General Surgery

CHICAGO – Implementing an enhanced recovery after surgery (ERAS) protocol at Canada’s second largest hospital significantly reduced morbidity and surgical site infections after elective colorectal surgery.

Rates of postoperative morbidity declined 48.7% from 27.3% before implementation to 14% after full ERAS implementation (P less than .05), while total surgical site infections fell 45% (20.2% vs. 11%; P less than .05).

Nonsignificant reductions were also seen in superficial surgical site infections (11.1% vs. 7.3%), deep SSIs (2% vs. 0.6%), and organ space SSIs (7.1% vs. 3.4%).

“Our results illustrate that using a multidisciplinary team, with attention to details and small multiple changes, aggregation of marginal gains can result in dramatic improvements in patient outcomes,” primary author Tracey Hong, R.N., said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.

The ERAS protocol was implemented at Vancouver General Hospital, after ACS NSQIP risk-adjusted reports showed the 743-bed hospital had a high odds ratio of 1.50 for colorectal operative mortality.

Patrice Wendling/Frontline Medical News

“We had a problem,” Ms. Hong, the hospital’s quality and patient safety coordinator, said.

ERAS documents were developed, staff were educated on the protocol, intraoperative components were implemented and audited, and the full protocol was initiated in November 2013.

To explore the effects of ERAS implementation, chart reviews were conducted on 278 general surgery patients undergoing elective colorectal surgery: 99 patients before ERAS implementation (July 2011 through June 2013) and 179 patients in the first 10 months after full implementation (November 2013 through August 2014).

Laparoscopic colon resections were performed in 53% of the pre-ERAS group and 62% of the post-ERAS group, laparoscopic anterior and abdominoperineal resections in 10% and 23%, and open anterior and abdominoperineal resections in 23% and 18%, respectively. The median American Society of Anesthesiologists classification in both groups was 2.

After ERAS implementation, there was a trend for less postoperative pneumonia, unplanned intubation, ventilator use greater than 48 hours, and urinary tract infections (data not presented).

The median length of stay was reduced from 7 to 5 days, while readmissions increased from 7.1% to 11.7% (both changes were nonsignificant), according to Ms. Hong, who won the conference’s 2015 Surgical Clinical Reviewers Abstract Competition.

The reason for the increased readmissions is unclear, but opportunities to avoid preventable readmissions have been identified and are currently being worked on, she said.

Process measures showed that the goal of achieving a minimum 80% compliance from August 2014 to March 2015 was met within 4 months and sustained for the preoperative and intraoperative ERAS components, in aggregate. The aggregate postoperative components, which include early oral nutrition, early ambulation, early catheter removal, use of chewing gum, and defined discharge criteria, were the slowest to change, but are trending in the right direction, Ms. Hong said.

The key to achieving better outcomes with ERAS lies in involving a multidisciplinary team in all stages of planning and implementation, ongoing communication and sharing of results with stakeholders to foster commitment and ownership, and real-time auditing and use of plan-do-study-act cycles to enhance the rate of improvement, she said.

“It takes time to change culture; tenacity is important,” Ms. Hong added.

In a separate poster presentation, Ms. Hong and her colleagues reported compliance of ERAS components under the control of the anesthesiologist. The highest rate of compliance was seen in practices with few barriers to implementation such as active pre- and intraoperative warming (96%) and appropriate admission of antibiotics (92%) and antiemetics (86%). Conversely, rates were lower for multimodal analgesia (72%) and goal-directed fluid therapy (50%), which can be more labor intensive. Also, there is controversy around goal-directed fluid therapy’s benefit in low-risk patients, which may contribute to the lower compliance rates, the study authors noted. Overall, just under three-quarters of patients received at least four out of five components in their care.

On the basis of the success of the protocol, ERAS is now used for patients undergoing radical cystectomy, with plans to expand its use to all emergent and urgent cases within general surgery at Vancouver General as well as bariatric surgery at Richmond Hospital, also a member of Vancouver Coastal Health, Andrea Bisaillon, operations director of surgical services at Vancouver General Hospital, said in an interview.

“We’re rolling out ERAS to all the surgical patients because it’s best practice for all of surgery, not just colorectal surgery anymore,” she said.

[email protected]

CHICAGO – Implementing an enhanced recovery after surgery (ERAS) protocol at Canada’s second largest hospital significantly reduced morbidity and surgical site infections after elective colorectal surgery.

Rates of postoperative morbidity declined 48.7% from 27.3% before implementation to 14% after full ERAS implementation (P less than .05), while total surgical site infections fell 45% (20.2% vs. 11%; P less than .05).

Nonsignificant reductions were also seen in superficial surgical site infections (11.1% vs. 7.3%), deep SSIs (2% vs. 0.6%), and organ space SSIs (7.1% vs. 3.4%).

“Our results illustrate that using a multidisciplinary team, with attention to details and small multiple changes, aggregation of marginal gains can result in dramatic improvements in patient outcomes,” primary author Tracey Hong, R.N., said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.

The ERAS protocol was implemented at Vancouver General Hospital, after ACS NSQIP risk-adjusted reports showed the 743-bed hospital had a high odds ratio of 1.50 for colorectal operative mortality.

Patrice Wendling/Frontline Medical News

“We had a problem,” Ms. Hong, the hospital’s quality and patient safety coordinator, said.

ERAS documents were developed, staff were educated on the protocol, intraoperative components were implemented and audited, and the full protocol was initiated in November 2013.

To explore the effects of ERAS implementation, chart reviews were conducted on 278 general surgery patients undergoing elective colorectal surgery: 99 patients before ERAS implementation (July 2011 through June 2013) and 179 patients in the first 10 months after full implementation (November 2013 through August 2014).

Laparoscopic colon resections were performed in 53% of the pre-ERAS group and 62% of the post-ERAS group, laparoscopic anterior and abdominoperineal resections in 10% and 23%, and open anterior and abdominoperineal resections in 23% and 18%, respectively. The median American Society of Anesthesiologists classification in both groups was 2.

After ERAS implementation, there was a trend for less postoperative pneumonia, unplanned intubation, ventilator use greater than 48 hours, and urinary tract infections (data not presented).

The median length of stay was reduced from 7 to 5 days, while readmissions increased from 7.1% to 11.7% (both changes were nonsignificant), according to Ms. Hong, who won the conference’s 2015 Surgical Clinical Reviewers Abstract Competition.

The reason for the increased readmissions is unclear, but opportunities to avoid preventable readmissions have been identified and are currently being worked on, she said.

Process measures showed that the goal of achieving a minimum 80% compliance from August 2014 to March 2015 was met within 4 months and sustained for the preoperative and intraoperative ERAS components, in aggregate. The aggregate postoperative components, which include early oral nutrition, early ambulation, early catheter removal, use of chewing gum, and defined discharge criteria, were the slowest to change, but are trending in the right direction, Ms. Hong said.

The key to achieving better outcomes with ERAS lies in involving a multidisciplinary team in all stages of planning and implementation, ongoing communication and sharing of results with stakeholders to foster commitment and ownership, and real-time auditing and use of plan-do-study-act cycles to enhance the rate of improvement, she said.

“It takes time to change culture; tenacity is important,” Ms. Hong added.

In a separate poster presentation, Ms. Hong and her colleagues reported compliance of ERAS components under the control of the anesthesiologist. The highest rate of compliance was seen in practices with few barriers to implementation such as active pre- and intraoperative warming (96%) and appropriate admission of antibiotics (92%) and antiemetics (86%). Conversely, rates were lower for multimodal analgesia (72%) and goal-directed fluid therapy (50%), which can be more labor intensive. Also, there is controversy around goal-directed fluid therapy’s benefit in low-risk patients, which may contribute to the lower compliance rates, the study authors noted. Overall, just under three-quarters of patients received at least four out of five components in their care.

On the basis of the success of the protocol, ERAS is now used for patients undergoing radical cystectomy, with plans to expand its use to all emergent and urgent cases within general surgery at Vancouver General as well as bariatric surgery at Richmond Hospital, also a member of Vancouver Coastal Health, Andrea Bisaillon, operations director of surgical services at Vancouver General Hospital, said in an interview.

“We’re rolling out ERAS to all the surgical patients because it’s best practice for all of surgery, not just colorectal surgery anymore,” she said.

[email protected]

CHICAGO – Implementing an enhanced recovery after surgery (ERAS) protocol at Canada’s second largest hospital significantly reduced morbidity and surgical site infections after elective colorectal surgery.

Rates of postoperative morbidity declined 48.7% from 27.3% before implementation to 14% after full ERAS implementation (P less than .05), while total surgical site infections fell 45% (20.2% vs. 11%; P less than .05).

Nonsignificant reductions were also seen in superficial surgical site infections (11.1% vs. 7.3%), deep SSIs (2% vs. 0.6%), and organ space SSIs (7.1% vs. 3.4%).

“Our results illustrate that using a multidisciplinary team, with attention to details and small multiple changes, aggregation of marginal gains can result in dramatic improvements in patient outcomes,” primary author Tracey Hong, R.N., said at the American College of Surgeons/National Surgical Quality Improvement Program National Conference.

The ERAS protocol was implemented at Vancouver General Hospital, after ACS NSQIP risk-adjusted reports showed the 743-bed hospital had a high odds ratio of 1.50 for colorectal operative mortality.

Patrice Wendling/Frontline Medical News

“We had a problem,” Ms. Hong, the hospital’s quality and patient safety coordinator, said.

ERAS documents were developed, staff were educated on the protocol, intraoperative components were implemented and audited, and the full protocol was initiated in November 2013.

To explore the effects of ERAS implementation, chart reviews were conducted on 278 general surgery patients undergoing elective colorectal surgery: 99 patients before ERAS implementation (July 2011 through June 2013) and 179 patients in the first 10 months after full implementation (November 2013 through August 2014).

Laparoscopic colon resections were performed in 53% of the pre-ERAS group and 62% of the post-ERAS group, laparoscopic anterior and abdominoperineal resections in 10% and 23%, and open anterior and abdominoperineal resections in 23% and 18%, respectively. The median American Society of Anesthesiologists classification in both groups was 2.

After ERAS implementation, there was a trend for less postoperative pneumonia, unplanned intubation, ventilator use greater than 48 hours, and urinary tract infections (data not presented).

The median length of stay was reduced from 7 to 5 days, while readmissions increased from 7.1% to 11.7% (both changes were nonsignificant), according to Ms. Hong, who won the conference’s 2015 Surgical Clinical Reviewers Abstract Competition.

The reason for the increased readmissions is unclear, but opportunities to avoid preventable readmissions have been identified and are currently being worked on, she said.

Process measures showed that the goal of achieving a minimum 80% compliance from August 2014 to March 2015 was met within 4 months and sustained for the preoperative and intraoperative ERAS components, in aggregate. The aggregate postoperative components, which include early oral nutrition, early ambulation, early catheter removal, use of chewing gum, and defined discharge criteria, were the slowest to change, but are trending in the right direction, Ms. Hong said.

The key to achieving better outcomes with ERAS lies in involving a multidisciplinary team in all stages of planning and implementation, ongoing communication and sharing of results with stakeholders to foster commitment and ownership, and real-time auditing and use of plan-do-study-act cycles to enhance the rate of improvement, she said.

“It takes time to change culture; tenacity is important,” Ms. Hong added.

In a separate poster presentation, Ms. Hong and her colleagues reported compliance of ERAS components under the control of the anesthesiologist. The highest rate of compliance was seen in practices with few barriers to implementation such as active pre- and intraoperative warming (96%) and appropriate admission of antibiotics (92%) and antiemetics (86%). Conversely, rates were lower for multimodal analgesia (72%) and goal-directed fluid therapy (50%), which can be more labor intensive. Also, there is controversy around goal-directed fluid therapy’s benefit in low-risk patients, which may contribute to the lower compliance rates, the study authors noted. Overall, just under three-quarters of patients received at least four out of five components in their care.

On the basis of the success of the protocol, ERAS is now used for patients undergoing radical cystectomy, with plans to expand its use to all emergent and urgent cases within general surgery at Vancouver General as well as bariatric surgery at Richmond Hospital, also a member of Vancouver Coastal Health, Andrea Bisaillon, operations director of surgical services at Vancouver General Hospital, said in an interview.

“We’re rolling out ERAS to all the surgical patients because it’s best practice for all of surgery, not just colorectal surgery anymore,” she said.

[email protected]

Five years after laparoscopic sleeve gastrectomy, patients will have regained, on average, about half of their preop excess weight, according to an Israeli investigation published online Aug. 5 in JAMA Surgery.

Things went better at first for the 443 patients in the study; at 1 year follow-up, they had lost, on average, 76.8% of their excess weight, but then it started to come back. At 3 years, patients were free of 69.7% of their excess weight, and at 5 years, just 56.1%. The failure rate – the number of patients with a percentage of excess weight loss less than 50% – increased from 13.3% at 1 year to 21.1% at 3 years and 38.5% at 5 years (JAMA Surg. 2015 Aug. 5. doi:10.1001/jamasurg.2015.2202).

The story was similar for obesity-related comorbidities; early gains eroded with time. Complete remission of diabetes, for instance, was maintained by 50.7% of patients at 1 year, 38.2% at 3 years, and just 20.0% at 5 years. Likewise, a drop in LDL cholesterol from baseline was significant at years 1 and 3, but not 5. Meanwhile, laparoscopic sleeve gastrectomy (LSG) didn’t significantly improve total cholesterol over baseline, and triglyceride improvements began to fade after year 1.

“In our opinion, the presence of obesity-related comorbidities should play a major role when choosing the appropriate procedure for a specific patient. For example, performing an operation that yields a low resolution rate of hyperlipidemia translates into lifelong medical treatment in a young patient with significant hyperlipidemia. In that case, a malabsorptive procedure might be more beneficial than LSG. If the recurrence of obesity is known to be followed by the remittance of an existing comorbidity in a specific procedure, an alternative procedure should be considered. The weight loss durability failure of almost 40% at 5 years of follow-up of LSG should be one of the deciding factors in such cases,” said senior investigator and bariatric surgeon Dr. Andrei Keidar of Beilinson Hospital in Petah Tikva, Israel, and his colleagues.

LSG is becoming more popular in part because it’s easier to learn and less disruptive than gastric bypass, but there are not enough data on long-term outcomes; the investigators sought to fill the gaps.

The average age in the study was 42.2 years; mean body mass index was 43.9 kg/m2, and mean preop excess weight was 51.2 kg. The majority of subjects were women. The operations were performed from 2006 to 2013, and there was considerable loss to follow-up during the project.

Baseline triglycerides followed overall trends with a drop from a mean of 155.2 mg/dL to 106.3 mg/dL at year 1, followed by a tick upward to 107.2 mg/dL at year 3 and 126.4 mg/dL at year 5.

The mean preop HDL cholesterol of 46.7 mg/dL rose to 52.8 mg/dL at year 1 and remained at about that level at 5 years. Improvements in hypertension were fairly durable, as well, with remission in 46.3% of patients at 1 year, 48.0% at 3 years, and 45.5% at 5 years.

“Surprisingly, our results showed that none of the changes in obesity-related comorbidity status correlated with” the amount of “excess weight prior to the surgery,” the investigators noted.

The authors didn’t compare LSG to other bariatric surgeries, but did note that in 2012, the American Society for Metabolic and Bariatric Surgery found that short-term weight loss and improvement in comorbidities was better with LSG than with Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric bypass. On the other hand, RYGB has been found to beat LSG on lipid fraction improvements and short term control of type 2 diabetes.

The investigators had no disclosures.

[email protected]

Five years after laparoscopic sleeve gastrectomy, patients will have regained, on average, about half of their preop excess weight, according to an Israeli investigation published online Aug. 5 in JAMA Surgery.

Things went better at first for the 443 patients in the study; at 1 year follow-up, they had lost, on average, 76.8% of their excess weight, but then it started to come back. At 3 years, patients were free of 69.7% of their excess weight, and at 5 years, just 56.1%. The failure rate – the number of patients with a percentage of excess weight loss less than 50% – increased from 13.3% at 1 year to 21.1% at 3 years and 38.5% at 5 years (JAMA Surg. 2015 Aug. 5. doi:10.1001/jamasurg.2015.2202).

The story was similar for obesity-related comorbidities; early gains eroded with time. Complete remission of diabetes, for instance, was maintained by 50.7% of patients at 1 year, 38.2% at 3 years, and just 20.0% at 5 years. Likewise, a drop in LDL cholesterol from baseline was significant at years 1 and 3, but not 5. Meanwhile, laparoscopic sleeve gastrectomy (LSG) didn’t significantly improve total cholesterol over baseline, and triglyceride improvements began to fade after year 1.

“In our opinion, the presence of obesity-related comorbidities should play a major role when choosing the appropriate procedure for a specific patient. For example, performing an operation that yields a low resolution rate of hyperlipidemia translates into lifelong medical treatment in a young patient with significant hyperlipidemia. In that case, a malabsorptive procedure might be more beneficial than LSG. If the recurrence of obesity is known to be followed by the remittance of an existing comorbidity in a specific procedure, an alternative procedure should be considered. The weight loss durability failure of almost 40% at 5 years of follow-up of LSG should be one of the deciding factors in such cases,” said senior investigator and bariatric surgeon Dr. Andrei Keidar of Beilinson Hospital in Petah Tikva, Israel, and his colleagues.

LSG is becoming more popular in part because it’s easier to learn and less disruptive than gastric bypass, but there are not enough data on long-term outcomes; the investigators sought to fill the gaps.

The average age in the study was 42.2 years; mean body mass index was 43.9 kg/m2, and mean preop excess weight was 51.2 kg. The majority of subjects were women. The operations were performed from 2006 to 2013, and there was considerable loss to follow-up during the project.

Baseline triglycerides followed overall trends with a drop from a mean of 155.2 mg/dL to 106.3 mg/dL at year 1, followed by a tick upward to 107.2 mg/dL at year 3 and 126.4 mg/dL at year 5.

The mean preop HDL cholesterol of 46.7 mg/dL rose to 52.8 mg/dL at year 1 and remained at about that level at 5 years. Improvements in hypertension were fairly durable, as well, with remission in 46.3% of patients at 1 year, 48.0% at 3 years, and 45.5% at 5 years.

“Surprisingly, our results showed that none of the changes in obesity-related comorbidity status correlated with” the amount of “excess weight prior to the surgery,” the investigators noted.

The authors didn’t compare LSG to other bariatric surgeries, but did note that in 2012, the American Society for Metabolic and Bariatric Surgery found that short-term weight loss and improvement in comorbidities was better with LSG than with Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric bypass. On the other hand, RYGB has been found to beat LSG on lipid fraction improvements and short term control of type 2 diabetes.

The investigators had no disclosures.

[email protected]

Five years after laparoscopic sleeve gastrectomy, patients will have regained, on average, about half of their preop excess weight, according to an Israeli investigation published online Aug. 5 in JAMA Surgery.

Things went better at first for the 443 patients in the study; at 1 year follow-up, they had lost, on average, 76.8% of their excess weight, but then it started to come back. At 3 years, patients were free of 69.7% of their excess weight, and at 5 years, just 56.1%. The failure rate – the number of patients with a percentage of excess weight loss less than 50% – increased from 13.3% at 1 year to 21.1% at 3 years and 38.5% at 5 years (JAMA Surg. 2015 Aug. 5. doi:10.1001/jamasurg.2015.2202).

The story was similar for obesity-related comorbidities; early gains eroded with time. Complete remission of diabetes, for instance, was maintained by 50.7% of patients at 1 year, 38.2% at 3 years, and just 20.0% at 5 years. Likewise, a drop in LDL cholesterol from baseline was significant at years 1 and 3, but not 5. Meanwhile, laparoscopic sleeve gastrectomy (LSG) didn’t significantly improve total cholesterol over baseline, and triglyceride improvements began to fade after year 1.

“In our opinion, the presence of obesity-related comorbidities should play a major role when choosing the appropriate procedure for a specific patient. For example, performing an operation that yields a low resolution rate of hyperlipidemia translates into lifelong medical treatment in a young patient with significant hyperlipidemia. In that case, a malabsorptive procedure might be more beneficial than LSG. If the recurrence of obesity is known to be followed by the remittance of an existing comorbidity in a specific procedure, an alternative procedure should be considered. The weight loss durability failure of almost 40% at 5 years of follow-up of LSG should be one of the deciding factors in such cases,” said senior investigator and bariatric surgeon Dr. Andrei Keidar of Beilinson Hospital in Petah Tikva, Israel, and his colleagues.

LSG is becoming more popular in part because it’s easier to learn and less disruptive than gastric bypass, but there are not enough data on long-term outcomes; the investigators sought to fill the gaps.

The average age in the study was 42.2 years; mean body mass index was 43.9 kg/m2, and mean preop excess weight was 51.2 kg. The majority of subjects were women. The operations were performed from 2006 to 2013, and there was considerable loss to follow-up during the project.

Baseline triglycerides followed overall trends with a drop from a mean of 155.2 mg/dL to 106.3 mg/dL at year 1, followed by a tick upward to 107.2 mg/dL at year 3 and 126.4 mg/dL at year 5.

The mean preop HDL cholesterol of 46.7 mg/dL rose to 52.8 mg/dL at year 1 and remained at about that level at 5 years. Improvements in hypertension were fairly durable, as well, with remission in 46.3% of patients at 1 year, 48.0% at 3 years, and 45.5% at 5 years.

“Surprisingly, our results showed that none of the changes in obesity-related comorbidity status correlated with” the amount of “excess weight prior to the surgery,” the investigators noted.

The authors didn’t compare LSG to other bariatric surgeries, but did note that in 2012, the American Society for Metabolic and Bariatric Surgery found that short-term weight loss and improvement in comorbidities was better with LSG than with Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric bypass. On the other hand, RYGB has been found to beat LSG on lipid fraction improvements and short term control of type 2 diabetes.

The investigators had no disclosures.

[email protected]

A coordinated approach to infection control and antibiotic stewardship would dramatically reduce the number of people affected by antibiotic-resistant pathogens and health care–associated infections (HAIs), saving tens of thousands of lives and billions of dollars over the next 5 years, according to a federal report.

With a nationwide prevention and antibiotic stewardship program, the total number of HAIs could be reduced by 619,000 over the next 5 years, saving 37,000 lives and reducing direct medical costs by $7.7 billion, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC), said in a telebriefing sponsored by the agency.

The coordinated approach requires both a public health tracking and alerting system and robust interfacility infection control practices. “Facilities that go it alone can’t effectively protect their own patients,” he said.

A CDC Vital Signs report projected outcomes for institution-based versus coordinated responses to antibiotic-resistant infections, predicting infections and deaths from 2014-2019 in a series of three scenarios.

Rachel Slayton, Ph.D., of the Center for Emerging and Zoonotic Infectious Diseases, used carbapenem-resistant Enterobacteriaceae (CRE) as the test case to determine the effect size of coordinated compared with institution-based infection control and alerting practices.*

She and her coauthors projected that the number of health care-associated CRE infections would rise about 10% over the next 5 years, from 310,000 to 340,000, under current practices. Using these prevalence figures, a coordinated approach would result in CRE prevalence within a health care network of just 2% after 5 years, compared with a 12% baseline prevalence and an 8.6% prevalence with augmented individual efforts.

“Two percent is still two percent too much, but it’s still a whole lot better than 12%,” said Dr. Frieden.

Infection control practices that are enhanced by interfacility coordination may include maintaining regional databases that permit alerts when an individual with an HAI transfers from one facility to the other; having inter-institution agreement about best practices for gowning, gloving, and isolation; and commencing enhanced screening for HAIs when public health officials identify a potential outbreak. Antibiotic stewardship is also enhanced when institutions explicitly agree to follow best prescribing practices.

Implementation of the coordinated approach would be supported by the CDC’s Antibiotic Resistance Solutions Initiative, with $264 million requested in the federal fiscal year 2016 budget for a broad set of programs. Part of this amount would provide for funding of a coordinated prevention approach in all 50 states, with support for state and local health departments, and a network of laboratory facilities for improved surveillance for resistant pathogens.

[email protected]

On Twitter: @karioakes

*CORRECTION 8/9/2015: The original version of this story misidentified the test case organism.

A coordinated approach to infection control and antibiotic stewardship would dramatically reduce the number of people affected by antibiotic-resistant pathogens and health care–associated infections (HAIs), saving tens of thousands of lives and billions of dollars over the next 5 years, according to a federal report.

With a nationwide prevention and antibiotic stewardship program, the total number of HAIs could be reduced by 619,000 over the next 5 years, saving 37,000 lives and reducing direct medical costs by $7.7 billion, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC), said in a telebriefing sponsored by the agency.

The coordinated approach requires both a public health tracking and alerting system and robust interfacility infection control practices. “Facilities that go it alone can’t effectively protect their own patients,” he said.

A CDC Vital Signs report projected outcomes for institution-based versus coordinated responses to antibiotic-resistant infections, predicting infections and deaths from 2014-2019 in a series of three scenarios.

Rachel Slayton, Ph.D., of the Center for Emerging and Zoonotic Infectious Diseases, used carbapenem-resistant Enterobacteriaceae (CRE) as the test case to determine the effect size of coordinated compared with institution-based infection control and alerting practices.*

She and her coauthors projected that the number of health care-associated CRE infections would rise about 10% over the next 5 years, from 310,000 to 340,000, under current practices. Using these prevalence figures, a coordinated approach would result in CRE prevalence within a health care network of just 2% after 5 years, compared with a 12% baseline prevalence and an 8.6% prevalence with augmented individual efforts.

“Two percent is still two percent too much, but it’s still a whole lot better than 12%,” said Dr. Frieden.

Infection control practices that are enhanced by interfacility coordination may include maintaining regional databases that permit alerts when an individual with an HAI transfers from one facility to the other; having inter-institution agreement about best practices for gowning, gloving, and isolation; and commencing enhanced screening for HAIs when public health officials identify a potential outbreak. Antibiotic stewardship is also enhanced when institutions explicitly agree to follow best prescribing practices.

Implementation of the coordinated approach would be supported by the CDC’s Antibiotic Resistance Solutions Initiative, with $264 million requested in the federal fiscal year 2016 budget for a broad set of programs. Part of this amount would provide for funding of a coordinated prevention approach in all 50 states, with support for state and local health departments, and a network of laboratory facilities for improved surveillance for resistant pathogens.

[email protected]

On Twitter: @karioakes

*CORRECTION 8/9/2015: The original version of this story misidentified the test case organism.

A coordinated approach to infection control and antibiotic stewardship would dramatically reduce the number of people affected by antibiotic-resistant pathogens and health care–associated infections (HAIs), saving tens of thousands of lives and billions of dollars over the next 5 years, according to a federal report.

With a nationwide prevention and antibiotic stewardship program, the total number of HAIs could be reduced by 619,000 over the next 5 years, saving 37,000 lives and reducing direct medical costs by $7.7 billion, Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention (CDC), said in a telebriefing sponsored by the agency.

The coordinated approach requires both a public health tracking and alerting system and robust interfacility infection control practices. “Facilities that go it alone can’t effectively protect their own patients,” he said.

A CDC Vital Signs report projected outcomes for institution-based versus coordinated responses to antibiotic-resistant infections, predicting infections and deaths from 2014-2019 in a series of three scenarios.

Rachel Slayton, Ph.D., of the Center for Emerging and Zoonotic Infectious Diseases, used carbapenem-resistant Enterobacteriaceae (CRE) as the test case to determine the effect size of coordinated compared with institution-based infection control and alerting practices.*

She and her coauthors projected that the number of health care-associated CRE infections would rise about 10% over the next 5 years, from 310,000 to 340,000, under current practices. Using these prevalence figures, a coordinated approach would result in CRE prevalence within a health care network of just 2% after 5 years, compared with a 12% baseline prevalence and an 8.6% prevalence with augmented individual efforts.

“Two percent is still two percent too much, but it’s still a whole lot better than 12%,” said Dr. Frieden.

Infection control practices that are enhanced by interfacility coordination may include maintaining regional databases that permit alerts when an individual with an HAI transfers from one facility to the other; having inter-institution agreement about best practices for gowning, gloving, and isolation; and commencing enhanced screening for HAIs when public health officials identify a potential outbreak. Antibiotic stewardship is also enhanced when institutions explicitly agree to follow best prescribing practices.

Implementation of the coordinated approach would be supported by the CDC’s Antibiotic Resistance Solutions Initiative, with $264 million requested in the federal fiscal year 2016 budget for a broad set of programs. Part of this amount would provide for funding of a coordinated prevention approach in all 50 states, with support for state and local health departments, and a network of laboratory facilities for improved surveillance for resistant pathogens.

[email protected]

On Twitter: @karioakes

*CORRECTION 8/9/2015: The original version of this story misidentified the test case organism.

The first intragastric balloon–based device designed to help obese people lose weight has been approved by the Food and Drug Administration, providing a treatment option that is less invasive than bariatric surgery and gastric banding.

The FDA approved the ReShape Integrated Dual Balloon System on July 28, for “weight reduction when used in conjunction with diet and exercise, in obese patients with a body mass index (BMI) of 30 kg/m²-40 kg/m² and one or more obesity-related comorbid conditions,” in adults who have not been able to lose weight with diet and exercise alone, according to the agency’s approval letter. Laparoscopic gastric banding is indicated for patients with a BMI of at least 40 kg/m² (or at least 30 kg/m² in people with one or more obesity-related comorbidities) and bariatric surgery is usually recommended for patients with a BMI of at least 40 kg/m² (or at least 35 kg/m² in people with at least one obesity-related comorbidity).

Courtesy ReShape Medical

The ReShape device is made up of two attached balloons that are placed in the stomach through a minimally invasive endoscopic procedure, where they are filled with about 2 cups of saline and methylene blue dye, under mild sedation; the balloons are sealed with mineral oil and left in place for up to 6 months. If a balloon ruptures, the dye appears in the urine. When it is time to remove the balloons, they are deflated then removed using another endoscopic procedure.

The device was evaluated in a pivotal study at eight U.S. sites of over 300 mostly female obese patients whose mean age was about 44 years; their mean weight was about 209-213 pounds, and their mean BMI was about 35 kg/m²; 187 received the device and 139 had the endoscopy only. All participants were on a medically managed diet and exercise program. At 6 months, those in the device group had lost a mean of about 24% of their weight, vs. a mean of about 11% among controls, a statistically significant difference (P = .0041). Those who had lost weight at 6 months “maintained 60% of this weight loss through 48 weeks of follow-up,” according to the FDA.

After placement of the device, common adverse events were vomiting, nausea, and abdominal pain, but most symptoms resolved within 30 days, according to the FDA. The development of gastric ulcerations is described as the “most worrisome” device-related risk, but “there were no unanticipated adverse device effects, no deaths, no intestinal obstructions, and no gastric perforations” in the study.

Among the 265 patients who received the device (those initially enrolled in the pivotal trial plus 78 who were in the control group and opted to receive the device after the first 6 months), 20 (7.5%) experienced severe adverse events; vomiting was the most common, in 4.5%. Serious events included gastric ulcers in two patients (0.8%) at 19 and at 97 days after the device was placed; in both cases, the device was removed. Almost 15% of those who received the device had to have it removed because of an adverse event. The rate of gastric ulcers after a minor change was made to the device was 10%; and the rate of balloon deflations without migration was 6%.

The FDA summary of the approval refers to the “marginal benefit of weight loss” among those in the treatment group, compared with controls, but adds that the decision to approve the device “is based in part on the limited options available to patients with mild to moderate obesity who have failed other means for conservative weight loss.” While the effectiveness of the device is better than what would be expected with diet and exercise or pharmacologic therapy,” it is “substantially less than what would be expected with gastric banding or other surgical interventions.” The list of contraindications includes previous gastrointestinal surgery “with sequelae,” such as an obstruction or adhesions; previous bariatric surgery; any GI inflammatory disease, severe coagulopathy; and women who are pregnant or breastfeeding.

“The company plans to make the ReShape procedure available to patients first in select markets, as physicians and allied health professionals are trained in the procedure and support program to optimize patient outcome,” according to the company’s statement announcing approval.

The ReShape device has been available in Europe since 2007.

Information posted by the FDA, including labeling for professionals, is available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P140012.

[email protected]

The first intragastric balloon–based device designed to help obese people lose weight has been approved by the Food and Drug Administration, providing a treatment option that is less invasive than bariatric surgery and gastric banding.

The FDA approved the ReShape Integrated Dual Balloon System on July 28, for “weight reduction when used in conjunction with diet and exercise, in obese patients with a body mass index (BMI) of 30 kg/m²-40 kg/m² and one or more obesity-related comorbid conditions,” in adults who have not been able to lose weight with diet and exercise alone, according to the agency’s approval letter. Laparoscopic gastric banding is indicated for patients with a BMI of at least 40 kg/m² (or at least 30 kg/m² in people with one or more obesity-related comorbidities) and bariatric surgery is usually recommended for patients with a BMI of at least 40 kg/m² (or at least 35 kg/m² in people with at least one obesity-related comorbidity).

Courtesy ReShape Medical

The ReShape device is made up of two attached balloons that are placed in the stomach through a minimally invasive endoscopic procedure, where they are filled with about 2 cups of saline and methylene blue dye, under mild sedation; the balloons are sealed with mineral oil and left in place for up to 6 months. If a balloon ruptures, the dye appears in the urine. When it is time to remove the balloons, they are deflated then removed using another endoscopic procedure.

The device was evaluated in a pivotal study at eight U.S. sites of over 300 mostly female obese patients whose mean age was about 44 years; their mean weight was about 209-213 pounds, and their mean BMI was about 35 kg/m²; 187 received the device and 139 had the endoscopy only. All participants were on a medically managed diet and exercise program. At 6 months, those in the device group had lost a mean of about 24% of their weight, vs. a mean of about 11% among controls, a statistically significant difference (P = .0041). Those who had lost weight at 6 months “maintained 60% of this weight loss through 48 weeks of follow-up,” according to the FDA.

After placement of the device, common adverse events were vomiting, nausea, and abdominal pain, but most symptoms resolved within 30 days, according to the FDA. The development of gastric ulcerations is described as the “most worrisome” device-related risk, but “there were no unanticipated adverse device effects, no deaths, no intestinal obstructions, and no gastric perforations” in the study.

Among the 265 patients who received the device (those initially enrolled in the pivotal trial plus 78 who were in the control group and opted to receive the device after the first 6 months), 20 (7.5%) experienced severe adverse events; vomiting was the most common, in 4.5%. Serious events included gastric ulcers in two patients (0.8%) at 19 and at 97 days after the device was placed; in both cases, the device was removed. Almost 15% of those who received the device had to have it removed because of an adverse event. The rate of gastric ulcers after a minor change was made to the device was 10%; and the rate of balloon deflations without migration was 6%.

The FDA summary of the approval refers to the “marginal benefit of weight loss” among those in the treatment group, compared with controls, but adds that the decision to approve the device “is based in part on the limited options available to patients with mild to moderate obesity who have failed other means for conservative weight loss.” While the effectiveness of the device is better than what would be expected with diet and exercise or pharmacologic therapy,” it is “substantially less than what would be expected with gastric banding or other surgical interventions.” The list of contraindications includes previous gastrointestinal surgery “with sequelae,” such as an obstruction or adhesions; previous bariatric surgery; any GI inflammatory disease, severe coagulopathy; and women who are pregnant or breastfeeding.

“The company plans to make the ReShape procedure available to patients first in select markets, as physicians and allied health professionals are trained in the procedure and support program to optimize patient outcome,” according to the company’s statement announcing approval.

The ReShape device has been available in Europe since 2007.

Information posted by the FDA, including labeling for professionals, is available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P140012.

[email protected]

The first intragastric balloon–based device designed to help obese people lose weight has been approved by the Food and Drug Administration, providing a treatment option that is less invasive than bariatric surgery and gastric banding.

The FDA approved the ReShape Integrated Dual Balloon System on July 28, for “weight reduction when used in conjunction with diet and exercise, in obese patients with a body mass index (BMI) of 30 kg/m²-40 kg/m² and one or more obesity-related comorbid conditions,” in adults who have not been able to lose weight with diet and exercise alone, according to the agency’s approval letter. Laparoscopic gastric banding is indicated for patients with a BMI of at least 40 kg/m² (or at least 30 kg/m² in people with one or more obesity-related comorbidities) and bariatric surgery is usually recommended for patients with a BMI of at least 40 kg/m² (or at least 35 kg/m² in people with at least one obesity-related comorbidity).

Courtesy ReShape Medical

The ReShape device is made up of two attached balloons that are placed in the stomach through a minimally invasive endoscopic procedure, where they are filled with about 2 cups of saline and methylene blue dye, under mild sedation; the balloons are sealed with mineral oil and left in place for up to 6 months. If a balloon ruptures, the dye appears in the urine. When it is time to remove the balloons, they are deflated then removed using another endoscopic procedure.

The device was evaluated in a pivotal study at eight U.S. sites of over 300 mostly female obese patients whose mean age was about 44 years; their mean weight was about 209-213 pounds, and their mean BMI was about 35 kg/m²; 187 received the device and 139 had the endoscopy only. All participants were on a medically managed diet and exercise program. At 6 months, those in the device group had lost a mean of about 24% of their weight, vs. a mean of about 11% among controls, a statistically significant difference (P = .0041). Those who had lost weight at 6 months “maintained 60% of this weight loss through 48 weeks of follow-up,” according to the FDA.

After placement of the device, common adverse events were vomiting, nausea, and abdominal pain, but most symptoms resolved within 30 days, according to the FDA. The development of gastric ulcerations is described as the “most worrisome” device-related risk, but “there were no unanticipated adverse device effects, no deaths, no intestinal obstructions, and no gastric perforations” in the study.

Among the 265 patients who received the device (those initially enrolled in the pivotal trial plus 78 who were in the control group and opted to receive the device after the first 6 months), 20 (7.5%) experienced severe adverse events; vomiting was the most common, in 4.5%. Serious events included gastric ulcers in two patients (0.8%) at 19 and at 97 days after the device was placed; in both cases, the device was removed. Almost 15% of those who received the device had to have it removed because of an adverse event. The rate of gastric ulcers after a minor change was made to the device was 10%; and the rate of balloon deflations without migration was 6%.

The FDA summary of the approval refers to the “marginal benefit of weight loss” among those in the treatment group, compared with controls, but adds that the decision to approve the device “is based in part on the limited options available to patients with mild to moderate obesity who have failed other means for conservative weight loss.” While the effectiveness of the device is better than what would be expected with diet and exercise or pharmacologic therapy,” it is “substantially less than what would be expected with gastric banding or other surgical interventions.” The list of contraindications includes previous gastrointestinal surgery “with sequelae,” such as an obstruction or adhesions; previous bariatric surgery; any GI inflammatory disease, severe coagulopathy; and women who are pregnant or breastfeeding.

“The company plans to make the ReShape procedure available to patients first in select markets, as physicians and allied health professionals are trained in the procedure and support program to optimize patient outcome,” according to the company’s statement announcing approval.

The ReShape device has been available in Europe since 2007.

Information posted by the FDA, including labeling for professionals, is available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P140012.

[email protected]

WASHINGTON – Postoperative cognitive decline, which occurs in roughly 20% of elderly patients who undergo major surgery, strikes older women with greater severity than it does similarly aged men, according to a retrospective analysis of data collected from 527 older Americans.

“We looked at the sex difference in postoperative cognitive decline and Alzheimer’s disease because of the sex difference in Alzheimer’s disease, where about two-thirds of patients are women,” Dr. Katie J. Schenning said in an interview during the Alzheimer’s Association International Conference 2015. “We know that a lot of the pathologic changes that happen to the brain after anesthesia and surgery are similar to the changes that happen in Alzheimer’s disease patients. But at this point that is all we can say about a link between the two. It is currently unknown whether there is a clear relationship between postoperative cognitive decline and Alzheimer’s disease,” said Dr. Schenning, an anesthesiologist at Oregon Health & Science University in Portland.

She and her associates studied data collected longitudinally from two cohorts, the Oregon Brain Aging Study and the Intelligent Systems for Assessment of Aging Changes. At baseline, the average age of the enrollees in the combined group was 83 years, and just under two-thirds were women. During follow-up, 182 of the participants underwent a total of 331 major surgeries, with some undergoing more than one surgery. The most common form of surgery was orthopedic, done in one-third of the patients, followed by general surgery, in a quarter.

The researchers running both studies collected data annually from participants using a battery of neuropsychological evaluations, brain MRIs, and information on their general health. Retrospective analysis of the data showed that following surgery, people showed evidence of statistically significant and clinically meaningful declines in several measures, compared with those who did not undergo surgery, including deficits measured by the Mini-Mental State Examination, instrumental activities of daily living, and logical memory delayed recall. The trajectory of these declines was significantly steeper in women following surgery, compared with men following surgery, Dr. Schenning reported in a poster at the meeting. In addition, the MRI scans showed ventricular enlargement in the postsurgical women but not in men, a change that is characteristic of neuropathology.

“Women who underwent surgery had a more rapid rate of decline in measures of cognition and function than women who did not have surgery, and it affected women in more categories than in men,” Dr. Schenning said.

The risk for postoperative cognitive decline “is one of the things that patients should take into consideration before undergoing elective surgery, especially if they are older or have pre-existing cognitive impairment,” Dr. Schenning suggested. The enhanced risk for postsurgical cognitive decline faced by older women and even the somewhat lesser risk that exists for older men “is certainly something that patients should discuss with their surgeon, anesthesiologist, and family members,” she said.

Dr. Schenning had no disclosures.

[email protected]

On Twitter @mitchelzoler

WASHINGTON – Postoperative cognitive decline, which occurs in roughly 20% of elderly patients who undergo major surgery, strikes older women with greater severity than it does similarly aged men, according to a retrospective analysis of data collected from 527 older Americans.

“We looked at the sex difference in postoperative cognitive decline and Alzheimer’s disease because of the sex difference in Alzheimer’s disease, where about two-thirds of patients are women,” Dr. Katie J. Schenning said in an interview during the Alzheimer’s Association International Conference 2015. “We know that a lot of the pathologic changes that happen to the brain after anesthesia and surgery are similar to the changes that happen in Alzheimer’s disease patients. But at this point that is all we can say about a link between the two. It is currently unknown whether there is a clear relationship between postoperative cognitive decline and Alzheimer’s disease,” said Dr. Schenning, an anesthesiologist at Oregon Health & Science University in Portland.

She and her associates studied data collected longitudinally from two cohorts, the Oregon Brain Aging Study and the Intelligent Systems for Assessment of Aging Changes. At baseline, the average age of the enrollees in the combined group was 83 years, and just under two-thirds were women. During follow-up, 182 of the participants underwent a total of 331 major surgeries, with some undergoing more than one surgery. The most common form of surgery was orthopedic, done in one-third of the patients, followed by general surgery, in a quarter.

The researchers running both studies collected data annually from participants using a battery of neuropsychological evaluations, brain MRIs, and information on their general health. Retrospective analysis of the data showed that following surgery, people showed evidence of statistically significant and clinically meaningful declines in several measures, compared with those who did not undergo surgery, including deficits measured by the Mini-Mental State Examination, instrumental activities of daily living, and logical memory delayed recall. The trajectory of these declines was significantly steeper in women following surgery, compared with men following surgery, Dr. Schenning reported in a poster at the meeting. In addition, the MRI scans showed ventricular enlargement in the postsurgical women but not in men, a change that is characteristic of neuropathology.

“Women who underwent surgery had a more rapid rate of decline in measures of cognition and function than women who did not have surgery, and it affected women in more categories than in men,” Dr. Schenning said.

The risk for postoperative cognitive decline “is one of the things that patients should take into consideration before undergoing elective surgery, especially if they are older or have pre-existing cognitive impairment,” Dr. Schenning suggested. The enhanced risk for postsurgical cognitive decline faced by older women and even the somewhat lesser risk that exists for older men “is certainly something that patients should discuss with their surgeon, anesthesiologist, and family members,” she said.

Dr. Schenning had no disclosures.

[email protected]

On Twitter @mitchelzoler

WASHINGTON – Postoperative cognitive decline, which occurs in roughly 20% of elderly patients who undergo major surgery, strikes older women with greater severity than it does similarly aged men, according to a retrospective analysis of data collected from 527 older Americans.

“We looked at the sex difference in postoperative cognitive decline and Alzheimer’s disease because of the sex difference in Alzheimer’s disease, where about two-thirds of patients are women,” Dr. Katie J. Schenning said in an interview during the Alzheimer’s Association International Conference 2015. “We know that a lot of the pathologic changes that happen to the brain after anesthesia and surgery are similar to the changes that happen in Alzheimer’s disease patients. But at this point that is all we can say about a link between the two. It is currently unknown whether there is a clear relationship between postoperative cognitive decline and Alzheimer’s disease,” said Dr. Schenning, an anesthesiologist at Oregon Health & Science University in Portland.

She and her associates studied data collected longitudinally from two cohorts, the Oregon Brain Aging Study and the Intelligent Systems for Assessment of Aging Changes. At baseline, the average age of the enrollees in the combined group was 83 years, and just under two-thirds were women. During follow-up, 182 of the participants underwent a total of 331 major surgeries, with some undergoing more than one surgery. The most common form of surgery was orthopedic, done in one-third of the patients, followed by general surgery, in a quarter.

The researchers running both studies collected data annually from participants using a battery of neuropsychological evaluations, brain MRIs, and information on their general health. Retrospective analysis of the data showed that following surgery, people showed evidence of statistically significant and clinically meaningful declines in several measures, compared with those who did not undergo surgery, including deficits measured by the Mini-Mental State Examination, instrumental activities of daily living, and logical memory delayed recall. The trajectory of these declines was significantly steeper in women following surgery, compared with men following surgery, Dr. Schenning reported in a poster at the meeting. In addition, the MRI scans showed ventricular enlargement in the postsurgical women but not in men, a change that is characteristic of neuropathology.

“Women who underwent surgery had a more rapid rate of decline in measures of cognition and function than women who did not have surgery, and it affected women in more categories than in men,” Dr. Schenning said.

The risk for postoperative cognitive decline “is one of the things that patients should take into consideration before undergoing elective surgery, especially if they are older or have pre-existing cognitive impairment,” Dr. Schenning suggested. The enhanced risk for postsurgical cognitive decline faced by older women and even the somewhat lesser risk that exists for older men “is certainly something that patients should discuss with their surgeon, anesthesiologist, and family members,” she said.

Dr. Schenning had no disclosures.

[email protected]

On Twitter @mitchelzoler

Patients who don’t receive surgical follow-up after an emergency department visit for cholelithiasis are at increased risk for further ED visits, extraneous imaging, and complications from the disease and from emergent cholecystectomy, according to the findings of a retrospective study.

“Our study identifies lack of surgical follow-up [as] a major contributor to the failure to perform cholecystecomy and highlights the importance of prompt surgical evaluation,” stated Taylor P. Williams of the University of Texas Medical Branch (UTMB), Galveston, and co-investigators.

Between August 2009 and May 2014, 71 patients were discharged from the ED at UTMB with a diagnosis of symptomatic gallstones. The study charted the care of these patients for a follow-up period of 2 years, and the findings were published the August issue of the Journal of Surgical Research (2015;197:318-23).

The mean age of patients was 41 years; 86% were women, and 49% were white. A majority of the patients (56.3%) had no health insurance, while 11.3% had Medicare, 11.3% were on Medicaid, and 21.1% had private insurance.

Wikimedia Commons/James Heilman/Creative Commons License

Of the 71 patients, 18 (25.4%) had outpatient surgical follow-up after an ED visit for a cholelithiasis episode, and they saw the surgeon an average of 7.7 days after the initial ED visit. In the 9 patients who then had an elective cholecystectomy, 8 of these operations occurred within a month of the initital ED visit.

A total of 53 (74.6%) had no immediate surgical follow-up after their ED visit.

The 62 patients who did not have a cholecystectomy had a different trajectory of care than did those who had surgery soon after their ED visit. Of the non-cholecystectomy group, 14.5% of this group eventually had outpatient surgical follow-up within a mean time of 137 days and 37.1% had repeat visits to the ED for gallstone symptoms (17.7% had two or more additional ED visits). Over half of those visits resulted in additional CT or ultrasound imaging. A total of 8 (12.9%) of the total group ended up with an emergent cholecystectomy.

The investigators looked at factors associated with surgical follow-up and eventual or emergent cholecystectomy. Laboratory values, demographics, and radiographic findings were similar between those who underwent cholecystectomy and those who did not. Patients with insurance were more likely to achieve surgical follow-up and more likely to have an elective cholecystectomy. Nausea and vomiting on presentation at the initial ED visit were associated with a greater likelihood of having a cholecystectomy.

The study showed that the 71 patients who presented at the ED with symptoms of cholelithiasis had a similar number of elective and emergent cholecystectomies. But those who did not pursue follow-up and delayed in having surgery incurred additional risks and costs.

A limitation of the study, according to the investigators, is that it involves a small sample from a single center in a community with a high proportion of patients who lack health insurance. In addition, UTMB protocol for acute gallbladder disease leads to a higher rate of admissions than is typical in the United States.

The investigators concluded that “lack of appropriate follow-up leads to multiple ED visits, high rates of emergent cholecystectomy, and redundant radiographic studies, increasing the cost of care and quality of life of those patients. Our data contribute to the literature supporting early surgical follow-up and elective cholecystectomy in preventing repeat ED visits and development of gallstone-related complications in patients presenting to the ED with symptomatic gallstones not severe enough to require emergency admission.”

The investigators had no relevant disclosures.

[email protected]

Patients who don’t receive surgical follow-up after an emergency department visit for cholelithiasis are at increased risk for further ED visits, extraneous imaging, and complications from the disease and from emergent cholecystectomy, according to the findings of a retrospective study.

“Our study identifies lack of surgical follow-up [as] a major contributor to the failure to perform cholecystecomy and highlights the importance of prompt surgical evaluation,” stated Taylor P. Williams of the University of Texas Medical Branch (UTMB), Galveston, and co-investigators.

Between August 2009 and May 2014, 71 patients were discharged from the ED at UTMB with a diagnosis of symptomatic gallstones. The study charted the care of these patients for a follow-up period of 2 years, and the findings were published the August issue of the Journal of Surgical Research (2015;197:318-23).

The mean age of patients was 41 years; 86% were women, and 49% were white. A majority of the patients (56.3%) had no health insurance, while 11.3% had Medicare, 11.3% were on Medicaid, and 21.1% had private insurance.

Wikimedia Commons/James Heilman/Creative Commons License

Of the 71 patients, 18 (25.4%) had outpatient surgical follow-up after an ED visit for a cholelithiasis episode, and they saw the surgeon an average of 7.7 days after the initial ED visit. In the 9 patients who then had an elective cholecystectomy, 8 of these operations occurred within a month of the initital ED visit.

A total of 53 (74.6%) had no immediate surgical follow-up after their ED visit.

The 62 patients who did not have a cholecystectomy had a different trajectory of care than did those who had surgery soon after their ED visit. Of the non-cholecystectomy group, 14.5% of this group eventually had outpatient surgical follow-up within a mean time of 137 days and 37.1% had repeat visits to the ED for gallstone symptoms (17.7% had two or more additional ED visits). Over half of those visits resulted in additional CT or ultrasound imaging. A total of 8 (12.9%) of the total group ended up with an emergent cholecystectomy.

The investigators looked at factors associated with surgical follow-up and eventual or emergent cholecystectomy. Laboratory values, demographics, and radiographic findings were similar between those who underwent cholecystectomy and those who did not. Patients with insurance were more likely to achieve surgical follow-up and more likely to have an elective cholecystectomy. Nausea and vomiting on presentation at the initial ED visit were associated with a greater likelihood of having a cholecystectomy.

The study showed that the 71 patients who presented at the ED with symptoms of cholelithiasis had a similar number of elective and emergent cholecystectomies. But those who did not pursue follow-up and delayed in having surgery incurred additional risks and costs.

A limitation of the study, according to the investigators, is that it involves a small sample from a single center in a community with a high proportion of patients who lack health insurance. In addition, UTMB protocol for acute gallbladder disease leads to a higher rate of admissions than is typical in the United States.

The investigators concluded that “lack of appropriate follow-up leads to multiple ED visits, high rates of emergent cholecystectomy, and redundant radiographic studies, increasing the cost of care and quality of life of those patients. Our data contribute to the literature supporting early surgical follow-up and elective cholecystectomy in preventing repeat ED visits and development of gallstone-related complications in patients presenting to the ED with symptomatic gallstones not severe enough to require emergency admission.”

The investigators had no relevant disclosures.

[email protected]

Patients who don’t receive surgical follow-up after an emergency department visit for cholelithiasis are at increased risk for further ED visits, extraneous imaging, and complications from the disease and from emergent cholecystectomy, according to the findings of a retrospective study.

“Our study identifies lack of surgical follow-up [as] a major contributor to the failure to perform cholecystecomy and highlights the importance of prompt surgical evaluation,” stated Taylor P. Williams of the University of Texas Medical Branch (UTMB), Galveston, and co-investigators.

Between August 2009 and May 2014, 71 patients were discharged from the ED at UTMB with a diagnosis of symptomatic gallstones. The study charted the care of these patients for a follow-up period of 2 years, and the findings were published the August issue of the Journal of Surgical Research (2015;197:318-23).

The mean age of patients was 41 years; 86% were women, and 49% were white. A majority of the patients (56.3%) had no health insurance, while 11.3% had Medicare, 11.3% were on Medicaid, and 21.1% had private insurance.

Wikimedia Commons/James Heilman/Creative Commons License

Of the 71 patients, 18 (25.4%) had outpatient surgical follow-up after an ED visit for a cholelithiasis episode, and they saw the surgeon an average of 7.7 days after the initial ED visit. In the 9 patients who then had an elective cholecystectomy, 8 of these operations occurred within a month of the initital ED visit.

A total of 53 (74.6%) had no immediate surgical follow-up after their ED visit.

The 62 patients who did not have a cholecystectomy had a different trajectory of care than did those who had surgery soon after their ED visit. Of the non-cholecystectomy group, 14.5% of this group eventually had outpatient surgical follow-up within a mean time of 137 days and 37.1% had repeat visits to the ED for gallstone symptoms (17.7% had two or more additional ED visits). Over half of those visits resulted in additional CT or ultrasound imaging. A total of 8 (12.9%) of the total group ended up with an emergent cholecystectomy.

The investigators looked at factors associated with surgical follow-up and eventual or emergent cholecystectomy. Laboratory values, demographics, and radiographic findings were similar between those who underwent cholecystectomy and those who did not. Patients with insurance were more likely to achieve surgical follow-up and more likely to have an elective cholecystectomy. Nausea and vomiting on presentation at the initial ED visit were associated with a greater likelihood of having a cholecystectomy.

The study showed that the 71 patients who presented at the ED with symptoms of cholelithiasis had a similar number of elective and emergent cholecystectomies. But those who did not pursue follow-up and delayed in having surgery incurred additional risks and costs.

A limitation of the study, according to the investigators, is that it involves a small sample from a single center in a community with a high proportion of patients who lack health insurance. In addition, UTMB protocol for acute gallbladder disease leads to a higher rate of admissions than is typical in the United States.

The investigators concluded that “lack of appropriate follow-up leads to multiple ED visits, high rates of emergent cholecystectomy, and redundant radiographic studies, increasing the cost of care and quality of life of those patients. Our data contribute to the literature supporting early surgical follow-up and elective cholecystectomy in preventing repeat ED visits and development of gallstone-related complications in patients presenting to the ED with symptomatic gallstones not severe enough to require emergency admission.”

The investigators had no relevant disclosures.

[email protected]

On postoperative day 1, elevated interleukin-6 level was associated with postoperative complications, according to a single-center cohort study of patients who had major abdominal surgery.

“Up to 28% of patients undergoing major abdominal surgery experience postoperative complications, including wound infection, sepsis, anastomotic dehiscence, pneumonia,cardiovascular or respiratory events, and mortality” but an accurate means of identifying those in the risk category would contribute the development of prevention stratetgies, the investigators wrote.

Previous studies of cardiothoracic surgery have supported an association of systemic inflammation to poor outcomes. Dr. Thijs Rettig and colleagues at St. Antonius Hospital, Nieuwegein, the Netherlands, sought to clarify if markers of inflammation and major abdominal surgery correlate with outcomes. Their results were published in the July issue of Annals of Surgery.

Researchers conducted a prospective cohort study at a single center using data obtained from the Myocardial Injury and Complications after major abdominal surgery (MICOLON) study. Participants in the MICOLON study were individuals aged 45 years or older who underwent elective major abdominal surgery. Other inclusion criteria included major cardiovascular (CV) risk factors, coronary artery disease, cerebrovascular accident, diabetes, renal insufficiency, atrial fibrillation, left ventricular dysfunction, aortic valve stenosis, or two minor CV risk factors.

Interleukin-6 (IL-6), tumor necrosis factor (TNF)-alpha, and C-reactive protein (CRP) levels were obtained at baseline and postoperative days 1, 3, and 7 in 137 patients. Systemic inflammatory response syndrome (SIRS) scores were calculated within 48 hours of surgery.

Primary endpoints were 30-day mortality, sepsis, pneumonia, wound infection, anastomotic dehiscence, reoperation, new-onset atrial fibrillation, respiratory insufficiency, congestive heart failure, and myocardial infarction. Data were also collected on length of stay and patients were followed up at 30 days postoperatively for further complications.

With a mean age of 68 years, 59% of patients were male and 30% (n = 40) had an ASA score of 3 or higher. Colorectal (50%), gastroesophageal (22%), and pancreatic (10%) surgery were the most common procedures performed. After excluding 2 patients from analysis for elevated baseline IL-6, 135 patients were analyzed.

At least one postoperative complication was observed in 29% (n = 39) of study subjects with a mean onset of 5 days after surgery. Use of preoperative steroids, aspirin, and statins were not associated with complications; however, blood loss and longer surgery duration where associated with worse outcomes.

In patients with and without complications, differences in IL-6 levels were observed at day 1 at 596 pg/mL vs. 303 pg/mL (P < .01), day 3 at 128 pg/mL vs. 69 pg/mL (P < .01), and day 7 at 76 pg/mL vs. 27 pg/mL (P = .02).

On day 1, CRP was similar in both groups (90 mg/L vs. 78 mg/L; P = .131), but on days 3 (223 mg/L vs. 131 mg/L; P < .001) and 7 (131 mg/L vs. 63 mg/L; P < .001) differences were observed.

Differences in TNF-alpha were observed between groups on day 7 (0.5 pg/mL vs. 0, P < .01). The two groups demonstrated similar leukocyte counts postoperatively.

Prediction for postoperative complications was associated with an IL-6 of 432 pg/mL at day 1, which was 70% specific and 64% sensitive, and had a positive predictive value (PPV) of 44% and negative predictive value (NPV) of 84%. A longer hospital stay of 12 days vs. 7 days (P < .001) was associated with high IL-6 (> 432 pg/mL) vs. a low IL-6 (< 432 pg/mL) at day 1.

Elevated IL-6 level on postoperative day 1 was independently associated with postoperative complications by multivariant regression analysis (AOR: 3.3; 95% confidence interval, 1.3-8.5; P < .02).

The researchers concluded that an increased IL-6 level on postoperative day 1 was associated with increased length of stay and threefold increased risk of complications after major abdominal surgery. They further continued, “It is plausible that early recognition of postoperative complications optimizes the chance of better outcome. One way to enhance early detection of complications is using inflammatory markers as predictors of outcome.”

The authors reported no conflicts of interest.

On postoperative day 1, elevated interleukin-6 level was associated with postoperative complications, according to a single-center cohort study of patients who had major abdominal surgery.

“Up to 28% of patients undergoing major abdominal surgery experience postoperative complications, including wound infection, sepsis, anastomotic dehiscence, pneumonia,cardiovascular or respiratory events, and mortality” but an accurate means of identifying those in the risk category would contribute the development of prevention stratetgies, the investigators wrote.

Previous studies of cardiothoracic surgery have supported an association of systemic inflammation to poor outcomes. Dr. Thijs Rettig and colleagues at St. Antonius Hospital, Nieuwegein, the Netherlands, sought to clarify if markers of inflammation and major abdominal surgery correlate with outcomes. Their results were published in the July issue of Annals of Surgery.

Researchers conducted a prospective cohort study at a single center using data obtained from the Myocardial Injury and Complications after major abdominal surgery (MICOLON) study. Participants in the MICOLON study were individuals aged 45 years or older who underwent elective major abdominal surgery. Other inclusion criteria included major cardiovascular (CV) risk factors, coronary artery disease, cerebrovascular accident, diabetes, renal insufficiency, atrial fibrillation, left ventricular dysfunction, aortic valve stenosis, or two minor CV risk factors.

Interleukin-6 (IL-6), tumor necrosis factor (TNF)-alpha, and C-reactive protein (CRP) levels were obtained at baseline and postoperative days 1, 3, and 7 in 137 patients. Systemic inflammatory response syndrome (SIRS) scores were calculated within 48 hours of surgery.

Primary endpoints were 30-day mortality, sepsis, pneumonia, wound infection, anastomotic dehiscence, reoperation, new-onset atrial fibrillation, respiratory insufficiency, congestive heart failure, and myocardial infarction. Data were also collected on length of stay and patients were followed up at 30 days postoperatively for further complications.

With a mean age of 68 years, 59% of patients were male and 30% (n = 40) had an ASA score of 3 or higher. Colorectal (50%), gastroesophageal (22%), and pancreatic (10%) surgery were the most common procedures performed. After excluding 2 patients from analysis for elevated baseline IL-6, 135 patients were analyzed.

At least one postoperative complication was observed in 29% (n = 39) of study subjects with a mean onset of 5 days after surgery. Use of preoperative steroids, aspirin, and statins were not associated with complications; however, blood loss and longer surgery duration where associated with worse outcomes.

In patients with and without complications, differences in IL-6 levels were observed at day 1 at 596 pg/mL vs. 303 pg/mL (P < .01), day 3 at 128 pg/mL vs. 69 pg/mL (P < .01), and day 7 at 76 pg/mL vs. 27 pg/mL (P = .02).

On day 1, CRP was similar in both groups (90 mg/L vs. 78 mg/L; P = .131), but on days 3 (223 mg/L vs. 131 mg/L; P < .001) and 7 (131 mg/L vs. 63 mg/L; P < .001) differences were observed.

Differences in TNF-alpha were observed between groups on day 7 (0.5 pg/mL vs. 0, P < .01). The two groups demonstrated similar leukocyte counts postoperatively.

Prediction for postoperative complications was associated with an IL-6 of 432 pg/mL at day 1, which was 70% specific and 64% sensitive, and had a positive predictive value (PPV) of 44% and negative predictive value (NPV) of 84%. A longer hospital stay of 12 days vs. 7 days (P < .001) was associated with high IL-6 (> 432 pg/mL) vs. a low IL-6 (< 432 pg/mL) at day 1.

Elevated IL-6 level on postoperative day 1 was independently associated with postoperative complications by multivariant regression analysis (AOR: 3.3; 95% confidence interval, 1.3-8.5; P < .02).

The researchers concluded that an increased IL-6 level on postoperative day 1 was associated with increased length of stay and threefold increased risk of complications after major abdominal surgery. They further continued, “It is plausible that early recognition of postoperative complications optimizes the chance of better outcome. One way to enhance early detection of complications is using inflammatory markers as predictors of outcome.”

The authors reported no conflicts of interest.

On postoperative day 1, elevated interleukin-6 level was associated with postoperative complications, according to a single-center cohort study of patients who had major abdominal surgery.

“Up to 28% of patients undergoing major abdominal surgery experience postoperative complications, including wound infection, sepsis, anastomotic dehiscence, pneumonia,cardiovascular or respiratory events, and mortality” but an accurate means of identifying those in the risk category would contribute the development of prevention stratetgies, the investigators wrote.

Previous studies of cardiothoracic surgery have supported an association of systemic inflammation to poor outcomes. Dr. Thijs Rettig and colleagues at St. Antonius Hospital, Nieuwegein, the Netherlands, sought to clarify if markers of inflammation and major abdominal surgery correlate with outcomes. Their results were published in the July issue of Annals of Surgery.

Researchers conducted a prospective cohort study at a single center using data obtained from the Myocardial Injury and Complications after major abdominal surgery (MICOLON) study. Participants in the MICOLON study were individuals aged 45 years or older who underwent elective major abdominal surgery. Other inclusion criteria included major cardiovascular (CV) risk factors, coronary artery disease, cerebrovascular accident, diabetes, renal insufficiency, atrial fibrillation, left ventricular dysfunction, aortic valve stenosis, or two minor CV risk factors.

Interleukin-6 (IL-6), tumor necrosis factor (TNF)-alpha, and C-reactive protein (CRP) levels were obtained at baseline and postoperative days 1, 3, and 7 in 137 patients. Systemic inflammatory response syndrome (SIRS) scores were calculated within 48 hours of surgery.

Primary endpoints were 30-day mortality, sepsis, pneumonia, wound infection, anastomotic dehiscence, reoperation, new-onset atrial fibrillation, respiratory insufficiency, congestive heart failure, and myocardial infarction. Data were also collected on length of stay and patients were followed up at 30 days postoperatively for further complications.

With a mean age of 68 years, 59% of patients were male and 30% (n = 40) had an ASA score of 3 or higher. Colorectal (50%), gastroesophageal (22%), and pancreatic (10%) surgery were the most common procedures performed. After excluding 2 patients from analysis for elevated baseline IL-6, 135 patients were analyzed.

At least one postoperative complication was observed in 29% (n = 39) of study subjects with a mean onset of 5 days after surgery. Use of preoperative steroids, aspirin, and statins were not associated with complications; however, blood loss and longer surgery duration where associated with worse outcomes.

In patients with and without complications, differences in IL-6 levels were observed at day 1 at 596 pg/mL vs. 303 pg/mL (P < .01), day 3 at 128 pg/mL vs. 69 pg/mL (P < .01), and day 7 at 76 pg/mL vs. 27 pg/mL (P = .02).

On day 1, CRP was similar in both groups (90 mg/L vs. 78 mg/L; P = .131), but on days 3 (223 mg/L vs. 131 mg/L; P < .001) and 7 (131 mg/L vs. 63 mg/L; P < .001) differences were observed.

Differences in TNF-alpha were observed between groups on day 7 (0.5 pg/mL vs. 0, P < .01). The two groups demonstrated similar leukocyte counts postoperatively.

Prediction for postoperative complications was associated with an IL-6 of 432 pg/mL at day 1, which was 70% specific and 64% sensitive, and had a positive predictive value (PPV) of 44% and negative predictive value (NPV) of 84%. A longer hospital stay of 12 days vs. 7 days (P < .001) was associated with high IL-6 (> 432 pg/mL) vs. a low IL-6 (< 432 pg/mL) at day 1.

Elevated IL-6 level on postoperative day 1 was independently associated with postoperative complications by multivariant regression analysis (AOR: 3.3; 95% confidence interval, 1.3-8.5; P < .02).

The researchers concluded that an increased IL-6 level on postoperative day 1 was associated with increased length of stay and threefold increased risk of complications after major abdominal surgery. They further continued, “It is plausible that early recognition of postoperative complications optimizes the chance of better outcome. One way to enhance early detection of complications is using inflammatory markers as predictors of outcome.”

The authors reported no conflicts of interest.

Chronic pain after total extraperitoneal inguinal hernia repair occurs infrequently in patients, and findings from a study suggest that the means of mesh fixation, permanent or nonpermanant, is not linked to greater risk of this outcome.

Dr. Nihad Gutlic and colleagues from the Skåne University Hospital at University of Lund, Sweden, sought to compare total extraperitoneal inguinal hernia repair (TEP) done with permanent fixture (PF) of mesh vs. nonfixed (NF) or nonpermanent fixation (NPF) and the impact of the means of mesh fixation on chronic pain. Their results were published online in the July issue of Annals of Surgery.

Prospective data were obtained from the Swedish Hernia Registry (SHR) and participants completed the Inguinal Pain Questionnaire (IPQ) and the Short Form-36 (SF-36) to measure health-related quality of life to assess chronic pain. Chronic pain was defined as pain that persisted more than 3 months after surgery.

The study included men aged 30-75 years, consecutively registered in the SHR for TEP repair of a primary groin hernia during January 2005 and May 2009, and the questionnaire was send between February 2010 and May 2010. A minimum follow-up of 6 months was stipulated. The IPQ assessed pain with 19 questions regarding the pain modalities intensity, frequency, duration, influence on daily activities, and testicular pain. Questions concerned “pain right now” and “pain past week” respectively, and answers were given on a 7-grade scale from “no pain” to “pain that could not be ignored – prompt medical advice sought.” Patients were followed for up to 33 months.

A total of 1,110 respondents were analyzed: 325 patients in the PF group and 785 patients in the NPF group (281 with fibrin glue and 504 NF). The PF group had more medial hernias (P < .003) and larger defect sizes (P < .002). There were no differences in the rate of reoperation between the two groups (P < .735).

For the IPQ questionnaire, 7.7% (n = 85) of patients reported having “pain that could not be ignored” in the last week with no difference between the PF group and the NF/NPF groups (P < .462). Of those patients responding, 5.4% reported having “pain right now” (n = 59) with no difference between the two groups (P < .270).

The authors conclude, “that TEP, carried out on men for primary inguinal hernia, is associated with a low frequency of chronic postoperative pain. No difference was seen between permanent and nonpermanent fixation regarding chronic pain.”

The authors declared no conflicts of interest. The study was supported by the Lund (Sweden) University, Region Skåne Research and Development Funds, and the Bard Norden AB and Helge B. Wulffs Foundation.

Chronic pain after total extraperitoneal inguinal hernia repair occurs infrequently in patients, and findings from a study suggest that the means of mesh fixation, permanent or nonpermanant, is not linked to greater risk of this outcome.

Dr. Nihad Gutlic and colleagues from the Skåne University Hospital at University of Lund, Sweden, sought to compare total extraperitoneal inguinal hernia repair (TEP) done with permanent fixture (PF) of mesh vs. nonfixed (NF) or nonpermanent fixation (NPF) and the impact of the means of mesh fixation on chronic pain. Their results were published online in the July issue of Annals of Surgery.

Prospective data were obtained from the Swedish Hernia Registry (SHR) and participants completed the Inguinal Pain Questionnaire (IPQ) and the Short Form-36 (SF-36) to measure health-related quality of life to assess chronic pain. Chronic pain was defined as pain that persisted more than 3 months after surgery.

The study included men aged 30-75 years, consecutively registered in the SHR for TEP repair of a primary groin hernia during January 2005 and May 2009, and the questionnaire was send between February 2010 and May 2010. A minimum follow-up of 6 months was stipulated. The IPQ assessed pain with 19 questions regarding the pain modalities intensity, frequency, duration, influence on daily activities, and testicular pain. Questions concerned “pain right now” and “pain past week” respectively, and answers were given on a 7-grade scale from “no pain” to “pain that could not be ignored – prompt medical advice sought.” Patients were followed for up to 33 months.

A total of 1,110 respondents were analyzed: 325 patients in the PF group and 785 patients in the NPF group (281 with fibrin glue and 504 NF). The PF group had more medial hernias (P < .003) and larger defect sizes (P < .002). There were no differences in the rate of reoperation between the two groups (P < .735).

For the IPQ questionnaire, 7.7% (n = 85) of patients reported having “pain that could not be ignored” in the last week with no difference between the PF group and the NF/NPF groups (P < .462). Of those patients responding, 5.4% reported having “pain right now” (n = 59) with no difference between the two groups (P < .270).

The authors conclude, “that TEP, carried out on men for primary inguinal hernia, is associated with a low frequency of chronic postoperative pain. No difference was seen between permanent and nonpermanent fixation regarding chronic pain.”

The authors declared no conflicts of interest. The study was supported by the Lund (Sweden) University, Region Skåne Research and Development Funds, and the Bard Norden AB and Helge B. Wulffs Foundation.

Chronic pain after total extraperitoneal inguinal hernia repair occurs infrequently in patients, and findings from a study suggest that the means of mesh fixation, permanent or nonpermanant, is not linked to greater risk of this outcome.

Dr. Nihad Gutlic and colleagues from the Skåne University Hospital at University of Lund, Sweden, sought to compare total extraperitoneal inguinal hernia repair (TEP) done with permanent fixture (PF) of mesh vs. nonfixed (NF) or nonpermanent fixation (NPF) and the impact of the means of mesh fixation on chronic pain. Their results were published online in the July issue of Annals of Surgery.

Prospective data were obtained from the Swedish Hernia Registry (SHR) and participants completed the Inguinal Pain Questionnaire (IPQ) and the Short Form-36 (SF-36) to measure health-related quality of life to assess chronic pain. Chronic pain was defined as pain that persisted more than 3 months after surgery.

The study included men aged 30-75 years, consecutively registered in the SHR for TEP repair of a primary groin hernia during January 2005 and May 2009, and the questionnaire was send between February 2010 and May 2010. A minimum follow-up of 6 months was stipulated. The IPQ assessed pain with 19 questions regarding the pain modalities intensity, frequency, duration, influence on daily activities, and testicular pain. Questions concerned “pain right now” and “pain past week” respectively, and answers were given on a 7-grade scale from “no pain” to “pain that could not be ignored – prompt medical advice sought.” Patients were followed for up to 33 months.

A total of 1,110 respondents were analyzed: 325 patients in the PF group and 785 patients in the NPF group (281 with fibrin glue and 504 NF). The PF group had more medial hernias (P < .003) and larger defect sizes (P < .002). There were no differences in the rate of reoperation between the two groups (P < .735).

For the IPQ questionnaire, 7.7% (n = 85) of patients reported having “pain that could not be ignored” in the last week with no difference between the PF group and the NF/NPF groups (P < .462). Of those patients responding, 5.4% reported having “pain right now” (n = 59) with no difference between the two groups (P < .270).

The authors conclude, “that TEP, carried out on men for primary inguinal hernia, is associated with a low frequency of chronic postoperative pain. No difference was seen between permanent and nonpermanent fixation regarding chronic pain.”

The authors declared no conflicts of interest. The study was supported by the Lund (Sweden) University, Region Skåne Research and Development Funds, and the Bard Norden AB and Helge B. Wulffs Foundation.