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.


METHODS
Prospective, observational study.


METHODS
Tertiary-care referral hospital in The Netherlands.


METHODS
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.


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


METHODS
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).


CONCLUSIONS
Small number of patients.


CONCLUSIONS
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.
Department of Gastroenterology and Hepatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Koen
K
de Jong
Elisabeth M H
EM
Mathus-Vliegen
Elisabeth A M L
EA
Veldhuyzen
Jan H
JH
Eshuis
Paul
P
Fockens
D000328:Adult; D000768:Anesthesia, General; D015992:Body Mass Index; D002299:Cardia / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D015391:Gastroplasty / Q000009:adverse effects / Q000295:instrumentation*; D005773:Gastroscopy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009767:Obesity, Morbid / Q000150:complications / Q000523:psychology / Q000628:therapy*; D011027:Pneumoperitoneum / Q000209:etiology; D011182:Postoperative Care; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D019736:Prostheses and Implants; D011788:Quality of Life / Q000523:psychology; D013525:Surgical Instruments; D017792:Surgical Stapling; D016896:Treatment Outcome; D015431:Weight Loss