HONOLULU – Telerehabilitation is as effective as in-clinic rehabilitation for improving arm function after stroke, according to research presented at the International Stroke Conference sponsored by the American Heart Association. Telerehabilitation also provides patient education as effectively as in-clinic rehabilitation, said Steven C. Cramer, MD, professor of neurology at the University of California, Irvine.

Stroke is a leading cause of disability, and more than 80% of patients with stroke have motor deficits when they present to the ED. Research indicates that high doses of rehabilitation therapy improve brain and motor function. However, many patients get low amounts of rehabilitation because of obstacles such as travel difficulties and shortages of therapy providers. “We reasoned that telerehabilitation is ideally suited to efficiently provide a large dose of useful, high-quality rehab therapy after stroke,” Dr. Cramer said.

Participants received supervised and unsupervised therapy

He and his colleagues enrolled patients who had experienced a stroke during the previous 4-36 weeks and who had arm motor deficits into their study. Eligible participants were adults, had experienced ischemic stroke or intracerebral hemorrhage, and had an arm Fugl-Meyer score between 22 and 56 out of 66.

Dr. Cramer’s group randomized 124 participants at 11 National Institutes of Health StrokeNet sites to 6 weeks of intensive arm rehabilitation therapy, plus stroke education, delivered in clinic or at home by a telehealth system. For both groups, treatment included 36 sessions that each lasted for 70 minutes. Half of the sessions were supervised and half were not. All sessions included at least 15 minutes of arm exercises and at least 15 minutes of functional training. Unsupervised sessions also included at least 5 minutes of stroke education on topics such as prevention, risk factors, recognition, and treatment. Participants in the in-clinic group worked with therapists in the clinic on supervised days and at home with a personalized booklet on unsupervised days. Participants in the telerehabilitation group played specially designed and individually tailored computer games at home on all days and had video conferences with therapists on supervised days. The treatment groups included approximately equal numbers of patients; treatment duration, intensity, and frequency were matched between groups.

The investigators hypothesized that telerehabilitation was not inferior to in-clinic rehabilitation. The study’s primary endpoint was change in Fugl-Meyer score from baseline to 30 days after the end of therapy. Secondary end points included Box and Blocks score (that is, a measure of arm function), Stroke Impact Scale–hand, and gains in stroke knowledge. The researchers defined the noninferiority margin as 30% of the gains of the in-clinic group. End points were evaluated by blinded assessors.

Patients had clinically meaningful gains

Participants’ average age was 61 years; the mean baseline arm Fugl-Meyer score was 42. Stroke onset had occurred at a mean of 4.5 months previously, and most strokes were ischemic. In all, 10 participants dropped out of the study. The rate of compliance was 98.3% in the telerehabilitation group and 93.0% in the in-clinic group.

The change in Fugl-Meyer score from baseline to 30 days post therapy was 8.36 points in the in-clinic group and 7.86 points in the telerehabilitation group. The changes in this score were higher than the minimal clinically important difference. The difference between groups, adjusted for covariance, was approximately 0. In addition, the 95% confidence interval for the change in score in the telerehabilitation group was within the noninferiority margin. “We can say that telerehabilitation is not inferior” to in-clinic therapy, said Dr. Cramer.

Telerehabilitation also was noninferior to in-clinic rehabilitation on the Box and Blocks score, and gains in stroke knowledge were significant and comparable in both groups. “Interestingly, the arm motor gains did not differ whether the subjects had aphasia or not,” said Dr. Cramer.

The investigators measured activity-inherent motivation (that is, how much a patient likes rehabilitation) using the Physical Activity Enjoyment Scale. Scores were higher in the in-clinic group, compared with the telerehabilitation group. “People like going to sit with a live human, and they like the longer time with the live human. This is something for us to study further and understand,” said Dr. Cramer.

Dr. Cramer and colleagues observed six serious adverse events in the in-clinic group and one in the telerehabilitation group, such as pneumonia or palpitations, all of which were deemed unrelated to therapy. Adverse events related to therapy (for example, shoulder pain and fatigue) were equally distributed between the two groups.

“What we were trying to do with home-based telehealth does not compete with or replace traditional rehab medicine. It is expanding tools for occupational and physical therapists, for nurses and physicians,” said Dr. Cramer.

Future studies could examine the efficacy of telerehabilitation in the treatment of language deficits, leg weakness, micturition, and dysphagia. “We might also study telehealth such as this to see how we can improve access and lower the cost of poststroke rehab care,” he concluded.

The study was funded by the Eunice Kennedy Shriver National Institute Of Child Health & Human Development and several grants from the National Institute of Neurological Disorders and Stroke. Dr. Cramer has an ownership interest in TRCare, a company that plans to market a telerehabilitation system and was not involved in the study. In addition, he is a consultant or advisor for MicroTransponder, Dart Neuroscience, Neurolutions, Regenera, Abbvie, SanBio, and TRCare.

egreb@mdedge.com

SOURCE: Cramer SC et al. ISC 2019, Abstract LB23.

HONOLULU – Telerehabilitation is as effective as in-clinic rehabilitation for improving arm function after stroke, according to research presented at the International Stroke Conference sponsored by the American Heart Association. Telerehabilitation also provides patient education as effectively as in-clinic rehabilitation, said Steven C. Cramer, MD, professor of neurology at the University of California, Irvine.

Stroke is a leading cause of disability, and more than 80% of patients with stroke have motor deficits when they present to the ED. Research indicates that high doses of rehabilitation therapy improve brain and motor function. However, many patients get low amounts of rehabilitation because of obstacles such as travel difficulties and shortages of therapy providers. “We reasoned that telerehabilitation is ideally suited to efficiently provide a large dose of useful, high-quality rehab therapy after stroke,” Dr. Cramer said.

Participants received supervised and unsupervised therapy

He and his colleagues enrolled patients who had experienced a stroke during the previous 4-36 weeks and who had arm motor deficits into their study. Eligible participants were adults, had experienced ischemic stroke or intracerebral hemorrhage, and had an arm Fugl-Meyer score between 22 and 56 out of 66.

Dr. Cramer’s group randomized 124 participants at 11 National Institutes of Health StrokeNet sites to 6 weeks of intensive arm rehabilitation therapy, plus stroke education, delivered in clinic or at home by a telehealth system. For both groups, treatment included 36 sessions that each lasted for 70 minutes. Half of the sessions were supervised and half were not. All sessions included at least 15 minutes of arm exercises and at least 15 minutes of functional training. Unsupervised sessions also included at least 5 minutes of stroke education on topics such as prevention, risk factors, recognition, and treatment. Participants in the in-clinic group worked with therapists in the clinic on supervised days and at home with a personalized booklet on unsupervised days. Participants in the telerehabilitation group played specially designed and individually tailored computer games at home on all days and had video conferences with therapists on supervised days. The treatment groups included approximately equal numbers of patients; treatment duration, intensity, and frequency were matched between groups.

The investigators hypothesized that telerehabilitation was not inferior to in-clinic rehabilitation. The study’s primary endpoint was change in Fugl-Meyer score from baseline to 30 days after the end of therapy. Secondary end points included Box and Blocks score (that is, a measure of arm function), Stroke Impact Scale–hand, and gains in stroke knowledge. The researchers defined the noninferiority margin as 30% of the gains of the in-clinic group. End points were evaluated by blinded assessors.

Patients had clinically meaningful gains

Participants’ average age was 61 years; the mean baseline arm Fugl-Meyer score was 42. Stroke onset had occurred at a mean of 4.5 months previously, and most strokes were ischemic. In all, 10 participants dropped out of the study. The rate of compliance was 98.3% in the telerehabilitation group and 93.0% in the in-clinic group.

The change in Fugl-Meyer score from baseline to 30 days post therapy was 8.36 points in the in-clinic group and 7.86 points in the telerehabilitation group. The changes in this score were higher than the minimal clinically important difference. The difference between groups, adjusted for covariance, was approximately 0. In addition, the 95% confidence interval for the change in score in the telerehabilitation group was within the noninferiority margin. “We can say that telerehabilitation is not inferior” to in-clinic therapy, said Dr. Cramer.

Telerehabilitation also was noninferior to in-clinic rehabilitation on the Box and Blocks score, and gains in stroke knowledge were significant and comparable in both groups. “Interestingly, the arm motor gains did not differ whether the subjects had aphasia or not,” said Dr. Cramer.

The investigators measured activity-inherent motivation (that is, how much a patient likes rehabilitation) using the Physical Activity Enjoyment Scale. Scores were higher in the in-clinic group, compared with the telerehabilitation group. “People like going to sit with a live human, and they like the longer time with the live human. This is something for us to study further and understand,” said Dr. Cramer.

Dr. Cramer and colleagues observed six serious adverse events in the in-clinic group and one in the telerehabilitation group, such as pneumonia or palpitations, all of which were deemed unrelated to therapy. Adverse events related to therapy (for example, shoulder pain and fatigue) were equally distributed between the two groups.

“What we were trying to do with home-based telehealth does not compete with or replace traditional rehab medicine. It is expanding tools for occupational and physical therapists, for nurses and physicians,” said Dr. Cramer.

Future studies could examine the efficacy of telerehabilitation in the treatment of language deficits, leg weakness, micturition, and dysphagia. “We might also study telehealth such as this to see how we can improve access and lower the cost of poststroke rehab care,” he concluded.

The study was funded by the Eunice Kennedy Shriver National Institute Of Child Health & Human Development and several grants from the National Institute of Neurological Disorders and Stroke. Dr. Cramer has an ownership interest in TRCare, a company that plans to market a telerehabilitation system and was not involved in the study. In addition, he is a consultant or advisor for MicroTransponder, Dart Neuroscience, Neurolutions, Regenera, Abbvie, SanBio, and TRCare.

egreb@mdedge.com

SOURCE: Cramer SC et al. ISC 2019, Abstract LB23.

HONOLULU – Telerehabilitation is as effective as in-clinic rehabilitation for improving arm function after stroke, according to research presented at the International Stroke Conference sponsored by the American Heart Association. Telerehabilitation also provides patient education as effectively as in-clinic rehabilitation, said Steven C. Cramer, MD, professor of neurology at the University of California, Irvine.

Stroke is a leading cause of disability, and more than 80% of patients with stroke have motor deficits when they present to the ED. Research indicates that high doses of rehabilitation therapy improve brain and motor function. However, many patients get low amounts of rehabilitation because of obstacles such as travel difficulties and shortages of therapy providers. “We reasoned that telerehabilitation is ideally suited to efficiently provide a large dose of useful, high-quality rehab therapy after stroke,” Dr. Cramer said.

Participants received supervised and unsupervised therapy

He and his colleagues enrolled patients who had experienced a stroke during the previous 4-36 weeks and who had arm motor deficits into their study. Eligible participants were adults, had experienced ischemic stroke or intracerebral hemorrhage, and had an arm Fugl-Meyer score between 22 and 56 out of 66.

Dr. Cramer’s group randomized 124 participants at 11 National Institutes of Health StrokeNet sites to 6 weeks of intensive arm rehabilitation therapy, plus stroke education, delivered in clinic or at home by a telehealth system. For both groups, treatment included 36 sessions that each lasted for 70 minutes. Half of the sessions were supervised and half were not. All sessions included at least 15 minutes of arm exercises and at least 15 minutes of functional training. Unsupervised sessions also included at least 5 minutes of stroke education on topics such as prevention, risk factors, recognition, and treatment. Participants in the in-clinic group worked with therapists in the clinic on supervised days and at home with a personalized booklet on unsupervised days. Participants in the telerehabilitation group played specially designed and individually tailored computer games at home on all days and had video conferences with therapists on supervised days. The treatment groups included approximately equal numbers of patients; treatment duration, intensity, and frequency were matched between groups.

The investigators hypothesized that telerehabilitation was not inferior to in-clinic rehabilitation. The study’s primary endpoint was change in Fugl-Meyer score from baseline to 30 days after the end of therapy. Secondary end points included Box and Blocks score (that is, a measure of arm function), Stroke Impact Scale–hand, and gains in stroke knowledge. The researchers defined the noninferiority margin as 30% of the gains of the in-clinic group. End points were evaluated by blinded assessors.

Patients had clinically meaningful gains

Participants’ average age was 61 years; the mean baseline arm Fugl-Meyer score was 42. Stroke onset had occurred at a mean of 4.5 months previously, and most strokes were ischemic. In all, 10 participants dropped out of the study. The rate of compliance was 98.3% in the telerehabilitation group and 93.0% in the in-clinic group.

The change in Fugl-Meyer score from baseline to 30 days post therapy was 8.36 points in the in-clinic group and 7.86 points in the telerehabilitation group. The changes in this score were higher than the minimal clinically important difference. The difference between groups, adjusted for covariance, was approximately 0. In addition, the 95% confidence interval for the change in score in the telerehabilitation group was within the noninferiority margin. “We can say that telerehabilitation is not inferior” to in-clinic therapy, said Dr. Cramer.

Telerehabilitation also was noninferior to in-clinic rehabilitation on the Box and Blocks score, and gains in stroke knowledge were significant and comparable in both groups. “Interestingly, the arm motor gains did not differ whether the subjects had aphasia or not,” said Dr. Cramer.

The investigators measured activity-inherent motivation (that is, how much a patient likes rehabilitation) using the Physical Activity Enjoyment Scale. Scores were higher in the in-clinic group, compared with the telerehabilitation group. “People like going to sit with a live human, and they like the longer time with the live human. This is something for us to study further and understand,” said Dr. Cramer.

Dr. Cramer and colleagues observed six serious adverse events in the in-clinic group and one in the telerehabilitation group, such as pneumonia or palpitations, all of which were deemed unrelated to therapy. Adverse events related to therapy (for example, shoulder pain and fatigue) were equally distributed between the two groups.

“What we were trying to do with home-based telehealth does not compete with or replace traditional rehab medicine. It is expanding tools for occupational and physical therapists, for nurses and physicians,” said Dr. Cramer.

Future studies could examine the efficacy of telerehabilitation in the treatment of language deficits, leg weakness, micturition, and dysphagia. “We might also study telehealth such as this to see how we can improve access and lower the cost of poststroke rehab care,” he concluded.

The study was funded by the Eunice Kennedy Shriver National Institute Of Child Health & Human Development and several grants from the National Institute of Neurological Disorders and Stroke. Dr. Cramer has an ownership interest in TRCare, a company that plans to market a telerehabilitation system and was not involved in the study. In addition, he is a consultant or advisor for MicroTransponder, Dart Neuroscience, Neurolutions, Regenera, Abbvie, SanBio, and TRCare.

egreb@mdedge.com

SOURCE: Cramer SC et al. ISC 2019, Abstract LB23.

The U.S. military has completely transformed trauma care over the past 17 years, and that success offers lessons for civilian medicine.

In the civilian world, it takes an average of 17 years for a new discovery to change medical practice, but the military has developed or significantly expanded more than 27 major innovations, such as redesigned tourniquets and new transport procedures, in about a decade. As a result, the death rate from battlefield wounds has decreased by half.

Reference

Kellermann A et al. How the US military reinvented trauma care and what this means for US medicine. Health Aff. 2018 Jul 3. doi: 10.1377/hblog20180628.431867.

The U.S. military has completely transformed trauma care over the past 17 years, and that success offers lessons for civilian medicine.

In the civilian world, it takes an average of 17 years for a new discovery to change medical practice, but the military has developed or significantly expanded more than 27 major innovations, such as redesigned tourniquets and new transport procedures, in about a decade. As a result, the death rate from battlefield wounds has decreased by half.

Reference

Kellermann A et al. How the US military reinvented trauma care and what this means for US medicine. Health Aff. 2018 Jul 3. doi: 10.1377/hblog20180628.431867.

The U.S. military has completely transformed trauma care over the past 17 years, and that success offers lessons for civilian medicine.

In the civilian world, it takes an average of 17 years for a new discovery to change medical practice, but the military has developed or significantly expanded more than 27 major innovations, such as redesigned tourniquets and new transport procedures, in about a decade. As a result, the death rate from battlefield wounds has decreased by half.

Reference

Kellermann A et al. How the US military reinvented trauma care and what this means for US medicine. Health Aff. 2018 Jul 3. doi: 10.1377/hblog20180628.431867.

LAS VEGAS – Women who had cesarean delivery and received a nonopioid pain control regimen at hospital discharge had lower pain scores by 4 weeks post partum than those who also received opioids, according to study results shared during a fellows session at the meeting presented by the Society for Maternal-Fetal Medicine.

FatCamera/E+/Getty Images

At 2-4 weeks post partum, the mean pain score on a visual analog scale (VAS) was 12/100 mm for women on the nonopioid regimen, compared with 16/100 mm for women who received opioids, using an intention-to-treat analysis. The median pain score for those in the nonopioid arm was 0, compared with 6 for those in the opioid arm.

The findings surprised Jenifer Dinis, MD, a maternal-fetal medicine fellow at the University of Texas, Houston, and her collaborators, because they had hypothesized merely that the two groups would have similar pain scores 2-4 weeks after delivery.

Although women in the nonopioid arm were able to obtain a rescue hydrocodone prescription through the study, and some women obtained opioids from their private physician, they still used less than half as much opioid medication as women in the opioid arm (21 versus 43 morphine milligram equivalents, P less than .01).

However, women in the nonopioid arm did not use significantly more ibuprofen or acetaminophen, and there was no difference in patient satisfaction with the outpatient postpartum analgesic regimen between study arms. Somnolence was more common in the opioid arm (P = .03); no other medication side effects were significantly more common in one group than the other.

Overall, 22 of 76 (29%) women in the nonopioid arm took any opioids after discharge, compared with 59/81 (73%) in the opioid arm (P less than .01).

After cesarean delivery, the 170 participating women had an inpatient pain control regimen determined by their primary ob.gyn., Dr. Dinis said in her presentation. Patients were randomized 1:1 to their outpatient analgesia regimens on postoperative day 2 or 3, with appropriate prescriptions placed in patient charts. Participants received either a nonopioid regimen with prescriptions for 60 ibuprofen tablets (600 mg) and 60 acetaminophen tablets (325 mg), or to an opioid regimen that included ibuprofen plus hydrocodone/acetaminophen 5 (325 mg) 1-2 tablets every 4 hours.

Pain scores were assessed between 2 and 4 weeks after delivery, either at an in-person appointment or by means of a phone call and a provided email link.

The single-site study was designed as a parallel-group equivalence trial, to show noninferiority of one pain control regimen over the other. Women between the ages of 18 and 50 years were included if they had a cesarean delivery; both English- and Spanish-speaking women were enrolled.

Allowing for attrition and crossover, Dr. Dinis and her colleagues enrolled 85 patients per study arm to achieve sufficient statistical power to detect the difference needed. The investigators planned both an intention-to-treat and a per-protocol analysis in their registered clinical trial.

Postpartum pain assessments were not obtained for 12 patients in the nonopioid group, and 9 in the opioid group, leaving 73 and 76 patients in each group for the per-protocol analysis, respectively.

At baseline, patients were a mean 28 years old, and a little over a quarter (28%) were nulliparous. Participants were overall about half African American and 34%-40% Hispanic. Over half (62%-72%) received Medicaid; most women (62%-75%) had body mass indices of 30 kg/m² or more.

The mean gestational age at delivery was a little more than 36 weeks, with about half of deliveries being the participant’s first cesarean delivery. About 90% of women had a Pfannenstiel skin incision, with a low transverse uterine incision.

Patients were aware of their allocation, and the study results aren’t applicable to women with opioid or benzodiazepine use disorder, she noted. However, the study was pragmatic, included all types of cesarean deliveries, and was adequately powered to detect “the smallest clinically significant difference.”

Dr. Dinis reported no outside sources of funding and no conflicts of interest.

SOURCE: Dinis J et al. Am J Obstet Gynecol. 2019 Jan;220(1):S34, Abstract 42.

LAS VEGAS – Women who had cesarean delivery and received a nonopioid pain control regimen at hospital discharge had lower pain scores by 4 weeks post partum than those who also received opioids, according to study results shared during a fellows session at the meeting presented by the Society for Maternal-Fetal Medicine.

FatCamera/E+/Getty Images

At 2-4 weeks post partum, the mean pain score on a visual analog scale (VAS) was 12/100 mm for women on the nonopioid regimen, compared with 16/100 mm for women who received opioids, using an intention-to-treat analysis. The median pain score for those in the nonopioid arm was 0, compared with 6 for those in the opioid arm.

The findings surprised Jenifer Dinis, MD, a maternal-fetal medicine fellow at the University of Texas, Houston, and her collaborators, because they had hypothesized merely that the two groups would have similar pain scores 2-4 weeks after delivery.

Although women in the nonopioid arm were able to obtain a rescue hydrocodone prescription through the study, and some women obtained opioids from their private physician, they still used less than half as much opioid medication as women in the opioid arm (21 versus 43 morphine milligram equivalents, P less than .01).

However, women in the nonopioid arm did not use significantly more ibuprofen or acetaminophen, and there was no difference in patient satisfaction with the outpatient postpartum analgesic regimen between study arms. Somnolence was more common in the opioid arm (P = .03); no other medication side effects were significantly more common in one group than the other.

Overall, 22 of 76 (29%) women in the nonopioid arm took any opioids after discharge, compared with 59/81 (73%) in the opioid arm (P less than .01).

After cesarean delivery, the 170 participating women had an inpatient pain control regimen determined by their primary ob.gyn., Dr. Dinis said in her presentation. Patients were randomized 1:1 to their outpatient analgesia regimens on postoperative day 2 or 3, with appropriate prescriptions placed in patient charts. Participants received either a nonopioid regimen with prescriptions for 60 ibuprofen tablets (600 mg) and 60 acetaminophen tablets (325 mg), or to an opioid regimen that included ibuprofen plus hydrocodone/acetaminophen 5 (325 mg) 1-2 tablets every 4 hours.

Pain scores were assessed between 2 and 4 weeks after delivery, either at an in-person appointment or by means of a phone call and a provided email link.

The single-site study was designed as a parallel-group equivalence trial, to show noninferiority of one pain control regimen over the other. Women between the ages of 18 and 50 years were included if they had a cesarean delivery; both English- and Spanish-speaking women were enrolled.

Allowing for attrition and crossover, Dr. Dinis and her colleagues enrolled 85 patients per study arm to achieve sufficient statistical power to detect the difference needed. The investigators planned both an intention-to-treat and a per-protocol analysis in their registered clinical trial.

Postpartum pain assessments were not obtained for 12 patients in the nonopioid group, and 9 in the opioid group, leaving 73 and 76 patients in each group for the per-protocol analysis, respectively.

At baseline, patients were a mean 28 years old, and a little over a quarter (28%) were nulliparous. Participants were overall about half African American and 34%-40% Hispanic. Over half (62%-72%) received Medicaid; most women (62%-75%) had body mass indices of 30 kg/m² or more.

The mean gestational age at delivery was a little more than 36 weeks, with about half of deliveries being the participant’s first cesarean delivery. About 90% of women had a Pfannenstiel skin incision, with a low transverse uterine incision.

Patients were aware of their allocation, and the study results aren’t applicable to women with opioid or benzodiazepine use disorder, she noted. However, the study was pragmatic, included all types of cesarean deliveries, and was adequately powered to detect “the smallest clinically significant difference.”

Dr. Dinis reported no outside sources of funding and no conflicts of interest.

SOURCE: Dinis J et al. Am J Obstet Gynecol. 2019 Jan;220(1):S34, Abstract 42.

LAS VEGAS – Women who had cesarean delivery and received a nonopioid pain control regimen at hospital discharge had lower pain scores by 4 weeks post partum than those who also received opioids, according to study results shared during a fellows session at the meeting presented by the Society for Maternal-Fetal Medicine.

FatCamera/E+/Getty Images

At 2-4 weeks post partum, the mean pain score on a visual analog scale (VAS) was 12/100 mm for women on the nonopioid regimen, compared with 16/100 mm for women who received opioids, using an intention-to-treat analysis. The median pain score for those in the nonopioid arm was 0, compared with 6 for those in the opioid arm.

The findings surprised Jenifer Dinis, MD, a maternal-fetal medicine fellow at the University of Texas, Houston, and her collaborators, because they had hypothesized merely that the two groups would have similar pain scores 2-4 weeks after delivery.

Although women in the nonopioid arm were able to obtain a rescue hydrocodone prescription through the study, and some women obtained opioids from their private physician, they still used less than half as much opioid medication as women in the opioid arm (21 versus 43 morphine milligram equivalents, P less than .01).

However, women in the nonopioid arm did not use significantly more ibuprofen or acetaminophen, and there was no difference in patient satisfaction with the outpatient postpartum analgesic regimen between study arms. Somnolence was more common in the opioid arm (P = .03); no other medication side effects were significantly more common in one group than the other.

Overall, 22 of 76 (29%) women in the nonopioid arm took any opioids after discharge, compared with 59/81 (73%) in the opioid arm (P less than .01).

After cesarean delivery, the 170 participating women had an inpatient pain control regimen determined by their primary ob.gyn., Dr. Dinis said in her presentation. Patients were randomized 1:1 to their outpatient analgesia regimens on postoperative day 2 or 3, with appropriate prescriptions placed in patient charts. Participants received either a nonopioid regimen with prescriptions for 60 ibuprofen tablets (600 mg) and 60 acetaminophen tablets (325 mg), or to an opioid regimen that included ibuprofen plus hydrocodone/acetaminophen 5 (325 mg) 1-2 tablets every 4 hours.

Pain scores were assessed between 2 and 4 weeks after delivery, either at an in-person appointment or by means of a phone call and a provided email link.

The single-site study was designed as a parallel-group equivalence trial, to show noninferiority of one pain control regimen over the other. Women between the ages of 18 and 50 years were included if they had a cesarean delivery; both English- and Spanish-speaking women were enrolled.

Allowing for attrition and crossover, Dr. Dinis and her colleagues enrolled 85 patients per study arm to achieve sufficient statistical power to detect the difference needed. The investigators planned both an intention-to-treat and a per-protocol analysis in their registered clinical trial.

Postpartum pain assessments were not obtained for 12 patients in the nonopioid group, and 9 in the opioid group, leaving 73 and 76 patients in each group for the per-protocol analysis, respectively.

At baseline, patients were a mean 28 years old, and a little over a quarter (28%) were nulliparous. Participants were overall about half African American and 34%-40% Hispanic. Over half (62%-72%) received Medicaid; most women (62%-75%) had body mass indices of 30 kg/m² or more.

The mean gestational age at delivery was a little more than 36 weeks, with about half of deliveries being the participant’s first cesarean delivery. About 90% of women had a Pfannenstiel skin incision, with a low transverse uterine incision.

Patients were aware of their allocation, and the study results aren’t applicable to women with opioid or benzodiazepine use disorder, she noted. However, the study was pragmatic, included all types of cesarean deliveries, and was adequately powered to detect “the smallest clinically significant difference.”

Dr. Dinis reported no outside sources of funding and no conflicts of interest.

SOURCE: Dinis J et al. Am J Obstet Gynecol. 2019 Jan;220(1):S34, Abstract 42.

Survival outcomes for patients with mantle cell lymphoma (MCL) substantially improved from 1995 to 2013, particularly for those with advanced-stage tumors, according to a retrospective analysis.

The median overall survival for the study period was 52 months and 57 months in two cancer databases.

“Over the past 20 years, many novel agents and treatment regimens have been developed to treat MCL,” Shuangshuang Fu, PhD, of the University of Texas, Houston, and her colleagues wrote in Cancer Epidemiology.

The researchers retrospectively studied population-based data from two separate databases: the national Surveillance, Epidemiology and End Results (SEER) database and the Texas Cancer Registry (TCR). They identified all adult patients who received a new diagnosis of MCL between Jan. 1, 1995, and Dec. 31, 2013.

A total of 9,610 patients were included in the study: 7,555 patients from SEER and 2,055 from the TCR. The team collected data related to MCL diagnosis, mortality, and other variables, including age at diagnosis, marital status, sex, and tumor stage.

In total, 76.2% and 61.6% of patients from the SEER and TCR databases, respectively, had an advanced-stage tumor.

Dr. Fu and her colleagues found that all-cause mortality rates in both groups were significantly reduced from 1995 to 2013 (SEER, P less than .001; TCR, P = .03).

In addition, the team reported that the median overall survival time for all patients in the SEER database was 52 months, and it was 57 months for the TCR database.

“MCL patients with [an] advanced stage tumor benefitted most from the introduction of newly developed regimens,” they added.

The researchers acknowledged that a key limitation of the study was the inability to assess treatment regimen–specific survival, which could only be estimated with these data.

“The findings of our study further confirmed the impact of novel agents on improved survival over time that was shown in other studies,” they wrote.

The study was supported by grant funding from the Cancer Prevention Research Institute of Texas and the National Institutes of Health. The researchers reported having no conflicts of interest.

SOURCE: Fu S et al. Cancer Epidemiol. 2019 Feb;58:89-97.

Survival outcomes for patients with mantle cell lymphoma (MCL) substantially improved from 1995 to 2013, particularly for those with advanced-stage tumors, according to a retrospective analysis.

The median overall survival for the study period was 52 months and 57 months in two cancer databases.

“Over the past 20 years, many novel agents and treatment regimens have been developed to treat MCL,” Shuangshuang Fu, PhD, of the University of Texas, Houston, and her colleagues wrote in Cancer Epidemiology.

The researchers retrospectively studied population-based data from two separate databases: the national Surveillance, Epidemiology and End Results (SEER) database and the Texas Cancer Registry (TCR). They identified all adult patients who received a new diagnosis of MCL between Jan. 1, 1995, and Dec. 31, 2013.

A total of 9,610 patients were included in the study: 7,555 patients from SEER and 2,055 from the TCR. The team collected data related to MCL diagnosis, mortality, and other variables, including age at diagnosis, marital status, sex, and tumor stage.

In total, 76.2% and 61.6% of patients from the SEER and TCR databases, respectively, had an advanced-stage tumor.

Dr. Fu and her colleagues found that all-cause mortality rates in both groups were significantly reduced from 1995 to 2013 (SEER, P less than .001; TCR, P = .03).

In addition, the team reported that the median overall survival time for all patients in the SEER database was 52 months, and it was 57 months for the TCR database.

“MCL patients with [an] advanced stage tumor benefitted most from the introduction of newly developed regimens,” they added.

The researchers acknowledged that a key limitation of the study was the inability to assess treatment regimen–specific survival, which could only be estimated with these data.

“The findings of our study further confirmed the impact of novel agents on improved survival over time that was shown in other studies,” they wrote.

The study was supported by grant funding from the Cancer Prevention Research Institute of Texas and the National Institutes of Health. The researchers reported having no conflicts of interest.

SOURCE: Fu S et al. Cancer Epidemiol. 2019 Feb;58:89-97.

Survival outcomes for patients with mantle cell lymphoma (MCL) substantially improved from 1995 to 2013, particularly for those with advanced-stage tumors, according to a retrospective analysis.

The median overall survival for the study period was 52 months and 57 months in two cancer databases.

“Over the past 20 years, many novel agents and treatment regimens have been developed to treat MCL,” Shuangshuang Fu, PhD, of the University of Texas, Houston, and her colleagues wrote in Cancer Epidemiology.

The researchers retrospectively studied population-based data from two separate databases: the national Surveillance, Epidemiology and End Results (SEER) database and the Texas Cancer Registry (TCR). They identified all adult patients who received a new diagnosis of MCL between Jan. 1, 1995, and Dec. 31, 2013.

A total of 9,610 patients were included in the study: 7,555 patients from SEER and 2,055 from the TCR. The team collected data related to MCL diagnosis, mortality, and other variables, including age at diagnosis, marital status, sex, and tumor stage.

In total, 76.2% and 61.6% of patients from the SEER and TCR databases, respectively, had an advanced-stage tumor.

Dr. Fu and her colleagues found that all-cause mortality rates in both groups were significantly reduced from 1995 to 2013 (SEER, P less than .001; TCR, P = .03).

In addition, the team reported that the median overall survival time for all patients in the SEER database was 52 months, and it was 57 months for the TCR database.

“MCL patients with [an] advanced stage tumor benefitted most from the introduction of newly developed regimens,” they added.

The researchers acknowledged that a key limitation of the study was the inability to assess treatment regimen–specific survival, which could only be estimated with these data.

“The findings of our study further confirmed the impact of novel agents on improved survival over time that was shown in other studies,” they wrote.

The study was supported by grant funding from the Cancer Prevention Research Institute of Texas and the National Institutes of Health. The researchers reported having no conflicts of interest.

SOURCE: Fu S et al. Cancer Epidemiol. 2019 Feb;58:89-97.

Doubling total body irradiation improved rates of engraftment without altering safety in patients with severe hemoglobinopathies undergoing haploidentical hematopoietic cell transplantation, new findings suggest.

Dr_Microbe/Thinkstock

“[A]lthough our previous study showed cures in most patients and low toxicity, the graft failure rate – albeit all with full host recovery – was 50%,” Francisco Javier Bolaños-Meade, MD, of Johns Hopkins University, Baltimore, and his colleagues wrote in the Lancet Haematology. The present study set out to decrease graft failure in these patients.

The researchers conducted a single-center study of 17 consecutive patients who underwent haploidentical hematopoietic cell transplantation for a severe hemoglobinopathy. A total of 12 patients had sickle cell disease and 5 had beta-thalassemia major.

Study participants received a nonmyeloablative conditioning regimen consisting of haploidentical related donors and postprocedure cyclophosphamide.

“The primary endpoint of the study was modified to evaluate engraftment by measurement of blood chimerism,” they wrote.

After analysis, Dr. Bolaños-Meade and his colleagues found that increasing total body irradiation dose from 200 cGy to 400 cGy lowered graft failure without raising toxicity. In particular, only one participant had primary graft failure, but experienced recovery of host hematopoiesis.

Of the 17 patients, 13 patients (76%) achieved full donor chimerism and 3 patients (18%) had mixed donor-host chimerism. Three patients remained on immunosuppression, the researchers reported.

With respect to safety, five patients developed acute GVHD, which varied from grade 2 to 4; chronic GVHD was seen in three patients.

“The results of our study warrant further investigation to determine whether the curative potential of allogeneic bone marrow transplantation can extend beyond the traditionally small fraction of patients with severe hemoglobinopathies who have matched donors and are healthy enough to receive myeloablative conditioning,” they wrote.

The study was funded by the National Institutes of Health and the Maryland Stem Cell Research Fund. The researchers reported financial disclosures related to Aduro Biotech, Amgen, Alexion Pharmaceuticals, Celgene, Takeda, and others.

SOURCE: Bolaños-Meade FJ et al. Lancet Haematol. 2019 Mar 13. doi: 10.1016/S2352-3026(19)30031-6.

Doubling total body irradiation improved rates of engraftment without altering safety in patients with severe hemoglobinopathies undergoing haploidentical hematopoietic cell transplantation, new findings suggest.

Dr_Microbe/Thinkstock

“[A]lthough our previous study showed cures in most patients and low toxicity, the graft failure rate – albeit all with full host recovery – was 50%,” Francisco Javier Bolaños-Meade, MD, of Johns Hopkins University, Baltimore, and his colleagues wrote in the Lancet Haematology. The present study set out to decrease graft failure in these patients.

The researchers conducted a single-center study of 17 consecutive patients who underwent haploidentical hematopoietic cell transplantation for a severe hemoglobinopathy. A total of 12 patients had sickle cell disease and 5 had beta-thalassemia major.

Study participants received a nonmyeloablative conditioning regimen consisting of haploidentical related donors and postprocedure cyclophosphamide.

“The primary endpoint of the study was modified to evaluate engraftment by measurement of blood chimerism,” they wrote.

After analysis, Dr. Bolaños-Meade and his colleagues found that increasing total body irradiation dose from 200 cGy to 400 cGy lowered graft failure without raising toxicity. In particular, only one participant had primary graft failure, but experienced recovery of host hematopoiesis.

Of the 17 patients, 13 patients (76%) achieved full donor chimerism and 3 patients (18%) had mixed donor-host chimerism. Three patients remained on immunosuppression, the researchers reported.

With respect to safety, five patients developed acute GVHD, which varied from grade 2 to 4; chronic GVHD was seen in three patients.

“The results of our study warrant further investigation to determine whether the curative potential of allogeneic bone marrow transplantation can extend beyond the traditionally small fraction of patients with severe hemoglobinopathies who have matched donors and are healthy enough to receive myeloablative conditioning,” they wrote.

The study was funded by the National Institutes of Health and the Maryland Stem Cell Research Fund. The researchers reported financial disclosures related to Aduro Biotech, Amgen, Alexion Pharmaceuticals, Celgene, Takeda, and others.

SOURCE: Bolaños-Meade FJ et al. Lancet Haematol. 2019 Mar 13. doi: 10.1016/S2352-3026(19)30031-6.

Doubling total body irradiation improved rates of engraftment without altering safety in patients with severe hemoglobinopathies undergoing haploidentical hematopoietic cell transplantation, new findings suggest.

Dr_Microbe/Thinkstock

“[A]lthough our previous study showed cures in most patients and low toxicity, the graft failure rate – albeit all with full host recovery – was 50%,” Francisco Javier Bolaños-Meade, MD, of Johns Hopkins University, Baltimore, and his colleagues wrote in the Lancet Haematology. The present study set out to decrease graft failure in these patients.

The researchers conducted a single-center study of 17 consecutive patients who underwent haploidentical hematopoietic cell transplantation for a severe hemoglobinopathy. A total of 12 patients had sickle cell disease and 5 had beta-thalassemia major.

Study participants received a nonmyeloablative conditioning regimen consisting of haploidentical related donors and postprocedure cyclophosphamide.

“The primary endpoint of the study was modified to evaluate engraftment by measurement of blood chimerism,” they wrote.

After analysis, Dr. Bolaños-Meade and his colleagues found that increasing total body irradiation dose from 200 cGy to 400 cGy lowered graft failure without raising toxicity. In particular, only one participant had primary graft failure, but experienced recovery of host hematopoiesis.

Of the 17 patients, 13 patients (76%) achieved full donor chimerism and 3 patients (18%) had mixed donor-host chimerism. Three patients remained on immunosuppression, the researchers reported.

With respect to safety, five patients developed acute GVHD, which varied from grade 2 to 4; chronic GVHD was seen in three patients.

“The results of our study warrant further investigation to determine whether the curative potential of allogeneic bone marrow transplantation can extend beyond the traditionally small fraction of patients with severe hemoglobinopathies who have matched donors and are healthy enough to receive myeloablative conditioning,” they wrote.

The study was funded by the National Institutes of Health and the Maryland Stem Cell Research Fund. The researchers reported financial disclosures related to Aduro Biotech, Amgen, Alexion Pharmaceuticals, Celgene, Takeda, and others.

SOURCE: Bolaños-Meade FJ et al. Lancet Haematol. 2019 Mar 13. doi: 10.1016/S2352-3026(19)30031-6.

HONOLULU – Compared with standard treatment, intensive blood pressure reduction does not significantly reduce the risk of recurrent stroke, according to research presented at the International Stroke Conference sponsored by the American Heart Association.

Combined with data from previous trials, these results support a target systolic blood pressure of less than 130 mm Hg and a diastolic blood pressure of less than 80 mm Hg for secondary stroke prevention, said Kazuo Kitagawa, MD, PhD.

Lowering blood pressure reduces the risk of recurrent stroke, but investigators have not identified the best target blood pressure for this indication. The Secondary Prevention of Small Subcortical Strokes Trial (SPS3) examined the efficacy of intensive blood pressure treatment for secondary stroke prevention. The investigators randomized more than 3,000 patients with recent lacunar stroke to intensive or standard blood pressure treatment. Intensive treatment (a target systolic blood pressure of less than 130 mm Hg) conferred a nonsignificant reduction of the risk of recurrent stroke. A 2018 meta-analysis of SPS3 and two smaller randomized controlled trials also showed that intensive treatment did not significantly reduce the risk of recurrent stroke.
 

A new multicenter trial

Dr. Kitagawa, of Tokyo Women’s Medical University, and colleagues conducted a new trial to evaluate whether intensive blood pressure reduction significantly reduced the risk of recurrent stroke, compared with standard treatment (a systolic target of less than 140 mm Hg and a diastolic target of less than 90 mm Hg). Between 2010 and 2016, they enrolled patients with a history of stroke within the previous 3 years at 140 hospitals in Japan. Participants were randomized to standard blood pressure treatment or intensive blood pressure treatment (defined in this study as a systolic target of less than 120 mm Hg and a diastolic target of less than 80 mm Hg). The primary end point was recurrent stroke.

Both treatment regimens were based on stepwise multidrug rationing. Step 1 was an angiotensin II receptor blockade (ARB), step 2 was the addition of diuretics, step 3 was the addition of calcium channel blockers, step 4 was an increase of the ARB, step 5 was increase of the calcium channel blocker, and step 6 was the addition of spironolactone.

This trial was stopped at the end of 2016 because of slow recruitment and funding cessation. Investigators randomized 1,280 patients out of a planned 2,000. Seventeen patients were excluded from analysis. At baseline, participants’ mean age was 67 years, and mean systolic blood pressure was 145 mm Hg. The qualifying event was ischemic stroke for 85% of patients and intracerebral hemorrhage for 15%. Mean follow-up duration was 3.9 years.
 

Intensive treatment reduced blood pressure

At 1 year, the mean systolic blood pressure was 132.0 mm Hg in the standard-treatment group and 123.7 mm Hg in the intensive-treatment group. Mean diastolic blood pressure was 77.5 mm Hg in the standard-treatment group and 72.8 mm Hg in the intensive-treatment group. The investigators observed a significant difference in blood pressure between the groups throughout the study period.

The annual rate of stroke recurrence was 2.26% in the standard-treatment group and 1.65% in the intensive-treatment group. Intensive treatment tended to reduce stroke recurrence (hazard ratio, 0.73), but the result was not statistically significant. “The nonsignificant finding might be due to early termination or the modest difference in blood pressure level [between groups],” said Dr. Kitagawa.

Subgroup analyses did not indicate any interaction between treatment group and age, sex, qualifying event, mean systolic blood pressure at baseline, or diabetes. The rate of ischemic stroke was similar between the two groups, but the rate of intracerebral hemorrhage was lower in the intensive treatment group than in the standard treatment group. The rate of serious adverse events was similar between treatment groups.

When Dr. Kitagawa and colleagues pooled their data with those examined in the 2018 meta-analysis, they found that intensive treatment significantly reduced the risk of recurrent stroke (hazard ratio, 0.68), compared with standard treatment.

This study was sponsored by Biomedis International.

egreb@mdedge.com

SOURCE: Kitagawa K et al. ISC 2019, Abstract LB10.

HONOLULU – Compared with standard treatment, intensive blood pressure reduction does not significantly reduce the risk of recurrent stroke, according to research presented at the International Stroke Conference sponsored by the American Heart Association.

Combined with data from previous trials, these results support a target systolic blood pressure of less than 130 mm Hg and a diastolic blood pressure of less than 80 mm Hg for secondary stroke prevention, said Kazuo Kitagawa, MD, PhD.

Lowering blood pressure reduces the risk of recurrent stroke, but investigators have not identified the best target blood pressure for this indication. The Secondary Prevention of Small Subcortical Strokes Trial (SPS3) examined the efficacy of intensive blood pressure treatment for secondary stroke prevention. The investigators randomized more than 3,000 patients with recent lacunar stroke to intensive or standard blood pressure treatment. Intensive treatment (a target systolic blood pressure of less than 130 mm Hg) conferred a nonsignificant reduction of the risk of recurrent stroke. A 2018 meta-analysis of SPS3 and two smaller randomized controlled trials also showed that intensive treatment did not significantly reduce the risk of recurrent stroke.
 

A new multicenter trial

Dr. Kitagawa, of Tokyo Women’s Medical University, and colleagues conducted a new trial to evaluate whether intensive blood pressure reduction significantly reduced the risk of recurrent stroke, compared with standard treatment (a systolic target of less than 140 mm Hg and a diastolic target of less than 90 mm Hg). Between 2010 and 2016, they enrolled patients with a history of stroke within the previous 3 years at 140 hospitals in Japan. Participants were randomized to standard blood pressure treatment or intensive blood pressure treatment (defined in this study as a systolic target of less than 120 mm Hg and a diastolic target of less than 80 mm Hg). The primary end point was recurrent stroke.

Both treatment regimens were based on stepwise multidrug rationing. Step 1 was an angiotensin II receptor blockade (ARB), step 2 was the addition of diuretics, step 3 was the addition of calcium channel blockers, step 4 was an increase of the ARB, step 5 was increase of the calcium channel blocker, and step 6 was the addition of spironolactone.

This trial was stopped at the end of 2016 because of slow recruitment and funding cessation. Investigators randomized 1,280 patients out of a planned 2,000. Seventeen patients were excluded from analysis. At baseline, participants’ mean age was 67 years, and mean systolic blood pressure was 145 mm Hg. The qualifying event was ischemic stroke for 85% of patients and intracerebral hemorrhage for 15%. Mean follow-up duration was 3.9 years.
 

Intensive treatment reduced blood pressure

At 1 year, the mean systolic blood pressure was 132.0 mm Hg in the standard-treatment group and 123.7 mm Hg in the intensive-treatment group. Mean diastolic blood pressure was 77.5 mm Hg in the standard-treatment group and 72.8 mm Hg in the intensive-treatment group. The investigators observed a significant difference in blood pressure between the groups throughout the study period.

The annual rate of stroke recurrence was 2.26% in the standard-treatment group and 1.65% in the intensive-treatment group. Intensive treatment tended to reduce stroke recurrence (hazard ratio, 0.73), but the result was not statistically significant. “The nonsignificant finding might be due to early termination or the modest difference in blood pressure level [between groups],” said Dr. Kitagawa.

Subgroup analyses did not indicate any interaction between treatment group and age, sex, qualifying event, mean systolic blood pressure at baseline, or diabetes. The rate of ischemic stroke was similar between the two groups, but the rate of intracerebral hemorrhage was lower in the intensive treatment group than in the standard treatment group. The rate of serious adverse events was similar between treatment groups.

When Dr. Kitagawa and colleagues pooled their data with those examined in the 2018 meta-analysis, they found that intensive treatment significantly reduced the risk of recurrent stroke (hazard ratio, 0.68), compared with standard treatment.

This study was sponsored by Biomedis International.

egreb@mdedge.com

SOURCE: Kitagawa K et al. ISC 2019, Abstract LB10.

HONOLULU – Compared with standard treatment, intensive blood pressure reduction does not significantly reduce the risk of recurrent stroke, according to research presented at the International Stroke Conference sponsored by the American Heart Association.

Combined with data from previous trials, these results support a target systolic blood pressure of less than 130 mm Hg and a diastolic blood pressure of less than 80 mm Hg for secondary stroke prevention, said Kazuo Kitagawa, MD, PhD.

Lowering blood pressure reduces the risk of recurrent stroke, but investigators have not identified the best target blood pressure for this indication. The Secondary Prevention of Small Subcortical Strokes Trial (SPS3) examined the efficacy of intensive blood pressure treatment for secondary stroke prevention. The investigators randomized more than 3,000 patients with recent lacunar stroke to intensive or standard blood pressure treatment. Intensive treatment (a target systolic blood pressure of less than 130 mm Hg) conferred a nonsignificant reduction of the risk of recurrent stroke. A 2018 meta-analysis of SPS3 and two smaller randomized controlled trials also showed that intensive treatment did not significantly reduce the risk of recurrent stroke.
 

A new multicenter trial

Dr. Kitagawa, of Tokyo Women’s Medical University, and colleagues conducted a new trial to evaluate whether intensive blood pressure reduction significantly reduced the risk of recurrent stroke, compared with standard treatment (a systolic target of less than 140 mm Hg and a diastolic target of less than 90 mm Hg). Between 2010 and 2016, they enrolled patients with a history of stroke within the previous 3 years at 140 hospitals in Japan. Participants were randomized to standard blood pressure treatment or intensive blood pressure treatment (defined in this study as a systolic target of less than 120 mm Hg and a diastolic target of less than 80 mm Hg). The primary end point was recurrent stroke.

Both treatment regimens were based on stepwise multidrug rationing. Step 1 was an angiotensin II receptor blockade (ARB), step 2 was the addition of diuretics, step 3 was the addition of calcium channel blockers, step 4 was an increase of the ARB, step 5 was increase of the calcium channel blocker, and step 6 was the addition of spironolactone.

This trial was stopped at the end of 2016 because of slow recruitment and funding cessation. Investigators randomized 1,280 patients out of a planned 2,000. Seventeen patients were excluded from analysis. At baseline, participants’ mean age was 67 years, and mean systolic blood pressure was 145 mm Hg. The qualifying event was ischemic stroke for 85% of patients and intracerebral hemorrhage for 15%. Mean follow-up duration was 3.9 years.
 

Intensive treatment reduced blood pressure

At 1 year, the mean systolic blood pressure was 132.0 mm Hg in the standard-treatment group and 123.7 mm Hg in the intensive-treatment group. Mean diastolic blood pressure was 77.5 mm Hg in the standard-treatment group and 72.8 mm Hg in the intensive-treatment group. The investigators observed a significant difference in blood pressure between the groups throughout the study period.

The annual rate of stroke recurrence was 2.26% in the standard-treatment group and 1.65% in the intensive-treatment group. Intensive treatment tended to reduce stroke recurrence (hazard ratio, 0.73), but the result was not statistically significant. “The nonsignificant finding might be due to early termination or the modest difference in blood pressure level [between groups],” said Dr. Kitagawa.

Subgroup analyses did not indicate any interaction between treatment group and age, sex, qualifying event, mean systolic blood pressure at baseline, or diabetes. The rate of ischemic stroke was similar between the two groups, but the rate of intracerebral hemorrhage was lower in the intensive treatment group than in the standard treatment group. The rate of serious adverse events was similar between treatment groups.

When Dr. Kitagawa and colleagues pooled their data with those examined in the 2018 meta-analysis, they found that intensive treatment significantly reduced the risk of recurrent stroke (hazard ratio, 0.68), compared with standard treatment.

This study was sponsored by Biomedis International.

egreb@mdedge.com

SOURCE: Kitagawa K et al. ISC 2019, Abstract LB10.

LAS VEGAS – Smoking cessation is mandatory before many hernia operations. Now, a surgeon is urging colleagues to examine the evidence and question whether this standard should still stand.

ricky_68fr/fotolia

"Quality improvement is not a static process. It requires constant reassessment to make sure you’re doing a good job,” said Michael J. Rosen, MD, director of the Cleveland Clinic Comprehensive Hernia Center, in a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

It’s worth raising questions since much of the data regarding surgical risks “does not come from hernia patients,” he said. “It’s extrapolated from other surgeries and might not be applicable.”

Dr. Rosen was careful to tell the audience that he’s not an apologist for tobacco users. He listed the downsides of lighting up, including harms to pulmonary function, cardiovascular function, immune response, tissue healing,and hepatic metabolism of drugs. “I’m not crazy. I know that smoking is not healthy,” he said, “and I don’t work for a tobacco company.”

But do current smokers actually pay a price in terms of hernia repair complications? Dr. Rosen and his colleagues examined the question in a 2019 study that matched two groups of 418 ventral hernia repair patients (Surgery. 2019 Feb;165[2]:406-11).

They found no statically significant difference between current smokers and never-smokers in surgical site infections, surgical site occurrences requiring procedural intervention, reoperation, and 30-day morbidity. Seromas were more common in smokers, however (5.5% vs. 1.2%; P = .0005)

Two recent studies warned about risks in current smokers who undergo hernia operations. But, Dr. Rosen said, they actually revealed minimal differences in hernia outcomes between never-smokers and current smokers (Am J Surg. 2018 Sep;216[3]:471-4; Surg Endosc. 2017 Feb;31[2]:917-21).

Tobacco use as a risk factor for hernia complications “might not be as bad as we thought it was, at least for wound morbidity,” he said. “It might not be necessary to cancel the case” because of smoking habits, he said, adding that “you should question canceling folks.”

However, he said, amount of smoking and complexity of the operations still are important factors to consider.

Doug Brunk/MDedge News

In his presentation, Dr. Rosen questioned another common standard in hernia procedures: The use of postoperative epidurals in elective ventral hernia repair.

He coauthored a 2018 study that compared two matched groups of hernia patients – 763 who received epidurals and 763 who did not. Patients who received epidurals had longer length of stay (5 days vs. 4 days) and higher postop complications (26% vs. 21%; P less than .05; Ann Surg. 2018 May;26[5]:971-6). Epidurals also were linked to worse outcomes in a subset of high-risk pulmonary patients.

Factors such as high rate of improper placement, extra fluid received, and Foley catheter and thromboprophylaxis issues may explain the higher rates of problems in epidurals, he said.

According to Dr. Rosen, a study into an alternative treatment, transversus abdominis plane block, is underway.

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Rosen disclosed having research support from Miromatrix, Intuitive, and Pacira, servicing as a board member for Ariste Medical, and serving as medical director for the Americas Hernia Society Quality Collaborative.

LAS VEGAS – Smoking cessation is mandatory before many hernia operations. Now, a surgeon is urging colleagues to examine the evidence and question whether this standard should still stand.

ricky_68fr/fotolia

"Quality improvement is not a static process. It requires constant reassessment to make sure you’re doing a good job,” said Michael J. Rosen, MD, director of the Cleveland Clinic Comprehensive Hernia Center, in a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

It’s worth raising questions since much of the data regarding surgical risks “does not come from hernia patients,” he said. “It’s extrapolated from other surgeries and might not be applicable.”

Dr. Rosen was careful to tell the audience that he’s not an apologist for tobacco users. He listed the downsides of lighting up, including harms to pulmonary function, cardiovascular function, immune response, tissue healing,and hepatic metabolism of drugs. “I’m not crazy. I know that smoking is not healthy,” he said, “and I don’t work for a tobacco company.”

But do current smokers actually pay a price in terms of hernia repair complications? Dr. Rosen and his colleagues examined the question in a 2019 study that matched two groups of 418 ventral hernia repair patients (Surgery. 2019 Feb;165[2]:406-11).

They found no statically significant difference between current smokers and never-smokers in surgical site infections, surgical site occurrences requiring procedural intervention, reoperation, and 30-day morbidity. Seromas were more common in smokers, however (5.5% vs. 1.2%; P = .0005)

Two recent studies warned about risks in current smokers who undergo hernia operations. But, Dr. Rosen said, they actually revealed minimal differences in hernia outcomes between never-smokers and current smokers (Am J Surg. 2018 Sep;216[3]:471-4; Surg Endosc. 2017 Feb;31[2]:917-21).

Tobacco use as a risk factor for hernia complications “might not be as bad as we thought it was, at least for wound morbidity,” he said. “It might not be necessary to cancel the case” because of smoking habits, he said, adding that “you should question canceling folks.”

However, he said, amount of smoking and complexity of the operations still are important factors to consider.

Doug Brunk/MDedge News

In his presentation, Dr. Rosen questioned another common standard in hernia procedures: The use of postoperative epidurals in elective ventral hernia repair.

He coauthored a 2018 study that compared two matched groups of hernia patients – 763 who received epidurals and 763 who did not. Patients who received epidurals had longer length of stay (5 days vs. 4 days) and higher postop complications (26% vs. 21%; P less than .05; Ann Surg. 2018 May;26[5]:971-6). Epidurals also were linked to worse outcomes in a subset of high-risk pulmonary patients.

Factors such as high rate of improper placement, extra fluid received, and Foley catheter and thromboprophylaxis issues may explain the higher rates of problems in epidurals, he said.

According to Dr. Rosen, a study into an alternative treatment, transversus abdominis plane block, is underway.

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Rosen disclosed having research support from Miromatrix, Intuitive, and Pacira, servicing as a board member for Ariste Medical, and serving as medical director for the Americas Hernia Society Quality Collaborative.

LAS VEGAS – Smoking cessation is mandatory before many hernia operations. Now, a surgeon is urging colleagues to examine the evidence and question whether this standard should still stand.

ricky_68fr/fotolia

"Quality improvement is not a static process. It requires constant reassessment to make sure you’re doing a good job,” said Michael J. Rosen, MD, director of the Cleveland Clinic Comprehensive Hernia Center, in a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

It’s worth raising questions since much of the data regarding surgical risks “does not come from hernia patients,” he said. “It’s extrapolated from other surgeries and might not be applicable.”

Dr. Rosen was careful to tell the audience that he’s not an apologist for tobacco users. He listed the downsides of lighting up, including harms to pulmonary function, cardiovascular function, immune response, tissue healing,and hepatic metabolism of drugs. “I’m not crazy. I know that smoking is not healthy,” he said, “and I don’t work for a tobacco company.”

But do current smokers actually pay a price in terms of hernia repair complications? Dr. Rosen and his colleagues examined the question in a 2019 study that matched two groups of 418 ventral hernia repair patients (Surgery. 2019 Feb;165[2]:406-11).

They found no statically significant difference between current smokers and never-smokers in surgical site infections, surgical site occurrences requiring procedural intervention, reoperation, and 30-day morbidity. Seromas were more common in smokers, however (5.5% vs. 1.2%; P = .0005)

Two recent studies warned about risks in current smokers who undergo hernia operations. But, Dr. Rosen said, they actually revealed minimal differences in hernia outcomes between never-smokers and current smokers (Am J Surg. 2018 Sep;216[3]:471-4; Surg Endosc. 2017 Feb;31[2]:917-21).

Tobacco use as a risk factor for hernia complications “might not be as bad as we thought it was, at least for wound morbidity,” he said. “It might not be necessary to cancel the case” because of smoking habits, he said, adding that “you should question canceling folks.”

However, he said, amount of smoking and complexity of the operations still are important factors to consider.

Doug Brunk/MDedge News

In his presentation, Dr. Rosen questioned another common standard in hernia procedures: The use of postoperative epidurals in elective ventral hernia repair.

He coauthored a 2018 study that compared two matched groups of hernia patients – 763 who received epidurals and 763 who did not. Patients who received epidurals had longer length of stay (5 days vs. 4 days) and higher postop complications (26% vs. 21%; P less than .05; Ann Surg. 2018 May;26[5]:971-6). Epidurals also were linked to worse outcomes in a subset of high-risk pulmonary patients.

Factors such as high rate of improper placement, extra fluid received, and Foley catheter and thromboprophylaxis issues may explain the higher rates of problems in epidurals, he said.

According to Dr. Rosen, a study into an alternative treatment, transversus abdominis plane block, is underway.

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Rosen disclosed having research support from Miromatrix, Intuitive, and Pacira, servicing as a board member for Ariste Medical, and serving as medical director for the Americas Hernia Society Quality Collaborative.

Black non-Hispanic patients with mantle cell lymphoma (MCL) have a lower rate of 5-year overall survival, compared with white non-Hispanic and Hispanic patients, according to a retrospective analysis of more than 18,000 cases.

Wikimedia Commons/TexasPathologistMSW/CC-ASA 4.0 International

However, black patients were also most likely to receive treatment at an academic center, which was an independent predictor of better survival, reported Nikesh N. Shah, MD, of Emory University, Atlanta, and his colleagues. This finding suggests that even academic centers still need to focus on overcoming demographic disparities.

“Racial and socioeconomic differences have been reported in many malignancies and certain lymphomas; however, few studies report on disparities in MCL,” the investigators wrote in Clinical Lymphoma, Myeloma & Leukemia. “To our knowledge this is the first such study to assess racial and socioeconomic disparities in this disease.”

The investigators reviewed 18,120 patients with MCL diagnosed between 2004 and 2013; data were drawn from the National Cancer Database. The primary endpoint was overall survival from the time of diagnosis, with analyses conducted to assess various associations with race/ethnicity, facility type, clinical/tumor characteristics, cancer stage, insurance type, and other factors.

Results showed that Hispanic patients had the highest rate of overall survival, at 55.8%, followed by white patients, at 50.1%. Trailing behind these groups were black patients (46.8%) and patients of other races/ethnicities (46.0%).

Along with survival disparities, race/ethnicity was tied to certain clinical and treatment characteristics. Compared with white patients, black patients were more likely to experience B symptoms (28% vs. 25%) and have Medicaid or lack insurance (15% vs. 5%). Black and Hispanic patients were also less likely than white non-Hispanic patients to receive stem cell transplant (13% vs. 10% vs. 10%).

Although black patients were more likely than white patients to receive treatment at an academic center (51% vs. 38%), a factor independently associated with best survival among center types, whatever advantage provided apparently did not exceed disadvantages associated with race.

“We report inferior overall survival in black patients after accounting for socioeconomic status, as seen in other malignancies,” the investigators wrote. “Surprisingly, these patients were more likely to be treated at academic centers, which independently showed improved overall survival in multivariable analysis that controlled for age, disease stage, insurance status, and other socioeconomic factors.”

The researchers cited a number of steps that could help close the survival gap, including providing more comprehensive supportive care between physician visits and enrollment of patients from diverse racial background on clinical trials.

The study was funded by the National Institutes of Health. The researchers reported having no conflicts of interest.

SOURCE: Shah NN et al. Clin Lymphoma Myeloma Leuk. 2019 Mar 11. doi: 10.1016/j.clml.2019.03.006.

Black non-Hispanic patients with mantle cell lymphoma (MCL) have a lower rate of 5-year overall survival, compared with white non-Hispanic and Hispanic patients, according to a retrospective analysis of more than 18,000 cases.

Wikimedia Commons/TexasPathologistMSW/CC-ASA 4.0 International

However, black patients were also most likely to receive treatment at an academic center, which was an independent predictor of better survival, reported Nikesh N. Shah, MD, of Emory University, Atlanta, and his colleagues. This finding suggests that even academic centers still need to focus on overcoming demographic disparities.

“Racial and socioeconomic differences have been reported in many malignancies and certain lymphomas; however, few studies report on disparities in MCL,” the investigators wrote in Clinical Lymphoma, Myeloma & Leukemia. “To our knowledge this is the first such study to assess racial and socioeconomic disparities in this disease.”

The investigators reviewed 18,120 patients with MCL diagnosed between 2004 and 2013; data were drawn from the National Cancer Database. The primary endpoint was overall survival from the time of diagnosis, with analyses conducted to assess various associations with race/ethnicity, facility type, clinical/tumor characteristics, cancer stage, insurance type, and other factors.

Results showed that Hispanic patients had the highest rate of overall survival, at 55.8%, followed by white patients, at 50.1%. Trailing behind these groups were black patients (46.8%) and patients of other races/ethnicities (46.0%).

Along with survival disparities, race/ethnicity was tied to certain clinical and treatment characteristics. Compared with white patients, black patients were more likely to experience B symptoms (28% vs. 25%) and have Medicaid or lack insurance (15% vs. 5%). Black and Hispanic patients were also less likely than white non-Hispanic patients to receive stem cell transplant (13% vs. 10% vs. 10%).

Although black patients were more likely than white patients to receive treatment at an academic center (51% vs. 38%), a factor independently associated with best survival among center types, whatever advantage provided apparently did not exceed disadvantages associated with race.

“We report inferior overall survival in black patients after accounting for socioeconomic status, as seen in other malignancies,” the investigators wrote. “Surprisingly, these patients were more likely to be treated at academic centers, which independently showed improved overall survival in multivariable analysis that controlled for age, disease stage, insurance status, and other socioeconomic factors.”

The researchers cited a number of steps that could help close the survival gap, including providing more comprehensive supportive care between physician visits and enrollment of patients from diverse racial background on clinical trials.

The study was funded by the National Institutes of Health. The researchers reported having no conflicts of interest.

SOURCE: Shah NN et al. Clin Lymphoma Myeloma Leuk. 2019 Mar 11. doi: 10.1016/j.clml.2019.03.006.

Black non-Hispanic patients with mantle cell lymphoma (MCL) have a lower rate of 5-year overall survival, compared with white non-Hispanic and Hispanic patients, according to a retrospective analysis of more than 18,000 cases.

Wikimedia Commons/TexasPathologistMSW/CC-ASA 4.0 International

However, black patients were also most likely to receive treatment at an academic center, which was an independent predictor of better survival, reported Nikesh N. Shah, MD, of Emory University, Atlanta, and his colleagues. This finding suggests that even academic centers still need to focus on overcoming demographic disparities.

“Racial and socioeconomic differences have been reported in many malignancies and certain lymphomas; however, few studies report on disparities in MCL,” the investigators wrote in Clinical Lymphoma, Myeloma & Leukemia. “To our knowledge this is the first such study to assess racial and socioeconomic disparities in this disease.”

The investigators reviewed 18,120 patients with MCL diagnosed between 2004 and 2013; data were drawn from the National Cancer Database. The primary endpoint was overall survival from the time of diagnosis, with analyses conducted to assess various associations with race/ethnicity, facility type, clinical/tumor characteristics, cancer stage, insurance type, and other factors.

Results showed that Hispanic patients had the highest rate of overall survival, at 55.8%, followed by white patients, at 50.1%. Trailing behind these groups were black patients (46.8%) and patients of other races/ethnicities (46.0%).

Along with survival disparities, race/ethnicity was tied to certain clinical and treatment characteristics. Compared with white patients, black patients were more likely to experience B symptoms (28% vs. 25%) and have Medicaid or lack insurance (15% vs. 5%). Black and Hispanic patients were also less likely than white non-Hispanic patients to receive stem cell transplant (13% vs. 10% vs. 10%).

Although black patients were more likely than white patients to receive treatment at an academic center (51% vs. 38%), a factor independently associated with best survival among center types, whatever advantage provided apparently did not exceed disadvantages associated with race.

“We report inferior overall survival in black patients after accounting for socioeconomic status, as seen in other malignancies,” the investigators wrote. “Surprisingly, these patients were more likely to be treated at academic centers, which independently showed improved overall survival in multivariable analysis that controlled for age, disease stage, insurance status, and other socioeconomic factors.”

The researchers cited a number of steps that could help close the survival gap, including providing more comprehensive supportive care between physician visits and enrollment of patients from diverse racial background on clinical trials.

The study was funded by the National Institutes of Health. The researchers reported having no conflicts of interest.

SOURCE: Shah NN et al. Clin Lymphoma Myeloma Leuk. 2019 Mar 11. doi: 10.1016/j.clml.2019.03.006.

Information obtained from computed tomography (CT) scans may help predict reherniation and surgical site infection (SSI) in patients who had complex ventral hernia repair with the component separation technique (CST), according to findings published in Hernia.

jacoblund/Thinkstock

In a study of 65 adults who had a CT performed before CST, visceral fat volume was a significant predictor of reherniation (P = .025, odds ratio 1.65), reported Harm Winters of the department of plastic and reconstructive surgery at Radboud University Medical Center, Nijmegen, the Netherlands, and coauthors.

Patients were 18-75 years of age, and had complex ventral hernia repair via CST between 2000 and 2013. Patients were excluded if the CT scan was performed earlier than 6 months before hernia repair, or if the scan did not cover the full abdomen.

Visceral fat volume, subcutaneous fat volume, loss of domain, rectus thickness and width, abdominal volume, hernia sac volume, total fat volume, sagittal distance, and waist circumference were measured. Mesh reinforcement during surgery was used in 45 patients (69.2%), the authors noted.

Hernia sac volume and subcutaneous fat volume per 1,000 cm³ were significant predictors of surgical site infection (P = .020, OR 2.10 and P = .034, OR 0.26, respectively).

“These findings suggest that CT measurements are a valuable tool for preoperative risk assessment in patients undergoing complex ventral hernia repair using the CST,” the researchers wrote. Future trials should “further identify the role of these CT scan-derived body morphometrics for patient-tailored risk assessment,” they concluded.

No conflicts of interest were reported.

SOURCE: Winters H et al. Hernia. 2019 Mar 7. doi: 10.1007/s10029-019-01899-8.

Information obtained from computed tomography (CT) scans may help predict reherniation and surgical site infection (SSI) in patients who had complex ventral hernia repair with the component separation technique (CST), according to findings published in Hernia.

jacoblund/Thinkstock

In a study of 65 adults who had a CT performed before CST, visceral fat volume was a significant predictor of reherniation (P = .025, odds ratio 1.65), reported Harm Winters of the department of plastic and reconstructive surgery at Radboud University Medical Center, Nijmegen, the Netherlands, and coauthors.

Patients were 18-75 years of age, and had complex ventral hernia repair via CST between 2000 and 2013. Patients were excluded if the CT scan was performed earlier than 6 months before hernia repair, or if the scan did not cover the full abdomen.

Visceral fat volume, subcutaneous fat volume, loss of domain, rectus thickness and width, abdominal volume, hernia sac volume, total fat volume, sagittal distance, and waist circumference were measured. Mesh reinforcement during surgery was used in 45 patients (69.2%), the authors noted.

Hernia sac volume and subcutaneous fat volume per 1,000 cm³ were significant predictors of surgical site infection (P = .020, OR 2.10 and P = .034, OR 0.26, respectively).

“These findings suggest that CT measurements are a valuable tool for preoperative risk assessment in patients undergoing complex ventral hernia repair using the CST,” the researchers wrote. Future trials should “further identify the role of these CT scan-derived body morphometrics for patient-tailored risk assessment,” they concluded.

No conflicts of interest were reported.

SOURCE: Winters H et al. Hernia. 2019 Mar 7. doi: 10.1007/s10029-019-01899-8.

Information obtained from computed tomography (CT) scans may help predict reherniation and surgical site infection (SSI) in patients who had complex ventral hernia repair with the component separation technique (CST), according to findings published in Hernia.

jacoblund/Thinkstock

In a study of 65 adults who had a CT performed before CST, visceral fat volume was a significant predictor of reherniation (P = .025, odds ratio 1.65), reported Harm Winters of the department of plastic and reconstructive surgery at Radboud University Medical Center, Nijmegen, the Netherlands, and coauthors.

Patients were 18-75 years of age, and had complex ventral hernia repair via CST between 2000 and 2013. Patients were excluded if the CT scan was performed earlier than 6 months before hernia repair, or if the scan did not cover the full abdomen.

Visceral fat volume, subcutaneous fat volume, loss of domain, rectus thickness and width, abdominal volume, hernia sac volume, total fat volume, sagittal distance, and waist circumference were measured. Mesh reinforcement during surgery was used in 45 patients (69.2%), the authors noted.

Hernia sac volume and subcutaneous fat volume per 1,000 cm³ were significant predictors of surgical site infection (P = .020, OR 2.10 and P = .034, OR 0.26, respectively).

“These findings suggest that CT measurements are a valuable tool for preoperative risk assessment in patients undergoing complex ventral hernia repair using the CST,” the researchers wrote. Future trials should “further identify the role of these CT scan-derived body morphometrics for patient-tailored risk assessment,” they concluded.

No conflicts of interest were reported.

SOURCE: Winters H et al. Hernia. 2019 Mar 7. doi: 10.1007/s10029-019-01899-8.

LAS VEGAS – Ajita Prabhu, MD, is intrigued enough by robotic inguinal hernia surgery to study it extensively. Her verdict: In general, it’s just not ready for prime time.

Randy Dotinga/MDedge News

“Right now, I don’t think I have any compelling evidence to tell a laparoscopic surgeon with good surgical times and good outcomes to convert to robotic surgery,” said Dr. Prabhu, an associate professor of surgery at the Cleveland Clinic Foundation, in a presentation the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

According to Dr. Prabhu, the number of robotic inguinal hernia surgeries in the United States has shot up over the past 8 years, but research into the technique has remained sparse and retrospective.

“There’s not a lot out there,” she said. “If I stood here and went through every one of those studies detail by detail, I think I could do it in 15 minutes.”

It is true, she said, that robotic surgery has possible advantages, such as better ergonomics for surgeons and, perhaps, a shorter learning curve than laparoscopy. Still, she said, “for those of us who grew up on it [laparoscopy], it’s a lot less hassle for us to get in and get out and get the job done,” even though the technique can hard to both learn and teach.

Robotic surgery has some disadvantages too, she said. “We’re finding additional evidence that it adds OR [operating room] time, and it’s expensive.” She pointed to an analysis that determined the average total cost for robotic unilateral inguinal hernia repair is $5,517 versus $3,269 for laparoscopic procedures (P less than .001). The cost difference is driven by fixed costs, particularly medical device expenses (Surg Endosc. 2018 Dec 7. doi: 10.1007/s00464-018-06606-9).

Moving forward, she said, robotic inguinal hernia surgery should be tested so “we can make sure it’s actually better, not just cool. We need to be able to justify our utilization.”

To that end, a multicenter, randomized, controlled study is now comparing robotic with laparoscopic surgery in inguinal hernias with 50 patients in each group, Dr. Prabhu said. Her institution, Cleveland Clinic Foundation, is one of the centers in the study (www.clinicaltrials.gov/ct2/show/NCT02816658).

In an interview, Dr. Prabhu said the study just finished enrollment; publication is expected within the next few months.

Dr. Prabhu disclosed relationships with Intuitive Surgical (research support and honoraria), Bard Davol (honoraria) and Medtronic (advisory board).

Global Academy for Medical Education and this news organization are owned by the same parent company.

LAS VEGAS – Ajita Prabhu, MD, is intrigued enough by robotic inguinal hernia surgery to study it extensively. Her verdict: In general, it’s just not ready for prime time.

Randy Dotinga/MDedge News

“Right now, I don’t think I have any compelling evidence to tell a laparoscopic surgeon with good surgical times and good outcomes to convert to robotic surgery,” said Dr. Prabhu, an associate professor of surgery at the Cleveland Clinic Foundation, in a presentation the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

According to Dr. Prabhu, the number of robotic inguinal hernia surgeries in the United States has shot up over the past 8 years, but research into the technique has remained sparse and retrospective.

“There’s not a lot out there,” she said. “If I stood here and went through every one of those studies detail by detail, I think I could do it in 15 minutes.”

It is true, she said, that robotic surgery has possible advantages, such as better ergonomics for surgeons and, perhaps, a shorter learning curve than laparoscopy. Still, she said, “for those of us who grew up on it [laparoscopy], it’s a lot less hassle for us to get in and get out and get the job done,” even though the technique can hard to both learn and teach.

Robotic surgery has some disadvantages too, she said. “We’re finding additional evidence that it adds OR [operating room] time, and it’s expensive.” She pointed to an analysis that determined the average total cost for robotic unilateral inguinal hernia repair is $5,517 versus $3,269 for laparoscopic procedures (P less than .001). The cost difference is driven by fixed costs, particularly medical device expenses (Surg Endosc. 2018 Dec 7. doi: 10.1007/s00464-018-06606-9).

Moving forward, she said, robotic inguinal hernia surgery should be tested so “we can make sure it’s actually better, not just cool. We need to be able to justify our utilization.”

To that end, a multicenter, randomized, controlled study is now comparing robotic with laparoscopic surgery in inguinal hernias with 50 patients in each group, Dr. Prabhu said. Her institution, Cleveland Clinic Foundation, is one of the centers in the study (www.clinicaltrials.gov/ct2/show/NCT02816658).

In an interview, Dr. Prabhu said the study just finished enrollment; publication is expected within the next few months.

Dr. Prabhu disclosed relationships with Intuitive Surgical (research support and honoraria), Bard Davol (honoraria) and Medtronic (advisory board).

Global Academy for Medical Education and this news organization are owned by the same parent company.

LAS VEGAS – Ajita Prabhu, MD, is intrigued enough by robotic inguinal hernia surgery to study it extensively. Her verdict: In general, it’s just not ready for prime time.

Randy Dotinga/MDedge News

“Right now, I don’t think I have any compelling evidence to tell a laparoscopic surgeon with good surgical times and good outcomes to convert to robotic surgery,” said Dr. Prabhu, an associate professor of surgery at the Cleveland Clinic Foundation, in a presentation the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

According to Dr. Prabhu, the number of robotic inguinal hernia surgeries in the United States has shot up over the past 8 years, but research into the technique has remained sparse and retrospective.

“There’s not a lot out there,” she said. “If I stood here and went through every one of those studies detail by detail, I think I could do it in 15 minutes.”

It is true, she said, that robotic surgery has possible advantages, such as better ergonomics for surgeons and, perhaps, a shorter learning curve than laparoscopy. Still, she said, “for those of us who grew up on it [laparoscopy], it’s a lot less hassle for us to get in and get out and get the job done,” even though the technique can hard to both learn and teach.

Robotic surgery has some disadvantages too, she said. “We’re finding additional evidence that it adds OR [operating room] time, and it’s expensive.” She pointed to an analysis that determined the average total cost for robotic unilateral inguinal hernia repair is $5,517 versus $3,269 for laparoscopic procedures (P less than .001). The cost difference is driven by fixed costs, particularly medical device expenses (Surg Endosc. 2018 Dec 7. doi: 10.1007/s00464-018-06606-9).

Moving forward, she said, robotic inguinal hernia surgery should be tested so “we can make sure it’s actually better, not just cool. We need to be able to justify our utilization.”

To that end, a multicenter, randomized, controlled study is now comparing robotic with laparoscopic surgery in inguinal hernias with 50 patients in each group, Dr. Prabhu said. Her institution, Cleveland Clinic Foundation, is one of the centers in the study (www.clinicaltrials.gov/ct2/show/NCT02816658).

In an interview, Dr. Prabhu said the study just finished enrollment; publication is expected within the next few months.

Dr. Prabhu disclosed relationships with Intuitive Surgical (research support and honoraria), Bard Davol (honoraria) and Medtronic (advisory board).

Global Academy for Medical Education and this news organization are owned by the same parent company.