Document Detail

Endoscopic Suturing for Transoral Outlet Reduction Increases Weight Loss Following Roux-en-Y Gastric Bypass Surgery.
MedLine Citation:
PMID:  23567348     Owner:  NLM     Status:  Publisher    
BACKGROUND & AIMS: Weight regain or insufficient loss following Roux-en-Y gastric bypass (RYGB) is common. This is partially attributable to dilatation of the gastrojejunostomy (GJ), which diminishes the restrictive capacity of RYGB. Endoluminal interventions for GJ reduction are being explored as alternatives to revision surgery. We performed a randomized, blinded, sham-controlled trial to evaluate weight loss following sutured transoral outlet reduction (TORe). METHODS: Patients with weight regain or inadequate loss after RYGB and GJ diameter > 2 cm were randomly assigned to groups that underwent TORe (n=50) or a sham procedure (controls, n=27). Intra-operative performance, safety, weight loss and clinical outcomes were assessed. RESULTS: Subjects that received TORe had a significantly greater mean percent weight loss, from baseline (3.5%; 95% confidence interval [CI], 1.8%-5.3%), than controls (0.4%; 95% CI, 2.3% weight gain to 3.0% weight loss) (P=.021), using last observation carried forward intent-to-treat analysis. As-treated analysis also demonstrated greater mean percent weight loss in the TORe group than controls (3.9% and 0.2% respectively; P=.014). Weight loss or stabilization was achieved in 96% subjects receiving TORe and 78% of controls (P=.019). The TORe group had reduced systolic and diastolic blood pressure (P<.001) and a trend toward improved metabolic indices. Additionally, 85% of the TORe group reported compliance with the healthy lifestyle eating program, compared with 53.8% of controls; 83% of TORe subjects said they would undergo the procedure again, and 78% said they would recommend the procedure to a friend. The groups had similar frequencies of adverse events. CONCLUSIONS: A multi-center randomized trial provides Level I evidence that TORe reduces weight regain following RYGB. These results were achieved using a superficial suction-based device; greater levels of weight loss could be achieved with newer, full-thickness suturing devices. TORe is one approach to avoid weight regain; a longitudinal multidisciplinary approach with dietary counseling and behavioral changes are required for long-term results.
Christopher C Thompson; Bipan Chand; Yang K Chen; Daniel C Demarco; Larry Miller; Michael Schweitzer; Richard I Rothstein; David B Lautz; James Slattery; Michele B Ryan; Stacy Brethauer; Phillip Schauer; Mack C Mitchell; Anthony Starpoli; Gregory B Haber; Marc F Catalano; Steven Edmundowicz; Annette M Fagnant; Lee M Kaplan; Mitchell S Roslin
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-4-5
Journal Detail:
Title:  Gastroenterology     Volume:  -     ISSN:  1528-0012     ISO Abbreviation:  Gastroenterology     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-4-9     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0374630     Medline TA:  Gastroenterology     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.
Division of Gastroenterology, Brigham & Women's Hospital, Boston, MA. Electronic address:
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