title: Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial.
abstract: OBJECTIVE
  Transoral esophagogastric fundoplication (TF) can decrease or eliminate features of gastroesophageal reflux disease (GERD) in some patients whose symptoms persist despite proton pump inhibitor (PPI) therapy. We performed a prospective, sham-controlled trial to determine if TF reduced troublesome regurgitation to a greater extent than PPIs in patients with GERD.
  
  
  METHODS
  We screened 696 patients with troublesome regurgitation despite daily PPI use with 3 validated GERD-specific symptom scales, on and off PPIs. Those with at least troublesome regurgitation (based on the Montreal definition) on PPIs underwent barium swallow, esophagogastroduodenoscopy, 48-hour esophageal pH monitoring (off PPIs), and high-resolution esophageal manometry analyses. Patients with GERD and hiatal hernias ≤2 cm were randomly assigned to groups that underwent TF and then received 6 months of placebo (n = 87), or sham surgery and 6 months of once- or twice-daily omeprazole (controls, n = 42). Patients were blinded to therapy during follow-up period and reassessed at 2, 12, and 26 weeks. At 6 months, patients underwent 48-hour esophageal pH monitoring and esophagogastroduodenoscopy.
  
  
  RESULTS
  By intention-to-treat analysis, TF eliminated troublesome regurgitation in a larger proportion of patients (67%) than PPIs (45%) (P = .023). A larger proportion of controls had no response at 3 months (36%) than subjects that received TF (11%; P = .004). Control of esophageal pH improved after TF (mean 9.3% before and 6.3% after; P < .001), but not after sham surgery (mean 8.6% before and 8.9% after). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare (3 subjects receiving TF and 1 receiving the sham surgery).
  
  
  CONCLUSIONS
  TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.
authors.affiliation: Department of Surgery, Oregon Health & Science University, Portland, Oregon. Electronic address: hunterj@ohsu.edu.
authors.forename: John G
authors.initials: JG
authors.lastname: Hunter
authors.affiliation: Department of Surgery and Department of Gastroenterology, Northwestern University, Chicago, Illinois.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Kahrilas
authors.affiliation: SurgOne Foregut Institute, Englewood, Colorado.
authors.forename: Reginald C W
authors.initials: RC
authors.lastname: Bell
authors.affiliation: Department of Surgery, University of Texas Health Science Center, Houston, Texas.
authors.forename: Erik B
authors.initials: EB
authors.lastname: Wilson
authors.affiliation: Department of Surgery, The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia; Reston Surgical Associates, Reston, Virginia.
authors.forename: Karim S
authors.initials: KS
authors.lastname: Trad
authors.affiliation: Department of Surgery, Oregon Health & Science University, Portland, Oregon.
authors.forename: James P
authors.initials: JP
authors.lastname: Dolan
authors.affiliation: Department of Surgery, The Ohio State University, Columbus, Ohio.
authors.forename: Kyle A
authors.initials: KA
authors.lastname: Perry
authors.affiliation: Department of Surgery, University of Washington, Seattle, Washington.
authors.forename: Brant K
authors.initials: BK
authors.lastname: Oelschlager
authors.affiliation: Department of Surgery and Department of Gastroenterology, Northwestern University, Chicago, Illinois.
authors.forename: Nathaniel J
authors.initials: NJ
authors.lastname: Soper
authors.affiliation: Department of Surgery, University of Texas Health Science Center, Houston, Texas.
authors.forename: Brad E
authors.initials: BE
authors.lastname: Snyder
authors.affiliation: Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Burch
authors.affiliation: Department of Surgery, The Ohio State University, Columbus, Ohio.
authors.forename: William Scott
authors.initials: WS
authors.lastname: Melvin
authors.affiliation: Department of Surgery, Oregon Health & Science University, Portland, Oregon; Department of Surgery, Oregon Clinic, Portland, Oregon.
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Reavis
authors.affiliation: Department of Surgery, The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia; Reston Surgical Associates, Reston, Virginia.
authors.forename: Daniel G
authors.initials: DG
authors.lastname: Turgeon
authors.affiliation: Department of Surgery and Department of Gastroenterology, Northwestern University, Chicago, Illinois.
authors.forename: Eric S
authors.initials: ES
authors.lastname: Hungness
authors.affiliation: Department of Surgery, Oregon Health & Science University, Portland, Oregon.
authors.forename: Brian S
authors.initials: BS
authors.lastname: Diggs
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D018662:Fundoplication / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000628:therapy*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D011182:Postoperative Care; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*
chemical_list: D054328:Proton Pump Inhibitors; D009853:Omeprazole
keywords: Esophagus; EsophyX; Stomach; TIF