title: Five-year follow-up of a multicenter, double-blind randomized clinical trial of laparoscopic Nissen vs anterior 90 degrees partial fundoplication.
abstract: OBJECTIVE
  Laparoscopic 90 degrees anterior partial fundoplication for gastroesophageal reflux disease achieves equivalent results to laparoscopic Nissen fundoplication.
  
  
  METHODS
  A multicenter, prospective, double-blind randomized clinical trial with a minimum of 5 years' follow-up.
  
  
  METHODS
  Nine university teaching hospitals in 6 major cities throughout Australia and New Zealand.
  
  
  METHODS
  One hundred twelve patients undergoing primary antireflux surgery were randomized to undergo either laparoscopic Nissen fundoplication (52 patients) or anterior 90 degrees partial fundoplication (60 patients).
  
  
  METHODS
  Laparoscopic Nissen fundoplication with division of the short gastric vessels or laparoscopic anterior 90 degrees partial fundoplication.
  
  
  METHODS
  Blinded assessment at 1 and 5 years' follow-up of clinical outcome for postoperative heartburn, dysphagia, gas-related symptoms, and satisfaction with the surgical outcome. Analog scales ranging from 0 to 10 were used to assess symptom severity.
  
  
  RESULTS
  Ninety-seven patients underwent follow-up at 5 years. Three others died during follow-up, 4 refused follow-up, and 8 were lost to follow-up; 89% remained at 5-years' follow-up. At 5 years' follow-up, mean analog scores for heartburn were 2.2 for anterior fundoplication vs 0.9 for Nissen fundoplication (P=.003). There were no significant differences between the groups for dysphagia scores. The mean score for outcome satisfaction was 7.1 after anterior fundoplication vs 8.1 after Nissen fundoplication (P=.18). Eighty-eight percent reported a good or excellent outcome following Nissen fundoplication vs 77% following anterior fundoplication.
  
  
  CONCLUSIONS
  Laparoscopic Nissen and anterior 90 degrees partial fundoplication achieve similar levels of patient satisfaction at 5 years' follow-up, with similar adverse effect profiles. However, at 5 years' follow-up, laparoscopic Nissen fundoplication achieves superior control of reflux symptoms.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Register Identifier: ACTRN12607000298415.
authors.affiliation: University of Adelaide, Adelaide, South Australia.
authors.forename: Rajwinder S
authors.initials: RS
authors.lastname: Nijjar
authors.forename: David I
authors.initials: DI
authors.lastname: Watson
authors.forename: Glyn G
authors.initials: GG
authors.lastname: Jamieson
authors.forename: Stephen
authors.initials: S
authors.lastname: Archer
authors.forename: Justin R
authors.initials: JR
authors.lastname: Bessell
authors.forename: Michael
authors.initials: M
authors.lastname: Booth
authors.forename: Richard
authors.initials: R
authors.lastname: Cade
authors.forename: Graham L
authors.initials: GL
authors.lastname: Cullingford
authors.forename: Peter G
authors.initials: PG
authors.lastname: Devitt
authors.forename: David R
authors.initials: DR
authors.lastname: Fletcher
authors.forename: James
authors.initials: J
authors.lastname: Hurley
authors.forename: George
authors.initials: G
authors.lastname: Kiroff
authors.forename: Ian J G
authors.initials: IJ
authors.lastname: Martin
authors.forename: Leslie K
authors.initials: LK
authors.lastname: Nathanson
authors.forename: John A
authors.initials: JA
authors.lastname: Windsor
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000009:adverse effects / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000601:surgery*; D006356:Heartburn / Q000175:diagnosis / Q000453:epidemiology; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology / Q000503:physiopathology; D011446:Prospective Studies; D012008:Recurrence; D012016:Reference Values; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome