Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients.

Background: Bariatric surgery for severe obesity has demonstrated significant health benefits, but it is not without complications. Transoral approaches to weight loss offer a minimally invasive option.

Objective: To evaluate the safety and feasibility of a transoral suturing procedure for weight loss.

Design: Single-center, uncontrolled study with a 1-year follow-up.

Setting: Hospital de Clinicas, Caracas, Venezuela.

Patients: Sixty-four patients (mean age [SD] 31.5 +/- 10.1 years, range 16-62 years; mean (SD) preoperative body mass index [BMI] 39.9 +/- 5.1 kg/m(2), range 28.0-60.2 kg/m(2)) were enrolled between 2003 and 2005.

Intervention: Endoluminal vertical gastroplasty by using a continuous suture pattern to treat obesity.

Main Outcome Measurements: Short-term complication monitoring and patient weight before the procedure and at 1, 3, and 12 months after the procedure.

Results: The outpatient procedures were performed in approximately 45 minutes. Patients had a significant reduction in BMI at 12 months (mean [SD] BMI 39.9 +/- 5.1 kg/m(2) vs 30.6 +/- 4.7 kg/m(2); P < .001) and a percentage of excess weight loss (%EWL) (SD) of 21.1 +/- 6.2, 39.6 +/- 11.3, and 58.1 +/- 19.9 at 1, 3, and 12 months, respectively. By comparing the study's subpopulations, group I (baseline BMI >or=40 kg/m(2), n = 33), group II (baseline BMI 35-40 kg/m(2), n = 19), and group III (baseline BMI <35 kg/m(2), n = 12) demonstrated a %EWL (SD) of 48.9 +/- 10.7, 56.5 +/- 13.9, and 85.1 +/- 24.0, respectively, at 12 months after the procedure (P = .037 when comparing group I vs II; P < .001 when comparing group II vs III and group I vs III). No patients experienced any serious adverse events.

Limitations: This study represents a single center's clinical experience, with no sham control.

Conclusions: Endoluminal vertical gastroplasty by using a continuous suture pattern is associated with significant weight loss. Additional studies are needed to demonstrate the procedure's long-term safety and efficacy.