title: A randomized trial on endoscopic full-thickness gastroplication versus laparoscopic antireflux surgery in GERD patients without hiatal hernias.
abstract: OBJECTIVE
  Endoscopic full-thickness gastroplication by the Plicator instrument has proven to be a safe and effective method to improve symptoms of gastroesophageal reflux disease. This is the first comparative objective data study for endoscopic versus laparoscopic antireflux procedures.
  
  
  METHODS
  In this single-center controlled open trial in 70 adult patients with documented gastroesophageal reflux disease without hiatal hernias, objective and subjective outcome parameters were evaluated prospectively and compared. Patients were randomly assigned to either endoscopic full-thickness gastroplication or laparoscopic antireflux surgery. Patients in the Plicator group received between 1 and 3 transmural-pledgeted sutures to the gastric cardia. Patients in the laparoscopic anti-reflux surgery (LARS) group underwent Nissen or Toupet fundoplication. Esophageal manometry, 24-hour impedance pH monitoring, Gastrointestinal Quality-of-Life Index, and symptom questionnaires were evaluated at baseline and at the 3-month follow-up for significant (P<0.05) changes and differences.
  
  
  RESULTS
  Lower esophageal sphincter pressures were increased in the LARS group and unchanged in the Plicator group. Total reflux numbers, acid, nonacid, proximal, upright, and recumbent reflux events were reduced in both groups, significantly more in the LARS group. Reductions in reflux-related esophageal acid scores were significant only in the LARS group. Similar improvements of Gastrointestinal Quality-of-Life Index were found in both groups. General and gas-related symptom scores were comparably reduced. Greater Reductions in reflux-specific symptom scores were found after LARS. Bowel dysfunction symptom scores were lower after LARS.
  
  
  CONCLUSIONS
  Improvements in the general subjective outcome parameters were similar after endoscopic full-thickness gastroplication compared with LARS despite a stronger reflux control provided by LARS. More effective relief of reflux-related symptoms favors LARS, and differences in side effect symptoms favor endoscopic full-thickness gastroplication.
authors.affiliation: Department of General Surgery, Public Hospital of Zell am See, Zell am See, Austria. kaindlstorfer@me.com
authors.forename: Adolf
authors.initials: A
authors.lastname: Kaindlstorfer
authors.forename: Oliver O
authors.initials: OO
authors.lastname: Koch
authors.forename: Stavros A
authors.initials: SA
authors.lastname: Antoniou
authors.forename: Kai-Uwe
authors.initials: KU
authors.lastname: Asche
authors.forename: Frank A
authors.initials: FA
authors.lastname: Granderath
authors.forename: Rudolph
authors.initials: R
authors.lastname: Pointner
mesh_terms: D000328:Adult; D000368:Aged; D004943:Esophagogastric Junction / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D005773:Gastroscopy / Q000379:methods*; D006551:Hernia, Hiatal / Q000150:complications; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D010149:Postoperative Pain / Q000503:physiopathology; D011183:Postoperative Complications / Q000503:physiopathology; D011446:Prospective Studies; D018570:Risk Assessment; D013270:Stomach / Q000601:surgery; D016896:Treatment Outcome