title: Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study.
abstract: BACKGROUND
  The aim of this randomized, crossover study was to determine if transoral fundoplication (TF) could further improve clinical outcomes in partial responders to high-dose (HD) proton-pump inhibitor (PPI) therapy and to evaluate durability of TF.
  
  
  METHODS
  In seven United States centers, patients with hiatal hernia ≤ 2 cm and abnormal esophageal acid exposure (EAE) were randomized to TF (n = 40) or HD PPIs (n = 23) group. At 6-month follow-up, PPI patients underwent crossover. We assessed clinical outcomes 6-month post TF in crossover patients (COP), as compared to 6-month of HD PPI therapy, and 12-month outcomes in patients initially randomized to TF. The primary outcome was symptom control evaluated by Reflux Disease Questionnaire and Reflux Symptom Index. Secondary outcomes included healing of esophagitis, normalization of EAE and PPI use after TF. We analyzed 21 COP and 39 TF patients. McNemar's test or Fisher exact test was used to compare proportions.
  
  
  RESULTS
  Of 63 randomized patients, 3 were lost to follow-up, leaving 39 TF and 21 COP for analyses. In the COP, TF further improved control of regurgitation and of atypical symptoms achieved after six months of HD PPIs. Of 20 patients with GERD symptoms after six months of high-dose PPI therapy, 65% (13/20) reported global elimination of troublesome regurgitation and atypical symptoms post TF off PPIs; 67% (6/9) reported no troublesome regurgitation. Esophagitis further healed in 75% (6/8) of patients. Seventy-one percent of COP patients were off PPIs six months following TF. Normalization of EAE decreased from 52% after HD PPIs (on PPIs) to 33% after TF (off PPIs), p =0.388. In the original TF group, 12-month post TF, 77% of patients achieved complete symptom control, 82% ceased PPI therapy, 100% healed esophagitis and 45% normalized EAE.
  
  
  CONCLUSIONS
  The results of this study indicate that in patients with incomplete symptom control on high-dose PPI therapy TF may provide further elimination of symptoms and esophagitis healing. In the original TF group, the clinical outcomes of TF remained stable between 6- and 12-month follow-up.
authors.affiliation: Department of Surgery, The George Washington University School of Medicine and Health Sciences, Washington DC, USA. ktrad@mfa.gwu.edu.
authors.forename: Karim Sami
authors.initials: KS
authors.lastname: Trad
authors.forename: Gilbert
authors.initials: G
authors.lastname: Simoni
authors.forename: William Edris
authors.initials: WE
authors.lastname: Barnes
authors.forename: Ahmad Bassel
authors.initials: AB
authors.lastname: Shughoury
authors.forename: Mamoon
authors.initials: M
authors.lastname: Raza
authors.forename: Jeffrey Alan
authors.initials: JA
authors.lastname: Heise
authors.forename: Daniel Gilles
authors.initials: DG
authors.lastname: Turgeon
authors.forename: Mark Alan
authors.initials: MA
authors.lastname: Fox
authors.forename: Peter George
authors.initials: PG
authors.lastname: Mavrelis
mesh_terms: D000328:Adult; D000368:Aged; D002908:Chronic Disease; D018592:Cross-Over Studies; D016145:Endoscopy, Digestive System / Q000379:methods; D005260:Female; D018662:Fundoplication / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000209:etiology / Q000601:surgery*; D006551:Hernia, Hiatal / Q000150:complications / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors