Multicenter, Phase 1, Open Prospective Trial of Gastric Electrical Stimulation for the Treatment of Obesity: First-in-Human Results with a Novel Implantable System.

BACKGROUND AND AIMS: To assess safety of the Exilis™ gastric electrical stimulation (GES) system and to investigate whether the settings can be adjusted for comfortable chronic use in subjects with morbid obesity. Gastric emptying and motility and meal intake were evaluated. METHOD: In a multicenter, phase 1, open prospective cohort study, 20 morbidly obese subjects (17 female, mean BMI of 40.8 ± 0.7 kg/m2) were implanted with the Exilis™ system. Amplitude of the Exilis™ system was individually set during titration visits. Subjects underwent two blinded baseline test days (GES ON vs. OFF), after which long-term, monthly follow-up continued for up to 52 weeks. RESULTS: The procedure was safe, and electrical stimulation was well tolerated and comfortable in all subjects. No significant differences in gastric emptying halftime (203 ± 16 vs. 212 ± 14 min, p > 0.05), food intake (713 ± 68 vs. 799 ± 69 kcal, p > 0.05), insulin AUC (2448 ± 347 vs. 2186 ± 204, p > 0.05), and glucose AUC (41 ± 2 vs.41 ± 2, p > 0.05) were found between GES ON and OFF. At week 4, 13, and 26, a significant (p < 0.01) reduction in weight loss was observed but not at week 52. At this time point, the mean excess weight loss (EWL) was 14.2 ± 4.5%. CONCLUSION: Gastric electrical stimulation with the Exilis™ system can be considered as safe. No significant effect on food intake, gastric emptying, or gastric motility was observed. The reduction in weight loss with Exilis™ GES was significant but short lasting. Further electrophysiological research is needed to gain more insight in optimal stimulation parameters and lead localization.

Bariatric surgery in adolescents: a prospective randomized controlled trial comparing laparoscopic gastric banding to combined lifestyle interventions in adolescents with severe obesity (BASIC trial).

BACKGROUND: Obesity in children and adolescents is an increasing problem associated with multiple co-morbidities including metabolic and endocrine changes, cardiovascular abnormalities, and impaired quality of life. Combined lifestyle interventions are the current standard treatment for severe obesity in children. However, the medium- and long-term results of these interventions are relatively poor. Bariatric surgery shows substantial weight loss and health improvement in adults and retrospective studies in adolescents show similar outcomes. However, well-designed prospective studies in this young age group are rare. Our objectives are to determine whether combining surgery with lifestyle interventions in severely obese adolescents leads to a significant additional weight reduction compared to lifestyle interventions solely, and to assess its effect on obesity-associated co-morbidities in a prospective randomized controlled setting. METHODS: Patients aged 14-16 years with sex- and age-adjusted BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidity) and failure to achieve weight reduction > 5% during at least one year of combined lifestyle interventions are included in this trial. Randomization determines whether laparoscopic adjustable gastric banding will be added to combined lifestyle intervention throughout the trial period. Sixty children will be included in this trial. Follow-up visits are planned at 6 months, 1,2 and 3 years. Primary endpoints are percentage of total weight loss, and change of BMI. Secondary endpoints include body composition, pubertal development, metabolic and endocrine changes, inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, quality of life and changes in behaviour. DISCUSSION: This randomized controlled trial is designed to provide important information about the safety and efficacy of laparoscopic adjustable gastric banding treatment in severely obese adolescents with unsuccessful combined lifestyle interventions. The reversibility of this surgical procedure forms a strong argument to decide for gastric banding over other surgical procedures, since bariatric surgery in adolescents is still in its infancy. TRIAL REGISTRATION: The BASIC trial is registered in the register of ClinicalTrials.gov since July 2010, Identifier: NCT01172899.

Splenic size after division of the short gastric vessels in Nissen fundoplication in children.

PURPOSE: Nissen fundoplication is an effective treatment for gastro-esophageal reflux disease (GERD). Mobilization of the gastric fundus during fundoplication requires division of short gastric vessels of the spleen, which may cause splenic ischemia. The aim of this study was to determine if Nissen fundoplication results in hypotrophy of the spleen. METHODS: We performed pre-operative and post-operative ultrasound measurements of the spleen in children undergoing Nissen fundoplication. During operation, the surgeon estimated the compromised blood flow by assessment of the percentage of discoloration of the spleen. RESULTS: Twenty-four consecutive children were analyzed. Discoloration of the upper pole of the spleen was observed in 11 patients (48%) of a median estimated splenic surface of 20% (range 5-50%). The median ratio for pre-operative and post-operative length, width, and area of the spleen was 0.97, 1.03, and 0.96, respectively. The percentage of the estimated perfusion defect during surgery was not correlated with the ratios. In three patients, the area ratio was smaller than 0.8 (0.67-0.75), meaning that the area decreased with at least 20% after surgery. In none of these patients a discoloration was observed. CONCLUSION: Discoloration of the spleen after Nissen fundoplication is not associated with post-operative splenic atrophy.