). Mean pain scores during the first 2 postoperative days were essentially the same.

"Maybe the patients who didn’t have the block were using narcotics more to achieve a lower pain score. That’s one way to think about it," Dr. Barr proposed.

The two groups had similar rates of perioperative outcomes such as operative time and complications. Estimated median blood loss was generally low, but significantly lower in the paracervical block group.

"Out of all 132 patients, we only had 7 patients who had a blood loss greater than or equal to 500 mL, and the largest blood loss was 900 mL. Also, there were no transfusions," she pointed out.

Three patients – two in the paracervical block group and one in the control group – developed a cervical infection after surgery. All were successfully treated with oral antibiotics.

"The hysterectomies were all supracervical so the results may not apply to total hysterectomies, and we did not control for additional procedures performed at the same time," Dr. Barr noted.

Dr. Barr disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – The advent of robotic technology has shifted both the approach used for hysterectomies and the involvement of residents in this surgery, suggest results of a retrospective cohort study reported at the annual meeting of the Society of Gynecologic Surgeons.

Researchers studied women undergoing hysterectomy at four hospitals that had both residents and fellows, comparing 732 surgeries from the pre-robot era (the year before the first robotic hysterectomy at the hospital) with 709 from the postrobot era (2011).

Results showed a significant decrease in the proportion of all hysterectomies that were total vaginal hysterectomies from 43% to 31%. Meanwhile, robotic hysterectomies accounted for 23% of the total by 2011.

In other findings, there was no significant change in the proportion of all hysterectomies having at least some resident involvement, according to operative reports: That value stood at 81% before robotic hysterectomy began and 82% afterward. However, in the postrobot era, residents were involved in nearly 89% of all nonrobotic hysterectomies, but only about 59% of robotic ones.

"These data provide early data on potential implications for robotic implementation," commented first author Dr. Peter C. Jeppson, a urogynecology fellow at Brown University, Providence, R.I. "At this point, the impact of the increasing diversity of hysterectomy approaches on resident education warrants further study."

"Resident involvement was based on dictated operative reports, so we do not know how much of each case was actually performed by the resident," he acknowledged at the meeting jointly sponsored by the American College of Surgeons. "However, one could argue that observing or assisting in more surgical cases provides important educational experience."

Invited discussant Dr. Shawn A. Menefee, an obstetrician-gynecologist at Kaiser Permanente, San Diego, noted, "While the rates of vaginal hysterectomy decreased in the postrobotic period, they still remained above what has been reported in the past. ... Given that resident training often reflects what technique is performed over a surgeon’s career, what impact do you believe this decrease in TVH [total vaginal hysterectomy] rates will have in the United States?"

"At this point, it’s a little bit speculative to state how this will impact the future global rates within the United States," Dr. Jeppson replied. "But I think that it is certainly possible that as the numbers decrease in training, that those numbers also decrease for postgraduates because it seems unlikely to me that residents in training, after graduating, would choose to do a procedure that they weren’t trained to do well."

Dr. Menefee noted that about one-fifth of cases were done by attendings who were urogynecologists. "Is vaginal hysterectomy becoming a procedure performed by subspecialists, and if you remove the urogynecologists at the sites, what would be the percentage of transvaginal hysterectomies performed?" he asked.

Urogynecologists performed about 40% of all hysterectomies in both eras, according to Dr. Jeppson. When these hysterectomies were removed from analyses, the share of the total that were done vaginally still fell, from 31% to 22%.

"While robotic hysterectomy offers limited-to-no benefits for benign hysterectomy, compared with other minimally invasive approaches, it does appear to impact residents’ already limited exposure. Can we adequately teach residents to safely perform multiple approaches, or do we have to choose which ones to teach?" Dr. Menefee wondered.

"My personal opinion is that we should be training residents to perform what’s best for the patients. So different patients may need a different type of surgery," Dr. Jeppson replied. "But with the restrictions placed on duty work hours and with the increasing diversity of the approaches that can be used, that may be difficult. But time will tell."

Session attendee Dr. Hal C. Lawrence III, executive vice president and CEO of the American Congress of Obstetricians and Gynecologists, asked, "What do you think we need to do as a specialty to get people back to doing vaginal surgery, which is just as effective, a whole lot less expensive, and has fewer complications?"

"I think that that will be something that we will have to address on the national level," Dr. Jeppson commented. "But having a commitment to vaginal surgery would be the place to start – there are other modalities that are important and useful, but to not abandon the proven approaches that have been established over a long period of time."

For the study, the researchers analyzed hysterectomies captured by the Fellows’ Pelvic Research Network, excluding those performed in the oncology setting and those done for emergent indications.

The women undergoing hysterectomy in the pre- and postrobot eras did not differ significantly with respect to age, body mass index, prior abdominal or pelvic surgery, insurance type, or mean uterine weight, reported Dr. Jeppson. Also, dysfunctional uterine bleeding was the most common indication for hysterectomy in both groups.

In addition to the observed decrease in vaginal hysterectomies and increase in robotic hysterectomies, there was also a significant reduction in the proportion of total abdominal hysterectomies, from 22% to 17%.

Dr. Jeppson disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – The advent of robotic technology has shifted both the approach used for hysterectomies and the involvement of residents in this surgery, suggest results of a retrospective cohort study reported at the annual meeting of the Society of Gynecologic Surgeons.

Researchers studied women undergoing hysterectomy at four hospitals that had both residents and fellows, comparing 732 surgeries from the pre-robot era (the year before the first robotic hysterectomy at the hospital) with 709 from the postrobot era (2011).

Results showed a significant decrease in the proportion of all hysterectomies that were total vaginal hysterectomies from 43% to 31%. Meanwhile, robotic hysterectomies accounted for 23% of the total by 2011.

In other findings, there was no significant change in the proportion of all hysterectomies having at least some resident involvement, according to operative reports: That value stood at 81% before robotic hysterectomy began and 82% afterward. However, in the postrobot era, residents were involved in nearly 89% of all nonrobotic hysterectomies, but only about 59% of robotic ones.

"These data provide early data on potential implications for robotic implementation," commented first author Dr. Peter C. Jeppson, a urogynecology fellow at Brown University, Providence, R.I. "At this point, the impact of the increasing diversity of hysterectomy approaches on resident education warrants further study."

"Resident involvement was based on dictated operative reports, so we do not know how much of each case was actually performed by the resident," he acknowledged at the meeting jointly sponsored by the American College of Surgeons. "However, one could argue that observing or assisting in more surgical cases provides important educational experience."

Invited discussant Dr. Shawn A. Menefee, an obstetrician-gynecologist at Kaiser Permanente, San Diego, noted, "While the rates of vaginal hysterectomy decreased in the postrobotic period, they still remained above what has been reported in the past. ... Given that resident training often reflects what technique is performed over a surgeon’s career, what impact do you believe this decrease in TVH [total vaginal hysterectomy] rates will have in the United States?"

"At this point, it’s a little bit speculative to state how this will impact the future global rates within the United States," Dr. Jeppson replied. "But I think that it is certainly possible that as the numbers decrease in training, that those numbers also decrease for postgraduates because it seems unlikely to me that residents in training, after graduating, would choose to do a procedure that they weren’t trained to do well."

Dr. Menefee noted that about one-fifth of cases were done by attendings who were urogynecologists. "Is vaginal hysterectomy becoming a procedure performed by subspecialists, and if you remove the urogynecologists at the sites, what would be the percentage of transvaginal hysterectomies performed?" he asked.

Urogynecologists performed about 40% of all hysterectomies in both eras, according to Dr. Jeppson. When these hysterectomies were removed from analyses, the share of the total that were done vaginally still fell, from 31% to 22%.

"While robotic hysterectomy offers limited-to-no benefits for benign hysterectomy, compared with other minimally invasive approaches, it does appear to impact residents’ already limited exposure. Can we adequately teach residents to safely perform multiple approaches, or do we have to choose which ones to teach?" Dr. Menefee wondered.

"My personal opinion is that we should be training residents to perform what’s best for the patients. So different patients may need a different type of surgery," Dr. Jeppson replied. "But with the restrictions placed on duty work hours and with the increasing diversity of the approaches that can be used, that may be difficult. But time will tell."

Session attendee Dr. Hal C. Lawrence III, executive vice president and CEO of the American Congress of Obstetricians and Gynecologists, asked, "What do you think we need to do as a specialty to get people back to doing vaginal surgery, which is just as effective, a whole lot less expensive, and has fewer complications?"

"I think that that will be something that we will have to address on the national level," Dr. Jeppson commented. "But having a commitment to vaginal surgery would be the place to start – there are other modalities that are important and useful, but to not abandon the proven approaches that have been established over a long period of time."

For the study, the researchers analyzed hysterectomies captured by the Fellows’ Pelvic Research Network, excluding those performed in the oncology setting and those done for emergent indications.

The women undergoing hysterectomy in the pre- and postrobot eras did not differ significantly with respect to age, body mass index, prior abdominal or pelvic surgery, insurance type, or mean uterine weight, reported Dr. Jeppson. Also, dysfunctional uterine bleeding was the most common indication for hysterectomy in both groups.

In addition to the observed decrease in vaginal hysterectomies and increase in robotic hysterectomies, there was also a significant reduction in the proportion of total abdominal hysterectomies, from 22% to 17%.

Dr. Jeppson disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – The advent of robotic technology has shifted both the approach used for hysterectomies and the involvement of residents in this surgery, suggest results of a retrospective cohort study reported at the annual meeting of the Society of Gynecologic Surgeons.

Researchers studied women undergoing hysterectomy at four hospitals that had both residents and fellows, comparing 732 surgeries from the pre-robot era (the year before the first robotic hysterectomy at the hospital) with 709 from the postrobot era (2011).

Results showed a significant decrease in the proportion of all hysterectomies that were total vaginal hysterectomies from 43% to 31%. Meanwhile, robotic hysterectomies accounted for 23% of the total by 2011.

In other findings, there was no significant change in the proportion of all hysterectomies having at least some resident involvement, according to operative reports: That value stood at 81% before robotic hysterectomy began and 82% afterward. However, in the postrobot era, residents were involved in nearly 89% of all nonrobotic hysterectomies, but only about 59% of robotic ones.

"These data provide early data on potential implications for robotic implementation," commented first author Dr. Peter C. Jeppson, a urogynecology fellow at Brown University, Providence, R.I. "At this point, the impact of the increasing diversity of hysterectomy approaches on resident education warrants further study."

"Resident involvement was based on dictated operative reports, so we do not know how much of each case was actually performed by the resident," he acknowledged at the meeting jointly sponsored by the American College of Surgeons. "However, one could argue that observing or assisting in more surgical cases provides important educational experience."

Invited discussant Dr. Shawn A. Menefee, an obstetrician-gynecologist at Kaiser Permanente, San Diego, noted, "While the rates of vaginal hysterectomy decreased in the postrobotic period, they still remained above what has been reported in the past. ... Given that resident training often reflects what technique is performed over a surgeon’s career, what impact do you believe this decrease in TVH [total vaginal hysterectomy] rates will have in the United States?"

"At this point, it’s a little bit speculative to state how this will impact the future global rates within the United States," Dr. Jeppson replied. "But I think that it is certainly possible that as the numbers decrease in training, that those numbers also decrease for postgraduates because it seems unlikely to me that residents in training, after graduating, would choose to do a procedure that they weren’t trained to do well."

Dr. Menefee noted that about one-fifth of cases were done by attendings who were urogynecologists. "Is vaginal hysterectomy becoming a procedure performed by subspecialists, and if you remove the urogynecologists at the sites, what would be the percentage of transvaginal hysterectomies performed?" he asked.

Urogynecologists performed about 40% of all hysterectomies in both eras, according to Dr. Jeppson. When these hysterectomies were removed from analyses, the share of the total that were done vaginally still fell, from 31% to 22%.

"While robotic hysterectomy offers limited-to-no benefits for benign hysterectomy, compared with other minimally invasive approaches, it does appear to impact residents’ already limited exposure. Can we adequately teach residents to safely perform multiple approaches, or do we have to choose which ones to teach?" Dr. Menefee wondered.

"My personal opinion is that we should be training residents to perform what’s best for the patients. So different patients may need a different type of surgery," Dr. Jeppson replied. "But with the restrictions placed on duty work hours and with the increasing diversity of the approaches that can be used, that may be difficult. But time will tell."

Session attendee Dr. Hal C. Lawrence III, executive vice president and CEO of the American Congress of Obstetricians and Gynecologists, asked, "What do you think we need to do as a specialty to get people back to doing vaginal surgery, which is just as effective, a whole lot less expensive, and has fewer complications?"

"I think that that will be something that we will have to address on the national level," Dr. Jeppson commented. "But having a commitment to vaginal surgery would be the place to start – there are other modalities that are important and useful, but to not abandon the proven approaches that have been established over a long period of time."

For the study, the researchers analyzed hysterectomies captured by the Fellows’ Pelvic Research Network, excluding those performed in the oncology setting and those done for emergent indications.

The women undergoing hysterectomy in the pre- and postrobot eras did not differ significantly with respect to age, body mass index, prior abdominal or pelvic surgery, insurance type, or mean uterine weight, reported Dr. Jeppson. Also, dysfunctional uterine bleeding was the most common indication for hysterectomy in both groups.

In addition to the observed decrease in vaginal hysterectomies and increase in robotic hysterectomies, there was also a significant reduction in the proportion of total abdominal hysterectomies, from 22% to 17%.

Dr. Jeppson disclosed no relevant conflicts of interest.

PHOENIX – In patients with recurrent papillary thyroid cancer, fine-needle aspiration cytology and thyroglobulin washout was a highly sensitive and specific means of detecting metastatic disease, according to a retrospective analysis.

Surgeon-performed FNA-Tg washout appears to increase the diagnostic accuracy in detecting metastatic disease in this patient population. Routine performance of the combined modalities should be considered in patients with suspicious metastatic lymphadenopathies, said Dr. Hossam Mohamed of the division of endocrine and oncological surgery in the department of surgery at Tulane University, New Orleans.

In a retrospective study of 117 patients with recurrent papillary thyroid cancer, the combination of surgeon-performed fine-needle aspiration cytology (FNAC) with fine-needle aspiration thyroglobulin washout (FNA-Tg) had a 100% specificity, 94.9% sensitivity, and negative predictive value of 93.75%, with a diagnostic accuracy of 97.1%, he said.

"Cervical lymph node involvement has been reported to be up to 46% at initial diagnosis, hence ultrasonography and fine-needle aspiration have been standard diagnostic modalities used to detect and evaluate cervical lymph nodes in patients with thyroid malignancies," he said at the annual Society of Surgical Oncology Cancer Symposium.

His team hypothesized that by adding surgeon-performed ultrasonography with Tg washout to FNAC for the management of patients with suspicious lymphadenopathies, they might be able to increase the accuracy of the combined tests for detecting metastatic disease in patients with recurrent papillary thyroid cancers.

In a retrospective study, they looked at results for patients who underwent preoperative FNAC and FNA-Tg washout followed by selective neck dissection. All dissections were performed by senior author Dr. Emad Kandil, chief of the endocrine surgery section at Tulane University.

They correlated the test results with the final pathology results of the dissected lymph nodes, and compared the sensitivity and specificity of the combined modalities to those of standard FNAC alone.

Of the 117 patients, 76% were female, and mean age was 52 years. Nearly half of the patients (47.6%) had cervical lymph node dissections, 39.7% had modified radical lymph node dissections, 6.35% had combined modified-radical, and 12.7% had combined modified-radical and cervical resections. Half of the group required second resections.

When the researchers compared the individual modalities to the final pathology results, they found that the respective sensitivity of FNAC, FNA-Tg, and the two combined were 84.6%, 89.4%, and 94.9%. They found the respective specificities to be 100%, 96.8%, and 100%.

The negative predictive value of FNAC was 87.1%. and of FNA-Tg was 85.7%. When the two diagnostic methods were used together, they ruled out metastases with 93.75% accuracy.

"Only one patient had a negative lymph node pathology with a positive FNA-Tg washout, which we couldn’t find an explanation for," Dr. Mohamed said.

Two patients who had negative FNA-Tg washout levels had evidence of atypical cells on FNAC and elevated serum Tg levels. These patients were therefore taken to surgery, and were found to have metastatic disease on final pathology, he said.

The study was internally funded. Dr. Mohamed reported having no financial disclosures.

PHOENIX – In patients with recurrent papillary thyroid cancer, fine-needle aspiration cytology and thyroglobulin washout was a highly sensitive and specific means of detecting metastatic disease, according to a retrospective analysis.

Surgeon-performed FNA-Tg washout appears to increase the diagnostic accuracy in detecting metastatic disease in this patient population. Routine performance of the combined modalities should be considered in patients with suspicious metastatic lymphadenopathies, said Dr. Hossam Mohamed of the division of endocrine and oncological surgery in the department of surgery at Tulane University, New Orleans.

In a retrospective study of 117 patients with recurrent papillary thyroid cancer, the combination of surgeon-performed fine-needle aspiration cytology (FNAC) with fine-needle aspiration thyroglobulin washout (FNA-Tg) had a 100% specificity, 94.9% sensitivity, and negative predictive value of 93.75%, with a diagnostic accuracy of 97.1%, he said.

"Cervical lymph node involvement has been reported to be up to 46% at initial diagnosis, hence ultrasonography and fine-needle aspiration have been standard diagnostic modalities used to detect and evaluate cervical lymph nodes in patients with thyroid malignancies," he said at the annual Society of Surgical Oncology Cancer Symposium.

His team hypothesized that by adding surgeon-performed ultrasonography with Tg washout to FNAC for the management of patients with suspicious lymphadenopathies, they might be able to increase the accuracy of the combined tests for detecting metastatic disease in patients with recurrent papillary thyroid cancers.

In a retrospective study, they looked at results for patients who underwent preoperative FNAC and FNA-Tg washout followed by selective neck dissection. All dissections were performed by senior author Dr. Emad Kandil, chief of the endocrine surgery section at Tulane University.

They correlated the test results with the final pathology results of the dissected lymph nodes, and compared the sensitivity and specificity of the combined modalities to those of standard FNAC alone.

Of the 117 patients, 76% were female, and mean age was 52 years. Nearly half of the patients (47.6%) had cervical lymph node dissections, 39.7% had modified radical lymph node dissections, 6.35% had combined modified-radical, and 12.7% had combined modified-radical and cervical resections. Half of the group required second resections.

When the researchers compared the individual modalities to the final pathology results, they found that the respective sensitivity of FNAC, FNA-Tg, and the two combined were 84.6%, 89.4%, and 94.9%. They found the respective specificities to be 100%, 96.8%, and 100%.

The negative predictive value of FNAC was 87.1%. and of FNA-Tg was 85.7%. When the two diagnostic methods were used together, they ruled out metastases with 93.75% accuracy.

"Only one patient had a negative lymph node pathology with a positive FNA-Tg washout, which we couldn’t find an explanation for," Dr. Mohamed said.

Two patients who had negative FNA-Tg washout levels had evidence of atypical cells on FNAC and elevated serum Tg levels. These patients were therefore taken to surgery, and were found to have metastatic disease on final pathology, he said.

The study was internally funded. Dr. Mohamed reported having no financial disclosures.

PHOENIX – In patients with recurrent papillary thyroid cancer, fine-needle aspiration cytology and thyroglobulin washout was a highly sensitive and specific means of detecting metastatic disease, according to a retrospective analysis.

Surgeon-performed FNA-Tg washout appears to increase the diagnostic accuracy in detecting metastatic disease in this patient population. Routine performance of the combined modalities should be considered in patients with suspicious metastatic lymphadenopathies, said Dr. Hossam Mohamed of the division of endocrine and oncological surgery in the department of surgery at Tulane University, New Orleans.

In a retrospective study of 117 patients with recurrent papillary thyroid cancer, the combination of surgeon-performed fine-needle aspiration cytology (FNAC) with fine-needle aspiration thyroglobulin washout (FNA-Tg) had a 100% specificity, 94.9% sensitivity, and negative predictive value of 93.75%, with a diagnostic accuracy of 97.1%, he said.

"Cervical lymph node involvement has been reported to be up to 46% at initial diagnosis, hence ultrasonography and fine-needle aspiration have been standard diagnostic modalities used to detect and evaluate cervical lymph nodes in patients with thyroid malignancies," he said at the annual Society of Surgical Oncology Cancer Symposium.

His team hypothesized that by adding surgeon-performed ultrasonography with Tg washout to FNAC for the management of patients with suspicious lymphadenopathies, they might be able to increase the accuracy of the combined tests for detecting metastatic disease in patients with recurrent papillary thyroid cancers.

In a retrospective study, they looked at results for patients who underwent preoperative FNAC and FNA-Tg washout followed by selective neck dissection. All dissections were performed by senior author Dr. Emad Kandil, chief of the endocrine surgery section at Tulane University.

They correlated the test results with the final pathology results of the dissected lymph nodes, and compared the sensitivity and specificity of the combined modalities to those of standard FNAC alone.

Of the 117 patients, 76% were female, and mean age was 52 years. Nearly half of the patients (47.6%) had cervical lymph node dissections, 39.7% had modified radical lymph node dissections, 6.35% had combined modified-radical, and 12.7% had combined modified-radical and cervical resections. Half of the group required second resections.

When the researchers compared the individual modalities to the final pathology results, they found that the respective sensitivity of FNAC, FNA-Tg, and the two combined were 84.6%, 89.4%, and 94.9%. They found the respective specificities to be 100%, 96.8%, and 100%.

The negative predictive value of FNAC was 87.1%. and of FNA-Tg was 85.7%. When the two diagnostic methods were used together, they ruled out metastases with 93.75% accuracy.

"Only one patient had a negative lymph node pathology with a positive FNA-Tg washout, which we couldn’t find an explanation for," Dr. Mohamed said.

Two patients who had negative FNA-Tg washout levels had evidence of atypical cells on FNAC and elevated serum Tg levels. These patients were therefore taken to surgery, and were found to have metastatic disease on final pathology, he said.

The study was internally funded. Dr. Mohamed reported having no financial disclosures.

PHOENIX – There is more evidence that it’s best to go with the pros: Adrenalectomies performed by higher-volume surgeons are associated with fewer complications, lower costs, and shorter lengths of stay than are those done by surgeons who dabble in the procedure.

The findings, presented at the annual Society of Surgical Oncology Cancer Symposium, come from a cross-sectional study of outcomes on all patients who underwent unilateral, partial, or bilateral adrenalectomies in the United States over a 7-year span.

©Jana Blašková/ Thinkstockphotos.com

"The frequency of adrenalectomy has steadily increased in the United States within the last few years, and with improvement of diagnostic and imaging modalities it’s likely that the rate of adrenal surgery will continue to rise," said Dr. Adam Hauch, a research resident in the department of surgery at Tulane University, New Orleans.

The prospects for the growth in the procedure prompted Dr. Hauch and colleagues to look at clinical and economic outcomes following adrenalectomy, and to see how surgeon volume, diagnosis, and type of surgery might affect outcomes.

They drew on discharge data from the Healthcare Cost and Utilization Project – National Inpatient Sample (HCUP-NIS), an administrative database sponsored by the U.S. Agency for Healthcare Research and Quality.

The information included International Classification of Diseases, Ninth Revision (ICD-9) codes identifying all adult patients who underwent adrenalectomies in U.S. hospitals from 2003 through 2009. Patients were divided into benign and malignant lesion groups.

The investigators found 7,829 procedures. Mean patient age was 50 years, most of the patients (74.4%) were white, and the majority were female (58.2%) and were privately insured (58.9%). Nearly all of the patients (98.3%) had one or no comorbidities at the time of admission. Only 42 patients (0.5%) died during their hospital stays.

More than three-fourths of the procedures (79.2%) were for benign disease; the remaining 20.8% of surgeries were for malignancies.

Low-volume surgeons, defined as those who performed one or fewer adrenalectomies on average per year, performed 41.7% of all procedures, compared with 34.7% for intermediate-volume surgeons (two to five per year) and 23.6% for high-volume surgeons (more than five per year).

The vast majority (97.1%) of procedures were unilateral/partial, and approximately 95% of surgeons in each experience category performed such procedures. Procedures for malignant disease accounted for 10.6% of cases for low-volume surgeons, 6.3% for intermediate-volume docs, and 4.3% of the most prolific surgeons.

It’s complicated

Risks for any complication were significantly higher among low-volume surgeons (18.8% of their cases), compared with 14.6% for those in the middle, and 11.6% for the high-volume operators (P less than .0001). High-volume performers had significantly lower risk for cardiovascular complications (P = .0008), pulmonary complications (P = .0481), bleeding (P = .0106), and technical difficulties during surgery (P = .0024).

In an analysis adjusted for patient demographic factors, payer, primary diagnosis, obesity, comorbidities, inpatient death, admission type, hospital teaching status and volume, surgeon, and type of procedure, low-volume surgeons were nearly twice as likely as were high-volume surgeons to have complications (adjusted odds ratio [aOR] 1.822, P less than .0001), and intermediate-volume surgeons had a nearly 1.5-fold higher risk (aOR 1.479, P = .0044).

Other risk factors for complications were bilateral vs. unilateral procedures (aOR 2.165, P = .0018), and malignant vs. benign disease (aOR 1.685, P less than .0001).

Not surprisingly, complications more than doubled mean total case charges, which ranged from $33,659 for uncomplicated unilateral cases to $73,021 for complicated cases (P = .0013), and from $47,284 for bilateral cases with no complications, to $141,461 for two-sided procedures with complications (P = .0221). Charges were higher for malignant cases than for benign cases without complications (P less than .0001), but complications brought the charges for both benign and malignant cases closer together .

Charges for noncomplicated procedures performed by high-volume surgeons were a comparative bargain at $27,324, compared with $33,499 for low- and intermediate-volume surgeons combined (P = .001). However, there were no significant differences by surgeon volume when complications arose.

Similarly, lengths of stay were prolonged when complications ensued for both unilateral cases (mean 3.7 days vs. 9.3 for complicated cases, P = .0042) and for bilateral cases (9.3 vs. 19.8, P = .025).

Higher volume surgeons managed to get patients out faster, averaging 2.7 days for cases without complications, compared with 4.2 for low/intermediate-volume surgeons (P less than .0001). When complications arose, patients of higher-volume surgeons still had shorter lengths of stay (8.5 vs. 10.4 days), but this difference was not statistically significant.

Dr. Lawrence Kim, professor of surgery at the University of North Carolina, Chapel Hill, said after the presentation that the study showed the limitations of using administrative data.

He said that approximately "98% of the patients [in the study presented] had no comorbidities, which just does not mesh with the realities I have ever faced with adrenal patients."

The study was internally funded. Dr. Hauch reported having no financial disclosures.

PHOENIX – There is more evidence that it’s best to go with the pros: Adrenalectomies performed by higher-volume surgeons are associated with fewer complications, lower costs, and shorter lengths of stay than are those done by surgeons who dabble in the procedure.

The findings, presented at the annual Society of Surgical Oncology Cancer Symposium, come from a cross-sectional study of outcomes on all patients who underwent unilateral, partial, or bilateral adrenalectomies in the United States over a 7-year span.

©Jana Blašková/ Thinkstockphotos.com

"The frequency of adrenalectomy has steadily increased in the United States within the last few years, and with improvement of diagnostic and imaging modalities it’s likely that the rate of adrenal surgery will continue to rise," said Dr. Adam Hauch, a research resident in the department of surgery at Tulane University, New Orleans.

The prospects for the growth in the procedure prompted Dr. Hauch and colleagues to look at clinical and economic outcomes following adrenalectomy, and to see how surgeon volume, diagnosis, and type of surgery might affect outcomes.

They drew on discharge data from the Healthcare Cost and Utilization Project – National Inpatient Sample (HCUP-NIS), an administrative database sponsored by the U.S. Agency for Healthcare Research and Quality.

The information included International Classification of Diseases, Ninth Revision (ICD-9) codes identifying all adult patients who underwent adrenalectomies in U.S. hospitals from 2003 through 2009. Patients were divided into benign and malignant lesion groups.

The investigators found 7,829 procedures. Mean patient age was 50 years, most of the patients (74.4%) were white, and the majority were female (58.2%) and were privately insured (58.9%). Nearly all of the patients (98.3%) had one or no comorbidities at the time of admission. Only 42 patients (0.5%) died during their hospital stays.

More than three-fourths of the procedures (79.2%) were for benign disease; the remaining 20.8% of surgeries were for malignancies.

Low-volume surgeons, defined as those who performed one or fewer adrenalectomies on average per year, performed 41.7% of all procedures, compared with 34.7% for intermediate-volume surgeons (two to five per year) and 23.6% for high-volume surgeons (more than five per year).

The vast majority (97.1%) of procedures were unilateral/partial, and approximately 95% of surgeons in each experience category performed such procedures. Procedures for malignant disease accounted for 10.6% of cases for low-volume surgeons, 6.3% for intermediate-volume docs, and 4.3% of the most prolific surgeons.

It’s complicated

Risks for any complication were significantly higher among low-volume surgeons (18.8% of their cases), compared with 14.6% for those in the middle, and 11.6% for the high-volume operators (P less than .0001). High-volume performers had significantly lower risk for cardiovascular complications (P = .0008), pulmonary complications (P = .0481), bleeding (P = .0106), and technical difficulties during surgery (P = .0024).

In an analysis adjusted for patient demographic factors, payer, primary diagnosis, obesity, comorbidities, inpatient death, admission type, hospital teaching status and volume, surgeon, and type of procedure, low-volume surgeons were nearly twice as likely as were high-volume surgeons to have complications (adjusted odds ratio [aOR] 1.822, P less than .0001), and intermediate-volume surgeons had a nearly 1.5-fold higher risk (aOR 1.479, P = .0044).

Other risk factors for complications were bilateral vs. unilateral procedures (aOR 2.165, P = .0018), and malignant vs. benign disease (aOR 1.685, P less than .0001).

Not surprisingly, complications more than doubled mean total case charges, which ranged from $33,659 for uncomplicated unilateral cases to $73,021 for complicated cases (P = .0013), and from $47,284 for bilateral cases with no complications, to $141,461 for two-sided procedures with complications (P = .0221). Charges were higher for malignant cases than for benign cases without complications (P less than .0001), but complications brought the charges for both benign and malignant cases closer together .

Charges for noncomplicated procedures performed by high-volume surgeons were a comparative bargain at $27,324, compared with $33,499 for low- and intermediate-volume surgeons combined (P = .001). However, there were no significant differences by surgeon volume when complications arose.

Similarly, lengths of stay were prolonged when complications ensued for both unilateral cases (mean 3.7 days vs. 9.3 for complicated cases, P = .0042) and for bilateral cases (9.3 vs. 19.8, P = .025).

Higher volume surgeons managed to get patients out faster, averaging 2.7 days for cases without complications, compared with 4.2 for low/intermediate-volume surgeons (P less than .0001). When complications arose, patients of higher-volume surgeons still had shorter lengths of stay (8.5 vs. 10.4 days), but this difference was not statistically significant.

Dr. Lawrence Kim, professor of surgery at the University of North Carolina, Chapel Hill, said after the presentation that the study showed the limitations of using administrative data.

He said that approximately "98% of the patients [in the study presented] had no comorbidities, which just does not mesh with the realities I have ever faced with adrenal patients."

The study was internally funded. Dr. Hauch reported having no financial disclosures.

PHOENIX – There is more evidence that it’s best to go with the pros: Adrenalectomies performed by higher-volume surgeons are associated with fewer complications, lower costs, and shorter lengths of stay than are those done by surgeons who dabble in the procedure.

The findings, presented at the annual Society of Surgical Oncology Cancer Symposium, come from a cross-sectional study of outcomes on all patients who underwent unilateral, partial, or bilateral adrenalectomies in the United States over a 7-year span.

©Jana Blašková/ Thinkstockphotos.com

"The frequency of adrenalectomy has steadily increased in the United States within the last few years, and with improvement of diagnostic and imaging modalities it’s likely that the rate of adrenal surgery will continue to rise," said Dr. Adam Hauch, a research resident in the department of surgery at Tulane University, New Orleans.

The prospects for the growth in the procedure prompted Dr. Hauch and colleagues to look at clinical and economic outcomes following adrenalectomy, and to see how surgeon volume, diagnosis, and type of surgery might affect outcomes.

They drew on discharge data from the Healthcare Cost and Utilization Project – National Inpatient Sample (HCUP-NIS), an administrative database sponsored by the U.S. Agency for Healthcare Research and Quality.

The information included International Classification of Diseases, Ninth Revision (ICD-9) codes identifying all adult patients who underwent adrenalectomies in U.S. hospitals from 2003 through 2009. Patients were divided into benign and malignant lesion groups.

The investigators found 7,829 procedures. Mean patient age was 50 years, most of the patients (74.4%) were white, and the majority were female (58.2%) and were privately insured (58.9%). Nearly all of the patients (98.3%) had one or no comorbidities at the time of admission. Only 42 patients (0.5%) died during their hospital stays.

More than three-fourths of the procedures (79.2%) were for benign disease; the remaining 20.8% of surgeries were for malignancies.

Low-volume surgeons, defined as those who performed one or fewer adrenalectomies on average per year, performed 41.7% of all procedures, compared with 34.7% for intermediate-volume surgeons (two to five per year) and 23.6% for high-volume surgeons (more than five per year).

The vast majority (97.1%) of procedures were unilateral/partial, and approximately 95% of surgeons in each experience category performed such procedures. Procedures for malignant disease accounted for 10.6% of cases for low-volume surgeons, 6.3% for intermediate-volume docs, and 4.3% of the most prolific surgeons.

It’s complicated

Risks for any complication were significantly higher among low-volume surgeons (18.8% of their cases), compared with 14.6% for those in the middle, and 11.6% for the high-volume operators (P less than .0001). High-volume performers had significantly lower risk for cardiovascular complications (P = .0008), pulmonary complications (P = .0481), bleeding (P = .0106), and technical difficulties during surgery (P = .0024).

In an analysis adjusted for patient demographic factors, payer, primary diagnosis, obesity, comorbidities, inpatient death, admission type, hospital teaching status and volume, surgeon, and type of procedure, low-volume surgeons were nearly twice as likely as were high-volume surgeons to have complications (adjusted odds ratio [aOR] 1.822, P less than .0001), and intermediate-volume surgeons had a nearly 1.5-fold higher risk (aOR 1.479, P = .0044).

Other risk factors for complications were bilateral vs. unilateral procedures (aOR 2.165, P = .0018), and malignant vs. benign disease (aOR 1.685, P less than .0001).

Not surprisingly, complications more than doubled mean total case charges, which ranged from $33,659 for uncomplicated unilateral cases to $73,021 for complicated cases (P = .0013), and from $47,284 for bilateral cases with no complications, to $141,461 for two-sided procedures with complications (P = .0221). Charges were higher for malignant cases than for benign cases without complications (P less than .0001), but complications brought the charges for both benign and malignant cases closer together .

Charges for noncomplicated procedures performed by high-volume surgeons were a comparative bargain at $27,324, compared with $33,499 for low- and intermediate-volume surgeons combined (P = .001). However, there were no significant differences by surgeon volume when complications arose.

Similarly, lengths of stay were prolonged when complications ensued for both unilateral cases (mean 3.7 days vs. 9.3 for complicated cases, P = .0042) and for bilateral cases (9.3 vs. 19.8, P = .025).

Higher volume surgeons managed to get patients out faster, averaging 2.7 days for cases without complications, compared with 4.2 for low/intermediate-volume surgeons (P less than .0001). When complications arose, patients of higher-volume surgeons still had shorter lengths of stay (8.5 vs. 10.4 days), but this difference was not statistically significant.

Dr. Lawrence Kim, professor of surgery at the University of North Carolina, Chapel Hill, said after the presentation that the study showed the limitations of using administrative data.

He said that approximately "98% of the patients [in the study presented] had no comorbidities, which just does not mesh with the realities I have ever faced with adrenal patients."

The study was internally funded. Dr. Hauch reported having no financial disclosures.

PHOENIX – More than one-fourth of men under age 50 undergoing surgery for benign goiter were found to have thyroid cancers, based on a chart review performed at the University of Pennsylvania.

The overall incidence of thyroid cancers in the patient series was 12%. Among men under age 45, the rate was "surprisingly" 28%, said Douglas R. Farquhar, a medical student at the University of Pennsylvania School of Medicine in Philadelphia.

Neil Osterweil/Frontline Medical News

Although thyroid goiters have traditionally been thought to be associated with a low risk for malignancy, recent studies have suggested otherwise. "In the literature we have seen published rates of up to 35%, which is much higher than we all had anticipated," Mr. Farquhar said at the annual Society of Surgical Oncology Cancer Symposium.

To get a better handle on the preoperative and patient characteristics associated with incident thyroid cancer and characterize the types of thyroid cancer discovered incidentally, Mr. Farquhar and his colleagues reviewed charts on all patients who underwent either total thyroidectomy or thyroid lobectomy for goiter at the center from 2004 through 2012.

Many cases of goiter can be medically managed, but surgery may be indicated in cases of pressure symptoms, cosmesis, or suspicion of malignancy, the investigators noted.

They excluded from their study patients with preoperative fine-needle aspiration pathology findings of Bethesda level III-VI (follicular lesion of undetermined significance, follicular neoplasm, suspicious or positive for malignancy).

Among 418 patients undergoing goiter surgery, 367 had goiter only, and 51 (12%) had an incident thyroid cancer. In all, 38 (75%) had papillary carcinomas, 10 (20%) had follicular carcinomas, 3 (6%) had Hürthle cell carcinomas, and 2 (4%) had thyroid lymphomas (two patients had multiple thyroid cancers, explaining the percentage greater than 100). An additional 67 patients (16%) were found to have micropapillary lesions.

Looking at the population as a whole, the investigators found that patients with thyroid cancer tended to be younger, with a mean age of 49.5 vs. 54.6 years (P = .012). There was a trend toward more cancers among men than women, but it was not significant.

There were no significant differences in any preoperative factors between patients with cancers and those with goiter only, including number of nodules, site of dominant nodule (right, left, or isthmus), thyroid function, thyroid weight, or fine-needle aspiration results (percentage deemed benign or nondiagnostic).

In a multivariate analysis, male sex was associated with a more than twofold risk for thyroid cancer (odds ratio, 2.39; 95% confidence interval, 1.152-4.978). There were also trends toward a lower risk of cancer with each additional decade of life, and a higher risk among patients who had undergone thyroid lobectomy, but these were nonsignificant associations.

"Knowledge of these associations may prove to be useful for both patient counseling and surgical decision making," Mr. Farquhar said.

The study was internally funded. The senior author was Dr. Douglas L. Fraker, chief of the division of endocrine and oncologic surgery at the University of Pennsylvania.

Mr. Farquhar and his coauthors reported having no relevant financial disclosures.

PHOENIX – More than one-fourth of men under age 50 undergoing surgery for benign goiter were found to have thyroid cancers, based on a chart review performed at the University of Pennsylvania.

The overall incidence of thyroid cancers in the patient series was 12%. Among men under age 45, the rate was "surprisingly" 28%, said Douglas R. Farquhar, a medical student at the University of Pennsylvania School of Medicine in Philadelphia.

Neil Osterweil/Frontline Medical News

Although thyroid goiters have traditionally been thought to be associated with a low risk for malignancy, recent studies have suggested otherwise. "In the literature we have seen published rates of up to 35%, which is much higher than we all had anticipated," Mr. Farquhar said at the annual Society of Surgical Oncology Cancer Symposium.

To get a better handle on the preoperative and patient characteristics associated with incident thyroid cancer and characterize the types of thyroid cancer discovered incidentally, Mr. Farquhar and his colleagues reviewed charts on all patients who underwent either total thyroidectomy or thyroid lobectomy for goiter at the center from 2004 through 2012.

Many cases of goiter can be medically managed, but surgery may be indicated in cases of pressure symptoms, cosmesis, or suspicion of malignancy, the investigators noted.

They excluded from their study patients with preoperative fine-needle aspiration pathology findings of Bethesda level III-VI (follicular lesion of undetermined significance, follicular neoplasm, suspicious or positive for malignancy).

Among 418 patients undergoing goiter surgery, 367 had goiter only, and 51 (12%) had an incident thyroid cancer. In all, 38 (75%) had papillary carcinomas, 10 (20%) had follicular carcinomas, 3 (6%) had Hürthle cell carcinomas, and 2 (4%) had thyroid lymphomas (two patients had multiple thyroid cancers, explaining the percentage greater than 100). An additional 67 patients (16%) were found to have micropapillary lesions.

Looking at the population as a whole, the investigators found that patients with thyroid cancer tended to be younger, with a mean age of 49.5 vs. 54.6 years (P = .012). There was a trend toward more cancers among men than women, but it was not significant.

There were no significant differences in any preoperative factors between patients with cancers and those with goiter only, including number of nodules, site of dominant nodule (right, left, or isthmus), thyroid function, thyroid weight, or fine-needle aspiration results (percentage deemed benign or nondiagnostic).

In a multivariate analysis, male sex was associated with a more than twofold risk for thyroid cancer (odds ratio, 2.39; 95% confidence interval, 1.152-4.978). There were also trends toward a lower risk of cancer with each additional decade of life, and a higher risk among patients who had undergone thyroid lobectomy, but these were nonsignificant associations.

"Knowledge of these associations may prove to be useful for both patient counseling and surgical decision making," Mr. Farquhar said.

The study was internally funded. The senior author was Dr. Douglas L. Fraker, chief of the division of endocrine and oncologic surgery at the University of Pennsylvania.

Mr. Farquhar and his coauthors reported having no relevant financial disclosures.

PHOENIX – More than one-fourth of men under age 50 undergoing surgery for benign goiter were found to have thyroid cancers, based on a chart review performed at the University of Pennsylvania.

The overall incidence of thyroid cancers in the patient series was 12%. Among men under age 45, the rate was "surprisingly" 28%, said Douglas R. Farquhar, a medical student at the University of Pennsylvania School of Medicine in Philadelphia.

Neil Osterweil/Frontline Medical News

Although thyroid goiters have traditionally been thought to be associated with a low risk for malignancy, recent studies have suggested otherwise. "In the literature we have seen published rates of up to 35%, which is much higher than we all had anticipated," Mr. Farquhar said at the annual Society of Surgical Oncology Cancer Symposium.

To get a better handle on the preoperative and patient characteristics associated with incident thyroid cancer and characterize the types of thyroid cancer discovered incidentally, Mr. Farquhar and his colleagues reviewed charts on all patients who underwent either total thyroidectomy or thyroid lobectomy for goiter at the center from 2004 through 2012.

Many cases of goiter can be medically managed, but surgery may be indicated in cases of pressure symptoms, cosmesis, or suspicion of malignancy, the investigators noted.

They excluded from their study patients with preoperative fine-needle aspiration pathology findings of Bethesda level III-VI (follicular lesion of undetermined significance, follicular neoplasm, suspicious or positive for malignancy).

Among 418 patients undergoing goiter surgery, 367 had goiter only, and 51 (12%) had an incident thyroid cancer. In all, 38 (75%) had papillary carcinomas, 10 (20%) had follicular carcinomas, 3 (6%) had Hürthle cell carcinomas, and 2 (4%) had thyroid lymphomas (two patients had multiple thyroid cancers, explaining the percentage greater than 100). An additional 67 patients (16%) were found to have micropapillary lesions.

Looking at the population as a whole, the investigators found that patients with thyroid cancer tended to be younger, with a mean age of 49.5 vs. 54.6 years (P = .012). There was a trend toward more cancers among men than women, but it was not significant.

There were no significant differences in any preoperative factors between patients with cancers and those with goiter only, including number of nodules, site of dominant nodule (right, left, or isthmus), thyroid function, thyroid weight, or fine-needle aspiration results (percentage deemed benign or nondiagnostic).

In a multivariate analysis, male sex was associated with a more than twofold risk for thyroid cancer (odds ratio, 2.39; 95% confidence interval, 1.152-4.978). There were also trends toward a lower risk of cancer with each additional decade of life, and a higher risk among patients who had undergone thyroid lobectomy, but these were nonsignificant associations.

"Knowledge of these associations may prove to be useful for both patient counseling and surgical decision making," Mr. Farquhar said.

The study was internally funded. The senior author was Dr. Douglas L. Fraker, chief of the division of endocrine and oncologic surgery at the University of Pennsylvania.

Mr. Farquhar and his coauthors reported having no relevant financial disclosures.

SCOTTSDALE, ARIZ. – Using a Foley catheter guide during midurethral sling surgery does not appear to reduce the risk of injury to the bladder and urethra, according to a retrospective study presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

Surgeons used the guide in 24.5% of the 310 women undergoing retropubic midurethral sling surgery, reported first author Dr. Jeannine M. Miranne, an ob.gyn. at Medstar Washington Hospital Center and Georgetown University, Washington.

The rate of cystotomy was 1.3% in the guide group and 5.6% in the no-guide group, a statistically indistinguishable difference and one that remained so even after adjustment for potential confounders. None of the patients studied experienced a urethrotomy.

"Foley catheter guide use does not decrease the risk of intraoperative lower urinary tract injury. However, larger prospective studies are needed to confirm this finding, given the possibility of a type 2 error," Dr. Miranne concluded.

Session attendee Dr. Eric Sokol, an assistant professor of obstetrics and gynecology, and of urology at Stanford (Calif.) University, wondered if injury rates were affected by the specific sling used.

"What I imagine has possibly influenced your results is the fact that you have changed also the sling that you use. As I understand it, you are using a lot of Advantage Fit slings," he said. In his experience in training residents, the bladder is often inadvertently punctured when this sling is used. "When I use other slings, with a rigid handle and a bigger curve, they don’t go in the bladder. So do you think there might be an influence of the exact sling that you are using?"

"There definitely may be an influence," Dr. Miranne replied. "Unfortunately, the majority of physicians in our group used the Advantage Fit sling for approximately 90% of their cases that were included. So it’s really hard to determine whether or not that played a role in the cystotomy rate in our study. But that’s definitely something to consider when you think about cystotomy – the type of retropubic sling."

Another attendee commented that using a Foley catheter guide adds an annoying, time-consuming step to the surgery. "It wasn’t our idea, but we have used the cystoscope shaft, and we will use that to manipulate the urethra. You have to put that in anyway to scope the patient, and it saves a lot of time putting things in and taking them out," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

Giving some background to the study, Dr. Miranne said that "synthetic midurethral sling has become a gold-standard surgical procedure for stress urinary incontinence. Different techniques have been introduced to decrease the risk of intraoperative lower urinary tract injury during sling placement. One such technique involves use of a rigid Foley catheter guide during retropubic sling placement."

"Although the manufacturer of the original tension-free vaginal tape continues to recommend Foley catheter guide use in its instructions, it is unclear whether use of this device decreases the risk of intraoperative lower urinary tract injury," she noted.

For the study, the investigators included women undergoing retropubic midurethral sling surgery at a single academic center during 2011 and 2012. They excluded any who underwent autologous bladder neck, transobturator, or mini-/single-incision sling surgery.

On average, the patients were 57 years old and had a body mass index of 28 kg/m², according to Dr. Miranne. Overall, 17% had previously undergone anti-incontinence surgery and 20% had previously undergone prolapse surgery, with no significant difference between groups.

Patients in the no-guide group were more likely to have anterior prolapse (95% vs. 78%) and to have a concomitant prolapse repair (65% vs. 51%). They were less likely to have a resident or fellow as first assistant in the surgery (91% vs. 99%) and to have local retropubic anesthesia (71% vs. 96%). Similar proportions had a concomitant hysterectomy.

In addition to showing no significant difference in injury rates, analyses revealed that the groups were statistically the same with respect to mean intraoperative time; mean blood loss; and mean hospital stay, which was less than 1 day for the entire cohort.

Dr. Miranne disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Using a Foley catheter guide during midurethral sling surgery does not appear to reduce the risk of injury to the bladder and urethra, according to a retrospective study presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

Surgeons used the guide in 24.5% of the 310 women undergoing retropubic midurethral sling surgery, reported first author Dr. Jeannine M. Miranne, an ob.gyn. at Medstar Washington Hospital Center and Georgetown University, Washington.

The rate of cystotomy was 1.3% in the guide group and 5.6% in the no-guide group, a statistically indistinguishable difference and one that remained so even after adjustment for potential confounders. None of the patients studied experienced a urethrotomy.

"Foley catheter guide use does not decrease the risk of intraoperative lower urinary tract injury. However, larger prospective studies are needed to confirm this finding, given the possibility of a type 2 error," Dr. Miranne concluded.

Session attendee Dr. Eric Sokol, an assistant professor of obstetrics and gynecology, and of urology at Stanford (Calif.) University, wondered if injury rates were affected by the specific sling used.

"What I imagine has possibly influenced your results is the fact that you have changed also the sling that you use. As I understand it, you are using a lot of Advantage Fit slings," he said. In his experience in training residents, the bladder is often inadvertently punctured when this sling is used. "When I use other slings, with a rigid handle and a bigger curve, they don’t go in the bladder. So do you think there might be an influence of the exact sling that you are using?"

"There definitely may be an influence," Dr. Miranne replied. "Unfortunately, the majority of physicians in our group used the Advantage Fit sling for approximately 90% of their cases that were included. So it’s really hard to determine whether or not that played a role in the cystotomy rate in our study. But that’s definitely something to consider when you think about cystotomy – the type of retropubic sling."

Another attendee commented that using a Foley catheter guide adds an annoying, time-consuming step to the surgery. "It wasn’t our idea, but we have used the cystoscope shaft, and we will use that to manipulate the urethra. You have to put that in anyway to scope the patient, and it saves a lot of time putting things in and taking them out," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

Giving some background to the study, Dr. Miranne said that "synthetic midurethral sling has become a gold-standard surgical procedure for stress urinary incontinence. Different techniques have been introduced to decrease the risk of intraoperative lower urinary tract injury during sling placement. One such technique involves use of a rigid Foley catheter guide during retropubic sling placement."

"Although the manufacturer of the original tension-free vaginal tape continues to recommend Foley catheter guide use in its instructions, it is unclear whether use of this device decreases the risk of intraoperative lower urinary tract injury," she noted.

For the study, the investigators included women undergoing retropubic midurethral sling surgery at a single academic center during 2011 and 2012. They excluded any who underwent autologous bladder neck, transobturator, or mini-/single-incision sling surgery.

On average, the patients were 57 years old and had a body mass index of 28 kg/m², according to Dr. Miranne. Overall, 17% had previously undergone anti-incontinence surgery and 20% had previously undergone prolapse surgery, with no significant difference between groups.

Patients in the no-guide group were more likely to have anterior prolapse (95% vs. 78%) and to have a concomitant prolapse repair (65% vs. 51%). They were less likely to have a resident or fellow as first assistant in the surgery (91% vs. 99%) and to have local retropubic anesthesia (71% vs. 96%). Similar proportions had a concomitant hysterectomy.

In addition to showing no significant difference in injury rates, analyses revealed that the groups were statistically the same with respect to mean intraoperative time; mean blood loss; and mean hospital stay, which was less than 1 day for the entire cohort.

Dr. Miranne disclosed no relevant conflicts of interest.

SCOTTSDALE, ARIZ. – Using a Foley catheter guide during midurethral sling surgery does not appear to reduce the risk of injury to the bladder and urethra, according to a retrospective study presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

Surgeons used the guide in 24.5% of the 310 women undergoing retropubic midurethral sling surgery, reported first author Dr. Jeannine M. Miranne, an ob.gyn. at Medstar Washington Hospital Center and Georgetown University, Washington.

The rate of cystotomy was 1.3% in the guide group and 5.6% in the no-guide group, a statistically indistinguishable difference and one that remained so even after adjustment for potential confounders. None of the patients studied experienced a urethrotomy.

"Foley catheter guide use does not decrease the risk of intraoperative lower urinary tract injury. However, larger prospective studies are needed to confirm this finding, given the possibility of a type 2 error," Dr. Miranne concluded.

Session attendee Dr. Eric Sokol, an assistant professor of obstetrics and gynecology, and of urology at Stanford (Calif.) University, wondered if injury rates were affected by the specific sling used.

"What I imagine has possibly influenced your results is the fact that you have changed also the sling that you use. As I understand it, you are using a lot of Advantage Fit slings," he said. In his experience in training residents, the bladder is often inadvertently punctured when this sling is used. "When I use other slings, with a rigid handle and a bigger curve, they don’t go in the bladder. So do you think there might be an influence of the exact sling that you are using?"

"There definitely may be an influence," Dr. Miranne replied. "Unfortunately, the majority of physicians in our group used the Advantage Fit sling for approximately 90% of their cases that were included. So it’s really hard to determine whether or not that played a role in the cystotomy rate in our study. But that’s definitely something to consider when you think about cystotomy – the type of retropubic sling."

Another attendee commented that using a Foley catheter guide adds an annoying, time-consuming step to the surgery. "It wasn’t our idea, but we have used the cystoscope shaft, and we will use that to manipulate the urethra. You have to put that in anyway to scope the patient, and it saves a lot of time putting things in and taking them out," he said at the meeting, which was jointly sponsored by the American College of Surgeons.

Giving some background to the study, Dr. Miranne said that "synthetic midurethral sling has become a gold-standard surgical procedure for stress urinary incontinence. Different techniques have been introduced to decrease the risk of intraoperative lower urinary tract injury during sling placement. One such technique involves use of a rigid Foley catheter guide during retropubic sling placement."

"Although the manufacturer of the original tension-free vaginal tape continues to recommend Foley catheter guide use in its instructions, it is unclear whether use of this device decreases the risk of intraoperative lower urinary tract injury," she noted.

For the study, the investigators included women undergoing retropubic midurethral sling surgery at a single academic center during 2011 and 2012. They excluded any who underwent autologous bladder neck, transobturator, or mini-/single-incision sling surgery.

On average, the patients were 57 years old and had a body mass index of 28 kg/m², according to Dr. Miranne. Overall, 17% had previously undergone anti-incontinence surgery and 20% had previously undergone prolapse surgery, with no significant difference between groups.

Patients in the no-guide group were more likely to have anterior prolapse (95% vs. 78%) and to have a concomitant prolapse repair (65% vs. 51%). They were less likely to have a resident or fellow as first assistant in the surgery (91% vs. 99%) and to have local retropubic anesthesia (71% vs. 96%). Similar proportions had a concomitant hysterectomy.

In addition to showing no significant difference in injury rates, analyses revealed that the groups were statistically the same with respect to mean intraoperative time; mean blood loss; and mean hospital stay, which was less than 1 day for the entire cohort.

Dr. Miranne disclosed no relevant conflicts of interest.

Website delays may curtail physicians’ ability to review data on payments they received from drug and device makers before the federal government publishes it Sept. 30.

"There is a compelling need to ensure that physicians have an adequate amount of time to register with the Open Payments Program system, to review their consolidated reports, to dispute errors, and obtain corrections," Dr. James L. Madara, AMA executive vice president, wrote in a letter to the Centers for Medicare & Medicaid Services.

CMS got a late start in launching its online system for data collection, created as part of the Affordable Care Act.

The Open Payments Program – colloquially known as the Sunshine Act program – requires manufacturers of drugs, devices, biologicals, and medical supplies to report the honoraria, fees, and other payments that they make to doctors. The information will be published in a searchable database.

Manufacturers began tabulating data in August 2013 and were supposed to start reporting to the CMS through a website on Jan. 1. The program called for doctors to be able to register for the website at the same time so they could begin reviewing data.

CMS launched the website 6 weeks late on Feb. 18 and made it available only to manufacturers and group purchasing organizations. The first registration and reporting phase ended March 31. The agency has not begun the second phase yet.

Registration and review for physicians and teaching hospitals will begin no later than Aug. 1, according to CMS.

The AMA is urging the CMS "to adjust the public reporting date until the agency can ensure that physician due process rights are protected, and the agency has in place a process and system that will produce accurate reports."

The AMA said that it is concerned that the agency might not be able to ensure timeliness or accuracy because "the CMS is building a new system that reportedly has not been beta tested."

The ACA requires the CMS to give physicians 60 days to review data and settle any disputes, according to Neil Kirschner, senior associate for health policy and regulatory affairs at the American College of Physicians. He said that the ACP will continue to monitor the CMS’s progress and advocate for a minimum of a 60-day review period.

Officials at the American College of Cardiology also are wary of the situation.

"Given the difficulties that physicians have had in obtaining access to their Physician Quality Reporting System reports and other similar documents that require authentication of identity, the College is concerned that there will not be sufficient time to both communicate to them the need to register and for the registration and authentication to occur before the reports are available," said Lisa Goldstein, ACC associate director of regulatory affairs.

"Instead, many will likely be scrambling to register and authenticate their identities during the limited review period before the information is made public, reducing the amount of time the physicians have to review their reports and file disputes as appropriate," she said.

Dr. Brett Coldiron, president of the American Academy of Dermatology, said that the academy "wants to ensure that the information that is shared through Open Payments is as accurate as possible, and that implementation of the program is seamless and does not create undue administrative burdens on physicians."

[email protected]

On Twitter @aliciaault

Website delays may curtail physicians’ ability to review data on payments they received from drug and device makers before the federal government publishes it Sept. 30.

"There is a compelling need to ensure that physicians have an adequate amount of time to register with the Open Payments Program system, to review their consolidated reports, to dispute errors, and obtain corrections," Dr. James L. Madara, AMA executive vice president, wrote in a letter to the Centers for Medicare & Medicaid Services.

CMS got a late start in launching its online system for data collection, created as part of the Affordable Care Act.

The Open Payments Program – colloquially known as the Sunshine Act program – requires manufacturers of drugs, devices, biologicals, and medical supplies to report the honoraria, fees, and other payments that they make to doctors. The information will be published in a searchable database.

Manufacturers began tabulating data in August 2013 and were supposed to start reporting to the CMS through a website on Jan. 1. The program called for doctors to be able to register for the website at the same time so they could begin reviewing data.

CMS launched the website 6 weeks late on Feb. 18 and made it available only to manufacturers and group purchasing organizations. The first registration and reporting phase ended March 31. The agency has not begun the second phase yet.

Registration and review for physicians and teaching hospitals will begin no later than Aug. 1, according to CMS.

The AMA is urging the CMS "to adjust the public reporting date until the agency can ensure that physician due process rights are protected, and the agency has in place a process and system that will produce accurate reports."

The AMA said that it is concerned that the agency might not be able to ensure timeliness or accuracy because "the CMS is building a new system that reportedly has not been beta tested."

The ACA requires the CMS to give physicians 60 days to review data and settle any disputes, according to Neil Kirschner, senior associate for health policy and regulatory affairs at the American College of Physicians. He said that the ACP will continue to monitor the CMS’s progress and advocate for a minimum of a 60-day review period.

Officials at the American College of Cardiology also are wary of the situation.

"Given the difficulties that physicians have had in obtaining access to their Physician Quality Reporting System reports and other similar documents that require authentication of identity, the College is concerned that there will not be sufficient time to both communicate to them the need to register and for the registration and authentication to occur before the reports are available," said Lisa Goldstein, ACC associate director of regulatory affairs.

"Instead, many will likely be scrambling to register and authenticate their identities during the limited review period before the information is made public, reducing the amount of time the physicians have to review their reports and file disputes as appropriate," she said.

Dr. Brett Coldiron, president of the American Academy of Dermatology, said that the academy "wants to ensure that the information that is shared through Open Payments is as accurate as possible, and that implementation of the program is seamless and does not create undue administrative burdens on physicians."

[email protected]

On Twitter @aliciaault

Website delays may curtail physicians’ ability to review data on payments they received from drug and device makers before the federal government publishes it Sept. 30.

"There is a compelling need to ensure that physicians have an adequate amount of time to register with the Open Payments Program system, to review their consolidated reports, to dispute errors, and obtain corrections," Dr. James L. Madara, AMA executive vice president, wrote in a letter to the Centers for Medicare & Medicaid Services.

CMS got a late start in launching its online system for data collection, created as part of the Affordable Care Act.

The Open Payments Program – colloquially known as the Sunshine Act program – requires manufacturers of drugs, devices, biologicals, and medical supplies to report the honoraria, fees, and other payments that they make to doctors. The information will be published in a searchable database.

Manufacturers began tabulating data in August 2013 and were supposed to start reporting to the CMS through a website on Jan. 1. The program called for doctors to be able to register for the website at the same time so they could begin reviewing data.

CMS launched the website 6 weeks late on Feb. 18 and made it available only to manufacturers and group purchasing organizations. The first registration and reporting phase ended March 31. The agency has not begun the second phase yet.

Registration and review for physicians and teaching hospitals will begin no later than Aug. 1, according to CMS.

The AMA is urging the CMS "to adjust the public reporting date until the agency can ensure that physician due process rights are protected, and the agency has in place a process and system that will produce accurate reports."

The AMA said that it is concerned that the agency might not be able to ensure timeliness or accuracy because "the CMS is building a new system that reportedly has not been beta tested."

The ACA requires the CMS to give physicians 60 days to review data and settle any disputes, according to Neil Kirschner, senior associate for health policy and regulatory affairs at the American College of Physicians. He said that the ACP will continue to monitor the CMS’s progress and advocate for a minimum of a 60-day review period.

Officials at the American College of Cardiology also are wary of the situation.

"Given the difficulties that physicians have had in obtaining access to their Physician Quality Reporting System reports and other similar documents that require authentication of identity, the College is concerned that there will not be sufficient time to both communicate to them the need to register and for the registration and authentication to occur before the reports are available," said Lisa Goldstein, ACC associate director of regulatory affairs.

"Instead, many will likely be scrambling to register and authenticate their identities during the limited review period before the information is made public, reducing the amount of time the physicians have to review their reports and file disputes as appropriate," she said.

Dr. Brett Coldiron, president of the American Academy of Dermatology, said that the academy "wants to ensure that the information that is shared through Open Payments is as accurate as possible, and that implementation of the program is seamless and does not create undue administrative burdens on physicians."

[email protected]

On Twitter @aliciaault