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Evidence-Based Medicine 2009;14:54; doi:10.1136/ebm.14.2.54
Copyright © 2009 by the BMJ Publishing Group Ltd.

THERAPEUTICS

Laparoscopic surgery was more effective than medical management for GORD disease

The first 150 words of the full text of this article appear below.

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 [controlled-trials.com] .

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 REFLUX quality-of-life score. Secondary outcomes included 5 REFLUX symptoms scores, quality-adjusted life-years (QALYs, based on EuroQol-5 Dimensions instrument), and healthcare costs.

Follow-up period:

12 months after surgery or an equivalent time in patients who . . . [Full text of this article]

Kalpesh Jani

Sigma Surgery, Baroda, Gujarata, India


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