Transoral gastric volume reduction for weight management: technique and feasibility in 18 patients.
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.


CONCLUSIONS
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.
Bariatric and Metabolic Institute, Cleveland Clinic, Cleveland, Ohio 44195, USA. brethas@ccf.org
Stacy A
SA
Brethauer
Bipan
B
Chand
Philip R
PR
Schauer
Christopher C
CC
Thompson
D000328:Adult; D050110:Bariatric Surgery / Q000295:instrumentation / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000601:surgery*; D010865:Pilot Projects; D013270:Stomach / Q000601:surgery*; D013536:Suture Techniques / Q000295:instrumentation; D016896:Treatment Outcome; D055815:Young Adult