Bariatric Surgery

Use of a robotics platform provides a surgeon with more information so they can make better decisions, especially in challenging situations of primary and revisional bariatric surgery, according to Cheguevara Afaneh, MD, of New York–Presbyterian Hospital and Weill Cornell Medical Center, New York.

“The value of modern technology is to be able to do the most difficult cases in a much simpler format,” he said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

Dr. Afaneh shared examples of how robotic assistance can help surgeons address challenges in bariatric surgery clinical practice, including managing super- and super-super-obese patients, dealing with gastroesophageal reflux disease (GERD), and negating the impact of surgical assistant experience.

“Super-obese patients pose more of a challenge interoperatively for both the surgeon and the assistant,” Dr. Afaneh noted. He and colleagues conducted a study of perioperative outcomes and found no significant differences between morbidly obese and super-obese patients in perioperative morbidity or operating time when a robotic platform was used.

The benefits to the surgeon when using robotic assistance in super-obese patients include effortless navigation of the abdominal wall, the ability to execute complex maneuvers in a challenging environment, and the security of a stable platform with no assistant fatigue, Dr. Afaneh emphasized. “When you are using the robotic platform, you are negating a lot of the patient factors” and fatigue factors that make bariatric surgery in super-obese and super-super-obese patients especially difficult, he said.

For example, in a patient who weighed nearly 500 pounds, pulling up on the stomach to get behind the actual stomach is easier because assistant fatigue is not a factor, so the surgeon can take more time and prevent a more difficult dissection, he said. In addition, Dr. Afaneh’s research showed no difference in operative time, and that the robot assistance outcomes were reproducible across a range of body mass index categories.

Robotic assistance also allows for comparable outcomes in surgeons with less experience, notably in revisional surgery, said Dr. Afaneh. He reviewed data from his first year of experience in revisional procedures using robotic assistance to his partners’ more than 20 years of laparoscopic experience. He found no significant differences in operative time, complications, or conversions to open procedures.

However, the more important message from the study was that less experienced surgeons were able to safely perform some of the most difficult revisional procedures without increasing morbidity, compared with more experienced surgeons. The data suggest that, with robotic assistance, surgeons early in their career can take on some of the bigger cases and expect outcomes similar to those of more experienced surgeons, Dr. Afaneh said.

Robotics has demonstrated improved outcomes in managing patients with GERD, which has become a common problem after bariatric surgery, noted Dr. Afaneh. When he and his colleagues reviewed data from their center on robotic-assisted approaches to GERD after bariatric surgery, they found that, even in primary magnetic sphincter operations, “robotics maintains comparable outcomes in revisional sleeve gastrectomy fields,” he said.

Another notable benefit of robotics in bariatric surgery is the negation of the “assistant effect,” said Dr. Afaneh. Often, less experienced surgeons are matched with less experienced assistants. “We took a look at the use of the robotic in cases of complex GI surgeries,” he said. They compared laparoscopic and robotic cases and stratified them by third-year assistant or fellow. “If you had a fellow, the operative time dropped by half an hour for laparoscopic cases, but the time was no different in robotics cases,” regardless of the use of fellow or third-year assistant, he said.

“The robotic platform allows you to assist yourself,” and allows for full surgeon autonomy, Dr. Afaneh emphasized. “You are the best person at predicting your next step.” The robotics platform also serves as a teaching tool. “For those who teach, there is no added morbidity based on the assistance of the trainee,” he said. In addition, the improved visualization of robotics “allows for better appreciation of scarred tissue planes and more precise suturing,” he noted.

Overall, “one of the values of the robotic platform is shortening the learning curve,” Dr. Afaneh said. He reviewed data from his fellows and himself, and found no difference in operative times. “My mentee was able to achieve operative times as good as my third year in practice. The robotic platform shaved off several years of learning experience,” he said. Dr. Afaneh’s operative times also decreased with robotics, which shows how experienced surgeons learn from this technology, he said.

Dr. Afaneh disclosed serving as a consultant for Intuitive Surgical.

Global Academy for Medical Education and this news organization are owned by the same parent company.

Use of a robotics platform provides a surgeon with more information so they can make better decisions, especially in challenging situations of primary and revisional bariatric surgery, according to Cheguevara Afaneh, MD, of New York–Presbyterian Hospital and Weill Cornell Medical Center, New York.

“The value of modern technology is to be able to do the most difficult cases in a much simpler format,” he said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

Dr. Afaneh shared examples of how robotic assistance can help surgeons address challenges in bariatric surgery clinical practice, including managing super- and super-super-obese patients, dealing with gastroesophageal reflux disease (GERD), and negating the impact of surgical assistant experience.

“Super-obese patients pose more of a challenge interoperatively for both the surgeon and the assistant,” Dr. Afaneh noted. He and colleagues conducted a study of perioperative outcomes and found no significant differences between morbidly obese and super-obese patients in perioperative morbidity or operating time when a robotic platform was used.

The benefits to the surgeon when using robotic assistance in super-obese patients include effortless navigation of the abdominal wall, the ability to execute complex maneuvers in a challenging environment, and the security of a stable platform with no assistant fatigue, Dr. Afaneh emphasized. “When you are using the robotic platform, you are negating a lot of the patient factors” and fatigue factors that make bariatric surgery in super-obese and super-super-obese patients especially difficult, he said.

For example, in a patient who weighed nearly 500 pounds, pulling up on the stomach to get behind the actual stomach is easier because assistant fatigue is not a factor, so the surgeon can take more time and prevent a more difficult dissection, he said. In addition, Dr. Afaneh’s research showed no difference in operative time, and that the robot assistance outcomes were reproducible across a range of body mass index categories.

Robotic assistance also allows for comparable outcomes in surgeons with less experience, notably in revisional surgery, said Dr. Afaneh. He reviewed data from his first year of experience in revisional procedures using robotic assistance to his partners’ more than 20 years of laparoscopic experience. He found no significant differences in operative time, complications, or conversions to open procedures.

However, the more important message from the study was that less experienced surgeons were able to safely perform some of the most difficult revisional procedures without increasing morbidity, compared with more experienced surgeons. The data suggest that, with robotic assistance, surgeons early in their career can take on some of the bigger cases and expect outcomes similar to those of more experienced surgeons, Dr. Afaneh said.

Robotics has demonstrated improved outcomes in managing patients with GERD, which has become a common problem after bariatric surgery, noted Dr. Afaneh. When he and his colleagues reviewed data from their center on robotic-assisted approaches to GERD after bariatric surgery, they found that, even in primary magnetic sphincter operations, “robotics maintains comparable outcomes in revisional sleeve gastrectomy fields,” he said.

Another notable benefit of robotics in bariatric surgery is the negation of the “assistant effect,” said Dr. Afaneh. Often, less experienced surgeons are matched with less experienced assistants. “We took a look at the use of the robotic in cases of complex GI surgeries,” he said. They compared laparoscopic and robotic cases and stratified them by third-year assistant or fellow. “If you had a fellow, the operative time dropped by half an hour for laparoscopic cases, but the time was no different in robotics cases,” regardless of the use of fellow or third-year assistant, he said.

“The robotic platform allows you to assist yourself,” and allows for full surgeon autonomy, Dr. Afaneh emphasized. “You are the best person at predicting your next step.” The robotics platform also serves as a teaching tool. “For those who teach, there is no added morbidity based on the assistance of the trainee,” he said. In addition, the improved visualization of robotics “allows for better appreciation of scarred tissue planes and more precise suturing,” he noted.

Overall, “one of the values of the robotic platform is shortening the learning curve,” Dr. Afaneh said. He reviewed data from his fellows and himself, and found no difference in operative times. “My mentee was able to achieve operative times as good as my third year in practice. The robotic platform shaved off several years of learning experience,” he said. Dr. Afaneh’s operative times also decreased with robotics, which shows how experienced surgeons learn from this technology, he said.

Dr. Afaneh disclosed serving as a consultant for Intuitive Surgical.

Global Academy for Medical Education and this news organization are owned by the same parent company.

Use of a robotics platform provides a surgeon with more information so they can make better decisions, especially in challenging situations of primary and revisional bariatric surgery, according to Cheguevara Afaneh, MD, of New York–Presbyterian Hospital and Weill Cornell Medical Center, New York.

“The value of modern technology is to be able to do the most difficult cases in a much simpler format,” he said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

Dr. Afaneh shared examples of how robotic assistance can help surgeons address challenges in bariatric surgery clinical practice, including managing super- and super-super-obese patients, dealing with gastroesophageal reflux disease (GERD), and negating the impact of surgical assistant experience.

“Super-obese patients pose more of a challenge interoperatively for both the surgeon and the assistant,” Dr. Afaneh noted. He and colleagues conducted a study of perioperative outcomes and found no significant differences between morbidly obese and super-obese patients in perioperative morbidity or operating time when a robotic platform was used.

The benefits to the surgeon when using robotic assistance in super-obese patients include effortless navigation of the abdominal wall, the ability to execute complex maneuvers in a challenging environment, and the security of a stable platform with no assistant fatigue, Dr. Afaneh emphasized. “When you are using the robotic platform, you are negating a lot of the patient factors” and fatigue factors that make bariatric surgery in super-obese and super-super-obese patients especially difficult, he said.

For example, in a patient who weighed nearly 500 pounds, pulling up on the stomach to get behind the actual stomach is easier because assistant fatigue is not a factor, so the surgeon can take more time and prevent a more difficult dissection, he said. In addition, Dr. Afaneh’s research showed no difference in operative time, and that the robot assistance outcomes were reproducible across a range of body mass index categories.

Robotic assistance also allows for comparable outcomes in surgeons with less experience, notably in revisional surgery, said Dr. Afaneh. He reviewed data from his first year of experience in revisional procedures using robotic assistance to his partners’ more than 20 years of laparoscopic experience. He found no significant differences in operative time, complications, or conversions to open procedures.

However, the more important message from the study was that less experienced surgeons were able to safely perform some of the most difficult revisional procedures without increasing morbidity, compared with more experienced surgeons. The data suggest that, with robotic assistance, surgeons early in their career can take on some of the bigger cases and expect outcomes similar to those of more experienced surgeons, Dr. Afaneh said.

Robotics has demonstrated improved outcomes in managing patients with GERD, which has become a common problem after bariatric surgery, noted Dr. Afaneh. When he and his colleagues reviewed data from their center on robotic-assisted approaches to GERD after bariatric surgery, they found that, even in primary magnetic sphincter operations, “robotics maintains comparable outcomes in revisional sleeve gastrectomy fields,” he said.

Another notable benefit of robotics in bariatric surgery is the negation of the “assistant effect,” said Dr. Afaneh. Often, less experienced surgeons are matched with less experienced assistants. “We took a look at the use of the robotic in cases of complex GI surgeries,” he said. They compared laparoscopic and robotic cases and stratified them by third-year assistant or fellow. “If you had a fellow, the operative time dropped by half an hour for laparoscopic cases, but the time was no different in robotics cases,” regardless of the use of fellow or third-year assistant, he said.

“The robotic platform allows you to assist yourself,” and allows for full surgeon autonomy, Dr. Afaneh emphasized. “You are the best person at predicting your next step.” The robotics platform also serves as a teaching tool. “For those who teach, there is no added morbidity based on the assistance of the trainee,” he said. In addition, the improved visualization of robotics “allows for better appreciation of scarred tissue planes and more precise suturing,” he noted.

Overall, “one of the values of the robotic platform is shortening the learning curve,” Dr. Afaneh said. He reviewed data from his fellows and himself, and found no difference in operative times. “My mentee was able to achieve operative times as good as my third year in practice. The robotic platform shaved off several years of learning experience,” he said. Dr. Afaneh’s operative times also decreased with robotics, which shows how experienced surgeons learn from this technology, he said.

Dr. Afaneh disclosed serving as a consultant for Intuitive Surgical.

Global Academy for Medical Education and this news organization are owned by the same parent company.

Patients who underwent conversion to a laparoscopic sleeve gastrectomy after a previous laparoscopic adjustable gastric banding procedure experienced similar weight loss with either a one- or two-step procedure, a study of 78 patients showed.

“Laparoscopic adjustable gastric banding (LAGB) has largely fallen out of favor, likely related to variable efficacy in weight reduction coupled with poor effectiveness in reducing obesity related comorbidities like type 2 diabetes and hypercholesterolemia,” Vasu Chirumamilla, MD, of Westchester Medical Center, Valhalla, N.Y., and colleagues wrote in a poster presented at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.

LAGB also can cause complications including, slippage, erosion, and gastric pouch dilation; subsequently many patients undergo conversion to laparoscopic sleeve gastrectomy (LSG). However, the impact of a one-step vs. two-step conversion procedure on patient weight loss remains unclear, the researchers said.

To compare weight loss after the two types of procedures, the researchers reviewed data from 78 patients (71 women) aged 15-74 years treated between 2013 and 2018 at a multi-surgeon, private practice bariatric surgery center. All patients had a history of LAGB; 31 underwent conversion to LSG in one stage, and 47 underwent conversion in two stages. Weight loss, defined as the percentage excess weight loss, was the primary endpoint.

The average excess weight loss was 44% for patients in both the one-stage and two-stage groups, and body mass index decreased by 8.9 points and 8.8 points, respectively, in the two groups, the researchers wrote.

Patients in the two-stage group experienced a significant increase in body mass index (P = .008) during the time between band removal to sleeve gastrectomy, which was an average of 207 days, they said.

The findings were limited in part by the small sample size and retrospective design, and more data are needed to compare complication rates in one-stage and two-stage procedures, the researchers noted. However, the results showed “no difference in excess weight loss in patients converted from laparoscopic adjustable gastric band to sleeve gastrectomy in one-stage versus a two-stage procedure,” they concluded.

“LAGB used to be a very popular weight loss procedure – bands were placed in a great deal of patients,” Dr. Chirumamilla said in an interview. “Now those patients are presenting with increasing frequency to bariatric surgeons with band complications or weight regain. The volume for LSG is increasing and results in percentage excess weight loss of approximately 65% versus approximately 42% for LAGB,” he said. A goal of the study was to provide patients and the surgeons with a more informed approach to performing and consenting to the particular operation, he added.

“The results have not surprised us, because as long as done by experienced surgeons on compliant patients the weight loss outcomes from the day of surgery onward should be equivalent,” Dr. Chirumamilla explained. “We were also not surprised to find that patients undergoing a two-stage conversion gained weight before their second-stage sleeve gastrectomy.”

The bottom line for clinicians is that “patients getting a conversion from band to sleeve in one-stage versus two-stages experience the same percentage excess body weight loss from time of surgery,” although two-stage patients do gain weight while awaiting their second-stage sleeve gastrectomy, Dr. Chirumamilla said.

“More research is needed to compare short- and long-term complications rates between one-stage and two-stage conversions. The ideal research situation would be a randomized, multicenter, large volume study to reduce bias,” he noted.

Dr. Chirumamilla’s collaborators included Akia Caine MD, Zachary Ballinger, Rebecca Castro, Thomas Cerabona MD, and Ashutosh Kaul MD, of the surgical group Advanced Surgeons at nygetfit.com.

Global Academy for Medical Education and this news organization are owned by the same parent company. The study received no outside funding. The researchers had no financial conflicts to disclose.
 

SOURCE: Chirumamilla V et al. MISS 2020. Poster PA-14.

Patients who underwent conversion to a laparoscopic sleeve gastrectomy after a previous laparoscopic adjustable gastric banding procedure experienced similar weight loss with either a one- or two-step procedure, a study of 78 patients showed.

“Laparoscopic adjustable gastric banding (LAGB) has largely fallen out of favor, likely related to variable efficacy in weight reduction coupled with poor effectiveness in reducing obesity related comorbidities like type 2 diabetes and hypercholesterolemia,” Vasu Chirumamilla, MD, of Westchester Medical Center, Valhalla, N.Y., and colleagues wrote in a poster presented at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.

LAGB also can cause complications including, slippage, erosion, and gastric pouch dilation; subsequently many patients undergo conversion to laparoscopic sleeve gastrectomy (LSG). However, the impact of a one-step vs. two-step conversion procedure on patient weight loss remains unclear, the researchers said.

To compare weight loss after the two types of procedures, the researchers reviewed data from 78 patients (71 women) aged 15-74 years treated between 2013 and 2018 at a multi-surgeon, private practice bariatric surgery center. All patients had a history of LAGB; 31 underwent conversion to LSG in one stage, and 47 underwent conversion in two stages. Weight loss, defined as the percentage excess weight loss, was the primary endpoint.

The average excess weight loss was 44% for patients in both the one-stage and two-stage groups, and body mass index decreased by 8.9 points and 8.8 points, respectively, in the two groups, the researchers wrote.

Patients in the two-stage group experienced a significant increase in body mass index (P = .008) during the time between band removal to sleeve gastrectomy, which was an average of 207 days, they said.

The findings were limited in part by the small sample size and retrospective design, and more data are needed to compare complication rates in one-stage and two-stage procedures, the researchers noted. However, the results showed “no difference in excess weight loss in patients converted from laparoscopic adjustable gastric band to sleeve gastrectomy in one-stage versus a two-stage procedure,” they concluded.

“LAGB used to be a very popular weight loss procedure – bands were placed in a great deal of patients,” Dr. Chirumamilla said in an interview. “Now those patients are presenting with increasing frequency to bariatric surgeons with band complications or weight regain. The volume for LSG is increasing and results in percentage excess weight loss of approximately 65% versus approximately 42% for LAGB,” he said. A goal of the study was to provide patients and the surgeons with a more informed approach to performing and consenting to the particular operation, he added.

“The results have not surprised us, because as long as done by experienced surgeons on compliant patients the weight loss outcomes from the day of surgery onward should be equivalent,” Dr. Chirumamilla explained. “We were also not surprised to find that patients undergoing a two-stage conversion gained weight before their second-stage sleeve gastrectomy.”

The bottom line for clinicians is that “patients getting a conversion from band to sleeve in one-stage versus two-stages experience the same percentage excess body weight loss from time of surgery,” although two-stage patients do gain weight while awaiting their second-stage sleeve gastrectomy, Dr. Chirumamilla said.

“More research is needed to compare short- and long-term complications rates between one-stage and two-stage conversions. The ideal research situation would be a randomized, multicenter, large volume study to reduce bias,” he noted.

Dr. Chirumamilla’s collaborators included Akia Caine MD, Zachary Ballinger, Rebecca Castro, Thomas Cerabona MD, and Ashutosh Kaul MD, of the surgical group Advanced Surgeons at nygetfit.com.

Global Academy for Medical Education and this news organization are owned by the same parent company. The study received no outside funding. The researchers had no financial conflicts to disclose.
 

SOURCE: Chirumamilla V et al. MISS 2020. Poster PA-14.

Patients who underwent conversion to a laparoscopic sleeve gastrectomy after a previous laparoscopic adjustable gastric banding procedure experienced similar weight loss with either a one- or two-step procedure, a study of 78 patients showed.

“Laparoscopic adjustable gastric banding (LAGB) has largely fallen out of favor, likely related to variable efficacy in weight reduction coupled with poor effectiveness in reducing obesity related comorbidities like type 2 diabetes and hypercholesterolemia,” Vasu Chirumamilla, MD, of Westchester Medical Center, Valhalla, N.Y., and colleagues wrote in a poster presented at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.

LAGB also can cause complications including, slippage, erosion, and gastric pouch dilation; subsequently many patients undergo conversion to laparoscopic sleeve gastrectomy (LSG). However, the impact of a one-step vs. two-step conversion procedure on patient weight loss remains unclear, the researchers said.

To compare weight loss after the two types of procedures, the researchers reviewed data from 78 patients (71 women) aged 15-74 years treated between 2013 and 2018 at a multi-surgeon, private practice bariatric surgery center. All patients had a history of LAGB; 31 underwent conversion to LSG in one stage, and 47 underwent conversion in two stages. Weight loss, defined as the percentage excess weight loss, was the primary endpoint.

The average excess weight loss was 44% for patients in both the one-stage and two-stage groups, and body mass index decreased by 8.9 points and 8.8 points, respectively, in the two groups, the researchers wrote.

Patients in the two-stage group experienced a significant increase in body mass index (P = .008) during the time between band removal to sleeve gastrectomy, which was an average of 207 days, they said.

The findings were limited in part by the small sample size and retrospective design, and more data are needed to compare complication rates in one-stage and two-stage procedures, the researchers noted. However, the results showed “no difference in excess weight loss in patients converted from laparoscopic adjustable gastric band to sleeve gastrectomy in one-stage versus a two-stage procedure,” they concluded.

“LAGB used to be a very popular weight loss procedure – bands were placed in a great deal of patients,” Dr. Chirumamilla said in an interview. “Now those patients are presenting with increasing frequency to bariatric surgeons with band complications or weight regain. The volume for LSG is increasing and results in percentage excess weight loss of approximately 65% versus approximately 42% for LAGB,” he said. A goal of the study was to provide patients and the surgeons with a more informed approach to performing and consenting to the particular operation, he added.

“The results have not surprised us, because as long as done by experienced surgeons on compliant patients the weight loss outcomes from the day of surgery onward should be equivalent,” Dr. Chirumamilla explained. “We were also not surprised to find that patients undergoing a two-stage conversion gained weight before their second-stage sleeve gastrectomy.”

The bottom line for clinicians is that “patients getting a conversion from band to sleeve in one-stage versus two-stages experience the same percentage excess body weight loss from time of surgery,” although two-stage patients do gain weight while awaiting their second-stage sleeve gastrectomy, Dr. Chirumamilla said.

“More research is needed to compare short- and long-term complications rates between one-stage and two-stage conversions. The ideal research situation would be a randomized, multicenter, large volume study to reduce bias,” he noted.

Dr. Chirumamilla’s collaborators included Akia Caine MD, Zachary Ballinger, Rebecca Castro, Thomas Cerabona MD, and Ashutosh Kaul MD, of the surgical group Advanced Surgeons at nygetfit.com.

Global Academy for Medical Education and this news organization are owned by the same parent company. The study received no outside funding. The researchers had no financial conflicts to disclose.
 

SOURCE: Chirumamilla V et al. MISS 2020. Poster PA-14.

New recommendations for the management of metabolic and bariatric surgery candidates during and after the COVID-19 pandemic shift the focus from body mass index (BMI) alone to medical conditions most likely to be ameliorated by the procedures.

Meant as a guide for both surgeons and referring clinicians, the document was published online May 7 as a Personal View in Lancet Diabetes & Endocrinology.

“Millions of elective operations have been on hold because of COVID-19. ... In the next few months, we’re going to face a huge backlog of procedures of all types. Even when we resume doing surgery it’s not going to be business as usual for many months. ... Hospital clinicians and managers want to make decisions about who’s going to get those slots first,” lead author of the international 23-member writing panel, Francesco Rubino, MD, told Medscape Medical News.

Rubino is professor of metabolic and bariatric surgery at King’s College Hospital, London, UK.

The recommendations include a guide for prioritizing patients eligible for bariatric or metabolic surgery – the former referring to when it’s performed primarily for obesity and the latter for type 2 diabetes – once the pandemic restrictions on nonessential surgery are lifted.

Rather than prioritizing patients by BMI, the scheme focuses on medical comorbidities to place patients into “expedited” or “standard” access categories.

Historically, bariatric and metabolic surgery have had a low uptake due to factors such as lack of insurance coverage and stigma, with many physicians inappropriately viewing it as risky, ineffective, and/or as a “last resort” treatment, Rubino said.

“They don’t refer for surgery even though we have all the evidence that the benefits for patients are unquestionable,” he added.

Because of that background, “in the situation of limited capacity, patients with obesity and type 2 diabetes are likely to be penalized compared to any other conditions that need elective surgery,” Rubino stressed.

Asked to comment, Scott Kahan, MD, director of the National Center for Weight and Wellness in Washington, D.C., called the document a “really valuable thought piece.”

Noting that only about 1% to 2% of people who are eligible for bariatric or metabolic surgery actually undergo the procedures, Kahan said, “because so few people get the surgery we’ve never really run into a situation of undersupply or overdemand.

“But, as we’re moving forward, one would think that we will run into that scenario. So, better prioritizing and triaging patients likely will be more important down the line, given how effective surgery has been shown to be now, both short term and long term.”

Risks of obesity, shifting away from BMI as the main metric

The new document extensively discusses the risks of obesity – including now as a major COVID-19 risk factor – and the benefits of the procedures and risks of delaying them.

It also addresses ongoing management of patients who had bariatric/metabolic surgery in the past and nonsurgical treatment to mitigate harm until patients can undergo the procedures.

Another important problem the document addresses, Rubino said, is the current BMI-focused bariatric/metabolic surgery criteria (≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity).

“BMI is an epidemiological measure, not a measure of disease. But we select patients for bariatric surgery by saying who is eligible [without assessing] who has more or less severe disease, and who is at more or less risk for short-term complications from the disease compared to others,” he explained. “We don’t have any mechanism, even in normal times, let alone during a pandemic, to differentiate between patients who need surgery sooner rather than later.”

Indeed, Kahan said, “Traditionally we tend to oversimplify risk stratification in terms of how heavy people are. While that is one factor of importance, it’s far from the only factor and may not be the most important factor.”

In “someone who is relatively lighter but sicker, it would be sensible, in my mind, to prioritize them for a potentially curative procedure compared with someone who is heavier – even much heavier – but is not as sick,” he added.
 

“Pandemic forces us to do what was long overdue”

The document confirms that bariatric/metabolic surgery should remain suspended during the most intense phase of the COVID-19 pandemic and only resume once overall restrictions on nonessential surgeries are lifted.

Exceptions are limited to emergency endoscopic interventions for complications of prior surgery, such as hemorrhage or leaks.

A section offers guidance for pharmacologic and other nonsurgical options to mitigate harm from delaying the procedures including use of drugs that promote weight loss, such as glucagonlike peptide-1 receptor agonists and/or sodium-glucose cotransporter 2 inhibitors.

Once less-urgent surgeries are allowed to resume, a prioritization scheme addresses which patients should receive “expedited access” (risk of harm if delayed beyond 90 days) versus “standard access” (unlikely to deteriorate within 6 months) within three indication categories: “diabetes (metabolic) surgery,” “obesity (bariatric) surgery,” or “adjuvant bariatric and metabolic surgery.”

Examples of patients who would qualify for “expedited” access in the “diabetes surgery” category include those with an A_1c of 8% or greater despite use of two or more oral medications or insulin use, those with a history of cardiovascular disease, and/or those with stage 3-4 chronic kidney disease.

For the “obesity surgery” group, priority patients include those with a BMI of 60 kg/m2 or greater or with severe obesity hypoventilation syndrome or severe sleep apnea.

And for the adjuvant category, those requiring weight loss to allow for other treatments, such as organ transplants, would be expedited.

Individuals with less-severe obesity or chronic conditions could have their surgeries put off until a later date.

The panel also recommends that even though keyhole surgery involves aerosol-generating techniques that could increase the risk for coronavirus infection, laparoscopic approaches are still preferred over open procedures because they carry lower risks for complications and result in shorter hospital stays, thereby lowering infection risk.

Appropriate personal protective equipment is, of course, advised for use by clinicians.

Kahan said of the document: “I think it’s a very sensible piece where they’re thinking through things that haven’t really needed to be thought through all that much. That’s partly with respect to COVID-19, but even beyond that I think this will be a valuable platform going forward.”

Indeed, Rubino said, “The pandemic forces us to do what was long overdue.”

Rubino has reported being on advisory boards for GI Dynamics, Keyron, and Novo Nordisk, has reported receiving consulting fees and research grants from Ethicon Endo-Surgery and Medtronic. Kahan has reported no relevant financial relationships.

This article first appeared on Medscape.com.

New recommendations for the management of metabolic and bariatric surgery candidates during and after the COVID-19 pandemic shift the focus from body mass index (BMI) alone to medical conditions most likely to be ameliorated by the procedures.

Meant as a guide for both surgeons and referring clinicians, the document was published online May 7 as a Personal View in Lancet Diabetes & Endocrinology.

“Millions of elective operations have been on hold because of COVID-19. ... In the next few months, we’re going to face a huge backlog of procedures of all types. Even when we resume doing surgery it’s not going to be business as usual for many months. ... Hospital clinicians and managers want to make decisions about who’s going to get those slots first,” lead author of the international 23-member writing panel, Francesco Rubino, MD, told Medscape Medical News.

Rubino is professor of metabolic and bariatric surgery at King’s College Hospital, London, UK.

The recommendations include a guide for prioritizing patients eligible for bariatric or metabolic surgery – the former referring to when it’s performed primarily for obesity and the latter for type 2 diabetes – once the pandemic restrictions on nonessential surgery are lifted.

Rather than prioritizing patients by BMI, the scheme focuses on medical comorbidities to place patients into “expedited” or “standard” access categories.

Historically, bariatric and metabolic surgery have had a low uptake due to factors such as lack of insurance coverage and stigma, with many physicians inappropriately viewing it as risky, ineffective, and/or as a “last resort” treatment, Rubino said.

“They don’t refer for surgery even though we have all the evidence that the benefits for patients are unquestionable,” he added.

Because of that background, “in the situation of limited capacity, patients with obesity and type 2 diabetes are likely to be penalized compared to any other conditions that need elective surgery,” Rubino stressed.

Asked to comment, Scott Kahan, MD, director of the National Center for Weight and Wellness in Washington, D.C., called the document a “really valuable thought piece.”

Noting that only about 1% to 2% of people who are eligible for bariatric or metabolic surgery actually undergo the procedures, Kahan said, “because so few people get the surgery we’ve never really run into a situation of undersupply or overdemand.

“But, as we’re moving forward, one would think that we will run into that scenario. So, better prioritizing and triaging patients likely will be more important down the line, given how effective surgery has been shown to be now, both short term and long term.”

Risks of obesity, shifting away from BMI as the main metric

The new document extensively discusses the risks of obesity – including now as a major COVID-19 risk factor – and the benefits of the procedures and risks of delaying them.

It also addresses ongoing management of patients who had bariatric/metabolic surgery in the past and nonsurgical treatment to mitigate harm until patients can undergo the procedures.

Another important problem the document addresses, Rubino said, is the current BMI-focused bariatric/metabolic surgery criteria (≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity).

“BMI is an epidemiological measure, not a measure of disease. But we select patients for bariatric surgery by saying who is eligible [without assessing] who has more or less severe disease, and who is at more or less risk for short-term complications from the disease compared to others,” he explained. “We don’t have any mechanism, even in normal times, let alone during a pandemic, to differentiate between patients who need surgery sooner rather than later.”

Indeed, Kahan said, “Traditionally we tend to oversimplify risk stratification in terms of how heavy people are. While that is one factor of importance, it’s far from the only factor and may not be the most important factor.”

In “someone who is relatively lighter but sicker, it would be sensible, in my mind, to prioritize them for a potentially curative procedure compared with someone who is heavier – even much heavier – but is not as sick,” he added.
 

“Pandemic forces us to do what was long overdue”

The document confirms that bariatric/metabolic surgery should remain suspended during the most intense phase of the COVID-19 pandemic and only resume once overall restrictions on nonessential surgeries are lifted.

Exceptions are limited to emergency endoscopic interventions for complications of prior surgery, such as hemorrhage or leaks.

A section offers guidance for pharmacologic and other nonsurgical options to mitigate harm from delaying the procedures including use of drugs that promote weight loss, such as glucagonlike peptide-1 receptor agonists and/or sodium-glucose cotransporter 2 inhibitors.

Once less-urgent surgeries are allowed to resume, a prioritization scheme addresses which patients should receive “expedited access” (risk of harm if delayed beyond 90 days) versus “standard access” (unlikely to deteriorate within 6 months) within three indication categories: “diabetes (metabolic) surgery,” “obesity (bariatric) surgery,” or “adjuvant bariatric and metabolic surgery.”

Examples of patients who would qualify for “expedited” access in the “diabetes surgery” category include those with an A_1c of 8% or greater despite use of two or more oral medications or insulin use, those with a history of cardiovascular disease, and/or those with stage 3-4 chronic kidney disease.

For the “obesity surgery” group, priority patients include those with a BMI of 60 kg/m2 or greater or with severe obesity hypoventilation syndrome or severe sleep apnea.

And for the adjuvant category, those requiring weight loss to allow for other treatments, such as organ transplants, would be expedited.

Individuals with less-severe obesity or chronic conditions could have their surgeries put off until a later date.

The panel also recommends that even though keyhole surgery involves aerosol-generating techniques that could increase the risk for coronavirus infection, laparoscopic approaches are still preferred over open procedures because they carry lower risks for complications and result in shorter hospital stays, thereby lowering infection risk.

Appropriate personal protective equipment is, of course, advised for use by clinicians.

Kahan said of the document: “I think it’s a very sensible piece where they’re thinking through things that haven’t really needed to be thought through all that much. That’s partly with respect to COVID-19, but even beyond that I think this will be a valuable platform going forward.”

Indeed, Rubino said, “The pandemic forces us to do what was long overdue.”

Rubino has reported being on advisory boards for GI Dynamics, Keyron, and Novo Nordisk, has reported receiving consulting fees and research grants from Ethicon Endo-Surgery and Medtronic. Kahan has reported no relevant financial relationships.

This article first appeared on Medscape.com.

New recommendations for the management of metabolic and bariatric surgery candidates during and after the COVID-19 pandemic shift the focus from body mass index (BMI) alone to medical conditions most likely to be ameliorated by the procedures.

Meant as a guide for both surgeons and referring clinicians, the document was published online May 7 as a Personal View in Lancet Diabetes & Endocrinology.

“Millions of elective operations have been on hold because of COVID-19. ... In the next few months, we’re going to face a huge backlog of procedures of all types. Even when we resume doing surgery it’s not going to be business as usual for many months. ... Hospital clinicians and managers want to make decisions about who’s going to get those slots first,” lead author of the international 23-member writing panel, Francesco Rubino, MD, told Medscape Medical News.

Rubino is professor of metabolic and bariatric surgery at King’s College Hospital, London, UK.

The recommendations include a guide for prioritizing patients eligible for bariatric or metabolic surgery – the former referring to when it’s performed primarily for obesity and the latter for type 2 diabetes – once the pandemic restrictions on nonessential surgery are lifted.

Rather than prioritizing patients by BMI, the scheme focuses on medical comorbidities to place patients into “expedited” or “standard” access categories.

Historically, bariatric and metabolic surgery have had a low uptake due to factors such as lack of insurance coverage and stigma, with many physicians inappropriately viewing it as risky, ineffective, and/or as a “last resort” treatment, Rubino said.

“They don’t refer for surgery even though we have all the evidence that the benefits for patients are unquestionable,” he added.

Because of that background, “in the situation of limited capacity, patients with obesity and type 2 diabetes are likely to be penalized compared to any other conditions that need elective surgery,” Rubino stressed.

Asked to comment, Scott Kahan, MD, director of the National Center for Weight and Wellness in Washington, D.C., called the document a “really valuable thought piece.”

Noting that only about 1% to 2% of people who are eligible for bariatric or metabolic surgery actually undergo the procedures, Kahan said, “because so few people get the surgery we’ve never really run into a situation of undersupply or overdemand.

“But, as we’re moving forward, one would think that we will run into that scenario. So, better prioritizing and triaging patients likely will be more important down the line, given how effective surgery has been shown to be now, both short term and long term.”

Risks of obesity, shifting away from BMI as the main metric

The new document extensively discusses the risks of obesity – including now as a major COVID-19 risk factor – and the benefits of the procedures and risks of delaying them.

It also addresses ongoing management of patients who had bariatric/metabolic surgery in the past and nonsurgical treatment to mitigate harm until patients can undergo the procedures.

Another important problem the document addresses, Rubino said, is the current BMI-focused bariatric/metabolic surgery criteria (≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity).

“BMI is an epidemiological measure, not a measure of disease. But we select patients for bariatric surgery by saying who is eligible [without assessing] who has more or less severe disease, and who is at more or less risk for short-term complications from the disease compared to others,” he explained. “We don’t have any mechanism, even in normal times, let alone during a pandemic, to differentiate between patients who need surgery sooner rather than later.”

Indeed, Kahan said, “Traditionally we tend to oversimplify risk stratification in terms of how heavy people are. While that is one factor of importance, it’s far from the only factor and may not be the most important factor.”

In “someone who is relatively lighter but sicker, it would be sensible, in my mind, to prioritize them for a potentially curative procedure compared with someone who is heavier – even much heavier – but is not as sick,” he added.
 

“Pandemic forces us to do what was long overdue”

The document confirms that bariatric/metabolic surgery should remain suspended during the most intense phase of the COVID-19 pandemic and only resume once overall restrictions on nonessential surgeries are lifted.

Exceptions are limited to emergency endoscopic interventions for complications of prior surgery, such as hemorrhage or leaks.

A section offers guidance for pharmacologic and other nonsurgical options to mitigate harm from delaying the procedures including use of drugs that promote weight loss, such as glucagonlike peptide-1 receptor agonists and/or sodium-glucose cotransporter 2 inhibitors.

Once less-urgent surgeries are allowed to resume, a prioritization scheme addresses which patients should receive “expedited access” (risk of harm if delayed beyond 90 days) versus “standard access” (unlikely to deteriorate within 6 months) within three indication categories: “diabetes (metabolic) surgery,” “obesity (bariatric) surgery,” or “adjuvant bariatric and metabolic surgery.”

Examples of patients who would qualify for “expedited” access in the “diabetes surgery” category include those with an A_1c of 8% or greater despite use of two or more oral medications or insulin use, those with a history of cardiovascular disease, and/or those with stage 3-4 chronic kidney disease.

For the “obesity surgery” group, priority patients include those with a BMI of 60 kg/m2 or greater or with severe obesity hypoventilation syndrome or severe sleep apnea.

And for the adjuvant category, those requiring weight loss to allow for other treatments, such as organ transplants, would be expedited.

Individuals with less-severe obesity or chronic conditions could have their surgeries put off until a later date.

The panel also recommends that even though keyhole surgery involves aerosol-generating techniques that could increase the risk for coronavirus infection, laparoscopic approaches are still preferred over open procedures because they carry lower risks for complications and result in shorter hospital stays, thereby lowering infection risk.

Appropriate personal protective equipment is, of course, advised for use by clinicians.

Kahan said of the document: “I think it’s a very sensible piece where they’re thinking through things that haven’t really needed to be thought through all that much. That’s partly with respect to COVID-19, but even beyond that I think this will be a valuable platform going forward.”

Indeed, Rubino said, “The pandemic forces us to do what was long overdue.”

Rubino has reported being on advisory boards for GI Dynamics, Keyron, and Novo Nordisk, has reported receiving consulting fees and research grants from Ethicon Endo-Surgery and Medtronic. Kahan has reported no relevant financial relationships.

This article first appeared on Medscape.com.

Despite an increasing rate of obesity in the United States, sleeve gastrectomy and postoperative antiobesity pharmacotherapy remain significantly underutilized, according to investigators.

A retrospective study involving almost 3 million adults with obesity found that only 0.94% had undergone sleeve gastrectomy, with 5.6% of those receiving weight-loss drugs after discharge, reported lead author Raj Shah, MD, of University Hospitals Cleveland Medical Center, and colleagues.

“While obesity has increased exponentially in the past decade, the trends of bariatric procedures and postoperative pharmacotherapy in this timeline is not well established,” the investigators wrote in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19.

According to coauthor Abbinaya Elangovan, MD, of MetroHealth Medical Center, Cleveland, existing data suggest a practice gap.

“We know from published studies that antiobesity measures – both surgical and pharmacotherapeutic – do not match the rates of obesity,” Dr. Elangovan said. “We wanted to see how many of the morbidly obese [patients] who get bariatric surgery get started on antiobesity pharmacotherapy. We selected sleeve gastrectomy, as that is the most common bariatric procedure performed in the United States in recent times.”

The investigators began by retrospectively screening 2,717,000 individuals with a body mass index (in kg/m₂) of at least 40 who entered the IBM Explorys database from 2010 to 2019. Out of this group, 25,540 individuals (0.94%) had undergone sleeve gastrectomy. Annual rates of the procedure increased from 0.06% in 2010 to 0.4% in 2019 (P < .0001).

Of the 25,540 patients who underwent sleeve gastrectomy, 1,440 (5.6%) were prescribed antiobesity medication after surgery, with about half (47%) of these prescriptions written within a year. The most common medication was phentermine (66%), followed by bupropion/naltrexone (16%) and phentermine/topiramate (14.4%).

Dr. Elangovan said that the rates of surgery and antiobesity pharmacotherapy found in the study were “sparse” compared with rates of obesity.

“[Future studies need] to find the barriers to antiobesity pharmacotherapy,” Dr. Elangovan said. “We know from some of the published studies that there are differences in provider perceptions, as well as patient populations who get the therapy.”

The present analysis showed that women, African Americans, and patients with commercial insurance were significantly more likely to receive postoperative weight-loss medications than other patient subgroups.

“I think insurance could be a potential concern,” Dr. Elangovan said. “This has been shown previously in the literature.” She also suggested that women may be accessing obesity-related health care more often than men.

Discussing steps to improve interventions for patients with obesity, Dr. Elangovan emphasized the amount of data supporting antiobesity pharmacotherapy.

“We know from studies published so far that combining pharmacotherapy with behavioral modifications has a greater percentage of success, compared to behavioral modifications by themselves,” Dr. Elangovan said.

According to Dr. Elangovan, primary care providers play a key role in connecting obese patients with the treatments they need, requiring familiarity with existing guidelines.

“It helps if practicing clinicians, especially primary care providers, are familiar with bariatric surgery criteria and institution policies,” Dr. Elangovan said. “It has been shown in some studies that limited experience in prescribing and concern for adverse reactions could affect the prescription of antiobesity pharmacotherapy. Targeted interventions such as educational programs may increase the appropriate usage of medications.”

Dr. Smith disclosed a relationship with US Endoscopy.

SOURCE: Shah R et al. DDW 2020, Abstract 791.

Despite an increasing rate of obesity in the United States, sleeve gastrectomy and postoperative antiobesity pharmacotherapy remain significantly underutilized, according to investigators.

A retrospective study involving almost 3 million adults with obesity found that only 0.94% had undergone sleeve gastrectomy, with 5.6% of those receiving weight-loss drugs after discharge, reported lead author Raj Shah, MD, of University Hospitals Cleveland Medical Center, and colleagues.

“While obesity has increased exponentially in the past decade, the trends of bariatric procedures and postoperative pharmacotherapy in this timeline is not well established,” the investigators wrote in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19.

According to coauthor Abbinaya Elangovan, MD, of MetroHealth Medical Center, Cleveland, existing data suggest a practice gap.

“We know from published studies that antiobesity measures – both surgical and pharmacotherapeutic – do not match the rates of obesity,” Dr. Elangovan said. “We wanted to see how many of the morbidly obese [patients] who get bariatric surgery get started on antiobesity pharmacotherapy. We selected sleeve gastrectomy, as that is the most common bariatric procedure performed in the United States in recent times.”

The investigators began by retrospectively screening 2,717,000 individuals with a body mass index (in kg/m₂) of at least 40 who entered the IBM Explorys database from 2010 to 2019. Out of this group, 25,540 individuals (0.94%) had undergone sleeve gastrectomy. Annual rates of the procedure increased from 0.06% in 2010 to 0.4% in 2019 (P < .0001).

Of the 25,540 patients who underwent sleeve gastrectomy, 1,440 (5.6%) were prescribed antiobesity medication after surgery, with about half (47%) of these prescriptions written within a year. The most common medication was phentermine (66%), followed by bupropion/naltrexone (16%) and phentermine/topiramate (14.4%).

Dr. Elangovan said that the rates of surgery and antiobesity pharmacotherapy found in the study were “sparse” compared with rates of obesity.

“[Future studies need] to find the barriers to antiobesity pharmacotherapy,” Dr. Elangovan said. “We know from some of the published studies that there are differences in provider perceptions, as well as patient populations who get the therapy.”

The present analysis showed that women, African Americans, and patients with commercial insurance were significantly more likely to receive postoperative weight-loss medications than other patient subgroups.

“I think insurance could be a potential concern,” Dr. Elangovan said. “This has been shown previously in the literature.” She also suggested that women may be accessing obesity-related health care more often than men.

Discussing steps to improve interventions for patients with obesity, Dr. Elangovan emphasized the amount of data supporting antiobesity pharmacotherapy.

“We know from studies published so far that combining pharmacotherapy with behavioral modifications has a greater percentage of success, compared to behavioral modifications by themselves,” Dr. Elangovan said.

According to Dr. Elangovan, primary care providers play a key role in connecting obese patients with the treatments they need, requiring familiarity with existing guidelines.

“It helps if practicing clinicians, especially primary care providers, are familiar with bariatric surgery criteria and institution policies,” Dr. Elangovan said. “It has been shown in some studies that limited experience in prescribing and concern for adverse reactions could affect the prescription of antiobesity pharmacotherapy. Targeted interventions such as educational programs may increase the appropriate usage of medications.”

Dr. Smith disclosed a relationship with US Endoscopy.

SOURCE: Shah R et al. DDW 2020, Abstract 791.

Despite an increasing rate of obesity in the United States, sleeve gastrectomy and postoperative antiobesity pharmacotherapy remain significantly underutilized, according to investigators.

A retrospective study involving almost 3 million adults with obesity found that only 0.94% had undergone sleeve gastrectomy, with 5.6% of those receiving weight-loss drugs after discharge, reported lead author Raj Shah, MD, of University Hospitals Cleveland Medical Center, and colleagues.

“While obesity has increased exponentially in the past decade, the trends of bariatric procedures and postoperative pharmacotherapy in this timeline is not well established,” the investigators wrote in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19.

According to coauthor Abbinaya Elangovan, MD, of MetroHealth Medical Center, Cleveland, existing data suggest a practice gap.

“We know from published studies that antiobesity measures – both surgical and pharmacotherapeutic – do not match the rates of obesity,” Dr. Elangovan said. “We wanted to see how many of the morbidly obese [patients] who get bariatric surgery get started on antiobesity pharmacotherapy. We selected sleeve gastrectomy, as that is the most common bariatric procedure performed in the United States in recent times.”

The investigators began by retrospectively screening 2,717,000 individuals with a body mass index (in kg/m₂) of at least 40 who entered the IBM Explorys database from 2010 to 2019. Out of this group, 25,540 individuals (0.94%) had undergone sleeve gastrectomy. Annual rates of the procedure increased from 0.06% in 2010 to 0.4% in 2019 (P < .0001).

Of the 25,540 patients who underwent sleeve gastrectomy, 1,440 (5.6%) were prescribed antiobesity medication after surgery, with about half (47%) of these prescriptions written within a year. The most common medication was phentermine (66%), followed by bupropion/naltrexone (16%) and phentermine/topiramate (14.4%).

Dr. Elangovan said that the rates of surgery and antiobesity pharmacotherapy found in the study were “sparse” compared with rates of obesity.

“[Future studies need] to find the barriers to antiobesity pharmacotherapy,” Dr. Elangovan said. “We know from some of the published studies that there are differences in provider perceptions, as well as patient populations who get the therapy.”

The present analysis showed that women, African Americans, and patients with commercial insurance were significantly more likely to receive postoperative weight-loss medications than other patient subgroups.

“I think insurance could be a potential concern,” Dr. Elangovan said. “This has been shown previously in the literature.” She also suggested that women may be accessing obesity-related health care more often than men.

Discussing steps to improve interventions for patients with obesity, Dr. Elangovan emphasized the amount of data supporting antiobesity pharmacotherapy.

“We know from studies published so far that combining pharmacotherapy with behavioral modifications has a greater percentage of success, compared to behavioral modifications by themselves,” Dr. Elangovan said.

According to Dr. Elangovan, primary care providers play a key role in connecting obese patients with the treatments they need, requiring familiarity with existing guidelines.

“It helps if practicing clinicians, especially primary care providers, are familiar with bariatric surgery criteria and institution policies,” Dr. Elangovan said. “It has been shown in some studies that limited experience in prescribing and concern for adverse reactions could affect the prescription of antiobesity pharmacotherapy. Targeted interventions such as educational programs may increase the appropriate usage of medications.”

Dr. Smith disclosed a relationship with US Endoscopy.

SOURCE: Shah R et al. DDW 2020, Abstract 791.

The results of two postapproval studies confirm the potential risk of hyperinflation and acute pancreatitis with the Orbera and ReShape liquid-filled intragastric balloon systems used to treat obesity.

The Orbera Intragastric Balloon System is manufactured by Apollo Endosurgery. The ReShape Integrated Dual Balloon System was previously manufactured by ReShape Medical but was acquired by Apollo Endosurgery in December 2018.

In the Orbera postapproval study, 6 of 258 patients (2.3%) experienced balloon hyperinflation, the Food and Drug Administration said today in a letter to health care providers. There were no hyperinflation events detected in the ReShape postapproval study.

Acute pancreatitis was reported in 2 of 159 patients (1.3%) in the ReShape study, with no cases of acute pancreatitis reported in the Orbera study.

No balloon hyperinflation or acute pancreatitis events were reported in the studies the companies submitted to the FDA to gain approval, the agency said.

No deaths were reported in the postapproval studies, though the agency notes that the studies were not powered to detect. However, since Orbera and ReShape were approved in 2015, the FDA has learned of 18 deaths worldwide, including 8 patients in the United States (5 with Orbera and 3 with ReShape).

The FDA issued previous letters to health care providers concerning issues with these devices in June 2018, August 2017, and February 2017.

As of Jan. 1, 2019, Apollo Endosurgery stopped selling the ReShape Balloon. The Orbera balloon remains available.

“The FDA wants to ensure healthcare professionals are aware of the rates of these potential complications observed in the post-approval studies so they can discuss the risks and benefits of weight loss treatments with patients and monitor patients during treatment,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device, and Human Factors Office at the FDA’s Center for Devices and Radiological Health, said in a statement.

“While these devices remain an appropriate treatment option for some patients with obesity, patients should always discuss with their doctors which treatment option is best for them,” said Dr. Fisher.

A version of this article originally appeared on Medscape.com.

The results of two postapproval studies confirm the potential risk of hyperinflation and acute pancreatitis with the Orbera and ReShape liquid-filled intragastric balloon systems used to treat obesity.

The Orbera Intragastric Balloon System is manufactured by Apollo Endosurgery. The ReShape Integrated Dual Balloon System was previously manufactured by ReShape Medical but was acquired by Apollo Endosurgery in December 2018.

In the Orbera postapproval study, 6 of 258 patients (2.3%) experienced balloon hyperinflation, the Food and Drug Administration said today in a letter to health care providers. There were no hyperinflation events detected in the ReShape postapproval study.

Acute pancreatitis was reported in 2 of 159 patients (1.3%) in the ReShape study, with no cases of acute pancreatitis reported in the Orbera study.

No balloon hyperinflation or acute pancreatitis events were reported in the studies the companies submitted to the FDA to gain approval, the agency said.

No deaths were reported in the postapproval studies, though the agency notes that the studies were not powered to detect. However, since Orbera and ReShape were approved in 2015, the FDA has learned of 18 deaths worldwide, including 8 patients in the United States (5 with Orbera and 3 with ReShape).

The FDA issued previous letters to health care providers concerning issues with these devices in June 2018, August 2017, and February 2017.

As of Jan. 1, 2019, Apollo Endosurgery stopped selling the ReShape Balloon. The Orbera balloon remains available.

“The FDA wants to ensure healthcare professionals are aware of the rates of these potential complications observed in the post-approval studies so they can discuss the risks and benefits of weight loss treatments with patients and monitor patients during treatment,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device, and Human Factors Office at the FDA’s Center for Devices and Radiological Health, said in a statement.

“While these devices remain an appropriate treatment option for some patients with obesity, patients should always discuss with their doctors which treatment option is best for them,” said Dr. Fisher.

A version of this article originally appeared on Medscape.com.

The results of two postapproval studies confirm the potential risk of hyperinflation and acute pancreatitis with the Orbera and ReShape liquid-filled intragastric balloon systems used to treat obesity.

The Orbera Intragastric Balloon System is manufactured by Apollo Endosurgery. The ReShape Integrated Dual Balloon System was previously manufactured by ReShape Medical but was acquired by Apollo Endosurgery in December 2018.

In the Orbera postapproval study, 6 of 258 patients (2.3%) experienced balloon hyperinflation, the Food and Drug Administration said today in a letter to health care providers. There were no hyperinflation events detected in the ReShape postapproval study.

Acute pancreatitis was reported in 2 of 159 patients (1.3%) in the ReShape study, with no cases of acute pancreatitis reported in the Orbera study.

No balloon hyperinflation or acute pancreatitis events were reported in the studies the companies submitted to the FDA to gain approval, the agency said.

No deaths were reported in the postapproval studies, though the agency notes that the studies were not powered to detect. However, since Orbera and ReShape were approved in 2015, the FDA has learned of 18 deaths worldwide, including 8 patients in the United States (5 with Orbera and 3 with ReShape).

The FDA issued previous letters to health care providers concerning issues with these devices in June 2018, August 2017, and February 2017.

As of Jan. 1, 2019, Apollo Endosurgery stopped selling the ReShape Balloon. The Orbera balloon remains available.

“The FDA wants to ensure healthcare professionals are aware of the rates of these potential complications observed in the post-approval studies so they can discuss the risks and benefits of weight loss treatments with patients and monitor patients during treatment,” Benjamin Fisher, PhD, director of the Reproductive, Gastro-Renal, Urological, General Hospital Device, and Human Factors Office at the FDA’s Center for Devices and Radiological Health, said in a statement.

“While these devices remain an appropriate treatment option for some patients with obesity, patients should always discuss with their doctors which treatment option is best for them,” said Dr. Fisher.

A version of this article originally appeared on Medscape.com.

People with diabetes may benefit less from bariatric surgery, compared with those without the disease, according to a retrospective review of patients receiving both sleeve gastrectomy and gastric bypass.

The difference was particularly pronounced and persistent for patients who had gastric bypass, Yingying Luo, MD, said during a virtual news conference held by the Endocrine Society. The study was slated for presentation during ENDO 2020, the society’s annual meeting, which was canceled because of the COVID-19 pandemic.

“Our findings demonstrated that having bariatric surgery before developing diabetes may result in greater weight loss from the surgery, especially within the first 3 years after surgery and in patients undergoing gastric bypass surgery,” said Dr. Luo.

More than a third of U.S. adults have obesity, and more than half the population is overweight or has obesity, said Dr. Luo, citing data from the Centers for Disease Control and Prevention.

Bariatric surgery not only reduces body weight, but also “can lead to remission of many metabolic disorders, including diabetes, hypertension, and dyslipidemia,” said Dr. Luo, a visiting scholar at the University of Michigan’s division of metabolism, endocrinology, and diabetes. However, until now, it has not been known how diabetes interacts with bariatric surgery to affect weight loss outcomes.

To address that question, Dr. Luo and her colleagues looked at patients in the Michigan Bariatric Surgery Cohort who were at least 18 years old and had a body mass index (BMI) of more than 40 kg/m², or of more than 35 kg/m² with comorbidities.

The researchers followed 380 patients who received gastric bypass and 334 who received sleeve gastrectomy for at least 5 years. Over time, sleeve gastrectomy became the predominant type of surgery conducted, noted Dr. Luo.

At baseline, and yearly for 5 years thereafter, the researchers recorded participants’ BMI as well as their lipid levels and other laboratory values. Medication use was also tracked. Patients with a diagnosis of diabetes also had their hemoglobin A_1c levels recorded at each visit.

Overall, patients in the sleeve gastrectomy group were more overweight, and those in the gastric bypass group had higher HbA_1c and total cholesterol levels. The mean baseline weight for the sleeve gastrectomy recipients was 141.5 kg, compared with 133.5 kg for those receiving gastric bypass (BMI, 49.9 vs. 47.3 kg/m², respectively; P < .01 for both measures). Mean HbA_1c was 6.5% for the gastric bypass group, compared with 6.3% for the sleeve gastrectomy group (P = .03).

At baseline, 149 (39.2%) of the gastric bypass patients had diabetes, compared with 108 (32.3%) of the sleeve gastrectomy patients, but the difference was not statistically significant.

About two-thirds of the full cohort were tracked for at least 5 years, which is still considered “a good follow-up rate in a real-world study,” said Dr. Luo.

Total weight loss was defined as the difference between initial weight and postoperative weight at a given point in time. Excess weight was the difference between initial weight and an individual’s ideal weight, that is, what their weight would have been if they had a BMI of 25 kg/m².

“The probability of achieving a BMI of less than 30 kg/m² or excess weight loss of 50% or more was higher in patients who did not have diabetes diagnosis at baseline. We found that the presence of diabetes at baseline substantially impacted the probability of achieving both indicators,” said Dr. Luo. “Individuals without diabetes had a 1.5 times higher chance of achieving a BMI of under 30 kg/m², and … [they also] had a 1.6 times higher chance of achieving excess body weight loss of 50%, or more.” Both of those differences were statistically significant on univariate analysis (P = .0249 and .0021, respectively).

The researchers conducted further statistical analysis – adjusted for age, gender, surgery type, and baseline weight – to examine whether diabetes still predicted future weight loss after bariatric surgery. After those adjustments, they still found that “the presence of diabetes before surgery is an indicator of future weight loss outcomes,” said Dr. Luo.

The differences in outcomes for those with and without diabetes tended to diminish over time in looking at the cohort as a whole. However, greater BMI reduction for those without diabetes persisted for the full 5 years of follow-up for the gastric bypass recipients. Those trends held when the researchers looked at the proportion of patients whose BMI dropped to below 30 kg/m², and those who achieved excess weight loss of more than 50%.

Dr. Luo acknowledged that an ideal study would track patients for longer than 5 years and that studies involving more patients would also be useful. Still, she said, “our study opens the door for further research to understand why diabetes diminishes the weight loss effect of bariatric surgery.”

The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

Dr. Luo reported no outside sources of funding and no conflicts of interest.
 

SOURCE: Luo Y et al. ENDO 2020, Abstract 590.

People with diabetes may benefit less from bariatric surgery, compared with those without the disease, according to a retrospective review of patients receiving both sleeve gastrectomy and gastric bypass.

The difference was particularly pronounced and persistent for patients who had gastric bypass, Yingying Luo, MD, said during a virtual news conference held by the Endocrine Society. The study was slated for presentation during ENDO 2020, the society’s annual meeting, which was canceled because of the COVID-19 pandemic.

“Our findings demonstrated that having bariatric surgery before developing diabetes may result in greater weight loss from the surgery, especially within the first 3 years after surgery and in patients undergoing gastric bypass surgery,” said Dr. Luo.

More than a third of U.S. adults have obesity, and more than half the population is overweight or has obesity, said Dr. Luo, citing data from the Centers for Disease Control and Prevention.

Bariatric surgery not only reduces body weight, but also “can lead to remission of many metabolic disorders, including diabetes, hypertension, and dyslipidemia,” said Dr. Luo, a visiting scholar at the University of Michigan’s division of metabolism, endocrinology, and diabetes. However, until now, it has not been known how diabetes interacts with bariatric surgery to affect weight loss outcomes.

To address that question, Dr. Luo and her colleagues looked at patients in the Michigan Bariatric Surgery Cohort who were at least 18 years old and had a body mass index (BMI) of more than 40 kg/m², or of more than 35 kg/m² with comorbidities.

The researchers followed 380 patients who received gastric bypass and 334 who received sleeve gastrectomy for at least 5 years. Over time, sleeve gastrectomy became the predominant type of surgery conducted, noted Dr. Luo.

At baseline, and yearly for 5 years thereafter, the researchers recorded participants’ BMI as well as their lipid levels and other laboratory values. Medication use was also tracked. Patients with a diagnosis of diabetes also had their hemoglobin A_1c levels recorded at each visit.

Overall, patients in the sleeve gastrectomy group were more overweight, and those in the gastric bypass group had higher HbA_1c and total cholesterol levels. The mean baseline weight for the sleeve gastrectomy recipients was 141.5 kg, compared with 133.5 kg for those receiving gastric bypass (BMI, 49.9 vs. 47.3 kg/m², respectively; P < .01 for both measures). Mean HbA_1c was 6.5% for the gastric bypass group, compared with 6.3% for the sleeve gastrectomy group (P = .03).

At baseline, 149 (39.2%) of the gastric bypass patients had diabetes, compared with 108 (32.3%) of the sleeve gastrectomy patients, but the difference was not statistically significant.

About two-thirds of the full cohort were tracked for at least 5 years, which is still considered “a good follow-up rate in a real-world study,” said Dr. Luo.

Total weight loss was defined as the difference between initial weight and postoperative weight at a given point in time. Excess weight was the difference between initial weight and an individual’s ideal weight, that is, what their weight would have been if they had a BMI of 25 kg/m².

“The probability of achieving a BMI of less than 30 kg/m² or excess weight loss of 50% or more was higher in patients who did not have diabetes diagnosis at baseline. We found that the presence of diabetes at baseline substantially impacted the probability of achieving both indicators,” said Dr. Luo. “Individuals without diabetes had a 1.5 times higher chance of achieving a BMI of under 30 kg/m², and … [they also] had a 1.6 times higher chance of achieving excess body weight loss of 50%, or more.” Both of those differences were statistically significant on univariate analysis (P = .0249 and .0021, respectively).

The researchers conducted further statistical analysis – adjusted for age, gender, surgery type, and baseline weight – to examine whether diabetes still predicted future weight loss after bariatric surgery. After those adjustments, they still found that “the presence of diabetes before surgery is an indicator of future weight loss outcomes,” said Dr. Luo.

The differences in outcomes for those with and without diabetes tended to diminish over time in looking at the cohort as a whole. However, greater BMI reduction for those without diabetes persisted for the full 5 years of follow-up for the gastric bypass recipients. Those trends held when the researchers looked at the proportion of patients whose BMI dropped to below 30 kg/m², and those who achieved excess weight loss of more than 50%.

Dr. Luo acknowledged that an ideal study would track patients for longer than 5 years and that studies involving more patients would also be useful. Still, she said, “our study opens the door for further research to understand why diabetes diminishes the weight loss effect of bariatric surgery.”

The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

Dr. Luo reported no outside sources of funding and no conflicts of interest.
 

SOURCE: Luo Y et al. ENDO 2020, Abstract 590.

People with diabetes may benefit less from bariatric surgery, compared with those without the disease, according to a retrospective review of patients receiving both sleeve gastrectomy and gastric bypass.

The difference was particularly pronounced and persistent for patients who had gastric bypass, Yingying Luo, MD, said during a virtual news conference held by the Endocrine Society. The study was slated for presentation during ENDO 2020, the society’s annual meeting, which was canceled because of the COVID-19 pandemic.

“Our findings demonstrated that having bariatric surgery before developing diabetes may result in greater weight loss from the surgery, especially within the first 3 years after surgery and in patients undergoing gastric bypass surgery,” said Dr. Luo.

More than a third of U.S. adults have obesity, and more than half the population is overweight or has obesity, said Dr. Luo, citing data from the Centers for Disease Control and Prevention.

Bariatric surgery not only reduces body weight, but also “can lead to remission of many metabolic disorders, including diabetes, hypertension, and dyslipidemia,” said Dr. Luo, a visiting scholar at the University of Michigan’s division of metabolism, endocrinology, and diabetes. However, until now, it has not been known how diabetes interacts with bariatric surgery to affect weight loss outcomes.

To address that question, Dr. Luo and her colleagues looked at patients in the Michigan Bariatric Surgery Cohort who were at least 18 years old and had a body mass index (BMI) of more than 40 kg/m², or of more than 35 kg/m² with comorbidities.

The researchers followed 380 patients who received gastric bypass and 334 who received sleeve gastrectomy for at least 5 years. Over time, sleeve gastrectomy became the predominant type of surgery conducted, noted Dr. Luo.

At baseline, and yearly for 5 years thereafter, the researchers recorded participants’ BMI as well as their lipid levels and other laboratory values. Medication use was also tracked. Patients with a diagnosis of diabetes also had their hemoglobin A_1c levels recorded at each visit.

Overall, patients in the sleeve gastrectomy group were more overweight, and those in the gastric bypass group had higher HbA_1c and total cholesterol levels. The mean baseline weight for the sleeve gastrectomy recipients was 141.5 kg, compared with 133.5 kg for those receiving gastric bypass (BMI, 49.9 vs. 47.3 kg/m², respectively; P < .01 for both measures). Mean HbA_1c was 6.5% for the gastric bypass group, compared with 6.3% for the sleeve gastrectomy group (P = .03).

At baseline, 149 (39.2%) of the gastric bypass patients had diabetes, compared with 108 (32.3%) of the sleeve gastrectomy patients, but the difference was not statistically significant.

About two-thirds of the full cohort were tracked for at least 5 years, which is still considered “a good follow-up rate in a real-world study,” said Dr. Luo.

Total weight loss was defined as the difference between initial weight and postoperative weight at a given point in time. Excess weight was the difference between initial weight and an individual’s ideal weight, that is, what their weight would have been if they had a BMI of 25 kg/m².

“The probability of achieving a BMI of less than 30 kg/m² or excess weight loss of 50% or more was higher in patients who did not have diabetes diagnosis at baseline. We found that the presence of diabetes at baseline substantially impacted the probability of achieving both indicators,” said Dr. Luo. “Individuals without diabetes had a 1.5 times higher chance of achieving a BMI of under 30 kg/m², and … [they also] had a 1.6 times higher chance of achieving excess body weight loss of 50%, or more.” Both of those differences were statistically significant on univariate analysis (P = .0249 and .0021, respectively).

The researchers conducted further statistical analysis – adjusted for age, gender, surgery type, and baseline weight – to examine whether diabetes still predicted future weight loss after bariatric surgery. After those adjustments, they still found that “the presence of diabetes before surgery is an indicator of future weight loss outcomes,” said Dr. Luo.

The differences in outcomes for those with and without diabetes tended to diminish over time in looking at the cohort as a whole. However, greater BMI reduction for those without diabetes persisted for the full 5 years of follow-up for the gastric bypass recipients. Those trends held when the researchers looked at the proportion of patients whose BMI dropped to below 30 kg/m², and those who achieved excess weight loss of more than 50%.

Dr. Luo acknowledged that an ideal study would track patients for longer than 5 years and that studies involving more patients would also be useful. Still, she said, “our study opens the door for further research to understand why diabetes diminishes the weight loss effect of bariatric surgery.”

The research will be published in a special supplemental issue of the Journal of the Endocrine Society. In addition to a series of news conferences on March 30-31, the society will host ENDO Online 2020 during June 8-22, which will present programming for clinicians and researchers.

Dr. Luo reported no outside sources of funding and no conflicts of interest.
 

SOURCE: Luo Y et al. ENDO 2020, Abstract 590.

Bariatric surgery was associated with a significant reduction in the risk of colorectal cancer among obese adults in a retrospective study of more than 1 million individuals.

Although some studies have suggested that bariatric surgery may reduce the risk of obesity-associated cancers, such as colorectal cancer, other studies have shown an increased colorectal cancer risk after surgery, according to Laurent Bailly, MD, of Université Côte d’Azur in Nice, France, and colleagues.

In a study published in JAMA Surgery, Dr. Bailly and colleagues compared the incidence of colorectal cancer in obese patients who underwent bariatric surgery with the incidence in obese patients who did not have surgery and the incidence in the general population.

Using the French National Health Insurance Information System database, the researchers identified 1,045,348 obese adults aged 50-75 years who had no colorectal cancer at baseline. Of these patients, 74,131 underwent bariatric surgery and 971,217 did not. The mean age was 57.3 years in the surgery group and 63.4 years in the nonsurgery group.

The mean follow-up period was 6.2 years for patients who underwent adjustable gastric banding, 5.5 years for those with sleeve gastrectomy, 5.7 years for those who underwent gastric bypass, and 5.3 years for the nonsurgery group.
 

Results

Overall, the colorectal cancer rate was 0.6% in the surgery group and 1.3% in the nonsurgery group (P < .001).

The researchers calculated standardized incidence ratios (SIRs) to compare the risk of colorectal cancer in the study population with the risk among the French general population; in other words, the number of observed colorectal cancer cases divided by the number of expected cases.

In the surgery group, 423 cases of colorectal cancer were observed and 428 cases were expected, which leads to an SIR of 1.0. In the nonsurgery group, 12,629 cases were observed and 9,417 cases were expected, leading to an SIR of 1.34.

These results suggest patients in the nonsurgery group had a 34% higher risk of colorectal cancer compared with the general population, whereas the risk in the surgery group was similar to that in the general population.

Patients who underwent either gastric bypass or sleeve gastrectomy had fewer new colorectal cancer diagnoses (0.5% for both) compared with patients who had adjustable gastric banding (0.7%).

The researchers noted that this study was limited by several factors, including the retrospective, observational design and potential selection bias among surgery patients. However, the results were strengthened by the large study population and long-term follow-up.
 

Putting results into context

The authors of an invited commentary noted that this study is supported by results from a retrospective, U.S.-based study, which indicated that bariatric surgery has a “protective effect” against colorectal cancer (Ann Surg. 2019 Jan;269[1]:95-101).

However, these results conflict with other retrospective studies. A study of Nordic patients suggested that bariatric surgery is associated with an increased risk of colon cancer but perhaps not rectal cancer (Int J Cancer. 2019. doi: 10.1002/ijc.32770).

And a study of English patients showed an increased risk of colorectal cancer in patients who underwent gastric bypass but not in those who underwent gastric banding or sleeve gastrectomy (Br J Surg. 2018;105(12):1650-7).

These conflicting results “imply that the jury is still out on whether bariatric surgery increases or decreases” the risk of colorectal cancer, the commentators wrote. They added that future studies “must account for differences in study population (i.e., race/ethnicity and national origin), mechanistic variation in bariatric surgical type, and length of follow-up, while also distinguishing between rectal and colon cancer before the case is settled.”

This study had no outside sponsorship, and the researchers and commentators had no financial conflicts to disclose.

SOURCE: Bailly L et al. JAMA Surg. 2020 Mar 11. doi:10.1001/jamasurg.2020.0089; Davidson LE et al. JAMA Surg. 2020 Mar. 11. doi:10.1001/jamasurg.2020.0090.

Bariatric surgery was associated with a significant reduction in the risk of colorectal cancer among obese adults in a retrospective study of more than 1 million individuals.

Although some studies have suggested that bariatric surgery may reduce the risk of obesity-associated cancers, such as colorectal cancer, other studies have shown an increased colorectal cancer risk after surgery, according to Laurent Bailly, MD, of Université Côte d’Azur in Nice, France, and colleagues.

In a study published in JAMA Surgery, Dr. Bailly and colleagues compared the incidence of colorectal cancer in obese patients who underwent bariatric surgery with the incidence in obese patients who did not have surgery and the incidence in the general population.

Using the French National Health Insurance Information System database, the researchers identified 1,045,348 obese adults aged 50-75 years who had no colorectal cancer at baseline. Of these patients, 74,131 underwent bariatric surgery and 971,217 did not. The mean age was 57.3 years in the surgery group and 63.4 years in the nonsurgery group.

The mean follow-up period was 6.2 years for patients who underwent adjustable gastric banding, 5.5 years for those with sleeve gastrectomy, 5.7 years for those who underwent gastric bypass, and 5.3 years for the nonsurgery group.
 

Results

Overall, the colorectal cancer rate was 0.6% in the surgery group and 1.3% in the nonsurgery group (P < .001).

The researchers calculated standardized incidence ratios (SIRs) to compare the risk of colorectal cancer in the study population with the risk among the French general population; in other words, the number of observed colorectal cancer cases divided by the number of expected cases.

In the surgery group, 423 cases of colorectal cancer were observed and 428 cases were expected, which leads to an SIR of 1.0. In the nonsurgery group, 12,629 cases were observed and 9,417 cases were expected, leading to an SIR of 1.34.

These results suggest patients in the nonsurgery group had a 34% higher risk of colorectal cancer compared with the general population, whereas the risk in the surgery group was similar to that in the general population.

Patients who underwent either gastric bypass or sleeve gastrectomy had fewer new colorectal cancer diagnoses (0.5% for both) compared with patients who had adjustable gastric banding (0.7%).

The researchers noted that this study was limited by several factors, including the retrospective, observational design and potential selection bias among surgery patients. However, the results were strengthened by the large study population and long-term follow-up.
 

Putting results into context

The authors of an invited commentary noted that this study is supported by results from a retrospective, U.S.-based study, which indicated that bariatric surgery has a “protective effect” against colorectal cancer (Ann Surg. 2019 Jan;269[1]:95-101).

However, these results conflict with other retrospective studies. A study of Nordic patients suggested that bariatric surgery is associated with an increased risk of colon cancer but perhaps not rectal cancer (Int J Cancer. 2019. doi: 10.1002/ijc.32770).

And a study of English patients showed an increased risk of colorectal cancer in patients who underwent gastric bypass but not in those who underwent gastric banding or sleeve gastrectomy (Br J Surg. 2018;105(12):1650-7).

These conflicting results “imply that the jury is still out on whether bariatric surgery increases or decreases” the risk of colorectal cancer, the commentators wrote. They added that future studies “must account for differences in study population (i.e., race/ethnicity and national origin), mechanistic variation in bariatric surgical type, and length of follow-up, while also distinguishing between rectal and colon cancer before the case is settled.”

This study had no outside sponsorship, and the researchers and commentators had no financial conflicts to disclose.

SOURCE: Bailly L et al. JAMA Surg. 2020 Mar 11. doi:10.1001/jamasurg.2020.0089; Davidson LE et al. JAMA Surg. 2020 Mar. 11. doi:10.1001/jamasurg.2020.0090.

Bariatric surgery was associated with a significant reduction in the risk of colorectal cancer among obese adults in a retrospective study of more than 1 million individuals.

Although some studies have suggested that bariatric surgery may reduce the risk of obesity-associated cancers, such as colorectal cancer, other studies have shown an increased colorectal cancer risk after surgery, according to Laurent Bailly, MD, of Université Côte d’Azur in Nice, France, and colleagues.

In a study published in JAMA Surgery, Dr. Bailly and colleagues compared the incidence of colorectal cancer in obese patients who underwent bariatric surgery with the incidence in obese patients who did not have surgery and the incidence in the general population.

Using the French National Health Insurance Information System database, the researchers identified 1,045,348 obese adults aged 50-75 years who had no colorectal cancer at baseline. Of these patients, 74,131 underwent bariatric surgery and 971,217 did not. The mean age was 57.3 years in the surgery group and 63.4 years in the nonsurgery group.

The mean follow-up period was 6.2 years for patients who underwent adjustable gastric banding, 5.5 years for those with sleeve gastrectomy, 5.7 years for those who underwent gastric bypass, and 5.3 years for the nonsurgery group.
 

Results

Overall, the colorectal cancer rate was 0.6% in the surgery group and 1.3% in the nonsurgery group (P < .001).

The researchers calculated standardized incidence ratios (SIRs) to compare the risk of colorectal cancer in the study population with the risk among the French general population; in other words, the number of observed colorectal cancer cases divided by the number of expected cases.

In the surgery group, 423 cases of colorectal cancer were observed and 428 cases were expected, which leads to an SIR of 1.0. In the nonsurgery group, 12,629 cases were observed and 9,417 cases were expected, leading to an SIR of 1.34.

These results suggest patients in the nonsurgery group had a 34% higher risk of colorectal cancer compared with the general population, whereas the risk in the surgery group was similar to that in the general population.

Patients who underwent either gastric bypass or sleeve gastrectomy had fewer new colorectal cancer diagnoses (0.5% for both) compared with patients who had adjustable gastric banding (0.7%).

The researchers noted that this study was limited by several factors, including the retrospective, observational design and potential selection bias among surgery patients. However, the results were strengthened by the large study population and long-term follow-up.
 

Putting results into context

The authors of an invited commentary noted that this study is supported by results from a retrospective, U.S.-based study, which indicated that bariatric surgery has a “protective effect” against colorectal cancer (Ann Surg. 2019 Jan;269[1]:95-101).

However, these results conflict with other retrospective studies. A study of Nordic patients suggested that bariatric surgery is associated with an increased risk of colon cancer but perhaps not rectal cancer (Int J Cancer. 2019. doi: 10.1002/ijc.32770).

And a study of English patients showed an increased risk of colorectal cancer in patients who underwent gastric bypass but not in those who underwent gastric banding or sleeve gastrectomy (Br J Surg. 2018;105(12):1650-7).

These conflicting results “imply that the jury is still out on whether bariatric surgery increases or decreases” the risk of colorectal cancer, the commentators wrote. They added that future studies “must account for differences in study population (i.e., race/ethnicity and national origin), mechanistic variation in bariatric surgical type, and length of follow-up, while also distinguishing between rectal and colon cancer before the case is settled.”

This study had no outside sponsorship, and the researchers and commentators had no financial conflicts to disclose.

SOURCE: Bailly L et al. JAMA Surg. 2020 Mar 11. doi:10.1001/jamasurg.2020.0089; Davidson LE et al. JAMA Surg. 2020 Mar. 11. doi:10.1001/jamasurg.2020.0090.

Patients with type 2 diabetes who underwent Roux-en-Y gastric bypass (RYGB) surgery experienced higher rates of diabetes remission, improved glycemic control, greater weight loss, and fewer diabetes relapse events, compared with those who had sleeve gastrectomy, according to findings from nearly 10,000 patients.

“Remission of type 2 diabetes is common after bariatric surgery and may reduce risk for subsequent microvascular and macrovascular disease,” but it is not clear which of the two most common procedures, RYGB or sleeve gastrectomy, has better long-term diabetes and weight outcomes, wrote Kathleen M. McTigue, MD, of the University of Pittsburgh, and colleagues in JAMA Surgery.

To examine the effectiveness of the two procedures, the researchers identified 9,710 adults with type 2 diabetes who were part of the National Patient-Centered Clinical Research Network Bariatric Study. They compared diabetes outcomes for up to 5 years after surgery for 6,233 patients who underwent RYGB and 3,477 who underwent sleeve gastrectomy. The average age of the patients was 50 years, and 73% were women. The average preoperative body mass index was 49 kg/m².

Overall, 6,141 patients experienced diabetes remission. The estimated adjusted cumulative remission rates for the RYGB and sleeve gastrectomy groups after 1 year were 59% and 56%, respectively, and after 5 years were 86% and 84%.

Weight loss was significantly greater in RYGB patients, compared with those who had the sleeve gastrectomy, with average differences in percentage points of 6.3 at 1 year and 8.1 at year 5. RYGB patients also showed significantly better long-term glycemic control, compared with sleeve gastrectomy patients. At 5 years, hemoglobin A_1c levels were 0.80 percentage points below baseline in the RYGB group, and 0.35 percentage points below baseline in the sleeve gastrectomy group.

In addition, after 1 year, diabetes relapse rates in the RYGB and sleeve gastrectomy groups were 8% and 11%, respectively, and 33% and 42% after 5 years.

The findings were limited by several factors, including the observational design of the study and the potential for confounding and coding inaccuracies, the researchers noted, adding that future studies should address the impact of weight loss on diabetes remission and relapse in bariatric surgery patients.

They also noted that their results were in contrast to findings in previous studies that established no significant differences in outcomes between the procedures, but emphasized that most previous studies were smaller and controlled and that outcome differences may be greater in clinical practice.

“For patients, clinicians, and policy makers to make informed decisions about which procedure is best suited to patients’ personal situations, additional data are needed to understand the adverse event profile of the procedures, as well as patient values regarding procedure choice and the role of surgery relative to other aspects of lifelong weight management,” they concluded.

In an accompanying commentary, Natalie Liu, MD, and Luke M. Funk, MD, of the department of surgery, University of Wisconsin–Madison, said the analysis made an important contribution to the existing literature, despite its limitations.

“It included long-term electronic health record data from a large cohort of U.S. patients who had bariatric surgery in a real-world setting,” they wrote, adding that, although the remission rates were high, the relapse rate in both treatment groups deserved further study.

Dr. Liu and Dr. Funk emphasized that the overall high remission rates for either surgery, compared with lifestyle interventions, suggest the need for continued advocacy for better insurance coverage of, and access to, bariatric surgery procedures for patients with type 2 diabetes, notably those with class 1 obesity.

The study was conducted using the National Patient-Centered Clinical Research Network, which was funded by the Patient-Centered Outcomes Research Institute. Dr. McTigue and Dr. Liu had reported no conflicts of interest. Dr. Funk disclosed a Veterans Affairs Health Services Research & Development Career Development Award, and grants from the VA, National Institutes of Health, and American College of Surgeons.

SOURCES: McTigue KM et al. JAMA Surg. 2020 Mar 4. doi: 10.1001/jamasurg.2020.0087; Lui N, Funk LM. JAMA Surg. 2020 Mar 4. doi: 10.1001/jamasurg.2020.0088.

Patients with type 2 diabetes who underwent Roux-en-Y gastric bypass (RYGB) surgery experienced higher rates of diabetes remission, improved glycemic control, greater weight loss, and fewer diabetes relapse events, compared with those who had sleeve gastrectomy, according to findings from nearly 10,000 patients.

“Remission of type 2 diabetes is common after bariatric surgery and may reduce risk for subsequent microvascular and macrovascular disease,” but it is not clear which of the two most common procedures, RYGB or sleeve gastrectomy, has better long-term diabetes and weight outcomes, wrote Kathleen M. McTigue, MD, of the University of Pittsburgh, and colleagues in JAMA Surgery.

To examine the effectiveness of the two procedures, the researchers identified 9,710 adults with type 2 diabetes who were part of the National Patient-Centered Clinical Research Network Bariatric Study. They compared diabetes outcomes for up to 5 years after surgery for 6,233 patients who underwent RYGB and 3,477 who underwent sleeve gastrectomy. The average age of the patients was 50 years, and 73% were women. The average preoperative body mass index was 49 kg/m².

Overall, 6,141 patients experienced diabetes remission. The estimated adjusted cumulative remission rates for the RYGB and sleeve gastrectomy groups after 1 year were 59% and 56%, respectively, and after 5 years were 86% and 84%.

Weight loss was significantly greater in RYGB patients, compared with those who had the sleeve gastrectomy, with average differences in percentage points of 6.3 at 1 year and 8.1 at year 5. RYGB patients also showed significantly better long-term glycemic control, compared with sleeve gastrectomy patients. At 5 years, hemoglobin A_1c levels were 0.80 percentage points below baseline in the RYGB group, and 0.35 percentage points below baseline in the sleeve gastrectomy group.

In addition, after 1 year, diabetes relapse rates in the RYGB and sleeve gastrectomy groups were 8% and 11%, respectively, and 33% and 42% after 5 years.

The findings were limited by several factors, including the observational design of the study and the potential for confounding and coding inaccuracies, the researchers noted, adding that future studies should address the impact of weight loss on diabetes remission and relapse in bariatric surgery patients.

They also noted that their results were in contrast to findings in previous studies that established no significant differences in outcomes between the procedures, but emphasized that most previous studies were smaller and controlled and that outcome differences may be greater in clinical practice.

“For patients, clinicians, and policy makers to make informed decisions about which procedure is best suited to patients’ personal situations, additional data are needed to understand the adverse event profile of the procedures, as well as patient values regarding procedure choice and the role of surgery relative to other aspects of lifelong weight management,” they concluded.

In an accompanying commentary, Natalie Liu, MD, and Luke M. Funk, MD, of the department of surgery, University of Wisconsin–Madison, said the analysis made an important contribution to the existing literature, despite its limitations.

“It included long-term electronic health record data from a large cohort of U.S. patients who had bariatric surgery in a real-world setting,” they wrote, adding that, although the remission rates were high, the relapse rate in both treatment groups deserved further study.

Dr. Liu and Dr. Funk emphasized that the overall high remission rates for either surgery, compared with lifestyle interventions, suggest the need for continued advocacy for better insurance coverage of, and access to, bariatric surgery procedures for patients with type 2 diabetes, notably those with class 1 obesity.

The study was conducted using the National Patient-Centered Clinical Research Network, which was funded by the Patient-Centered Outcomes Research Institute. Dr. McTigue and Dr. Liu had reported no conflicts of interest. Dr. Funk disclosed a Veterans Affairs Health Services Research & Development Career Development Award, and grants from the VA, National Institutes of Health, and American College of Surgeons.

SOURCES: McTigue KM et al. JAMA Surg. 2020 Mar 4. doi: 10.1001/jamasurg.2020.0087; Lui N, Funk LM. JAMA Surg. 2020 Mar 4. doi: 10.1001/jamasurg.2020.0088.

Patients with type 2 diabetes who underwent Roux-en-Y gastric bypass (RYGB) surgery experienced higher rates of diabetes remission, improved glycemic control, greater weight loss, and fewer diabetes relapse events, compared with those who had sleeve gastrectomy, according to findings from nearly 10,000 patients.

“Remission of type 2 diabetes is common after bariatric surgery and may reduce risk for subsequent microvascular and macrovascular disease,” but it is not clear which of the two most common procedures, RYGB or sleeve gastrectomy, has better long-term diabetes and weight outcomes, wrote Kathleen M. McTigue, MD, of the University of Pittsburgh, and colleagues in JAMA Surgery.

To examine the effectiveness of the two procedures, the researchers identified 9,710 adults with type 2 diabetes who were part of the National Patient-Centered Clinical Research Network Bariatric Study. They compared diabetes outcomes for up to 5 years after surgery for 6,233 patients who underwent RYGB and 3,477 who underwent sleeve gastrectomy. The average age of the patients was 50 years, and 73% were women. The average preoperative body mass index was 49 kg/m².

Overall, 6,141 patients experienced diabetes remission. The estimated adjusted cumulative remission rates for the RYGB and sleeve gastrectomy groups after 1 year were 59% and 56%, respectively, and after 5 years were 86% and 84%.

Weight loss was significantly greater in RYGB patients, compared with those who had the sleeve gastrectomy, with average differences in percentage points of 6.3 at 1 year and 8.1 at year 5. RYGB patients also showed significantly better long-term glycemic control, compared with sleeve gastrectomy patients. At 5 years, hemoglobin A_1c levels were 0.80 percentage points below baseline in the RYGB group, and 0.35 percentage points below baseline in the sleeve gastrectomy group.

In addition, after 1 year, diabetes relapse rates in the RYGB and sleeve gastrectomy groups were 8% and 11%, respectively, and 33% and 42% after 5 years.

The findings were limited by several factors, including the observational design of the study and the potential for confounding and coding inaccuracies, the researchers noted, adding that future studies should address the impact of weight loss on diabetes remission and relapse in bariatric surgery patients.

They also noted that their results were in contrast to findings in previous studies that established no significant differences in outcomes between the procedures, but emphasized that most previous studies were smaller and controlled and that outcome differences may be greater in clinical practice.

“For patients, clinicians, and policy makers to make informed decisions about which procedure is best suited to patients’ personal situations, additional data are needed to understand the adverse event profile of the procedures, as well as patient values regarding procedure choice and the role of surgery relative to other aspects of lifelong weight management,” they concluded.

In an accompanying commentary, Natalie Liu, MD, and Luke M. Funk, MD, of the department of surgery, University of Wisconsin–Madison, said the analysis made an important contribution to the existing literature, despite its limitations.

“It included long-term electronic health record data from a large cohort of U.S. patients who had bariatric surgery in a real-world setting,” they wrote, adding that, although the remission rates were high, the relapse rate in both treatment groups deserved further study.

Dr. Liu and Dr. Funk emphasized that the overall high remission rates for either surgery, compared with lifestyle interventions, suggest the need for continued advocacy for better insurance coverage of, and access to, bariatric surgery procedures for patients with type 2 diabetes, notably those with class 1 obesity.

The study was conducted using the National Patient-Centered Clinical Research Network, which was funded by the Patient-Centered Outcomes Research Institute. Dr. McTigue and Dr. Liu had reported no conflicts of interest. Dr. Funk disclosed a Veterans Affairs Health Services Research & Development Career Development Award, and grants from the VA, National Institutes of Health, and American College of Surgeons.

SOURCES: McTigue KM et al. JAMA Surg. 2020 Mar 4. doi: 10.1001/jamasurg.2020.0087; Lui N, Funk LM. JAMA Surg. 2020 Mar 4. doi: 10.1001/jamasurg.2020.0088.

Young people treated with bariatric surgery for severe obesity did not experience better mental health in the 5 years following their procedures, Swedish researchers said, and indeed fared worse than their nontreated peers on certain measures.

The results of this study do not necessarily argue “that metabolic and bariatric surgery during adolescence causes mental health problems,” the investigators wrote in the Lancet Child and Adolescent Health, but “it is reasonable to conclude that metabolic and bariatric surgery does not result in a substantial alleviation of mental health problems in adolescents with severe obesity,” and that “long-term mental health support should be required in programs providing adolescent metabolic and bariatric surgery.”

Kajsa Järvholm, PhD, of Skåne University Hospital, in Malmö, Sweden, and colleagues reported results from a prospective nonrandomized study that recruited 81 adolescents in Sweden aged 13-18 years (mean age, 16.5) who had a body mass index of 40 or higher, or BMI of 35 with obesity-related comorbidities and who underwent Roux-en-Y gastric bypass for weight loss. Subjects were matched by age, sex, and BMI to 80 controls (mean age, 15.8 years) who were assigned to conventional nonsurgical treatment. All patients were assessed at 1, 2, and 5 years.

Although mental health treatment, including use of psychiatric drugs, did not differ between the groups at baseline, during the follow-up period the subjects who underwent surgery saw 15% more impatient and outpatient mental health treatment, compared with controls, a significant difference. About a quarter of patients in the surgically treated group required specialized mental health treatment for the first time after their surgeries.

Though the surgical group lost much more weight – mean BMI was 32.3 at 5 years, compared with 41.7 for controls – none of the mental health changes from baseline were significantly associated with percentage change of BMI at 5 years.

The findings from the study are consistent with results from studies in adults in which bariatric surgery improves many health outcomes but does not alter the need for mental health treatment. Although 5 years is a longer follow-up than in previous studies in young patients – a key strength of the study – Dr. Järvholm and colleagues acknowledged some weaknesses, including a nonrandomized design, lack of a comparison group of nonobese youths for mental health measures, a small sample size, and a surgical procedure that is now out of favor in adolescents.

The study was funded by Swedish government and health foundations. Dr. Järvholm disclosed pharmaceutical industry funding not related to the study, and three coauthors also disclosed industry relationships.

SOURCE: Järvholm K et al. Lancet Child Adolesc Health. 2020. doi: 10.1016/s2352-4642(20)30024-9.

Young people treated with bariatric surgery for severe obesity did not experience better mental health in the 5 years following their procedures, Swedish researchers said, and indeed fared worse than their nontreated peers on certain measures.

The results of this study do not necessarily argue “that metabolic and bariatric surgery during adolescence causes mental health problems,” the investigators wrote in the Lancet Child and Adolescent Health, but “it is reasonable to conclude that metabolic and bariatric surgery does not result in a substantial alleviation of mental health problems in adolescents with severe obesity,” and that “long-term mental health support should be required in programs providing adolescent metabolic and bariatric surgery.”

Kajsa Järvholm, PhD, of Skåne University Hospital, in Malmö, Sweden, and colleagues reported results from a prospective nonrandomized study that recruited 81 adolescents in Sweden aged 13-18 years (mean age, 16.5) who had a body mass index of 40 or higher, or BMI of 35 with obesity-related comorbidities and who underwent Roux-en-Y gastric bypass for weight loss. Subjects were matched by age, sex, and BMI to 80 controls (mean age, 15.8 years) who were assigned to conventional nonsurgical treatment. All patients were assessed at 1, 2, and 5 years.

Although mental health treatment, including use of psychiatric drugs, did not differ between the groups at baseline, during the follow-up period the subjects who underwent surgery saw 15% more impatient and outpatient mental health treatment, compared with controls, a significant difference. About a quarter of patients in the surgically treated group required specialized mental health treatment for the first time after their surgeries.

Though the surgical group lost much more weight – mean BMI was 32.3 at 5 years, compared with 41.7 for controls – none of the mental health changes from baseline were significantly associated with percentage change of BMI at 5 years.

The findings from the study are consistent with results from studies in adults in which bariatric surgery improves many health outcomes but does not alter the need for mental health treatment. Although 5 years is a longer follow-up than in previous studies in young patients – a key strength of the study – Dr. Järvholm and colleagues acknowledged some weaknesses, including a nonrandomized design, lack of a comparison group of nonobese youths for mental health measures, a small sample size, and a surgical procedure that is now out of favor in adolescents.

The study was funded by Swedish government and health foundations. Dr. Järvholm disclosed pharmaceutical industry funding not related to the study, and three coauthors also disclosed industry relationships.

SOURCE: Järvholm K et al. Lancet Child Adolesc Health. 2020. doi: 10.1016/s2352-4642(20)30024-9.

Young people treated with bariatric surgery for severe obesity did not experience better mental health in the 5 years following their procedures, Swedish researchers said, and indeed fared worse than their nontreated peers on certain measures.

The results of this study do not necessarily argue “that metabolic and bariatric surgery during adolescence causes mental health problems,” the investigators wrote in the Lancet Child and Adolescent Health, but “it is reasonable to conclude that metabolic and bariatric surgery does not result in a substantial alleviation of mental health problems in adolescents with severe obesity,” and that “long-term mental health support should be required in programs providing adolescent metabolic and bariatric surgery.”

Kajsa Järvholm, PhD, of Skåne University Hospital, in Malmö, Sweden, and colleagues reported results from a prospective nonrandomized study that recruited 81 adolescents in Sweden aged 13-18 years (mean age, 16.5) who had a body mass index of 40 or higher, or BMI of 35 with obesity-related comorbidities and who underwent Roux-en-Y gastric bypass for weight loss. Subjects were matched by age, sex, and BMI to 80 controls (mean age, 15.8 years) who were assigned to conventional nonsurgical treatment. All patients were assessed at 1, 2, and 5 years.

Although mental health treatment, including use of psychiatric drugs, did not differ between the groups at baseline, during the follow-up period the subjects who underwent surgery saw 15% more impatient and outpatient mental health treatment, compared with controls, a significant difference. About a quarter of patients in the surgically treated group required specialized mental health treatment for the first time after their surgeries.

Though the surgical group lost much more weight – mean BMI was 32.3 at 5 years, compared with 41.7 for controls – none of the mental health changes from baseline were significantly associated with percentage change of BMI at 5 years.

The findings from the study are consistent with results from studies in adults in which bariatric surgery improves many health outcomes but does not alter the need for mental health treatment. Although 5 years is a longer follow-up than in previous studies in young patients – a key strength of the study – Dr. Järvholm and colleagues acknowledged some weaknesses, including a nonrandomized design, lack of a comparison group of nonobese youths for mental health measures, a small sample size, and a surgical procedure that is now out of favor in adolescents.

The study was funded by Swedish government and health foundations. Dr. Järvholm disclosed pharmaceutical industry funding not related to the study, and three coauthors also disclosed industry relationships.

SOURCE: Järvholm K et al. Lancet Child Adolesc Health. 2020. doi: 10.1016/s2352-4642(20)30024-9.

Sleeve gastrectomy was associated with significantly fewer postsurgical interventions and operations than was Roux-en-Y gastric bypass over longer-term follow-up in a recent cohort study based on real-world clinical data, according to investigators.

Interventions, operations, and hospitalizations were “relatively common” for both procedures over the 5-year follow-up, though significantly less so with sleeve gastrectomy, which has become the most common bariatric operation, the investigators said in a recent report on the study.

The benefit of sleeve gastrectomy seemed to be most pronounced in patients with lower body mass index and those with fewer comorbidities, according to the authors of the report, led by bariatric and general surgeon Anita Courcoulas, MD, of the University of Pittsburgh Medical Center.

That finding is counterintuitive, since in clinical practice, sleeve gastrectomy is frequently thought of as the preferred procedure for individuals with higher BMI or more comorbidities, though Dr. Courcoulas and colleagues cautioned that the findings were “exploratory” and require further investigation. Historically, Roux-en-Y gastric bypass provided more weight loss.

Safety results from this study, balanced by weight loss and health outcomes data, will “help inform procedure-specific decision making for prospective patients and physicians,” said Dr. Courcoulas and coauthors of the report, which appears in JAMA Surgery.

The study included 33,560 adults who had undergone the Roux-en-Y procedure or sleeve gastrectomy, making it one of the largest bariatric cohort studies ever to be done, according to the investigators.

The majority of patients in the study (54%) underwent Roux-en-Y gastric bypass, though the number of sleeve gastrectomy procedures increased each year in the study, which included patients who underwent a primary bariatric surgery procedure between January 2005 and September 2015 at 1 of 10 sites in the National Patient-Centered Clinical Research Network.

Most of the patients were female (80%) and white (66%), and 26% were Hispanic, according to the researchers, who said their study was more racially diverse than other bariatric studies, and therefore potentially more generalizable to real-world clinical practice.

Over the 5-year follow-up period, patients who underwent sleeve gastrectomy were less likely to subsequently undergo operations involving the abdomen, or interventions for enteral access, such as placement of gastrostomy tubes, according to the investigators, who reported a hazard ratio (HR) of 0.72 (95% confidence interval [CI], 0.65-0.79; P less than .001).

The estimated cumulative rate of operations or interventions at 5 years was 8.94% (95% CI, 8.23%-9.65%) for the patients who underwent sleeve gastrectomy, compared with 12.27% (95% CI, 11.49%-13.05%) for those who underwent the Roux-en-Y procedure, according to the report.

Hospitalization was also less likely for sleeve gastrectomy versus Roux-en-Y gastric bypass, with a hazard ratio of 0.82 and estimated cumulative incidence rates of 32.79% and 38.33%, respectively. Likewise, endoscopy was less likely in the sleeve gastrectomy group.

All-cause mortality did not differ between the groups at this 5-year follow-up, the investigators said.

“The present data were gathered from clinical care in the real world, yet the results are comparable to controlled studies and therefore lend additional support to the findings of these other types of studies that operation and intervention occur less commonly after sleeve gastrectomy than after Roux-en-Y gastric bypass for up to 5 years,” Dr. Courcoulas and coauthors noted in a discussion of their results.

This work was funded by the Patient-Centered Outcomes Research Institute. Dr. Courcoulas reported receiving a grant from Allurion. Coauthors provided disclosures related to the National Institutes of Health, IFSO Latin America Chapter, and the Food and Drug Administration.

*This story was updated on January 16, 2020.

SOURCE: Courcoulas A et al. JAMA Surg. 2020 Jan 15. doi: 10.1001/jamasurg.2019.5470.

Sleeve gastrectomy was associated with significantly fewer postsurgical interventions and operations than was Roux-en-Y gastric bypass over longer-term follow-up in a recent cohort study based on real-world clinical data, according to investigators.

Interventions, operations, and hospitalizations were “relatively common” for both procedures over the 5-year follow-up, though significantly less so with sleeve gastrectomy, which has become the most common bariatric operation, the investigators said in a recent report on the study.

The benefit of sleeve gastrectomy seemed to be most pronounced in patients with lower body mass index and those with fewer comorbidities, according to the authors of the report, led by bariatric and general surgeon Anita Courcoulas, MD, of the University of Pittsburgh Medical Center.

That finding is counterintuitive, since in clinical practice, sleeve gastrectomy is frequently thought of as the preferred procedure for individuals with higher BMI or more comorbidities, though Dr. Courcoulas and colleagues cautioned that the findings were “exploratory” and require further investigation. Historically, Roux-en-Y gastric bypass provided more weight loss.

Safety results from this study, balanced by weight loss and health outcomes data, will “help inform procedure-specific decision making for prospective patients and physicians,” said Dr. Courcoulas and coauthors of the report, which appears in JAMA Surgery.

The study included 33,560 adults who had undergone the Roux-en-Y procedure or sleeve gastrectomy, making it one of the largest bariatric cohort studies ever to be done, according to the investigators.

The majority of patients in the study (54%) underwent Roux-en-Y gastric bypass, though the number of sleeve gastrectomy procedures increased each year in the study, which included patients who underwent a primary bariatric surgery procedure between January 2005 and September 2015 at 1 of 10 sites in the National Patient-Centered Clinical Research Network.

Most of the patients were female (80%) and white (66%), and 26% were Hispanic, according to the researchers, who said their study was more racially diverse than other bariatric studies, and therefore potentially more generalizable to real-world clinical practice.

Over the 5-year follow-up period, patients who underwent sleeve gastrectomy were less likely to subsequently undergo operations involving the abdomen, or interventions for enteral access, such as placement of gastrostomy tubes, according to the investigators, who reported a hazard ratio (HR) of 0.72 (95% confidence interval [CI], 0.65-0.79; P less than .001).

The estimated cumulative rate of operations or interventions at 5 years was 8.94% (95% CI, 8.23%-9.65%) for the patients who underwent sleeve gastrectomy, compared with 12.27% (95% CI, 11.49%-13.05%) for those who underwent the Roux-en-Y procedure, according to the report.

Hospitalization was also less likely for sleeve gastrectomy versus Roux-en-Y gastric bypass, with a hazard ratio of 0.82 and estimated cumulative incidence rates of 32.79% and 38.33%, respectively. Likewise, endoscopy was less likely in the sleeve gastrectomy group.

All-cause mortality did not differ between the groups at this 5-year follow-up, the investigators said.

“The present data were gathered from clinical care in the real world, yet the results are comparable to controlled studies and therefore lend additional support to the findings of these other types of studies that operation and intervention occur less commonly after sleeve gastrectomy than after Roux-en-Y gastric bypass for up to 5 years,” Dr. Courcoulas and coauthors noted in a discussion of their results.

This work was funded by the Patient-Centered Outcomes Research Institute. Dr. Courcoulas reported receiving a grant from Allurion. Coauthors provided disclosures related to the National Institutes of Health, IFSO Latin America Chapter, and the Food and Drug Administration.

*This story was updated on January 16, 2020.

SOURCE: Courcoulas A et al. JAMA Surg. 2020 Jan 15. doi: 10.1001/jamasurg.2019.5470.

Sleeve gastrectomy was associated with significantly fewer postsurgical interventions and operations than was Roux-en-Y gastric bypass over longer-term follow-up in a recent cohort study based on real-world clinical data, according to investigators.

Interventions, operations, and hospitalizations were “relatively common” for both procedures over the 5-year follow-up, though significantly less so with sleeve gastrectomy, which has become the most common bariatric operation, the investigators said in a recent report on the study.

The benefit of sleeve gastrectomy seemed to be most pronounced in patients with lower body mass index and those with fewer comorbidities, according to the authors of the report, led by bariatric and general surgeon Anita Courcoulas, MD, of the University of Pittsburgh Medical Center.

That finding is counterintuitive, since in clinical practice, sleeve gastrectomy is frequently thought of as the preferred procedure for individuals with higher BMI or more comorbidities, though Dr. Courcoulas and colleagues cautioned that the findings were “exploratory” and require further investigation. Historically, Roux-en-Y gastric bypass provided more weight loss.

Safety results from this study, balanced by weight loss and health outcomes data, will “help inform procedure-specific decision making for prospective patients and physicians,” said Dr. Courcoulas and coauthors of the report, which appears in JAMA Surgery.

The study included 33,560 adults who had undergone the Roux-en-Y procedure or sleeve gastrectomy, making it one of the largest bariatric cohort studies ever to be done, according to the investigators.

The majority of patients in the study (54%) underwent Roux-en-Y gastric bypass, though the number of sleeve gastrectomy procedures increased each year in the study, which included patients who underwent a primary bariatric surgery procedure between January 2005 and September 2015 at 1 of 10 sites in the National Patient-Centered Clinical Research Network.

Most of the patients were female (80%) and white (66%), and 26% were Hispanic, according to the researchers, who said their study was more racially diverse than other bariatric studies, and therefore potentially more generalizable to real-world clinical practice.

Over the 5-year follow-up period, patients who underwent sleeve gastrectomy were less likely to subsequently undergo operations involving the abdomen, or interventions for enteral access, such as placement of gastrostomy tubes, according to the investigators, who reported a hazard ratio (HR) of 0.72 (95% confidence interval [CI], 0.65-0.79; P less than .001).

The estimated cumulative rate of operations or interventions at 5 years was 8.94% (95% CI, 8.23%-9.65%) for the patients who underwent sleeve gastrectomy, compared with 12.27% (95% CI, 11.49%-13.05%) for those who underwent the Roux-en-Y procedure, according to the report.

Hospitalization was also less likely for sleeve gastrectomy versus Roux-en-Y gastric bypass, with a hazard ratio of 0.82 and estimated cumulative incidence rates of 32.79% and 38.33%, respectively. Likewise, endoscopy was less likely in the sleeve gastrectomy group.

All-cause mortality did not differ between the groups at this 5-year follow-up, the investigators said.

“The present data were gathered from clinical care in the real world, yet the results are comparable to controlled studies and therefore lend additional support to the findings of these other types of studies that operation and intervention occur less commonly after sleeve gastrectomy than after Roux-en-Y gastric bypass for up to 5 years,” Dr. Courcoulas and coauthors noted in a discussion of their results.

This work was funded by the Patient-Centered Outcomes Research Institute. Dr. Courcoulas reported receiving a grant from Allurion. Coauthors provided disclosures related to the National Institutes of Health, IFSO Latin America Chapter, and the Food and Drug Administration.

*This story was updated on January 16, 2020.

SOURCE: Courcoulas A et al. JAMA Surg. 2020 Jan 15. doi: 10.1001/jamasurg.2019.5470.