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Depression linked to persistent opioid use after hysterectomy
VANCOUVER –
Women with depression had an 8% increased risk of perioperative opioid use but a 43% increased risk of persistent use, defined as at least one perioperative prescription followed by at least one prescription 90 days or longer after surgery.
Opioid prescriptions after surgery have been on the rise in recent years, and this has led to a focus on how chronic pain disorders are managed. But studies have shown that patients undergoing general surgery, both minor and major, are at increased risk of persistent opioid use, even after a single surgery, according to Erin Carey, MD, director of the division of minimally invasive gynecologic surgery at the University of North Carolina at Chapel Hill, who presented the research at the meeting sponsored by AAGL.
“We also know that preoperative depression has been linked to adverse outcomes after hysterectomy, both acute postoperative pain in the first 2 days after surgery, and increasing the risk of chronic postoperative pain,” Dr. Carey said.
That prompted her and her team to look at whether preoperative depression might influence the risk of new persistent opioid use after hysterectomy. They analyzed data from the IBM Watson/Truven Health Analytics MarketScan database of claims-based data, which collects information from a variety of sources, including electronic medical records and workplace records such as absences, disability, and long-term disability.
“So it does allow for long-term tracking, which makes it optimal for this type of study,” said Dr. Carey.
The study included 382,078 hysterectomies performed between 2001 and 2015 on women who had continuous prescription plans 180 days before to 180 days after the procedure, excluding anyone who had an opioid prescription in the previous 180 days; 60% of the procedures were minimally invasive. About 20% of women were considered to have depression before the procedure, based on a diagnosis (55%), an antidepressant prescription (22%), or both (23%).
There were some differences at baseline between the two populations: Women with preoperative depression were more likely to have a comorbid pain disorder, compared with patients without depression (20% vs. 14%), another psychiatric disorder (2% vs. less than 1%), and a Charlson comorbidity (12% vs. 9%). They also were less likely to undergo a minimally invasive procedure than women without depression (66% vs. 79%). There was an increase in the prevalence of depression over time, from 16% to 23%.
Overall, 74% of women were prescribed an opioid during the perioperative period; 17% were filled before the hysterectomy was performed. Preoperative fills also increased over time, from 4% in 2001 to 21% in 2015.
Women with preoperative depression were at a slightly greater risk for perioperative opioid use (risk ratio, 1.08), but a greater risk for persistent postoperative opioid use (11% vs. 8%; RR, 1.43). The heightened risk for opioid use was similar whether the surgery was performed on an outpatient or inpatient basis.
The presence of other comorbidities in women with diagnosed depression or prescribed antidepressants complicates the findings, according to Dr. Carey. “There may be additional chronic pain factors that are confounding this data, but it is consistent with other data that de novo postoperative opioid dependence may be a higher risk for these patients, so it’s important for us to look at that critically.”
Dr. Carey has been a consultant for Teleflex Medical and a speaker for Med-IQ.
VANCOUVER –
Women with depression had an 8% increased risk of perioperative opioid use but a 43% increased risk of persistent use, defined as at least one perioperative prescription followed by at least one prescription 90 days or longer after surgery.
Opioid prescriptions after surgery have been on the rise in recent years, and this has led to a focus on how chronic pain disorders are managed. But studies have shown that patients undergoing general surgery, both minor and major, are at increased risk of persistent opioid use, even after a single surgery, according to Erin Carey, MD, director of the division of minimally invasive gynecologic surgery at the University of North Carolina at Chapel Hill, who presented the research at the meeting sponsored by AAGL.
“We also know that preoperative depression has been linked to adverse outcomes after hysterectomy, both acute postoperative pain in the first 2 days after surgery, and increasing the risk of chronic postoperative pain,” Dr. Carey said.
That prompted her and her team to look at whether preoperative depression might influence the risk of new persistent opioid use after hysterectomy. They analyzed data from the IBM Watson/Truven Health Analytics MarketScan database of claims-based data, which collects information from a variety of sources, including electronic medical records and workplace records such as absences, disability, and long-term disability.
“So it does allow for long-term tracking, which makes it optimal for this type of study,” said Dr. Carey.
The study included 382,078 hysterectomies performed between 2001 and 2015 on women who had continuous prescription plans 180 days before to 180 days after the procedure, excluding anyone who had an opioid prescription in the previous 180 days; 60% of the procedures were minimally invasive. About 20% of women were considered to have depression before the procedure, based on a diagnosis (55%), an antidepressant prescription (22%), or both (23%).
There were some differences at baseline between the two populations: Women with preoperative depression were more likely to have a comorbid pain disorder, compared with patients without depression (20% vs. 14%), another psychiatric disorder (2% vs. less than 1%), and a Charlson comorbidity (12% vs. 9%). They also were less likely to undergo a minimally invasive procedure than women without depression (66% vs. 79%). There was an increase in the prevalence of depression over time, from 16% to 23%.
Overall, 74% of women were prescribed an opioid during the perioperative period; 17% were filled before the hysterectomy was performed. Preoperative fills also increased over time, from 4% in 2001 to 21% in 2015.
Women with preoperative depression were at a slightly greater risk for perioperative opioid use (risk ratio, 1.08), but a greater risk for persistent postoperative opioid use (11% vs. 8%; RR, 1.43). The heightened risk for opioid use was similar whether the surgery was performed on an outpatient or inpatient basis.
The presence of other comorbidities in women with diagnosed depression or prescribed antidepressants complicates the findings, according to Dr. Carey. “There may be additional chronic pain factors that are confounding this data, but it is consistent with other data that de novo postoperative opioid dependence may be a higher risk for these patients, so it’s important for us to look at that critically.”
Dr. Carey has been a consultant for Teleflex Medical and a speaker for Med-IQ.
VANCOUVER –
Women with depression had an 8% increased risk of perioperative opioid use but a 43% increased risk of persistent use, defined as at least one perioperative prescription followed by at least one prescription 90 days or longer after surgery.
Opioid prescriptions after surgery have been on the rise in recent years, and this has led to a focus on how chronic pain disorders are managed. But studies have shown that patients undergoing general surgery, both minor and major, are at increased risk of persistent opioid use, even after a single surgery, according to Erin Carey, MD, director of the division of minimally invasive gynecologic surgery at the University of North Carolina at Chapel Hill, who presented the research at the meeting sponsored by AAGL.
“We also know that preoperative depression has been linked to adverse outcomes after hysterectomy, both acute postoperative pain in the first 2 days after surgery, and increasing the risk of chronic postoperative pain,” Dr. Carey said.
That prompted her and her team to look at whether preoperative depression might influence the risk of new persistent opioid use after hysterectomy. They analyzed data from the IBM Watson/Truven Health Analytics MarketScan database of claims-based data, which collects information from a variety of sources, including electronic medical records and workplace records such as absences, disability, and long-term disability.
“So it does allow for long-term tracking, which makes it optimal for this type of study,” said Dr. Carey.
The study included 382,078 hysterectomies performed between 2001 and 2015 on women who had continuous prescription plans 180 days before to 180 days after the procedure, excluding anyone who had an opioid prescription in the previous 180 days; 60% of the procedures were minimally invasive. About 20% of women were considered to have depression before the procedure, based on a diagnosis (55%), an antidepressant prescription (22%), or both (23%).
There were some differences at baseline between the two populations: Women with preoperative depression were more likely to have a comorbid pain disorder, compared with patients without depression (20% vs. 14%), another psychiatric disorder (2% vs. less than 1%), and a Charlson comorbidity (12% vs. 9%). They also were less likely to undergo a minimally invasive procedure than women without depression (66% vs. 79%). There was an increase in the prevalence of depression over time, from 16% to 23%.
Overall, 74% of women were prescribed an opioid during the perioperative period; 17% were filled before the hysterectomy was performed. Preoperative fills also increased over time, from 4% in 2001 to 21% in 2015.
Women with preoperative depression were at a slightly greater risk for perioperative opioid use (risk ratio, 1.08), but a greater risk for persistent postoperative opioid use (11% vs. 8%; RR, 1.43). The heightened risk for opioid use was similar whether the surgery was performed on an outpatient or inpatient basis.
The presence of other comorbidities in women with diagnosed depression or prescribed antidepressants complicates the findings, according to Dr. Carey. “There may be additional chronic pain factors that are confounding this data, but it is consistent with other data that de novo postoperative opioid dependence may be a higher risk for these patients, so it’s important for us to look at that critically.”
Dr. Carey has been a consultant for Teleflex Medical and a speaker for Med-IQ.
REPORTING FROM THE AAGL GLOBAL CONGRESS
Opioid prescribing patterns mostly ‘unchanged’ with laparoscopy
SAN FRANCISCO – Opioid prescription is surprisingly high after laparoscopic colorectal surgery, and is higher at larger hospitals and in some regions of the United States, according to a new study.
“In theory, for management of pain, any opioids required should be lower after laparoscopic surgery, but opioids are still ubiquitous and prescribing patterns have largely been unchanged with laparoscopy,” Deborah S. Keller, MD, assistant professor of surgery at Columbia University, New York, said at the annual clinical congress of the American College of Surgeons.
Several studies show wide variation in opioid use and prescribing after laparoscopic colorectal surgery, Dr. Keller said. She also pointed out that available data are limited on inpatient opioid use and the causes of high opioid use.
The team analyzed records of 18,395 subjects from the Premier Inpatient Database, between Jan. 1, 2014, and Sept. 30, 2015. The mean age was 61 years, and 54% were female. The distribution of hospital-stay milligram morphine equivalents (MME) was 48 at the 25th percentile, 108 at the 50th, and 246 at the 75th percentile. Overall, 18% of patients were in the high use category.
Some factors were associated with high opioid use, including emergency surgery (odds ratio, 1.28; P = .0002), being aged 18-34 (OR, 5.8; P less than .0001), major severity of illness (OR, 4.2; P less than .0001), chronic obstructive pulmonary disease comorbidity (OR, 1.13; P =.0350), having Medicaid insurance (OR, 1.35; P less than .0001), and being treated in a rural hospital (OR, 1.44; P less than.0001).
Factors associated with lower opioid use included female sex (OR, 0.90; P = .0064), being treated in a facility with fewer than 500 beds (OR, 0.706-0.822, all statistically significant), being treated in the Midwest (OR, 0.62; P less than .0001) or the South (OR, 0.66; P less than .0001), and treatment by a surgeon with a lower surgical volume (fewer than 65 cases vs. 300; OR, 0.58; P = .0286).
, and one questioner at the session wondered about the validity of the 75% cutoff for high use, suggesting that it would be better to pick a value that was associated with a known increased risk of opioid dependence.
The findings could help inform future guidelines, Dr. Keller said. “On a local level, it can help optimize enhanced recovery protocols, (assist) providers to proactively recognize patients and scenarios at risk for high use, and create targeted education for younger patients, hospitals in specific geographic regions, and larger bedside hospitals so that they can follow best practices,” she added.
The finding that institutions with fewer beds were associated with lower chances of high opioid use was a surprise. “We’re looking into that,” she said.
Dr. Keller had no relevant financial disclosures.
SOURCE: Keller DS et al. Clinical Congress 2019, Abstract.
SAN FRANCISCO – Opioid prescription is surprisingly high after laparoscopic colorectal surgery, and is higher at larger hospitals and in some regions of the United States, according to a new study.
“In theory, for management of pain, any opioids required should be lower after laparoscopic surgery, but opioids are still ubiquitous and prescribing patterns have largely been unchanged with laparoscopy,” Deborah S. Keller, MD, assistant professor of surgery at Columbia University, New York, said at the annual clinical congress of the American College of Surgeons.
Several studies show wide variation in opioid use and prescribing after laparoscopic colorectal surgery, Dr. Keller said. She also pointed out that available data are limited on inpatient opioid use and the causes of high opioid use.
The team analyzed records of 18,395 subjects from the Premier Inpatient Database, between Jan. 1, 2014, and Sept. 30, 2015. The mean age was 61 years, and 54% were female. The distribution of hospital-stay milligram morphine equivalents (MME) was 48 at the 25th percentile, 108 at the 50th, and 246 at the 75th percentile. Overall, 18% of patients were in the high use category.
Some factors were associated with high opioid use, including emergency surgery (odds ratio, 1.28; P = .0002), being aged 18-34 (OR, 5.8; P less than .0001), major severity of illness (OR, 4.2; P less than .0001), chronic obstructive pulmonary disease comorbidity (OR, 1.13; P =.0350), having Medicaid insurance (OR, 1.35; P less than .0001), and being treated in a rural hospital (OR, 1.44; P less than.0001).
Factors associated with lower opioid use included female sex (OR, 0.90; P = .0064), being treated in a facility with fewer than 500 beds (OR, 0.706-0.822, all statistically significant), being treated in the Midwest (OR, 0.62; P less than .0001) or the South (OR, 0.66; P less than .0001), and treatment by a surgeon with a lower surgical volume (fewer than 65 cases vs. 300; OR, 0.58; P = .0286).
, and one questioner at the session wondered about the validity of the 75% cutoff for high use, suggesting that it would be better to pick a value that was associated with a known increased risk of opioid dependence.
The findings could help inform future guidelines, Dr. Keller said. “On a local level, it can help optimize enhanced recovery protocols, (assist) providers to proactively recognize patients and scenarios at risk for high use, and create targeted education for younger patients, hospitals in specific geographic regions, and larger bedside hospitals so that they can follow best practices,” she added.
The finding that institutions with fewer beds were associated with lower chances of high opioid use was a surprise. “We’re looking into that,” she said.
Dr. Keller had no relevant financial disclosures.
SOURCE: Keller DS et al. Clinical Congress 2019, Abstract.
SAN FRANCISCO – Opioid prescription is surprisingly high after laparoscopic colorectal surgery, and is higher at larger hospitals and in some regions of the United States, according to a new study.
“In theory, for management of pain, any opioids required should be lower after laparoscopic surgery, but opioids are still ubiquitous and prescribing patterns have largely been unchanged with laparoscopy,” Deborah S. Keller, MD, assistant professor of surgery at Columbia University, New York, said at the annual clinical congress of the American College of Surgeons.
Several studies show wide variation in opioid use and prescribing after laparoscopic colorectal surgery, Dr. Keller said. She also pointed out that available data are limited on inpatient opioid use and the causes of high opioid use.
The team analyzed records of 18,395 subjects from the Premier Inpatient Database, between Jan. 1, 2014, and Sept. 30, 2015. The mean age was 61 years, and 54% were female. The distribution of hospital-stay milligram morphine equivalents (MME) was 48 at the 25th percentile, 108 at the 50th, and 246 at the 75th percentile. Overall, 18% of patients were in the high use category.
Some factors were associated with high opioid use, including emergency surgery (odds ratio, 1.28; P = .0002), being aged 18-34 (OR, 5.8; P less than .0001), major severity of illness (OR, 4.2; P less than .0001), chronic obstructive pulmonary disease comorbidity (OR, 1.13; P =.0350), having Medicaid insurance (OR, 1.35; P less than .0001), and being treated in a rural hospital (OR, 1.44; P less than.0001).
Factors associated with lower opioid use included female sex (OR, 0.90; P = .0064), being treated in a facility with fewer than 500 beds (OR, 0.706-0.822, all statistically significant), being treated in the Midwest (OR, 0.62; P less than .0001) or the South (OR, 0.66; P less than .0001), and treatment by a surgeon with a lower surgical volume (fewer than 65 cases vs. 300; OR, 0.58; P = .0286).
, and one questioner at the session wondered about the validity of the 75% cutoff for high use, suggesting that it would be better to pick a value that was associated with a known increased risk of opioid dependence.
The findings could help inform future guidelines, Dr. Keller said. “On a local level, it can help optimize enhanced recovery protocols, (assist) providers to proactively recognize patients and scenarios at risk for high use, and create targeted education for younger patients, hospitals in specific geographic regions, and larger bedside hospitals so that they can follow best practices,” she added.
The finding that institutions with fewer beds were associated with lower chances of high opioid use was a surprise. “We’re looking into that,” she said.
Dr. Keller had no relevant financial disclosures.
SOURCE: Keller DS et al. Clinical Congress 2019, Abstract.
REPORTING FROM CLINICAL CONGRESS 2019
Opioid reduction works after minimally invasive gynecologic surgery
VANCOUVER – Two new randomized trials demonstrate that pain following minimally invasive gynecologic surgery can be successfully managed using reduced opioid prescriptions.
In each case, patients were randomized to receive higher or lower numbers of oxycodone tablets. In both trials, the lower amount was five 5-mg oxycodone tablets. The work should reassure surgeons who wish to change their prescribing patterns, but may worry about patient dissatisfaction, at least in the context of prolapse repair and benign minor gynecologic laparoscopy, which were the focus of the two studies.
The ob.gyn. literature cites rates of 4%-6% of persistent opioid use after surgery on opioid-naive patients, and that’s a risk that needs to be addressed. “If we look at this as a risk factor of our surgical process, this is much higher than any other risk in patients undergoing surgery, and it’s not something we routinely talk to patients about,” Kari Plewniak, MD, an ob.gyn. at Montefiore Medical Center, New York, said during her presentation on pain control during benign gynecologic laparoscopy at the meeting sponsored by AAGL.
The trials provide some welcome guidance. “They provide pretty concrete guidelines with strong evidence of safety, so this is really helpful,” said Sean Dowdy, MD, chair of gynecologic oncology at Mayo Clinic in Rochester, Minn., while speaking as a discussant for the presentations.
Emily Davidson, MD, and associates at the Cleveland Clinic conducted a single-institution, noninferiority trial of standard- versus reduced-prescription opioids in 116 women undergoing prolapse repair. Half were randomized to receive 28 tablets of 5 mg oxycodone (routine arm) and half were prescribed just 5 tablets (reduced arm). All patients also received multimodal pain therapy featuring acetaminophen and ibuprofen. The mean age of patients was 62 years, 91% were white, and 84% were post menopausal. The most common surgery was hysterectomy combined with native tissue repair (60.2%), followed by vaginal colpopexy (15.3%), hysteropexy (15.3%), and sacrocolpopexy (9.3%).
At their postsurgical visit, patients were asked about their satisfaction with their postoperative pain management; 93% in the reduced arm reported that they were very satisfied or somewhat satisfied, as did 93% in the routine arm, which met the standard for noninferiority with a 15% margin. About 15% of patients in the reduced arm used more opioids than originally prescribed, compared with 2% of patients in the routine arm (P less than .01). The reduced arm had an average of 4 unused opioid tablets, compared with 26 in the routine arm. On average, the reduced arm used one tablet, compared with three in the routine arm (P = .03).
The researchers suggested that clinicians should consider prescribing 5-10 tablets for most patients, and all patients should receive multimodal pain management.
The noninferiority nature of the design was welcome, according to Dr. Dowdy. “I think we need to do more noninferiority trial designs because it allows us to make more observations about other parts of the value equation, so if we have two interventions that are equivalent, we can pick the one that has the best patient experience and the lowest cost, so it simplifies a lot of our management.”
The other study, conducted at Montefiore Medical Center, set out to see if a similar regimen of 5 5-mg oxycodone tablets, combined with acetaminophen and ibuprofen, could adequately manage postoperative pain after minor benign gynecologic laparoscopy (excluding hysterectomy), compared with a 10-tablet regimen. All patients received 25 tablets of 600 mg ibuprofen (1 tablet every 6 hours or as needed), plus 50 tablets of 250 mg acetaminophen (1-2 tablets every 6 hours or as needed).
The median number of opioid tablets taken was 2.0 in the 5-tablet group and 2.5 in the 10-tablet group; 32% and 28% took no tablets, and 68% and 65% took three or fewer tablets in the respective groups. The median number of leftover opioid tablets was 3 in the 5-tablet group and 8 in the 10-tablet group, reported Dr. Plewniak.
The studies are a good first step, but more is needed, according to Dr. Dowdy. It’s important to begin looking at more-challenging patient groups, such as those who are not opioid naive, as well as patients taking buprenorphine. “That creates some unique challenges with postoperative pain management,” he said.
Dr. Dowdy, Dr. Davidson, and Dr. Plewniak have no relevant financial disclosures.*
* This article was updated 11/27/2019.
VANCOUVER – Two new randomized trials demonstrate that pain following minimally invasive gynecologic surgery can be successfully managed using reduced opioid prescriptions.
In each case, patients were randomized to receive higher or lower numbers of oxycodone tablets. In both trials, the lower amount was five 5-mg oxycodone tablets. The work should reassure surgeons who wish to change their prescribing patterns, but may worry about patient dissatisfaction, at least in the context of prolapse repair and benign minor gynecologic laparoscopy, which were the focus of the two studies.
The ob.gyn. literature cites rates of 4%-6% of persistent opioid use after surgery on opioid-naive patients, and that’s a risk that needs to be addressed. “If we look at this as a risk factor of our surgical process, this is much higher than any other risk in patients undergoing surgery, and it’s not something we routinely talk to patients about,” Kari Plewniak, MD, an ob.gyn. at Montefiore Medical Center, New York, said during her presentation on pain control during benign gynecologic laparoscopy at the meeting sponsored by AAGL.
The trials provide some welcome guidance. “They provide pretty concrete guidelines with strong evidence of safety, so this is really helpful,” said Sean Dowdy, MD, chair of gynecologic oncology at Mayo Clinic in Rochester, Minn., while speaking as a discussant for the presentations.
Emily Davidson, MD, and associates at the Cleveland Clinic conducted a single-institution, noninferiority trial of standard- versus reduced-prescription opioids in 116 women undergoing prolapse repair. Half were randomized to receive 28 tablets of 5 mg oxycodone (routine arm) and half were prescribed just 5 tablets (reduced arm). All patients also received multimodal pain therapy featuring acetaminophen and ibuprofen. The mean age of patients was 62 years, 91% were white, and 84% were post menopausal. The most common surgery was hysterectomy combined with native tissue repair (60.2%), followed by vaginal colpopexy (15.3%), hysteropexy (15.3%), and sacrocolpopexy (9.3%).
At their postsurgical visit, patients were asked about their satisfaction with their postoperative pain management; 93% in the reduced arm reported that they were very satisfied or somewhat satisfied, as did 93% in the routine arm, which met the standard for noninferiority with a 15% margin. About 15% of patients in the reduced arm used more opioids than originally prescribed, compared with 2% of patients in the routine arm (P less than .01). The reduced arm had an average of 4 unused opioid tablets, compared with 26 in the routine arm. On average, the reduced arm used one tablet, compared with three in the routine arm (P = .03).
The researchers suggested that clinicians should consider prescribing 5-10 tablets for most patients, and all patients should receive multimodal pain management.
The noninferiority nature of the design was welcome, according to Dr. Dowdy. “I think we need to do more noninferiority trial designs because it allows us to make more observations about other parts of the value equation, so if we have two interventions that are equivalent, we can pick the one that has the best patient experience and the lowest cost, so it simplifies a lot of our management.”
The other study, conducted at Montefiore Medical Center, set out to see if a similar regimen of 5 5-mg oxycodone tablets, combined with acetaminophen and ibuprofen, could adequately manage postoperative pain after minor benign gynecologic laparoscopy (excluding hysterectomy), compared with a 10-tablet regimen. All patients received 25 tablets of 600 mg ibuprofen (1 tablet every 6 hours or as needed), plus 50 tablets of 250 mg acetaminophen (1-2 tablets every 6 hours or as needed).
The median number of opioid tablets taken was 2.0 in the 5-tablet group and 2.5 in the 10-tablet group; 32% and 28% took no tablets, and 68% and 65% took three or fewer tablets in the respective groups. The median number of leftover opioid tablets was 3 in the 5-tablet group and 8 in the 10-tablet group, reported Dr. Plewniak.
The studies are a good first step, but more is needed, according to Dr. Dowdy. It’s important to begin looking at more-challenging patient groups, such as those who are not opioid naive, as well as patients taking buprenorphine. “That creates some unique challenges with postoperative pain management,” he said.
Dr. Dowdy, Dr. Davidson, and Dr. Plewniak have no relevant financial disclosures.*
* This article was updated 11/27/2019.
VANCOUVER – Two new randomized trials demonstrate that pain following minimally invasive gynecologic surgery can be successfully managed using reduced opioid prescriptions.
In each case, patients were randomized to receive higher or lower numbers of oxycodone tablets. In both trials, the lower amount was five 5-mg oxycodone tablets. The work should reassure surgeons who wish to change their prescribing patterns, but may worry about patient dissatisfaction, at least in the context of prolapse repair and benign minor gynecologic laparoscopy, which were the focus of the two studies.
The ob.gyn. literature cites rates of 4%-6% of persistent opioid use after surgery on opioid-naive patients, and that’s a risk that needs to be addressed. “If we look at this as a risk factor of our surgical process, this is much higher than any other risk in patients undergoing surgery, and it’s not something we routinely talk to patients about,” Kari Plewniak, MD, an ob.gyn. at Montefiore Medical Center, New York, said during her presentation on pain control during benign gynecologic laparoscopy at the meeting sponsored by AAGL.
The trials provide some welcome guidance. “They provide pretty concrete guidelines with strong evidence of safety, so this is really helpful,” said Sean Dowdy, MD, chair of gynecologic oncology at Mayo Clinic in Rochester, Minn., while speaking as a discussant for the presentations.
Emily Davidson, MD, and associates at the Cleveland Clinic conducted a single-institution, noninferiority trial of standard- versus reduced-prescription opioids in 116 women undergoing prolapse repair. Half were randomized to receive 28 tablets of 5 mg oxycodone (routine arm) and half were prescribed just 5 tablets (reduced arm). All patients also received multimodal pain therapy featuring acetaminophen and ibuprofen. The mean age of patients was 62 years, 91% were white, and 84% were post menopausal. The most common surgery was hysterectomy combined with native tissue repair (60.2%), followed by vaginal colpopexy (15.3%), hysteropexy (15.3%), and sacrocolpopexy (9.3%).
At their postsurgical visit, patients were asked about their satisfaction with their postoperative pain management; 93% in the reduced arm reported that they were very satisfied or somewhat satisfied, as did 93% in the routine arm, which met the standard for noninferiority with a 15% margin. About 15% of patients in the reduced arm used more opioids than originally prescribed, compared with 2% of patients in the routine arm (P less than .01). The reduced arm had an average of 4 unused opioid tablets, compared with 26 in the routine arm. On average, the reduced arm used one tablet, compared with three in the routine arm (P = .03).
The researchers suggested that clinicians should consider prescribing 5-10 tablets for most patients, and all patients should receive multimodal pain management.
The noninferiority nature of the design was welcome, according to Dr. Dowdy. “I think we need to do more noninferiority trial designs because it allows us to make more observations about other parts of the value equation, so if we have two interventions that are equivalent, we can pick the one that has the best patient experience and the lowest cost, so it simplifies a lot of our management.”
The other study, conducted at Montefiore Medical Center, set out to see if a similar regimen of 5 5-mg oxycodone tablets, combined with acetaminophen and ibuprofen, could adequately manage postoperative pain after minor benign gynecologic laparoscopy (excluding hysterectomy), compared with a 10-tablet regimen. All patients received 25 tablets of 600 mg ibuprofen (1 tablet every 6 hours or as needed), plus 50 tablets of 250 mg acetaminophen (1-2 tablets every 6 hours or as needed).
The median number of opioid tablets taken was 2.0 in the 5-tablet group and 2.5 in the 10-tablet group; 32% and 28% took no tablets, and 68% and 65% took three or fewer tablets in the respective groups. The median number of leftover opioid tablets was 3 in the 5-tablet group and 8 in the 10-tablet group, reported Dr. Plewniak.
The studies are a good first step, but more is needed, according to Dr. Dowdy. It’s important to begin looking at more-challenging patient groups, such as those who are not opioid naive, as well as patients taking buprenorphine. “That creates some unique challenges with postoperative pain management,” he said.
Dr. Dowdy, Dr. Davidson, and Dr. Plewniak have no relevant financial disclosures.*
* This article was updated 11/27/2019.
REPORTING FROM THE AAGL GLOBAL CONGRESS
Surgical staging improves cervical cancer outcomes
VANCOUVER – Follow-up oncologic data from the UTERUS-11 trial shows advantages to surgical staging over clinical staging in stage IIB-IVA cervical cancer, with little apparent risk.
Compared with clinical staging using CT, laparoscopic staging led to an improvement in cancer-specific survival, with no delays in treatment or increases in toxicity. It also prompted surgical up-staging and led to treatment changes in 33% of cases. There was no difference in overall survival, but progression-free survival trended towards better outcomes in the surgical-staging group.
The new study presents 5-year follow-up data from patients randomly assigned to surgical (n = 121) or clinical staging (n = 114). The original study, published in 2017 (Oncology. 2017;92[4]:213-20), reported that 33% of surgical-staging patients in the surgical staging were up-staged as a result, compared with 6% who were revealed to have positive paraaortic lymph nodes through a CT-guided core biopsy after suspicious CT results. After a median follow-up of 90 months in both arms, overall survival was similar between the two groups, and progression-free survival trended towards an improvement in the surgical-staging group (P = .088). Cancer-specific survival was better in the surgical-staging arm, compared with clinical staging (P=.028), Audrey Tsunoda, MD, PhD, reported.
Surgical staging didn’t impact the toxicity profile, said Dr. Tsunoda, a surgical oncologist focused in gynecologic cancer surgery who practices at Hospital Erasto Gaertner in Curitiba, Brazil.
The mean time to initiation of chemoradiotherapy following surgery was 14 days (range, 7-21 days) after surgery: 64% had intensity-modulated radiotherapy and 36% had three-dimensional radiotherapy. There were no grade 5 toxicities during chemoradiotherapy and both groups had similar gastrointestinal and genitourinary toxicity profiles. About 97% of the surgical staging procedures were conducted laparoscopically. Two patients had a blood loss of more than 500 cc, and two had a delay to primary chemoradiotherapy (4 days and 5 days). One patient had to be converted to an open approach because of obesity and severe adhesions, and there was no intraoperative mortality.
Previous retrospective studies examining surgical staging in these patients led to confusion and disagreements among guidelines. Surgical staging is clearly associated with increased up-staging, but the oncologic benefit is uncertain. The LiLACS study attempted to address the question with prospective data, but failed to accrue enough patients and was later abandoned. That leaves the UTERUS-11 study, the initial results of which were published in 2017, as the first prospective study to examine the benefit of surgical staging.
The new follow-up results suggest a benefit to surgical staging, but they leave an important question unanswered, according to Lois Ramondetta, MD, professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center, Houston, who served as a discussant at the meeting sponsored by AAGL. “Paraaortic lymph node status does connect to clinical benefit, but the question is really [whether] the removal of the lymph nodes accounts for the benefit, or is the identification of them and the change in treatment plan responsible? [If the latter is the case], a PET scan would have done a better job,” said Dr. Ramondetta. “The question remains unanswered, but I think this was huge progress in trying to answer it. Future studies need to incorporate a PET scan.”
Dr. Tsunoda has received honoraria from AstraZeneca and Roche. Dr. Ramondetta has no relevant financial disclosures.
VANCOUVER – Follow-up oncologic data from the UTERUS-11 trial shows advantages to surgical staging over clinical staging in stage IIB-IVA cervical cancer, with little apparent risk.
Compared with clinical staging using CT, laparoscopic staging led to an improvement in cancer-specific survival, with no delays in treatment or increases in toxicity. It also prompted surgical up-staging and led to treatment changes in 33% of cases. There was no difference in overall survival, but progression-free survival trended towards better outcomes in the surgical-staging group.
The new study presents 5-year follow-up data from patients randomly assigned to surgical (n = 121) or clinical staging (n = 114). The original study, published in 2017 (Oncology. 2017;92[4]:213-20), reported that 33% of surgical-staging patients in the surgical staging were up-staged as a result, compared with 6% who were revealed to have positive paraaortic lymph nodes through a CT-guided core biopsy after suspicious CT results. After a median follow-up of 90 months in both arms, overall survival was similar between the two groups, and progression-free survival trended towards an improvement in the surgical-staging group (P = .088). Cancer-specific survival was better in the surgical-staging arm, compared with clinical staging (P=.028), Audrey Tsunoda, MD, PhD, reported.
Surgical staging didn’t impact the toxicity profile, said Dr. Tsunoda, a surgical oncologist focused in gynecologic cancer surgery who practices at Hospital Erasto Gaertner in Curitiba, Brazil.
The mean time to initiation of chemoradiotherapy following surgery was 14 days (range, 7-21 days) after surgery: 64% had intensity-modulated radiotherapy and 36% had three-dimensional radiotherapy. There were no grade 5 toxicities during chemoradiotherapy and both groups had similar gastrointestinal and genitourinary toxicity profiles. About 97% of the surgical staging procedures were conducted laparoscopically. Two patients had a blood loss of more than 500 cc, and two had a delay to primary chemoradiotherapy (4 days and 5 days). One patient had to be converted to an open approach because of obesity and severe adhesions, and there was no intraoperative mortality.
Previous retrospective studies examining surgical staging in these patients led to confusion and disagreements among guidelines. Surgical staging is clearly associated with increased up-staging, but the oncologic benefit is uncertain. The LiLACS study attempted to address the question with prospective data, but failed to accrue enough patients and was later abandoned. That leaves the UTERUS-11 study, the initial results of which were published in 2017, as the first prospective study to examine the benefit of surgical staging.
The new follow-up results suggest a benefit to surgical staging, but they leave an important question unanswered, according to Lois Ramondetta, MD, professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center, Houston, who served as a discussant at the meeting sponsored by AAGL. “Paraaortic lymph node status does connect to clinical benefit, but the question is really [whether] the removal of the lymph nodes accounts for the benefit, or is the identification of them and the change in treatment plan responsible? [If the latter is the case], a PET scan would have done a better job,” said Dr. Ramondetta. “The question remains unanswered, but I think this was huge progress in trying to answer it. Future studies need to incorporate a PET scan.”
Dr. Tsunoda has received honoraria from AstraZeneca and Roche. Dr. Ramondetta has no relevant financial disclosures.
VANCOUVER – Follow-up oncologic data from the UTERUS-11 trial shows advantages to surgical staging over clinical staging in stage IIB-IVA cervical cancer, with little apparent risk.
Compared with clinical staging using CT, laparoscopic staging led to an improvement in cancer-specific survival, with no delays in treatment or increases in toxicity. It also prompted surgical up-staging and led to treatment changes in 33% of cases. There was no difference in overall survival, but progression-free survival trended towards better outcomes in the surgical-staging group.
The new study presents 5-year follow-up data from patients randomly assigned to surgical (n = 121) or clinical staging (n = 114). The original study, published in 2017 (Oncology. 2017;92[4]:213-20), reported that 33% of surgical-staging patients in the surgical staging were up-staged as a result, compared with 6% who were revealed to have positive paraaortic lymph nodes through a CT-guided core biopsy after suspicious CT results. After a median follow-up of 90 months in both arms, overall survival was similar between the two groups, and progression-free survival trended towards an improvement in the surgical-staging group (P = .088). Cancer-specific survival was better in the surgical-staging arm, compared with clinical staging (P=.028), Audrey Tsunoda, MD, PhD, reported.
Surgical staging didn’t impact the toxicity profile, said Dr. Tsunoda, a surgical oncologist focused in gynecologic cancer surgery who practices at Hospital Erasto Gaertner in Curitiba, Brazil.
The mean time to initiation of chemoradiotherapy following surgery was 14 days (range, 7-21 days) after surgery: 64% had intensity-modulated radiotherapy and 36% had three-dimensional radiotherapy. There were no grade 5 toxicities during chemoradiotherapy and both groups had similar gastrointestinal and genitourinary toxicity profiles. About 97% of the surgical staging procedures were conducted laparoscopically. Two patients had a blood loss of more than 500 cc, and two had a delay to primary chemoradiotherapy (4 days and 5 days). One patient had to be converted to an open approach because of obesity and severe adhesions, and there was no intraoperative mortality.
Previous retrospective studies examining surgical staging in these patients led to confusion and disagreements among guidelines. Surgical staging is clearly associated with increased up-staging, but the oncologic benefit is uncertain. The LiLACS study attempted to address the question with prospective data, but failed to accrue enough patients and was later abandoned. That leaves the UTERUS-11 study, the initial results of which were published in 2017, as the first prospective study to examine the benefit of surgical staging.
The new follow-up results suggest a benefit to surgical staging, but they leave an important question unanswered, according to Lois Ramondetta, MD, professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center, Houston, who served as a discussant at the meeting sponsored by AAGL. “Paraaortic lymph node status does connect to clinical benefit, but the question is really [whether] the removal of the lymph nodes accounts for the benefit, or is the identification of them and the change in treatment plan responsible? [If the latter is the case], a PET scan would have done a better job,” said Dr. Ramondetta. “The question remains unanswered, but I think this was huge progress in trying to answer it. Future studies need to incorporate a PET scan.”
Dr. Tsunoda has received honoraria from AstraZeneca and Roche. Dr. Ramondetta has no relevant financial disclosures.
REPORTING FROM THE AAGL GLOBAL CONGRESS
Storytelling tool can assist elderly in the ICU
SAN FRANCISCO – A “Best Case/Worst Case” (BCWC) framework tool has been adapted for use with geriatric trauma patients in the ICU, where it can help track a patient’s progress and enable better communication with patients and loved ones. The tool relies on a combination of graphics and text that surgeons update daily during rounds, and creates a longitudinal view of a patient’s trajectory during their stay in the ICU.
– for example, after a complication has arisen.
“Each day during rounds, the ICU team records important events on the graphic aid that change the patient’s course. The team draws a star to represent the best case, and a line to represent prognostic uncertainty. The attending trauma surgeon then uses the geriatric trauma outcome score, their knowledge of the health state of the patient, and their own clinical experience to tell a story about treatments, recovery, and outcomes if everything goes as well as we might hope. This story is written down in the best-case scenario box,” Christopher Zimmerman, MD, a general surgery resident at the University of Wisconsin–Madison, said during a presentation about the BCWC tool at the annual clinical congress of the American College of Surgeons
“We often like to talk to patients and their families [about best- and worst-case scenarios] anyway, but [the research team] have tried to formalize it,” said Tam Pham, MD, professor of surgery at the University of Washington, in an interview. Dr. Pham comoderated the session where the research was presented.
“When we’re able to communicate where the uncertainty is and where the boundaries are around the course of care and possible outcomes, we can build an alliance with patients and families that will be helpful when there is a big decision to make, say about a laparotomy for a perforated viscus,” said Dr. Zimmerman.
Dr. Zimmerman gave an example of a patient who came into the ICU after suffering multiple fractures from falling down a set of stairs. The team created an initial BCWC with a hoped-for best-case scenario. Later, the patient developed hypoxemic respiratory failure and had to be intubated overnight. “This event is recorded on the graphic, and her star representing the best case has changed position, the line representing uncertainty has shortened, and the contents of her best-case scenario has changed. Each day in rounds, this process is repeated,” said Dr. Zimmerman.
Palliative care physicians, education experts, and surgeons at the University of Wisconsin–Madison developed the tool in an effort to reduce unwanted care at the end of life, in the context of high-risk surgeries. The researchers adapted the tool to the trauma setting by gathering six focus groups of trauma practitioners at the University of Wisconsin; University of Texas, Dallas; and Oregon Health & Science University, Portland. They modified the tool after incorporating comments, and then iteratively modified it through tasks carried out in the ICU as part of a qualitative improvement initiative at the University of Wisconsin–Madison. They generated a change to the tool, implemented it in the ICU during subsequent rounds, then collected observations and field notes, then revised and repeated the process, streamlining it to fit into the ICU environment, according to Dr. Zimmerman.
The back side of the tool is available for family members to write important details about their loved ones, leading insight into the patient’s personality and desires, such as favorite music or affection for a family pet.
The work was supported by the National Institutes of Health. Dr. Zimmerman and Dr. Pham have no relevant financial disclosures.
SOURCE: Zimmerman C et al. Clinical Congress 2019, Abstract.
SAN FRANCISCO – A “Best Case/Worst Case” (BCWC) framework tool has been adapted for use with geriatric trauma patients in the ICU, where it can help track a patient’s progress and enable better communication with patients and loved ones. The tool relies on a combination of graphics and text that surgeons update daily during rounds, and creates a longitudinal view of a patient’s trajectory during their stay in the ICU.
– for example, after a complication has arisen.
“Each day during rounds, the ICU team records important events on the graphic aid that change the patient’s course. The team draws a star to represent the best case, and a line to represent prognostic uncertainty. The attending trauma surgeon then uses the geriatric trauma outcome score, their knowledge of the health state of the patient, and their own clinical experience to tell a story about treatments, recovery, and outcomes if everything goes as well as we might hope. This story is written down in the best-case scenario box,” Christopher Zimmerman, MD, a general surgery resident at the University of Wisconsin–Madison, said during a presentation about the BCWC tool at the annual clinical congress of the American College of Surgeons
“We often like to talk to patients and their families [about best- and worst-case scenarios] anyway, but [the research team] have tried to formalize it,” said Tam Pham, MD, professor of surgery at the University of Washington, in an interview. Dr. Pham comoderated the session where the research was presented.
“When we’re able to communicate where the uncertainty is and where the boundaries are around the course of care and possible outcomes, we can build an alliance with patients and families that will be helpful when there is a big decision to make, say about a laparotomy for a perforated viscus,” said Dr. Zimmerman.
Dr. Zimmerman gave an example of a patient who came into the ICU after suffering multiple fractures from falling down a set of stairs. The team created an initial BCWC with a hoped-for best-case scenario. Later, the patient developed hypoxemic respiratory failure and had to be intubated overnight. “This event is recorded on the graphic, and her star representing the best case has changed position, the line representing uncertainty has shortened, and the contents of her best-case scenario has changed. Each day in rounds, this process is repeated,” said Dr. Zimmerman.
Palliative care physicians, education experts, and surgeons at the University of Wisconsin–Madison developed the tool in an effort to reduce unwanted care at the end of life, in the context of high-risk surgeries. The researchers adapted the tool to the trauma setting by gathering six focus groups of trauma practitioners at the University of Wisconsin; University of Texas, Dallas; and Oregon Health & Science University, Portland. They modified the tool after incorporating comments, and then iteratively modified it through tasks carried out in the ICU as part of a qualitative improvement initiative at the University of Wisconsin–Madison. They generated a change to the tool, implemented it in the ICU during subsequent rounds, then collected observations and field notes, then revised and repeated the process, streamlining it to fit into the ICU environment, according to Dr. Zimmerman.
The back side of the tool is available for family members to write important details about their loved ones, leading insight into the patient’s personality and desires, such as favorite music or affection for a family pet.
The work was supported by the National Institutes of Health. Dr. Zimmerman and Dr. Pham have no relevant financial disclosures.
SOURCE: Zimmerman C et al. Clinical Congress 2019, Abstract.
SAN FRANCISCO – A “Best Case/Worst Case” (BCWC) framework tool has been adapted for use with geriatric trauma patients in the ICU, where it can help track a patient’s progress and enable better communication with patients and loved ones. The tool relies on a combination of graphics and text that surgeons update daily during rounds, and creates a longitudinal view of a patient’s trajectory during their stay in the ICU.
– for example, after a complication has arisen.
“Each day during rounds, the ICU team records important events on the graphic aid that change the patient’s course. The team draws a star to represent the best case, and a line to represent prognostic uncertainty. The attending trauma surgeon then uses the geriatric trauma outcome score, their knowledge of the health state of the patient, and their own clinical experience to tell a story about treatments, recovery, and outcomes if everything goes as well as we might hope. This story is written down in the best-case scenario box,” Christopher Zimmerman, MD, a general surgery resident at the University of Wisconsin–Madison, said during a presentation about the BCWC tool at the annual clinical congress of the American College of Surgeons
“We often like to talk to patients and their families [about best- and worst-case scenarios] anyway, but [the research team] have tried to formalize it,” said Tam Pham, MD, professor of surgery at the University of Washington, in an interview. Dr. Pham comoderated the session where the research was presented.
“When we’re able to communicate where the uncertainty is and where the boundaries are around the course of care and possible outcomes, we can build an alliance with patients and families that will be helpful when there is a big decision to make, say about a laparotomy for a perforated viscus,” said Dr. Zimmerman.
Dr. Zimmerman gave an example of a patient who came into the ICU after suffering multiple fractures from falling down a set of stairs. The team created an initial BCWC with a hoped-for best-case scenario. Later, the patient developed hypoxemic respiratory failure and had to be intubated overnight. “This event is recorded on the graphic, and her star representing the best case has changed position, the line representing uncertainty has shortened, and the contents of her best-case scenario has changed. Each day in rounds, this process is repeated,” said Dr. Zimmerman.
Palliative care physicians, education experts, and surgeons at the University of Wisconsin–Madison developed the tool in an effort to reduce unwanted care at the end of life, in the context of high-risk surgeries. The researchers adapted the tool to the trauma setting by gathering six focus groups of trauma practitioners at the University of Wisconsin; University of Texas, Dallas; and Oregon Health & Science University, Portland. They modified the tool after incorporating comments, and then iteratively modified it through tasks carried out in the ICU as part of a qualitative improvement initiative at the University of Wisconsin–Madison. They generated a change to the tool, implemented it in the ICU during subsequent rounds, then collected observations and field notes, then revised and repeated the process, streamlining it to fit into the ICU environment, according to Dr. Zimmerman.
The back side of the tool is available for family members to write important details about their loved ones, leading insight into the patient’s personality and desires, such as favorite music or affection for a family pet.
The work was supported by the National Institutes of Health. Dr. Zimmerman and Dr. Pham have no relevant financial disclosures.
SOURCE: Zimmerman C et al. Clinical Congress 2019, Abstract.
REPORTING FROM CLINICAL CONGRESS 2019
Prescribing guide recommends fewer opioids after colorectal surgery
SAN FRANCISCO – Opioids may not always be necessary following elective colorectal surgery. That’s the message coming from a retrospective study of medical records at the University of Massachusetts Medical Center, Worcester, which found that over
“We found that over half of the patients took no opioid pills after discharge, and 60% of the prescribed pills were left over,” said David Meyer, MD, during a presentation of the study at the annual clinical congress of the American College of Surgeons. Dr. Meyer is a surgical resident at the University of Massachusetts.
The team also used the results of their analysis to develop a guideline for the amount of opioid to prescribe following major colorectal surgery, with specific amounts of pills recommended based on the amount of opioid use during the last 24 hours of hospitalization.
“It shows a real interest in tailoring our postoperative care in pain management. They’re trying to find a way to hit a sweet spot to get patients the right amount of pain control,” said Jonathan Mitchem, MD, in an interview. Dr. Mitchem is an assistant professor at University of Missouri–Columbia, and comoderated the session where the research was presented.
The researchers performed a retrospective analysis of major elective colorectal procedures at their institution, including colectomy, rectal resection, and ostomy reversal. The analysis included 100 patients (55 female), with a mean age of 59 years. A total of 71% were opioid naive, meaning there was no evidence of an opioid prescription in the year prior to surgery. A total of 74% underwent a laparoscopic procedure, and 75% had a partial colectomy. The postoperative stay averaged 4.5 days.
The researchers converted in-hospital opioid use categories (IOUC) to equianalgesic 5-mg oxycodone pills (EOPs). In the last 24 hours before release, 53% of patients had no opioids at all (no IOUC, 0 EOPs), 25% received low amounts of opioids (low IOUC, 0.1-3.0 EOPs), and 22% high amounts (high IOUC, more than 3.1 EOPs). Overall, prescribed EOP was 17.5, and just 38% was consumed. These numbers were lowest in the no-IOUC group (15.7, 16%), followed by the low-IOUC group (16.0, 32%), and the high group (23.7, 79%; P less than .01).
The researchers then looked at the 85th percentile of EOPs for each group, and used that to develop a guideline for opioid prescription. For the no-IOUC group, they recommend 3 EOPs, for the low-IOUC group they recommend 12 EOPs, and for the high-IOUC group they recommend 30 EOPs.
The researchers examined various factors that might have influenced opioid use, correcting for whether the patient was opioid naive, case type, postoperative length of stay, and new ostomy creation. The only factor with a significant association for excessive opioid use was inflammatory bowel disease, which was linked to a nearly 900% increased risk of using more than the guideline amounts (adjusted odds ratio, 8.3; P less than .01; area under the curve, 0.85).
The study is limited by the fact that it was conducted at a single center, and that patient opioid use was self-reported. The guidelines need to be validated prospectively.
No funding information was disclosed. Dr. Meyer and Dr. Mitchem had no relevant financial disclosures.
SOURCE: Meyer D et al. Clinical Congress 2019, Abstract.
SAN FRANCISCO – Opioids may not always be necessary following elective colorectal surgery. That’s the message coming from a retrospective study of medical records at the University of Massachusetts Medical Center, Worcester, which found that over
“We found that over half of the patients took no opioid pills after discharge, and 60% of the prescribed pills were left over,” said David Meyer, MD, during a presentation of the study at the annual clinical congress of the American College of Surgeons. Dr. Meyer is a surgical resident at the University of Massachusetts.
The team also used the results of their analysis to develop a guideline for the amount of opioid to prescribe following major colorectal surgery, with specific amounts of pills recommended based on the amount of opioid use during the last 24 hours of hospitalization.
“It shows a real interest in tailoring our postoperative care in pain management. They’re trying to find a way to hit a sweet spot to get patients the right amount of pain control,” said Jonathan Mitchem, MD, in an interview. Dr. Mitchem is an assistant professor at University of Missouri–Columbia, and comoderated the session where the research was presented.
The researchers performed a retrospective analysis of major elective colorectal procedures at their institution, including colectomy, rectal resection, and ostomy reversal. The analysis included 100 patients (55 female), with a mean age of 59 years. A total of 71% were opioid naive, meaning there was no evidence of an opioid prescription in the year prior to surgery. A total of 74% underwent a laparoscopic procedure, and 75% had a partial colectomy. The postoperative stay averaged 4.5 days.
The researchers converted in-hospital opioid use categories (IOUC) to equianalgesic 5-mg oxycodone pills (EOPs). In the last 24 hours before release, 53% of patients had no opioids at all (no IOUC, 0 EOPs), 25% received low amounts of opioids (low IOUC, 0.1-3.0 EOPs), and 22% high amounts (high IOUC, more than 3.1 EOPs). Overall, prescribed EOP was 17.5, and just 38% was consumed. These numbers were lowest in the no-IOUC group (15.7, 16%), followed by the low-IOUC group (16.0, 32%), and the high group (23.7, 79%; P less than .01).
The researchers then looked at the 85th percentile of EOPs for each group, and used that to develop a guideline for opioid prescription. For the no-IOUC group, they recommend 3 EOPs, for the low-IOUC group they recommend 12 EOPs, and for the high-IOUC group they recommend 30 EOPs.
The researchers examined various factors that might have influenced opioid use, correcting for whether the patient was opioid naive, case type, postoperative length of stay, and new ostomy creation. The only factor with a significant association for excessive opioid use was inflammatory bowel disease, which was linked to a nearly 900% increased risk of using more than the guideline amounts (adjusted odds ratio, 8.3; P less than .01; area under the curve, 0.85).
The study is limited by the fact that it was conducted at a single center, and that patient opioid use was self-reported. The guidelines need to be validated prospectively.
No funding information was disclosed. Dr. Meyer and Dr. Mitchem had no relevant financial disclosures.
SOURCE: Meyer D et al. Clinical Congress 2019, Abstract.
SAN FRANCISCO – Opioids may not always be necessary following elective colorectal surgery. That’s the message coming from a retrospective study of medical records at the University of Massachusetts Medical Center, Worcester, which found that over
“We found that over half of the patients took no opioid pills after discharge, and 60% of the prescribed pills were left over,” said David Meyer, MD, during a presentation of the study at the annual clinical congress of the American College of Surgeons. Dr. Meyer is a surgical resident at the University of Massachusetts.
The team also used the results of their analysis to develop a guideline for the amount of opioid to prescribe following major colorectal surgery, with specific amounts of pills recommended based on the amount of opioid use during the last 24 hours of hospitalization.
“It shows a real interest in tailoring our postoperative care in pain management. They’re trying to find a way to hit a sweet spot to get patients the right amount of pain control,” said Jonathan Mitchem, MD, in an interview. Dr. Mitchem is an assistant professor at University of Missouri–Columbia, and comoderated the session where the research was presented.
The researchers performed a retrospective analysis of major elective colorectal procedures at their institution, including colectomy, rectal resection, and ostomy reversal. The analysis included 100 patients (55 female), with a mean age of 59 years. A total of 71% were opioid naive, meaning there was no evidence of an opioid prescription in the year prior to surgery. A total of 74% underwent a laparoscopic procedure, and 75% had a partial colectomy. The postoperative stay averaged 4.5 days.
The researchers converted in-hospital opioid use categories (IOUC) to equianalgesic 5-mg oxycodone pills (EOPs). In the last 24 hours before release, 53% of patients had no opioids at all (no IOUC, 0 EOPs), 25% received low amounts of opioids (low IOUC, 0.1-3.0 EOPs), and 22% high amounts (high IOUC, more than 3.1 EOPs). Overall, prescribed EOP was 17.5, and just 38% was consumed. These numbers were lowest in the no-IOUC group (15.7, 16%), followed by the low-IOUC group (16.0, 32%), and the high group (23.7, 79%; P less than .01).
The researchers then looked at the 85th percentile of EOPs for each group, and used that to develop a guideline for opioid prescription. For the no-IOUC group, they recommend 3 EOPs, for the low-IOUC group they recommend 12 EOPs, and for the high-IOUC group they recommend 30 EOPs.
The researchers examined various factors that might have influenced opioid use, correcting for whether the patient was opioid naive, case type, postoperative length of stay, and new ostomy creation. The only factor with a significant association for excessive opioid use was inflammatory bowel disease, which was linked to a nearly 900% increased risk of using more than the guideline amounts (adjusted odds ratio, 8.3; P less than .01; area under the curve, 0.85).
The study is limited by the fact that it was conducted at a single center, and that patient opioid use was self-reported. The guidelines need to be validated prospectively.
No funding information was disclosed. Dr. Meyer and Dr. Mitchem had no relevant financial disclosures.
SOURCE: Meyer D et al. Clinical Congress 2019, Abstract.
REPORTING FROM CLINICAL CONGRESS 2019
One in five chest tube placements/removals goes awry
SAN FRANCISCO – , according to a prospective observational study conducted at 14 adult trauma centers.
“The sad part is, I don’t know if it was surprisingly high, but I’m glad somebody has taken the time to document it,” said Robert Sawyer, MD, professor of surgery at Western Michigan University, Kalamazoo, Mich., who comoderated the session at the annual clinical congress of the American College of Surgeons, where the study was presented.
The researchers examined error rates in both insertions and removals, and compared some of the practices and characteristics of trauma centers with unusually good or poor records. The work could begin to inform quality improvement initiatives. “That’s very parallel to where we were 20 or 25 years ago with central venous catheters. We used to put them in and thought it was never a problem, and then we started taking a close look at it and found out, yeah, there was a problem. We systematically made our procedures more consistent and had better outcomes. I think chest tubes is going to be ripe for that,” Dr. Sawyer said in an interview.
“In some ways we have been lying to ourselves. We acknowledge that trainees have a high rate of complications in chest tube insertion and removal, but we haven’t fixed it as a systematic problem. We’re behind in our work to reduce complications for this bedside procedure,” echoed the session’s other comoderator, Tam Pham, MD, professor of surgery at the University of Washington, Seattle, in an interview.
The researchers defined chest tube errors as anything that resulted in a need to manipulate, replace, or revise an existing tube; a worsening of the condition that the tube was intended to address; or complications that resulted in additional length of stay or interventions. A total of 381 chest tubes were placed in 273 patients over a 3-month period, about 55% by residents and about 28% by trauma attending physicians. Around 80% were traditional chest tubes, and most of the rest were Pigtail, with a very small fraction of Trocar chest tubes, according to a pie chart displayed by Michaela West, MD, a trauma surgeon at North Memorial Health, Robbinsdale, Minn., who presented the research.
Dr. West reported a wide range of complication rates among the 14 institutions, ranging from under 10% to nearly 60%, and some centers reported far more complications with removal or insertion, while some had closer to an even split. The overall average rate of insertion complications was 18.7%, and the average for removal was 17.7%.
When the researchers looked at some of the best and worst performing centers, they identified some trends. A total of 98.6% of chest tubes were tunneled in the best-performing centers, while 14.3% were tunneled in the worst. An initial air leak was more common in the best performing centers (52.5% versus 21.7%). Higher performing centers had a greater percentage of patients with gunshot wounds (24.3% versus 13%), and had a longer duration of stay (5.3 days versus 3.4 days; P less than .05 for all).
In the single highest performing center, all chest tubes were removed by midlevel individuals, and the other two best performing centers relied on an attending physician or resident. The worst performing centers often had postgraduate year 1 and 2 residents removing the chest tubes.
Dr. West, Dr. Pham, and Dr. Sawyer have no relevant financial disclosures.
SOURCE: West M et al. Clinical Congress 2019 Abstract.
SAN FRANCISCO – , according to a prospective observational study conducted at 14 adult trauma centers.
“The sad part is, I don’t know if it was surprisingly high, but I’m glad somebody has taken the time to document it,” said Robert Sawyer, MD, professor of surgery at Western Michigan University, Kalamazoo, Mich., who comoderated the session at the annual clinical congress of the American College of Surgeons, where the study was presented.
The researchers examined error rates in both insertions and removals, and compared some of the practices and characteristics of trauma centers with unusually good or poor records. The work could begin to inform quality improvement initiatives. “That’s very parallel to where we were 20 or 25 years ago with central venous catheters. We used to put them in and thought it was never a problem, and then we started taking a close look at it and found out, yeah, there was a problem. We systematically made our procedures more consistent and had better outcomes. I think chest tubes is going to be ripe for that,” Dr. Sawyer said in an interview.
“In some ways we have been lying to ourselves. We acknowledge that trainees have a high rate of complications in chest tube insertion and removal, but we haven’t fixed it as a systematic problem. We’re behind in our work to reduce complications for this bedside procedure,” echoed the session’s other comoderator, Tam Pham, MD, professor of surgery at the University of Washington, Seattle, in an interview.
The researchers defined chest tube errors as anything that resulted in a need to manipulate, replace, or revise an existing tube; a worsening of the condition that the tube was intended to address; or complications that resulted in additional length of stay or interventions. A total of 381 chest tubes were placed in 273 patients over a 3-month period, about 55% by residents and about 28% by trauma attending physicians. Around 80% were traditional chest tubes, and most of the rest were Pigtail, with a very small fraction of Trocar chest tubes, according to a pie chart displayed by Michaela West, MD, a trauma surgeon at North Memorial Health, Robbinsdale, Minn., who presented the research.
Dr. West reported a wide range of complication rates among the 14 institutions, ranging from under 10% to nearly 60%, and some centers reported far more complications with removal or insertion, while some had closer to an even split. The overall average rate of insertion complications was 18.7%, and the average for removal was 17.7%.
When the researchers looked at some of the best and worst performing centers, they identified some trends. A total of 98.6% of chest tubes were tunneled in the best-performing centers, while 14.3% were tunneled in the worst. An initial air leak was more common in the best performing centers (52.5% versus 21.7%). Higher performing centers had a greater percentage of patients with gunshot wounds (24.3% versus 13%), and had a longer duration of stay (5.3 days versus 3.4 days; P less than .05 for all).
In the single highest performing center, all chest tubes were removed by midlevel individuals, and the other two best performing centers relied on an attending physician or resident. The worst performing centers often had postgraduate year 1 and 2 residents removing the chest tubes.
Dr. West, Dr. Pham, and Dr. Sawyer have no relevant financial disclosures.
SOURCE: West M et al. Clinical Congress 2019 Abstract.
SAN FRANCISCO – , according to a prospective observational study conducted at 14 adult trauma centers.
“The sad part is, I don’t know if it was surprisingly high, but I’m glad somebody has taken the time to document it,” said Robert Sawyer, MD, professor of surgery at Western Michigan University, Kalamazoo, Mich., who comoderated the session at the annual clinical congress of the American College of Surgeons, where the study was presented.
The researchers examined error rates in both insertions and removals, and compared some of the practices and characteristics of trauma centers with unusually good or poor records. The work could begin to inform quality improvement initiatives. “That’s very parallel to where we were 20 or 25 years ago with central venous catheters. We used to put them in and thought it was never a problem, and then we started taking a close look at it and found out, yeah, there was a problem. We systematically made our procedures more consistent and had better outcomes. I think chest tubes is going to be ripe for that,” Dr. Sawyer said in an interview.
“In some ways we have been lying to ourselves. We acknowledge that trainees have a high rate of complications in chest tube insertion and removal, but we haven’t fixed it as a systematic problem. We’re behind in our work to reduce complications for this bedside procedure,” echoed the session’s other comoderator, Tam Pham, MD, professor of surgery at the University of Washington, Seattle, in an interview.
The researchers defined chest tube errors as anything that resulted in a need to manipulate, replace, or revise an existing tube; a worsening of the condition that the tube was intended to address; or complications that resulted in additional length of stay or interventions. A total of 381 chest tubes were placed in 273 patients over a 3-month period, about 55% by residents and about 28% by trauma attending physicians. Around 80% were traditional chest tubes, and most of the rest were Pigtail, with a very small fraction of Trocar chest tubes, according to a pie chart displayed by Michaela West, MD, a trauma surgeon at North Memorial Health, Robbinsdale, Minn., who presented the research.
Dr. West reported a wide range of complication rates among the 14 institutions, ranging from under 10% to nearly 60%, and some centers reported far more complications with removal or insertion, while some had closer to an even split. The overall average rate of insertion complications was 18.7%, and the average for removal was 17.7%.
When the researchers looked at some of the best and worst performing centers, they identified some trends. A total of 98.6% of chest tubes were tunneled in the best-performing centers, while 14.3% were tunneled in the worst. An initial air leak was more common in the best performing centers (52.5% versus 21.7%). Higher performing centers had a greater percentage of patients with gunshot wounds (24.3% versus 13%), and had a longer duration of stay (5.3 days versus 3.4 days; P less than .05 for all).
In the single highest performing center, all chest tubes were removed by midlevel individuals, and the other two best performing centers relied on an attending physician or resident. The worst performing centers often had postgraduate year 1 and 2 residents removing the chest tubes.
Dr. West, Dr. Pham, and Dr. Sawyer have no relevant financial disclosures.
SOURCE: West M et al. Clinical Congress 2019 Abstract.
REPORTING FROM CLINICAL CONGRESS 2019
Lung cancer screening, early diagnosis still lower among blacks, Hispanics
SAN FRANCISCO – A review of lung cancer cases in New York suggests that 2011 guidelines issued by the National Comprehensive Cancer Network (NCCN) have made little difference in addressing ethnic and socioeconomic disparities in lung cancer diagnosis. The review showed some progress; however, . The researchers also found a reduced incidence of lung cancer only in whites.
The guidelines call for CT screening for smokers aged 55-74 years that have a 30 pack-year history within the past 15 years and were based on a lung cancer screening trial showing that annual low-dose CT led to a 20% reduction in lung cancer deaths, compared with chest x-ray (N Eng J Med. 2011;365:395-409).
Nonwhites “aren’t always exposed to screening opportunities, and may be taken care of by providers who haven’t necessarily bought into screening or aren’t necessarily aware of it. So the downstream effects of the lack of access to screening hurts them doubly, because they’re diagnosed later and they also have disparities in access to treatment,” said Elizabeth David, MD, in an interview. Dr. David is an associate professor of surgery of University of Southern California, Los Angeles. She comoderated a session at the annual congress of the American College of Surgeons, where the research was presented.
The findings underscore the need to get the word out to primary care providers in all communities that catching lung cancer early can make all the difference to patients. “The more we can do to talk about lung cancer as a treatable disease and a cancer that can become a chronically managed medical problem for patients, rather than a death sentence, which it has the misperception of being, the more we can encourage people to seek treatment when they have a symptom, instead of being afraid and doing nothing,” said Dr. David.
The researchers considered metropolitan New York to be a good test case to examine the impact of the screening guidelines since it is socioeconomically and racially diverse. “New York presents a microcosm of what’s going on nationally in other urban areas,” said Tamar Nobel, MD, from Mount Sinai Hospital, New York, who presented the study.
The researchers analyzed records from the New York State Cancer Registry from the period 2008-201 and compared that with data from 2012-2015 (total, n = 18,284). The incidence of lung cancer declined among whites from the first period to the second, at an average annual percent change of –1.5% (95% confidence interval, –1.0% to –2.0%). A similar result was seen in Hispanics (–1.7%; 95% CI, –0.4% to –2.9%), but not among blacks (–1.2%; not significant). There was an increase among Asians/Pacific Islanders (+1.4%; 95% CI, 0.6% to 2.2%).
There were also inequalities when it came to the odds of a stage I diagnosis. Although the percentages increased in whites (+3.5%; 95% CI, 0.6%-6.4%) and blacks (+6.0%; 95% CI, 2.3%-9.7%), the median percentage was higher among whites (27.6% versus 18.2%; no overlap among 95% CIs; odds ratio, 0.62; 95% CI, 0.56-0.68). Hispanics and Asians/Pacific Islanders experienced no significant changes in their odds of a stage I diagnosis, and both groups remained significantly less likely than whites to be diagnosed with stage I disease (OR, 0.72 and 0.86, respectively, both significant).
No funding was disclosed. Dr. David and Dr. Nobel have no relevant financial disclosures.
SOURCE: Nobel T et al. ACS Clinical Congress 2019. Abstract, doi: 10.1016/j.jamcollsurg.2019.08.607.
SAN FRANCISCO – A review of lung cancer cases in New York suggests that 2011 guidelines issued by the National Comprehensive Cancer Network (NCCN) have made little difference in addressing ethnic and socioeconomic disparities in lung cancer diagnosis. The review showed some progress; however, . The researchers also found a reduced incidence of lung cancer only in whites.
The guidelines call for CT screening for smokers aged 55-74 years that have a 30 pack-year history within the past 15 years and were based on a lung cancer screening trial showing that annual low-dose CT led to a 20% reduction in lung cancer deaths, compared with chest x-ray (N Eng J Med. 2011;365:395-409).
Nonwhites “aren’t always exposed to screening opportunities, and may be taken care of by providers who haven’t necessarily bought into screening or aren’t necessarily aware of it. So the downstream effects of the lack of access to screening hurts them doubly, because they’re diagnosed later and they also have disparities in access to treatment,” said Elizabeth David, MD, in an interview. Dr. David is an associate professor of surgery of University of Southern California, Los Angeles. She comoderated a session at the annual congress of the American College of Surgeons, where the research was presented.
The findings underscore the need to get the word out to primary care providers in all communities that catching lung cancer early can make all the difference to patients. “The more we can do to talk about lung cancer as a treatable disease and a cancer that can become a chronically managed medical problem for patients, rather than a death sentence, which it has the misperception of being, the more we can encourage people to seek treatment when they have a symptom, instead of being afraid and doing nothing,” said Dr. David.
The researchers considered metropolitan New York to be a good test case to examine the impact of the screening guidelines since it is socioeconomically and racially diverse. “New York presents a microcosm of what’s going on nationally in other urban areas,” said Tamar Nobel, MD, from Mount Sinai Hospital, New York, who presented the study.
The researchers analyzed records from the New York State Cancer Registry from the period 2008-201 and compared that with data from 2012-2015 (total, n = 18,284). The incidence of lung cancer declined among whites from the first period to the second, at an average annual percent change of –1.5% (95% confidence interval, –1.0% to –2.0%). A similar result was seen in Hispanics (–1.7%; 95% CI, –0.4% to –2.9%), but not among blacks (–1.2%; not significant). There was an increase among Asians/Pacific Islanders (+1.4%; 95% CI, 0.6% to 2.2%).
There were also inequalities when it came to the odds of a stage I diagnosis. Although the percentages increased in whites (+3.5%; 95% CI, 0.6%-6.4%) and blacks (+6.0%; 95% CI, 2.3%-9.7%), the median percentage was higher among whites (27.6% versus 18.2%; no overlap among 95% CIs; odds ratio, 0.62; 95% CI, 0.56-0.68). Hispanics and Asians/Pacific Islanders experienced no significant changes in their odds of a stage I diagnosis, and both groups remained significantly less likely than whites to be diagnosed with stage I disease (OR, 0.72 and 0.86, respectively, both significant).
No funding was disclosed. Dr. David and Dr. Nobel have no relevant financial disclosures.
SOURCE: Nobel T et al. ACS Clinical Congress 2019. Abstract, doi: 10.1016/j.jamcollsurg.2019.08.607.
SAN FRANCISCO – A review of lung cancer cases in New York suggests that 2011 guidelines issued by the National Comprehensive Cancer Network (NCCN) have made little difference in addressing ethnic and socioeconomic disparities in lung cancer diagnosis. The review showed some progress; however, . The researchers also found a reduced incidence of lung cancer only in whites.
The guidelines call for CT screening for smokers aged 55-74 years that have a 30 pack-year history within the past 15 years and were based on a lung cancer screening trial showing that annual low-dose CT led to a 20% reduction in lung cancer deaths, compared with chest x-ray (N Eng J Med. 2011;365:395-409).
Nonwhites “aren’t always exposed to screening opportunities, and may be taken care of by providers who haven’t necessarily bought into screening or aren’t necessarily aware of it. So the downstream effects of the lack of access to screening hurts them doubly, because they’re diagnosed later and they also have disparities in access to treatment,” said Elizabeth David, MD, in an interview. Dr. David is an associate professor of surgery of University of Southern California, Los Angeles. She comoderated a session at the annual congress of the American College of Surgeons, where the research was presented.
The findings underscore the need to get the word out to primary care providers in all communities that catching lung cancer early can make all the difference to patients. “The more we can do to talk about lung cancer as a treatable disease and a cancer that can become a chronically managed medical problem for patients, rather than a death sentence, which it has the misperception of being, the more we can encourage people to seek treatment when they have a symptom, instead of being afraid and doing nothing,” said Dr. David.
The researchers considered metropolitan New York to be a good test case to examine the impact of the screening guidelines since it is socioeconomically and racially diverse. “New York presents a microcosm of what’s going on nationally in other urban areas,” said Tamar Nobel, MD, from Mount Sinai Hospital, New York, who presented the study.
The researchers analyzed records from the New York State Cancer Registry from the period 2008-201 and compared that with data from 2012-2015 (total, n = 18,284). The incidence of lung cancer declined among whites from the first period to the second, at an average annual percent change of –1.5% (95% confidence interval, –1.0% to –2.0%). A similar result was seen in Hispanics (–1.7%; 95% CI, –0.4% to –2.9%), but not among blacks (–1.2%; not significant). There was an increase among Asians/Pacific Islanders (+1.4%; 95% CI, 0.6% to 2.2%).
There were also inequalities when it came to the odds of a stage I diagnosis. Although the percentages increased in whites (+3.5%; 95% CI, 0.6%-6.4%) and blacks (+6.0%; 95% CI, 2.3%-9.7%), the median percentage was higher among whites (27.6% versus 18.2%; no overlap among 95% CIs; odds ratio, 0.62; 95% CI, 0.56-0.68). Hispanics and Asians/Pacific Islanders experienced no significant changes in their odds of a stage I diagnosis, and both groups remained significantly less likely than whites to be diagnosed with stage I disease (OR, 0.72 and 0.86, respectively, both significant).
No funding was disclosed. Dr. David and Dr. Nobel have no relevant financial disclosures.
SOURCE: Nobel T et al. ACS Clinical Congress 2019. Abstract, doi: 10.1016/j.jamcollsurg.2019.08.607.
REPORTING FROM CLINICAL CONGRESS 2019
Bedside near infrared spectroscopy could reveal brain injury during ECMO
SAN FRANCISCO – In patients on extracorporeal membrane oxygenation (ECMO) support, a 25% drop in regional oxygen saturation index (rSO2) value on a bedside near-infrared spectroscopy (NIRS) system is a potential indicator of acute brain injury (ABI), according to a new pilot study. Patients on ECMO are in dire straits, with about a 50% survival rate, but the odds become much worse in the presence of brain injury – the fatality rate rises to about 90%. In addition, ABIs and other neurological complications are common in ECMO patients, occurring in about half.
Currently, clinicians must rely on clinical signs to pinpoint and address emerging injuries, but a bedside NIRS system could flag problems for earlier intervention. “Changes in brain oxygenation could prompt clinicians to do earlier investigations of what’s going on, and maybe they can intervene and reduce the extent of the injury,” Toan Huynh, MD, director of research at Carolinas Medical Center, Charlotte, N.C., said in an interview. Dr. Huynh comoderated the session at the annual clinical congress of the American College of Surgeons, where the research was presented. The study was “very novel,” Dr. Huynh added.
NIRS monitors oxygenation noninvasively. Its rSO2 value balances cerebral oxygen delivery and oxygen consumption, reflecting aerobic metabolism, and therefore has the potential to reveal a patient’s status. A previous study (Artif Organs. 2012;36:659-67) showed that a drop in rSO2 of more than 25%, or absolute values below 40, could predict ABI in ECMO patients, but the work was done retrospectively and is subject to the usual limitations.
The current work, which was presented by medical student Megan Hunt of Johns Hopkins School of Medicine, Baltimore, sought to determine the potential value of NIRS in a prospective study, as well as to determine the interpretation of NIRS that had the best predictive value.
The researchers enrolled 47 consecutive ECMO patients (39 venoarterial, 8 venovenous). Twenty-seven of 39 (69%) of venoarterial ECMO patients, and 6 of 8 (75%) of venovenous ECMO patients had a desaturation event; 53.2% of patients overall experienced an ABI – a number that was in line with previous studies. The researchers found that ABI risk factors such as atrial fibrillation, a lower pre-ECMO Glasgow Coma Score, and more blood transfusions were linked to greater odds of ABI. “Generally, more critically ill patients [had] acute brain injuries,” Ms. Hunt said during her talk.
A total of 65.6% of patients who had an ABI registered a 25% or more drop in rSO2 from baseline, while 26.7% had no change (P = .03). No other measure showed a statistically significant association. A multivariate regression model of ABI variables found that a 25% decline in rSO2 from baseline predicted ABI (adjusted odds ratio, 7.6; P = .03), which outperformed APACHE II (aOR, 1.2; P = .002). A receiver operating characteristic (ROC) curve showed that a 25% drop from baseline had a sensitivity of 85% and a specificity of 55% for ABI.
The study is limited by its small sample size, the fact that it was done at a single institution, and its lack of a control group for validation, but Ms. Hunt was confident in its value. “Ultimately, I think this data is significant in that it shows that NIRS can serve as a real-time bedside monitoring tool for detecting acute brain injury. A drop of greater than 25% should be worrisome for clinicians using this monitoring tool,” she said, and she called for further research to establish a consistent protocol.
The source of funding was not disclosed. Ms. Hunt and Dr. Huynh had no relevant disclosures.
SOURCE: Hunt MF et al. Clinical Congress 2019. Abstract, doi: 10.1016/j.jamcollsurg.2019.08.666.
SAN FRANCISCO – In patients on extracorporeal membrane oxygenation (ECMO) support, a 25% drop in regional oxygen saturation index (rSO2) value on a bedside near-infrared spectroscopy (NIRS) system is a potential indicator of acute brain injury (ABI), according to a new pilot study. Patients on ECMO are in dire straits, with about a 50% survival rate, but the odds become much worse in the presence of brain injury – the fatality rate rises to about 90%. In addition, ABIs and other neurological complications are common in ECMO patients, occurring in about half.
Currently, clinicians must rely on clinical signs to pinpoint and address emerging injuries, but a bedside NIRS system could flag problems for earlier intervention. “Changes in brain oxygenation could prompt clinicians to do earlier investigations of what’s going on, and maybe they can intervene and reduce the extent of the injury,” Toan Huynh, MD, director of research at Carolinas Medical Center, Charlotte, N.C., said in an interview. Dr. Huynh comoderated the session at the annual clinical congress of the American College of Surgeons, where the research was presented. The study was “very novel,” Dr. Huynh added.
NIRS monitors oxygenation noninvasively. Its rSO2 value balances cerebral oxygen delivery and oxygen consumption, reflecting aerobic metabolism, and therefore has the potential to reveal a patient’s status. A previous study (Artif Organs. 2012;36:659-67) showed that a drop in rSO2 of more than 25%, or absolute values below 40, could predict ABI in ECMO patients, but the work was done retrospectively and is subject to the usual limitations.
The current work, which was presented by medical student Megan Hunt of Johns Hopkins School of Medicine, Baltimore, sought to determine the potential value of NIRS in a prospective study, as well as to determine the interpretation of NIRS that had the best predictive value.
The researchers enrolled 47 consecutive ECMO patients (39 venoarterial, 8 venovenous). Twenty-seven of 39 (69%) of venoarterial ECMO patients, and 6 of 8 (75%) of venovenous ECMO patients had a desaturation event; 53.2% of patients overall experienced an ABI – a number that was in line with previous studies. The researchers found that ABI risk factors such as atrial fibrillation, a lower pre-ECMO Glasgow Coma Score, and more blood transfusions were linked to greater odds of ABI. “Generally, more critically ill patients [had] acute brain injuries,” Ms. Hunt said during her talk.
A total of 65.6% of patients who had an ABI registered a 25% or more drop in rSO2 from baseline, while 26.7% had no change (P = .03). No other measure showed a statistically significant association. A multivariate regression model of ABI variables found that a 25% decline in rSO2 from baseline predicted ABI (adjusted odds ratio, 7.6; P = .03), which outperformed APACHE II (aOR, 1.2; P = .002). A receiver operating characteristic (ROC) curve showed that a 25% drop from baseline had a sensitivity of 85% and a specificity of 55% for ABI.
The study is limited by its small sample size, the fact that it was done at a single institution, and its lack of a control group for validation, but Ms. Hunt was confident in its value. “Ultimately, I think this data is significant in that it shows that NIRS can serve as a real-time bedside monitoring tool for detecting acute brain injury. A drop of greater than 25% should be worrisome for clinicians using this monitoring tool,” she said, and she called for further research to establish a consistent protocol.
The source of funding was not disclosed. Ms. Hunt and Dr. Huynh had no relevant disclosures.
SOURCE: Hunt MF et al. Clinical Congress 2019. Abstract, doi: 10.1016/j.jamcollsurg.2019.08.666.
SAN FRANCISCO – In patients on extracorporeal membrane oxygenation (ECMO) support, a 25% drop in regional oxygen saturation index (rSO2) value on a bedside near-infrared spectroscopy (NIRS) system is a potential indicator of acute brain injury (ABI), according to a new pilot study. Patients on ECMO are in dire straits, with about a 50% survival rate, but the odds become much worse in the presence of brain injury – the fatality rate rises to about 90%. In addition, ABIs and other neurological complications are common in ECMO patients, occurring in about half.
Currently, clinicians must rely on clinical signs to pinpoint and address emerging injuries, but a bedside NIRS system could flag problems for earlier intervention. “Changes in brain oxygenation could prompt clinicians to do earlier investigations of what’s going on, and maybe they can intervene and reduce the extent of the injury,” Toan Huynh, MD, director of research at Carolinas Medical Center, Charlotte, N.C., said in an interview. Dr. Huynh comoderated the session at the annual clinical congress of the American College of Surgeons, where the research was presented. The study was “very novel,” Dr. Huynh added.
NIRS monitors oxygenation noninvasively. Its rSO2 value balances cerebral oxygen delivery and oxygen consumption, reflecting aerobic metabolism, and therefore has the potential to reveal a patient’s status. A previous study (Artif Organs. 2012;36:659-67) showed that a drop in rSO2 of more than 25%, or absolute values below 40, could predict ABI in ECMO patients, but the work was done retrospectively and is subject to the usual limitations.
The current work, which was presented by medical student Megan Hunt of Johns Hopkins School of Medicine, Baltimore, sought to determine the potential value of NIRS in a prospective study, as well as to determine the interpretation of NIRS that had the best predictive value.
The researchers enrolled 47 consecutive ECMO patients (39 venoarterial, 8 venovenous). Twenty-seven of 39 (69%) of venoarterial ECMO patients, and 6 of 8 (75%) of venovenous ECMO patients had a desaturation event; 53.2% of patients overall experienced an ABI – a number that was in line with previous studies. The researchers found that ABI risk factors such as atrial fibrillation, a lower pre-ECMO Glasgow Coma Score, and more blood transfusions were linked to greater odds of ABI. “Generally, more critically ill patients [had] acute brain injuries,” Ms. Hunt said during her talk.
A total of 65.6% of patients who had an ABI registered a 25% or more drop in rSO2 from baseline, while 26.7% had no change (P = .03). No other measure showed a statistically significant association. A multivariate regression model of ABI variables found that a 25% decline in rSO2 from baseline predicted ABI (adjusted odds ratio, 7.6; P = .03), which outperformed APACHE II (aOR, 1.2; P = .002). A receiver operating characteristic (ROC) curve showed that a 25% drop from baseline had a sensitivity of 85% and a specificity of 55% for ABI.
The study is limited by its small sample size, the fact that it was done at a single institution, and its lack of a control group for validation, but Ms. Hunt was confident in its value. “Ultimately, I think this data is significant in that it shows that NIRS can serve as a real-time bedside monitoring tool for detecting acute brain injury. A drop of greater than 25% should be worrisome for clinicians using this monitoring tool,” she said, and she called for further research to establish a consistent protocol.
The source of funding was not disclosed. Ms. Hunt and Dr. Huynh had no relevant disclosures.
SOURCE: Hunt MF et al. Clinical Congress 2019. Abstract, doi: 10.1016/j.jamcollsurg.2019.08.666.
REPORTING FROM CLINICAL CONGRESS 2019
KRAS-mutation colon, rectal cancers have distinct survival profiles
SAN FRANCISCO – When it comes to KRAS mutational status, liver metastases originating from left-sided colon tumors have different clinical and survival characteristics from those originating from primary rectal tumors. There was no significant difference in survival between bearers of mutated versus wild-type (WT) KRAS in rectal tumor cases, while there was a significant difference in survival from left-sided colon cases, according to a first-time analysis of the effect of KRAS status in this specific population.
The work was presented at the annual clinical congress of the American College of Surgeons by Neda Amini, MD. “The liver metastasis originating from a rectal tumor might have a different biology than from a primary colon tumor, and we should have stratification according to the primary tumor location in clinical trials testing chemotherapy and targeted agents,” said Dr. Amini, who is a surgical resident at Sinai Hospital of Baltimore, during her presentation of the research.
“I thought that was interesting because most of the studies that have been done look at KRAS mutations in colorectal cancers, and [colon and rectal cancers] are two completely different entities,” said session comoderator Valentine Nfonsam, MD, associate professor of surgery at the University of Arizona, Tucson, in an interview. The findings could also impact clinical practice. “If a patient has rectal cancer, if they have a KRAS mutation, whether you treat them with cetuximab or not, the overall survival doesn’t really change. Whereas for colon cancer patients you really want to make that distinction. You want to truly personalize their therapy, because of the difference in survival in a patient with the KRAS mutation in colon cancer” Dr. Nfonsam said.
“It gets to the heart that there might be different biology between colon cancers and rectal cancers. It’s important to understand the differences in the basic biology, which affects the treatment and the surgery,” said the other comoderator, Jonathan Mitchem, MD, in an interview. Dr. Mitchem is an assistant professor at the University of Missouri–Columbia.
KRAS is common in colorectal cancer, occurring in 30% of cases, and multiple trials have shown it is associated with nonresponse to the epidermal growth factor receptor inhibitors cetuximab or panitumumab. All colorectal cancer patients with liver metastases should be screened for KRAS mutations, according to National Comprehensive Cancer Network guidelines.
The researchers conducted a retrospective analysis of 1,304 patients who underwent curative-intent surgery for colorectal liver metastases at nine institutions between 2000 and 2016. The KRAS mutation rate was similar in the primary colon and rectal tumors (34.2% vs. 30.9%; P = .24). The frequency was highest in right-sided colon tumors (39.4%). There was a statistically significant difference in the frequency of KRAS mutation between primary rectal tumors (30.9%), and left-sided colon tumors (21.1%; P = .001).
There were several differences in clinical characteristics between left-sided colon cancers and rectal cancers. Rectal cancer patients were more likely to be male (73.4% vs. 62.4%; P = .001); more likely to be stage T1-T2 (16.6% vs. 10.6%; P = .012); less likely to have serum carcinoembryonic antigen greater than 100 ng/mL (8.4% vs. 14.1%; P = .018); and less likely to have a liver metastasis under 3 cm (36.1% vs. 49.3%).
There were significant differences between KRAS mutant and KRAS wild-type patients with a colon primary tumor, including greater likelihood of lymph node metastasis in WT (65.2% vs. 55.37%; P = .004), greater likelihood of liver metastasis greater than 3 cm in WT (48.8% versus 39.3%; P = .01), greater likelihood of extrahepatic disease in mutant KRAS (16.3% vs. 10.4%; P = .01), greater likelihood of prehepatic resection chemotherapy in WT (65.5% vs. 56.0%; P = .005), greater likelihood of posthepatic resection chemotherapy in mutant KRAS (64.5% vs. 55.5%; P = .01), and greater likelihood of receiving anti–epidermal growth factor therapy in WT (5.7% vs. 0.3%; P less than .001). The only difference seen in patients with rectal primary tumors was the odds of receiving post-hepatic surgery chemotherapy, which was higher among patients with mutated KRAS (70.8% vs. 59.0%; P = .03).
After a median follow-up of 26.4 months, the 1-, 3-, and 5-year overall survival rates were 88.9%, 62.5%, and 44.5%. Among patients with primary colon cancer, there was a statistically significant lower survival curve in patients with a KRAS mutation overall and in those with left-sided colon tumors (log rank P less than .001 for both), but there was no significant survival difference between mutation bearers and wild-type patients with a primary rectal tumor (log rank P = .53). A multivariate analysis showed an 82% risk of death from KRAS mutation in primary colon cancer (hazard ratio, 1.82; P less than .001), but a univariate analysis showed no significant mortality association in rectal primary tumors (hazard ratio, 1.13; P = .46).
The funding source was not disclosed. The authors had no relevant financial disclosures.
SOURCE: Amini N et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S69-70.
SAN FRANCISCO – When it comes to KRAS mutational status, liver metastases originating from left-sided colon tumors have different clinical and survival characteristics from those originating from primary rectal tumors. There was no significant difference in survival between bearers of mutated versus wild-type (WT) KRAS in rectal tumor cases, while there was a significant difference in survival from left-sided colon cases, according to a first-time analysis of the effect of KRAS status in this specific population.
The work was presented at the annual clinical congress of the American College of Surgeons by Neda Amini, MD. “The liver metastasis originating from a rectal tumor might have a different biology than from a primary colon tumor, and we should have stratification according to the primary tumor location in clinical trials testing chemotherapy and targeted agents,” said Dr. Amini, who is a surgical resident at Sinai Hospital of Baltimore, during her presentation of the research.
“I thought that was interesting because most of the studies that have been done look at KRAS mutations in colorectal cancers, and [colon and rectal cancers] are two completely different entities,” said session comoderator Valentine Nfonsam, MD, associate professor of surgery at the University of Arizona, Tucson, in an interview. The findings could also impact clinical practice. “If a patient has rectal cancer, if they have a KRAS mutation, whether you treat them with cetuximab or not, the overall survival doesn’t really change. Whereas for colon cancer patients you really want to make that distinction. You want to truly personalize their therapy, because of the difference in survival in a patient with the KRAS mutation in colon cancer” Dr. Nfonsam said.
“It gets to the heart that there might be different biology between colon cancers and rectal cancers. It’s important to understand the differences in the basic biology, which affects the treatment and the surgery,” said the other comoderator, Jonathan Mitchem, MD, in an interview. Dr. Mitchem is an assistant professor at the University of Missouri–Columbia.
KRAS is common in colorectal cancer, occurring in 30% of cases, and multiple trials have shown it is associated with nonresponse to the epidermal growth factor receptor inhibitors cetuximab or panitumumab. All colorectal cancer patients with liver metastases should be screened for KRAS mutations, according to National Comprehensive Cancer Network guidelines.
The researchers conducted a retrospective analysis of 1,304 patients who underwent curative-intent surgery for colorectal liver metastases at nine institutions between 2000 and 2016. The KRAS mutation rate was similar in the primary colon and rectal tumors (34.2% vs. 30.9%; P = .24). The frequency was highest in right-sided colon tumors (39.4%). There was a statistically significant difference in the frequency of KRAS mutation between primary rectal tumors (30.9%), and left-sided colon tumors (21.1%; P = .001).
There were several differences in clinical characteristics between left-sided colon cancers and rectal cancers. Rectal cancer patients were more likely to be male (73.4% vs. 62.4%; P = .001); more likely to be stage T1-T2 (16.6% vs. 10.6%; P = .012); less likely to have serum carcinoembryonic antigen greater than 100 ng/mL (8.4% vs. 14.1%; P = .018); and less likely to have a liver metastasis under 3 cm (36.1% vs. 49.3%).
There were significant differences between KRAS mutant and KRAS wild-type patients with a colon primary tumor, including greater likelihood of lymph node metastasis in WT (65.2% vs. 55.37%; P = .004), greater likelihood of liver metastasis greater than 3 cm in WT (48.8% versus 39.3%; P = .01), greater likelihood of extrahepatic disease in mutant KRAS (16.3% vs. 10.4%; P = .01), greater likelihood of prehepatic resection chemotherapy in WT (65.5% vs. 56.0%; P = .005), greater likelihood of posthepatic resection chemotherapy in mutant KRAS (64.5% vs. 55.5%; P = .01), and greater likelihood of receiving anti–epidermal growth factor therapy in WT (5.7% vs. 0.3%; P less than .001). The only difference seen in patients with rectal primary tumors was the odds of receiving post-hepatic surgery chemotherapy, which was higher among patients with mutated KRAS (70.8% vs. 59.0%; P = .03).
After a median follow-up of 26.4 months, the 1-, 3-, and 5-year overall survival rates were 88.9%, 62.5%, and 44.5%. Among patients with primary colon cancer, there was a statistically significant lower survival curve in patients with a KRAS mutation overall and in those with left-sided colon tumors (log rank P less than .001 for both), but there was no significant survival difference between mutation bearers and wild-type patients with a primary rectal tumor (log rank P = .53). A multivariate analysis showed an 82% risk of death from KRAS mutation in primary colon cancer (hazard ratio, 1.82; P less than .001), but a univariate analysis showed no significant mortality association in rectal primary tumors (hazard ratio, 1.13; P = .46).
The funding source was not disclosed. The authors had no relevant financial disclosures.
SOURCE: Amini N et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S69-70.
SAN FRANCISCO – When it comes to KRAS mutational status, liver metastases originating from left-sided colon tumors have different clinical and survival characteristics from those originating from primary rectal tumors. There was no significant difference in survival between bearers of mutated versus wild-type (WT) KRAS in rectal tumor cases, while there was a significant difference in survival from left-sided colon cases, according to a first-time analysis of the effect of KRAS status in this specific population.
The work was presented at the annual clinical congress of the American College of Surgeons by Neda Amini, MD. “The liver metastasis originating from a rectal tumor might have a different biology than from a primary colon tumor, and we should have stratification according to the primary tumor location in clinical trials testing chemotherapy and targeted agents,” said Dr. Amini, who is a surgical resident at Sinai Hospital of Baltimore, during her presentation of the research.
“I thought that was interesting because most of the studies that have been done look at KRAS mutations in colorectal cancers, and [colon and rectal cancers] are two completely different entities,” said session comoderator Valentine Nfonsam, MD, associate professor of surgery at the University of Arizona, Tucson, in an interview. The findings could also impact clinical practice. “If a patient has rectal cancer, if they have a KRAS mutation, whether you treat them with cetuximab or not, the overall survival doesn’t really change. Whereas for colon cancer patients you really want to make that distinction. You want to truly personalize their therapy, because of the difference in survival in a patient with the KRAS mutation in colon cancer” Dr. Nfonsam said.
“It gets to the heart that there might be different biology between colon cancers and rectal cancers. It’s important to understand the differences in the basic biology, which affects the treatment and the surgery,” said the other comoderator, Jonathan Mitchem, MD, in an interview. Dr. Mitchem is an assistant professor at the University of Missouri–Columbia.
KRAS is common in colorectal cancer, occurring in 30% of cases, and multiple trials have shown it is associated with nonresponse to the epidermal growth factor receptor inhibitors cetuximab or panitumumab. All colorectal cancer patients with liver metastases should be screened for KRAS mutations, according to National Comprehensive Cancer Network guidelines.
The researchers conducted a retrospective analysis of 1,304 patients who underwent curative-intent surgery for colorectal liver metastases at nine institutions between 2000 and 2016. The KRAS mutation rate was similar in the primary colon and rectal tumors (34.2% vs. 30.9%; P = .24). The frequency was highest in right-sided colon tumors (39.4%). There was a statistically significant difference in the frequency of KRAS mutation between primary rectal tumors (30.9%), and left-sided colon tumors (21.1%; P = .001).
There were several differences in clinical characteristics between left-sided colon cancers and rectal cancers. Rectal cancer patients were more likely to be male (73.4% vs. 62.4%; P = .001); more likely to be stage T1-T2 (16.6% vs. 10.6%; P = .012); less likely to have serum carcinoembryonic antigen greater than 100 ng/mL (8.4% vs. 14.1%; P = .018); and less likely to have a liver metastasis under 3 cm (36.1% vs. 49.3%).
There were significant differences between KRAS mutant and KRAS wild-type patients with a colon primary tumor, including greater likelihood of lymph node metastasis in WT (65.2% vs. 55.37%; P = .004), greater likelihood of liver metastasis greater than 3 cm in WT (48.8% versus 39.3%; P = .01), greater likelihood of extrahepatic disease in mutant KRAS (16.3% vs. 10.4%; P = .01), greater likelihood of prehepatic resection chemotherapy in WT (65.5% vs. 56.0%; P = .005), greater likelihood of posthepatic resection chemotherapy in mutant KRAS (64.5% vs. 55.5%; P = .01), and greater likelihood of receiving anti–epidermal growth factor therapy in WT (5.7% vs. 0.3%; P less than .001). The only difference seen in patients with rectal primary tumors was the odds of receiving post-hepatic surgery chemotherapy, which was higher among patients with mutated KRAS (70.8% vs. 59.0%; P = .03).
After a median follow-up of 26.4 months, the 1-, 3-, and 5-year overall survival rates were 88.9%, 62.5%, and 44.5%. Among patients with primary colon cancer, there was a statistically significant lower survival curve in patients with a KRAS mutation overall and in those with left-sided colon tumors (log rank P less than .001 for both), but there was no significant survival difference between mutation bearers and wild-type patients with a primary rectal tumor (log rank P = .53). A multivariate analysis showed an 82% risk of death from KRAS mutation in primary colon cancer (hazard ratio, 1.82; P less than .001), but a univariate analysis showed no significant mortality association in rectal primary tumors (hazard ratio, 1.13; P = .46).
The funding source was not disclosed. The authors had no relevant financial disclosures.
SOURCE: Amini N et al. J Am Coll Surg. 2019 Oct;229(4):Suppl 1, S69-70.
REPORTING FROM CLINICAL CONGRESS 2019