Sajani Shah

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.

Roux-en-Y gastric bypass: hyperamylasemia is associated with small bowel obstruction

BACKGROUND Small bowel obstruction after Roux-en-Y gastric bypass (RYGB) can be difficult to diagnose, but usually requires surgical treatment; clinical presentation may be nonspecific. Delay in diagnosis can result in catastrophic outcomes. Patients who present with small bowel obstruction after gastric bypass occasionally have pancreatic enzyme elevation and have been misdiagnosed as having acute pancreatitis. The objective of this study was to determine if there was an association between small bowel obstruction and an elevated amylase or lipase after RYGB. METHODS Ninety-nine cases of small bowel obstruction treated surgically were prospectively collected and retrospectively analyzed from a database of 4014 RYGB patients. Fifty-eight had a measurement of amylase or lipase at the time of operation. RESULTS An elevated amylase or lipase was found in 48% of all patients. These elevated rates were higher in an acute obstruction compared to those presenting with chronic symptoms (64% versus 28%; P=.007) and in obstruction involving the biliopancreatic limb compared to those that did not involve that limb (65% versus 21%; P<.001). These elevated rates were most notable in acute biliopancreatic limb obstruction compared to an acute obstruction not in the biliopancreatic limb (94% versus 27%; P<.001). CONCLUSION In RYGB patients, there is an association between small bowel obstruction and an elevated amylase or lipase. Acute obstruction of the biliopancreatic limb can be difficult to diagnose, and in these patients, the sensitivity of elevated amylase or lipase is very high. RYGB patients with abdominal pain should have their amylase and lipase measured. It is important to recognize that an elevation of these enzymes is not likely a result of acute pancreatitis.

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.

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 patients postoperative management.

Neurohormonal Procedures in Obesity Treatment

Bariatric surgery is one of the most effective methods for achieving sustainable weight loss, though it can be associated with treatment failures, risks, and potential side effects that are not negligible. Neuromodulation techniques offer a novel approach to the treatment and prevention of obesity and related comorbidities through less invasive means while simultaneously offering a lower side effect profile. Vagal blockade, deep brain stimulation, and bariatric vascular embolization are three of the most promising techniques currently emerging in the field of neuromodulation for the treatment of obesity. Here we review the pathophysiology and rationale behind these approaches, as well as the current evidence in the literature and future applications for their use.

36 Alternative Minimally Invasive Options: Neural Modulation

Neuromodulation is an investigational approach for weight management. This type of therapy is intended to provide a less invasive option for obese patients and can involve neuromodulation of gastric or small bowel motility and vagal blockade. Several different devices have been tested in the United States and worldwide with variable results. This chapter provides a review of the clinical studies evaluating neuromodulation for weight loss.