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.