title: Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX).
abstract: OBJECTIVE
  To determine the long term clinical effectiveness of laparoscopic fundoplication as an alternative to drug treatment for chronic gastro-oesophageal reflux disease (GORD).
  
  
  METHODS
  Five year follow-up of multicentre, pragmatic randomised trial (with parallel non-randomised preference groups).
  
  
  METHODS
  Initial recruitment in 21 UK hospitals.
  
  
  METHODS
  Responders to annual questionnaires among 810 original participants. At entry, all had had GORD for >12 months.
  
  
  METHODS
  The surgeon chose the type of fundoplication. Medical therapy was reviewed and optimised by a specialist. Subsequent management was at the discretion of the clinician responsible for care, usually in primary care.
  
  
  METHODS
  Primary outcome measure was self reported quality of life score on disease-specific REFLUX questionnaire. Other measures were health status (with SF-36 and EuroQol EQ-5D questionnaires), use of antireflux medication, and complications.
  
  
  RESULTS
  By five years, 63% (112/178) of patients randomised to surgery and 13% (24/179) of those randomised to medical management had received a fundoplication (plus 85% (222/261) and 3% (6/192) of those who expressed a preference for surgery and for medical management). Among responders at 5 years, 44% (56/127) of those randomised to surgery were taking antireflux medication versus 82% (98/119) of those randomised to medical management. Differences in the REFLUX score significantly favoured the randomised surgery group (mean difference 8.5 (95% CI 3.9 to 13.1), P<0.001, at five years). SF-36 and EQ-5D scores also favoured surgery, but were not statistically significant at five years. After fundoplication, 3% (12/364) had surgical treatment for a complication and 4% (16) had subsequent reflux-related operations-most often revision of the wrap. Long term rates of dysphagia, flatulence, and inability to vomit were similar in the two randomised groups.
  
  
  CONCLUSIONS
  After five years, laparoscopic fundoplication continued to provide better relief of GORD symptoms than medical management. Adverse effects of surgery were uncommon and generally observed soon after surgery. A small proportion had re-operations. There was no evidence of long term adverse symptoms caused by surgery.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN15517081.
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen AB25 2ZD, UK.
authors.forename: A M
authors.initials: AM
authors.lastname: Grant
authors.forename: S C
authors.initials: SC
authors.lastname: Cotton
authors.forename: C
authors.initials: C
authors.lastname: Boachie
authors.forename: C R
authors.initials: CR
authors.lastname: Ramsay
authors.forename: Z H
authors.initials: ZH
authors.lastname: Krukowski
authors.forename: R C
authors.initials: RC
authors.lastname: Heading
authors.forename: M K
authors.initials: MK
authors.lastname: Campbell
mesh_terms: D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000009:adverse effects / Q000379:methods*; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000601:surgery*; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome