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/m2 or between 35 and 40 kg/m2 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/m2.
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.
Abbreviations: BMI, body mass index, TERIS, Trans-oral Endoscopic Restrictive Implant System
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DISCLOSURE: All authors disclosed no financial relationships relevant to this publication.
If you would like to chat with an author of this article, you may contact Dr Fockens at p.fockens@amc.nl.
PII: S0016-5107(10)00265-8
doi:10.1016/j.gie.2010.02.053
© 2010 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.
