Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial.

IMPORTANCE: Although conventional bariatric surgery results in weight loss, it does so with potential short-term and long-term morbidity. OBJECTIVE: To evaluate the effectiveness and safety of intermittent, reversible vagal nerve blockade therapy for obesity treatment. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, sham-controlled clinical trial involving 239 participants who had a body mass index of 40 to 45 or 35 to 40 and 1 or more obesity-related condition was conducted at 10 sites in the United States and Australia between May and December 2011. The 12-month blinded portion of the 5-year study was completed in January 2013. INTERVENTIONS: One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device. All participants received weight management education. MAIN OUTCOMES AND MEASURES: The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point margin with at least 55% of patients in the vagal block group achieving a 20% loss and 45% achieving a 25% loss. The primary safety objective was to determine whether the rate of serious adverse events related to device, procedure, or therapy in the vagal block group was less than 15%. RESULTS: In the intent-to-treat analysis, the vagal nerve block group had a mean 24.4% excess weight loss (9.2% of their initial body weight loss) vs 15.9% excess weight loss (6.0% initial body weight loss) in the sham group. The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points (95% CI, 3.1-13.9), which did not meet the 10-point target (P = .71), although weight loss was statistically greater in the vagal nerve block group (P = .002 for treatment difference in a post hoc analysis). At 12 months, 52% of patients in the vagal nerve block group achieved 20% or more excess weight loss and 38% achieved 25% or more excess weight loss vs 32% in the sham group who achieved 20% or more loss and 23% who achieved 25% or more loss. The device, procedure, or therapy-related serious adverse event rate in the vagal nerve block group was 3.7% (95% CI, 1.4%-7.9%), significantly lower than the 15% goal. The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy; all were reported as mild or moderate in severity. CONCLUSION AND RELEVANCE: Among patients with morbid obesity, the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives, although weight loss in the vagal block group was statistically greater than in the sham device group. The treatment was well tolerated, having met the primary safety objective. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01327976.

The association of sex with pain scores and perioperative opioid administration following laparoscopic sleeve gastrectomy.

Aim: We investigated whether sex is associated with pain scores and opioid administration after laparoscopic sleeve gastrectomy. Materials & methods: We performed a single-center, retrospective analysis of laparoscopic sleeve gastrectomy patients from December 2016-July 2018. Multivariable linear regressions were performed to investigate the association of sex with pain scores and opioid administration. Results: Baseline pain scores were similar between women and men (n = 266; 78% women). Men reported lower pain scores in all phases of care and received more opioids during their hospitalization (ß = 25.48; 95% CI: 5.77-45.20; p = 0.01), compared with women. Conclusion: Our data suggest that women self-report greater postoperative pain scores, while men received more opioids during their hospitalization. Further studies are needed to understand the reasons for such differences in postoperative pain management.

Men are at higher risk for long-term opioid use compared with women, but it remains unclear whether perioperative management is a sentinel event for such outcomes. Since patients who receive higher amounts of postoperative opioids are more likely to remain on long term narcotics, we investigated whether sex is associated with pain scores and opioid administration after bariatric surgery. We demonstrate that men self-report lower pain scores in the postanesthesia care unit, surgical floor and at discharge, compared with women. We also show that while men and women received comparable doses of opioids in the operating room and postanesthesia care unit, men received more opioids on the surgical floor. Our findings suggest that strategies to reduce opioid administration after bariatric surgery should largely focus on care after the immediate postoperative period.

The significance of histologic examination of gastrectomy specimens: a clinicopathologic study of 511 cases.

BACKGROUND: Sleeve gastrectomy (SG) is quickly becoming the preferred procedure for bariatric surgery. According to the American Society for Metabolic and Bariatric Surgery guidelines, routine preoperative upper gastrointestinal endoscopies are not recommended universally for bariatric surgery. Some studies have shown that the histologic examination of SG specimens is insignificant and not a cost-effective practice. However, some speculate SG examination may unveil pertinent findings and prevent further progression of precursor lesions. OBJECTIVES: This study aims to explore the clinically significant or actionable lesions that can be revealed with SG examination. SETTING: Tufts Medical Center, Boston, USA. RESULTS: We analyzed 511 SG specimens obtained during bariatric surgery. Incidental findings were grouped in 2 categories: clinically significant/actionable and minor lesions. The clinically significant lesions accounted for 5.8%. This category included 5 cases of gastrointestinal stromal tumor; one case of MALT lymphoma; 4 cases of autoimmune gastritis with concomitant pancreatic metaplasia or neuroendocrine dysplasia. Intestinal metaplasia without dysplasia was identified in 3 cases; 14 cases of Helicobacter pylori associated active gastritis; 1 case of iron pill induced gastritis and 1 case of gastric glandular siderosis. The minor lesions accounted for 6.3%, showing findings other than chronic gastritis. This category included 19 cases of fundic polyps and 1 case of hyperplastic polyp; one case of leiomyoma; 11 cases of H pylori negative active gastritis. CONCLUSIONS: The majority of histopathology results after SG showed no significant changes. However, a few cases had clinically significant lesions in seemingly healthy patients, altering patient's postoperative management.

Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial.

BACKGROUND: The ReCharge Trial demonstrated that a vagal blocking device (vBloc) is a safe and effective treatment for moderate to severe obesity. This report summarizes 24-month outcomes. METHODS: Participants with body mass index (BMI) 40 to 45 kg/m2, or 35 to 40 kg/m2 with at least one comorbid condition were randomized to either vBloc therapy or sham intervention for 12 months. After 12 months, participants randomized to vBloc continued open-label vBloc therapy and are the focus of this report. Weight loss, adverse events, comorbid risk factors, and quality of life (QOL) will be assessed for 5 years. RESULTS: At 24 months, 123 (76 %) vBloc participants remained in the trial. Participants who presented at 24 months (n = 103) had a mean excess weight loss (EWL) of 21 % (8 % total weight loss [TWL]); 58 % of participants had ≥5 % TWL and 34 % had ≥10 % TWL. Among the subset of participants with abnormal preoperative values, significant improvements were observed in mean LDL (-16 mg/dL) and HDL cholesterol (+4 mg/dL), triglycerides (-46 mg/dL), HbA1c (-0.3 %), and systolic (-11 mmHg) and diastolic blood pressures (-10 mmHg). QOL measures were significantly improved. Heartburn/dyspepsia and implant site pain were the most frequently reported adverse events. The primary related serious adverse event rate was 4.3 %. CONCLUSIONS: vBloc therapy continues to result in medically meaningful weight loss with a favorable safety profile through 2 years. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01327976.

Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study.

BACKGROUND: Vagal nerve blockade (vBloc) therapy was shown to be a safe and effective treatment for moderate to severe obesity. This report summarizes the safety and efficacy of vBloc therapy in the prespecified subgroup of patients with moderate obesity. METHODS: The ReCharge Trial is a double-blind, randomized controlled clinical trial of participants with body mass index (BMI) of 40-45 or 35-40 kg/m(2) with at least one obesity-related comorbid condition. Participants were randomized 2:1 to implantation with either a vBloc or sham device with weight management counseling. Eighty-four subjects had moderate obesity (BMI 35-40 kg/m(2)) at randomization. RESULTS: Fifty-three participants were randomized to vBloc and 31 to sham. Qualifying obesity-related comorbidities included dyslipidemia (73%), hypertension (58%), sleep apnea (33%), and type 2 diabetes (8%). The vBloc group achieved a percentage excess weight loss (%EWL) of 33% (11% total weight loss (%TWL)) compared to 19% EWL (6% TWL) with sham at 12 months (treatment difference 14 percentage points, 95% CI, 7-22; p < 0.0001). Common adverse events of vBloc through 12 months were heartburn/dyspepsia and implant site pain; the majority of events were reported as mild or moderate. CONCLUSIONS: vBloc therapy resulted in significantly greater weight loss than the sham control among participants with moderate obesity and comorbidities with a well-tolerated safety profile.

Risk factors for 30-day readmissions and modifying postoperative care after gastric bypass surgery.

BACKGROUND: Although hospital 30-day readmissions policies currently focus on medical conditions, readmission penalties will be expanding to encompass surgical procedures, logically beginning with common and standardized procedures, such as gastric bypass. Therefore, understanding predictors of readmission is essential in lowering readmission rate for these procedures. STUDY DESIGN: This is a retrospective case-control study of patients undergoing laparoscopic gastric bypass at Tufts Medical Center from 2007 to 2012. Variables analyzed included demographics, comorbidities, intraoperative events, postoperative complications, discharge disposition, and readmission diagnoses. Univariate analysis was used to identify factors associated with readmission, which were then subjected to multivariable logistic regression analysis. RESULTS: We reviewed 358 patients undergoing laparoscopic gastric bypass, 119 readmits, and 239 controls. By univariate analysis, public insurance, body mass index >60 kg/m(2), duration of procedure, high American Society of Anesthesiologists (ASA) class, and discharge with visiting nurse services (VNA) were significantly associated with 30-day readmissions. In the regression model, duration of procedure, high ASA class, and discharge with visiting nurse services (VNA) remained significantly associated with readmission when controlling for other factors (odds ratio [OR] 1.523, 95% CI 1.314 to 1.766; OR 2.447, 95% CI 1.305 to 4.487; and OR 0.053 with 95% CI 0.011 to 0.266, respectively). The majority of readmissions occurred within the first week after discharge. Gastrointestinal-related issues were the most common diagnoses on readmission, and included anastomotic leaks, postoperative ileus, and bowel obstruction. The next 2 most common reasons for readmission were wound infection and fluid depletion. CONCLUSIONS: Using readmission risk, we can stratify patients into tiered clinical pathways. Because most readmissions occur within the first postdischarge week and are most commonly associated with dehydration, pain, or wound issues, focusing our postoperative protocols and patient education should further lower the incidence of readmission.