Background: Endoluminal suturing to reduce the gastric volume might provide an additional option for the treatment of obesity. Potential advantages of a nonoperative endoluminal intervention include less pain, the ability to perform it as an outpatient procedure, and a high level of patient acceptance. The purpose of the present pilot study was to demonstrate the feasibility and procedural safety of transoral gastric volume reduction (TRIM procedure) using the Restore Suturing System in patients with a body mass index of 30-45 kg/m(2). Successful completion of the procedure and adverse events were evaluated at academic/university hospitals.
Methods: This was a nonrandomized feasibility study performed at 2 institutions. After institutional review board approval, the patients underwent the TRIM endoluminal gastric plication procedure with the Restore Suturing System (Restore device). Gastric plications were completed to approximate the anterior and posterior gastric walls to achieve restriction of the upper stomach. The number and location of successful plications were recorded, and patients were monitored for complications. The present report described the short-term procedural results (≤ 24 hours after the procedure) of the studied cohort.
Results: A total of 18 patients were enrolled in the present study. The TRIM procedure was successfully completed in all patients, with placement of 4-8 plications (average 6 per patient). The average procedure time was 125 ± 23 minutes, and no serious or significant procedure-related complications occurred. After the procedure, common patient complaints were nausea, vomiting, and abdominal discomfort. The first 10 patients enrolled were kept overnight according to the study protocol, and the remaining 8 patients were discharged on the day of the procedure.
Conclusion: Endoluminal suturing using the TRIM procedure and the Restore device was technically feasible, and no serious or significant procedure-related complications were reported. Weight loss, co-morbidity improvement, and durability are under assessment.
Copyright © 2010 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.