Doug Brunk

Enacting risk-based gun removal laws and prohibiting guns from people involuntarily detained in short-term psychiatric hospitalization may have a positive impact on gun-related suicide and violent crime among people with serious mental illnesses.

Those are among the recommendations published June 6 by Jeffrey W. Swanson, Ph.D., and his associates, who studied 81,704 adults diagnosed with schizophrenia, bipolar disorder, or major depression in two large Florida counties between 2002 and 2011 (Health Aff. 2016 Jun 6;35[6]:1067-75. doi:10.1377/hlthaff.2016.0017).

Dr. Swanson and his associates found that 62% of arrests from gun crimes and 28% of suicides by gun involved individuals who were not legally permitted to have a gun. In addition, they found that suicide was nearly four times as prevalent among adults diagnosed with a serious mental illness, compared with their counterparts in the general population (64.4 vs.17.7 per 100,000 persons).

Also, 20% of suicides among adults with a serious mental illness were by firearm, compared with 48% of adults in the general Florida population, reported Dr. Swanson, a professor in the department of psychiatry and behavioral sciences at Duke University, Durham, N.C.

Gun violence by suicide claims the lives of 33,000 people each year in the United States, and two-thirds of the country’s gun fatalities are suicides, Dr. Swanson said in a video describing his study.

“We’re focused on laws that restrict access to guns as public health interventions,” Dr. Swanson said. “One of the things that sticks with me is there’s a lost public health opportunity, because people with mental illnesses ... who end their life in suicide often are not going to be prohibited people – they can go and legally buy a gun on the day that they use one to end their life. But many of them actually are known to the mental health care system. That’s the opportunity. States could say, ‘let’s use this as a time to separate that individual from guns.’ ”

The study was funded by the National Science Foundation, the Robert Wood Johnson Foundation program in Public Health Law Research, the Brain and Behavior Research Foundation, and the Elizabeth K. Dollard Charitable Trust.

[email protected]

Enacting risk-based gun removal laws and prohibiting guns from people involuntarily detained in short-term psychiatric hospitalization may have a positive impact on gun-related suicide and violent crime among people with serious mental illnesses.

Those are among the recommendations published June 6 by Jeffrey W. Swanson, Ph.D., and his associates, who studied 81,704 adults diagnosed with schizophrenia, bipolar disorder, or major depression in two large Florida counties between 2002 and 2011 (Health Aff. 2016 Jun 6;35[6]:1067-75. doi:10.1377/hlthaff.2016.0017).

Dr. Swanson and his associates found that 62% of arrests from gun crimes and 28% of suicides by gun involved individuals who were not legally permitted to have a gun. In addition, they found that suicide was nearly four times as prevalent among adults diagnosed with a serious mental illness, compared with their counterparts in the general population (64.4 vs.17.7 per 100,000 persons).

Also, 20% of suicides among adults with a serious mental illness were by firearm, compared with 48% of adults in the general Florida population, reported Dr. Swanson, a professor in the department of psychiatry and behavioral sciences at Duke University, Durham, N.C.

Gun violence by suicide claims the lives of 33,000 people each year in the United States, and two-thirds of the country’s gun fatalities are suicides, Dr. Swanson said in a video describing his study.

“We’re focused on laws that restrict access to guns as public health interventions,” Dr. Swanson said. “One of the things that sticks with me is there’s a lost public health opportunity, because people with mental illnesses ... who end their life in suicide often are not going to be prohibited people – they can go and legally buy a gun on the day that they use one to end their life. But many of them actually are known to the mental health care system. That’s the opportunity. States could say, ‘let’s use this as a time to separate that individual from guns.’ ”

The study was funded by the National Science Foundation, the Robert Wood Johnson Foundation program in Public Health Law Research, the Brain and Behavior Research Foundation, and the Elizabeth K. Dollard Charitable Trust.

[email protected]

Enacting risk-based gun removal laws and prohibiting guns from people involuntarily detained in short-term psychiatric hospitalization may have a positive impact on gun-related suicide and violent crime among people with serious mental illnesses.

Those are among the recommendations published June 6 by Jeffrey W. Swanson, Ph.D., and his associates, who studied 81,704 adults diagnosed with schizophrenia, bipolar disorder, or major depression in two large Florida counties between 2002 and 2011 (Health Aff. 2016 Jun 6;35[6]:1067-75. doi:10.1377/hlthaff.2016.0017).

Dr. Swanson and his associates found that 62% of arrests from gun crimes and 28% of suicides by gun involved individuals who were not legally permitted to have a gun. In addition, they found that suicide was nearly four times as prevalent among adults diagnosed with a serious mental illness, compared with their counterparts in the general population (64.4 vs.17.7 per 100,000 persons).

Also, 20% of suicides among adults with a serious mental illness were by firearm, compared with 48% of adults in the general Florida population, reported Dr. Swanson, a professor in the department of psychiatry and behavioral sciences at Duke University, Durham, N.C.

Gun violence by suicide claims the lives of 33,000 people each year in the United States, and two-thirds of the country’s gun fatalities are suicides, Dr. Swanson said in a video describing his study.

“We’re focused on laws that restrict access to guns as public health interventions,” Dr. Swanson said. “One of the things that sticks with me is there’s a lost public health opportunity, because people with mental illnesses ... who end their life in suicide often are not going to be prohibited people – they can go and legally buy a gun on the day that they use one to end their life. But many of them actually are known to the mental health care system. That’s the opportunity. States could say, ‘let’s use this as a time to separate that individual from guns.’ ”

The study was funded by the National Science Foundation, the Robert Wood Johnson Foundation program in Public Health Law Research, the Brain and Behavior Research Foundation, and the Elizabeth K. Dollard Charitable Trust.

[email protected]

LOS ANGELES – The inpatient use of infliximab for severe ulcerative colitis does not avoid the need for colectomy in patients who fail steroid therapy, results from a single-center study demonstrated.

In an interview at the annual meeting of the American Society of Colon and Rectal Surgeons, lead study author Dr. Rachel E. Andrew, a third-year resident in the department of surgery at Penn State Hershey Medical Center in Hershey, Pa., said that despite recent interest in providing inpatient infliximab as an alternative to surgery for those with steroid-refractory disease, 82% of those who received salvage infliximab went on to undergo a total abdominal colectomy during the same admission.

“Our findings suggest that inpatient infliximab was not effective at improving the severity of colitis in these patients,” she said. “Further, infliximab was unreliable in avoiding the need for a total colectomy in this population of ulcerative colitis patients. One difference between our study and those previously published on this subject is that our study focuses on patients with a severity of colitis that resulted in their admission to a surgery service. In terms of evaluating the benefit of infliximab and providing a reliable avoidance of colectomy, we feel that this population of ulcerative colitis patients would be most appropriate to evaluate this issue. This possible difference in patient population may explain the difference in our study findings and those previously published.”

The researchers compared colectomy rates in 173 patients with severe ulcerative colitis who were admitted to the colorectal surgery service at Penn State Hershey Medical Center. Their mean age was 41 years, with 155 (90%) treated with high-dose steroids alone, and with 18 (10%) having received inpatient infliximab as salvage therapy due to a lack of response to steroids alone. Of the patients who received high-dose steroids alone, 81 (52%) required total colectomy, compared with 14 (82%) who received infliximab salvage therapy (P = .046).

The researchers observed no statistically significant differences between the two groups regarding rates of hospital readmission, superficial, deep and organ space surgical-site infections, unplanned return to the operating room, and all complication rates (P greater than .05). Among patients who required total colectomy, hospital costs were 27% higher among those who received infliximab compared with those who received high-dose steroids alone (a mean of $19,880 vs. $14,492, respectively), but because of the small sample size of the infliximab cohort this difference did not reach statistical significance.

“In our institution, salvage infliximab has not been shown to be effective,” Dr. Andrew said. “One key difference between our findings and other studies is that our study population had a high colectomy rate; 82% is much higher than the approximately 30% colectomy rate described in many reports from colleagues in gastroenterology. While there are several potential explanations for our higher rate of colectomy, including the potential concerns that surgeons might be inclined to opt for surgery more readily than non-surgical providers, it is likely that the patients in our study had more severe forms of colitis. It might be the case that there are certain severities of colitis that are beyond the ability of infliximab to salvage, which would be an important issue in selecting which patients to provide inpatient infliximab, so as to not unnecessarily delay surgery, increase hospital costs and to avoid escalating the degree of immunosuppression without a reasonable likelihood of clinical improvement.”

Dr. Andrew reported having no financial disclosures.

[email protected]

LOS ANGELES – The inpatient use of infliximab for severe ulcerative colitis does not avoid the need for colectomy in patients who fail steroid therapy, results from a single-center study demonstrated.

In an interview at the annual meeting of the American Society of Colon and Rectal Surgeons, lead study author Dr. Rachel E. Andrew, a third-year resident in the department of surgery at Penn State Hershey Medical Center in Hershey, Pa., said that despite recent interest in providing inpatient infliximab as an alternative to surgery for those with steroid-refractory disease, 82% of those who received salvage infliximab went on to undergo a total abdominal colectomy during the same admission.

“Our findings suggest that inpatient infliximab was not effective at improving the severity of colitis in these patients,” she said. “Further, infliximab was unreliable in avoiding the need for a total colectomy in this population of ulcerative colitis patients. One difference between our study and those previously published on this subject is that our study focuses on patients with a severity of colitis that resulted in their admission to a surgery service. In terms of evaluating the benefit of infliximab and providing a reliable avoidance of colectomy, we feel that this population of ulcerative colitis patients would be most appropriate to evaluate this issue. This possible difference in patient population may explain the difference in our study findings and those previously published.”

The researchers compared colectomy rates in 173 patients with severe ulcerative colitis who were admitted to the colorectal surgery service at Penn State Hershey Medical Center. Their mean age was 41 years, with 155 (90%) treated with high-dose steroids alone, and with 18 (10%) having received inpatient infliximab as salvage therapy due to a lack of response to steroids alone. Of the patients who received high-dose steroids alone, 81 (52%) required total colectomy, compared with 14 (82%) who received infliximab salvage therapy (P = .046).

The researchers observed no statistically significant differences between the two groups regarding rates of hospital readmission, superficial, deep and organ space surgical-site infections, unplanned return to the operating room, and all complication rates (P greater than .05). Among patients who required total colectomy, hospital costs were 27% higher among those who received infliximab compared with those who received high-dose steroids alone (a mean of $19,880 vs. $14,492, respectively), but because of the small sample size of the infliximab cohort this difference did not reach statistical significance.

“In our institution, salvage infliximab has not been shown to be effective,” Dr. Andrew said. “One key difference between our findings and other studies is that our study population had a high colectomy rate; 82% is much higher than the approximately 30% colectomy rate described in many reports from colleagues in gastroenterology. While there are several potential explanations for our higher rate of colectomy, including the potential concerns that surgeons might be inclined to opt for surgery more readily than non-surgical providers, it is likely that the patients in our study had more severe forms of colitis. It might be the case that there are certain severities of colitis that are beyond the ability of infliximab to salvage, which would be an important issue in selecting which patients to provide inpatient infliximab, so as to not unnecessarily delay surgery, increase hospital costs and to avoid escalating the degree of immunosuppression without a reasonable likelihood of clinical improvement.”

Dr. Andrew reported having no financial disclosures.

[email protected]

LOS ANGELES – The inpatient use of infliximab for severe ulcerative colitis does not avoid the need for colectomy in patients who fail steroid therapy, results from a single-center study demonstrated.

In an interview at the annual meeting of the American Society of Colon and Rectal Surgeons, lead study author Dr. Rachel E. Andrew, a third-year resident in the department of surgery at Penn State Hershey Medical Center in Hershey, Pa., said that despite recent interest in providing inpatient infliximab as an alternative to surgery for those with steroid-refractory disease, 82% of those who received salvage infliximab went on to undergo a total abdominal colectomy during the same admission.

“Our findings suggest that inpatient infliximab was not effective at improving the severity of colitis in these patients,” she said. “Further, infliximab was unreliable in avoiding the need for a total colectomy in this population of ulcerative colitis patients. One difference between our study and those previously published on this subject is that our study focuses on patients with a severity of colitis that resulted in their admission to a surgery service. In terms of evaluating the benefit of infliximab and providing a reliable avoidance of colectomy, we feel that this population of ulcerative colitis patients would be most appropriate to evaluate this issue. This possible difference in patient population may explain the difference in our study findings and those previously published.”

The researchers compared colectomy rates in 173 patients with severe ulcerative colitis who were admitted to the colorectal surgery service at Penn State Hershey Medical Center. Their mean age was 41 years, with 155 (90%) treated with high-dose steroids alone, and with 18 (10%) having received inpatient infliximab as salvage therapy due to a lack of response to steroids alone. Of the patients who received high-dose steroids alone, 81 (52%) required total colectomy, compared with 14 (82%) who received infliximab salvage therapy (P = .046).

The researchers observed no statistically significant differences between the two groups regarding rates of hospital readmission, superficial, deep and organ space surgical-site infections, unplanned return to the operating room, and all complication rates (P greater than .05). Among patients who required total colectomy, hospital costs were 27% higher among those who received infliximab compared with those who received high-dose steroids alone (a mean of $19,880 vs. $14,492, respectively), but because of the small sample size of the infliximab cohort this difference did not reach statistical significance.

“In our institution, salvage infliximab has not been shown to be effective,” Dr. Andrew said. “One key difference between our findings and other studies is that our study population had a high colectomy rate; 82% is much higher than the approximately 30% colectomy rate described in many reports from colleagues in gastroenterology. While there are several potential explanations for our higher rate of colectomy, including the potential concerns that surgeons might be inclined to opt for surgery more readily than non-surgical providers, it is likely that the patients in our study had more severe forms of colitis. It might be the case that there are certain severities of colitis that are beyond the ability of infliximab to salvage, which would be an important issue in selecting which patients to provide inpatient infliximab, so as to not unnecessarily delay surgery, increase hospital costs and to avoid escalating the degree of immunosuppression without a reasonable likelihood of clinical improvement.”

Dr. Andrew reported having no financial disclosures.

[email protected]

After implementation of surgical safety checklists in a tertiary care hospital, researchers observed a 27% reduction of risk-adjusted all-cause 90-day mortality, but adjusted all-cause 30-day mortality remained unchanged.

In addition, length of stay was reduced but 30-day readmission rate was not, according to the study published online in JAMA Surgery. Those key findings are from an effort to assess the association between the implementation of surgical safety checklists (SSCs) and rates of all-cause 90- and 30-day mortality.

©PixelEmbargo/Thinkstock

Previous studies have analyzed in-hospital mortality or 30-day mortality “but not intermediate-term outcome variables,” said lead author Dr. Matthias Bock of the department of anesthesiology and intensive care medicine at Merano Hospital, Merano, Italy. “Almost one-quarter (23.6%) of the deaths within 30 days after surgery occurred after discharge, and 39.7% of patients undergoing surgery experienced only post-discharge complications. Ninety-day mortality often doubles 30-day mortality. In-hospital mortality and 30-day mortality might therefore underreport the real risk to these patients, especially after tumor surgery or among the elderly. Studies of the effect or the association of the implementation of surgical safety checklists (SSCs) on 90-day mortality are lacking.”

Dr. Bock and his associates retrospectively evaluated the outcomes of surgical procedures performed during the six months before and six months after implementation of SSCs at the 715-bed Central Hospital of Bolzano (CHB) in Italy (Jan. 1-June 30, 2010, and Jan. 1-June 30, 2013, respectively). The key outcome measures were risk-adjusted rates of 90- and 30-day mortality, readmission rate, and LOS (JAMA Surg. 2016 Feb 3. doi:10.1001/jamasurg.2015.5490).

The study sample consisted of 10,741 patients, including 5,444 pre-intervention and 5,297 post-intervention patients. Of these, 53% were female and their mean age was 53 years.

The researchers reported that 90-day all-cause mortality was 2.4% before SSC implementation, compared with 2.2% after implementation, for an adjusted odds ratio (AOR) of 0.73 (P = .02). However, 30-day all-cause mortality was 1.36% before SSC implementation, compared with 1.32% after implementation, for an AOR of 0.79 (P = .17), remaining essentially unchanged.

Dr. Bock and his associates also found that 30-day readmission rates were similar in the pre-implementation and post-implementation groups (14.6% vs. 14.5%, respectively: P = .90), but the adjusted length of stay favored the post-implementation group (a mean of 9.6 days, compared with a mean of 10.4 days in the in the pre-implementation group; P less than .001).

The researchers acknowledged certain limitations of the study, including its single-center design and the lack of a control group. “The study design highly reduces the risk for observation bias (Hawthorne effect),” they wrote. “Furthermore, we did not inform the staff about the purpose of our study. We analyzed only objective outcome data to reduce reporting bias as much as possible.”

The finding of a decline in LOS “suggests potential cost savings after the implementation of SSCs,” they concluded. “Further trials should address this hypothesis and the effect on quality of care owing to a reduction of the costs of complications or unplanned reoperations.”

The study was supported by the Public Health Care Company of South Tyrol, Italy, and by the Autonomous Province of Bolzano, Italy. The researchers reported having no financial disclosures.

[email protected]

After implementation of surgical safety checklists in a tertiary care hospital, researchers observed a 27% reduction of risk-adjusted all-cause 90-day mortality, but adjusted all-cause 30-day mortality remained unchanged.

In addition, length of stay was reduced but 30-day readmission rate was not, according to the study published online in JAMA Surgery. Those key findings are from an effort to assess the association between the implementation of surgical safety checklists (SSCs) and rates of all-cause 90- and 30-day mortality.

©PixelEmbargo/Thinkstock

Previous studies have analyzed in-hospital mortality or 30-day mortality “but not intermediate-term outcome variables,” said lead author Dr. Matthias Bock of the department of anesthesiology and intensive care medicine at Merano Hospital, Merano, Italy. “Almost one-quarter (23.6%) of the deaths within 30 days after surgery occurred after discharge, and 39.7% of patients undergoing surgery experienced only post-discharge complications. Ninety-day mortality often doubles 30-day mortality. In-hospital mortality and 30-day mortality might therefore underreport the real risk to these patients, especially after tumor surgery or among the elderly. Studies of the effect or the association of the implementation of surgical safety checklists (SSCs) on 90-day mortality are lacking.”

Dr. Bock and his associates retrospectively evaluated the outcomes of surgical procedures performed during the six months before and six months after implementation of SSCs at the 715-bed Central Hospital of Bolzano (CHB) in Italy (Jan. 1-June 30, 2010, and Jan. 1-June 30, 2013, respectively). The key outcome measures were risk-adjusted rates of 90- and 30-day mortality, readmission rate, and LOS (JAMA Surg. 2016 Feb 3. doi:10.1001/jamasurg.2015.5490).

The study sample consisted of 10,741 patients, including 5,444 pre-intervention and 5,297 post-intervention patients. Of these, 53% were female and their mean age was 53 years.

The researchers reported that 90-day all-cause mortality was 2.4% before SSC implementation, compared with 2.2% after implementation, for an adjusted odds ratio (AOR) of 0.73 (P = .02). However, 30-day all-cause mortality was 1.36% before SSC implementation, compared with 1.32% after implementation, for an AOR of 0.79 (P = .17), remaining essentially unchanged.

Dr. Bock and his associates also found that 30-day readmission rates were similar in the pre-implementation and post-implementation groups (14.6% vs. 14.5%, respectively: P = .90), but the adjusted length of stay favored the post-implementation group (a mean of 9.6 days, compared with a mean of 10.4 days in the in the pre-implementation group; P less than .001).

The researchers acknowledged certain limitations of the study, including its single-center design and the lack of a control group. “The study design highly reduces the risk for observation bias (Hawthorne effect),” they wrote. “Furthermore, we did not inform the staff about the purpose of our study. We analyzed only objective outcome data to reduce reporting bias as much as possible.”

The finding of a decline in LOS “suggests potential cost savings after the implementation of SSCs,” they concluded. “Further trials should address this hypothesis and the effect on quality of care owing to a reduction of the costs of complications or unplanned reoperations.”

The study was supported by the Public Health Care Company of South Tyrol, Italy, and by the Autonomous Province of Bolzano, Italy. The researchers reported having no financial disclosures.

[email protected]

After implementation of surgical safety checklists in a tertiary care hospital, researchers observed a 27% reduction of risk-adjusted all-cause 90-day mortality, but adjusted all-cause 30-day mortality remained unchanged.

In addition, length of stay was reduced but 30-day readmission rate was not, according to the study published online in JAMA Surgery. Those key findings are from an effort to assess the association between the implementation of surgical safety checklists (SSCs) and rates of all-cause 90- and 30-day mortality.

©PixelEmbargo/Thinkstock

Previous studies have analyzed in-hospital mortality or 30-day mortality “but not intermediate-term outcome variables,” said lead author Dr. Matthias Bock of the department of anesthesiology and intensive care medicine at Merano Hospital, Merano, Italy. “Almost one-quarter (23.6%) of the deaths within 30 days after surgery occurred after discharge, and 39.7% of patients undergoing surgery experienced only post-discharge complications. Ninety-day mortality often doubles 30-day mortality. In-hospital mortality and 30-day mortality might therefore underreport the real risk to these patients, especially after tumor surgery or among the elderly. Studies of the effect or the association of the implementation of surgical safety checklists (SSCs) on 90-day mortality are lacking.”

Dr. Bock and his associates retrospectively evaluated the outcomes of surgical procedures performed during the six months before and six months after implementation of SSCs at the 715-bed Central Hospital of Bolzano (CHB) in Italy (Jan. 1-June 30, 2010, and Jan. 1-June 30, 2013, respectively). The key outcome measures were risk-adjusted rates of 90- and 30-day mortality, readmission rate, and LOS (JAMA Surg. 2016 Feb 3. doi:10.1001/jamasurg.2015.5490).

The study sample consisted of 10,741 patients, including 5,444 pre-intervention and 5,297 post-intervention patients. Of these, 53% were female and their mean age was 53 years.

The researchers reported that 90-day all-cause mortality was 2.4% before SSC implementation, compared with 2.2% after implementation, for an adjusted odds ratio (AOR) of 0.73 (P = .02). However, 30-day all-cause mortality was 1.36% before SSC implementation, compared with 1.32% after implementation, for an AOR of 0.79 (P = .17), remaining essentially unchanged.

Dr. Bock and his associates also found that 30-day readmission rates were similar in the pre-implementation and post-implementation groups (14.6% vs. 14.5%, respectively: P = .90), but the adjusted length of stay favored the post-implementation group (a mean of 9.6 days, compared with a mean of 10.4 days in the in the pre-implementation group; P less than .001).

The researchers acknowledged certain limitations of the study, including its single-center design and the lack of a control group. “The study design highly reduces the risk for observation bias (Hawthorne effect),” they wrote. “Furthermore, we did not inform the staff about the purpose of our study. We analyzed only objective outcome data to reduce reporting bias as much as possible.”

The finding of a decline in LOS “suggests potential cost savings after the implementation of SSCs,” they concluded. “Further trials should address this hypothesis and the effect on quality of care owing to a reduction of the costs of complications or unplanned reoperations.”

The study was supported by the Public Health Care Company of South Tyrol, Italy, and by the Autonomous Province of Bolzano, Italy. The researchers reported having no financial disclosures.

[email protected]

LOS ANGELES – Treatment with neoadjuvant chemotherapy leads to significant downstaging in a selected group of patients with advanced colon cancer, results from a large registry study showed.

“Neoadjuvant chemotherapy is already established as a treatment strategy in several other types of cancers, such as breast cancer, gastric cancer, and rectal cancer,” lead study author Dr. Moniek Verstegen said at the annual meeting of the American Society of Colon and Rectal Surgeons. “It reduces tumor size and promotes resectability. In colon cancer, however, this treatment strategy is relatively new and not applied very often.”

©BluePlanetEarth/thinkstockphotos.com

Preliminary results from the ongoing FOxTROT trial in the United Kingdom showed that preoperative chemotherapy for radiologically staged, locally advanced, operable primary colon cancer is feasible, with acceptable toxicity and perioperative morbidity, but long-term results are not yet available. The aim of the current study was to see how often neoadjuvant chemotherapy is used in the Netherlands for stage II and III colon cancer and to assess the tumor and nodal downsizing effects. Moreover, perioperative results and long-term outcomes were compared between those treated with neoadjuvant chemotherapy and those who were treated with adjuvant chemotherapy for locally advanced colon cancer.

The researchers searched the Netherlands Cancer Registry from 2008-2012 to identify 24,944 patients diagnosed with stage II and III colon cancer. Dr. Verstegen, a researcher in the department of surgery at Radboud University Medical Center, Nijmegen, Netherlands, reported results from 85 patients who received neoadjuvant chemotherapy and 2,216 who received adjuvant chemotherapy (the control group). Both groups were similar in terms of age (a median of about 65 years), gender, localization of the primary tumor, differentiation grade, morphology, and clinical T and N stage. Multivisceral resections were performed significantly more often in the neoadjuvant group, compared with the control group (21% vs. 5%, respectively; P less than .001). There were no differences between groups in the number of complete resections, nor in the rate of complications. Furthermore, no patient died within 30 days of neoadjuvant chemotherapy after surgery.

Tumor downstaging was observed in 47% of patients treated with neoadjuvant chemotherapy and there were three complete responses. At the same time, nodal downstaging was observed in 50% of patients treated with neoadjuvant chemotherapy. The 3-year overall survival was 73% in both groups.

Dr. Verstegen acknowledged certain limitations of the study, including its retrospective design and the lack of data on recurrences and disease-free survival. “Neoadjuvant chemotherapy seems to be a safe treatment strategy, since we have low postoperative morbidity and mortality rates,” she concluded. “We see comparable outcomes compared to the control group. Prospective trials are needed to confirm the safety and value of neoadjuvant chemotherapy.”

Dr. Verstegen reported having no financial disclosures.

[email protected]

LOS ANGELES – Treatment with neoadjuvant chemotherapy leads to significant downstaging in a selected group of patients with advanced colon cancer, results from a large registry study showed.

“Neoadjuvant chemotherapy is already established as a treatment strategy in several other types of cancers, such as breast cancer, gastric cancer, and rectal cancer,” lead study author Dr. Moniek Verstegen said at the annual meeting of the American Society of Colon and Rectal Surgeons. “It reduces tumor size and promotes resectability. In colon cancer, however, this treatment strategy is relatively new and not applied very often.”

©BluePlanetEarth/thinkstockphotos.com

Preliminary results from the ongoing FOxTROT trial in the United Kingdom showed that preoperative chemotherapy for radiologically staged, locally advanced, operable primary colon cancer is feasible, with acceptable toxicity and perioperative morbidity, but long-term results are not yet available. The aim of the current study was to see how often neoadjuvant chemotherapy is used in the Netherlands for stage II and III colon cancer and to assess the tumor and nodal downsizing effects. Moreover, perioperative results and long-term outcomes were compared between those treated with neoadjuvant chemotherapy and those who were treated with adjuvant chemotherapy for locally advanced colon cancer.

The researchers searched the Netherlands Cancer Registry from 2008-2012 to identify 24,944 patients diagnosed with stage II and III colon cancer. Dr. Verstegen, a researcher in the department of surgery at Radboud University Medical Center, Nijmegen, Netherlands, reported results from 85 patients who received neoadjuvant chemotherapy and 2,216 who received adjuvant chemotherapy (the control group). Both groups were similar in terms of age (a median of about 65 years), gender, localization of the primary tumor, differentiation grade, morphology, and clinical T and N stage. Multivisceral resections were performed significantly more often in the neoadjuvant group, compared with the control group (21% vs. 5%, respectively; P less than .001). There were no differences between groups in the number of complete resections, nor in the rate of complications. Furthermore, no patient died within 30 days of neoadjuvant chemotherapy after surgery.

Tumor downstaging was observed in 47% of patients treated with neoadjuvant chemotherapy and there were three complete responses. At the same time, nodal downstaging was observed in 50% of patients treated with neoadjuvant chemotherapy. The 3-year overall survival was 73% in both groups.

Dr. Verstegen acknowledged certain limitations of the study, including its retrospective design and the lack of data on recurrences and disease-free survival. “Neoadjuvant chemotherapy seems to be a safe treatment strategy, since we have low postoperative morbidity and mortality rates,” she concluded. “We see comparable outcomes compared to the control group. Prospective trials are needed to confirm the safety and value of neoadjuvant chemotherapy.”

Dr. Verstegen reported having no financial disclosures.

[email protected]

LOS ANGELES – Treatment with neoadjuvant chemotherapy leads to significant downstaging in a selected group of patients with advanced colon cancer, results from a large registry study showed.

“Neoadjuvant chemotherapy is already established as a treatment strategy in several other types of cancers, such as breast cancer, gastric cancer, and rectal cancer,” lead study author Dr. Moniek Verstegen said at the annual meeting of the American Society of Colon and Rectal Surgeons. “It reduces tumor size and promotes resectability. In colon cancer, however, this treatment strategy is relatively new and not applied very often.”

©BluePlanetEarth/thinkstockphotos.com

Preliminary results from the ongoing FOxTROT trial in the United Kingdom showed that preoperative chemotherapy for radiologically staged, locally advanced, operable primary colon cancer is feasible, with acceptable toxicity and perioperative morbidity, but long-term results are not yet available. The aim of the current study was to see how often neoadjuvant chemotherapy is used in the Netherlands for stage II and III colon cancer and to assess the tumor and nodal downsizing effects. Moreover, perioperative results and long-term outcomes were compared between those treated with neoadjuvant chemotherapy and those who were treated with adjuvant chemotherapy for locally advanced colon cancer.

The researchers searched the Netherlands Cancer Registry from 2008-2012 to identify 24,944 patients diagnosed with stage II and III colon cancer. Dr. Verstegen, a researcher in the department of surgery at Radboud University Medical Center, Nijmegen, Netherlands, reported results from 85 patients who received neoadjuvant chemotherapy and 2,216 who received adjuvant chemotherapy (the control group). Both groups were similar in terms of age (a median of about 65 years), gender, localization of the primary tumor, differentiation grade, morphology, and clinical T and N stage. Multivisceral resections were performed significantly more often in the neoadjuvant group, compared with the control group (21% vs. 5%, respectively; P less than .001). There were no differences between groups in the number of complete resections, nor in the rate of complications. Furthermore, no patient died within 30 days of neoadjuvant chemotherapy after surgery.

Tumor downstaging was observed in 47% of patients treated with neoadjuvant chemotherapy and there were three complete responses. At the same time, nodal downstaging was observed in 50% of patients treated with neoadjuvant chemotherapy. The 3-year overall survival was 73% in both groups.

Dr. Verstegen acknowledged certain limitations of the study, including its retrospective design and the lack of data on recurrences and disease-free survival. “Neoadjuvant chemotherapy seems to be a safe treatment strategy, since we have low postoperative morbidity and mortality rates,” she concluded. “We see comparable outcomes compared to the control group. Prospective trials are needed to confirm the safety and value of neoadjuvant chemotherapy.”

Dr. Verstegen reported having no financial disclosures.

[email protected]

In what is believed to be the first case of its kind in the United States, researchers identified a female patient with colistin-resistant Escherichia coli. The patient harbored mcr-1, a gene resistant to colistin, an antibiotic used as a last resort for infections that are resistant to carbapenems.

The finding comes at a time when a search for colistin-resistant bacteria by officials from the U.S. Department of Agriculture and the U.S. Department of Health and Human Services revealed colistin-resistant E. coli in a single sample from a pig intestine. Combined, “these discoveries are of concern because colistin is used as a last-resort drug to treat patients with multidrug resistant infections,” according to a communication from the HHS dated May 26. “Finding colistin-resistant bacteria in the United States is important, as it was only last November that scientists in China first reported that the mcr-1 gene in bacteria confers colistin resistance.”

Researchers led by Patrick McGann, Ph.D., who reported the human case in an article published online May 26 in Antimicrobial Agents and Chemotherapy, wrote that the recent discovery of a plasmid-borne colistin resistance gene, mcr-1, “heralds the emergence of truly pan-drug resistant bacteria. The gene has been found primarily in Escherichia coli, but has also been identified in other members of the Enterobacteriaceae from human, animal, food and environmental samples on every continent” (Antimicrob Agents Chemother. 2016 May 26. doi: 10.1128/AAC.01103-16).

As a result of this threat, in May, Dr. McGann, of the Department of Defense’s Multidrug-resistant Organism Repository and Surveillance Network at Walter Reed Army Institute of Research, Silver Spring, Md., and his associates began analyzing all extended-spectrum beta-lactamase (ESBL)–producing E. coli clinical isolates submitted to Walter Reed National Military Medical Center for analysis for resistance to colistin by E-test.

The case of interest was the presence of mcr-1 in an E. coli isolate cultured from a 49-year-old woman who presented to a military clinic in Pennsylvania with symptoms suggestive of a urinary tract infection, and who reported no travel history within the prior 5 months. Susceptibility testing at Walter Reed indicated an ESBL phenotype.

“The isolate was included in the first 6 ESBL-producing E. coli selected for colistin susceptibility testing, and it was the only isolate to have a MIC of colistin of 4 mcg/mL [all others had MICs of 0.25 mcg/mL or less]. Colistin MIC was confirmed by microbroth dilution and mcr-1 detected by real-time PCR.”

Since mcr-1 testing at Walter Reed has been underway for a short time, “it remains unclear what the true prevalence of mcr-1 is in the population,” the researchers noted. “The association between mcr-1 and IncF plasmids is concerning as these plasmids are vehicles for the dissemination of antibiotic resistance and virulence genes against Enterobacteriaceae. Continued surveillance to determine the true frequency for this gene in the USA is critical.”

The researchers reported having no financial disclosures.

[email protected]

In what is believed to be the first case of its kind in the United States, researchers identified a female patient with colistin-resistant Escherichia coli. The patient harbored mcr-1, a gene resistant to colistin, an antibiotic used as a last resort for infections that are resistant to carbapenems.

The finding comes at a time when a search for colistin-resistant bacteria by officials from the U.S. Department of Agriculture and the U.S. Department of Health and Human Services revealed colistin-resistant E. coli in a single sample from a pig intestine. Combined, “these discoveries are of concern because colistin is used as a last-resort drug to treat patients with multidrug resistant infections,” according to a communication from the HHS dated May 26. “Finding colistin-resistant bacteria in the United States is important, as it was only last November that scientists in China first reported that the mcr-1 gene in bacteria confers colistin resistance.”

Researchers led by Patrick McGann, Ph.D., who reported the human case in an article published online May 26 in Antimicrobial Agents and Chemotherapy, wrote that the recent discovery of a plasmid-borne colistin resistance gene, mcr-1, “heralds the emergence of truly pan-drug resistant bacteria. The gene has been found primarily in Escherichia coli, but has also been identified in other members of the Enterobacteriaceae from human, animal, food and environmental samples on every continent” (Antimicrob Agents Chemother. 2016 May 26. doi: 10.1128/AAC.01103-16).

As a result of this threat, in May, Dr. McGann, of the Department of Defense’s Multidrug-resistant Organism Repository and Surveillance Network at Walter Reed Army Institute of Research, Silver Spring, Md., and his associates began analyzing all extended-spectrum beta-lactamase (ESBL)–producing E. coli clinical isolates submitted to Walter Reed National Military Medical Center for analysis for resistance to colistin by E-test.

The case of interest was the presence of mcr-1 in an E. coli isolate cultured from a 49-year-old woman who presented to a military clinic in Pennsylvania with symptoms suggestive of a urinary tract infection, and who reported no travel history within the prior 5 months. Susceptibility testing at Walter Reed indicated an ESBL phenotype.

“The isolate was included in the first 6 ESBL-producing E. coli selected for colistin susceptibility testing, and it was the only isolate to have a MIC of colistin of 4 mcg/mL [all others had MICs of 0.25 mcg/mL or less]. Colistin MIC was confirmed by microbroth dilution and mcr-1 detected by real-time PCR.”

Since mcr-1 testing at Walter Reed has been underway for a short time, “it remains unclear what the true prevalence of mcr-1 is in the population,” the researchers noted. “The association between mcr-1 and IncF plasmids is concerning as these plasmids are vehicles for the dissemination of antibiotic resistance and virulence genes against Enterobacteriaceae. Continued surveillance to determine the true frequency for this gene in the USA is critical.”

The researchers reported having no financial disclosures.

[email protected]

In what is believed to be the first case of its kind in the United States, researchers identified a female patient with colistin-resistant Escherichia coli. The patient harbored mcr-1, a gene resistant to colistin, an antibiotic used as a last resort for infections that are resistant to carbapenems.

The finding comes at a time when a search for colistin-resistant bacteria by officials from the U.S. Department of Agriculture and the U.S. Department of Health and Human Services revealed colistin-resistant E. coli in a single sample from a pig intestine. Combined, “these discoveries are of concern because colistin is used as a last-resort drug to treat patients with multidrug resistant infections,” according to a communication from the HHS dated May 26. “Finding colistin-resistant bacteria in the United States is important, as it was only last November that scientists in China first reported that the mcr-1 gene in bacteria confers colistin resistance.”

Researchers led by Patrick McGann, Ph.D., who reported the human case in an article published online May 26 in Antimicrobial Agents and Chemotherapy, wrote that the recent discovery of a plasmid-borne colistin resistance gene, mcr-1, “heralds the emergence of truly pan-drug resistant bacteria. The gene has been found primarily in Escherichia coli, but has also been identified in other members of the Enterobacteriaceae from human, animal, food and environmental samples on every continent” (Antimicrob Agents Chemother. 2016 May 26. doi: 10.1128/AAC.01103-16).

As a result of this threat, in May, Dr. McGann, of the Department of Defense’s Multidrug-resistant Organism Repository and Surveillance Network at Walter Reed Army Institute of Research, Silver Spring, Md., and his associates began analyzing all extended-spectrum beta-lactamase (ESBL)–producing E. coli clinical isolates submitted to Walter Reed National Military Medical Center for analysis for resistance to colistin by E-test.

The case of interest was the presence of mcr-1 in an E. coli isolate cultured from a 49-year-old woman who presented to a military clinic in Pennsylvania with symptoms suggestive of a urinary tract infection, and who reported no travel history within the prior 5 months. Susceptibility testing at Walter Reed indicated an ESBL phenotype.

“The isolate was included in the first 6 ESBL-producing E. coli selected for colistin susceptibility testing, and it was the only isolate to have a MIC of colistin of 4 mcg/mL [all others had MICs of 0.25 mcg/mL or less]. Colistin MIC was confirmed by microbroth dilution and mcr-1 detected by real-time PCR.”

Since mcr-1 testing at Walter Reed has been underway for a short time, “it remains unclear what the true prevalence of mcr-1 is in the population,” the researchers noted. “The association between mcr-1 and IncF plasmids is concerning as these plasmids are vehicles for the dissemination of antibiotic resistance and virulence genes against Enterobacteriaceae. Continued surveillance to determine the true frequency for this gene in the USA is critical.”

The researchers reported having no financial disclosures.

[email protected]

LOS ANGELES – Implementation of a perioperative protocol designed to enhance recovery in patients undergoing elective laparoscopic colorectal surgery decreased hospital length of stay, the rate of complications, and overall direct costs, results from a single-center study showed.

“Until recently patients undergoing colorectal surgery were counseled to accept a 20%-25% risk of complications and a 7- to 10-day postoperative stay in the hospital,” lead study author Dr. Daniel S. Lavy said at the annual meeting of the American Society of Colon and Rectal Surgeons. “Studies from the 1990s have shown that length of stay rates improved when one single component of care was changed.”

©Andrei Malov/Thinkstock

Dr. Lavy of the department of surgery at Monmouth Medical Center, Long Branch, N.J., discussed results from a study of Enhanced Recovery After Surgery (ERAS), which he described as “a multimodal perioperative care pathway designed to achieve early recovery for patients undergoing major surgery. Many of its elements challenge existing surgical doctrine, including optimizing nutrition, standardized nonnarcotic and anesthetic regimens, early mobilization, and early initiation of enteral feeding.” The protocol also includes multimodal analgesia aimed at reducing the use of narcotics by intravenous Toradol (ketorolac), intravenous Tylenol (acetaminophen), and a transverse abdominis plane block; preoperative intravenous Solu-Medrol (methylprednisolone); prevention of fluid overload; preoperative and postoperative Entereg (alvimopan); preoperative enteral feedings and early postoperative diet initiation; and aggressive postoperative rehabilitation.

In an effort to evaluate the impact of the protocol in patients undergoing colorectal surgery, Dr. Lavy and his associates analyzed records from 283 elective laparoscopic colon procedures performed at Monmouth Medical Center from July 2013 to December 2015, a time period that included 11 months prior to implementation of ERAS and 18 months after implementation. The data were analyzed using control charts to assess for process changes, while open or emergent procedures were excluded from review. Key measures assessed included hospital length of stay, direct hospital costs, 30-day readmissions, and complications.

Dr. Lavy reported that following implementation of the ERAS protocol, the median length of stay decreased from 3.8 days to 2.8 days; the median direct hospital costs fell 8.5%, resulting in a savings of $876 per case; and the complication rate dropped from 20% to 16%. No changes were observed in the 30-day readmission rate, which held steady at 8%.

“This multifaceted approach has decreased hospital stay, decreased hospital cost and complication rate, did not change the 30-day readmission rate, and maintained patient safety while improving patient care,” Dr. Lavy said. “We suggest research be conducted to determine how this pathway can be altered to further improve quality of care given to patients while simultaneously reducing hospital costs. Also, these methods may be able to be applied to other surgical subspecialties, including ob.gyn., orthopedics, and urology.”

Dr. Lavy reported having no relevant financial disclosures.

[email protected]

LOS ANGELES – Implementation of a perioperative protocol designed to enhance recovery in patients undergoing elective laparoscopic colorectal surgery decreased hospital length of stay, the rate of complications, and overall direct costs, results from a single-center study showed.

“Until recently patients undergoing colorectal surgery were counseled to accept a 20%-25% risk of complications and a 7- to 10-day postoperative stay in the hospital,” lead study author Dr. Daniel S. Lavy said at the annual meeting of the American Society of Colon and Rectal Surgeons. “Studies from the 1990s have shown that length of stay rates improved when one single component of care was changed.”

©Andrei Malov/Thinkstock

Dr. Lavy of the department of surgery at Monmouth Medical Center, Long Branch, N.J., discussed results from a study of Enhanced Recovery After Surgery (ERAS), which he described as “a multimodal perioperative care pathway designed to achieve early recovery for patients undergoing major surgery. Many of its elements challenge existing surgical doctrine, including optimizing nutrition, standardized nonnarcotic and anesthetic regimens, early mobilization, and early initiation of enteral feeding.” The protocol also includes multimodal analgesia aimed at reducing the use of narcotics by intravenous Toradol (ketorolac), intravenous Tylenol (acetaminophen), and a transverse abdominis plane block; preoperative intravenous Solu-Medrol (methylprednisolone); prevention of fluid overload; preoperative and postoperative Entereg (alvimopan); preoperative enteral feedings and early postoperative diet initiation; and aggressive postoperative rehabilitation.

In an effort to evaluate the impact of the protocol in patients undergoing colorectal surgery, Dr. Lavy and his associates analyzed records from 283 elective laparoscopic colon procedures performed at Monmouth Medical Center from July 2013 to December 2015, a time period that included 11 months prior to implementation of ERAS and 18 months after implementation. The data were analyzed using control charts to assess for process changes, while open or emergent procedures were excluded from review. Key measures assessed included hospital length of stay, direct hospital costs, 30-day readmissions, and complications.

Dr. Lavy reported that following implementation of the ERAS protocol, the median length of stay decreased from 3.8 days to 2.8 days; the median direct hospital costs fell 8.5%, resulting in a savings of $876 per case; and the complication rate dropped from 20% to 16%. No changes were observed in the 30-day readmission rate, which held steady at 8%.

“This multifaceted approach has decreased hospital stay, decreased hospital cost and complication rate, did not change the 30-day readmission rate, and maintained patient safety while improving patient care,” Dr. Lavy said. “We suggest research be conducted to determine how this pathway can be altered to further improve quality of care given to patients while simultaneously reducing hospital costs. Also, these methods may be able to be applied to other surgical subspecialties, including ob.gyn., orthopedics, and urology.”

Dr. Lavy reported having no relevant financial disclosures.

[email protected]

LOS ANGELES – Implementation of a perioperative protocol designed to enhance recovery in patients undergoing elective laparoscopic colorectal surgery decreased hospital length of stay, the rate of complications, and overall direct costs, results from a single-center study showed.

“Until recently patients undergoing colorectal surgery were counseled to accept a 20%-25% risk of complications and a 7- to 10-day postoperative stay in the hospital,” lead study author Dr. Daniel S. Lavy said at the annual meeting of the American Society of Colon and Rectal Surgeons. “Studies from the 1990s have shown that length of stay rates improved when one single component of care was changed.”

©Andrei Malov/Thinkstock

Dr. Lavy of the department of surgery at Monmouth Medical Center, Long Branch, N.J., discussed results from a study of Enhanced Recovery After Surgery (ERAS), which he described as “a multimodal perioperative care pathway designed to achieve early recovery for patients undergoing major surgery. Many of its elements challenge existing surgical doctrine, including optimizing nutrition, standardized nonnarcotic and anesthetic regimens, early mobilization, and early initiation of enteral feeding.” The protocol also includes multimodal analgesia aimed at reducing the use of narcotics by intravenous Toradol (ketorolac), intravenous Tylenol (acetaminophen), and a transverse abdominis plane block; preoperative intravenous Solu-Medrol (methylprednisolone); prevention of fluid overload; preoperative and postoperative Entereg (alvimopan); preoperative enteral feedings and early postoperative diet initiation; and aggressive postoperative rehabilitation.

In an effort to evaluate the impact of the protocol in patients undergoing colorectal surgery, Dr. Lavy and his associates analyzed records from 283 elective laparoscopic colon procedures performed at Monmouth Medical Center from July 2013 to December 2015, a time period that included 11 months prior to implementation of ERAS and 18 months after implementation. The data were analyzed using control charts to assess for process changes, while open or emergent procedures were excluded from review. Key measures assessed included hospital length of stay, direct hospital costs, 30-day readmissions, and complications.

Dr. Lavy reported that following implementation of the ERAS protocol, the median length of stay decreased from 3.8 days to 2.8 days; the median direct hospital costs fell 8.5%, resulting in a savings of $876 per case; and the complication rate dropped from 20% to 16%. No changes were observed in the 30-day readmission rate, which held steady at 8%.

“This multifaceted approach has decreased hospital stay, decreased hospital cost and complication rate, did not change the 30-day readmission rate, and maintained patient safety while improving patient care,” Dr. Lavy said. “We suggest research be conducted to determine how this pathway can be altered to further improve quality of care given to patients while simultaneously reducing hospital costs. Also, these methods may be able to be applied to other surgical subspecialties, including ob.gyn., orthopedics, and urology.”

Dr. Lavy reported having no relevant financial disclosures.

[email protected]

LOS ANGELES – A multicenter of patients who had low anterior resection with stapled anastomosis for rectal cancer found no clinical or economic benefit in routinely sending anastomotic doughnuts for histopathological evaluation.

“Several small studies outside the United States have found no benefit in histologic examination of anastomotic stapler doughnuts,” lead study author Dr. Jeremy Sugrue said at the annual meeting of the American Society of Colon and Rectal Surgeons. “We wanted to see if this held true in our population.”

Dr. Sugrue, of the division of colon and rectal surgery in the department of surgery at the University of Illinois at Chicago, and his associates performed a retrospective review of 486 patients who underwent a low anterior resection with stapled anastomosis for rectal cancer between 2002 and 2015 at three medical institutions. The primary outcome was pathologic findings in the doughnuts and their impact on patient management. Secondary outcomes included tumor characteristics that may influence how often a surgeon may send a doughnut to pathology, along with approximate cost.

The mean age of the 486 patients was 60 years, 55% were male, and the mean gross distal margin of the primary tumor specimen was 2.9 cm. “The majority of tumors were located in the middle rectum, and the rest were evenly distributed between the lower rectum, upper rectum, and rectosigmoid regions,” said Dr. Sugrue, who is a general surgery resident. About half of the patients received neoadjuvant radiation or chemotherapy.

Benign findings were found in 33 patients. Among these, 16 had inflammatory changes, including 12 who had nonspecific changes, 3 who had changes from radiation, and 1 had inflammatory bowel disease changes. In addition, 13 patients with benign findings had polyps in their doughnuts (10 hyperplastic and 3 adenomatous), while 4 patients had miscellaneous changes including two cases of vessel micro calcification, one case of diverticuli, and one case of melanosis coli.

Among the 412 patients with malignant findings, 410 (99.5%) had no cancer in the doughnuts and no cancer at the distal resection margin in the primary tumor specimens. “In the two patients where we found cancer in the doughnuts, these patients also had a positive distal margin,” Dr. Sugrue said. “We did not find any patients with a positive distal margin and a negative doughnut. Likewise, we did not find any patients with a negative distal margin or an unexpectedly positive doughnut.”

The researchers also found that patients with low rectal tumors were significantly more likely to have their doughnut sent to pathology, compared with those with rectosigmoid tumors. “However, when we looked at distal margin comparing patients who had doughnuts reported on pathology with those who did not, there was no statistically significant difference,” Dr. Sugrue said. After averaging pathology professional fees and technical fees across all three institutions, he and his associates determined that doughnuts add $643 in cost when processed by pathology as a unique specimen.

Limitations of the study, he said, include its retrospective design, “which inherently introduces selection bias, and we did not perform a precise cost-benefit analysis.”

Dr. Sugrue reported having no financial disclosures.

[email protected]

LOS ANGELES – A multicenter of patients who had low anterior resection with stapled anastomosis for rectal cancer found no clinical or economic benefit in routinely sending anastomotic doughnuts for histopathological evaluation.

“Several small studies outside the United States have found no benefit in histologic examination of anastomotic stapler doughnuts,” lead study author Dr. Jeremy Sugrue said at the annual meeting of the American Society of Colon and Rectal Surgeons. “We wanted to see if this held true in our population.”

Dr. Sugrue, of the division of colon and rectal surgery in the department of surgery at the University of Illinois at Chicago, and his associates performed a retrospective review of 486 patients who underwent a low anterior resection with stapled anastomosis for rectal cancer between 2002 and 2015 at three medical institutions. The primary outcome was pathologic findings in the doughnuts and their impact on patient management. Secondary outcomes included tumor characteristics that may influence how often a surgeon may send a doughnut to pathology, along with approximate cost.

The mean age of the 486 patients was 60 years, 55% were male, and the mean gross distal margin of the primary tumor specimen was 2.9 cm. “The majority of tumors were located in the middle rectum, and the rest were evenly distributed between the lower rectum, upper rectum, and rectosigmoid regions,” said Dr. Sugrue, who is a general surgery resident. About half of the patients received neoadjuvant radiation or chemotherapy.

Benign findings were found in 33 patients. Among these, 16 had inflammatory changes, including 12 who had nonspecific changes, 3 who had changes from radiation, and 1 had inflammatory bowel disease changes. In addition, 13 patients with benign findings had polyps in their doughnuts (10 hyperplastic and 3 adenomatous), while 4 patients had miscellaneous changes including two cases of vessel micro calcification, one case of diverticuli, and one case of melanosis coli.

Among the 412 patients with malignant findings, 410 (99.5%) had no cancer in the doughnuts and no cancer at the distal resection margin in the primary tumor specimens. “In the two patients where we found cancer in the doughnuts, these patients also had a positive distal margin,” Dr. Sugrue said. “We did not find any patients with a positive distal margin and a negative doughnut. Likewise, we did not find any patients with a negative distal margin or an unexpectedly positive doughnut.”

The researchers also found that patients with low rectal tumors were significantly more likely to have their doughnut sent to pathology, compared with those with rectosigmoid tumors. “However, when we looked at distal margin comparing patients who had doughnuts reported on pathology with those who did not, there was no statistically significant difference,” Dr. Sugrue said. After averaging pathology professional fees and technical fees across all three institutions, he and his associates determined that doughnuts add $643 in cost when processed by pathology as a unique specimen.

Limitations of the study, he said, include its retrospective design, “which inherently introduces selection bias, and we did not perform a precise cost-benefit analysis.”

Dr. Sugrue reported having no financial disclosures.

[email protected]

LOS ANGELES – A multicenter of patients who had low anterior resection with stapled anastomosis for rectal cancer found no clinical or economic benefit in routinely sending anastomotic doughnuts for histopathological evaluation.

“Several small studies outside the United States have found no benefit in histologic examination of anastomotic stapler doughnuts,” lead study author Dr. Jeremy Sugrue said at the annual meeting of the American Society of Colon and Rectal Surgeons. “We wanted to see if this held true in our population.”

Dr. Sugrue, of the division of colon and rectal surgery in the department of surgery at the University of Illinois at Chicago, and his associates performed a retrospective review of 486 patients who underwent a low anterior resection with stapled anastomosis for rectal cancer between 2002 and 2015 at three medical institutions. The primary outcome was pathologic findings in the doughnuts and their impact on patient management. Secondary outcomes included tumor characteristics that may influence how often a surgeon may send a doughnut to pathology, along with approximate cost.

The mean age of the 486 patients was 60 years, 55% were male, and the mean gross distal margin of the primary tumor specimen was 2.9 cm. “The majority of tumors were located in the middle rectum, and the rest were evenly distributed between the lower rectum, upper rectum, and rectosigmoid regions,” said Dr. Sugrue, who is a general surgery resident. About half of the patients received neoadjuvant radiation or chemotherapy.

Benign findings were found in 33 patients. Among these, 16 had inflammatory changes, including 12 who had nonspecific changes, 3 who had changes from radiation, and 1 had inflammatory bowel disease changes. In addition, 13 patients with benign findings had polyps in their doughnuts (10 hyperplastic and 3 adenomatous), while 4 patients had miscellaneous changes including two cases of vessel micro calcification, one case of diverticuli, and one case of melanosis coli.

Among the 412 patients with malignant findings, 410 (99.5%) had no cancer in the doughnuts and no cancer at the distal resection margin in the primary tumor specimens. “In the two patients where we found cancer in the doughnuts, these patients also had a positive distal margin,” Dr. Sugrue said. “We did not find any patients with a positive distal margin and a negative doughnut. Likewise, we did not find any patients with a negative distal margin or an unexpectedly positive doughnut.”

The researchers also found that patients with low rectal tumors were significantly more likely to have their doughnut sent to pathology, compared with those with rectosigmoid tumors. “However, when we looked at distal margin comparing patients who had doughnuts reported on pathology with those who did not, there was no statistically significant difference,” Dr. Sugrue said. After averaging pathology professional fees and technical fees across all three institutions, he and his associates determined that doughnuts add $643 in cost when processed by pathology as a unique specimen.

Limitations of the study, he said, include its retrospective design, “which inherently introduces selection bias, and we did not perform a precise cost-benefit analysis.”

Dr. Sugrue reported having no financial disclosures.

[email protected]

Interim safety results from an ongoing clinical trial found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin, according to an FDA Drug Safety Communication on May 18, 2016.

The agency currently is investigating the safety issue but has yet to determine if taking canagliflozin is associated with an increased risk of leg and foot amputations. A sodium-glucose cotransporter 2 inhibitor, canagliflozin is marketed as Invokana and Invokamet by Janssen Pharmaceuticals, and was approved by the FDA in March 2013.

“Patients should not stop or change their diabetes medicines without first talking to their health care professional,” the communication states. “Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canagliflozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.”

The agency advises health care professionals to follow the recommendations in the canagliflozin drug labels and to monitor patients for the signs and symptoms described above.

Upon its approval, the FDA required five postmarketing studies for canagliflozin: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study. In late 2015, investigators determined that the risk of bone fracture is increased with canagliflozin treatment.

Individuals who experience side effects while taking canagliflozin should submit a report through the FDA’s MedWatch program, or contact 1-800-332-1088 for more information.

[email protected]

Interim safety results from an ongoing clinical trial found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin, according to an FDA Drug Safety Communication on May 18, 2016.

The agency currently is investigating the safety issue but has yet to determine if taking canagliflozin is associated with an increased risk of leg and foot amputations. A sodium-glucose cotransporter 2 inhibitor, canagliflozin is marketed as Invokana and Invokamet by Janssen Pharmaceuticals, and was approved by the FDA in March 2013.

“Patients should not stop or change their diabetes medicines without first talking to their health care professional,” the communication states. “Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canagliflozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.”

The agency advises health care professionals to follow the recommendations in the canagliflozin drug labels and to monitor patients for the signs and symptoms described above.

Upon its approval, the FDA required five postmarketing studies for canagliflozin: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study. In late 2015, investigators determined that the risk of bone fracture is increased with canagliflozin treatment.

Individuals who experience side effects while taking canagliflozin should submit a report through the FDA’s MedWatch program, or contact 1-800-332-1088 for more information.

[email protected]

Interim safety results from an ongoing clinical trial found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin, according to an FDA Drug Safety Communication on May 18, 2016.

The agency currently is investigating the safety issue but has yet to determine if taking canagliflozin is associated with an increased risk of leg and foot amputations. A sodium-glucose cotransporter 2 inhibitor, canagliflozin is marketed as Invokana and Invokamet by Janssen Pharmaceuticals, and was approved by the FDA in March 2013.

“Patients should not stop or change their diabetes medicines without first talking to their health care professional,” the communication states. “Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems, including blindness, nerve and kidney damage, and heart disease. Patients taking canagliflozin should notify their health care professionals right away if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet.”

The agency advises health care professionals to follow the recommendations in the canagliflozin drug labels and to monitor patients for the signs and symptoms described above.

Upon its approval, the FDA required five postmarketing studies for canagliflozin: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study. In late 2015, investigators determined that the risk of bone fracture is increased with canagliflozin treatment.

Individuals who experience side effects while taking canagliflozin should submit a report through the FDA’s MedWatch program, or contact 1-800-332-1088 for more information.

[email protected]