Erik B. Wilson

The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity

BACKGROUND Saline-filled intragastric balloon devices are reversible endoscopic devices designed to occupy stomach volume and reduce food intake. OBJECTIVE To evaluate the safety and effectiveness of a dual balloon system plus diet and exercise in the treatment of obesity compared to diet and exercise alone. SETTING Academic and community practice, United States. METHODS Participants (n = 326) with body mass index (BMI) 30-40 kg/m(2) were randomized to endoscopic DBS treatment plus diet and exercise (DUO, n = 187) or sham endoscopy plus diet and exercise alone (DIET, n = 139). Co-primary endpoints were a between-group comparison of percent excess weight loss (%EWL) and DUO subject responder rate, both at 24 weeks. Thereafter DUO patients had the DBS retrieved followed by 24 additional weeks of counseling; DIET patients were offered DBS treatment. RESULTS Mean BMI was 35.4. Both primary endpoints were met. DUO weight loss was over twice that of DIET. DUO patients had significantly greater %EWL at 24 weeks (25.1% intent-to-treat (ITT), 27.9% completed cases (CC, n = 167) compared with DIET patients (11.3% ITT, P = .004, 12.3% CC, n = 126). DUO patients significantly exceeded a 35% response rate (49.1% ITT, P<.001, 54.5% CC) for weight loss dichotomized at 25%EWL. Accommodative symptoms abated rapidly with support and medication. Balloon deflation occurred in 6% without migrations. Early retrieval for nonulcer intolerance occurred in 9%. Gastric ulcers were observed; a minor device change led to significantly reduced ulcer size and frequency (10%). CONCLUSION The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile.

THE EVOLUTION OF ROBOTIC GENERAL SURGERY

Surgical robotics in general surgery has a relatively short but very interesting evolution. Just as minimally invasive and laparoscopic techniques have radically changed general surgery and fractionated it into subspecialization, robotic technology is likely to repeat the process of fractionation even further. Though it appears that robotics is growing more quickly in other specialties, the changes digital platforms are causing in the general surgical arena are likely to permanently alter general surgery. This review examines the evolution of robotics in minimally invasive general surgery looking forward to a time where robotics platforms will be fundamental to elective general surgery. Learning curves and adoption techniques are explored. Foregut, hepatobiliary, endocrine, colorectal, and bariatric surgery will be examined as growth areas for robotics, as well as revealing the current uses of this technology.

Dramatic Reversal of Derangements in Muscle Metabolism and Left Ventricular Function After Bariatric Surgery

OBJECTIVE The study objective was to define muscle metabolic and cardiovascular changes after surgical intervention in clinically severe obese patients. METHODS Obesity is a state of metabolic dysregulation that can lead to maladaptive changes in heart and skeletal muscle, including insulin resistance and heart failure. In a prospective longitudinal study, 43 consecutive patients underwent metabolic profiling, skeletal muscle biopsies, and resting echocardiograms at baseline and 3 and 9 months after bariatric surgery. RESULTS Body mass index decreased (mean changes, 95% confidence interval [CI]): 7.7 kg/m(2) (95% CI, 6.70-8.89) at 3 months and 5.6 kg/m(2) (95% CI, 4.45-6.80; P<.0001) at 9 months after surgery, with restoration of insulin sensitivity and decreases in plasma leptin at the same time points. Concurrent with these changes were dramatic decreases in skeletal muscle transcript levels of stearoyl coenzyme-A desaturase and pyruvate dehydrogenase kinase-4 at 3 and 9 months (P<.0001, for both) and a significant decrease in peroxisome proliferation activated receptor-alpha-regulated genes at 9 months. Left ventricular relaxation impairment, assessed by tissue Doppler imaging, normalized 9 months after surgery. CONCLUSION Weight loss results in the reversal of systemic and muscle metabolic derangements and is accompanied by a normalization of left ventricular diastolic function.

Laparoscopic revision from LAP-BAND® to gastric bypass

BackgroundWhile the majority of patients achieve good outcomes with the LAP-BAND®, there is a subset of patients who experience complications or fail to lose sufficient weight after the banding procedure. This study examines the feasibility and outcome of performing laparoscopic Roux-en-Y gastric bypass (RYGBP) as a single-step revision surgery after a failed LAP-BAND procedure.MethodsIn the past five years we have performed more than 1400 LAP-BAND procedures. We laparoscopically converted 33 (30 females) of these patients (mean age = 43.8 years) from LAP-BAND to RYGBP because of inadequate weight loss and/or complications. Key steps in the revision procedures were (1) identification and release of the band capsule; (2) careful dissection of the gastrogastric sutures; (3) creation of a small gastric pouch; and (4) Roux-en-Y anterior colic anterior gastric pouch-jejunum anastomosis. Revisions took place at a mean 28.2 months (range = 11–46; SD = 11.3) after the original gastric banding. Change in body mass index (BMI) between pre- and postrevision was evaluated with paired t tests.ResultsAmong the 33 patients who would undergo revision surgery, the mean BMI before the LAP-BAND procedure was 45.7 kg/m2 (range = 39.9–53.0; SD = 3.4) and the mean weight was 126 kg (range = 99–155; SD = 17). The lowest BMI achieved by this group with the LAP-BAND before revision was 39.7 kg/m2 (range = 30–49.2; SD = 4.9); however, the mean BMI at the time of revision was 42.8 kg/m2 (range = 33.1–50; SD = 4.8). The mean revision operative time was 105 min (range = 85–175), and the mean hospital stay was 2.8 days (range = 1–10). Complications included one patient who underwent open reoperation and splenectomy for a bleeding spleen and one patient who required repair of an internal hernia. After conversion to RYGBP, mean BMI decreased to 33.9 kg/m2 at 6 months (p < 0.001) and 30.7 kg/m2 (range = 22–39.6; SD = 5.3) at 12 months or more of followup (average = 15.7 months; p < 0.0001).ConclusionsLaparoscopic conversion from LAP-BAND to RYGBP is safe and can be an alternative for patients who failed the LAP-BAND procedure. However, revision surgery is technically challenging and should be performed only by surgeons who have completed the learning curve for laparoscopic RYGBP.

Efficacy of Transoral Fundoplication vs Omeprazole for Treatment of Regurgitation in a Randomized Controlled Trial

BACKGROUND & AIMS Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD. METHODS We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy. RESULTS By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P = .004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery). CONCLUSIONS TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.

Progressive regression of left ventricular hypertrophy two years after bariatric surgery.

BACKGROUND Obesity is a systemic disorder associated with an increase in left ventricular mass and premature death and disability from cardiovascular disease. Although bariatric surgery reverses many of the hormonal and hemodynamic derangements, the long-term collective effects on body composition and left ventricular mass have not been considered before. We hypothesized that the decrease in fat mass and lean mass after weight loss surgery is associated with a decrease in left ventricular mass. METHODS Fifteen severely obese women (mean body mass index [BMI]: 46.7+/-1.7 kg/m(2)) with medically controlled hypertension underwent bariatric surgery. Left ventricular mass and plasma markers of systemic metabolism, together with body mass index (BMI), waist and hip circumferences, body composition (fat mass and lean mass), and resting energy expenditure were measured at 0, 3, 9, 12, and 24 months. RESULTS Left ventricular mass continued to decrease linearly over the entire period of observation, while rates of weight loss, loss of lean mass, loss of fat mass, and resting energy expenditure all plateaued at 9 [corrected] months (P <.001 for all). Parameters of systemic metabolism normalized by 9 months, and showed no further change at 24 months after surgery. CONCLUSIONS Even though parameters of obesity, including BMI and body composition, plateau, the benefits of bariatric surgery on systemic metabolism and left ventricular mass are sustained. We propose that the progressive decrease of left ventricular mass after weight loss surgery is regulated by neurohumoral factors, and may contribute to improved long-term survival.

Robotic-assisted Roux-en-Y gastric bypass: update from 2 high-volume centers

BACKGROUND Laparoscopic Roux-en-Y gastric bypass (RYGB) is a challenging operation in the most experienced hands. Robotic surgery allows the capabilities of the minimally invasive surgeon to be extended. An increasing number of robotic gastric bypasses are being performed each year with the assumption that the complication rates are decreased. The objectives of the present study were to review the results of robotic-assisted RYGB (RARYGB) from 2 high-volume centers, including 1 university and 1 private practice. METHODS We report the most recently compiled, largest series of RARYGB in the world to show the effectiveness, morbidity, and mortality of this method. Databases were searched for patients undergoing RARYGB from 2002 to 2010, and the endpoints were recorded. RESULTS A total of 1100 RARYGBs matched our search. The patients had a mean preoperative age of 46.9 years, mean weight of 131.9 kg, and mean body mass index of 47.9 kg/m(2). The mean operative time was 155 minutes. There were no conversions. The mean body mass index was 39.8 kg/m(2) at 3 months postoperatively (79% follow-up). Complications were few, and included 2 cases of pulmonary embolism (.19%), 3 cases of deep venous thrombosis (.27%), 1 case of gastrojejunal anastomotic leak (.09%), and 9 cases of staple line bleeding (.82%). No patients died. CONCLUSION RARYGB is safe and effective. Although the operative time might be increased, the complication rates, most notably of anastomotic leak, are extremely low.

Limited public knowledge of obesity and endometrial cancer risk: what women know.

OBJECTIVE: To estimate if women in the general population are aware of the relationship between obesity and cancer risk, and to identify groups who may benefit from educational programs. METHODS: A self-administered survey was distributed to women in the Houston community. The questions were taken from a bank of validated questions published by the Center for Disease Control, Behavioral Risk Factor Surveillance System, and the Harvard Forums on Health Survey. Demographic information and participant knowledge of obesity-related cancer risk was collected. Logistic regression and Cochran-Armitage tests for trend were use to assess the association between predictor variables and knowledge. RESULTS: One thousand five hundred forty-five women completed the survey; 28% were normal weight (body mass index [BMI] less than 25 kg/m2), 24% were overweight (BMI 25–30 kg/m2), and 45% were obese (BMI at least 30 kg/m2). Fifty-eight percent (95% confidence interval 56–61%) were not aware that obesity increased risk for endometrial cancer. There was no difference in knowledge of endometrial cancer risk associated with any of the demographic characteristics studied. Black women were the most likely to respond that they did not know about the relationship between obesity and cancer. There was no association between personal weight and knowledge of obesity-associated risk. CONCLUSION: There is limited knowledge of the relationship between obesity and cancer risk, particularly among black women. Patient education regarding these risks may increase awareness of the relationship between obesity and endometrial cancer among women. LEVEL OF EVIDENCE: III

Comparison of those who succeed in losing significant excessive weight after bariatric surgery and those who fail

BackgroundGastric bypass and adjustable gastric banding currently are the most commonly performed weight loss surgeries. The results are encouraging for most patients, but some patients have a better experience than others. This report aims to define differences between those who succeeded and those that failed to lose significant excessive weight after bariatric surgery.MethodsThe authors retrospectively reviewed their database over the past 4 years. They studied 484 bariatric patients who had 1 year of follow-up evaluation. Success was defined as more than 50% excess weight loss (EWL) and failure as less than 30% EWL. Student’s t-tests were performed between the groups of bypass patients, band patients, men, women, whites, and minorities.Results An overall success rate of 58% and a failure rate of 15% were observed. The successful group was significantly younger. The starting body mass index (BMI) was significantly lower for the successful band patients. The starting excess weight was significantly less in both the successful band and bypass groups, as was the starting weight. The successful whites were significantly younger, and the starting BMI was significantly lower in the successful minority group. The unsuccessful bypass patients and whites were significantly taller than the successful group. Gender was not a significant variable in success or failure regardless of procedure.ConclusionWithout consideration for the procedure performed, the patients who successfully lost weight were younger. The unsuccessful band patients had a higher starting BMI, whereas the successful band and bypass patients had lower average starting and excess weights. The successful bypass patients were significantly shorter. Among whites, the successful patients were significantly younger and shorter. The successful minorities had a lower starting BMI. These variables give further insight into the complexity of successful excess weight loss.

The evolution of robotic bariatric surgery.

IntroductionThe growth of bariatric surgery has resulted in varying types of procedures with increasing complexity. Robotic digital platforms are employed in bariatric surgery to address this increasing complexity in the high-risk obese patient population with difficult anatomy.Materials and MethodsThis review explores the literature and examines the reported outcomes and complications in using robotics for bariatric surgery. Robotic approaches to adjustable gastric banding, sleeve gastrectomy, gastric bypass, and biliopancreatic diversion with duodenal switch are examined. Revisional cases, learning curves, and cost effectiveness are reviewed, with an eye toward the future of bariatric surgery as the use of robotics is adopted.ConclusionDigital platforms are showing great promise as enabling technology which advance bariatric outcomes. With increasingly complex bariatric cases being performed and revised, the insertion of digital information between the surgeon and the patient leads to better operations for the patient and the surgeon.