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.

Feasibility of implementing a meditative movement intervention with bariatric patients.

UNLABELLED: Successful interventions are needed to help improve obesity rates in the United States. Roughly two-thirds of adults in the United States are overweight, and almost one-third are obese. In 1991, the National Institutes of Health released a consensus statement endorsing bariatric surgery as the only means for sustainable weight loss for severely obese patients. However, approximately one-third of bariatric patients will experience significant post surgical weight gain. PURPOSE OF STUDY: This study is designed to determine if meditative movement (MM) would be a feasible physical activity (PA) modality to initiate weight loss in bariatric surgery patients who have re-gained weight. METHODS USED: A feasibility study was recently completed in 39 bariatric patients at Scottsdale Bariatric Center (SBC) during regularly scheduled bariatric support groups at SBC. A short demonstration of MM was presented after which a short focus group was conducted to gauge interest level, acceptability and the potential demand for MM programs in this population. Attitudes and intentions surrounding MM were also collected. FINDINGS: Approximately 75% of participants indicated they would consider practicing MM as part of their post surgical PA routine. CONCLUSIONS: MM may be a feasible PA modality in bariatric patients to improve bariatric surgery weight outcomes.

The First Modified Delphi Consensus Statement for Resuming Bariatric and Metabolic Surgery in the COVID-19 Times.

The purpose of this study was to achieve consensus amongst a global panel of expert bariatric surgeons on various aspects of resuming Bariatric and Metabolic Surgery (BMS) during the Coronavirus Disease-2019 (COVID-19) pandemic. A modified Delphi consensus-building protocol was used to build consensus amongst 44 globally recognised bariatric surgeons. The experts were asked to either agree or disagree with 111 statements they collectively proposed over two separate rounds. An agreement amongst ≥ 70.0% of experts was construed as consensus as per the predetermined methodology. We present here 38 of our key recommendations. This first global consensus statement on the resumption of BMS can provide a framework for multidisciplinary BMS teams planning to resume local services as well as guide future research in this area.

Predicting stricture in morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass: a logistic regression analysis.

Gastrojejunostomy stricture after Roux-en-Y gastric bypass occurs in 3 to 27% of morbidly obese patients in the USA. We questioned whether preoperative patient characteristics, including demographic attributes and comorbid disease, might be significant factors in the etiology of stricture. In this study from November 2001 to February 2006 (51 months), at a high-volume bariatric center, of the 1,351 patients who underwent laparoscopic gastric bypass, 92 developed stricture (6.8%). All but two were treated successfully by endoscopic dilation. All patients stopped nonsteroidal anti-inflammatory medications 2 weeks prior to surgery and did not restart them. The operative procedure included the use of a 21-mm transoral circular stapler to create the gastrojejunostomy; the Roux limb was brought retrogastric, retrocolic. In an effort to reduce our center's stricture rate, late in the study, U-clips used at the gastrojejunostomy were replaced by absorbable sutures, and postoperative H2 antagonists were added to the treatment protocol. The change to absorbable polyglactin suture proved to be significant, resulting in a lower stricture rate. The addition of H2 antagonists showed no significant effect. Following the retrospective review of the prospective database, univariate and multivariate logistic regression analyses identified factors associated with the development of stricture. Gastroesophageal reflux disease and age were each shown to be statistically significant independent predictors of stricture following laparoscopic gastric bypass.

Metabolic acuity score: effect on major complications after bariatric surgery.

BACKGROUND: Co-morbid conditions in obese patients contribute to the incidence and severity of major complications after bariatric surgery and significantly increase the cost of the procedure. Previous publications have validated the patient factors that increase the risk of mortality; however, it is currently a rare event. The development of a metabolic acuity score (MAS) to augment the body mass index might allow for accurate preoperative assessment and optimal treatment of patients. The present study has proposed a MAS for decreasing major complications. METHODS: Prospectively collected outcomes of 2416 patients undergoing Roux-en-Y gastric bypass (n = 1821) or laparoscopic adjustable gastric banding (n = 595) in a community hospital were evaluated for the incidence of major complications, readmissions, and reoperations. Beginning in August of 2006, 1072 patients were divided into MAS groups of 1-4 according to age, body mass index, weight, history of deep vein thrombosis/pulmonary embolism, sleep apnea, diabetes, hypertension, immobility, heart disease, and psychological classification. The acuity groups were compared with each other and with 1344 patients who underwent treatment before the MAS was implemented. RESULTS: A significant decrease occurred in the readmission rates within 30 days after the MAS was put into practice (8.5% before MAS versus 1.7% after MAS, P <.001) for the Roux-en-Y gastric bypass patients. The postoperative infection rates were lower after implementing the MAS (3.5% before MAS, .7% after MAS, P <.001). After adjusting for random and fixed effects of covariates, the implementation of the MAS significantly reduced the incidence of postoperative internal hernias, infections, deep vein thrombosis, readmissions, and reoperations. CONCLUSION: Recognition of specific patient acuity characteristics through the implementation of MAS and aggressive preoperative and perioperative management led to lower major complication rates and decreased the incidence of readmissions and reoperations after bariatric surgery.

Psychological classification as a communication and management tool in obese patients undergoing bariatric surgery.

BACKGROUND: Psychological evaluations are used to ascertain patient suitability for bariatric surgery and to challenge their ability to comply with therapy. The modern paradigm of obesity includes a neurobiologic component working in parallel with the limbic system of appetite and reward. To achieve the goals of surgery, an evaluation of the psychological fitness of the patient is often included in the clinical pathway. We present a psychological classification system with the goal of integrating the psychological factors into patient treatment. METHODS: All patients (Roux-en-Y gastric bypass, n = 1814; laparoscopic adjustable gastric banding, n = 589) were evaluated using psychological testing/interview and assigned to groups 1-4 before surgery. The group 1 patients (n = 788; 32.8%) did not necessitate intervention, group 2 (n = 1110; 46.2%) were requested to attend the support group, groups 3A (n = 394; 16.4%) and 3B (n = 111; 4.6%) required intervention to continue to surgery, and group 4 patients were not recommended for surgery. The main outcome measures, including complication, readmission, and reoperation rates, were analyzed for differences among the psychological groups. RESULTS: After comparing the outcome measures between each classification, no significant differences were found in the major complication rates, readmissions, reoperations, or length of stay among the groups. Groups 3A and 3B were able to achieve similar rates of success, despite their psychosocial impairment at the initial evaluation. CONCLUSION: The assignment of a psychological classification can facilitate bariatric team recognition of the unique psychological factors that affect the success of surgery. Assessing the patient's psychological composition and addressing potential psychosocial barriers before surgery can increase the positive long-term outcomes and reduce the incidence of complications after bariatric surgery.