TBD Meeting (4019-17)

 

PHILADELPHIA –  The safety of sentinel lymph node biopsy (SLNB) alone without axillary lymph node dissection (ALND) has been established for patients with cT1-2N0 cancer that are found to have one or two metastatic sentinel lymph nodes who undergo breast conservation therapy, but questions regarding the role of regional radiation have persisted. 
This issue is addressed by the results of a large, prospective, 5+ year study at Memorial Sloan Kettering Cancer Center which confirmed the safety of omitting axillary lymph node dissection and suggested that regional radiation provides minimal benefit. 

“Axillary dissection can no longer be considered standard management for women with clinical T1 and T2 [human epidermal growth factor receptor]–negative breast cancers undergoing breast conservation and found to have sample node metastases,” Monica Morrow, MD, said at the 137th annual meeting of the American Surgical Association here. The study involved 793 women, who were found to have sentinel node metastases, undergoing breast-conserving surgery at Memorial Sloan Kettering Cancer Center (MSKCC) in New York from September 2010 to March 2016.

Dr. Morrow explained that, in August 2010, the breast surgery service at MSKCC adopted the guidelines that arose from the American College of Surgeons Oncology Group’s multicenter Z0011 trial and abandoned routine use of ALND in eligible patients. The goal of the study, she reported, was to determine how frequently axillary dissection was avoided in a consecutive, otherwise unselected, series of patients and to determine the incidence of local regional recurrence after SLNB alone in a population treated with known radiotherapy fields.

Eligible subjects had T1 or T2 node-negative breast cancer, were undergoing breast-conserving surgery with planned whole-breast irradiation, and were found to have hematoxylin-eosin-detected sentinel node metastases. Patients receiving neoadjuvant chemotherapy or requiring conversion to mastectomy, or those in whom partial breast irradiation or no radiotherapy was planned, were ineligible. Axillary imaging was not used in select patients. Criteria for axillary dissection were metastases in three or more sentinel nodes or the presence of matted nodes identified intraoperatively. The researchers did not use the MSKCC nomogram to predict the likelihood of non–sentinel node metastases.

Median patient age was 58 years and median tumor size 1.7 cm. With regard to tumor pathology, 87% had infiltrating ductal tumors, 94% had grade 2 or 3 disease, and the most common subtype was HR+, HER2– disease in 84%. “In this node-positive cohort of patients, 98% received adjuvant systemic therapy, most commonly both chemotherapy and endocrine therapy (received by 65%), and 93% completed radiotherapy,” Dr. Morrow said.

In the entire patient cohort, 84% (663) were treated with SLNB alone, Dr. Morrow said. Among the 130 patients requiring ALND, 68% (88) had metastases in three or more nodes, 26% (34) were found to have had matted nodes intraoperatively, and 6% (8) were eligible for SLNB alone but opted for ALND or had it recommended by their surgeon. “All of these occurred early in our experience, and this has not been repeated since,” Dr. Morrow said.

Among the SLNB-only patients, the 5-year event-free survival was 93%. “There were no isolated axillary recurrences,” Dr. Morrow said. The study reported four combined breast and axillary recurrences, three in nonradiated patients, and four combined nodal and distant recurrences, only one of which involved the axillary nodes. “The median time to any nodal recurrence was 25 months,” Dr. Morrow added. Among 484 patients who had 1 year or more of follow-up, 58% (280) received conventional supine breast tangents, 21% were treated prone – “meaning their axilla received essentially no radiotherapy,” Dr. Morrow said – and 21% had node field irradiation.

“If we compare patient characteristics based on radiotherapy fields treated, it’s clear that the patients who received nodal irradiation were a higher-risk group,” Dr. Morrow said. While all three groups had a median of one positive sentinel node, that “skewed towards two” in the nodal irradiation group, she said. This group also had higher rates of lymphovascular invasion (72% vs. 56% and 49% in the supine and prone groups, respectively) and extracapsular extension (41% vs. 31% and 25%).

The rates of nodal relapse were not statistically significant among the three groups: 1% in the prone group, 1.4% in the supine group, and 0% in the node irradiation group.

“Factors associated with a higher risk of distant metastases, such as young patient age, estrogen receptor negativity, or HER2 over-expression, were not associated with the need for axillary dissection and should not be used as priority selection criteria,” Dr. Morrow said. “Nodal recurrence was uncommon in the absence of routine nodal radiation therapy, and no isolated nodal failures were observed.

In his comments, Armando Giuliano, MD, of Cedars Sinai Medical Center in Los Angeles, principal investigator of the Z0011 trial, said the MSKCC study “extends and informs” the Z0011 findings. He noted that the prone treatment group in the MSKCC trial had a low rate of axillary recurrence. “Can you speculate how such excellent results are achieved without resection or irradiation?” he asked Dr. Morrow. “To me it appears that nodal irradiation provides very little benefit to this selected group of patients.”

The patients in the prone group were in the lowest-risk category of the study, Dr. Morrow said, but the fact that not all nodal disease becomes clinically evident, even in patients who do not receive radiotherapy or systemic therapy, along with the high use of systemic therapy in this group, may explain the low rates of axillary recurrence. “What I think we still need to find out, though, is whether or not failure to irradiate the nodes at all is in any way associated with decreased survival, as would be suggested in the MA.20 trial,” she said. “I think we will find that out from ongoing trials looking at no axillary dissection in mastectomy patients.”

Dr. Morrow and Dr. Giuliano reported no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is to be published in Annals of Surgery pending editorial review.

 

PHILADELPHIA –  The safety of sentinel lymph node biopsy (SLNB) alone without axillary lymph node dissection (ALND) has been established for patients with cT1-2N0 cancer that are found to have one or two metastatic sentinel lymph nodes who undergo breast conservation therapy, but questions regarding the role of regional radiation have persisted. 
This issue is addressed by the results of a large, prospective, 5+ year study at Memorial Sloan Kettering Cancer Center which confirmed the safety of omitting axillary lymph node dissection and suggested that regional radiation provides minimal benefit. 

“Axillary dissection can no longer be considered standard management for women with clinical T1 and T2 [human epidermal growth factor receptor]–negative breast cancers undergoing breast conservation and found to have sample node metastases,” Monica Morrow, MD, said at the 137th annual meeting of the American Surgical Association here. The study involved 793 women, who were found to have sentinel node metastases, undergoing breast-conserving surgery at Memorial Sloan Kettering Cancer Center (MSKCC) in New York from September 2010 to March 2016.

Dr. Morrow explained that, in August 2010, the breast surgery service at MSKCC adopted the guidelines that arose from the American College of Surgeons Oncology Group’s multicenter Z0011 trial and abandoned routine use of ALND in eligible patients. The goal of the study, she reported, was to determine how frequently axillary dissection was avoided in a consecutive, otherwise unselected, series of patients and to determine the incidence of local regional recurrence after SLNB alone in a population treated with known radiotherapy fields.

Eligible subjects had T1 or T2 node-negative breast cancer, were undergoing breast-conserving surgery with planned whole-breast irradiation, and were found to have hematoxylin-eosin-detected sentinel node metastases. Patients receiving neoadjuvant chemotherapy or requiring conversion to mastectomy, or those in whom partial breast irradiation or no radiotherapy was planned, were ineligible. Axillary imaging was not used in select patients. Criteria for axillary dissection were metastases in three or more sentinel nodes or the presence of matted nodes identified intraoperatively. The researchers did not use the MSKCC nomogram to predict the likelihood of non–sentinel node metastases.

Median patient age was 58 years and median tumor size 1.7 cm. With regard to tumor pathology, 87% had infiltrating ductal tumors, 94% had grade 2 or 3 disease, and the most common subtype was HR+, HER2– disease in 84%. “In this node-positive cohort of patients, 98% received adjuvant systemic therapy, most commonly both chemotherapy and endocrine therapy (received by 65%), and 93% completed radiotherapy,” Dr. Morrow said.

In the entire patient cohort, 84% (663) were treated with SLNB alone, Dr. Morrow said. Among the 130 patients requiring ALND, 68% (88) had metastases in three or more nodes, 26% (34) were found to have had matted nodes intraoperatively, and 6% (8) were eligible for SLNB alone but opted for ALND or had it recommended by their surgeon. “All of these occurred early in our experience, and this has not been repeated since,” Dr. Morrow said.

Among the SLNB-only patients, the 5-year event-free survival was 93%. “There were no isolated axillary recurrences,” Dr. Morrow said. The study reported four combined breast and axillary recurrences, three in nonradiated patients, and four combined nodal and distant recurrences, only one of which involved the axillary nodes. “The median time to any nodal recurrence was 25 months,” Dr. Morrow added. Among 484 patients who had 1 year or more of follow-up, 58% (280) received conventional supine breast tangents, 21% were treated prone – “meaning their axilla received essentially no radiotherapy,” Dr. Morrow said – and 21% had node field irradiation.

“If we compare patient characteristics based on radiotherapy fields treated, it’s clear that the patients who received nodal irradiation were a higher-risk group,” Dr. Morrow said. While all three groups had a median of one positive sentinel node, that “skewed towards two” in the nodal irradiation group, she said. This group also had higher rates of lymphovascular invasion (72% vs. 56% and 49% in the supine and prone groups, respectively) and extracapsular extension (41% vs. 31% and 25%).

The rates of nodal relapse were not statistically significant among the three groups: 1% in the prone group, 1.4% in the supine group, and 0% in the node irradiation group.

“Factors associated with a higher risk of distant metastases, such as young patient age, estrogen receptor negativity, or HER2 over-expression, were not associated with the need for axillary dissection and should not be used as priority selection criteria,” Dr. Morrow said. “Nodal recurrence was uncommon in the absence of routine nodal radiation therapy, and no isolated nodal failures were observed.

In his comments, Armando Giuliano, MD, of Cedars Sinai Medical Center in Los Angeles, principal investigator of the Z0011 trial, said the MSKCC study “extends and informs” the Z0011 findings. He noted that the prone treatment group in the MSKCC trial had a low rate of axillary recurrence. “Can you speculate how such excellent results are achieved without resection or irradiation?” he asked Dr. Morrow. “To me it appears that nodal irradiation provides very little benefit to this selected group of patients.”

The patients in the prone group were in the lowest-risk category of the study, Dr. Morrow said, but the fact that not all nodal disease becomes clinically evident, even in patients who do not receive radiotherapy or systemic therapy, along with the high use of systemic therapy in this group, may explain the low rates of axillary recurrence. “What I think we still need to find out, though, is whether or not failure to irradiate the nodes at all is in any way associated with decreased survival, as would be suggested in the MA.20 trial,” she said. “I think we will find that out from ongoing trials looking at no axillary dissection in mastectomy patients.”

Dr. Morrow and Dr. Giuliano reported no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is to be published in Annals of Surgery pending editorial review.

 

PHILADELPHIA –  The safety of sentinel lymph node biopsy (SLNB) alone without axillary lymph node dissection (ALND) has been established for patients with cT1-2N0 cancer that are found to have one or two metastatic sentinel lymph nodes who undergo breast conservation therapy, but questions regarding the role of regional radiation have persisted. 
This issue is addressed by the results of a large, prospective, 5+ year study at Memorial Sloan Kettering Cancer Center which confirmed the safety of omitting axillary lymph node dissection and suggested that regional radiation provides minimal benefit. 

“Axillary dissection can no longer be considered standard management for women with clinical T1 and T2 [human epidermal growth factor receptor]–negative breast cancers undergoing breast conservation and found to have sample node metastases,” Monica Morrow, MD, said at the 137th annual meeting of the American Surgical Association here. The study involved 793 women, who were found to have sentinel node metastases, undergoing breast-conserving surgery at Memorial Sloan Kettering Cancer Center (MSKCC) in New York from September 2010 to March 2016.

Dr. Morrow explained that, in August 2010, the breast surgery service at MSKCC adopted the guidelines that arose from the American College of Surgeons Oncology Group’s multicenter Z0011 trial and abandoned routine use of ALND in eligible patients. The goal of the study, she reported, was to determine how frequently axillary dissection was avoided in a consecutive, otherwise unselected, series of patients and to determine the incidence of local regional recurrence after SLNB alone in a population treated with known radiotherapy fields.

Eligible subjects had T1 or T2 node-negative breast cancer, were undergoing breast-conserving surgery with planned whole-breast irradiation, and were found to have hematoxylin-eosin-detected sentinel node metastases. Patients receiving neoadjuvant chemotherapy or requiring conversion to mastectomy, or those in whom partial breast irradiation or no radiotherapy was planned, were ineligible. Axillary imaging was not used in select patients. Criteria for axillary dissection were metastases in three or more sentinel nodes or the presence of matted nodes identified intraoperatively. The researchers did not use the MSKCC nomogram to predict the likelihood of non–sentinel node metastases.

Median patient age was 58 years and median tumor size 1.7 cm. With regard to tumor pathology, 87% had infiltrating ductal tumors, 94% had grade 2 or 3 disease, and the most common subtype was HR+, HER2– disease in 84%. “In this node-positive cohort of patients, 98% received adjuvant systemic therapy, most commonly both chemotherapy and endocrine therapy (received by 65%), and 93% completed radiotherapy,” Dr. Morrow said.

In the entire patient cohort, 84% (663) were treated with SLNB alone, Dr. Morrow said. Among the 130 patients requiring ALND, 68% (88) had metastases in three or more nodes, 26% (34) were found to have had matted nodes intraoperatively, and 6% (8) were eligible for SLNB alone but opted for ALND or had it recommended by their surgeon. “All of these occurred early in our experience, and this has not been repeated since,” Dr. Morrow said.

Among the SLNB-only patients, the 5-year event-free survival was 93%. “There were no isolated axillary recurrences,” Dr. Morrow said. The study reported four combined breast and axillary recurrences, three in nonradiated patients, and four combined nodal and distant recurrences, only one of which involved the axillary nodes. “The median time to any nodal recurrence was 25 months,” Dr. Morrow added. Among 484 patients who had 1 year or more of follow-up, 58% (280) received conventional supine breast tangents, 21% were treated prone – “meaning their axilla received essentially no radiotherapy,” Dr. Morrow said – and 21% had node field irradiation.

“If we compare patient characteristics based on radiotherapy fields treated, it’s clear that the patients who received nodal irradiation were a higher-risk group,” Dr. Morrow said. While all three groups had a median of one positive sentinel node, that “skewed towards two” in the nodal irradiation group, she said. This group also had higher rates of lymphovascular invasion (72% vs. 56% and 49% in the supine and prone groups, respectively) and extracapsular extension (41% vs. 31% and 25%).

The rates of nodal relapse were not statistically significant among the three groups: 1% in the prone group, 1.4% in the supine group, and 0% in the node irradiation group.

“Factors associated with a higher risk of distant metastases, such as young patient age, estrogen receptor negativity, or HER2 over-expression, were not associated with the need for axillary dissection and should not be used as priority selection criteria,” Dr. Morrow said. “Nodal recurrence was uncommon in the absence of routine nodal radiation therapy, and no isolated nodal failures were observed.

In his comments, Armando Giuliano, MD, of Cedars Sinai Medical Center in Los Angeles, principal investigator of the Z0011 trial, said the MSKCC study “extends and informs” the Z0011 findings. He noted that the prone treatment group in the MSKCC trial had a low rate of axillary recurrence. “Can you speculate how such excellent results are achieved without resection or irradiation?” he asked Dr. Morrow. “To me it appears that nodal irradiation provides very little benefit to this selected group of patients.”

The patients in the prone group were in the lowest-risk category of the study, Dr. Morrow said, but the fact that not all nodal disease becomes clinically evident, even in patients who do not receive radiotherapy or systemic therapy, along with the high use of systemic therapy in this group, may explain the low rates of axillary recurrence. “What I think we still need to find out, though, is whether or not failure to irradiate the nodes at all is in any way associated with decreased survival, as would be suggested in the MA.20 trial,” she said. “I think we will find that out from ongoing trials looking at no axillary dissection in mastectomy patients.”

Dr. Morrow and Dr. Giuliano reported no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is to be published in Annals of Surgery pending editorial review.

 

PHILADELPHIA – A nomogram that assigns a disease severity score to individuals with type 2 diabetes may provide a tool that helps surgeons, endocrinologists, and primary care physicians determine which weight-loss surgical procedure would be most effective, according to an analysis of 900 patients from Cleveland Clinic and University Hospital Clinic, Barcelona, reported at the annual meeting of the American Surgical Association.

“This is the largest reported cohort with long-term glycemic follow-up data that categorizes diabetes into three validated stages of severity to guide procedure selection,” said Ali Aminian, MD, of Cleveland Clinic. The study also highlighted the importance of surgery in early diabetes. The study involved a modeling cohort of 659 patients who had bariatric procedures at Cleveland Clinic from 2005 to 2011 and a separate data set of 241 patients from Barcelona to validate the findings. Roux-en-Y gastric bypass (RYGB) was performed in 78% of the Cleveland Clinic group and 49% of the Barcelona group, with the remainder having sleeve gastrectomy (SG).

RYGB and SG account for more than 95% of all bariatric procedures in people with type 2 diabetes, Dr. Aminian said, but outcomes of clinical trials have been variable, some reporting up to half of patients having long-term relapses. The Cleveland Clinic study involved all patients with type 2 diabetes who had RYGB or SG from 2005 to 2011 with 5 years or more of glycemic data, with a median follow-up of 7 years. The study used American Diabetes Association targets to define remission and glycemic control.

“Long-term response after bariatric surgery in patients with diabetes significantly differs according to diabetes severity,” Dr. Aminian said. “For example, the outcome of surgery in a patient who has diabetes for 2 years is significantly different than a patient who has diabetes for 15 years taking three medications, including insulin.”

The researchers generated the nomogram based on these four independent preoperative factors:

• Number of preoperative diabetes medications (P less than .0001).
• Insulin use (P = .002).
• Duration of diabetes (P less than .0001).
• Glycemic control (P = .002).

 

“These factors are readily available in clinical practice and are considered a proxy of functional pancreatic beta-cell reserve,” Dr. Aminian said. The nomogram scores the severity of each factor on a scale of 0 to 100. For example, one preoperative medication scores 12, but five scores 63; duration of diabetes of 1 year scores five points, but 16 years scores 60. The patient’s total points represent the Individualized Metabolic Surgery score.

The researchers assigned three categories: A score of 25 or less represents mild disease, a score of 25-95 represents moderate, and 95 to the maximum 180 is severe disease.

Based on the Cleveland Clinic and Barcelona cohorts, the researchers next developed recommendations for average risk patients in each category.

RYGB is “suggested” in mild disease based on remission rates of 92% in the Cleveland subgroup and 91% in the Barcelona subgroup vs. SG remission rates of 74% and 91%, respectively. On the other end of the spectrum, in patients with severe diabetes, both procedures were less effective in achieving long-term diabetes remission. The disparities were more pronounced for the moderate group: 60% and 70% for RYGB and 25% and 56% for SG in the Cleveland Clinic and Barcelona subgroups, respectively. Hence the nomogram highly “recommends” RYGB. An online calculator to determine Individualized Metabolic Surgery score is available at http://riskcalc.org/Metabolic_Surgery_Score/.

“Obviously, this is the first attempt toward individualized procedure selection and more work needs to be done,” Dr. Aminian said. “Our findings also highlight the importance of surgical intervention in early stages of diabetes in order to achieve sustainable remission.”

In his discussion, Matthew M. Hutter, MD, FACS, of Harvard Medical School, Boston, offered to “quibble” with Dr. Aminian’s conclusions. “I challenge you on your conclusion for the mild and severe categories,” Dr. Hutter said. “My rate-of-cure data makes me want to recommend bypass for any patient with diabetes – mild, moderate or severe.”

Dr. Aminian acknowledged that the number of SG cases in the severe subgroup – 51 – was not great, and long-term diabetes remission was comparable between the two procedures. The key distinguishing measure in the severe category was a net 8% difference between two procedures in glycemic control at last follow-up. “This is the difference that we must decide whether it’s clinically important or not – whether we’re willing to recommend a riskier procedure for an extra 8% achieving glycemic control,” Dr. Aminian said. “If someone thinks it’s worth the risk, then they may suggest gastric bypass. If someone thinks it’s not worth the risk, then they may suggest a sleeve gastrectomy. But, we should remember that patients in the severe group are very high-risk patients.”

Dr. Aminian reported no financial disclosures. Dr. Hutter disclosed receiving conference reimbursement from Olympus.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is to be published in Annals of Surgery pending editorial review.

 

PHILADELPHIA – A nomogram that assigns a disease severity score to individuals with type 2 diabetes may provide a tool that helps surgeons, endocrinologists, and primary care physicians determine which weight-loss surgical procedure would be most effective, according to an analysis of 900 patients from Cleveland Clinic and University Hospital Clinic, Barcelona, reported at the annual meeting of the American Surgical Association.

“This is the largest reported cohort with long-term glycemic follow-up data that categorizes diabetes into three validated stages of severity to guide procedure selection,” said Ali Aminian, MD, of Cleveland Clinic. The study also highlighted the importance of surgery in early diabetes. The study involved a modeling cohort of 659 patients who had bariatric procedures at Cleveland Clinic from 2005 to 2011 and a separate data set of 241 patients from Barcelona to validate the findings. Roux-en-Y gastric bypass (RYGB) was performed in 78% of the Cleveland Clinic group and 49% of the Barcelona group, with the remainder having sleeve gastrectomy (SG).

RYGB and SG account for more than 95% of all bariatric procedures in people with type 2 diabetes, Dr. Aminian said, but outcomes of clinical trials have been variable, some reporting up to half of patients having long-term relapses. The Cleveland Clinic study involved all patients with type 2 diabetes who had RYGB or SG from 2005 to 2011 with 5 years or more of glycemic data, with a median follow-up of 7 years. The study used American Diabetes Association targets to define remission and glycemic control.

“Long-term response after bariatric surgery in patients with diabetes significantly differs according to diabetes severity,” Dr. Aminian said. “For example, the outcome of surgery in a patient who has diabetes for 2 years is significantly different than a patient who has diabetes for 15 years taking three medications, including insulin.”

The researchers generated the nomogram based on these four independent preoperative factors:

• Number of preoperative diabetes medications (P less than .0001).
• Insulin use (P = .002).
• Duration of diabetes (P less than .0001).
• Glycemic control (P = .002).

 

“These factors are readily available in clinical practice and are considered a proxy of functional pancreatic beta-cell reserve,” Dr. Aminian said. The nomogram scores the severity of each factor on a scale of 0 to 100. For example, one preoperative medication scores 12, but five scores 63; duration of diabetes of 1 year scores five points, but 16 years scores 60. The patient’s total points represent the Individualized Metabolic Surgery score.

The researchers assigned three categories: A score of 25 or less represents mild disease, a score of 25-95 represents moderate, and 95 to the maximum 180 is severe disease.

Based on the Cleveland Clinic and Barcelona cohorts, the researchers next developed recommendations for average risk patients in each category.

RYGB is “suggested” in mild disease based on remission rates of 92% in the Cleveland subgroup and 91% in the Barcelona subgroup vs. SG remission rates of 74% and 91%, respectively. On the other end of the spectrum, in patients with severe diabetes, both procedures were less effective in achieving long-term diabetes remission. The disparities were more pronounced for the moderate group: 60% and 70% for RYGB and 25% and 56% for SG in the Cleveland Clinic and Barcelona subgroups, respectively. Hence the nomogram highly “recommends” RYGB. An online calculator to determine Individualized Metabolic Surgery score is available at http://riskcalc.org/Metabolic_Surgery_Score/.

“Obviously, this is the first attempt toward individualized procedure selection and more work needs to be done,” Dr. Aminian said. “Our findings also highlight the importance of surgical intervention in early stages of diabetes in order to achieve sustainable remission.”

In his discussion, Matthew M. Hutter, MD, FACS, of Harvard Medical School, Boston, offered to “quibble” with Dr. Aminian’s conclusions. “I challenge you on your conclusion for the mild and severe categories,” Dr. Hutter said. “My rate-of-cure data makes me want to recommend bypass for any patient with diabetes – mild, moderate or severe.”

Dr. Aminian acknowledged that the number of SG cases in the severe subgroup – 51 – was not great, and long-term diabetes remission was comparable between the two procedures. The key distinguishing measure in the severe category was a net 8% difference between two procedures in glycemic control at last follow-up. “This is the difference that we must decide whether it’s clinically important or not – whether we’re willing to recommend a riskier procedure for an extra 8% achieving glycemic control,” Dr. Aminian said. “If someone thinks it’s worth the risk, then they may suggest gastric bypass. If someone thinks it’s not worth the risk, then they may suggest a sleeve gastrectomy. But, we should remember that patients in the severe group are very high-risk patients.”

Dr. Aminian reported no financial disclosures. Dr. Hutter disclosed receiving conference reimbursement from Olympus.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is to be published in Annals of Surgery pending editorial review.

 

PHILADELPHIA – A nomogram that assigns a disease severity score to individuals with type 2 diabetes may provide a tool that helps surgeons, endocrinologists, and primary care physicians determine which weight-loss surgical procedure would be most effective, according to an analysis of 900 patients from Cleveland Clinic and University Hospital Clinic, Barcelona, reported at the annual meeting of the American Surgical Association.

“This is the largest reported cohort with long-term glycemic follow-up data that categorizes diabetes into three validated stages of severity to guide procedure selection,” said Ali Aminian, MD, of Cleveland Clinic. The study also highlighted the importance of surgery in early diabetes. The study involved a modeling cohort of 659 patients who had bariatric procedures at Cleveland Clinic from 2005 to 2011 and a separate data set of 241 patients from Barcelona to validate the findings. Roux-en-Y gastric bypass (RYGB) was performed in 78% of the Cleveland Clinic group and 49% of the Barcelona group, with the remainder having sleeve gastrectomy (SG).

RYGB and SG account for more than 95% of all bariatric procedures in people with type 2 diabetes, Dr. Aminian said, but outcomes of clinical trials have been variable, some reporting up to half of patients having long-term relapses. The Cleveland Clinic study involved all patients with type 2 diabetes who had RYGB or SG from 2005 to 2011 with 5 years or more of glycemic data, with a median follow-up of 7 years. The study used American Diabetes Association targets to define remission and glycemic control.

“Long-term response after bariatric surgery in patients with diabetes significantly differs according to diabetes severity,” Dr. Aminian said. “For example, the outcome of surgery in a patient who has diabetes for 2 years is significantly different than a patient who has diabetes for 15 years taking three medications, including insulin.”

The researchers generated the nomogram based on these four independent preoperative factors:

• Number of preoperative diabetes medications (P less than .0001).
• Insulin use (P = .002).
• Duration of diabetes (P less than .0001).
• Glycemic control (P = .002).

 

“These factors are readily available in clinical practice and are considered a proxy of functional pancreatic beta-cell reserve,” Dr. Aminian said. The nomogram scores the severity of each factor on a scale of 0 to 100. For example, one preoperative medication scores 12, but five scores 63; duration of diabetes of 1 year scores five points, but 16 years scores 60. The patient’s total points represent the Individualized Metabolic Surgery score.

The researchers assigned three categories: A score of 25 or less represents mild disease, a score of 25-95 represents moderate, and 95 to the maximum 180 is severe disease.

Based on the Cleveland Clinic and Barcelona cohorts, the researchers next developed recommendations for average risk patients in each category.

RYGB is “suggested” in mild disease based on remission rates of 92% in the Cleveland subgroup and 91% in the Barcelona subgroup vs. SG remission rates of 74% and 91%, respectively. On the other end of the spectrum, in patients with severe diabetes, both procedures were less effective in achieving long-term diabetes remission. The disparities were more pronounced for the moderate group: 60% and 70% for RYGB and 25% and 56% for SG in the Cleveland Clinic and Barcelona subgroups, respectively. Hence the nomogram highly “recommends” RYGB. An online calculator to determine Individualized Metabolic Surgery score is available at http://riskcalc.org/Metabolic_Surgery_Score/.

“Obviously, this is the first attempt toward individualized procedure selection and more work needs to be done,” Dr. Aminian said. “Our findings also highlight the importance of surgical intervention in early stages of diabetes in order to achieve sustainable remission.”

In his discussion, Matthew M. Hutter, MD, FACS, of Harvard Medical School, Boston, offered to “quibble” with Dr. Aminian’s conclusions. “I challenge you on your conclusion for the mild and severe categories,” Dr. Hutter said. “My rate-of-cure data makes me want to recommend bypass for any patient with diabetes – mild, moderate or severe.”

Dr. Aminian acknowledged that the number of SG cases in the severe subgroup – 51 – was not great, and long-term diabetes remission was comparable between the two procedures. The key distinguishing measure in the severe category was a net 8% difference between two procedures in glycemic control at last follow-up. “This is the difference that we must decide whether it’s clinically important or not – whether we’re willing to recommend a riskier procedure for an extra 8% achieving glycemic control,” Dr. Aminian said. “If someone thinks it’s worth the risk, then they may suggest gastric bypass. If someone thinks it’s not worth the risk, then they may suggest a sleeve gastrectomy. But, we should remember that patients in the severe group are very high-risk patients.”

Dr. Aminian reported no financial disclosures. Dr. Hutter disclosed receiving conference reimbursement from Olympus.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is to be published in Annals of Surgery pending editorial review.

 

PHILADELPHIA – Overlapping and concurrent surgical procedures operations are not uncommon, but data on their safety and quality are scarce.

An analysis of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) data suggests that concurrent operations do not pose any greater risk to patients than do nonconcurrent operations.

“We found that concurrent operations were more often elective inpatient operations at large academic hospitals,” Jason Liu, MD, a clinical scholar-in-residence with the American College of Surgeons, Chicago, said at the annual meeting of the American Surgical Association.

VILevi/Thinkstock

The ACS Statement of Principles defines concurrent operations as those in which the critical components of operations overlap in time, whereas overlapping operations are those in which the critical components do not overlap. However, it is the attending surgeon’s judgment that currently determines which components are critical. This study specifically defined concurrent operations as those that overlapped by at least 60 minutes or in their entirety.

The study evaluated 12,010 concurrent and 521,656 nonconcurrent operations in the ASC NSQIP registry between 2014 and 2015, and propensity-score matched 11,044 operations of each type to evaluate safety. “We then analyzed the three primary outcomes – death or serious morbidity, unplanned reoperation, and unplanned readmission,” Dr. Liu said. “After propensity matching and risk adjustment, we detected no association of concurrent operations with these adverse outcomes.”

Death or serious morbidity had an odds ratio of 1.08, while the odds ratio for reoperation and readmission were 1.16 and 1.14, respectively.

Of the five surgery subspecialty groups presented, ear, nose and throat surgeons performed the highest proportion of concurrent operations, comprising 11.2% of all operations within the subspecialty, followed by neurosurgeons (8.4%) and urological surgeons (5.2%). General surgeons performed more total concurrent cases than did any of the other surgical subspecialties, but these comprised only 1.5% of all general surgery cases.

Among the individual operations presented, the highest percentage of concurrent cases was for spinal operations, comprising 7.1% of all spinal surgeries, followed by total knee and hip replacements, at 2.1% each. Among general surgery procedures, concurrent operations comprised 1.9% of colon surgeries, 1.5% of ventral hernia repairs, and 0.9% of cholecystectomies.

“We found that patients who had concurrent operations tended to have fewer comorbidities,” Dr. Liu said.

Despite the findings suggesting concurrent operations are safe, Dr. Liu added that “failure to detect an effect does not prove its absence. Additional studies and continued vigilance are certainly needed moving forward.”

In her discussion, Valerie W. Rusch, MD, FACS, of Memorial Sloan-Kettering Cancer Center, New York, pointed out that the American College of Surgeons has not revised its statement that considers concurrent surgery “not appropriate,” and that the study itself “reflects both the strengths and weaknesses of ‘big data.’ ” While ACS NSQIP provides a large number of patients, the study authors were still constrained in using time as a proxy for concurrence, she said. “Also, as noted, this analysis reports only a sample of operations rather than all the procedures performed, and the authors were constrained to using simulated statistical methods to avoid misclassification of cases,” Dr. Rusch said.

The death or serious morbidity composite measure the study used may not identify procedure-specific or specialty-specific adverse events that could reflect differences in outcomes between concurrent and nonconcurrent operations, she said. “Nonetheless, this study represents an important step toward bringing science to an extremely important and rightfully contentious aspect of surgical practice,” Dr. Rusch said.

Senior coauthor David Hoyt, MD, FACS, of the ACS, acknowledged the many study limitations Dr. Rusch pointed out. “What this analysis shows is that probably there’s not a huge problem with morbidity and mortality,” Dr. Hoyt said. “It doesn’t really say that we should pursue this without some care of how we do this.”

A key element in planning concurrent surgery is disclosing that to the patient. “Much of what came out of the discussion that led to this was because patients felt that they were not informed,” Dr. Hoyt said. “It really has to do with an ethical issue of patient autonomy.”

Dr. Liu, Dr. Hoyt, and Dr. Rusch had no financial relationships to disclose.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is anticipated to be published in the Annals of Surgery pending editorial review.

 

PHILADELPHIA – Overlapping and concurrent surgical procedures operations are not uncommon, but data on their safety and quality are scarce.

An analysis of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) data suggests that concurrent operations do not pose any greater risk to patients than do nonconcurrent operations.

“We found that concurrent operations were more often elective inpatient operations at large academic hospitals,” Jason Liu, MD, a clinical scholar-in-residence with the American College of Surgeons, Chicago, said at the annual meeting of the American Surgical Association.

VILevi/Thinkstock

The ACS Statement of Principles defines concurrent operations as those in which the critical components of operations overlap in time, whereas overlapping operations are those in which the critical components do not overlap. However, it is the attending surgeon’s judgment that currently determines which components are critical. This study specifically defined concurrent operations as those that overlapped by at least 60 minutes or in their entirety.

The study evaluated 12,010 concurrent and 521,656 nonconcurrent operations in the ASC NSQIP registry between 2014 and 2015, and propensity-score matched 11,044 operations of each type to evaluate safety. “We then analyzed the three primary outcomes – death or serious morbidity, unplanned reoperation, and unplanned readmission,” Dr. Liu said. “After propensity matching and risk adjustment, we detected no association of concurrent operations with these adverse outcomes.”

Death or serious morbidity had an odds ratio of 1.08, while the odds ratio for reoperation and readmission were 1.16 and 1.14, respectively.

Of the five surgery subspecialty groups presented, ear, nose and throat surgeons performed the highest proportion of concurrent operations, comprising 11.2% of all operations within the subspecialty, followed by neurosurgeons (8.4%) and urological surgeons (5.2%). General surgeons performed more total concurrent cases than did any of the other surgical subspecialties, but these comprised only 1.5% of all general surgery cases.

Among the individual operations presented, the highest percentage of concurrent cases was for spinal operations, comprising 7.1% of all spinal surgeries, followed by total knee and hip replacements, at 2.1% each. Among general surgery procedures, concurrent operations comprised 1.9% of colon surgeries, 1.5% of ventral hernia repairs, and 0.9% of cholecystectomies.

“We found that patients who had concurrent operations tended to have fewer comorbidities,” Dr. Liu said.

Despite the findings suggesting concurrent operations are safe, Dr. Liu added that “failure to detect an effect does not prove its absence. Additional studies and continued vigilance are certainly needed moving forward.”

In her discussion, Valerie W. Rusch, MD, FACS, of Memorial Sloan-Kettering Cancer Center, New York, pointed out that the American College of Surgeons has not revised its statement that considers concurrent surgery “not appropriate,” and that the study itself “reflects both the strengths and weaknesses of ‘big data.’ ” While ACS NSQIP provides a large number of patients, the study authors were still constrained in using time as a proxy for concurrence, she said. “Also, as noted, this analysis reports only a sample of operations rather than all the procedures performed, and the authors were constrained to using simulated statistical methods to avoid misclassification of cases,” Dr. Rusch said.

The death or serious morbidity composite measure the study used may not identify procedure-specific or specialty-specific adverse events that could reflect differences in outcomes between concurrent and nonconcurrent operations, she said. “Nonetheless, this study represents an important step toward bringing science to an extremely important and rightfully contentious aspect of surgical practice,” Dr. Rusch said.

Senior coauthor David Hoyt, MD, FACS, of the ACS, acknowledged the many study limitations Dr. Rusch pointed out. “What this analysis shows is that probably there’s not a huge problem with morbidity and mortality,” Dr. Hoyt said. “It doesn’t really say that we should pursue this without some care of how we do this.”

A key element in planning concurrent surgery is disclosing that to the patient. “Much of what came out of the discussion that led to this was because patients felt that they were not informed,” Dr. Hoyt said. “It really has to do with an ethical issue of patient autonomy.”

Dr. Liu, Dr. Hoyt, and Dr. Rusch had no financial relationships to disclose.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is anticipated to be published in the Annals of Surgery pending editorial review.

 

PHILADELPHIA – Overlapping and concurrent surgical procedures operations are not uncommon, but data on their safety and quality are scarce.

An analysis of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) data suggests that concurrent operations do not pose any greater risk to patients than do nonconcurrent operations.

“We found that concurrent operations were more often elective inpatient operations at large academic hospitals,” Jason Liu, MD, a clinical scholar-in-residence with the American College of Surgeons, Chicago, said at the annual meeting of the American Surgical Association.

VILevi/Thinkstock

The ACS Statement of Principles defines concurrent operations as those in which the critical components of operations overlap in time, whereas overlapping operations are those in which the critical components do not overlap. However, it is the attending surgeon’s judgment that currently determines which components are critical. This study specifically defined concurrent operations as those that overlapped by at least 60 minutes or in their entirety.

The study evaluated 12,010 concurrent and 521,656 nonconcurrent operations in the ASC NSQIP registry between 2014 and 2015, and propensity-score matched 11,044 operations of each type to evaluate safety. “We then analyzed the three primary outcomes – death or serious morbidity, unplanned reoperation, and unplanned readmission,” Dr. Liu said. “After propensity matching and risk adjustment, we detected no association of concurrent operations with these adverse outcomes.”

Death or serious morbidity had an odds ratio of 1.08, while the odds ratio for reoperation and readmission were 1.16 and 1.14, respectively.

Of the five surgery subspecialty groups presented, ear, nose and throat surgeons performed the highest proportion of concurrent operations, comprising 11.2% of all operations within the subspecialty, followed by neurosurgeons (8.4%) and urological surgeons (5.2%). General surgeons performed more total concurrent cases than did any of the other surgical subspecialties, but these comprised only 1.5% of all general surgery cases.

Among the individual operations presented, the highest percentage of concurrent cases was for spinal operations, comprising 7.1% of all spinal surgeries, followed by total knee and hip replacements, at 2.1% each. Among general surgery procedures, concurrent operations comprised 1.9% of colon surgeries, 1.5% of ventral hernia repairs, and 0.9% of cholecystectomies.

“We found that patients who had concurrent operations tended to have fewer comorbidities,” Dr. Liu said.

Despite the findings suggesting concurrent operations are safe, Dr. Liu added that “failure to detect an effect does not prove its absence. Additional studies and continued vigilance are certainly needed moving forward.”

In her discussion, Valerie W. Rusch, MD, FACS, of Memorial Sloan-Kettering Cancer Center, New York, pointed out that the American College of Surgeons has not revised its statement that considers concurrent surgery “not appropriate,” and that the study itself “reflects both the strengths and weaknesses of ‘big data.’ ” While ACS NSQIP provides a large number of patients, the study authors were still constrained in using time as a proxy for concurrence, she said. “Also, as noted, this analysis reports only a sample of operations rather than all the procedures performed, and the authors were constrained to using simulated statistical methods to avoid misclassification of cases,” Dr. Rusch said.

The death or serious morbidity composite measure the study used may not identify procedure-specific or specialty-specific adverse events that could reflect differences in outcomes between concurrent and nonconcurrent operations, she said. “Nonetheless, this study represents an important step toward bringing science to an extremely important and rightfully contentious aspect of surgical practice,” Dr. Rusch said.

Senior coauthor David Hoyt, MD, FACS, of the ACS, acknowledged the many study limitations Dr. Rusch pointed out. “What this analysis shows is that probably there’s not a huge problem with morbidity and mortality,” Dr. Hoyt said. “It doesn’t really say that we should pursue this without some care of how we do this.”

A key element in planning concurrent surgery is disclosing that to the patient. “Much of what came out of the discussion that led to this was because patients felt that they were not informed,” Dr. Hoyt said. “It really has to do with an ethical issue of patient autonomy.”

Dr. Liu, Dr. Hoyt, and Dr. Rusch had no financial relationships to disclose.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is anticipated to be published in the Annals of Surgery pending editorial review.

 

PHILADELPHIA – No large-scale study has evaluated the culture of operating room safety and 30-day postoperative death, but a statewide evaluation of South Carolina hospitals found that those in which operating-room personnel perceived a high degree of safety reported lower all-cause 30-day postoperative mortality rates.

“Reducing postoperative death rates and improving patient safety require that, in addition to technical competence, surgeons lead surgical teams in ways that foster the creation of a culture in operating rooms where personnel feel respected and invited to speak up on behalf of patient safety,” George Molina, MD, MPH, said at the annual meeting of the American Surgical Association. Dr. Molina is with Brigham and Women’s Hospital, Harvard T.H. Chan School of Public Health, and Massachusetts General Hospital, Boston.

The study objective was to evaluate whether the perceived culture of surgical safety among operating personnel, based on survey responses, is associated with hospital-level 30-day postoperative death.

The study drew on a statewide quality and safety program of the South Carolina Hospital Association known as Safe Surgery 2015, one component of which was a survey sent to operating-room (OR) personnel to measure baseline culture of surgical safety. The survey evaluated five teamwork factors: mutual respect, clinical leadership, assertiveness, coordination, and effective communication. The overall response rate of OR staff at 31 surveyed hospitals was 38.1% with 1,793 completed surveys, with a physicians response rate of 29%.

The researchers analyzed statewide claims data of nearly all surgery in the state (except for operations at Veterans Affairs, military and Shriners’ centers) and a state-level death registry to identify patients who died within 30 days after an inpatient operation. The unadjusted median 30-day postoperative death rate at the 31 participating hospitals was 3.2%, Dr. Molina said.

The study evaluated the association between hospital-level mean scores for each survey statement and postoperative death, and used machine learning to adjust for potential confounders. The analysis also took into account hospital-level variables such as patient gender, Charlson Comorbidity Index, primary payer status, and procedure type.

“Among the factors that make up the teamwork dimension, respect, leadership and assertiveness on behalf of patient safety were significantly associated with lower 30-day postoperative death rates,” Dr. Molina said. “For every one-point increase on a seven-point Likert scale and the hospital level mean score for respect, clinical leadership, and assertiveness among all survey respondents, there were associated decreases in postoperative mortality following surgery, ranging from 14% to 29%.”

Of the five teamwork variables, assertiveness had the lowest relative risk, 0.71 (P = .01), whereas communication had the highest, 0.98 (P = .77).

Dr. Molina noted a number of limitations to the study, such as the inability to generalize findings from a single state and the use of cross-sectional data, which precludes a causal link between culture and mortality. “Postoperative mortality is most likely due to multiple factors that take place not only in the operating room, but also during the course of preoperative and postoperative course,” he said.

In his discussion, Justin Dimick, MD, of the University of Michigan, Ann Arbor, asked Dr. Molina what interventions beyond OR checklists are available to improve safety culture.

“It’s not a matter of changing perceptions but actually changing behaviors and then actually improving the culture,” Dr. Molina said. OR team training that includes simulated emergency response is one such intervention. Other strategies he offered: “Working on communication, in particular closed-loop communication among health care providers working in the operating room, and then also quality and safety programs such as Safe Surgery 2015.”

Dr. Molina reported no financial disclosures. Dr. Dimick is cofounder of Arbor Metrix and receives royalties.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is anticipated to be published in the Annals of Surgery pending editorial review.
 

 

 

PHILADELPHIA – No large-scale study has evaluated the culture of operating room safety and 30-day postoperative death, but a statewide evaluation of South Carolina hospitals found that those in which operating-room personnel perceived a high degree of safety reported lower all-cause 30-day postoperative mortality rates.

“Reducing postoperative death rates and improving patient safety require that, in addition to technical competence, surgeons lead surgical teams in ways that foster the creation of a culture in operating rooms where personnel feel respected and invited to speak up on behalf of patient safety,” George Molina, MD, MPH, said at the annual meeting of the American Surgical Association. Dr. Molina is with Brigham and Women’s Hospital, Harvard T.H. Chan School of Public Health, and Massachusetts General Hospital, Boston.

The study objective was to evaluate whether the perceived culture of surgical safety among operating personnel, based on survey responses, is associated with hospital-level 30-day postoperative death.

The study drew on a statewide quality and safety program of the South Carolina Hospital Association known as Safe Surgery 2015, one component of which was a survey sent to operating-room (OR) personnel to measure baseline culture of surgical safety. The survey evaluated five teamwork factors: mutual respect, clinical leadership, assertiveness, coordination, and effective communication. The overall response rate of OR staff at 31 surveyed hospitals was 38.1% with 1,793 completed surveys, with a physicians response rate of 29%.

The researchers analyzed statewide claims data of nearly all surgery in the state (except for operations at Veterans Affairs, military and Shriners’ centers) and a state-level death registry to identify patients who died within 30 days after an inpatient operation. The unadjusted median 30-day postoperative death rate at the 31 participating hospitals was 3.2%, Dr. Molina said.

The study evaluated the association between hospital-level mean scores for each survey statement and postoperative death, and used machine learning to adjust for potential confounders. The analysis also took into account hospital-level variables such as patient gender, Charlson Comorbidity Index, primary payer status, and procedure type.

“Among the factors that make up the teamwork dimension, respect, leadership and assertiveness on behalf of patient safety were significantly associated with lower 30-day postoperative death rates,” Dr. Molina said. “For every one-point increase on a seven-point Likert scale and the hospital level mean score for respect, clinical leadership, and assertiveness among all survey respondents, there were associated decreases in postoperative mortality following surgery, ranging from 14% to 29%.”

Of the five teamwork variables, assertiveness had the lowest relative risk, 0.71 (P = .01), whereas communication had the highest, 0.98 (P = .77).

Dr. Molina noted a number of limitations to the study, such as the inability to generalize findings from a single state and the use of cross-sectional data, which precludes a causal link between culture and mortality. “Postoperative mortality is most likely due to multiple factors that take place not only in the operating room, but also during the course of preoperative and postoperative course,” he said.

In his discussion, Justin Dimick, MD, of the University of Michigan, Ann Arbor, asked Dr. Molina what interventions beyond OR checklists are available to improve safety culture.

“It’s not a matter of changing perceptions but actually changing behaviors and then actually improving the culture,” Dr. Molina said. OR team training that includes simulated emergency response is one such intervention. Other strategies he offered: “Working on communication, in particular closed-loop communication among health care providers working in the operating room, and then also quality and safety programs such as Safe Surgery 2015.”

Dr. Molina reported no financial disclosures. Dr. Dimick is cofounder of Arbor Metrix and receives royalties.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is anticipated to be published in the Annals of Surgery pending editorial review.
 

 

 

PHILADELPHIA – No large-scale study has evaluated the culture of operating room safety and 30-day postoperative death, but a statewide evaluation of South Carolina hospitals found that those in which operating-room personnel perceived a high degree of safety reported lower all-cause 30-day postoperative mortality rates.

“Reducing postoperative death rates and improving patient safety require that, in addition to technical competence, surgeons lead surgical teams in ways that foster the creation of a culture in operating rooms where personnel feel respected and invited to speak up on behalf of patient safety,” George Molina, MD, MPH, said at the annual meeting of the American Surgical Association. Dr. Molina is with Brigham and Women’s Hospital, Harvard T.H. Chan School of Public Health, and Massachusetts General Hospital, Boston.

The study objective was to evaluate whether the perceived culture of surgical safety among operating personnel, based on survey responses, is associated with hospital-level 30-day postoperative death.

The study drew on a statewide quality and safety program of the South Carolina Hospital Association known as Safe Surgery 2015, one component of which was a survey sent to operating-room (OR) personnel to measure baseline culture of surgical safety. The survey evaluated five teamwork factors: mutual respect, clinical leadership, assertiveness, coordination, and effective communication. The overall response rate of OR staff at 31 surveyed hospitals was 38.1% with 1,793 completed surveys, with a physicians response rate of 29%.

The researchers analyzed statewide claims data of nearly all surgery in the state (except for operations at Veterans Affairs, military and Shriners’ centers) and a state-level death registry to identify patients who died within 30 days after an inpatient operation. The unadjusted median 30-day postoperative death rate at the 31 participating hospitals was 3.2%, Dr. Molina said.

The study evaluated the association between hospital-level mean scores for each survey statement and postoperative death, and used machine learning to adjust for potential confounders. The analysis also took into account hospital-level variables such as patient gender, Charlson Comorbidity Index, primary payer status, and procedure type.

“Among the factors that make up the teamwork dimension, respect, leadership and assertiveness on behalf of patient safety were significantly associated with lower 30-day postoperative death rates,” Dr. Molina said. “For every one-point increase on a seven-point Likert scale and the hospital level mean score for respect, clinical leadership, and assertiveness among all survey respondents, there were associated decreases in postoperative mortality following surgery, ranging from 14% to 29%.”

Of the five teamwork variables, assertiveness had the lowest relative risk, 0.71 (P = .01), whereas communication had the highest, 0.98 (P = .77).

Dr. Molina noted a number of limitations to the study, such as the inability to generalize findings from a single state and the use of cross-sectional data, which precludes a causal link between culture and mortality. “Postoperative mortality is most likely due to multiple factors that take place not only in the operating room, but also during the course of preoperative and postoperative course,” he said.

In his discussion, Justin Dimick, MD, of the University of Michigan, Ann Arbor, asked Dr. Molina what interventions beyond OR checklists are available to improve safety culture.

“It’s not a matter of changing perceptions but actually changing behaviors and then actually improving the culture,” Dr. Molina said. OR team training that includes simulated emergency response is one such intervention. Other strategies he offered: “Working on communication, in particular closed-loop communication among health care providers working in the operating room, and then also quality and safety programs such as Safe Surgery 2015.”

Dr. Molina reported no financial disclosures. Dr. Dimick is cofounder of Arbor Metrix and receives royalties.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is anticipated to be published in the Annals of Surgery pending editorial review.
 

 

 

PHILADELPHIA – In surgery for small-bowel obstruction, laparoscopy is more likely to result in bowel injury than is open surgery but with ultimately better outcomes overall. This means that surgeons should proceed with “considerable caution” when performing minimally invasive surgery in the small bowel, researchers at University of Toronto reported during the annual meeting of the American Surgical Association.

The study also showed that laparoscopic surgery for small-bowel obstruction (SBO) resulted in lower 30-day mortality and fewer serious complications, Ramy Behman, MD, of the University, said. “We found that patient selection in this population is important,” he said.

In explaining the rationale for the study, Dr. Behman said, “Several studies have shown that over the last several years [that] the utilization of laparoscopic techniques for adhesive small-bowel obstruction has become increasingly common. However, these procedures have some inherent challenges.” Those technical challenges include introducing the trocar into an abdomen filled with distended bowel, trying to manipulate the distended bowel with laparoscopic bowel graspers, and the potentially ischemic bowel wall, he said.

The University of Toronto researchers performed a population-based retrospective cohort study of 8,584 patients in the Ministry of Health Ontario database from 2005 to 2014. The primary outcome was a composite, consisting of bowel repair, including operative billing codes for either via intraoperative enterotomy or suture repair of the intestine, or bowel resection. Secondary outcomes were serious complications and 30-day mortality.

During the study period, the share of SBO procedures performed laparoscopically increased from 4% in 2005 to 14.3% in 2014, Dr. Behman said.

“Patients in the laparoscopic group were slightly younger, had a lower overall comorbidity burden, and tended to be treated at larger hospitals and hospitals without teaching designations,” Dr. Behman said. Specifically, the average age of the 673 patients who had laparoscopy was 63 years vs. 67 years for the 7,911 open-procedure patients. As for comorbidities, 9% and 50% in the laparoscopic group were healthy and low users and high and very high users, respectively, vs. 7% and 57% of the open-procedure group.

The incidence of any bowel intervention was 53.5% in the laparoscopic group vs. 42% in the open group, Dr. Behman said. After a multivariable regression analysis, the researchers determined the following factors raised a patient’s odds of having a bowel intervention: older age; female sex; having had an after-hours procedure; and having had the procedure earlier in the study period. “However, even after [the researchers adjusted] for all of these covariates, the variable in our model that was most significantly associated with a bowel intervention was having had a laparoscopic procedure, with an odds ratio of 1.6,” Dr. Behman said.

When analyzing secondary outcomes, the researchers found that laparoscopy was associated with a lower risk of 30-day mortality (OR, 0.6) and serious complication (OR, 0.8). “So, there does appear to be a direct trade-off with laparoscopy probably having better clinical outcomes, but also being a risk factor for bowel intervention,” Dr. Behman said. So the researchers preformed a secondary analysis that divided the cohort into four subgroups: laparoscopy with and without bowel intervention; and open surgery with and without bowel intervention.

“The next question we wanted to ask was, in patients that are at high risk of a laparoscopic bowel injury, is an open approach or early conversion to open beneficial?” Dr. Behman said. “To put this another way, is it more important to avoid a bowel intervention or to avoid the morbidity associated with an open procedure?”

The secondary analysis confirmed that laparoscopic patients had lower rates of serious complications: in those without bowel intervention, 5% for laparoscopy vs. 10% for open; and in those who had a bowel intervention, 15% for laparoscopy vs. 22% for open. However, those who had an open procedure without a bowel intervention had lower complication rates than did those who had a laparoscopic operation with a bowel intervention, Dr. Behman said, “suggesting that perhaps the bowel intervention is a greater driver of serious complications than having an open procedure.”

These findings can inform patient selection, Dr. Behman added. “In light of the fact that laparoscopic approaches are likely associated with a greater risk of bowel intervention, appropriate caution should accompany these procedures,” he said. “In patients who are at high risk for a bowel intervention, an open approach or early conversion to a laparotomy should be considered.”

In his discussion of the study, Lawrence Diebel, MD, FACS, of Wayne State University, Detroit, asked if the study accounted for timing of surgery, the etiology of laparoscopic-related bowel interventions, and if serosal tears were included as bowel injuries. Dr. Behman said that the study did include timing of surgery in the initial analysis and found it to be a nonfactor. However, the database did not specify the causes for bowel resections or reasons for conversions.

Dr. Behman and Dr. Diebel reported having no financial disclosures

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in the Annals of Surgery pending editorial review.

 

PHILADELPHIA – In surgery for small-bowel obstruction, laparoscopy is more likely to result in bowel injury than is open surgery but with ultimately better outcomes overall. This means that surgeons should proceed with “considerable caution” when performing minimally invasive surgery in the small bowel, researchers at University of Toronto reported during the annual meeting of the American Surgical Association.

The study also showed that laparoscopic surgery for small-bowel obstruction (SBO) resulted in lower 30-day mortality and fewer serious complications, Ramy Behman, MD, of the University, said. “We found that patient selection in this population is important,” he said.

In explaining the rationale for the study, Dr. Behman said, “Several studies have shown that over the last several years [that] the utilization of laparoscopic techniques for adhesive small-bowel obstruction has become increasingly common. However, these procedures have some inherent challenges.” Those technical challenges include introducing the trocar into an abdomen filled with distended bowel, trying to manipulate the distended bowel with laparoscopic bowel graspers, and the potentially ischemic bowel wall, he said.

The University of Toronto researchers performed a population-based retrospective cohort study of 8,584 patients in the Ministry of Health Ontario database from 2005 to 2014. The primary outcome was a composite, consisting of bowel repair, including operative billing codes for either via intraoperative enterotomy or suture repair of the intestine, or bowel resection. Secondary outcomes were serious complications and 30-day mortality.

During the study period, the share of SBO procedures performed laparoscopically increased from 4% in 2005 to 14.3% in 2014, Dr. Behman said.

“Patients in the laparoscopic group were slightly younger, had a lower overall comorbidity burden, and tended to be treated at larger hospitals and hospitals without teaching designations,” Dr. Behman said. Specifically, the average age of the 673 patients who had laparoscopy was 63 years vs. 67 years for the 7,911 open-procedure patients. As for comorbidities, 9% and 50% in the laparoscopic group were healthy and low users and high and very high users, respectively, vs. 7% and 57% of the open-procedure group.

The incidence of any bowel intervention was 53.5% in the laparoscopic group vs. 42% in the open group, Dr. Behman said. After a multivariable regression analysis, the researchers determined the following factors raised a patient’s odds of having a bowel intervention: older age; female sex; having had an after-hours procedure; and having had the procedure earlier in the study period. “However, even after [the researchers adjusted] for all of these covariates, the variable in our model that was most significantly associated with a bowel intervention was having had a laparoscopic procedure, with an odds ratio of 1.6,” Dr. Behman said.

When analyzing secondary outcomes, the researchers found that laparoscopy was associated with a lower risk of 30-day mortality (OR, 0.6) and serious complication (OR, 0.8). “So, there does appear to be a direct trade-off with laparoscopy probably having better clinical outcomes, but also being a risk factor for bowel intervention,” Dr. Behman said. So the researchers preformed a secondary analysis that divided the cohort into four subgroups: laparoscopy with and without bowel intervention; and open surgery with and without bowel intervention.

“The next question we wanted to ask was, in patients that are at high risk of a laparoscopic bowel injury, is an open approach or early conversion to open beneficial?” Dr. Behman said. “To put this another way, is it more important to avoid a bowel intervention or to avoid the morbidity associated with an open procedure?”

The secondary analysis confirmed that laparoscopic patients had lower rates of serious complications: in those without bowel intervention, 5% for laparoscopy vs. 10% for open; and in those who had a bowel intervention, 15% for laparoscopy vs. 22% for open. However, those who had an open procedure without a bowel intervention had lower complication rates than did those who had a laparoscopic operation with a bowel intervention, Dr. Behman said, “suggesting that perhaps the bowel intervention is a greater driver of serious complications than having an open procedure.”

These findings can inform patient selection, Dr. Behman added. “In light of the fact that laparoscopic approaches are likely associated with a greater risk of bowel intervention, appropriate caution should accompany these procedures,” he said. “In patients who are at high risk for a bowel intervention, an open approach or early conversion to a laparotomy should be considered.”

In his discussion of the study, Lawrence Diebel, MD, FACS, of Wayne State University, Detroit, asked if the study accounted for timing of surgery, the etiology of laparoscopic-related bowel interventions, and if serosal tears were included as bowel injuries. Dr. Behman said that the study did include timing of surgery in the initial analysis and found it to be a nonfactor. However, the database did not specify the causes for bowel resections or reasons for conversions.

Dr. Behman and Dr. Diebel reported having no financial disclosures

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in the Annals of Surgery pending editorial review.

 

PHILADELPHIA – In surgery for small-bowel obstruction, laparoscopy is more likely to result in bowel injury than is open surgery but with ultimately better outcomes overall. This means that surgeons should proceed with “considerable caution” when performing minimally invasive surgery in the small bowel, researchers at University of Toronto reported during the annual meeting of the American Surgical Association.

The study also showed that laparoscopic surgery for small-bowel obstruction (SBO) resulted in lower 30-day mortality and fewer serious complications, Ramy Behman, MD, of the University, said. “We found that patient selection in this population is important,” he said.

In explaining the rationale for the study, Dr. Behman said, “Several studies have shown that over the last several years [that] the utilization of laparoscopic techniques for adhesive small-bowel obstruction has become increasingly common. However, these procedures have some inherent challenges.” Those technical challenges include introducing the trocar into an abdomen filled with distended bowel, trying to manipulate the distended bowel with laparoscopic bowel graspers, and the potentially ischemic bowel wall, he said.

The University of Toronto researchers performed a population-based retrospective cohort study of 8,584 patients in the Ministry of Health Ontario database from 2005 to 2014. The primary outcome was a composite, consisting of bowel repair, including operative billing codes for either via intraoperative enterotomy or suture repair of the intestine, or bowel resection. Secondary outcomes were serious complications and 30-day mortality.

During the study period, the share of SBO procedures performed laparoscopically increased from 4% in 2005 to 14.3% in 2014, Dr. Behman said.

“Patients in the laparoscopic group were slightly younger, had a lower overall comorbidity burden, and tended to be treated at larger hospitals and hospitals without teaching designations,” Dr. Behman said. Specifically, the average age of the 673 patients who had laparoscopy was 63 years vs. 67 years for the 7,911 open-procedure patients. As for comorbidities, 9% and 50% in the laparoscopic group were healthy and low users and high and very high users, respectively, vs. 7% and 57% of the open-procedure group.

The incidence of any bowel intervention was 53.5% in the laparoscopic group vs. 42% in the open group, Dr. Behman said. After a multivariable regression analysis, the researchers determined the following factors raised a patient’s odds of having a bowel intervention: older age; female sex; having had an after-hours procedure; and having had the procedure earlier in the study period. “However, even after [the researchers adjusted] for all of these covariates, the variable in our model that was most significantly associated with a bowel intervention was having had a laparoscopic procedure, with an odds ratio of 1.6,” Dr. Behman said.

When analyzing secondary outcomes, the researchers found that laparoscopy was associated with a lower risk of 30-day mortality (OR, 0.6) and serious complication (OR, 0.8). “So, there does appear to be a direct trade-off with laparoscopy probably having better clinical outcomes, but also being a risk factor for bowel intervention,” Dr. Behman said. So the researchers preformed a secondary analysis that divided the cohort into four subgroups: laparoscopy with and without bowel intervention; and open surgery with and without bowel intervention.

“The next question we wanted to ask was, in patients that are at high risk of a laparoscopic bowel injury, is an open approach or early conversion to open beneficial?” Dr. Behman said. “To put this another way, is it more important to avoid a bowel intervention or to avoid the morbidity associated with an open procedure?”

The secondary analysis confirmed that laparoscopic patients had lower rates of serious complications: in those without bowel intervention, 5% for laparoscopy vs. 10% for open; and in those who had a bowel intervention, 15% for laparoscopy vs. 22% for open. However, those who had an open procedure without a bowel intervention had lower complication rates than did those who had a laparoscopic operation with a bowel intervention, Dr. Behman said, “suggesting that perhaps the bowel intervention is a greater driver of serious complications than having an open procedure.”

These findings can inform patient selection, Dr. Behman added. “In light of the fact that laparoscopic approaches are likely associated with a greater risk of bowel intervention, appropriate caution should accompany these procedures,” he said. “In patients who are at high risk for a bowel intervention, an open approach or early conversion to a laparotomy should be considered.”

In his discussion of the study, Lawrence Diebel, MD, FACS, of Wayne State University, Detroit, asked if the study accounted for timing of surgery, the etiology of laparoscopic-related bowel interventions, and if serosal tears were included as bowel injuries. Dr. Behman said that the study did include timing of surgery in the initial analysis and found it to be a nonfactor. However, the database did not specify the causes for bowel resections or reasons for conversions.

Dr. Behman and Dr. Diebel reported having no financial disclosures

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in the Annals of Surgery pending editorial review.

 

PHILADELPHIA – How a patient reacts to postoperative pain and how the pain progresses or regresses can be key predictors for 30-day hospital readmissions and emergency department visits after hospital discharge, according to an analysis of more than 200,000 operations in a national database.

“Surgical readmissions, as we all know, have come under increased scrutiny, because they are associated with both increased costs and resource utilization, and preventable readmissions are thought to account for up to 17% of all hospital payments, resulting in a cost average of $13,433 per readmission,” Mary T. Hawn, MD, FACS, of Stanford (Calif.) University said in reporting results of the study. That estimate is based on Medicare data on 3.9 million readmissions in 2013. The study findings were reported at the annual meeting of the American Surgical Association.

The study sample included 211,213 operations in the Veterans Affairs Surgical Quality Improvement Program during 2008-2014, 45% of which were orthopedic in nature, 37% general, and 18% vascular. The overall 30-day unplanned readmission rate was 10.8% and the 30-day ED utilization rate was 14.2%, Dr. Hawn said.

The study identified six distinct postoperative inpatient pain trajectories based on postop pain scores: persistently low (4.5%); mild to low (9%); persistently mild (15.3%); moderate to low (12.1%); persistently moderate (40.2%); and persistently high (18.9%). One of the study objectives, Dr. Hawn said, “was to see if we could identify patterns of postoperative pain trajectories in a surgical cohort, and to describe these subpopulations by their trajectories, and then to determine whether there was an association with postdischarge health care utilization.” The hypothesis was that inpatient postoperative pain trajectory would be associated with 30-day readmission and ED visits as well as postop complications, Dr. Hawn added.

Patients with high pain trajectories had highest rates of postdischarge readmission and ED visits, 14.4% and 16.3%, respectively, Dr. Hawn said.

“Patients in the low-pain categories were more likely to undergo general and vascular procedures compared to orthopedic procedures in the high-pain categories,” Dr. Hawn said. “In the low-pain categories, they were older and less likely to be female. They were less likely to have independent functional status whereas patients in the high-pain category had a 26% prevalence of preoperative diagnosis of depression.”

Those in the high-pain category had a 1.5 times greater risk of an unplanned readmission and a 4 times greater risk in pain-related readmission, according to an odds ratio analysis of the data.

“As for the prevalence of our outcomes, 10.7% had an unplanned readmission. A total of 1.5% from the overall cohort had a pain-related readmission, 8.6% had an emergency visit within 30 days of discharge that did not result in a readmission, and 4.4% had at least one postdischarge complication,” Dr. Hawn said.

In his discussion, Clifford Y. Ko, MD, FACS, of the University of California, Los Angeles, asked what was the take-home for surgeons managing patients postoperatively in the era of the opioid epidemic. “For these types of patients, we need to get our colleagues, the pain specialists, involved much earlier,” Dr. Hawn said. “We need to rethink that strategy of treating the pain-score number. And I think there’s been so much national attention to this that we will stop focusing on that number as a measure of quality of care and patient satisfaction. Those are some trends we’ll see in the future.”

Neither Dr. Hawn nor Dr. Ko reported any financial disclosures

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is anticipated to be published in the Annals of Surgery pending editorial review.

 

PHILADELPHIA – How a patient reacts to postoperative pain and how the pain progresses or regresses can be key predictors for 30-day hospital readmissions and emergency department visits after hospital discharge, according to an analysis of more than 200,000 operations in a national database.

“Surgical readmissions, as we all know, have come under increased scrutiny, because they are associated with both increased costs and resource utilization, and preventable readmissions are thought to account for up to 17% of all hospital payments, resulting in a cost average of $13,433 per readmission,” Mary T. Hawn, MD, FACS, of Stanford (Calif.) University said in reporting results of the study. That estimate is based on Medicare data on 3.9 million readmissions in 2013. The study findings were reported at the annual meeting of the American Surgical Association.

The study sample included 211,213 operations in the Veterans Affairs Surgical Quality Improvement Program during 2008-2014, 45% of which were orthopedic in nature, 37% general, and 18% vascular. The overall 30-day unplanned readmission rate was 10.8% and the 30-day ED utilization rate was 14.2%, Dr. Hawn said.

The study identified six distinct postoperative inpatient pain trajectories based on postop pain scores: persistently low (4.5%); mild to low (9%); persistently mild (15.3%); moderate to low (12.1%); persistently moderate (40.2%); and persistently high (18.9%). One of the study objectives, Dr. Hawn said, “was to see if we could identify patterns of postoperative pain trajectories in a surgical cohort, and to describe these subpopulations by their trajectories, and then to determine whether there was an association with postdischarge health care utilization.” The hypothesis was that inpatient postoperative pain trajectory would be associated with 30-day readmission and ED visits as well as postop complications, Dr. Hawn added.

Patients with high pain trajectories had highest rates of postdischarge readmission and ED visits, 14.4% and 16.3%, respectively, Dr. Hawn said.

“Patients in the low-pain categories were more likely to undergo general and vascular procedures compared to orthopedic procedures in the high-pain categories,” Dr. Hawn said. “In the low-pain categories, they were older and less likely to be female. They were less likely to have independent functional status whereas patients in the high-pain category had a 26% prevalence of preoperative diagnosis of depression.”

Those in the high-pain category had a 1.5 times greater risk of an unplanned readmission and a 4 times greater risk in pain-related readmission, according to an odds ratio analysis of the data.

“As for the prevalence of our outcomes, 10.7% had an unplanned readmission. A total of 1.5% from the overall cohort had a pain-related readmission, 8.6% had an emergency visit within 30 days of discharge that did not result in a readmission, and 4.4% had at least one postdischarge complication,” Dr. Hawn said.

In his discussion, Clifford Y. Ko, MD, FACS, of the University of California, Los Angeles, asked what was the take-home for surgeons managing patients postoperatively in the era of the opioid epidemic. “For these types of patients, we need to get our colleagues, the pain specialists, involved much earlier,” Dr. Hawn said. “We need to rethink that strategy of treating the pain-score number. And I think there’s been so much national attention to this that we will stop focusing on that number as a measure of quality of care and patient satisfaction. Those are some trends we’ll see in the future.”

Neither Dr. Hawn nor Dr. Ko reported any financial disclosures

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is anticipated to be published in the Annals of Surgery pending editorial review.

 

PHILADELPHIA – How a patient reacts to postoperative pain and how the pain progresses or regresses can be key predictors for 30-day hospital readmissions and emergency department visits after hospital discharge, according to an analysis of more than 200,000 operations in a national database.

“Surgical readmissions, as we all know, have come under increased scrutiny, because they are associated with both increased costs and resource utilization, and preventable readmissions are thought to account for up to 17% of all hospital payments, resulting in a cost average of $13,433 per readmission,” Mary T. Hawn, MD, FACS, of Stanford (Calif.) University said in reporting results of the study. That estimate is based on Medicare data on 3.9 million readmissions in 2013. The study findings were reported at the annual meeting of the American Surgical Association.

The study sample included 211,213 operations in the Veterans Affairs Surgical Quality Improvement Program during 2008-2014, 45% of which were orthopedic in nature, 37% general, and 18% vascular. The overall 30-day unplanned readmission rate was 10.8% and the 30-day ED utilization rate was 14.2%, Dr. Hawn said.

The study identified six distinct postoperative inpatient pain trajectories based on postop pain scores: persistently low (4.5%); mild to low (9%); persistently mild (15.3%); moderate to low (12.1%); persistently moderate (40.2%); and persistently high (18.9%). One of the study objectives, Dr. Hawn said, “was to see if we could identify patterns of postoperative pain trajectories in a surgical cohort, and to describe these subpopulations by their trajectories, and then to determine whether there was an association with postdischarge health care utilization.” The hypothesis was that inpatient postoperative pain trajectory would be associated with 30-day readmission and ED visits as well as postop complications, Dr. Hawn added.

Patients with high pain trajectories had highest rates of postdischarge readmission and ED visits, 14.4% and 16.3%, respectively, Dr. Hawn said.

“Patients in the low-pain categories were more likely to undergo general and vascular procedures compared to orthopedic procedures in the high-pain categories,” Dr. Hawn said. “In the low-pain categories, they were older and less likely to be female. They were less likely to have independent functional status whereas patients in the high-pain category had a 26% prevalence of preoperative diagnosis of depression.”

Those in the high-pain category had a 1.5 times greater risk of an unplanned readmission and a 4 times greater risk in pain-related readmission, according to an odds ratio analysis of the data.

“As for the prevalence of our outcomes, 10.7% had an unplanned readmission. A total of 1.5% from the overall cohort had a pain-related readmission, 8.6% had an emergency visit within 30 days of discharge that did not result in a readmission, and 4.4% had at least one postdischarge complication,” Dr. Hawn said.

In his discussion, Clifford Y. Ko, MD, FACS, of the University of California, Los Angeles, asked what was the take-home for surgeons managing patients postoperatively in the era of the opioid epidemic. “For these types of patients, we need to get our colleagues, the pain specialists, involved much earlier,” Dr. Hawn said. “We need to rethink that strategy of treating the pain-score number. And I think there’s been so much national attention to this that we will stop focusing on that number as a measure of quality of care and patient satisfaction. Those are some trends we’ll see in the future.”

Neither Dr. Hawn nor Dr. Ko reported any financial disclosures

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is anticipated to be published in the Annals of Surgery pending editorial review.

 

PHILADELPHIA – A randomized multicenter trial that compared patients who had distal pancreatectomy with and without routine peritoneal drainage found no appreciable difference in the complication rates between the two groups, the lead investigator reported at the annual meeting of the American Surgical Association here.

“This randomized, prospective, multicenter trial provides Level 1 data that clinical outcomes are comparable in distal pancreatectomy with or without intraperitoneal drainage,” George Van Buren II, MD, FACS, of Baylor College of Medicine in Houston, said in reporting the results. “Distal pancreatectomy without routine intraperitoneal drainage is an acceptable practice.”

The trial randomized 202 patients to the intraperitoneal drainage group and 197 to the nondrainage group. The groups were well matched in terms of patients who dropped out because of metastatic disease or other reason, as well as demographics and operative data. “They were equally matched for laparoscopic vs. open, equally matched for vascular resection, equally matched for pancreatic texture and duct size, equally matched for method of transection, equally matched for operative time and blood loss and equally matched for surgical pathology,” Dr. Van Buren said.

The primary outcome was frequency of grade 2 complications or greater, which occurred in 44% (76) of the drainage group and 42% (72) of the nondrainage group (P = .804). “Similarly, the groups were equal for grade 3 severe complications as well as median complication severity and median number of complications,” Dr. Van Buren said. The rates of complications of grade 3 or greater were 29% (51) for the drainage group and 26% (44) for the nondrainage group (P = .477). Ninety-day mortality also was similar between the two groups: None died in the drainage group and two (1%) died in the nondrainage group (P = .24).

Drilling down into types of complications, Dr. Van Buren added that rates were similar across the board. “There was no difference in clinically relevant postoperative pancreatic fistula between the drain and no-drain group,” he said. “There was no difference in intra-abdominal abscess, no difference in the rates of postoperative imaging, no difference in the rates of postoperative percutaneous drain placements, and there was no difference in readmission or reoperation.”

One outcome that was noticeably different between the two groups was intra-abdominal fluid collections, reported in 9% (15) of the drainage group and 22% (38) of the nondrainage group (P = .0004). “However,” Dr. Van Buren said, “these were asymptomatic.”

In his discussion of the presentation, Charles Yeo, MD, FACS, of Thomas Jefferson University, Philadelphia, said that “the scope and the rigor of this study are impressive and quite laudable” but raised a number of questions, including concerns about the two deaths in the nondrainage group in the context of two other trials: a smaller multicenter trial, coauthored by Dr. Van Buren, that compared postoperative use of drains and nondrainage in pancreaticoduodenectomy but was halted because of eight deaths in the nondrainage group (Ann Surg. 2014;259:605-12); and the German PANDRA trial reported at last year’s ASA meeting that found nondrainage after pancreaticoduodenectomy to be superior to drainage in terms of reintervention and fistula rates.

Dr. Van Buren replied that the first study from Baylor – referenced by Dr. Yeo – involved “well-balanced groups, and they were equally matched and had minimal dropout throughout.” Because of that, the finding that drain placement for the pancreaticoduodenectomy “was definitive,” whereas the PANDRA trial was subject to some criticisms. The screening and randomization processes in PANDRA have been criticized because 3,200 patients were eligible for enrollment, suggesting a screening bias, Dr. Van Buren said. In addition, drains were placed in 21% of patients who were allocated to the no-drain group, suggesting surgeons deviated from the protocol in higher-risk situations, resulting in additional selection bias. This implies PANDRA was more of a selective draining trial, he said.

Dr. Van Buren and Dr. Yeo reported having no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in Annals of Surgery pending editorial review.

 

PHILADELPHIA – A randomized multicenter trial that compared patients who had distal pancreatectomy with and without routine peritoneal drainage found no appreciable difference in the complication rates between the two groups, the lead investigator reported at the annual meeting of the American Surgical Association here.

“This randomized, prospective, multicenter trial provides Level 1 data that clinical outcomes are comparable in distal pancreatectomy with or without intraperitoneal drainage,” George Van Buren II, MD, FACS, of Baylor College of Medicine in Houston, said in reporting the results. “Distal pancreatectomy without routine intraperitoneal drainage is an acceptable practice.”

The trial randomized 202 patients to the intraperitoneal drainage group and 197 to the nondrainage group. The groups were well matched in terms of patients who dropped out because of metastatic disease or other reason, as well as demographics and operative data. “They were equally matched for laparoscopic vs. open, equally matched for vascular resection, equally matched for pancreatic texture and duct size, equally matched for method of transection, equally matched for operative time and blood loss and equally matched for surgical pathology,” Dr. Van Buren said.

The primary outcome was frequency of grade 2 complications or greater, which occurred in 44% (76) of the drainage group and 42% (72) of the nondrainage group (P = .804). “Similarly, the groups were equal for grade 3 severe complications as well as median complication severity and median number of complications,” Dr. Van Buren said. The rates of complications of grade 3 or greater were 29% (51) for the drainage group and 26% (44) for the nondrainage group (P = .477). Ninety-day mortality also was similar between the two groups: None died in the drainage group and two (1%) died in the nondrainage group (P = .24).

Drilling down into types of complications, Dr. Van Buren added that rates were similar across the board. “There was no difference in clinically relevant postoperative pancreatic fistula between the drain and no-drain group,” he said. “There was no difference in intra-abdominal abscess, no difference in the rates of postoperative imaging, no difference in the rates of postoperative percutaneous drain placements, and there was no difference in readmission or reoperation.”

One outcome that was noticeably different between the two groups was intra-abdominal fluid collections, reported in 9% (15) of the drainage group and 22% (38) of the nondrainage group (P = .0004). “However,” Dr. Van Buren said, “these were asymptomatic.”

In his discussion of the presentation, Charles Yeo, MD, FACS, of Thomas Jefferson University, Philadelphia, said that “the scope and the rigor of this study are impressive and quite laudable” but raised a number of questions, including concerns about the two deaths in the nondrainage group in the context of two other trials: a smaller multicenter trial, coauthored by Dr. Van Buren, that compared postoperative use of drains and nondrainage in pancreaticoduodenectomy but was halted because of eight deaths in the nondrainage group (Ann Surg. 2014;259:605-12); and the German PANDRA trial reported at last year’s ASA meeting that found nondrainage after pancreaticoduodenectomy to be superior to drainage in terms of reintervention and fistula rates.

Dr. Van Buren replied that the first study from Baylor – referenced by Dr. Yeo – involved “well-balanced groups, and they were equally matched and had minimal dropout throughout.” Because of that, the finding that drain placement for the pancreaticoduodenectomy “was definitive,” whereas the PANDRA trial was subject to some criticisms. The screening and randomization processes in PANDRA have been criticized because 3,200 patients were eligible for enrollment, suggesting a screening bias, Dr. Van Buren said. In addition, drains were placed in 21% of patients who were allocated to the no-drain group, suggesting surgeons deviated from the protocol in higher-risk situations, resulting in additional selection bias. This implies PANDRA was more of a selective draining trial, he said.

Dr. Van Buren and Dr. Yeo reported having no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in Annals of Surgery pending editorial review.

 

PHILADELPHIA – A randomized multicenter trial that compared patients who had distal pancreatectomy with and without routine peritoneal drainage found no appreciable difference in the complication rates between the two groups, the lead investigator reported at the annual meeting of the American Surgical Association here.

“This randomized, prospective, multicenter trial provides Level 1 data that clinical outcomes are comparable in distal pancreatectomy with or without intraperitoneal drainage,” George Van Buren II, MD, FACS, of Baylor College of Medicine in Houston, said in reporting the results. “Distal pancreatectomy without routine intraperitoneal drainage is an acceptable practice.”

The trial randomized 202 patients to the intraperitoneal drainage group and 197 to the nondrainage group. The groups were well matched in terms of patients who dropped out because of metastatic disease or other reason, as well as demographics and operative data. “They were equally matched for laparoscopic vs. open, equally matched for vascular resection, equally matched for pancreatic texture and duct size, equally matched for method of transection, equally matched for operative time and blood loss and equally matched for surgical pathology,” Dr. Van Buren said.

The primary outcome was frequency of grade 2 complications or greater, which occurred in 44% (76) of the drainage group and 42% (72) of the nondrainage group (P = .804). “Similarly, the groups were equal for grade 3 severe complications as well as median complication severity and median number of complications,” Dr. Van Buren said. The rates of complications of grade 3 or greater were 29% (51) for the drainage group and 26% (44) for the nondrainage group (P = .477). Ninety-day mortality also was similar between the two groups: None died in the drainage group and two (1%) died in the nondrainage group (P = .24).

Drilling down into types of complications, Dr. Van Buren added that rates were similar across the board. “There was no difference in clinically relevant postoperative pancreatic fistula between the drain and no-drain group,” he said. “There was no difference in intra-abdominal abscess, no difference in the rates of postoperative imaging, no difference in the rates of postoperative percutaneous drain placements, and there was no difference in readmission or reoperation.”

One outcome that was noticeably different between the two groups was intra-abdominal fluid collections, reported in 9% (15) of the drainage group and 22% (38) of the nondrainage group (P = .0004). “However,” Dr. Van Buren said, “these were asymptomatic.”

In his discussion of the presentation, Charles Yeo, MD, FACS, of Thomas Jefferson University, Philadelphia, said that “the scope and the rigor of this study are impressive and quite laudable” but raised a number of questions, including concerns about the two deaths in the nondrainage group in the context of two other trials: a smaller multicenter trial, coauthored by Dr. Van Buren, that compared postoperative use of drains and nondrainage in pancreaticoduodenectomy but was halted because of eight deaths in the nondrainage group (Ann Surg. 2014;259:605-12); and the German PANDRA trial reported at last year’s ASA meeting that found nondrainage after pancreaticoduodenectomy to be superior to drainage in terms of reintervention and fistula rates.

Dr. Van Buren replied that the first study from Baylor – referenced by Dr. Yeo – involved “well-balanced groups, and they were equally matched and had minimal dropout throughout.” Because of that, the finding that drain placement for the pancreaticoduodenectomy “was definitive,” whereas the PANDRA trial was subject to some criticisms. The screening and randomization processes in PANDRA have been criticized because 3,200 patients were eligible for enrollment, suggesting a screening bias, Dr. Van Buren said. In addition, drains were placed in 21% of patients who were allocated to the no-drain group, suggesting surgeons deviated from the protocol in higher-risk situations, resulting in additional selection bias. This implies PANDRA was more of a selective draining trial, he said.

Dr. Van Buren and Dr. Yeo reported having no financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, is to be published in Annals of Surgery pending editorial review.

 

PHILADELPHIA – The question of how prepared general surgery residents are to operate independently after their training is longstanding, but clear definitions of competency and readiness have been elusive. A consortium of general surgery residencies has developed a metric for assessing surgeon readiness, but what the metric revealed may be a cause for concern for the surgical profession.

Brian C. George, MD, of the University of Michigan, Ann Arbor, reported at the annual meeting of the American Surgical Association on results of a study designed to measure the autonomy and readiness for independent practice of residents at 14 general surgery programs.

“There’s increasing concern that U.S. general surgery residents are not ready to operate independently by the time they graduate,” Dr. George said. “The true scope of this problem is unknown.”

The study found that in the final 6 months of training, 96% of residents were rated competent by their observers to perform a straightforward appendectomy on their own, but only 71% were rated the same for partial colectomy, Dr. George said.

The participating general surgery attendings rated residents according to three scales (J Surg Educ. 2016;73:e118-130):
 

•“Performance” scale to measure readiness for independent practice, with competence defined as practice-ready and exceptional performance.

• “Zwisch” scale, named after Jay Zwischenberger, MD, FACS, of the University of Kentucky, to assess the amount of autonomy granted to a resident by the supervising surgical attending.

• “Complexity” scale to measure the patient-related complexity of the case at hand.

The study used a smartphone-based app, SIMPL, to collect data from September 2015 through December 2016. In evaluating performance, 437 observers provided 8,526 different ratings of 522 residents.

In a subset analysis, the study authors focused on the 132 operations the Surgical Council on Resident Education considers the core procedures of general surgery and found that 77% of fifth-year residents were rated as competent. Further restricting the analysis to residents in their final 6 months of training performing the five most commonly rated core procedures – appendectomy, cholecystectomy, ventral hernia repair, inguinal/femoral hernia repair, and partial colectomy – the researchers found that competency ranged from a high of 96% for appendectomy to a low of 71% for partial colectomy.

“If you combine all five procedures into one category, on average the residents are rated competent 84% of the time during the last 6 months of training,” Dr. George said. “But what’s really interesting – and I think this is probably the most important result for this study – is that looking at just the less-frequently rated core procedures and excluding the top five, residents are deemed competent in the last 6 months of training for 74% of those observed procedures.”

According to the Zwisch” scale to measure autonomy, residents in their last 6 months of training displayed what Dr. George termed “meaningful autonomy” in 77% of their observed operations for the core procedures. “Interestingly,” he added, “they were observed to have maximum autonomy, which is the supervision-only level, for 33% of all observed procedures.”

The researchers did an adjusted analysis to account for confounding factors such as the stringency of individual raters and patient complexity. “Using this type of analysis, the likelihood that a typical trainee rated by a typical attendee would be deemed competent by the end of training for a relatively straightforward laparoscopy appendectomy is 97%,” Dr. George said. “For a difficult laparoscopic appendectomy, by the end of training, they’re likely to be deemed competent 92% of time.” In the adjusted analysis, for a straightforward partial colectomy the raters predicted trainees to be competent 91.8% of time, but only 81.8% of the time for a complicated partial colectomy. “For less-frequently performed core procedures, there are many for which residents are likely to be deemed competent at a much lower level,” Dr. George added.

In discussing the study, Ara Darzi, MD, of St. Mary’s Hospital, London, called the methodology “unique and commendable,” and asked “Would you make the case to say we should increase the number of years of trainees from PG5 to PG6 or at least make your fellowships compulsory?”

Dr. George answered that 80% of general surgery residents already go into fellowships. “Whether it’s required or not is above my pay grade,” he said. “I hope not. Five years is already a big ask for a lot of medical students who are considering this profession. If we increase the training requirements, we’re going to have a supply problem that we will then need to address. We will be trading one problem for another.” He later added “The 20,000 hours of surgical residency should be enough to train a general surgeon to competence – its up to us to figure out how.”

The following organizations supported the research: American Board of Surgery, Association for Surgical Education, Association for Program Directors in Surgery, Massachusetts General Hospital, Northwestern University, Indiana University, and the members of the Procedural Learning and Safety Collaborative.

Neither Dr. George nor Dr. Darzi had any relevant financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is to be published in Annals of Surgery pending editorial review.

 

PHILADELPHIA – The question of how prepared general surgery residents are to operate independently after their training is longstanding, but clear definitions of competency and readiness have been elusive. A consortium of general surgery residencies has developed a metric for assessing surgeon readiness, but what the metric revealed may be a cause for concern for the surgical profession.

Brian C. George, MD, of the University of Michigan, Ann Arbor, reported at the annual meeting of the American Surgical Association on results of a study designed to measure the autonomy and readiness for independent practice of residents at 14 general surgery programs.

“There’s increasing concern that U.S. general surgery residents are not ready to operate independently by the time they graduate,” Dr. George said. “The true scope of this problem is unknown.”

The study found that in the final 6 months of training, 96% of residents were rated competent by their observers to perform a straightforward appendectomy on their own, but only 71% were rated the same for partial colectomy, Dr. George said.

The participating general surgery attendings rated residents according to three scales (J Surg Educ. 2016;73:e118-130):
 

•“Performance” scale to measure readiness for independent practice, with competence defined as practice-ready and exceptional performance.

• “Zwisch” scale, named after Jay Zwischenberger, MD, FACS, of the University of Kentucky, to assess the amount of autonomy granted to a resident by the supervising surgical attending.

• “Complexity” scale to measure the patient-related complexity of the case at hand.

The study used a smartphone-based app, SIMPL, to collect data from September 2015 through December 2016. In evaluating performance, 437 observers provided 8,526 different ratings of 522 residents.

In a subset analysis, the study authors focused on the 132 operations the Surgical Council on Resident Education considers the core procedures of general surgery and found that 77% of fifth-year residents were rated as competent. Further restricting the analysis to residents in their final 6 months of training performing the five most commonly rated core procedures – appendectomy, cholecystectomy, ventral hernia repair, inguinal/femoral hernia repair, and partial colectomy – the researchers found that competency ranged from a high of 96% for appendectomy to a low of 71% for partial colectomy.

“If you combine all five procedures into one category, on average the residents are rated competent 84% of the time during the last 6 months of training,” Dr. George said. “But what’s really interesting – and I think this is probably the most important result for this study – is that looking at just the less-frequently rated core procedures and excluding the top five, residents are deemed competent in the last 6 months of training for 74% of those observed procedures.”

According to the Zwisch” scale to measure autonomy, residents in their last 6 months of training displayed what Dr. George termed “meaningful autonomy” in 77% of their observed operations for the core procedures. “Interestingly,” he added, “they were observed to have maximum autonomy, which is the supervision-only level, for 33% of all observed procedures.”

The researchers did an adjusted analysis to account for confounding factors such as the stringency of individual raters and patient complexity. “Using this type of analysis, the likelihood that a typical trainee rated by a typical attendee would be deemed competent by the end of training for a relatively straightforward laparoscopy appendectomy is 97%,” Dr. George said. “For a difficult laparoscopic appendectomy, by the end of training, they’re likely to be deemed competent 92% of time.” In the adjusted analysis, for a straightforward partial colectomy the raters predicted trainees to be competent 91.8% of time, but only 81.8% of the time for a complicated partial colectomy. “For less-frequently performed core procedures, there are many for which residents are likely to be deemed competent at a much lower level,” Dr. George added.

In discussing the study, Ara Darzi, MD, of St. Mary’s Hospital, London, called the methodology “unique and commendable,” and asked “Would you make the case to say we should increase the number of years of trainees from PG5 to PG6 or at least make your fellowships compulsory?”

Dr. George answered that 80% of general surgery residents already go into fellowships. “Whether it’s required or not is above my pay grade,” he said. “I hope not. Five years is already a big ask for a lot of medical students who are considering this profession. If we increase the training requirements, we’re going to have a supply problem that we will then need to address. We will be trading one problem for another.” He later added “The 20,000 hours of surgical residency should be enough to train a general surgeon to competence – its up to us to figure out how.”

The following organizations supported the research: American Board of Surgery, Association for Surgical Education, Association for Program Directors in Surgery, Massachusetts General Hospital, Northwestern University, Indiana University, and the members of the Procedural Learning and Safety Collaborative.

Neither Dr. George nor Dr. Darzi had any relevant financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is to be published in Annals of Surgery pending editorial review.

 

PHILADELPHIA – The question of how prepared general surgery residents are to operate independently after their training is longstanding, but clear definitions of competency and readiness have been elusive. A consortium of general surgery residencies has developed a metric for assessing surgeon readiness, but what the metric revealed may be a cause for concern for the surgical profession.

Brian C. George, MD, of the University of Michigan, Ann Arbor, reported at the annual meeting of the American Surgical Association on results of a study designed to measure the autonomy and readiness for independent practice of residents at 14 general surgery programs.

“There’s increasing concern that U.S. general surgery residents are not ready to operate independently by the time they graduate,” Dr. George said. “The true scope of this problem is unknown.”

The study found that in the final 6 months of training, 96% of residents were rated competent by their observers to perform a straightforward appendectomy on their own, but only 71% were rated the same for partial colectomy, Dr. George said.

The participating general surgery attendings rated residents according to three scales (J Surg Educ. 2016;73:e118-130):
 

•“Performance” scale to measure readiness for independent practice, with competence defined as practice-ready and exceptional performance.

• “Zwisch” scale, named after Jay Zwischenberger, MD, FACS, of the University of Kentucky, to assess the amount of autonomy granted to a resident by the supervising surgical attending.

• “Complexity” scale to measure the patient-related complexity of the case at hand.

The study used a smartphone-based app, SIMPL, to collect data from September 2015 through December 2016. In evaluating performance, 437 observers provided 8,526 different ratings of 522 residents.

In a subset analysis, the study authors focused on the 132 operations the Surgical Council on Resident Education considers the core procedures of general surgery and found that 77% of fifth-year residents were rated as competent. Further restricting the analysis to residents in their final 6 months of training performing the five most commonly rated core procedures – appendectomy, cholecystectomy, ventral hernia repair, inguinal/femoral hernia repair, and partial colectomy – the researchers found that competency ranged from a high of 96% for appendectomy to a low of 71% for partial colectomy.

“If you combine all five procedures into one category, on average the residents are rated competent 84% of the time during the last 6 months of training,” Dr. George said. “But what’s really interesting – and I think this is probably the most important result for this study – is that looking at just the less-frequently rated core procedures and excluding the top five, residents are deemed competent in the last 6 months of training for 74% of those observed procedures.”

According to the Zwisch” scale to measure autonomy, residents in their last 6 months of training displayed what Dr. George termed “meaningful autonomy” in 77% of their observed operations for the core procedures. “Interestingly,” he added, “they were observed to have maximum autonomy, which is the supervision-only level, for 33% of all observed procedures.”

The researchers did an adjusted analysis to account for confounding factors such as the stringency of individual raters and patient complexity. “Using this type of analysis, the likelihood that a typical trainee rated by a typical attendee would be deemed competent by the end of training for a relatively straightforward laparoscopy appendectomy is 97%,” Dr. George said. “For a difficult laparoscopic appendectomy, by the end of training, they’re likely to be deemed competent 92% of time.” In the adjusted analysis, for a straightforward partial colectomy the raters predicted trainees to be competent 91.8% of time, but only 81.8% of the time for a complicated partial colectomy. “For less-frequently performed core procedures, there are many for which residents are likely to be deemed competent at a much lower level,” Dr. George added.

In discussing the study, Ara Darzi, MD, of St. Mary’s Hospital, London, called the methodology “unique and commendable,” and asked “Would you make the case to say we should increase the number of years of trainees from PG5 to PG6 or at least make your fellowships compulsory?”

Dr. George answered that 80% of general surgery residents already go into fellowships. “Whether it’s required or not is above my pay grade,” he said. “I hope not. Five years is already a big ask for a lot of medical students who are considering this profession. If we increase the training requirements, we’re going to have a supply problem that we will then need to address. We will be trading one problem for another.” He later added “The 20,000 hours of surgical residency should be enough to train a general surgeon to competence – its up to us to figure out how.”

The following organizations supported the research: American Board of Surgery, Association for Surgical Education, Association for Program Directors in Surgery, Massachusetts General Hospital, Northwestern University, Indiana University, and the members of the Procedural Learning and Safety Collaborative.

Neither Dr. George nor Dr. Darzi had any relevant financial disclosures.

The complete manuscript of this study and its presentation at the American Surgical Association’s 137th Annual Meeting, April 2017, in Philadelphia, Pennsylvania, is to be published in Annals of Surgery pending editorial review.