Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial
BMJ 2008; 337 doi: https://doi.org/10.1136/bmj.a2664 (Published 15 December 2008) Cite this as: BMJ 2008;337:a2664
- 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
- 1Health Services Research Unit, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD
- 2Aberdeen Royal Infirmary, Foresterhill, Aberdeen AB25 1LD
- 3Department of Gastroenterology, Royal Infirmary, Glasgow G4 0SF
- 4Faculty of Medicine, Imperial College, St Mary’s Campus, London W2 1PG
- Correspondence to: A M Grant a.grant{at}abdn.ac.uk
- Accepted 24 September 2008
Abstract
Objective To determine the relative benefits and risks of laparoscopic fundoplication surgery as an alternative to long term drug treatment for chronic gastro-oesophageal reflux disease (GORD).
Design Multicentre, pragmatic randomised trial (with parallel preference groups).
Setting 21 hospitals in the United Kingdom.
Participants 357 randomised participants (178 surgical, 179 medical) and 453 preference participants (261, 192); mean age 46; 66% men. All participants had documented evidence of GORD and symptoms for >12 months.
Intervention The type of laparoscopic fundoplication used was left to the discretion of the surgeon. Those allocated to medical treatment had their treatment reviewed and adjusted as necessary by a local gastroenterologist, and subsequent clinical management was at the discretion of the clinician responsible for care.
Main outcome measures The disease specific REFLUX quality of life score (primary outcome), SF-36, EQ-5D, and medication use, measured at time points equivalent to three and 12 months after surgery, and surgical complications.
Main results Randomised participants had received drugs for GORD for median of 32 months before trial entry. Baseline REFLUX scores were 63.6 (SD 24.1) and 66.8 (SD 24.5) in the surgical and medical randomised groups, respectively. Of those randomised to surgery, 111 (62%) actually had total or partial fundoplication. Surgical complications were uncommon with a conversion rate of 0.6% and no mortality. By 12 months, 38% (59/154) randomised to surgery (14% (14/104) among those who had fundoplication) were taking reflux medication versus 90% (147/164) randomised medical management. The REFLUX score favoured the randomised surgical 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 status measures also favoured the randomised surgical group. Baseline scores in the preference for surgery group were the worst; by 12 months these were better than in the preference for medical treatment group.
Conclusion At least up to 12 months after surgery, laparoscopic fundoplication significantly increased measures of health status in patients with GORD.
Trial registration ISRCTN15517081.
Footnotes
We thank Maureen G C Gillan, Marie Cameron, and Christiane Pflanz-Sinclair for their assistance in study coordination, recruitment of participants, and follow-up; Sharon McCann, who was involved in piloting the practical arrangements of this trial; Allan Walker for database and programming support; and Janice Cruden and Pauline Garden for their secretarial support and data management.
Trial coordination team
Garry Barton (1999-2002), Laura Bojke, Marion Campbell, David Epstein, Adrian Grant, Sue Macran, Craig Ramsay, Mark Sculpher, Samantha Wileman.
Trial steering group
Wendy Atkin (chair, independent of trial), John Bancewicz, Ara Darzi, Robert Heading, Janusz Jankowski (independent of trial), Zygmunt Krukowski, Richard Lilford (independent of trial), Iain Martin (1997-2000), Ashley Mowat, Ian Russell, Mark Thursz.
Data monitoring committee
Jon Nicholl, Chris Hawkey, Iain MacIntyre (all independent of trial)
Members of the REFLUX trial group responsible for recruitment in the clinical centres
A Mowat, Z Krukowski, E El-Omar, P Phull, T Sinclair, L Swan (Aberdeen Royal Infirmary); B Clements, J Collins, A Kennedy, H Lawther (Royal Victoria Hospital, Belfast); D Bennett, N Davies, S Toop, P Winwood (Royal Bournemouth Hospital); D Alderson, P Barham, K Green, R Mittal (Bristol Royal Infirmary); M Asante, S El Hasani (Princess Royal University Hospital, Bromley); A De Beaux, R Heading, L Meekison, S Paterson-Brown, H Barkell (Royal Infirmary of Edinburgh); G Ferns, M Bailey, N Karanjia, TA Rockall, L Skelly (Royal Surrey County Hospital, Guildford); M Dakkak, C Royston, P Sedman (Hull Royal Infirmary); K Gordon, L F Potts, C Smith, PL Zentler-Munro, A Munro (Raigmore Hospital, Inverness); S Dexter, P Moayeddi (General Infirmary at Leeds); DM Lloyd (Leicester Royal Infirmary); V Loh, M Thursz, A Darzi (St Mary’s Hospital, London); A Ahmed, R Greaves, A Sawyerr, J Wellwood, T Taylor (Whipps Cross Hospital, London); S Hosking, S Lowrey, J Snook (Poole Hospital); P Goggin, T Johns, A Quine, S Somers, S Toh (Queen Alexandra Hospital, Portsmouth); J Bancewicz, M Greenhalgh, W Rees (Hope Hospital, Salford); CVN Cheruvu, M Deakin, S Evans, J Green, F Leslie (North Staffordshire Hospital, Stoke-on-Trent); J N Baxter, P Duane, M M Rahman, M Thomas, J Williams (Morriston Hospital, Swansea); D Maxton, A Sigurdsson, M S H Smith, G Townson (Princess Royal Hospital, Telford); C Buckley, S Gore, RH Kennedy, Z H Khan, J Knight (Yeovil District Hospital); D Alexander, G Miller, D Parker, A Turnbull, J Turvill (York District Hospital).
Contributors: AMG was the principal grant holder and contributed to development of the trial protocol and preparation of the paper and had overall responsibility for the conduct of the trial. SMW contributed to development of the trial design, was responsible for the day to day management of the trial, monitored data collection and assisted in the preparation of the paper. CRR contributed to the grant application and trial design and conducted the statistical analysis. ZHK, NAM, RCH, and MRT advised on clinical aspects of the trial design and the conduct of the trial and commented on the draft paper. MKC contributed to the development of the trial design, commented on all aspects of the conduct of the trial, and contributed to the preparation of the paper. AMG is guarantor.
Funding: This study was funded by the NIHR Health Technology Assessment Programme (as part of project No 97/10/99), and the full project report is published in Health Technology Assessment 2008;12:1-181. The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health Directorates. The funders of this study (NCCHTA), other than the initial peer review process before funding and six monthly progress reviews, did not have any involvement in study design; in the collection, analysis, and interpretation of data; in the writing of the report; nor in the decision to submit the paper for publication. The views and opinions expressed in this paper are those of the authors and do not necessarily reflect those of the Department of Health or the funders that provide institutional support for the authors.
Competing interests: None declared.
Ethical approval: This study was approved by the Scottish multicentre research ethics committee and the appropriate local research ethics committees. All participants gave informed consent.
Provenance and peer review: Not commissioned; externally peer reviewed.
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.