The impact of bariatric surgery on pregnancy complication rates.

BACKGROUND: Obesity is associated with multiple pregnancy-related complications. Bariatric surgery is frequently performed in women of childbearing age. While the impact of bariatric surgery on fertility and nutritional complications has been characterized, few studies on effects of bariatric surgery on obesity-related pregnancy complications exist. The purpose of this study is to examine the impact of bariatric surgery on pregnancy complications in a US insured population. METHODS: Pregnancy-related claims from 2011-2019 were obtained from MarketScan commercial claims database for bariatric surgical patients and non-surgical patients with no history of obesity. Claims were grouped into 3 time periods: pre-surgery (time of first claim to date of surgery), peri-surgery (date of surgery to 24 month postoperatively), and post-surgery (> 24 month postoperatively). Peri-surgery period was defined based on the recommendation to avoid pregnancy for the first 12-24 months following surgery. Codes for both maternal and fetal pregnancy-related complications were extracted from the database. Standardized incidence rates in person-months (pms) were calculated and generalized estimating equations with Poisson distribution tested for differences in each category at the three time intervals. RESULTS: The final cohort included 163612 female bariatric surgery patients. The rate of successful births was 3/1000 pms in the pre-surgery and peri-surgery period and increased to 4/1000 pms in the post-surgery period, compared to a rate of 7/1000 in the control group. The rate of pregnancy complications in the pre-surgery group was 4/1000 pms and dropped to 2/1000 pms in the peri- and post-surgery periods. The complication rate in the control group was 4/1000 pms. CONCLUSION: After bariatric surgery, the rate of pregnancy complications is lower than non-obese, non-bariatric surgery patients. Compared to before surgery, pregnancy complications decrease by 63% in the peri-surgery period and 57% in the post-surgery period. In the US, bariatric surgery is an important intervention for decreasing pregnancy complications in patients with obesity.

Long-term cancer outcomes after bariatric surgery.

OBJECTIVE: Obesity is associated with increased cancer risk. Because of the substantial and sustained weight loss following bariatric surgery, postsurgical patients are ideal to study the association of weight loss and cancer. METHODS: Retrospectively (1982-2019), 21,837 bariatric surgery patients (surgery, 1982-2018) were matched 1:1 by age, sex, and BMI with a nonsurgical comparison group. Procedures included gastric bypass, gastric banding, sleeve gastrectomy, and duodenal switch. Primary outcomes included cancer incidence and mortality, stratified by obesity- and non-obesity-related cancers, sex, cancer stage, and procedure. RESULTS: Bariatric surgery patients had a 25% lower risk of developing any cancers compared with a nonsurgical comparison group (hazard ratio [HR] 0.75; 95% CI 0.69-0.81; p < 0.001). Cancer incidence was lower among female (HR 0.67; 95% CI 0.62-0.74; p < 0.001) but not male surgery patients, with the HR lower for females than for males (p < 0.001). Female surgery patients had a 41% lower risk for obesity-related cancers (i.e., breast, ovarian, uterine, and colon) compared with nonsurgical females (HR 0.59; 95% CI 0.52-0.66; p < 0.001). Cancer mortality was significantly lower after surgery in females (HR 0.53; 95% CI 0.44-0.64; p < 0.001). CONCLUSIONS: Bariatric surgery was associated with lower all-cancer and obesity-related cancer incidence among female patients. Cancer mortality was significantly lower among females in the surgical group versus the nonsurgical group.

Surgeon experience with insurance barriers to offering gastric bypass as an evidence-based operation for pathologic GERD.

INTRODUCTION: Obesity is an increasingly prevalent public health problem often associated with poorly controlled gastroesophageal reflux disease. Fundoplication has been shown to have limited long-term efficacy in patients with morbid obesity and does not address additional weight-related co-morbidities. Roux-en-Y gastric bypass (RYGB) is the gold standard operation for durable resolution of GERD in patients with obesity, and is also used as a salvage operation for GERD after prior foregut surgery. Surgeons report access to RYGB as surgical treatment for GERD is often limited by RYGB-specific benefit exclusions embedded within insurance policies, but the magnitude and scope of this problem is unknown. METHODS: A 9-item survey evaluating surgeon practice and experience with insurance coverage for RYGB for GERD was developed and piloted by a SAGES Foregut Taskforce working group. This survey was then administered to surgeon members of the SAGES Foregut Taskforce and to surgeons participating in the SAGES Bariatrics and/or Foregut Facebook groups. RESULTS: 187 surgeons completed the survey. 89% reported using the RYGB as an anti-reflux procedure. 44% and 26% used a BMI of 35 kg/m2 and 30 kg/m2 respectively as cutoff for the RYGB. 89% viewed RYGB as the procedure of choice for GERD after bariatric surgery. 69% reported using RYGB to address recurrent reflux secondary to failed fundoplication. 74% of responders experienced trouble with insurance coverage at least half the time RYGB was offered for GERD, and 8% reported they were never able to get approval for RYGB for GERD indications in their patient populations. CONCLUSION: For many patients, GERD and obesity are related diseases that are best addressed with RYGB. However, insurance coverage for RYGB for GERD is often limited by policies which run contrary to evidence-based medicine. Advocacy is critical to improve access to appropriate surgical care for GERD in patients with obesity.

BMPER is a marker of adipose progenitors and adipocytes and a positive modulator of adipogenesis.

Autocrine and paracrine signaling regulating adipogenesis in white adipose tissue remains largely unclear. Here we used single-cell RNA-sequencing (RNA-seq) and single nuclei RNA-sequencing (snRNA-seq) to identify markers of adipose progenitor cells (APCs) and adipogenic modulators in visceral adipose tissue (VAT) of humans and mice. Our study confirmed the presence of major cellular clusters in humans and mice and established important sex and diet-specific dissimilarities in cell proportions. Here we show that bone morphogenetic protein (BMP)-binding endothelial regulator (BMPER) is a conserved marker for APCs and adipocytes in VAT in humans and mice. Further, BMPER is highly enriched in lineage negative stromal vascular cells and its expression is significantly higher in visceral compared to subcutaneous APCs in mice. BMPER expression and release peaked by day four post-differentiation in 3T3-L1 preadipocytes. We reveal that BMPER is required for adipogenesis both in 3T3-L1 preadipocytes and in mouse APCs. Together, this study identified BMPER as a positive modulator of adipogenesis.

Metabolic and bariatric surgery and obesity pharmacotherapy for cancer prevention: current status and future possibilities.

Obesity is a chronic, relapsing, progressive disease of excess adiposity that increases the risk of developing at least 13 types of cancer. This report provides a concise review of the current state of the science regarding metabolic and bariatric surgery and obesity pharmacotherapy related to cancer risk. Meta-analyses of cohort studies report that metabolic and bariatric surgery is independently associated with a lower risk of incident cancer than nonsurgical obesity care. Less is known regarding the cancer-preventive effects of obesity pharmacotherapy. The recent approval and promising pipeline of obesity drugs will provide the opportunity to understand the potential for obesity therapy to emerge as an evidence-based cancer prevention strategy. There are myriad research opportunities to advance our understanding of how metabolic and bariatric surgery and obesity pharmacotherapy may be used for cancer prevention.

Long-term all-cause and cause-specific mortality for four bariatric surgery procedures.

OBJECTIVE: This retrospective study incorporated long-term mortality results after different bariatric surgery procedures and for multiple age at surgery groups. METHODS: Participants with bariatric surgery (surgery) and without (non-surgery) were matched (1:1) for age, sex, BMI, and surgery date with a driver license application/renewal date. Mortality rates were compared by Cox regression, stratified by sex, surgery type, and age at surgery. RESULTS: Participants included 21,837 matched surgery and non-surgery pairs. Follow-up was up to 40 years (mean [SD], 13.2 [9.5] years). All-cause mortality was 16% lower in surgery compared with non-surgery groups (hazard ratio, 0.84; 95% CI: 0.79-0.90; p < 0.001). Significantly lower mortality after bariatric surgery was observed for both females and males. Mortality after surgery versus non-surgery decreased significantly by 29%, 43%, and 72% for cardiovascular disease, cancer, and diabetes, respectively. The hazard ratio for suicide was 2.4 times higher in surgery compared with non-surgery participants (95% CI: 1.57-3.68; p < 0.001), primarily in participants with ages at surgery between 18 and 34 years. CONCLUSIONS: Reduced all-cause mortality was durable for multiple decades, for multiple bariatric surgical procedures, for females and males, and for greater than age 34 years at surgery. Rate of death from suicide was significantly higher in surgery versus non-surgery participants only in the youngest age at surgery participants.

Repairing small type I hiatal hernias at the time of RYGB is not necessary to achieve resolution of reflux symptoms.

INTRODUCTION: Roux-en-Y gastric bypass (RYGB) is the gold standard operation for gastroesophageal reflux disease (GERD) in patients with severe obesity, but there is variability in surgeon opinion regarding whether small type I hiatal hernias (HH) require routine repair concurrently with RYGB. We sought to examine whether leaving small type I HHs unrepaired during RYGB affected GERD outcomes. METHODS: Pre-operatively our patients all receive endoscopy, and select patients with reflux symptoms receive esophagram based on attending surgeon practice and preference. We routinely repair paraesophageal hernias (PEH) concurrently with RYGB, but refrain from repairing small type I HH if, intra-operatively, the gastric fat pad and cardia are below the diaphragm with no evidence of retraction into the mediastinum. Records from 268 consecutive patients undergoing primary RYGB between January 2016 and February 2021 who completed pre-operative GERD-HRQL assessments were reviewed for presence of type I HH or PEH. Mann-Whitney U tests examined the pre-operative to post-operative change in GERD-HRQL in patients with type I HH left unrepaired at the time of RYGB (HH group) and patients with no hernia (NH group). RESULTS: Pre-operatively, GERD-HRQL scores were not statistically different between HH group (median = 7, mean = 8.5, n = 100) and NH group (median = 6.5, mean = 7.2, n = 141) (p > 0.05). Post-operatively, there was no increase in GERD-HRQL scores patients whose hernias were left unrepaired. Neither group had clinically pathologic post-operative GERD-HRQL scores, with median 6 months scores of 1 for HH group (n = 68) versus 1.5 for NH group (n = 90) (p > 0.05), and median 12 months scores of 1.5 for HH group (n = 40) versus 1 for NH group (n = 56) (p > 0.05). CONCLUSION: Repair of small type I HH is not necessary to achieve effective, durable resolution of reflux symptoms with RYGB. Omitting repair reduces operative time, cost, and potential risk without adverse impact on post-operative reflux symptoms.

The utility of endoscopy prior to bariatric surgery: an 11-year retrospective analysis of 885 patients.

INTRODUCTION: Our aim was to evaluate the diagnostic yield of routine preoperative esophagogastroduodenoscopy (p-EGD) in patients undergoing bariatric surgery. Many medical problems that are common in patients with obesity, including gastroesophageal reflux disease (GERD) and hiatal hernias, have important implications for patients undergoing bariatric surgery. While p-EGD is considered standard of care prior to antireflux surgery, the role of p-EGD in bariatric surgery patients remains controversial. METHODS AND PROCEDURES: We performed a retrospective chart review of 885 patients who underwent primary bariatric surgery at a university hospital-based bariatric surgery program between March 2011 and February 2022. Clinical history, demographics, and preoperative EGD reports were reviewed for abnormal findings. RESULTS: Of the 885 patients evaluated in this study, one or more abnormal EGD findings were observed in 83.2% of patients. More than half of our patients (54.7%) presented with history of heartburn, reflux, or GERD. EGD findings demonstrated a hernia in 43.1% of patients [(Type I: 40.6%; Type II: 0.5%; Type III: 2.1%)]. 68.0% of patients were biopsied. Among patients who were biopsied, other findings included gastritis (32.4%), esophagitis (8.0%), eosinophilic esophagitis (4.7%), or duodenitis (2.7%). We found ulcers in 6.7% of patients. Pathology was consistent with H. pylori in 9.8% of biopsies taken and consistent with BE in 2.7%. Following routine p-EGD, 11.2% of patients were placed on PPI and 8.3% were recommended to stop NSAIDs. CONCLUSION: Gastroesophageal reflux disease and associated pathology are common in the bariatric population. Preoperative EGD in patients undergoing bariatric surgery frequently identifies clinically significant UGI pathology. This may have important implications for medical and surgical management. Given the rate of abnormal preoperative endoscopic findings in obese patients, the work-up for bariatric surgery should align with the current recommendations for foregut surgery.

Following Roux-en-Y gastric bypass surgery, serum ceramides demarcate patients that will fail to achieve normoglycemia and diabetes remission.

BACKGROUND: Obesity is a prevalent health threat and risk factor for type 2 diabetes. In this study, we evaluate the relationship between ceramides, which inhibit insulin secretion and sensitivity, and markers of glucose homeostasis and diabetes remission or recursion in patients who have undergone a Roux-en-Y gastric bypass (RYGB). METHODS: The Utah Obesity Study is a prospective cohort study, with targeted ceramide and dihydroceramide measurements performed on banked serum samples. The Utah Obesity Study consists of 1,156 participants in three groups: a RYGB surgery group, a non-surgery group denied insurance coverage, and severely obese population controls. Clinical examinations and ceramide assessments were performed at baseline and 2 and 12 years after RYGB surgery. FINDINGS: Surgery patients (84% female, 42.2 ± 10.6 years of age at baseline) displayed lower levels of several serum dihydroceramides and ceramides at 2 and 12 years after RYGB. By contrast, neither the control group (77% female, 48.7± 6.4 years of age at baseline) nor the non-surgery group (95% female, 43.0± 11.4 years of age at baseline) experienced significant decreases in any species. Using a linear mixed effect model, we found that multiple dihydroceramides and ceramides positively associated with the glycemic control measures HOMA-IR and HbA1c. In surgery group participants with prevalent diabetes, ceramides inversely predict diabetes remission, independent of changes in weight. CONCLUSIONS: Ceramide decreases may explain the insulin sensitization and diabetes resolution observed in most RYGB surgery patients. FUNDING: Funded by the National Institutes of health (NIH), The Juvenile Diabetes Research Foundation, and the American Heart Association.

Overvaluation of Shape and Weight (Not BMI) Associated with Depressive Symptoms and Binge Eating Symptoms Pre- and Post-bariatric Surgery.

PURPOSE: Overvaluation of shape and weight (OSW) involves defining self-worth by body shape/weight. Among persons seeking bariatric surgery, cross-sectional studies have found associations between OSW, depressive symptoms, and disordered eating. MATERIALS AND METHODS: Relationships among OSW, depressive symptoms, binge eating symptoms, and BMI were analyzed both cross-sectionally and over time among 145 adults who had bariatric surgery. Participants completed the following measures pre-surgery and 1.5 to 3 years post-surgery: Eating Disorder Examination Questionnaire (EDE-Q), Binge Eating Scale, Patient Health Questionnaire, and body weight and height. OSW was measured by averaging two items on the EDE-Q which ask participants to rate how much their weight/shape influences how they judge themselves as a person. Analyses included Wilcoxon signed-ranks, bootstrapped Pearson correlations, and bootstrapped hierarchical linear regressions. RESULTS: OSW was significantly associated with depressive symptoms and binge eating symptoms both pre- and post-surgery, but was not associated with BMI at either timepoint. Improvements in OSW were associated with concurrent changes in depression and binge eating; reductions in BMI were not significantly associated with changes in any of these variables. CONCLUSIONS: Findings suggest that self-evaluation is more important in regard to changes in depressive and binge eating symptoms than is BMI (and vice versa), and support the importance of assessing and treating psychological considerations among persons seeking bariatric surgery.

The Role of Resilience in Psychological Health Among Bariatric Surgery Patients.

OBJECTIVE: Many individuals who undergo bariatric surgery have experienced repeated unsuccessful diet attempts and negative messages from healthcare providers, family, and others about their weight. Research pre- and post-operatively has taken a pathological or risk-based approach, investigating psychiatric problems and disordered eating. In contrast, the current study explores resilience in this population. METHODS: Participants were 148 bariatric surgery patients. Participants completed measures pre-operatively and 1.5-3 years post-operatively, including the Binge Eating Scale, Eating Disorder Examination Questionnaire, Patient Health Questionnaire, Generalized Anxiety Questionnaire, Impact of Weight on Quality of Life, Coping Responses Inventory, and Duke Social Support and Stress Scales. The Connor-Davidson Resilience Scale was measured post-operatively. RESULTS: Correlations demonstrated a significant association between post-operative resilience and lower symptoms of binge eating, disordered eating, depression, anxiety, and impact of weight on quality of life. Resilience was also associated with greater social support and less social stress, and greater use of approach coping strategies. Resilience was significantly associated with improvements in symptoms of binge eating, disordered eating, depression, anxiety, and impact of weight on quality of life from pre- to post-operative assessments. In regression models, associations remained significant after controlling for psychosocial variables at baseline (e.g., binge eating symptoms pre-operatively) and demographic covariates. CONCLUSIONS: Psychological resilience has been under-studied in the literature on obesity and bariatric surgery, with a primary focus on risk factors for poor outcomes. This study was among the first to investigate associations between resilience and post-operative psychological outcomes. Results suggest the field would benefit from consideration of patient resilience in psychological assessments and interventions.

Laparoscopic management of symptomatic congenital diaphragmatic hernia of Morgagni in the adult.

BACKGROUND: Currently, there is a relative paucity of literature regarding the management of symptomatic congenital diaphragmatic hernia of the foramen of Morgagni in the adult. This study aims to describe our unique surgical technique and outcomes in adult patients undergoing laparoscopic repair of symptomatic Morgagni hernia. METHODS: This is a retrospective review of adult patients from 2003 to 2020 who underwent a laparoscopic Morgagni hernia repair at our institution. All patients underwent a similar laparoscopic approach, utilizing the surgical principles of reduction of intra-abdominal contents, complete resection of the hernia sac, followed by primary repair of the hernia defect and mesh reinforcement with permanent mesh if the primary repair was subjectively under tension. RESULTS: The study population consisted of 12 consecutive patients with a Morgagni hernia. Patients presented with a variety of symptoms attributed to the hernia, including pain 83% (n = 10), respiratory symptoms and shortness of breath 58% (7), and gastrointestinal obstruction 25% (3). Other complaints included: nausea 33% (4), reflux 50% (6), early satiety 8% (1), palpitations 16% (2), a gurgling sensation in the chest 8% (1), and weight loss 8% (1). Primary repair was possible in all patients following complete reduction of hernia contents including the hernia sac. Mesh reinforcement was used in 5 of 12 patients. Average surgical operative time was 93 (± 37) min. Median length of stay was 1.3 days (range 0.5-5.5 days). At a median follow-up of 10.9 months (IQR 8.0-41.5 months), all symptoms attributed to the hernia had resolved. No recurrences were identified. CONCLUSIONS: Adults with symptomatic Morgagni hernia should undergo surgical repair. A laparoscopic approach utilizing the surgical principles of reduction of intra-abdominal contents, complete resection of the hernia sac, followed by primary repair of the hernia defect (when possible), with or without mesh reinforcement can be performed safely and effectively.

The impact of patient-reported outcomes on loss to follow-up care after bariatric surgery.

BACKGROUND: High rates of attrition to post-bariatric surgical care continue to be common, despite recommendations for lifelong follow-up. There is little available work focusing on the etiology of attrition to post-bariatric surgical follow-up. Patient-reported outcomes (PROs) are metrics of patients' perceptions of their own health and have been used for their predictive value in other specialties. The relationships between PROs and loss to follow-up have not been explored. METHODS: PRO data from patients who met the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) definition of loss to follow-up at 1-year postoperatively were reviewed and compared to patients who were compliant with 1-year follow-up. Patient-reported outcomes measurement information system (PROMIS) measures are routinely collected pre- and postoperatively at our institution using a series of validated computer-adaptive tests that assess depression, satisfaction with social roles, pain interference, and physical function. A series of univariate logistic regressions tested whether baseline PROs or change in PROs from baseline to 6-month postoperatively predicted loss to follow-up at 1 year. RESULTS: Neither baseline PROs nor change in depression, satisfaction with social roles, pain interference, or physical function were significant predictors of loss to follow-up. Similarly, patient state of residence, Charlson Comorbidity Index, BMI, and percent excess weight loss were not significant predictors of follow-up attrition. CONCLUSION: The PROs in this study were not significant predictors of loss to follow-up at 1-year postoperatively. The rate of bariatric procedures continues to increase nationally, so does the potential for late post-surgical complications. Given the potential impact of loss to follow-up on adverse late post-surgical outcomes, there is a need to facilitate long-term post-surgical follow-up and more investigation is needed to identify and intervene on underlying causes of bariatric patient follow-up attrition.

Self-Pay Payer Status Predicts Long-Term Loss to Follow-Up After Bariatric Surgery.

PURPOSE: In spite of widespread recommendations for lifelong patient follow-up with a bariatric provider after bariatric surgery, attrition to follow-up is common. Over the past two decades, many programs have sought to expand access to care for patients lacking insurance coverage for bariatric surgery by offering "self-pay" packages; however, the impact of this financing on long-term follow-up is unclear. We sought to determine whether payer status impacts loss to follow-up within 1 year after bariatric surgery. MATERIALS AND METHODS: Records of 554 consecutive patients undergoing bariatric surgery who were eligible for 1-year post-surgical follow-up between 2014 and 2019 were retrospectively reviewed. Multiple logistic regression examined the relationship between demographics, psychological variables, payer status, and loss to follow-up. RESULTS: Self-pay status more than tripled the odds of loss to follow-up (OR = 3.44, p < 0.01) at 1 year following surgery. Males had more than double the odds of attrition (OR = 2.43, p < 0.01), and members of racial and ethnic minority groups (OR = 2.51, p < 0.05) were more likely to experience loss. CONCLUSIONS: Self-pay patients, males and members of racial and ethnic minority groups, may face additional barriers to long-term access to postoperative bariatric care. Further investigation is greatly needed to develop strategies to overcome barriers to and disparities in long-term post-surgical care for more frequently lost groups.

Prospective Collection of PROMIS Physical Function Measure Demonstrates Significant Improvement After Bariatric Surgery.

BACKGROUND: We evaluated quality of life among bariatric surgery patients using patient-reported outcomes (PROs). We hypothesized that physical function would improve after bariatric surgery. METHODS: We prospectively collected PROs beginning in December 2015. We used the validated Patient-Reported Outcomes Measurement Information System (PROMIS) instruments because of their broad applicability and ability to use computer-adapted technology to survey. Measures are repeated at clinic visits, both pre- and postoperatively. Data were reviewed through February 2018. Data were analyzed comparing pre- and postop physical function PRO (PF PRO) by procedure: laparoscopic Roux-en-Y gastric bypass (LRYGB) or sleeve gastrectomy (LSG). Additional variables were included in an adjusted linear mixed-effects regression model in order to isolate the effect of surgery on PF PRO over time. RESULTS: This cohort included 279 bariatric surgery patients. The mean follow-up time was 1.5 years after surgery. The procedure groups were similar in terms of age and race but differed by gender and preoperative BMI. The PF-PRO measure showed significant improvement following surgery for both procedures. CONCLUSION: Patient-reported physical function improved significantly after bariatric surgery. There was no significant difference between procedures.

Associations Between Approach and Avoidance Coping, Psychological Distress, and Disordered Eating Among Candidates for Bariatric Surgery.

BACKGROUND: Individuals seeking bariatric surgery evidence risk for binge and disordered eating behaviors, which can lead to poorer post-surgical weight loss outcomes. Use of avoidant coping strategies to manage stress, along with symptoms of depression, are associated with disordered eating in the general population. However, the role of coping has not been examined among candidates for bariatric surgery, and coping and depression have rarely been considered in combination. Given the emerging standard that psychologists are involved in evaluations and treatment before and after surgery, consideration of these variables is clinically relevant. METHODS: Participants were 399 patients undergoing pre-surgical bariatric psychological assessment. Hierarchical linear regression analyses tested whether gender, age, and BMI; approach and avoidance coping; and depression and anxiety were associated with disordered eating (binge eating, restraint, eating concerns, shape concerns, weight concerns) in a cross-sectional study design. RESULTS: In initial steps of the model controlling demographic variables, approach coping predicted less and avoidance coping predicted more disordered eating across most outcomes examined. In models including depression and anxiety, avoidance (but not approach) coping remained a relevant predictor. The effects of depression were also quite robust, such that participants who were more depressed reported more disordered eating. More anxious participants reported more restrained eating. CONCLUSIONS: Avoidance coping and depressive symptoms emerged as key variables in understanding recent disordered eating among patients considering bariatric surgery. Pre-surgical psychological evaluations and treatment approaches could be enhanced with consideration of patient coping strategies, particularly avoidant coping responses to stress, independent of psychological distress.

Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss.

BACKGROUND: Obesity is a significant health problem and additional therapies are needed to improve obesity treatment. OBJECTIVE: Determine the efficacy and safety of a 6-month swallowable gas-filled intragastric balloon system for weight loss. SETTING: Fifteen academic and private practice centers in the United States. METHODS: This was a double-blind, randomized sham-controlled trial of the swallowable gas-filled intragastric balloon system plus lifestyle therapy compared with lifestyle therapy alone for weight loss at 6 months in participants aged 22 to 60 years with body mass index 30 to 40 kg/m2, across 15 sites in the United States. The following endpoints were included: difference in percent total weight loss in treatment group versus control group was >2.1%, and a responder rate of >35% in the treatment group. RESULTS: Three hundred eighty-seven patients swallowed at least 1 capsule. Of participants, 93.3% completed all 24 weeks of blinded study testing. Nonserious adverse events occurred in 91.1% of patients, but only .4% were severe. One bleeding ulcer and 1 balloon deflation occurred. In analysis of patients who completed treatment, the treatment and control groups achieved 7.1 ± 5.0% and 3.6 ± 5.1% total weight loss, respectively, and a mean difference of 3.5% (P = .0085). Total weight loss in treatment and control groups were 7.1 ± 5.3 and 3.6 ± 5.1 kg (P < .0001), and body mass index change in the treatment and control groups were 2.5 ± 1.8 and 1.3 ± 1.8 kg/m2 (P < .0001), respectively. The responder rate in the treatment group was 66.7% (P < .0001). Weight loss maintenance in the treatment group was 88.5% at 48 weeks. CONCLUSIONS: Treatment with lifestyle therapy and the 6-month swallowable gas-filled intragastric balloon system was safe and resulted in twice as much weight loss compared with a sham control, with high weight loss maintenance at 48 weeks.

Dual Ring Wound Protector Reduces Circular Stapler Related Surgical Site Infections in Patients Undergoing Laparoscopic Roux-En-Y Gastric Bypass.

BACKGROUND: While there are various techniques to create the gastrojejunostomy during a laparoscopic Roux-en-Y gastric bypass (LRYGB), many surgeons prefer using a circular stapler. One drawback of this method, however, is the higher incidence of surgical site infections (SSIs). To investigate the effect of a dual ring wound protector on SSIs during LRYGB. METHODS: In April 2016, our bariatric surgical group implemented an intervention whereby a dual ring wound protector in conjunction with a conical EEA stapler introducer was used when creating the gastrojejunostomy. SSIs from pre- and post-intervention were compared using Fisher's exact test. Only LRYGBs performed with a circular stapler were included in our analysis. Student's t test and χ2 were used to compare pre- and post-intervention groups with respect to demographics and co-morbidities. RESULTS: Between April 2015 and January 31st, 2017, our surgeons performed 158 LRYGBs using a circular stapler for the gastrojejunostomy. There were 84 patients (53%) in the pre-intervention group and 74 (47%) in the post-intervention group. The pre- and post-intervention groups were not statistically different. The SSI rate for the pre-intervention group was 9.5% while the SSI rate was 1.35% in the post-intervention group (p = 0.0371). The use of a dual ring wound protector for LRYGBs with circular stapled gastrojejunostomy was associated with an 86% relative risk reduction in SSIs. CONCLUSION: Using a dual ring wound protector in conjunction with a conical EEA introducer for LRYGBs with circular stapled gastrojejunostomy significantly decreased SSIs.

Weight and Metabolic Outcomes 12 Years after Gastric Bypass.

BACKGROUND: Few long-term or controlled studies of bariatric surgery have been conducted to date. We report the 12-year follow-up results of an observational, prospective study of Roux-en-Y gastric bypass that was conducted in the United States. METHODS: A total of 1156 patients with severe obesity comprised three groups: 418 patients who sought and underwent Roux-en-Y gastric bypass (surgery group), 417 patients who sought but did not undergo surgery (primarily for insurance reasons) (nonsurgery group 1), and 321 patients who did not seek surgery (nonsurgery group 2). We performed clinical examinations at baseline and at 2 years, 6 years, and 12 years to ascertain the presence of type 2 diabetes, hypertension, and dyslipidemia. RESULTS: The follow-up rate exceeded 90% at 12 years. The adjusted mean change from baseline in body weight in the surgery group was -45.0 kg (95% confidence interval [CI], -47.2 to -42.9; mean percent change, -35.0) at 2 years, -36.3 kg (95% CI, -39.0 to -33.5; mean percent change, -28.0) at 6 years, and -35.0 kg (95% CI, -38.4 to -31.7; mean percent change, -26.9) at 12 years; the mean change at 12 years in nonsurgery group 1 was -2.9 kg (95% CI, -6.9 to 1.0; mean percent change, -2.0), and the mean change at 12 years in nonsurgery group 2 was 0 kg (95% CI, -3.5 to 3.5; mean percent change, -0.9). Among the patients in the surgery group who had type 2 diabetes at baseline, type 2 diabetes remitted in 66 of 88 patients (75%) at 2 years, in 54 of 87 patients (62%) at 6 years, and in 43 of 84 patients (51%) at 12 years. The odds ratio for the incidence of type 2 diabetes at 12 years was 0.08 (95% CI, 0.03 to 0.24) for the surgery group versus nonsurgery group 1 and 0.09 (95% CI, 0.03 to 0.29) for the surgery group versus nonsurgery group 2 (P<0.001 for both comparisons). The surgery group had higher remission rates and lower incidence rates of hypertension and dyslipidemia than did nonsurgery group 1 (P<0.05 for all comparisons). CONCLUSIONS: This study showed long-term durability of weight loss and effective remission and prevention of type 2 diabetes, hypertension, and dyslipidemia after Roux-en-Y gastric bypass. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others.).

Preventing Returns to the Emergency Department FollowingBariatric Surgery.

BACKGROUND: Unnecessary emergency department (ED) visits following bariatric surgery represent a significant source of inefficient resource utilization. This study aimed to identify potential strategies aimed at preventing unnecessary returns to the ED following bariatric surgery. The study was conducted in University Hospital, USA. METHODS: The electronic medical records of all patients who underwent bariatric surgery at our institution between January 2011 and October 2015 were retrospectively reviewed. Information regarding procedure, gender, age, preoperative BMI, obesity-related comorbid conditions, postoperative length of stay (LOS), and reasons for ED visits within 90 days of surgery were obtained. Six practitioners (four attending surgeons, one resident physician, and one physician assistant) independently reviewed patient chief complaint and clinical findings at the time of ED returns. Reasons for ED return were scored as either preventable or non-preventable. "Preventable" denoted that an ED return could potentially be avoided by means of a system change in our bariatric practice. RESULTS: Our institution performed 361 bariatric procedures during the study period. Of these, 65 patients had 91 ED visits, 23 of which resulted in readmissions, and two of which required operative interventions. The ≤90-day all-cause postoperative ED visit rate was 18% (n = 65). Of the 91 ED visits, 47% were deemed preventable (n = 43). The most common preventable reasons for ED returns were nausea, vomiting, dehydration (NVD) (27.9%), postoperative pain (25.6%), wound evaluations (20.9%), and compliance issues (14%). CONCLUSIONS: Postoperative ED visits following bariatric surgery are prevalent and costly. Many of these visits are potentially preventable. Implementing outpatient strategies to address these causes will likely attenuate inefficient resource utilization.