Endoscopic gastric reduction with an endoluminal suturing device: a multicenter prospective trial with 1-year follow-up.

BACKGROUND: Obesity is the pandemic disease of this century. Surgery is the only effective treatment but cannot be offered to every patient. Endoscopic sutured gastroplasty is a minimally invasive technique that may potentially fill the gap between surgery and behavioral therapy. In this study, we prospectively investigated the efficacy and safety of a novel suturing device. METHODS: After a pre-bariatric multidisciplinary work-up, class 1 and 2 obese patients were included. Using a simple triangulation platform, transmural sutures with serosa-to-serosa apposition were performed in the gastric cavity. Patients were followed according to the same routines as those performed for bariatric procedures. RESULTS: Between November 2015 and December 2016, 51 patients were included across three European Centers. Mean body mass index at baseline was 35.1 kg/m2 (SD 3.0). Excess weight loss and total body weight loss at 1 year were 29 % (SD 28) and 7.4 % (SD 7), respectively, for the whole cohort (45 patients). At follow-up gastroscopy, 88 % of sutures were still in place (30 patients). No severe adverse events were observed. CONCLUSIONS: Endoscopic sutured gastroplasty using this novel device is safe and achieved weight loss results in line with criteria expected for these endoluminal techniques. Further prospective studies vs. placebo or nutritional support are needed.

Transoral gastroplasty for morbid obesity: a multicenter trial with a 1-year outcome.

BACKGROUND: Bariatric surgery is associated with specific complications and mortality. Transoral gastroplasty (TOGA) is a transoral restrictive bariatric procedure that might offer the benefits of surgery with a reduced complication rate. OBJECTIVE: To evaluate the safety and efficacy of TOGA at 12-month follow-up. DESIGN: Prospective, multicenter, single-arm trial. SETTING: Two tertiary-care referral medical centers. PATIENTS: This study involved 67 patients (average age 41.0 years, 47 women, baseline body mass index [BMI] 41.5 kg/m(2); 20 patients with BMI <40). INTERVENTION: The TOGA procedures were performed by using 2 stapling devices that were used to create a small, restrictive pouch along the lesser gastric curvature. The pouch is designed to give the patient a sustained feeling of satiety after small meals. MAIN OUTCOME MEASUREMENTS: Excess weight loss, excess BMI loss, safety, and improvements in quality of life, obesity-related comorbidities, and medication use. RESULTS: Fifty-three patients were available at the 12-month follow-up. Excess BMI loss was 33.9%, 42.6%, and 44.8% at 3, 6, and 12 months, respectively. At 12 months, excess BMI loss was 52.2% for patients with a baseline BMI of <40.0 and 41.3% for patients with a baseline BMI of ≥ 40.0 (P < .05). At 12 months, hemoglobin A(1c) levels decreased from 7.0% at baseline to 5.7% (P = .01); triglyceride levels decreased from 142.9 mg/dL to 98 mg/dL (P < .0001); high-density lipoprotein levels increased from 47.0 mg/dL to 57.5 mg/dL (P < .0001). Two complications occurred: a case of respiratory insufficiency and an asymptomatic pneumoperitoneum treated conservatively. LIMITATIONS: Small number of patients. Short-term follow-up. Twenty-one percent of patients were not available for the 12-month follow-up. CONCLUSION: The TOGA procedure allowed a substantial weight loss 1 year after the operation without severe complications. A long-term evaluation is needed before definitive conclusions can be drawn.

Single vs repeated treatment with the intragastric balloon: a 5-year weight loss study.

BACKGROUND: Saline-filled intragastric balloons (IB) may be inserted for 6 months to promote weight loss. We aimed to assess potential benefits of repeating IB therapy. METHODS: One hundred eighteen consecutive subjects (median body mass index, 34.0 kg/m(2); interquartile range [IQR], 31.2-36.9) treated with IB were included in a prospective non-randomized multicenter study. RESULTS: Nineteen (16%) subjects had repeat IB therapy at their own request, either to prolong first treatment (n = 8) or after a IB-free interval (n = 11). Higher weight loss 3 months after first IB insertion independently predicted repeat therapy (P = 0.008). Median weight loss in subjects who had repeat therapy was lower with second vs first IB (9.0 vs 14.6 kg; 30.4% vs 49.3% excess weight [EW]; P = 0.003). Compared to subjects with single treatment (n = 99), those with repeat treatment (n = 19) had greater weight loss at first IB extraction (14.6 vs 11.0 kg; 49.3% vs 30.7% EW; P = 0.026) and 1 year later (12.0 vs 6.0 kg; 40.9% vs 20.8% EW; P = 0.008) but the difference became less than 2 kg starting at 3 years. At final follow-up (4.9 years; IQR, 3.4-6.7), the whole subject population had lost a median of 2.0 kg (IQR, -3.0 to 10.3) or 6.2% EW (IQR, -8.1 to 31.6) and identical proportions of subjects with single/repeat treatment had >or=10% baseline weight loss (26%) or bariatric surgery (32%). CONCLUSION: Higher weight loss at 3 months independently predicted repeat IB therapy; weight loss with the second IB was lower compared to first IB. Repeat treatment had no effect on proportions of subjects with >or=10% baseline weight loss or bariatric surgery at final follow-up.