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A Grant
Dr A Grant, University of Aberdeen, Aberdeen, UK; a.grant@abdn.ac.uk
STUDY DESIGN
Design:
randomised controlled trial and economic analysis. Current Controlled Trials ISRCTN15517081.
Allocation concealment:
concealed.*
Blinding:
unblinded.*
STUDY QUESTION
Setting:
21 hospitals in the UK.
Patients:
357 patients ⩾18 years of age (mean age 46 y, 66% men) who had documented evidence of gastro-oesophageal reflux disease (GORD) and symptoms for >12 months and for whom the best management policy was uncertain. Exclusion criteria included body mass index >40 kg/m2, Barrett oesophagus >3 cm, evidence of dysplasia, paraoesophageal hernia, and oesophageal stricture.
Intervention:
a strategy of laparoscopic fundoplication (technique selected by surgeon) (n = 178) or a strategy of best medical management with proton pump inhibitors (PPIs) or histamine-receptor antagonists (n = 179).
Outcomes:
primary outcome was …
Footnotes
Source of funding: Health Technology Assessment Programme.