title: Transoral gastroplasty for morbid obesity: a multicenter trial with a 1-year outcome.
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.
  
  
  METHODS
  Prospective, multicenter, single-arm trial.
  
  
  METHODS
  Two tertiary-care referral medical centers.
  
  
  METHODS
  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).
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  Small number of patients. Short-term follow-up. Twenty-one percent of patients were not available for the 12-month follow-up.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Digestive Endoscopy Unit, Università Cattolica del Sacro Cuore, Gemelli University Hospital, Rome, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Familiari
authors.forename: Guido
authors.initials: G
authors.lastname: Costamagna
authors.forename: Daniel
authors.initials: D
authors.lastname: Bléro
authors.forename: Olivier
authors.initials: O
authors.lastname: Le Moine
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Perri
authors.forename: Ivo
authors.initials: I
authors.lastname: Boskoski
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Coppens
authors.forename: Marie
authors.initials: M
authors.lastname: Barea
authors.forename: Amerigo
authors.initials: A
authors.lastname: Iaconelli
authors.forename: Gertrude
authors.initials: G
authors.lastname: Mingrone
authors.forename: Christophe
authors.initials: C
authors.lastname: Moreno
authors.forename: Jacques
authors.initials: J
authors.lastname: Devière
mesh_terms: D000328:Adult; D015992:Body Mass Index; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D015391:Gastroplasty / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D057605:Natural Orifice Endoscopic Surgery / Q000295:instrumentation*; D009767:Obesity, Morbid / Q000601:surgery*; D011446:Prospective Studies; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D015431:Weight Loss; D055815:Young Adult