title: Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease.
abstract: OBJECTIVE
  Transoral incisionless fundoplication (TIF) was developed in an attempt to create a minimally invasive endoscopic procedure that mimics antireflux surgery. The objective of this trial was to evaluate effectiveness of TIF compared with proton pump inhibition in a population consisting of gastroesophageal reflux disease (GERD) patients controlled with proton pump inhibitors (PPIs) who opted for an endoscopic intervention over lifelong drug dependence.
  
  
  METHODS
  Patients with chronic GERD were randomized (2:1) for TIF or continuation of PPI therapy. American Society of Anesthesiologists >2, body mass index >35 kg/m(2), hiatal hernia >2 cm, and esophageal motility disorders were exclusion criteria. Primary outcome measure was GERD-related quality of life. Secondary outcome measures were esophageal acid exposure, number of reflux episodes, PPI usage, appearance of the gastroesophageal valve, and healing of reflux esophagitis. Crossover for the PPI group was allowed after 6 months.
  
  
  RESULTS
  A total of 60 patients (TIF n=40, PPI n=20, mean body mass index 26 kg/m(2), 37 male) were included. At 6 months, GERD symptoms were more improved in the TIF group compared with the PPI group (P<0.001), with a similar improvement of distal esophageal acid exposure (P=0.228) compared with baseline. The pH normalization for TIF group and PPI group was 50% and 63%, respectively. All patients allocated for PPI treatment opted for crossover. At 12 months, quality of life remained improved after TIF compared with baseline (P<0.05), but no improvement in esophageal acid exposure compared with baseline was found (P=0.171) and normalization of pH was accomplished in only 29% in conjunction with deteriorated valve appearances at endoscopy and resumption of PPIs in 61%.
  
  
  CONCLUSIONS
  Although TIF resulted in an improved GERD-related quality of life and produced a short-term improvement of the antireflux barrier in a selected group of GERD patients, no long-term objective reflux control was achieved.
authors.affiliation: 1] Department of Surgery, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands [2] Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.
authors.forename: Bart P L
authors.initials: BP
authors.lastname: Witteman
authors.affiliation: Department of Gastroenterology and Hepatology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.
authors.forename: Jose M
authors.initials: JM
authors.lastname: Conchillo
authors.affiliation: Department of Gastroenterology and Hepatology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.
authors.forename: Nicolaas F
authors.initials: NF
authors.lastname: Rinsma
authors.affiliation: Department of Surgery, Rijnstate Hospital, Arnhem, The Netherlands.
authors.forename: Bark
authors.initials: B
authors.lastname: Betzel
authors.affiliation: Department of Clinical Epidemiolgy and Medical Technology Assessment, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.
authors.forename: Andrea
authors.initials: A
authors.lastname: Peeters
authors.affiliation: Department of Gastroenterology and Hepatology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.
authors.forename: Ger H
authors.initials: GH
authors.lastname: Koek
authors.affiliation: Department of Surgery, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.
authors.forename: Laurents P S
authors.initials: LP
authors.lastname: Stassen
authors.affiliation: Department of Surgery, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands.
authors.forename: Nicole D
authors.initials: ND
authors.lastname: Bouvy
mesh_terms: D000328:Adult; D000368:Aged; D004942:Esophagitis, Peptic / Q000209:etiology; D004945:Esophagoscopy; D005500:Follow-Up Studies; D018662:Fundoplication / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy* / Q000601:surgery*; D005773:Gastroscopy; D006801:Humans; D008875:Middle Aged; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D011788:Quality of Life; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors
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