title: Transoral mucosal excision sutured gastroplasty: a pilot study for GERD and obesity with two-year follow-up.
abstract: BACKGROUND
  An outpatient transoral endoscopic procedure for gastroesophageal reflux disease (GERD) and obesity would be appealing if safe, effective, and durable. We present the first in human experience with a new system.
  
  
  METHODS
  Eight patients with GERD (3) and obesity (5) were selected according to a preapproved study protocol. All GERD patients had preprocedure manometry and pH monitoring to document GERD as well as quality of life and symptom questionnaires. Obese patients (body mass index >35) underwent a psychological evaluation and tests for comorbidities. Under general anesthesia, a procedure was performed at the gastroesophageal junction including mucosal excision, suturing of the excision beds for apposition, and suture knotting.
  
  
  RESULTS
  One patient with micrognathia could not undergo the required preprocedural passage of a 60 F dilator and was excluded. The first 2 GERD patients had incomplete procedures due to instrument malfunction. The subsequent 5 subjects had a successfully completed procedure. Four patients were treated for obesity and had an average excess weight loss of 30.3% at 2-year follow-up. Of these patients, one had an 8-mm outlet at the end of the procedure recognized on video review--a correctable error--and another vomited multiple times postoperatively and loosened the gastroplasty sutures. The treated GERD patient had resolution of reflux-related symptoms and is off all antisecretory medications at 2-year follow-up. Her DeMeester score was 8.9 at 24 months.
  
  
  CONCLUSIONS
  The initial human clinical experience showed promising results for effective and safe GERD and obesity therapy.
authors.affiliation: Saint George University Teaching Hospital, Szekesfehervar, Hungary.
authors.forename: Andras
authors.initials: A
authors.lastname: Legner
authors.affiliation: Saint George University Teaching Hospital, Szekesfehervar, Hungary.
authors.forename: Aron
authors.initials: A
authors.lastname: Altorjay
authors.affiliation: Saint George University Teaching Hospital, Szekesfehervar, Hungary.
authors.forename: Arpad
authors.initials: A
authors.lastname: Juhasz
authors.affiliation: Klinikum Nuremberg, Nuremberg, Germany.
authors.forename: Rudolph
authors.initials: R
authors.lastname: Stadlhuber
authors.affiliation: Creighton University School of Medicine, Omaha, NE, USA.
authors.forename: Viktor
authors.initials: V
authors.lastname: Reich
authors.affiliation: SafeStitch Medical Inc, Miami, FL, USA.
authors.forename: Brandon
authors.initials: B
authors.lastname: Hunt
authors.affiliation: Dartmouth Medical School, Lebanon, NH, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Rothstein
authors.affiliation: Creighton University School of Medicine, Omaha, NE, USA SafeStitch Medical Inc, Miami, FL, USA cjf@safestitch.com.
authors.forename: Charles
authors.initials: C
authors.lastname: Filipi
mesh_terms: D004724:Endoscopy / Q000379:methods*; D004943:Esophagogastric Junction / Q000601:surgery; D005500:Follow-Up Studies; D005764:Gastroesophageal Reflux / Q000601:surgery*; D015391:Gastroplasty / Q000295:instrumentation* / Q000379:methods*; D006801:Humans; D009765:Obesity / Q000601:surgery*; D010865:Pilot Projects
keywords: NOTES; esophageal surgery; flexible endoscopy; gastric surgery; interventional endoscopy