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Randomized Controlled Trial
. 2013 Apr 18;346:f1908.
doi: 10.1136/bmj.f1908.

Minimal Access Surgery Compared With Medical Management for Gastro-Oesophageal Reflux Disease: Five Year Follow-Up of a Randomised Controlled Trial (REFLUX)

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Free PMC article
Randomized Controlled Trial

Minimal Access Surgery Compared With Medical Management for Gastro-Oesophageal Reflux Disease: Five Year Follow-Up of a Randomised Controlled Trial (REFLUX)

A M Grant et al. BMJ. .
Free PMC article

Abstract

Objectives: To determine the long term clinical effectiveness of laparoscopic fundoplication as an alternative to drug treatment for chronic gastro-oesophageal reflux disease (GORD).

Design: Five year follow-up of multicentre, pragmatic randomised trial (with parallel non-randomised preference groups).

Setting: Initial recruitment in 21 UK hospitals.

Participants: Responders to annual questionnaires among 810 original participants. At entry, all had had GORD for >12 months.

Intervention: 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.

Main outcome measures: 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.

Trial registration: Current Controlled Trials ISRCTN15517081.

Conflict of interest statement

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support for the submitted work; RCH has received money from Reckitt Benckiser as chairman of its Medical Advisory Board and for consultancy and lectures, he has also received money for lectures from Nycomed (Takeda) and holds stock in Procter & Gamble, Reckitt Benckiser, and Novartis; AMG received partial salary support from the NIHR as director of the NIHR Programme Grants for Applied Research programme; no other relationships or activities that could appear to have influenced the submitted work have been declared.

Figures

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Fig 1 Consort diagram of flow of participants through study
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Fig 2 Use of any antireflux drugs at baseline and at follow-up among participants with chronic gastro-oesophageal reflux disease who were randomised to or selected surgical or medical treatment
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Fig 3 Mean REFLUX questionnaire score at baseline and at follow-up points among participants with chronic gastro-oesophageal reflux disease who were randomised to or selected surgical or medical treatment. Scores range 0–100, the higher the score the better the participant felt

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References

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