This document was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in Feb 2018.
Dana A. Telem1 · Daniel B. Jones2 · Philip R. Schauer3 · Stacy A. Brethauer4 · Raul J. Rosenthal4· David Provost5 · Stephanie B. Jones6
Background: During the 2004 annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), a panel of experts convened to provide updated information on best practices in bariatric surgery. The rapid evolution of endoluminal technologies, surgical indications, and training in bariatric surgery since 2004 has led to new questions and concerns about optimal treatment algorithms, patient selection, and the preparation of our current and future bariatric workforce.
Methods: An expert panel was convened at the SAGES 2017 annual meeting to provide a summative update on current practice patterns, techniques, and training in bariatric surgery in order to review and establish best practices. This was a joint effort by SAGES, International Society for the Perioperative Care of the Obese Patient, and the American Society for Metabolic and Bariatric Surgery.
Results: On March 23, 2017, seven expert faculty convened to address current areas of controversy in bariatric surgery and provide updated guidelines and practice recommendations. Areas addressed included the expanded indications for use of metabolic surgery in the treatment of diabetes, the safety and efficacy of new and investigational endoluminal procedures, updates on new guidelines for the management of airway and sleep apnea in the obese patient, the development of clinical pathways to reduce variation in the management of the bariatric patient, and new guidelines for training, credentialing, and bariatric program accreditation. The following article is a summary of this panel.
Conclusion: Bariatric surgery is a field that continues to evolve. A timely, systematic approach, such as described here, that coalesces data and establishes best practices on the current body of available evidence is imperative for optimal patient care and to inform provider, insurer, and policy decisions.
Keywords: Bariatric surgery · Diabetes · Credentialing · Endoluminal devices · Centers of excellence · Fellowship
1 Department of Surgery, University of Michigan, 1500 E. Medical Center Drive, Ann Arbor, MI 48109, USA
2 Department of Surgery, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA
3 Department of General Surgery, Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, OH, USA
4 Department of General Surgery and The Bariatric and Metabolic Institute, Cleveland Clinic Florida, Weston, FL, USA
5 Provost Bariatrics, Scott and White Clinic, Temple, TX, USA
6 Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA
Best practices are defined as “professional procedures that are accepted or prescribed as being correct or most effective.” In 2004, SAGES conducted an Appropriateness Conference on the topic of the “Optimal management of the morbidly obese patient.” The SAGES Appropriateness Conference determined that the laparoscopic Roux-en-Y gastric bypass (RYGB) affords improved short-term recovery compared to open gastric bypass . The experts also agreed that laparoscopic adjustable gastric banding (LAGB) can be performed with lower average mortality than RYGB or any of the malabsorptive operations [jejunal–ileal bypass, vertical band gastroplasty, biliopancreatic diversion duodenal switch (BPD)], and produces variable degrees of short-term weight loss . It was concluded that prospective randomized trials were needed to compare gastric bypass, malabsorptive, and restrictive procedures .
Much has changed since 2004 given the rapid advancement of new technologies and techniques in bariatric surgery as well as the changing landscape in surgical education and accreditation. Today, nearly the majority of weight loss operations are performed laparoscopically. However, both RYGB and LAGB are performed less often as newer procedures such as the laparoscopic sleeve gastrectomy (LSG) have gained popularity. Safer operations and shorter hospitalizations are forcing surgeons to rethink surgical indications. This is particularly relevant for the surgical treatment of diabetes, where multiple randomized control trials demonstrate efficacy of surgery when compared to medical treatment alone . With safe and effective operations, should we update our indications for surgery in those with diabetes?
Endoluminal procedures are gaining traction in the United States and abroad as a means to fill the “gap” between medical therapy and surgery. In the United States, the intragastric balloon has recently gained FDA approval, opening new opportunities for obesity treatment. These opportunities, however, create new considerations. Who will benefit most from these procedures? Should endoluminal procedures be performed by bariatric surgeons within a multidisciplinary bariatric team, or can balloons be place by gastroenterologists in the endoscopy suite without the support of a bariatric team? What are the data on risks, benefits, failure to lose weight, and weight regain for these novel procedures?
Optimal patient management has also changed over time [3, 4]. Patients of size pose airway challenges to the anesthesiologist during intubation and emergence. On the floor and in the radiology suite, over-sedation can prove lethal to the patient with obstructive sleep apnea. Anesthesiology societies have established guidelines for monitoring the bariatric surgery patient. While in the past patients would often be observed for an extended period in the PACU or step down unit after bariatric operations due to risk of airway complications, there is increasing production pressures to get patients discharged sooner. How do we ensure the safe management and discharge of our patients? Similarly, minimizing variation in patient management and care is a hallmark of efficacy and outcome optimization. In high-volume centers, can clinical care pathways improve outcomes? Can evidence-based medicine help guide practice patterns?
Finally, the days of a weekend course to learn laparoscopic gastric bypass or simply “hanging your shingle” to practice no longer exist. The current standard is the yearlong fellowship where trainees mature in their ability to perform preoperative assessments, intraoperative techniques, and long-term follow-up of the bariatric patient. As the type and complexity of operations change over time, so too must the Fellowship Council criteria evolve. When one emerges from training to practice, practicing in an accredited Center of Excellence has become the norm. Accreditation has vastly changed since 2004 . While some voice that accreditation is costly and does not guarantee quality, most believe that adherence to accreditation standards promotes better care for our patients. As part of accreditation, centers are required to enter data into a national registry. Questions remain as to how we are using these data to promote improved patient outcomes and advance quality improvement.
The indications and best practices for obesity surgery are evolving rapidly in the era of laparoscopy, endoscopy, multidisciplinary teams, facility accreditation, and specialty training. The 2017 Appropriateness Conference updates the 2004 statement based on new guidelines from multiple societies. The summative update follows below.
New indications for surgery: BMI and diabetes
The association between bariatric and metabolic surgery and improvement in weight-related medical conditions such as diabetes are well established. In 2016, a paper by Rubino et al. summarized data from 11 randomized control trials comparing surgery to medically supervised weight loss and concluded that metabolic surgery achieves excellent glycemic control, albeit in the short/mid-term . Two randomized control trials report 5-year data. In 2015, a study in the Lancet reported the 5-year outcomes of bariatric–metabolic surgery versus conventional medical therapy in the treatment of obesity in patients with type 2 diabetes . The single-center randomized control trial compared 5-year remission rates in patients randomized to receive no medical treatment versus RYGB or BPD. At 5 years, 37% in the RYGB and 63% of the BPD group maintained diabetes remission, as compared to 0% of the medically treated patients (P = 0.007) . In 2017, Schauer et al. reported the 5-year results of a randomized control trial comparing bariatric surgery to intensive medical therapy for diabetes . The success rate at achieving HbA1c ≤ 6.0% at 5 years was met by 2 of 38 patients (5%) who received medical therapy alone, as compared with 14 of 49 patients (29%) who underwent RYGB (unadjusted P = 0.01) and 11 of 47 patients (23%) who underwent sleeve gastrectomy (P = 0.03).
At 5 years of follow-up compared to baseline, the surgical group demonstrated 57% improvement, 39% no change, and 4% worsening of glycemic control as assessed by percent change in glycosylated hemoglobin. This was significant when compared to the medical group where 13% demonstrated improvement, 71% no change, and 16% worsening of glycemic control .
Notably, this study also compared outcomes in patients with a body mass index (BMI) above and below 35 kg/ m2. Patients with BMI < 35 kg/m2 who underwent surgical procedures had a much greater reduction from baseline in glycated hemoglobin level then did patients who received medical therapy alone, and these reductions were comparable to those whose BMI ≥ 35 kg/m2. These data are important as they demonstrate the efficacy of surgery for the management of diabetes in patients who have a BMI below the current threshold for surgical treatment .
Despite the growing body of data supporting the use of metabolic surgery for the treatment of diabetes, the medical community had been slow to change recommendations and expand indications for surgery. It was not until 2016, when a joint statement on metabolic surgery in the treatment algorithm for type 2 diabetes was published by the international diabetes organizations, did new guidelines emerge . Based on the evidence, they concluded that bariatric surgery should be recommended for patients with BMI ≥ 40 kg/m2 regardless of glycemic control and for those with BMI ≥ 35 kg/m2 with inadequately controlled hyperglycemia. Furthermore, surgery should be considered for patients with a BMI 30–34.9 kg/m2 and inadequately controlled hyperglycemia and for Asian patients with BMI as low as 27.5 kg/m2 and inadequately controlled hyperglycemia . This conference subsequently prompted changes to the standards of diabetes care in the United States. The American Diabetes Association (ADA) published updated guidelines in the 2017 edition of Diabetes Care reflects these recommendations . Metabolic surgery is now recommended for patients with BMI ≥ 40 kg/m2 independent of glycemic control and for those patients with BMI ≥ 35 kg/ m2 not well controlled on medications. Notably, the ADA also states that metabolic surgery should be considered for those patients with BMI 30–35 kg/m2 and inadequate glycemic control . The inclusion of metabolic surgery to treat diabetes in a widely endorsed evidence-based guideline will both benefit our patients clinically as well as inform policy and coverage decisions to expand surgical access.
Accepted and emerging endoluminal therapies for weight loss
The “gap” between medical and surgical therapy based on risk and efficacy considerations for patients is well recognized. Endoluminal therapies are quickly emerging to fill this void and are in various stages of evolution. Identifying the correct patient population that will benefit most from these procedures remains an ongoing challenge. Much of this determination will be subject to ongoing data collection and analyses, as mid- to long-term data are not yet available. Thus, ensuring performance of these procedures within comprehensive weight loss centers with mandated data reporting will be imperative to monitor the safety, efficacy, and durability of endoluminal therapies.
Of the endoluminal procedures, intragastric balloons are the most prevalent. Currently, three intragastric balloons are Food and Drug Administration (FDA) approved for weight loss. While the placement, inflation, and retrieval of the balloons vary, the mechanism of action is similar. Balloons are a temporary, intragastric space-occupying devices that are removed after a maximum of 6 months following placement. In 2015, a meta-analysis assessing short-term results of the intragastric balloon was published. Aggregated data from studies with time points ranging from 3 to 12 months and sample sizes varying from 21 to 128 patients demonstrated significantly improved weight loss in patients undergoing balloon placement versus controls . Effect sizes of weight reduction (− 8.9 kg), BMI reduction (− 3.1 kg/m2), and percent excess weight loss (− 21.0%) were demonstrated as compared to a control group which had nominal weight reductions (− 1.5 kg) and BMI reductions (− 1.2 kg/m2). While the intervention group had significantly more gastrointestinal-related symptoms on initial placement (nausea, emesis, abdominal discomfort), this was offset by the longer term weight loss benefits . A safety analysis showed no serious or fatal complications. The other FDA-approved endoluminal device is an aspiration device that enters the stomach similar to a gastrostomy tube and is manually emptied by patients after meals to evacuate 30% of the meal content. Early studies demonstrate good weight loss, with 55% excess weight loss out to 2 years [11. At this time, aspiration therapy is not widely utilized and it is unclear where it will fit into the treatment paradigm moving forward.
Stapling and suturing procedures are also described and performed. Endoluminal gastroplasty is a promising technique that initially emerged from South America; however, it did not demonstrate the same efficacy when trialed in the US. Twelve-month results from the transoral gastric volume reduction as intervention for weight management (TRIM) trial showed a mean weight loss of 11 kg, BMI reduction of − 4 kg/m2, and percent excess weight loss of 27.7 . There were responders and nonresponders within the cohort, and variability in degree of response. Half of patients achieved greater than 30% excess weight loss; however, many regained the weight as the plications came undone . To improve results, the technology evolved and currently involves a different pattern of suture for the plication and the ability to take deeper bites that are more surgical in nature. Initial data from 22 patients are promising and demonstrate no major adverse events, mean BMI loss of 7.3 kg/m2, and mean percentage of total body weight loss of 18.7 ± 10.7 kg at 1 year . Endoscopic sleeve gastroplasty is a feasible and promising procedure to treat obesity. The device manufacturer is currently seeking FDA approval for an obesity treatment indication and the ASMBS is waiting to discuss any formal endorsement of the procedure until more data emerge.
Other emerging endoluminal procedures that are not currently FDA approved include primary obesity surgery endoluminal (POSE), the transpyloric shuttle, endoluminal barrier devices, and duodenal mucosal resurfacing. Initial trials of POSE in Spain demonstrated no adverse events and promising weight loss. Based upon these results, a study in the US was initiated. This study failed to reach the primary endpoint in terms of total body weight loss. While it did not demonstrate efficacy in weight loss, the trial did result in significant differences in the treatment group for quality of life metrics such as less hunger, earlier fullness, and less food cravings . The transpyloric shuttle is a newer, dumbbell-shaped device that is endoscopically placed across the pylorus to create intermittent gastric outlet obstruction to promote early satiety and delayed gastric emptying. This procedure is currently under investigation and patients are being enrolled for its pivotal trial.
Devices meant to replicate portions of the RYGB and alter nutrient, bile acid, and mucosal interactions in the proximal small bowel are under investigation both for the treatment of obesity and its associated metabolic comorbid conditions. The endobarrier device is a 60-cm impermeable sleeve placed endoscopically with the proximal end anchored in the duodenal bulb, was one of the first to be evaluated. Initially, this device demonstrated a significant 18% total body weight loss and 42% excess weight loss at the 6-month study end point. The procedure was also noted to significantly impact glycemic control in diabetics. A reduction in diabetic medication, alterations in glucose meal response, and increased meal-induced GLP-1 and PYY similar to the RYGB and sleeve gastrectomy were demonstrated . The Achilles heel of the procedure, however, was poor patient tolerance and adverse events. During the pivotal trial in the US, seven patients developed hepatic abscesses and device use was halted pending further review by the manufacturer and the FDA . A newer endoluminal technique meant to reproduce this same mechanism is endoscopic duodenal resurfacing in which the duodenal mucosa is thermally ablated. The first human “proof of concept” trial was recently published and demonstrated that long- and short-segment ablations could significantly reduce glycosylated hemoglobin levels by 1.2% at 6 months; longer segment ablations were more potent. Several patients did go on to develop strictures requiring dilation. More data are needed on long-term efficacy and safety .
Anesthesia considerations: airway and sleep apnea management in the patient with obesity
Airway management in patients with obesity can be a challenge, particularly in those with obstructive sleep apnea (OSA). Preventing major airway complications (death, brain damage, need for surgical airway, unplanned intensive care unit admission) is a central focus in this patient population. Assessment of the ASA Closed Claims Project database demonstrated that 37% of claims related to induction and 67% of claims related to extubation were in obese patients; 28% of extubation claims were in patients with OSA . As such, a thorough airway examination and screening for OSA are essential components to of the preoperative evaluation of persons with obesity undergoing surgery [18<]. Given the potential dangers and complications associated with obesity, OSA and the airway, it is important that surgeons and anesthesiologists work together to implement evidence-based protocols to minimize and address complications as they arise. While patients may be at increased risk, several guidelines have been established to implement strategies to reduce intraoperative and perioperative complications.
In 2015, the Difficult Airway Society published guidelines for management of unanticipated difficult intubation in adults . Within these guidelines, obesity is mentioned in the context of ramping, preoxygenation with the head elevated and continuous positive airway pressure (CPAP), and apneic oxygenation . In 2014, the updated ASA OSA guidelines were published . For patients with known and treated OSA, perioperative recommendations were as follows: use of multimodal/regional anesthesia to decrease need for opioid pain medications, reduction in sedatives as they increase risk for respiratory depression, supplemental oxygen (with the caveat that this may delay recognition of respiratory depression), CPAP postoperatively if used prior to surgery, continuous pulse oximetry postoperatively as long as a patient remains at increased risk, and elevation of the head of the bed. Additionally, patients at increased risk from OSA should not be discharged from the recovery area to an unmonitored setting until they are no longer at risk of postoperative respiratory depression which may translate to longer stays .
For patients who present with unknown or untreated/ partially treated OSA, there is insufficent evidence to cancel or delay surgery for formal testing or treatment unless there is evidence of associated significant or uncontrolled systemic disease . Such systemic diseases include hypoventilation syndromes, severe pulmonary hypertension, and resting hypoxemia. Otherwise patients should be screened and managed with the aforementioned strategies . Use of CPAP in this naïve population should be assessed on a case-by-case basis and if continued perioperatively.
Clinical pathways for the bariatric patient
Clinical care pathways are tools that integrate evidence-based healthcare into clinical practice. Pathways are intended to improve healthcare delivery and quality, while minimizing healthcare costs. The end goal of a clinical care pathway is to provide evidence-based guidelines for routine patient care. A pathway ideally also provides structure for patient care in situations that require deviation from the routine treatment path. Such pathways have important implications as we transition to value-based healthcare [22, 23]. The value of care pathways is well recognized in bariatric surgery. Several single institutional studies demonstrate that implementation of pathways reduces cost and decreases hospital length of stay and perioperative complications [24–28]. Maintaining and adhering to clinical care pathways is required for accreditation by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) .
While required for MBSAQIP accreditation, a uniform, evidence-based pathway was not available. Moreover, little was known about the content and variability of such pathways on a national level. A study identified considerable national variations in clinical pathways used by practicing bariatric surgeons . Only 6 of the 40 perioperative variables that were assessed were concordant among pathways: preoperative nutritional evaluation, preoperative psychological evaluation, mention of intraoperative venous thromboembolism prophylaxis, mention of antiemetic utilization in the postoperative period, dedicated perioperative pain protocols, and mention of obtaining postoperative laboratory values. Further evaluation of these pathways also demonstrated that the majority of metrics, even when mentioned, were nonspecific, without clear recommendations as to whether they should be followed routinely or selectively and for whom .
This study highlighted a key opportunity for the ASMBS to develop and implement an evidence-based national care pathway for sleeve gastrectomy. A task force from ASMBS was selected to carry out this project. The sleeve pathway is currently available to members on the ASMBS website, as well as a summary in SOARD . This pathway reflects the summative output of integrating over 150 manuscripts with expert consensus . This care pathway is dynamic and will continually update as new evidence becomes available. We hope that this pathway will serve as a valuable resource to aid new and existing programs in an effort to provide value-based care. The development of this pathway has also highlighted critical knowledge gaps impacting the care of our patients. These clinical gaps should serve as a guide for future research and quality improvement projects.
Accreditation and certification of bariatric surgeons
Surgical training is rapidly evolving. Changes in duty hours, limitations impeding residents from participating in operations (e.g., administrative responsibilities, formal didactics lectures), and the introduction of new techniques and technologies such as laparoscopy and robotics has created new challenges in surgical education. The increased complexity and demands of training have created a paradigm where the vast majority of graduating surgical residents undergo additional fellowship training after residency. This was well recognized in 1997, and the fellowship council (FC) was formed. The FC is responsible for coordinating the annual matching process for graduating surgical residents entering Minimally Invasive, Flexible Endoscopy, Bariatric, Thoracic, Colorectal, and Hepato-Pancreato-Biliary surgery fellowships and the accreditation of 172 training programs. Anticipating the educational needs of residency graduates, the FC has been proactive in developing strategies to both train and maintain a competent surgical workforce. Ongoing projects addressing this goal include an overhaul of the fellowship accreditation process, the development of a certificate of expertise demonstrating continued proficiency in bariatric surgery for practicing surgeons, and the development of a multiple society-sponsored advanced gastrointestinal surgery training curriculum.
Perhaps the most innovative project at present centers on transitioning from volume-based to competency-based training through the development of unified standards of competency for bariatric surgery fellows via an entrustable professional activities (EPA) model. Efforts to implement a competency-based curriculum are currently underway . This curriculum is based on modules that contain both a cognitive and technical component. Learners must meet each milestone set forth by the module, and cannot progress to the next level until they have demonstrated they are competent in achieving the set milestones. The modules are not time based, and progression is fluid based on the individual. The curriculum is composed of 6 bariatric modules: introduction, primary bariatric surgery, short- and long-term complications, endoscopy, revisional surgery, and long-term complications, and practice management, MBSAQIP, and quality. A learner must be competent in all milestones from all modules before “compentency” is granted. In order to gauge the module milestones, EPAs were created. To date, EPAs have been created to assess performance of primary anastomotic procedures, adjustable gastric banding, management of short-term complications, and the performance of diagnostic and therapeutic endoscopy. While still in its early stages, it is currently being tested in a small number of programs and this curriculum is anticipated to integrate into all bariatric fellowship training programs in the coming years .
MBSAQIP bariatric program accreditation
In 2012, the American College of Surgeons (ACS) and the ASMBS merged their respective bariatric surgery accreditation programs into a single, unified program, the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) . Accreditation as an MBSAQIP Center of Excellence relies on three key tenets for assessing “excellence” within bariatric surgery: structural measures (e.g., volume), process measures, and outcomes measures. This program is responsible for accrediting inpatient and outpatient bariatric surgery centers in the United States and Canada. To date, there are 834 centers participating in the MBSAQIP.
The mission of the MBSQIP is to improve efficiency, efficacy, and safety of metabolic and bariatric surgery. To accomplish this task, there is a robust network in place that starts with the establishment of tools, guidelines, and standards that impact high-quality surgical care. As part of this mission, each accredited center is required to enter data on their bariatric procedures into a National Data Registry which are then analyzed and risk adjusted. Each center is then provided feedback as to their performance against an aggregated national benchmark.
The key to MBSAQIP hinges on the benefit of this data collection and feedback. Every metabolic and bariatric operation and intervention performed at a MBSAQIP accredited center, including primary operations, reoperations and reinterventions, and endoluminal therapeutic interventions, are captured within the data registry. Data entry is performed by rigorously trained Metabolic and Bariatric Surgical Clinical Reviewers (MBSCR) via patient chart review. MBSCRs are not permitted to be involved in supervising patient care and may not chart any of the variables that are subsequently collected in the MBSAQIP workstation. The data registry collects prospective, clinically rich data based on over 200 preoperative, intraoperative, and postoperative variables with standardized definitions. Longitudinal patient data are collected at 30 days, 6 months, 1 year, and yearly thereafter. The benefit of this data collection are in its use for benchmarking surgical outcomes. As part of MBSAQIP, each accredited center receives a report of their data. This SAR report, which stands for “Semiannual Report”, is a comprehensive dataset of how an individual center performs as compared to other centers on a risk-adjusted basis.
Each center must use their data to create an institution-specific quality improvement initiative to address areas identified in need of improvement. These data allow for the optimization of cross-departmental partnerships and collaboration through shared knowledge. It also provides proactive, value-oriented performance measures that providers may use for internal quality improvement as well as to meet external reporting requirements. The MBSAQIP data registry is a qualified clinical data registry (QCDR) for the Centers for Medicaid and Medicare Services (CMS) merit-based incentive payment system (MIPS). MBSAQIP participants may elect to have their MBSAQIP QCDR quality measures submitted to CMS to comply with MIPS.
A dataset from 2015 is now available for research or broad quality improvement projects. In January 2017, the inaugural Participant Use File (PUF) from the MBSAQIP data registry was made available to participating MBSAQIP centers. This PUF was released for the express purpose of providing researchers a data resource to investigate and advance the quality of care delivered to the metabolic and bariatric surgical patient. Also, new in 2017 for MBSAQIP is the approval of data collection from international centers, a designated bariatric track at the ACS patient safety and quality improvement meeting, and migration of MBSAQIP to a single data registry platform with other ACS quality programs.
Bariatric and metabolic surgery is a rapidly evolving field that is adapting to new indications, technologies, guidelines, training, and accreditation models. Bariatric surgery has moved past initial concerns over “safety and efficacy” into a new domain of expanded indications, optimization of outcomes, and the assurance of safe adoption of new techniques and technologies that will likely benefit our patients. To ensure the continuation of our mission to improve the efficiency, efficacy, and safety of metabolic and bariatric surgery, we must continue to focus on the training and competency of our current and future workforce and the use of MBSAQIP data to push us forward as a field.
Compliance with ethical standards
Dr. Schauer has the following relationships: (1) Advisory Board: The Medicines Company, GI Dynamics, Neurotronic, Pacira; (2) Consultant: Ethicon, The Medicines Company, Novo Nordisk; (3) Research Support: Ethicon, National Institutes of Health, Medtronic,
Dr. Rosenthal has the following relationships: (1) Speaker, Medtronic.
Dr. Daniel Jones: (1) Allurion Gastric Ballon.
Dr. Dana Telem: (1) Consultant, Medtronic.
Otherwise, the rest of the authors have no conflict of interest and nothing to disclose.
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This document was prepared and revised by Dana A. Telem · Daniel B. Jones · Philip R. Schauer · Stacy A. Brethauer · Raul J. Rosenthal · David Provost · Stephanie B. Jones
This document was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in Feb 2018.
SAGES publication #BPOBESITY1
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Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision.
Guidelines are developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.