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Randomized Controlled Trial
, 74 (6), 1248-58

Transoral Gastroplasty for Morbid Obesity: A Multicenter Trial With a 1-year Outcome

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Randomized Controlled Trial

Transoral Gastroplasty for Morbid Obesity: A Multicenter Trial With a 1-year Outcome

Pietro Familiari et al. Gastrointest Endosc.

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01067625.

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