Christopher C Thompson1, Bipan Chand2, Yang K Chen3, Daniel C DeMarco4, Larry Miller5, Michael Schweitzer6, Richard I Rothstein7, David B Lautz8, James Slattery9, Michele B Ryan9, Stacy Brethauer10, Phillip Schauer10, Mack C Mitchell11, Anthony Starpoli12, Gregory B Haber12, Marc F Catalano13, Steven Edmundowicz14, Annette M Fagnant15, Lee M Kaplan16, Mitchell S Roslin17. 1. Division of Gastroenterology, Brigham & Women's Hospital, Boston, Massachusetts. Electronic address: cthompson@hms.harvard.edu. 2. Loyola University Medical Center, Maywood, Illinois. 3. Division of Gastroenterology, University of Colorado Hospital, Aurora, Colorado. 4. Division of Gastroenterology, Baylor University Medical Center, Dallas, Texas. 5. Section of Gastroenterology, Temple University Hospital, Philadelphia, Pennsylvania. 6. Department of Bariatric Surgery, John Hopkins Bayview Medical Center, Baltimore, Maryland. 7. Section of Gastroenterology, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire. 8. Department of Surgery, Brigham & Women's Hospital, Boston, Massachusetts. 9. Division of Gastroenterology, Brigham & Women's Hospital, Boston, Massachusetts. 10. Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio. 11. Division of Gastroenterology, John Hopkins Bayview Medical Center, Baltimore, Maryland. 12. Division of Gastroenterology, Lenox Hill Hospital, New York, New York. 13. Division of Gastroenterology, St. Luke's Medical Center, Milwaukee, Wisconsin. 14. Division of Gastroenterology, Washington University School of Medicine, St. Louis, Missouri. 15. Independent Consultant to Davol, Inc, Foster, Rhode Island. 16. MGH Weight Center and Gastrointestinal Unit, Massachusetts General Hospital; Boston, Massachusetts. 17. Department of General Surgery, Lenox Hill Hospital, New York, New York.
Abstract
BACKGROUND & AIMS:Weight regain or insufficient loss after 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 after sutured transoral outlet reduction (TORe). METHODS:Patients with weight regain or inadequate loss after RYGB and GJ diameter greater than 2 cm were assigned randomly to groups that underwent TORe (n = 50) or a sham procedure (controls, n = 27). Intraoperative performance, safety, weight loss, and clinical outcomes were assessed. RESULTS: Subjects who received TORe had a significantly greater mean percentage weight loss from baseline (3.5%; 95% confidence interval, 1.8%-5.3%) than controls (0.4%; 95% confidence interval, 2.3% weight gain to 3.0% weight loss) (P = .021), using a last observation carried forward intent-to-treat analysis. As-treated analysis also showed greater mean percentage 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. In addition, 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 multicenter randomized trial provides Level I evidence that TORe reduces weight regain after 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. ClinicalTrials.gov identifier: NCT00394212.
RCT Entities:
BACKGROUND & AIMS: Weight regain or insufficient loss after 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 after sutured transoral outlet reduction (TORe). METHODS:Patients with weight regain or inadequate loss after RYGB and GJ diameter greater than 2 cm were assigned randomly to groups that underwent TORe (n = 50) or a sham procedure (controls, n = 27). Intraoperative performance, safety, weight loss, and clinical outcomes were assessed. RESULTS: Subjects who received TORe had a significantly greater mean percentage weight loss from baseline (3.5%; 95% confidence interval, 1.8%-5.3%) than controls (0.4%; 95% confidence interval, 2.3% weight gain to 3.0% weight loss) (P = .021), using a last observation carried forward intent-to-treat analysis. As-treated analysis also showed greater mean percentage 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. In addition, 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 multicenter randomized trial provides Level I evidence that TORe reduces weight regain after 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. ClinicalTrials.gov identifier: NCT00394212.
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