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In era of infliximab, ulcerative colitis surgical outcomes worsen
WASHINGTON – The era of powerful biologics has led to unforeseen surgical outcomes in patients with ulcerative colitis.
Patients undergoing surgery for ulcerative colitis now are 38% more likely to die in the hospital than they were 15 years ago, before infliximab and other biologics were adopted as medical therapy for the disease. A database review covering 18 years found that other surgical outcomes are worse, too, Jonathan Abelson, MD, said at the annual clinical congress of the American College of Surgeons.
“These very powerful agents could be completely eliminating the need for surgery in patients with mild disease, leaving surgery for those who have very advanced disease and didn’t respond well to medical therapy,” said Dr. Abelson, a clinical research fellow at New York–Presbyterian Hospital, N.Y. “We are operating now only on patients with very severe disease, not the wider range of patients we had 15 years ago, when there weren’t as effective medical options.”
He and his colleagues used the New York Statewide Planning and Research Cooperative System (SPARCS) database to identify 7,070 patients who had undergone bowel resection for ulcerative colitis during two epochs: prebiologics (1995-2005) and postbiologics (2006-2013). The cohorts were about evenly split in numbers.
There were some statistically significant differences in baseline characteristics. Patients in epoch 2 were about a year older (51 vs. 50 years). Significantly more of them had at least two major comorbidities (28% vs. 18%). Minimally invasive surgery was significantly more common in epoch 2 (28% vs. 3%).
Significantly more surgeries in epoch 2 were staged into three or more procedures (14% vs. 9%). This finding probably reflects the level of disease severity in those presenting for surgery or the fact that they underwent surgery after recently receiving biologics, Dr. Abelson said.
“One of the limits of this study is that we don’t know exactly the reasons for these one-, two-, or three-stage surgeries. The theory is that patients who were more ill at presentation are more likely to have a multistaged surgery. Another reason could be that if they are on these powerful immunosuppressive regimens, the surgeon might be concerned about not healing well from a definitive one- or two-stage surgery.”
He then conducted a multivariate analysis that controlled for baseline factors, including a variety of individual comorbid conditions. In this analysis, patients in epoch 2 were 38% more likely to die in the hospital and 51% more likely to experience a major postoperative event, like shock, pulmonary embolism, stroke, or heart attack. The chance of a surgical complication was increased by 39%, and these patients were 25% more likely to need a transfusion during surgery than those from epoch 1.
The poorer outcomes held for an at least an entire year after surgery, Dr. Abelson said. At 1 year, patients in epoch 2 were 36% more likely to have a readmission than those in epoch 1. Major events and procedural complications were both 46% more likely. Patients were also 36% more likely to require an additional procedure.
“These are not the outcomes we want to see, especially in this era when our surgical techniques have improved so much,” Dr. Abelson said. “If what this represents, though, is that we are now operating on a higher-risk population, we can’t just say, ‘Well, that’s how it’s going to be.’ We need to figure out how to minimize morbidity and mortality in this high-risk patient population.”
One goal, he suggested, would be to assess response to a biologic regimen earlier in the hopes of determining who will respond well, and moving ahead with surgery in those who don’t.
This is a tough sell for patients, he said.
“There is a big fear of this surgery. It usually requires a temporary ileostomy and a stoma bag, and patients are terrified of that. There have been a few studies demonstrating that earlier referral to surgery improves quality of life; living with advanced ulcerative colitis can be extremely difficult and patients often feel a lot better after we remove their diseased colon. But getting there is a challenge.”
Dr. Abelson had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
WASHINGTON – The era of powerful biologics has led to unforeseen surgical outcomes in patients with ulcerative colitis.
Patients undergoing surgery for ulcerative colitis now are 38% more likely to die in the hospital than they were 15 years ago, before infliximab and other biologics were adopted as medical therapy for the disease. A database review covering 18 years found that other surgical outcomes are worse, too, Jonathan Abelson, MD, said at the annual clinical congress of the American College of Surgeons.
“These very powerful agents could be completely eliminating the need for surgery in patients with mild disease, leaving surgery for those who have very advanced disease and didn’t respond well to medical therapy,” said Dr. Abelson, a clinical research fellow at New York–Presbyterian Hospital, N.Y. “We are operating now only on patients with very severe disease, not the wider range of patients we had 15 years ago, when there weren’t as effective medical options.”
He and his colleagues used the New York Statewide Planning and Research Cooperative System (SPARCS) database to identify 7,070 patients who had undergone bowel resection for ulcerative colitis during two epochs: prebiologics (1995-2005) and postbiologics (2006-2013). The cohorts were about evenly split in numbers.
There were some statistically significant differences in baseline characteristics. Patients in epoch 2 were about a year older (51 vs. 50 years). Significantly more of them had at least two major comorbidities (28% vs. 18%). Minimally invasive surgery was significantly more common in epoch 2 (28% vs. 3%).
Significantly more surgeries in epoch 2 were staged into three or more procedures (14% vs. 9%). This finding probably reflects the level of disease severity in those presenting for surgery or the fact that they underwent surgery after recently receiving biologics, Dr. Abelson said.
“One of the limits of this study is that we don’t know exactly the reasons for these one-, two-, or three-stage surgeries. The theory is that patients who were more ill at presentation are more likely to have a multistaged surgery. Another reason could be that if they are on these powerful immunosuppressive regimens, the surgeon might be concerned about not healing well from a definitive one- or two-stage surgery.”
He then conducted a multivariate analysis that controlled for baseline factors, including a variety of individual comorbid conditions. In this analysis, patients in epoch 2 were 38% more likely to die in the hospital and 51% more likely to experience a major postoperative event, like shock, pulmonary embolism, stroke, or heart attack. The chance of a surgical complication was increased by 39%, and these patients were 25% more likely to need a transfusion during surgery than those from epoch 1.
The poorer outcomes held for an at least an entire year after surgery, Dr. Abelson said. At 1 year, patients in epoch 2 were 36% more likely to have a readmission than those in epoch 1. Major events and procedural complications were both 46% more likely. Patients were also 36% more likely to require an additional procedure.
“These are not the outcomes we want to see, especially in this era when our surgical techniques have improved so much,” Dr. Abelson said. “If what this represents, though, is that we are now operating on a higher-risk population, we can’t just say, ‘Well, that’s how it’s going to be.’ We need to figure out how to minimize morbidity and mortality in this high-risk patient population.”
One goal, he suggested, would be to assess response to a biologic regimen earlier in the hopes of determining who will respond well, and moving ahead with surgery in those who don’t.
This is a tough sell for patients, he said.
“There is a big fear of this surgery. It usually requires a temporary ileostomy and a stoma bag, and patients are terrified of that. There have been a few studies demonstrating that earlier referral to surgery improves quality of life; living with advanced ulcerative colitis can be extremely difficult and patients often feel a lot better after we remove their diseased colon. But getting there is a challenge.”
Dr. Abelson had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
WASHINGTON – The era of powerful biologics has led to unforeseen surgical outcomes in patients with ulcerative colitis.
Patients undergoing surgery for ulcerative colitis now are 38% more likely to die in the hospital than they were 15 years ago, before infliximab and other biologics were adopted as medical therapy for the disease. A database review covering 18 years found that other surgical outcomes are worse, too, Jonathan Abelson, MD, said at the annual clinical congress of the American College of Surgeons.
“These very powerful agents could be completely eliminating the need for surgery in patients with mild disease, leaving surgery for those who have very advanced disease and didn’t respond well to medical therapy,” said Dr. Abelson, a clinical research fellow at New York–Presbyterian Hospital, N.Y. “We are operating now only on patients with very severe disease, not the wider range of patients we had 15 years ago, when there weren’t as effective medical options.”
He and his colleagues used the New York Statewide Planning and Research Cooperative System (SPARCS) database to identify 7,070 patients who had undergone bowel resection for ulcerative colitis during two epochs: prebiologics (1995-2005) and postbiologics (2006-2013). The cohorts were about evenly split in numbers.
There were some statistically significant differences in baseline characteristics. Patients in epoch 2 were about a year older (51 vs. 50 years). Significantly more of them had at least two major comorbidities (28% vs. 18%). Minimally invasive surgery was significantly more common in epoch 2 (28% vs. 3%).
Significantly more surgeries in epoch 2 were staged into three or more procedures (14% vs. 9%). This finding probably reflects the level of disease severity in those presenting for surgery or the fact that they underwent surgery after recently receiving biologics, Dr. Abelson said.
“One of the limits of this study is that we don’t know exactly the reasons for these one-, two-, or three-stage surgeries. The theory is that patients who were more ill at presentation are more likely to have a multistaged surgery. Another reason could be that if they are on these powerful immunosuppressive regimens, the surgeon might be concerned about not healing well from a definitive one- or two-stage surgery.”
He then conducted a multivariate analysis that controlled for baseline factors, including a variety of individual comorbid conditions. In this analysis, patients in epoch 2 were 38% more likely to die in the hospital and 51% more likely to experience a major postoperative event, like shock, pulmonary embolism, stroke, or heart attack. The chance of a surgical complication was increased by 39%, and these patients were 25% more likely to need a transfusion during surgery than those from epoch 1.
The poorer outcomes held for an at least an entire year after surgery, Dr. Abelson said. At 1 year, patients in epoch 2 were 36% more likely to have a readmission than those in epoch 1. Major events and procedural complications were both 46% more likely. Patients were also 36% more likely to require an additional procedure.
“These are not the outcomes we want to see, especially in this era when our surgical techniques have improved so much,” Dr. Abelson said. “If what this represents, though, is that we are now operating on a higher-risk population, we can’t just say, ‘Well, that’s how it’s going to be.’ We need to figure out how to minimize morbidity and mortality in this high-risk patient population.”
One goal, he suggested, would be to assess response to a biologic regimen earlier in the hopes of determining who will respond well, and moving ahead with surgery in those who don’t.
This is a tough sell for patients, he said.
“There is a big fear of this surgery. It usually requires a temporary ileostomy and a stoma bag, and patients are terrified of that. There have been a few studies demonstrating that earlier referral to surgery improves quality of life; living with advanced ulcerative colitis can be extremely difficult and patients often feel a lot better after we remove their diseased colon. But getting there is a challenge.”
Dr. Abelson had no financial disclosures.
[email protected]
On Twitter @Alz_Gal
AT THE ACS CLINICAL CONGRESS
Key clinical point:
Major finding: Patients are 38% more likely to die in the hospital than they were 15 years ago.
Data source: The 18-year database review comprised more than 7,000 surgeries.
Disclosures: Dr. Abelson had no financial disclosures.
Surgical infections, early discharge hike readmissions in extrahepatic cholangiocarcinoma
WASHINGTON – Hospital readmissions are common after resection of extrahepatic cholangiocarcinoma, with about 20% of patients returning in the first 90 days after surgery.
Two factors – surgical site infections and an abbreviated length of stay – both quadrupled the risk of readmission, Michail Mavros, MD, said at the American College of Surgeons Clinical Congress.
“Surgeons are scrutinized over length of stay and, as a result, these fast-track recovery pathways are increasingly important. Readmission rates are being used as a quality metric and performance indicator, and tied to reimbursement. But our data suggest that we should be somewhat cautious in implementing those with this surgery. The patient may look great with good pain control, and be eating and ambulating by day 4 or 5, but it may be premature to discharge at that point, and safer to wait a little longer. The financial penalty for readmission is probably not worth that small bonus we get for early discharge.”
The study comprised 422 patients who underwent resection with curative intent for extrahepatic cholangiocarcinoma. This is a rare tumor with about 5,000 cases presenting each year. Dr. Mavros and his colleagues extracted their data from the U.S. Extrahepatic Cholangiocarcinoma Collaborative. The primary outcomes were 30- and 90-day readmission rates.
The patients’ median age was 67 years. About a third had mild comorbidities with an American Society of Anesthesiologist (ASA) comorbidity class of 1-2. The rest had moderate to severe comorbidities (ASA class 3-4). Hypertension was common (48%); 18% had diabetes.
Tumor location was split almost equally between distal and hilar; the median tumor size was 2.3 cm.
Final margins were positive in 28% and half of the cohort had positive regional lymph nodes.
The procedures were quite varied, and included common bile duct resection (18%); hepatectomy plus common bile duct resection (40%); and Whipple procedure (42%). The median estimated blood loss was 500 cc; 28% of the cohort required transfusion with packed red blood cells and 8% with fresh frozen plasma.
Postoperative complications were common (63%), with half of those being classed as serious. Infectious complications were most common, including superficial (11%), deep (7%), and organ space infections (16%).
Bile leaks occurred in 4% of cases. Reoperations were necessary in 7%. The 30-day mortality was 4.5% and 90-day mortality, 8%.The median length of stay was 8 days but this ranged from 7 to 18 days.
The 30-day readmission rate was 19% and the 90-day readmission rate was 23%. Most readmissions occurred fairly quickly – the median time to readmission was 12 days, with a range of 6-24 days.
The investigators conducted a multivariate analysis to determine independent predictors of readmission. The strongest predictors were any surgical complications (odds ratio, 8.4); organ-space infection (OR, 4.5); and length of stay of 8 days or less (OR, 4.3). Other predictors were advancing age (OR, 1.5 for each 10 years) and having had a liver resection (OR, 2.0).
“It’s clear from these results that avoidance of complications, especially infectious complications, may improve readmission rates dramatically,” Dr. Mavros said. “We would advise caution in implementing any fast-track protocols with these patients, given the finding that early discharge was associated with a higher rate of readmission.”
Dr. Mavros had no financial disclosures.
[email protected]
On Twitter @alz_gal
WASHINGTON – Hospital readmissions are common after resection of extrahepatic cholangiocarcinoma, with about 20% of patients returning in the first 90 days after surgery.
Two factors – surgical site infections and an abbreviated length of stay – both quadrupled the risk of readmission, Michail Mavros, MD, said at the American College of Surgeons Clinical Congress.
“Surgeons are scrutinized over length of stay and, as a result, these fast-track recovery pathways are increasingly important. Readmission rates are being used as a quality metric and performance indicator, and tied to reimbursement. But our data suggest that we should be somewhat cautious in implementing those with this surgery. The patient may look great with good pain control, and be eating and ambulating by day 4 or 5, but it may be premature to discharge at that point, and safer to wait a little longer. The financial penalty for readmission is probably not worth that small bonus we get for early discharge.”
The study comprised 422 patients who underwent resection with curative intent for extrahepatic cholangiocarcinoma. This is a rare tumor with about 5,000 cases presenting each year. Dr. Mavros and his colleagues extracted their data from the U.S. Extrahepatic Cholangiocarcinoma Collaborative. The primary outcomes were 30- and 90-day readmission rates.
The patients’ median age was 67 years. About a third had mild comorbidities with an American Society of Anesthesiologist (ASA) comorbidity class of 1-2. The rest had moderate to severe comorbidities (ASA class 3-4). Hypertension was common (48%); 18% had diabetes.
Tumor location was split almost equally between distal and hilar; the median tumor size was 2.3 cm.
Final margins were positive in 28% and half of the cohort had positive regional lymph nodes.
The procedures were quite varied, and included common bile duct resection (18%); hepatectomy plus common bile duct resection (40%); and Whipple procedure (42%). The median estimated blood loss was 500 cc; 28% of the cohort required transfusion with packed red blood cells and 8% with fresh frozen plasma.
Postoperative complications were common (63%), with half of those being classed as serious. Infectious complications were most common, including superficial (11%), deep (7%), and organ space infections (16%).
Bile leaks occurred in 4% of cases. Reoperations were necessary in 7%. The 30-day mortality was 4.5% and 90-day mortality, 8%.The median length of stay was 8 days but this ranged from 7 to 18 days.
The 30-day readmission rate was 19% and the 90-day readmission rate was 23%. Most readmissions occurred fairly quickly – the median time to readmission was 12 days, with a range of 6-24 days.
The investigators conducted a multivariate analysis to determine independent predictors of readmission. The strongest predictors were any surgical complications (odds ratio, 8.4); organ-space infection (OR, 4.5); and length of stay of 8 days or less (OR, 4.3). Other predictors were advancing age (OR, 1.5 for each 10 years) and having had a liver resection (OR, 2.0).
“It’s clear from these results that avoidance of complications, especially infectious complications, may improve readmission rates dramatically,” Dr. Mavros said. “We would advise caution in implementing any fast-track protocols with these patients, given the finding that early discharge was associated with a higher rate of readmission.”
Dr. Mavros had no financial disclosures.
[email protected]
On Twitter @alz_gal
WASHINGTON – Hospital readmissions are common after resection of extrahepatic cholangiocarcinoma, with about 20% of patients returning in the first 90 days after surgery.
Two factors – surgical site infections and an abbreviated length of stay – both quadrupled the risk of readmission, Michail Mavros, MD, said at the American College of Surgeons Clinical Congress.
“Surgeons are scrutinized over length of stay and, as a result, these fast-track recovery pathways are increasingly important. Readmission rates are being used as a quality metric and performance indicator, and tied to reimbursement. But our data suggest that we should be somewhat cautious in implementing those with this surgery. The patient may look great with good pain control, and be eating and ambulating by day 4 or 5, but it may be premature to discharge at that point, and safer to wait a little longer. The financial penalty for readmission is probably not worth that small bonus we get for early discharge.”
The study comprised 422 patients who underwent resection with curative intent for extrahepatic cholangiocarcinoma. This is a rare tumor with about 5,000 cases presenting each year. Dr. Mavros and his colleagues extracted their data from the U.S. Extrahepatic Cholangiocarcinoma Collaborative. The primary outcomes were 30- and 90-day readmission rates.
The patients’ median age was 67 years. About a third had mild comorbidities with an American Society of Anesthesiologist (ASA) comorbidity class of 1-2. The rest had moderate to severe comorbidities (ASA class 3-4). Hypertension was common (48%); 18% had diabetes.
Tumor location was split almost equally between distal and hilar; the median tumor size was 2.3 cm.
Final margins were positive in 28% and half of the cohort had positive regional lymph nodes.
The procedures were quite varied, and included common bile duct resection (18%); hepatectomy plus common bile duct resection (40%); and Whipple procedure (42%). The median estimated blood loss was 500 cc; 28% of the cohort required transfusion with packed red blood cells and 8% with fresh frozen plasma.
Postoperative complications were common (63%), with half of those being classed as serious. Infectious complications were most common, including superficial (11%), deep (7%), and organ space infections (16%).
Bile leaks occurred in 4% of cases. Reoperations were necessary in 7%. The 30-day mortality was 4.5% and 90-day mortality, 8%.The median length of stay was 8 days but this ranged from 7 to 18 days.
The 30-day readmission rate was 19% and the 90-day readmission rate was 23%. Most readmissions occurred fairly quickly – the median time to readmission was 12 days, with a range of 6-24 days.
The investigators conducted a multivariate analysis to determine independent predictors of readmission. The strongest predictors were any surgical complications (odds ratio, 8.4); organ-space infection (OR, 4.5); and length of stay of 8 days or less (OR, 4.3). Other predictors were advancing age (OR, 1.5 for each 10 years) and having had a liver resection (OR, 2.0).
“It’s clear from these results that avoidance of complications, especially infectious complications, may improve readmission rates dramatically,” Dr. Mavros said. “We would advise caution in implementing any fast-track protocols with these patients, given the finding that early discharge was associated with a higher rate of readmission.”
Dr. Mavros had no financial disclosures.
[email protected]
On Twitter @alz_gal
Key clinical point:
Major finding: Organ space infections and a shorter length of stay both quadrupled the risk of a readmission.
Data source: The database review comprised 422 patients.
Disclosures: Dr. Mavros had no financial disclosures.
TBI scoring system predicts outcomes with only initial head CT findings
WASHINGTON – A simple 8-point scoring system based on head CT accurately predicts mortality, morbidity, and even discharge disposition among patients with a traumatic brain injury (TBI).
In its first clinical study, the Cranial CT Scoring Tool (CCTST) predictive power rivaled both the Glasgow Coma Score (GCS) and the Abbreviated Injury Scale (AIS), Ronnie Mubang, MD, said at the American College of Surgeons’ Clinical Congress.
In addition to adding valuable prognostic information, the CCTST is quick, easy, and completely objective, said Dr. Mubang, of St. Luke’s University Health Network, Bethlehem, Pa.
“The near-universal head CT makes this tool valuable in immediate prognostication and clinical risk assessment for physicians, patients and families. It can serve as a potential adjunct to the Glasgow score and Abbreviated Injury Score for risk assessment,” he said. Of note, the final AIS-Head may not be available until relatively late in the patient’s clinical course, and the GCS has important limitations in terms of outcome prognostication.
The CCTST is an 8-point assessment with one point assigned to each individual cranial CT finding: epidural hematoma, subdural hematoma, subarachnoid hemorrhage, intraventricular hemorrhage, cerebral contusion/ intraparenchymal hemorrhage, skull fracture, brain edema/herniation, and midline shift. The ninth factor is the presence of an external injury to the head.
Dr. Mubang, a fourth-year surgical resident, and his colleagues retrospectively examined the CCTST in 620 patients included in an administrative database at the three-hospital St. Luke’s Regional Trauma Network. Patients were older than 45 years. Half of them underwent neurosurgical intervention within 24 hours of admission and were matched with 310 patients who did not require neurosurgery. The primary clinical endpoint was mortality from head injury. Secondary endpoints included morbidity, hospital and intensive care unit length of stay, and post-discharge destination.
The mean age of the cohort was 73 years. Almost all injuries (99%) were due to blunt force trauma. The mean GCS was 11; the mean Injury Severity Score (ISS) was 24; and the mean AIS – Head score was 4.6, indicating severe to critical level of TBI. Midline shift was significantly greater in the surgical group (0.74 cm vs. 0.29 cm).
Several CT findings were significantly more common in the surgical group, including subdural hematoma (96% vs. 7%); midline shift (74% vs. 29%); brain edema (39% vs. 23%); and epidural hematoma (10% vs. 3%).
As the total CCTST score increased, outcomes worsened accordingly, Dr. Mubang said. Patients with a score of 1-2 had a 20%-30% chance of complications and an approximately 10% chance of injury-related mortality. Patients with higher scores (7-8) had a 60%-75% chance of morbidity and a 55% chance of mortality.
Rising scores correlated well with both hospital and ICU length of stay, with a score of 1-2 associated with a 3-day average stay, and a score of 8 associated with stays exceeding 10 days. The same pattern occurred with overall hospital length of stay: the lowest scores were associated with a stay of about a week, while the highest scores with a stay exceeding 2 weeks.
CCTST was highly associated with discharge disposition. With every additional point, the chance of discharge to home fell. While the majority of patients with scores below 2 were discharged home, no patients with a score of 8 were discharged home.
Finally, the investigators performed a multivariate analysis that controlled for sex; GCS, ISS, and AIS-head scores; time in the trauma bay; and preinjury anticoagulation treatment. The CCTST score was strongly associated with patient mortality (OR 1.31), rivaling both GCS (OR, 1.14) and AIS-Head (OR, 2.68). Neither ISS nor pre-injury anticoagulation predicted mortality. CCTST was also the only variable independently associated with the need for neurosurgical intervention.
The team is planning a multicenter retrospective validation, followed by a prospective observational study in the next 2 years, according to Dr. Stan Stawicki, the senior investigator, also with St. Luke’s. “CCTST offers potential promise to add much needed granularity to our existing TBI clinical assessment paradigm that continues to rely heavily on AIS-Head and GCS,” he said.
Neither Dr. Mubang nor Dr. Stawicki had any financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @Alz_Gal
WASHINGTON – A simple 8-point scoring system based on head CT accurately predicts mortality, morbidity, and even discharge disposition among patients with a traumatic brain injury (TBI).
In its first clinical study, the Cranial CT Scoring Tool (CCTST) predictive power rivaled both the Glasgow Coma Score (GCS) and the Abbreviated Injury Scale (AIS), Ronnie Mubang, MD, said at the American College of Surgeons’ Clinical Congress.
In addition to adding valuable prognostic information, the CCTST is quick, easy, and completely objective, said Dr. Mubang, of St. Luke’s University Health Network, Bethlehem, Pa.
“The near-universal head CT makes this tool valuable in immediate prognostication and clinical risk assessment for physicians, patients and families. It can serve as a potential adjunct to the Glasgow score and Abbreviated Injury Score for risk assessment,” he said. Of note, the final AIS-Head may not be available until relatively late in the patient’s clinical course, and the GCS has important limitations in terms of outcome prognostication.
The CCTST is an 8-point assessment with one point assigned to each individual cranial CT finding: epidural hematoma, subdural hematoma, subarachnoid hemorrhage, intraventricular hemorrhage, cerebral contusion/ intraparenchymal hemorrhage, skull fracture, brain edema/herniation, and midline shift. The ninth factor is the presence of an external injury to the head.
Dr. Mubang, a fourth-year surgical resident, and his colleagues retrospectively examined the CCTST in 620 patients included in an administrative database at the three-hospital St. Luke’s Regional Trauma Network. Patients were older than 45 years. Half of them underwent neurosurgical intervention within 24 hours of admission and were matched with 310 patients who did not require neurosurgery. The primary clinical endpoint was mortality from head injury. Secondary endpoints included morbidity, hospital and intensive care unit length of stay, and post-discharge destination.
The mean age of the cohort was 73 years. Almost all injuries (99%) were due to blunt force trauma. The mean GCS was 11; the mean Injury Severity Score (ISS) was 24; and the mean AIS – Head score was 4.6, indicating severe to critical level of TBI. Midline shift was significantly greater in the surgical group (0.74 cm vs. 0.29 cm).
Several CT findings were significantly more common in the surgical group, including subdural hematoma (96% vs. 7%); midline shift (74% vs. 29%); brain edema (39% vs. 23%); and epidural hematoma (10% vs. 3%).
As the total CCTST score increased, outcomes worsened accordingly, Dr. Mubang said. Patients with a score of 1-2 had a 20%-30% chance of complications and an approximately 10% chance of injury-related mortality. Patients with higher scores (7-8) had a 60%-75% chance of morbidity and a 55% chance of mortality.
Rising scores correlated well with both hospital and ICU length of stay, with a score of 1-2 associated with a 3-day average stay, and a score of 8 associated with stays exceeding 10 days. The same pattern occurred with overall hospital length of stay: the lowest scores were associated with a stay of about a week, while the highest scores with a stay exceeding 2 weeks.
CCTST was highly associated with discharge disposition. With every additional point, the chance of discharge to home fell. While the majority of patients with scores below 2 were discharged home, no patients with a score of 8 were discharged home.
Finally, the investigators performed a multivariate analysis that controlled for sex; GCS, ISS, and AIS-head scores; time in the trauma bay; and preinjury anticoagulation treatment. The CCTST score was strongly associated with patient mortality (OR 1.31), rivaling both GCS (OR, 1.14) and AIS-Head (OR, 2.68). Neither ISS nor pre-injury anticoagulation predicted mortality. CCTST was also the only variable independently associated with the need for neurosurgical intervention.
The team is planning a multicenter retrospective validation, followed by a prospective observational study in the next 2 years, according to Dr. Stan Stawicki, the senior investigator, also with St. Luke’s. “CCTST offers potential promise to add much needed granularity to our existing TBI clinical assessment paradigm that continues to rely heavily on AIS-Head and GCS,” he said.
Neither Dr. Mubang nor Dr. Stawicki had any financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @Alz_Gal
WASHINGTON – A simple 8-point scoring system based on head CT accurately predicts mortality, morbidity, and even discharge disposition among patients with a traumatic brain injury (TBI).
In its first clinical study, the Cranial CT Scoring Tool (CCTST) predictive power rivaled both the Glasgow Coma Score (GCS) and the Abbreviated Injury Scale (AIS), Ronnie Mubang, MD, said at the American College of Surgeons’ Clinical Congress.
In addition to adding valuable prognostic information, the CCTST is quick, easy, and completely objective, said Dr. Mubang, of St. Luke’s University Health Network, Bethlehem, Pa.
“The near-universal head CT makes this tool valuable in immediate prognostication and clinical risk assessment for physicians, patients and families. It can serve as a potential adjunct to the Glasgow score and Abbreviated Injury Score for risk assessment,” he said. Of note, the final AIS-Head may not be available until relatively late in the patient’s clinical course, and the GCS has important limitations in terms of outcome prognostication.
The CCTST is an 8-point assessment with one point assigned to each individual cranial CT finding: epidural hematoma, subdural hematoma, subarachnoid hemorrhage, intraventricular hemorrhage, cerebral contusion/ intraparenchymal hemorrhage, skull fracture, brain edema/herniation, and midline shift. The ninth factor is the presence of an external injury to the head.
Dr. Mubang, a fourth-year surgical resident, and his colleagues retrospectively examined the CCTST in 620 patients included in an administrative database at the three-hospital St. Luke’s Regional Trauma Network. Patients were older than 45 years. Half of them underwent neurosurgical intervention within 24 hours of admission and were matched with 310 patients who did not require neurosurgery. The primary clinical endpoint was mortality from head injury. Secondary endpoints included morbidity, hospital and intensive care unit length of stay, and post-discharge destination.
The mean age of the cohort was 73 years. Almost all injuries (99%) were due to blunt force trauma. The mean GCS was 11; the mean Injury Severity Score (ISS) was 24; and the mean AIS – Head score was 4.6, indicating severe to critical level of TBI. Midline shift was significantly greater in the surgical group (0.74 cm vs. 0.29 cm).
Several CT findings were significantly more common in the surgical group, including subdural hematoma (96% vs. 7%); midline shift (74% vs. 29%); brain edema (39% vs. 23%); and epidural hematoma (10% vs. 3%).
As the total CCTST score increased, outcomes worsened accordingly, Dr. Mubang said. Patients with a score of 1-2 had a 20%-30% chance of complications and an approximately 10% chance of injury-related mortality. Patients with higher scores (7-8) had a 60%-75% chance of morbidity and a 55% chance of mortality.
Rising scores correlated well with both hospital and ICU length of stay, with a score of 1-2 associated with a 3-day average stay, and a score of 8 associated with stays exceeding 10 days. The same pattern occurred with overall hospital length of stay: the lowest scores were associated with a stay of about a week, while the highest scores with a stay exceeding 2 weeks.
CCTST was highly associated with discharge disposition. With every additional point, the chance of discharge to home fell. While the majority of patients with scores below 2 were discharged home, no patients with a score of 8 were discharged home.
Finally, the investigators performed a multivariate analysis that controlled for sex; GCS, ISS, and AIS-head scores; time in the trauma bay; and preinjury anticoagulation treatment. The CCTST score was strongly associated with patient mortality (OR 1.31), rivaling both GCS (OR, 1.14) and AIS-Head (OR, 2.68). Neither ISS nor pre-injury anticoagulation predicted mortality. CCTST was also the only variable independently associated with the need for neurosurgical intervention.
The team is planning a multicenter retrospective validation, followed by a prospective observational study in the next 2 years, according to Dr. Stan Stawicki, the senior investigator, also with St. Luke’s. “CCTST offers potential promise to add much needed granularity to our existing TBI clinical assessment paradigm that continues to rely heavily on AIS-Head and GCS,” he said.
Neither Dr. Mubang nor Dr. Stawicki had any financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @Alz_Gal
AT ACS 2016
Key clinical point:
Major finding: CCTST score was strongly associated with patient mortality (Odds ratio, 1.31), rivaling both the Glasgow Coma Score (OR, 1.14) and the Abbreviated Injury Score – Head (OR, 2.68)Data source: The retrospective database study comprised 620 head trauma patients.
Disclosures: Neither Ronnie Mubang, MD, or Stan Stawicki, MD, had financial disclosures.
VIDEO: Pre–gastric bypass antibiotics alter gut microbiome
WASHINGTON – Antibiotics given in advance of gastric bypass surgery preferentially alter the microbiome, nudging it toward a more “lean” physiologic profile.
Given before a sleeve gastrectomy, vancomycin, which has little gut penetration, barely shifted the high ratio of Firmicutes to Bacteroidetes, a profile typically associated with obesity and insulin resistance. But cefazolin, which has much higher gut penetration, suppressed the presence of Firmicutes, which metabolize fat, and allowed the expansion of carbohydrate-loving Bacteroidetes – a profile generally seen in lean people.
Cyrus Jahansouz, MD, of the University of Minnesota, Minneapolis, and his colleagues wanted to examine whether a shift in preoperative antibiotics might affect the way the microbiome re-establishes itself in the wake of vertical sleeve gastrectomy. They enrolled 32 patients who were candidates for the procedure. None had undergone prior gastrointestinal surgery, and none had been exposed to antibiotics in the 3 months prior to bariatric surgery. They were similar in age, weight, body mass index, and fasting glucose. The mean HbA1c was about 6%.
Patients were randomized to three groups: maximal diet therapy (800 calories per day) without surgery; vertical sleeve gastrectomy with the usual preoperative antibiotic cefazolin and the postsurgical diet; and vertical sleeve gastrectomy with preoperative vancomycin and the postsurgical diet. All patients gave a fecal sample immediately before surgery and another one 6 days after surgery.
Preoperative cluster analysis of bacterial DNA showed that all of the samples had a similar composition, predominated by Firmicutes species (60%-70%). Bacteroidetes species made up about 20%-30%, with Proteobacteriae, Actinobacteriae, Verrucomicrobia, and other phyla comprising the remainder of the microbiome.
At the second sampling, the diet-only group showed no microbiome changes at all. The vancomycin group showed a very small but not significant expansion of Bacteroidetes and reduction of Firmicutes.
Patients in the cefazolin group showed a significant shift in the ratio – and it was quite striking, Dr. Jahansouz said. Among these patients, Firmicutes had decreased from 70% to 40% of the community. Bacteroidetes showed a corresponding shift, increasing from 20% of the community to 45%. The findings are quite surprising, he noted, considering that only one dose of antibiotic was associated with the changes and that they were evident within just a few days.
Although “a little hard to interpret” because of its small size and short follow-up, the study suggests that antibiotic choice might contribute to the success of weight-loss surgery, Dr. Jahansouz said at the annual clinical congress of the American College of Surgeons.
“There are still several factors in the perioperative period that we have to study to be able to identify what other things might have also influenced the shift,” he said in an interview. “But I do think that, in the future, these changes can be manipulated to benefit metabolic outcomes.”
Two phyla – Bacteroidetes and Firmicutes – dominate the human gut microbiome in a dynamic ratio that is highly associated with the way energy is extracted from food. Bacteroidetes species specialize in carbohydrate digestion and Firmicutes in fat digestion. “In a lean, insulin-sensitive state, Bacteroidetes dominates the human gut microbiome,” Dr. Jahansouz said. “With the progression of obesity and insulin resistance, there is a subsequent shift in the microbiome phenotype, favoring the growth of Firmicutes at the expense and reduction of Bacteroidetes. This is a significant change, because this obesity-associated phenotype has an increased capacity to harvest energy. It’s not the same for a lean person to consume 1,000 calories as it is for an obese person to consume them.”
Bariatric surgery has been shown to alter the gut microbiome, shifting it toward this more “lean” profile (Cell Metab. 2015 Aug 4;22[2]:228-38). This shift may be an important component of the still not fully elucidated mechanisms by which bariatric surgery causes weight loss and normalizes insulin signaling, Dr. Jahansouz said.
Dr. Jahansouz is following this group of patients to explore whether there are differences in weight loss and insulin signaling. He also will track whether the microbiome stabilizes at its early postsurgical profile, or continues to shift, either toward an even higher Bacteroidetes to Firmicutes ratio, or back to a more “obese” profile.
He and his colleagues are also investigating the effect of antibiotics and gastric bypass surgery in mouse models. “I can say that antibiotics seem to have a remarkable impact on the effect of mouse sleeve gastrectomy. We’re not quite there yet with humans,” but the data are compelling.
Dr. Jahansouz said that he had no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @Alz_Gal
WASHINGTON – Antibiotics given in advance of gastric bypass surgery preferentially alter the microbiome, nudging it toward a more “lean” physiologic profile.
Given before a sleeve gastrectomy, vancomycin, which has little gut penetration, barely shifted the high ratio of Firmicutes to Bacteroidetes, a profile typically associated with obesity and insulin resistance. But cefazolin, which has much higher gut penetration, suppressed the presence of Firmicutes, which metabolize fat, and allowed the expansion of carbohydrate-loving Bacteroidetes – a profile generally seen in lean people.
Cyrus Jahansouz, MD, of the University of Minnesota, Minneapolis, and his colleagues wanted to examine whether a shift in preoperative antibiotics might affect the way the microbiome re-establishes itself in the wake of vertical sleeve gastrectomy. They enrolled 32 patients who were candidates for the procedure. None had undergone prior gastrointestinal surgery, and none had been exposed to antibiotics in the 3 months prior to bariatric surgery. They were similar in age, weight, body mass index, and fasting glucose. The mean HbA1c was about 6%.
Patients were randomized to three groups: maximal diet therapy (800 calories per day) without surgery; vertical sleeve gastrectomy with the usual preoperative antibiotic cefazolin and the postsurgical diet; and vertical sleeve gastrectomy with preoperative vancomycin and the postsurgical diet. All patients gave a fecal sample immediately before surgery and another one 6 days after surgery.
Preoperative cluster analysis of bacterial DNA showed that all of the samples had a similar composition, predominated by Firmicutes species (60%-70%). Bacteroidetes species made up about 20%-30%, with Proteobacteriae, Actinobacteriae, Verrucomicrobia, and other phyla comprising the remainder of the microbiome.
At the second sampling, the diet-only group showed no microbiome changes at all. The vancomycin group showed a very small but not significant expansion of Bacteroidetes and reduction of Firmicutes.
Patients in the cefazolin group showed a significant shift in the ratio – and it was quite striking, Dr. Jahansouz said. Among these patients, Firmicutes had decreased from 70% to 40% of the community. Bacteroidetes showed a corresponding shift, increasing from 20% of the community to 45%. The findings are quite surprising, he noted, considering that only one dose of antibiotic was associated with the changes and that they were evident within just a few days.
Although “a little hard to interpret” because of its small size and short follow-up, the study suggests that antibiotic choice might contribute to the success of weight-loss surgery, Dr. Jahansouz said at the annual clinical congress of the American College of Surgeons.
“There are still several factors in the perioperative period that we have to study to be able to identify what other things might have also influenced the shift,” he said in an interview. “But I do think that, in the future, these changes can be manipulated to benefit metabolic outcomes.”
Two phyla – Bacteroidetes and Firmicutes – dominate the human gut microbiome in a dynamic ratio that is highly associated with the way energy is extracted from food. Bacteroidetes species specialize in carbohydrate digestion and Firmicutes in fat digestion. “In a lean, insulin-sensitive state, Bacteroidetes dominates the human gut microbiome,” Dr. Jahansouz said. “With the progression of obesity and insulin resistance, there is a subsequent shift in the microbiome phenotype, favoring the growth of Firmicutes at the expense and reduction of Bacteroidetes. This is a significant change, because this obesity-associated phenotype has an increased capacity to harvest energy. It’s not the same for a lean person to consume 1,000 calories as it is for an obese person to consume them.”
Bariatric surgery has been shown to alter the gut microbiome, shifting it toward this more “lean” profile (Cell Metab. 2015 Aug 4;22[2]:228-38). This shift may be an important component of the still not fully elucidated mechanisms by which bariatric surgery causes weight loss and normalizes insulin signaling, Dr. Jahansouz said.
Dr. Jahansouz is following this group of patients to explore whether there are differences in weight loss and insulin signaling. He also will track whether the microbiome stabilizes at its early postsurgical profile, or continues to shift, either toward an even higher Bacteroidetes to Firmicutes ratio, or back to a more “obese” profile.
He and his colleagues are also investigating the effect of antibiotics and gastric bypass surgery in mouse models. “I can say that antibiotics seem to have a remarkable impact on the effect of mouse sleeve gastrectomy. We’re not quite there yet with humans,” but the data are compelling.
Dr. Jahansouz said that he had no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @Alz_Gal
WASHINGTON – Antibiotics given in advance of gastric bypass surgery preferentially alter the microbiome, nudging it toward a more “lean” physiologic profile.
Given before a sleeve gastrectomy, vancomycin, which has little gut penetration, barely shifted the high ratio of Firmicutes to Bacteroidetes, a profile typically associated with obesity and insulin resistance. But cefazolin, which has much higher gut penetration, suppressed the presence of Firmicutes, which metabolize fat, and allowed the expansion of carbohydrate-loving Bacteroidetes – a profile generally seen in lean people.
Cyrus Jahansouz, MD, of the University of Minnesota, Minneapolis, and his colleagues wanted to examine whether a shift in preoperative antibiotics might affect the way the microbiome re-establishes itself in the wake of vertical sleeve gastrectomy. They enrolled 32 patients who were candidates for the procedure. None had undergone prior gastrointestinal surgery, and none had been exposed to antibiotics in the 3 months prior to bariatric surgery. They were similar in age, weight, body mass index, and fasting glucose. The mean HbA1c was about 6%.
Patients were randomized to three groups: maximal diet therapy (800 calories per day) without surgery; vertical sleeve gastrectomy with the usual preoperative antibiotic cefazolin and the postsurgical diet; and vertical sleeve gastrectomy with preoperative vancomycin and the postsurgical diet. All patients gave a fecal sample immediately before surgery and another one 6 days after surgery.
Preoperative cluster analysis of bacterial DNA showed that all of the samples had a similar composition, predominated by Firmicutes species (60%-70%). Bacteroidetes species made up about 20%-30%, with Proteobacteriae, Actinobacteriae, Verrucomicrobia, and other phyla comprising the remainder of the microbiome.
At the second sampling, the diet-only group showed no microbiome changes at all. The vancomycin group showed a very small but not significant expansion of Bacteroidetes and reduction of Firmicutes.
Patients in the cefazolin group showed a significant shift in the ratio – and it was quite striking, Dr. Jahansouz said. Among these patients, Firmicutes had decreased from 70% to 40% of the community. Bacteroidetes showed a corresponding shift, increasing from 20% of the community to 45%. The findings are quite surprising, he noted, considering that only one dose of antibiotic was associated with the changes and that they were evident within just a few days.
Although “a little hard to interpret” because of its small size and short follow-up, the study suggests that antibiotic choice might contribute to the success of weight-loss surgery, Dr. Jahansouz said at the annual clinical congress of the American College of Surgeons.
“There are still several factors in the perioperative period that we have to study to be able to identify what other things might have also influenced the shift,” he said in an interview. “But I do think that, in the future, these changes can be manipulated to benefit metabolic outcomes.”
Two phyla – Bacteroidetes and Firmicutes – dominate the human gut microbiome in a dynamic ratio that is highly associated with the way energy is extracted from food. Bacteroidetes species specialize in carbohydrate digestion and Firmicutes in fat digestion. “In a lean, insulin-sensitive state, Bacteroidetes dominates the human gut microbiome,” Dr. Jahansouz said. “With the progression of obesity and insulin resistance, there is a subsequent shift in the microbiome phenotype, favoring the growth of Firmicutes at the expense and reduction of Bacteroidetes. This is a significant change, because this obesity-associated phenotype has an increased capacity to harvest energy. It’s not the same for a lean person to consume 1,000 calories as it is for an obese person to consume them.”
Bariatric surgery has been shown to alter the gut microbiome, shifting it toward this more “lean” profile (Cell Metab. 2015 Aug 4;22[2]:228-38). This shift may be an important component of the still not fully elucidated mechanisms by which bariatric surgery causes weight loss and normalizes insulin signaling, Dr. Jahansouz said.
Dr. Jahansouz is following this group of patients to explore whether there are differences in weight loss and insulin signaling. He also will track whether the microbiome stabilizes at its early postsurgical profile, or continues to shift, either toward an even higher Bacteroidetes to Firmicutes ratio, or back to a more “obese” profile.
He and his colleagues are also investigating the effect of antibiotics and gastric bypass surgery in mouse models. “I can say that antibiotics seem to have a remarkable impact on the effect of mouse sleeve gastrectomy. We’re not quite there yet with humans,” but the data are compelling.
Dr. Jahansouz said that he had no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @Alz_Gal
EXPERT ANALYSIS FROM THE ACS CLINICAL CONGRESS
VIDEO: Open, robotic, laparoscopic approaches equally effective in pancreatectomy
WASHINGTON – Minimally invasive surgery – whether robotic or laparoscopic – is just as effective as open surgery in pancreatectomy.
Both minimally invasive approaches had perioperative and oncologic outcomes that were similar to open approaches, as well as to each other, Katelin Mirkin, MD, reported at the annual clinical congress of the American College of Surgeons. And while minimally invasive surgery (MIS) techniques were associated with a slightly faster move to neoadjuvant chemotherapy, survival outcomes in all three surgical approaches were similar.
Dr. Mirkin, a surgery resident at Penn State Milton S. Hershey Medical Center, Hershey, Pa., plumbed the National Cancer Database for patients with stage I-III pancreatic cancer who were treated by surgical resection from 2010 to 2012. Her cohort comprised 9,047 patients; of these, 7,924 were treated with open surgery, 992 with laparoscopic surgery, and 131 with robotic surgery. She examined a number of factors including lymph node harvest and surgical margins, length of stay and time to adjuvant chemotherapy, and survival.
Patients who had MIS were older (67 vs. 66 years) and more often treated at an academic center, but otherwise there were no significant baseline differences.
Dr. Mirkin first compared the open surgeries with MIS. There were no significant associations with surgical approach and cancer stage. However, distal resections were significantly more likely to be dealt with by MIS, and Whipple procedures by open approaches. There were also more open than MIS total resections.
MIS was more likely to conclude with negative surgical margins (79% vs. 75%), and open surgery more likely to end with positive margins (22% vs. 19%).
Perioperative outcomes favored MIS approaches for all types of surgery, with a mean overall stay of 9.5 days vs. 11.3 days for open surgery. The mean length of stay for a distal resection was 7 days for MIS vs. 8 for open. For a Whipple procedure, the mean stay was 10.7 vs. 11.9 days. For a total resection, it was 10 vs. 11.8 days.
MIS was also associated with a significantly shorter time to the initiation of adjuvant chemotherapy overall (56 vs. 59 days). For a Whipple, time to chemotherapy was 58 vs. 60 days, respectively. For a distal resection, it was 52 vs. 56 days, and for a total resection, 52 vs. 58 days.
Neither approach offered a survival benefit over the other, Dr. Mirkin noted. For stage I cancers, less than 50% of MIS patients and less than 25% of open patients were alive by 50 months. For those with stage II tumors, less than 25% of each group was alive by 40 months. For stage III tumors, the 40-month survival rates were about 10% for MIS patients and 15% for open patients.
Dr. Mirkin then examined perioperative, oncologic, and survival outcomes among those who underwent laparoscopic and robotic surgeries. There were no demographic differences between these groups.
Oncologic outcomes were almost identical with regard to the number of positive regional nodes harvested (six), and surgical margins. Nodes were negative in 82% of robotic cases vs. 78% of laparoscopic cases and positive in 17.6% of robotic cases and 19.4% of laparoscopic cases.
Length of stay was significantly shorter for a laparoscopic approach overall (10 vs. 9.4 days) and particularly in distal resection (7 vs. 10 days). However, there were no differences in length of stay in any other surgery type. Nor was there any difference in the time to neoadjuvant chemotherapy.
Survival outcomes were similar as well. For stage I cancers, 40-month survival was about 40% in the laparoscopic group and 25% in the robotic group. For stage II cancers, 40-month survival was about 15% and 25%, respectively. For stage III tumors, 20-month survival in the robotic group was near 0 and 25% in the laparoscopic group. By 40 months almost all patients were deceased.
A multivariate survival analysis controlled for age, sex, race, comorbidities, facility type and location, surgery type, surgical margins, pathologic stage, and systemic therapy. It found only one significant association: Patients with 12 or more lymph nodes harvested were 19% more likely to die than those with fewer than 12 nodes harvested.
Time to chemotherapy (longer or shorter than 57 days) did not significantly impact survival, Dr. Mirkin said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @alz_gal
WASHINGTON – Minimally invasive surgery – whether robotic or laparoscopic – is just as effective as open surgery in pancreatectomy.
Both minimally invasive approaches had perioperative and oncologic outcomes that were similar to open approaches, as well as to each other, Katelin Mirkin, MD, reported at the annual clinical congress of the American College of Surgeons. And while minimally invasive surgery (MIS) techniques were associated with a slightly faster move to neoadjuvant chemotherapy, survival outcomes in all three surgical approaches were similar.
Dr. Mirkin, a surgery resident at Penn State Milton S. Hershey Medical Center, Hershey, Pa., plumbed the National Cancer Database for patients with stage I-III pancreatic cancer who were treated by surgical resection from 2010 to 2012. Her cohort comprised 9,047 patients; of these, 7,924 were treated with open surgery, 992 with laparoscopic surgery, and 131 with robotic surgery. She examined a number of factors including lymph node harvest and surgical margins, length of stay and time to adjuvant chemotherapy, and survival.
Patients who had MIS were older (67 vs. 66 years) and more often treated at an academic center, but otherwise there were no significant baseline differences.
Dr. Mirkin first compared the open surgeries with MIS. There were no significant associations with surgical approach and cancer stage. However, distal resections were significantly more likely to be dealt with by MIS, and Whipple procedures by open approaches. There were also more open than MIS total resections.
MIS was more likely to conclude with negative surgical margins (79% vs. 75%), and open surgery more likely to end with positive margins (22% vs. 19%).
Perioperative outcomes favored MIS approaches for all types of surgery, with a mean overall stay of 9.5 days vs. 11.3 days for open surgery. The mean length of stay for a distal resection was 7 days for MIS vs. 8 for open. For a Whipple procedure, the mean stay was 10.7 vs. 11.9 days. For a total resection, it was 10 vs. 11.8 days.
MIS was also associated with a significantly shorter time to the initiation of adjuvant chemotherapy overall (56 vs. 59 days). For a Whipple, time to chemotherapy was 58 vs. 60 days, respectively. For a distal resection, it was 52 vs. 56 days, and for a total resection, 52 vs. 58 days.
Neither approach offered a survival benefit over the other, Dr. Mirkin noted. For stage I cancers, less than 50% of MIS patients and less than 25% of open patients were alive by 50 months. For those with stage II tumors, less than 25% of each group was alive by 40 months. For stage III tumors, the 40-month survival rates were about 10% for MIS patients and 15% for open patients.
Dr. Mirkin then examined perioperative, oncologic, and survival outcomes among those who underwent laparoscopic and robotic surgeries. There were no demographic differences between these groups.
Oncologic outcomes were almost identical with regard to the number of positive regional nodes harvested (six), and surgical margins. Nodes were negative in 82% of robotic cases vs. 78% of laparoscopic cases and positive in 17.6% of robotic cases and 19.4% of laparoscopic cases.
Length of stay was significantly shorter for a laparoscopic approach overall (10 vs. 9.4 days) and particularly in distal resection (7 vs. 10 days). However, there were no differences in length of stay in any other surgery type. Nor was there any difference in the time to neoadjuvant chemotherapy.
Survival outcomes were similar as well. For stage I cancers, 40-month survival was about 40% in the laparoscopic group and 25% in the robotic group. For stage II cancers, 40-month survival was about 15% and 25%, respectively. For stage III tumors, 20-month survival in the robotic group was near 0 and 25% in the laparoscopic group. By 40 months almost all patients were deceased.
A multivariate survival analysis controlled for age, sex, race, comorbidities, facility type and location, surgery type, surgical margins, pathologic stage, and systemic therapy. It found only one significant association: Patients with 12 or more lymph nodes harvested were 19% more likely to die than those with fewer than 12 nodes harvested.
Time to chemotherapy (longer or shorter than 57 days) did not significantly impact survival, Dr. Mirkin said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @alz_gal
WASHINGTON – Minimally invasive surgery – whether robotic or laparoscopic – is just as effective as open surgery in pancreatectomy.
Both minimally invasive approaches had perioperative and oncologic outcomes that were similar to open approaches, as well as to each other, Katelin Mirkin, MD, reported at the annual clinical congress of the American College of Surgeons. And while minimally invasive surgery (MIS) techniques were associated with a slightly faster move to neoadjuvant chemotherapy, survival outcomes in all three surgical approaches were similar.
Dr. Mirkin, a surgery resident at Penn State Milton S. Hershey Medical Center, Hershey, Pa., plumbed the National Cancer Database for patients with stage I-III pancreatic cancer who were treated by surgical resection from 2010 to 2012. Her cohort comprised 9,047 patients; of these, 7,924 were treated with open surgery, 992 with laparoscopic surgery, and 131 with robotic surgery. She examined a number of factors including lymph node harvest and surgical margins, length of stay and time to adjuvant chemotherapy, and survival.
Patients who had MIS were older (67 vs. 66 years) and more often treated at an academic center, but otherwise there were no significant baseline differences.
Dr. Mirkin first compared the open surgeries with MIS. There were no significant associations with surgical approach and cancer stage. However, distal resections were significantly more likely to be dealt with by MIS, and Whipple procedures by open approaches. There were also more open than MIS total resections.
MIS was more likely to conclude with negative surgical margins (79% vs. 75%), and open surgery more likely to end with positive margins (22% vs. 19%).
Perioperative outcomes favored MIS approaches for all types of surgery, with a mean overall stay of 9.5 days vs. 11.3 days for open surgery. The mean length of stay for a distal resection was 7 days for MIS vs. 8 for open. For a Whipple procedure, the mean stay was 10.7 vs. 11.9 days. For a total resection, it was 10 vs. 11.8 days.
MIS was also associated with a significantly shorter time to the initiation of adjuvant chemotherapy overall (56 vs. 59 days). For a Whipple, time to chemotherapy was 58 vs. 60 days, respectively. For a distal resection, it was 52 vs. 56 days, and for a total resection, 52 vs. 58 days.
Neither approach offered a survival benefit over the other, Dr. Mirkin noted. For stage I cancers, less than 50% of MIS patients and less than 25% of open patients were alive by 50 months. For those with stage II tumors, less than 25% of each group was alive by 40 months. For stage III tumors, the 40-month survival rates were about 10% for MIS patients and 15% for open patients.
Dr. Mirkin then examined perioperative, oncologic, and survival outcomes among those who underwent laparoscopic and robotic surgeries. There were no demographic differences between these groups.
Oncologic outcomes were almost identical with regard to the number of positive regional nodes harvested (six), and surgical margins. Nodes were negative in 82% of robotic cases vs. 78% of laparoscopic cases and positive in 17.6% of robotic cases and 19.4% of laparoscopic cases.
Length of stay was significantly shorter for a laparoscopic approach overall (10 vs. 9.4 days) and particularly in distal resection (7 vs. 10 days). However, there were no differences in length of stay in any other surgery type. Nor was there any difference in the time to neoadjuvant chemotherapy.
Survival outcomes were similar as well. For stage I cancers, 40-month survival was about 40% in the laparoscopic group and 25% in the robotic group. For stage II cancers, 40-month survival was about 15% and 25%, respectively. For stage III tumors, 20-month survival in the robotic group was near 0 and 25% in the laparoscopic group. By 40 months almost all patients were deceased.
A multivariate survival analysis controlled for age, sex, race, comorbidities, facility type and location, surgery type, surgical margins, pathologic stage, and systemic therapy. It found only one significant association: Patients with 12 or more lymph nodes harvested were 19% more likely to die than those with fewer than 12 nodes harvested.
Time to chemotherapy (longer or shorter than 57 days) did not significantly impact survival, Dr. Mirkin said.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @alz_gal
AT THE ACS CLINICAL CONGRESS
Key clinical point:
Major finding: For stage I cancers, less than 50% of minimally invasive surgery patients and less than 25% of open surgery patients were alive by 50 months. For those with stage II tumors, less than 25% of each group was alive by 40 months.
Data source: The database review comprised 9,047 cases.
Disclosures: Dr. Mirkin had no financial disclosures.
The mesh tradeoff: Lower recurrence risk vs. complicaitons
Among patients undergoing elective incisional repair of abdominal wall hernias, the use of mesh reinforcement decreases the short-term recurrence rate by 5% but increases major complications by approximately the same amount over the subsequent 5 years, Dunja Kokotovic, MB, reported at the annual clinical congress of the American College of Surgeons.
“Given the continuously increasing incidence of mesh-related complications with time, it is expected that, with even longer follow-up up than the 5 years observed in this study, mesh-related complications continue to accrue,” said Dr. Kokotovic of the Center for Surgical Science, Zealand University Hospital, Koge, Denmark. The findings of this observational registry-based cohort study were presented at the congress and simultaneously published online in JAMA (2016 Oct 17. doi: 10.1001/jama.2016.15217).
These results highlight the need to assess the long-term safety of interventions before making definitive conclusions about their benefits and widely adopting them. In the United States, manufacturers are required to demonstrate the long-term safety of drugs but not of some devices, including hernia meshes. There were approximately 190,000 such hernia repairs performed in the United States alone during the most recent year for which data are available, and mesh is estimated to have been used in at least half, Dr. Kokotovic noted.
She and her associates analyzed the 5-year outcomes for virtually all incisional hernia repairs performed in Denmark from 2007 through 2010 using data in a mandatory national registry. Their analysis included 3,242 patients (mean age, 58 years): 1,119 (34.5%) who had open mesh repair, 1,757 (54.2%) who had laparoscopic mesh repair, and 366 (11.3%) who had nonmesh repair.
The cumulative risk of reoperation for hernia recurrence was significantly lower for patients who had open mesh repair (12.3%) or laparoscopic mesh repair (10.6%) than for those who had nonmesh repair (17.1%). However, this benefit was offset by the rate of major mesh-related complications requiring surgical intervention – including surgical site infection, formation of a chronic sinus tract, late-onset intra-abdominal abscess, enterocutaneous fistula, bowel obstruction, and bowel perforation – which progressively increased over time. The cumulative incidence of such complications was 5.6% for open mesh repair and 3.7% for laparoscopic mesh repair.
This study was limited in that it was observational rather than being based on randomized data, so selection bias and imbalances among the study groups couldn’t be fully controlled for. However, two strengths of this study were that it reflects the real-world experience of an entire country and all the surgeons performing hernia repairs there, and it had 100% follow-up, the researchers said.
This study was partly funded by the Edgar Schnohr and Wife Gilberte Schnohr’s Foundation supporting independent surgical and anesthesiological research. Dr. Kokotovic reported having no relevant financial disclosures; one investigator reported receiving personal fees from Bard and Etichon for educational presentations.
These study findings suggest that the risk-benefit ratio of mesh reinforcement is not as clear as previously thought and call into question the current widespread use of mesh, even for repair of small hernias, when mesh is the norm for all incisional hernia repairs of any size.
Although the study by Kokotovic and colleagues is one of the most comprehensive long-term studies in hernia surgery, many questions remain about the optimal approach for repairing ventral hernia. To provide more rigorous data to better understand optimal approaches to this common clinical problem, surgeons will need to design large multicenter pragmatic trials with long-term follow-up.
Kamal M. F. Itani, MD, is at the VA Boston Health Care System, Boston University, West Roxbury, Mass., and Harvard Medical School in Boston. He reported having served as a research consultant to Davol 4 years ago regarding an antibiotic-coated mesh product. These remarks are excerpted from an editorial accompanying Dr. Kokotovic’s report (JAMA 2016 Oct 17. doi: 10.1001/jama.2016.15722).
These study findings suggest that the risk-benefit ratio of mesh reinforcement is not as clear as previously thought and call into question the current widespread use of mesh, even for repair of small hernias, when mesh is the norm for all incisional hernia repairs of any size.
Although the study by Kokotovic and colleagues is one of the most comprehensive long-term studies in hernia surgery, many questions remain about the optimal approach for repairing ventral hernia. To provide more rigorous data to better understand optimal approaches to this common clinical problem, surgeons will need to design large multicenter pragmatic trials with long-term follow-up.
Kamal M. F. Itani, MD, is at the VA Boston Health Care System, Boston University, West Roxbury, Mass., and Harvard Medical School in Boston. He reported having served as a research consultant to Davol 4 years ago regarding an antibiotic-coated mesh product. These remarks are excerpted from an editorial accompanying Dr. Kokotovic’s report (JAMA 2016 Oct 17. doi: 10.1001/jama.2016.15722).
These study findings suggest that the risk-benefit ratio of mesh reinforcement is not as clear as previously thought and call into question the current widespread use of mesh, even for repair of small hernias, when mesh is the norm for all incisional hernia repairs of any size.
Although the study by Kokotovic and colleagues is one of the most comprehensive long-term studies in hernia surgery, many questions remain about the optimal approach for repairing ventral hernia. To provide more rigorous data to better understand optimal approaches to this common clinical problem, surgeons will need to design large multicenter pragmatic trials with long-term follow-up.
Kamal M. F. Itani, MD, is at the VA Boston Health Care System, Boston University, West Roxbury, Mass., and Harvard Medical School in Boston. He reported having served as a research consultant to Davol 4 years ago regarding an antibiotic-coated mesh product. These remarks are excerpted from an editorial accompanying Dr. Kokotovic’s report (JAMA 2016 Oct 17. doi: 10.1001/jama.2016.15722).
Among patients undergoing elective incisional repair of abdominal wall hernias, the use of mesh reinforcement decreases the short-term recurrence rate by 5% but increases major complications by approximately the same amount over the subsequent 5 years, Dunja Kokotovic, MB, reported at the annual clinical congress of the American College of Surgeons.
“Given the continuously increasing incidence of mesh-related complications with time, it is expected that, with even longer follow-up up than the 5 years observed in this study, mesh-related complications continue to accrue,” said Dr. Kokotovic of the Center for Surgical Science, Zealand University Hospital, Koge, Denmark. The findings of this observational registry-based cohort study were presented at the congress and simultaneously published online in JAMA (2016 Oct 17. doi: 10.1001/jama.2016.15217).
These results highlight the need to assess the long-term safety of interventions before making definitive conclusions about their benefits and widely adopting them. In the United States, manufacturers are required to demonstrate the long-term safety of drugs but not of some devices, including hernia meshes. There were approximately 190,000 such hernia repairs performed in the United States alone during the most recent year for which data are available, and mesh is estimated to have been used in at least half, Dr. Kokotovic noted.
She and her associates analyzed the 5-year outcomes for virtually all incisional hernia repairs performed in Denmark from 2007 through 2010 using data in a mandatory national registry. Their analysis included 3,242 patients (mean age, 58 years): 1,119 (34.5%) who had open mesh repair, 1,757 (54.2%) who had laparoscopic mesh repair, and 366 (11.3%) who had nonmesh repair.
The cumulative risk of reoperation for hernia recurrence was significantly lower for patients who had open mesh repair (12.3%) or laparoscopic mesh repair (10.6%) than for those who had nonmesh repair (17.1%). However, this benefit was offset by the rate of major mesh-related complications requiring surgical intervention – including surgical site infection, formation of a chronic sinus tract, late-onset intra-abdominal abscess, enterocutaneous fistula, bowel obstruction, and bowel perforation – which progressively increased over time. The cumulative incidence of such complications was 5.6% for open mesh repair and 3.7% for laparoscopic mesh repair.
This study was limited in that it was observational rather than being based on randomized data, so selection bias and imbalances among the study groups couldn’t be fully controlled for. However, two strengths of this study were that it reflects the real-world experience of an entire country and all the surgeons performing hernia repairs there, and it had 100% follow-up, the researchers said.
This study was partly funded by the Edgar Schnohr and Wife Gilberte Schnohr’s Foundation supporting independent surgical and anesthesiological research. Dr. Kokotovic reported having no relevant financial disclosures; one investigator reported receiving personal fees from Bard and Etichon for educational presentations.
Among patients undergoing elective incisional repair of abdominal wall hernias, the use of mesh reinforcement decreases the short-term recurrence rate by 5% but increases major complications by approximately the same amount over the subsequent 5 years, Dunja Kokotovic, MB, reported at the annual clinical congress of the American College of Surgeons.
“Given the continuously increasing incidence of mesh-related complications with time, it is expected that, with even longer follow-up up than the 5 years observed in this study, mesh-related complications continue to accrue,” said Dr. Kokotovic of the Center for Surgical Science, Zealand University Hospital, Koge, Denmark. The findings of this observational registry-based cohort study were presented at the congress and simultaneously published online in JAMA (2016 Oct 17. doi: 10.1001/jama.2016.15217).
These results highlight the need to assess the long-term safety of interventions before making definitive conclusions about their benefits and widely adopting them. In the United States, manufacturers are required to demonstrate the long-term safety of drugs but not of some devices, including hernia meshes. There were approximately 190,000 such hernia repairs performed in the United States alone during the most recent year for which data are available, and mesh is estimated to have been used in at least half, Dr. Kokotovic noted.
She and her associates analyzed the 5-year outcomes for virtually all incisional hernia repairs performed in Denmark from 2007 through 2010 using data in a mandatory national registry. Their analysis included 3,242 patients (mean age, 58 years): 1,119 (34.5%) who had open mesh repair, 1,757 (54.2%) who had laparoscopic mesh repair, and 366 (11.3%) who had nonmesh repair.
The cumulative risk of reoperation for hernia recurrence was significantly lower for patients who had open mesh repair (12.3%) or laparoscopic mesh repair (10.6%) than for those who had nonmesh repair (17.1%). However, this benefit was offset by the rate of major mesh-related complications requiring surgical intervention – including surgical site infection, formation of a chronic sinus tract, late-onset intra-abdominal abscess, enterocutaneous fistula, bowel obstruction, and bowel perforation – which progressively increased over time. The cumulative incidence of such complications was 5.6% for open mesh repair and 3.7% for laparoscopic mesh repair.
This study was limited in that it was observational rather than being based on randomized data, so selection bias and imbalances among the study groups couldn’t be fully controlled for. However, two strengths of this study were that it reflects the real-world experience of an entire country and all the surgeons performing hernia repairs there, and it had 100% follow-up, the researchers said.
This study was partly funded by the Edgar Schnohr and Wife Gilberte Schnohr’s Foundation supporting independent surgical and anesthesiological research. Dr. Kokotovic reported having no relevant financial disclosures; one investigator reported receiving personal fees from Bard and Etichon for educational presentations.
FROM THE ACS CLINICAL CONGRESS
Key clinical point: Among patients undergoing elective incisional repair of abdominal wall hernias, the use of mesh reinforcement decreases the short-term recurrence rate by 5% but increases major complications by 5.6% over the subsequent 5 years.
Major finding: The cumulative rate of major mesh-related complications requiring surgical intervention was 5.6% for open mesh repair and 3.7% for laparoscopic mesh repair, compared with 0% for nonmesh repair.
Data source: A nationwide observational registry-based cohort study involving virtually all incisional hernia repairs (3,242) performed in Denmark from 2007 through 2010.
Disclosures: This study was partly funded by the Edgar Schnohr and Wife Gilberte Schnohr’s Foundation supporting independent surgical and anesthesiological research. Dr. Kokotovic reported having no relevant financial disclosures; one investigator reported receiving personal fees from Bard and Etichon for educational presentations.