title: A prospective multicenter registry of patients with chronic gastroesophageal reflux disease receiving transoral incisionless fundoplication.
abstract: BACKGROUND
  This study was undertaken to validate previously reported safety and symptomatic outcomes of transoral incisionless fundoplication (TIF), evaluate the relative benefit of TIF within different gastroesophageal reflux disease (GERD) subgroups, and to determine predictors of success in community settings.
  
  
  METHODS
  Between January 2010 and February 2011, 100 consecutive patients who underwent TIF procedures at 10 centers were enrolled in this prospective, open-label, multicenter, single-arm study. Symptom improvement and objective outcomes of TIF were analyzed at 6-month follow-up.
  
  
  RESULTS
  One hundred TIF procedures were performed. No complications were reported. Median GERD symptom duration was 9 years (range 1 to 35 years) and median duration of proton pump inhibitor (PPI) use was 7 years (1 to 20 years). Maximal medical therapy resulted in incomplete symptom control for 92% of patients; GERD Health-Related Quality of Life (GERD-HRQL) total score was normalized in 73%. Median heartburn and regurgitation scores improved significantly, from 18 (range 0 to 30) and 15 (range 0 to 30) on PPIs before TIF to 3 (range 0 to 25) and 0 (range 0 to 25), respectively; p < 0.001. Median Reflux Symptom Index scores were reduced after TIF from 24 (range 14 to 41) to 7 (range 0 to 44); p < 0.001. Eighty percent of patients were completely off PPIs after TIF vs 92% of patients on PPIs before TIF. Preoperative factors associated with clinical outcomes were less severe heartburn (total GERD-HRQL ≤ 30, p = 0.02) and the presence of esophagitis (p < 0.02).
  
  
  CONCLUSIONS
  Transoral incisionless fundoplication is safe and effective in multiple community-based settings in the treatment of medically refractory GERD, as demonstrated by an absence of complications, excellent symptom relief, and complete cessation of PPIs at 6-month follow-up.
authors.affiliation: SurgOne, PC, 401 W Hampden Pl., Englewood, CO 90110, USA. rbell@surgone.com
authors.forename: Reginald C W
authors.initials: RC
authors.lastname: Bell
authors.forename: Peter G
authors.initials: PG
authors.lastname: Mavrelis
authors.forename: William E
authors.initials: WE
authors.lastname: Barnes
authors.forename: David
authors.initials: D
authors.lastname: Dargis
authors.forename: Bart J
authors.initials: BJ
authors.lastname: Carter
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Hoddinott
authors.forename: Robert W
authors.initials: RW
authors.lastname: Sewell
authors.forename: Karim S
authors.initials: KS
authors.lastname: Trad
authors.forename: Brian
authors.initials: B
authors.lastname: DaCosta Gill
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Ihde
mesh_terms: D002908:Chronic Disease; D005500:Follow-Up Studies; D018662:Fundoplication / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D009055:Mouth; D057605:Natural Orifice Endoscopic Surgery / Q000379:methods*; D011446:Prospective Studies; D011788:Quality of Life; D012042:Registries; D016896:Treatment Outcome