title: Endoscopic suturing for transoral outlet reduction increases weight loss after Roux-en-Y gastric bypass surgery.
abstract: OBJECTIVE
  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.
authors.affiliation: Division of Gastroenterology, Brigham & Women's Hospital, Boston, Massachusetts. Electronic address: cthompson@hms.harvard.edu.
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Thompson
authors.affiliation: Loyola University Medical Center, Maywood, Illinois.
authors.forename: Bipan
authors.initials: B
authors.lastname: Chand
authors.affiliation: Division of Gastroenterology, University of Colorado Hospital, Aurora, Colorado.
authors.forename: Yang K
authors.initials: YK
authors.lastname: Chen
authors.affiliation: Division of Gastroenterology, Baylor University Medical Center, Dallas, Texas.
authors.forename: Daniel C
authors.initials: DC
authors.lastname: DeMarco
authors.affiliation: Section of Gastroenterology, Temple University Hospital, Philadelphia, Pennsylvania.
authors.forename: Larry
authors.initials: L
authors.lastname: Miller
authors.affiliation: Department of Bariatric Surgery, John Hopkins Bayview Medical Center, Baltimore, Maryland.
authors.forename: Michael
authors.initials: M
authors.lastname: Schweitzer
authors.affiliation: Section of Gastroenterology, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire.
authors.forename: Richard I
authors.initials: RI
authors.lastname: Rothstein
authors.affiliation: Department of Surgery, Brigham & Women's Hospital, Boston, Massachusetts.
authors.forename: David B
authors.initials: DB
authors.lastname: Lautz
authors.affiliation: Division of Gastroenterology, Brigham & Women's Hospital, Boston, Massachusetts.
authors.forename: James
authors.initials: J
authors.lastname: Slattery
authors.affiliation: Division of Gastroenterology, Brigham & Women's Hospital, Boston, Massachusetts.
authors.forename: Michele B
authors.initials: MB
authors.lastname: Ryan
authors.affiliation: Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
authors.forename: Stacy
authors.initials: S
authors.lastname: Brethauer
authors.affiliation: Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
authors.forename: Phillip
authors.initials: P
authors.lastname: Schauer
authors.affiliation: Division of Gastroenterology, John Hopkins Bayview Medical Center, Baltimore, Maryland.
authors.forename: Mack C
authors.initials: MC
authors.lastname: Mitchell
authors.affiliation: Division of Gastroenterology, Lenox Hill Hospital, New York, New York.
authors.forename: Anthony
authors.initials: A
authors.lastname: Starpoli
authors.affiliation: Division of Gastroenterology, Lenox Hill Hospital, New York, New York.
authors.forename: Gregory B
authors.initials: GB
authors.lastname: Haber
authors.affiliation: Division of Gastroenterology, St. Luke's Medical Center, Milwaukee, Wisconsin.
authors.forename: Marc F
authors.initials: MF
authors.lastname: Catalano
authors.affiliation: Division of Gastroenterology, Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Steven
authors.initials: S
authors.lastname: Edmundowicz
authors.affiliation: Independent Consultant to Davol, Inc, Foster, Rhode Island.
authors.forename: Annette M
authors.initials: AM
authors.lastname: Fagnant
authors.affiliation: MGH Weight Center and Gastrointestinal Unit, Massachusetts General Hospital; Boston, Massachusetts.
authors.forename: Lee M
authors.initials: LM
authors.lastname: Kaplan
authors.affiliation: Department of General Surgery, Lenox Hill Hospital, New York, New York.
authors.forename: Mitchell S
authors.initials: MS
authors.lastname: Roslin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000713:Anastomosis, Roux-en-Y; D016099:Endoscopy, Gastrointestinal; D005260:Female; D015390:Gastric Bypass / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013536:Suture Techniques; D015431:Weight Loss