Short-term safety and efficacy of the Trans-oral Endoscopic Restrictive Implant System for the treatment of obesity.

Background: Medical treatment of obesity often fails, and surgical treatment, although successful, is aggressive.

Objective: To evaluate the short-term safety and efficacy of an endoscopic restrictive implant procedure in the treatment of obesity.

Design: Prospective, observational study.

Setting: Tertiary-care referral hospital in The Netherlands.

Patients: This study involved 13 patients with body mass indexes of between 40 and 50 kg/m(2) or between 35 and 40 kg/m(2) with obesity-related comorbidities.

Intervention: A new transoral endoscopic restrictive implant procedure in the treatment of obesity.

Main Outcome Measurements: Safety of the procedure, percentage of excess weight loss, change in body mass index.

Results: In 1 patient, the procedure was abandoned after a gastric perforation related to stapler malfunctioning. In 2 patients, pneumoperitoneum was detected. This was desufflated with a percutaneous hollow needle in one patient and treated conservatively in the other. After these complications, technical adjustments were made in the procedure, and no subsequent procedural complications were seen. At 3 months postprocedure, patients obtained a median excess weight loss of 28%. Median body mass index decreased from 42.1 to 37.9 kg/m(2).

Limitations: Small number of patients.

Conclusion: Preliminary results of this transoral endoscopic restrictive implant system for the treatment of obesity showed successful placement in 12 of 13 patients. Procedural complications occurred in 3 patients. Weight loss was comparable to that of laparoscopic gastric band placement. Further long-term studies are under way.