title: Clinical and economic evaluation of laparoscopic surgery compared with medical management for gastro-oesophageal reflux disease: 5-year follow-up of multicentre randomised trial (the REFLUX trial).
abstract: BACKGROUND
  Despite promising evidence that laparoscopic fundoplication provides better short-term relief of gastro-oesophageal reflux disease (GORD) than continued medical management, uncertainty remains about whether benefits are sustained and outweigh risks.
  
  
  OBJECTIVE
  To evaluate the long-term clinical effectiveness, cost-effectiveness and safety of laparoscopic surgery among people with GORD requiring long-term medication and suitable for both surgical and medical management.
  
  
  METHODS
  Five-year follow-up of a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgery-based policy with a continued medical management policy. Cost-effectiveness was assessed alongside the trial using a NHS perspective for costs and expressing health outcomes in terms of quality-adjusted life-years (QALYs).
  
  
  METHODS
  Follow-up was by annual postal questionnaire and selective hospital case notes review; initial recruitment in 21 UK hospitals.
  
  
  METHODS
  Questionnaire responders among the 810 original participants. At entry, all had documented evidence of GORD and symptoms for > 12 months. Questionnaire response rates (years 1-5) were from 89.5% to 68.9%.
  
  
  METHODS
  Three hundred and fifty-seven participants were recruited to the randomised comparison (178 randomised to surgical management and 179 randomised to continued medical management) and 453 to the preference groups (261 surgical management and 192 medical management). The surgeon chose the type of fundoplication.
  
  
  METHODS
  Primary: disease-specific outcome measure (the REFLUX questionnaire); secondary: Short Form questionnaire-36 items (SF-36), European Quality of Life-5 Dimensions (EQ-5D), NHS resource use, reflux medication, complications.
  
  
  RESULTS
  The randomised groups were well balanced. By 5 years, 63% in the randomised surgical group and 13% in the randomised medical management group had received a total or partial wrap fundoplication (85% and 3% in the preference groups), with few perioperative complications and no associated deaths. At 1 year (and 5 years) after surgery, 36% (41%) in the randomised surgical group - 15% (26%) of those who had surgery - were taking proton pump inhibitor medication compared with 87% (82%) in the randomised medical group. At each year, differences in the REFLUX score significantly favoured the randomised surgical group (a third of a SD; p< 0.01 at 5 years). SF-36 and EQ-5D scores also favoured surgery, but differences attenuated over time and were generally not statistically significant at 5 years. The worse the symptoms at trial entry, the larger the benefit observed after surgery. Those randomised to medical management who subsequently had surgery had low baseline scores that markedly improved after surgery. Following fundoplication, 3% had surgical treatment for a complication and 4% had subsequent reflux-related operations - most often revision of the wrap. Dysphagia, flatulence and inability to vomit were similar in the two randomised groups. The economic analysis indicated that surgery was the more cost-effective option for this patient group. The incremental cost-effectiveness ratio for surgery in the base case was £7028 per additional QALY; these findings were robust to changes in approaches and assumptions. The probability of surgery being cost-effective at a threshold of £20,000 per additional QALY was > 0.80 for all analyses.
  
  
  CONCLUSIONS
  After 5 years, laparoscopic fundoplication continues to provide better relief of GORD symptoms with associated improved health-related quality of life. Complications of surgery were uncommon. Despite being initially more costly, a surgical policy is highly likely to be cost-effective.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN15517081.
  
  
  BACKGROUND
  This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 22. See the HTA programme website for further project information.
authors.affiliation: Health Services Research Unit, Health Sciences Building, University of Aberdeen, Aberdeen, UK. a.grant@abdn.ac.uk
authors.forename: A M
authors.initials: AM
authors.lastname: Grant
authors.forename: C
authors.initials: C
authors.lastname: Boachie
authors.forename: S C
authors.initials: SC
authors.lastname: Cotton
authors.forename: R
authors.initials: R
authors.lastname: Faria
authors.forename: L
authors.initials: L
authors.lastname: Bojke
authors.forename: D M
authors.initials: DM
authors.lastname: Epstein
authors.forename: C R
authors.initials: CR
authors.lastname: Ramsay
authors.forename: B
authors.initials: B
authors.lastname: Corbacho
authors.forename: M
authors.initials: M
authors.lastname: Sculpher
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: D003362:Cost-Benefit Analysis; D005260:Female; D005500:Follow-Up Studies; D018662:Fundoplication / Q000009:adverse effects / Q000706:statistics & numerical data; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000191:economics* / Q000379:methods*; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011183:Postoperative Complications / Q000453:epidemiology; D054328:Proton Pump Inhibitors / Q000191:economics* / Q000627:therapeutic use*; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D013222:State Medicine / Q000706:statistics & numerical data; D013673:Technology Assessment, Biomedical; D006113:United Kingdom
chemical_list: D054328:Proton Pump Inhibitors