Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial

doi:10.1136/bmj.a2664

Published 15 December 2008, doi:10.1136/bmj.a2664
Cite this as: BMJ 2008;337:a2664

Research

Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial

Adrian M Grant, professor of health services research¹, Samantha M Wileman, trial coordinator¹, Craig R Ramsay, senior statistician¹, N Ashley Mowat, physician², Zygmunt H Krukowski, surgeon², Robert C Heading, physician³, Mark R Thursz, physician⁴, Marion K Campbell, director¹, and the REFLUX Trial Group

¹ Health Services Research Unit, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD, ² Aberdeen Royal Infirmary, Foresterhill, Aberdeen AB25 1LD, ³ Department of Gastroenterology, Royal Infirmary, Glasgow G4 0SF, ⁴ Faculty of Medicine, Imperial College, St Mary’s Campus, London W2 1PG

Correspondence to: A M Grant a.grant{at}abdn.ac.uk

Objective To determine the relative benefits and risks of laparoscopicfundoplication surgery as an alternative to long term drug treatmentfor chronic gastro-oesophageal reflux disease (GORD).

Design Multicentre, pragmatic randomised trial (with parallelpreference groups).

Setting 21 hospitals in the United Kingdom.

Participants 357 randomised participants (178 surgical, 179medical) and 453 preference participants (261, 192); mean age46; 66% men. All participants had documented evidence of GORDand symptoms for >12 months.

Intervention The type of laparoscopic fundoplication used wasleft to the discretion of the surgeon. Those allocated to medicaltreatment had their treatment reviewed and adjusted as necessaryby a local gastroenterologist, and subsequent clinical managementwas at the discretion of the clinician responsible for care.

Main outcome measures The disease specific REFLUX quality oflife score (primary outcome), SF-36, EQ-5D, and medication use,measured at time points equivalent to three and 12 months aftersurgery, and surgical complications.

Main results Randomised participants had received drugs forGORD for median of 32 months before trial entry. Baseline REFLUXscores were 63.6 (SD 24.1) and 66.8 (SD 24.5) in the surgicaland medical randomised groups, respectively. Of those randomisedto surgery, 111 (62%) actually had total or partial fundoplication.Surgical complications were uncommon with a conversion rateof 0.6% and no mortality. By 12 months, 38% (59/154) randomisedto surgery (14% (14/104) among those who had fundoplication)were taking reflux medication versus 90% (147/164) randomisedmedical management. The REFLUX score favoured the randomisedsurgical group (14.0, 95% confidence interval 9.6 to 18.4; P<0.001).Differences of a third to half of 1 SD in other health statusmeasures also favoured the randomised surgical group. Baselinescores in the preference for surgery group were the worst; by12 months these were better than in the preference for medicaltreatment group.

Conclusion At least up to 12 months after surgery, laparoscopicfundoplication significantly increased measures of health statusin patients with GORD.

Trial registration ISRCTN15517081 [controlled-trials.com] .

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