Evidence map›Paper›PMID 19074946›Full record

Trial reportBMJ (Clinical research ed.)2008

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

Adrian M Grant, Samantha M Wileman, Craig R Ramsay, N Ashley Mowat, Zygmunt H Krukowski, Robert C Heading, Mark R Thursz, Marion K Campbell, REFLUX Trial Group

Open access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 10 pooled it
7.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 10 syntheses or guidelines pooled it, 111 citations in OpenAlex.

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  7. Outcomes for patients with the same disease treated inside and outside of randomized trials: a systematic review and meta-analysis.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2014
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Adrian M GrantHealth Services Research Unit, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen AB25 2ZD. a.grant@abdn.ac.uk
Samantha M Wileman
Craig R Ramsay
N Ashley Mowat
Zygmunt H Krukowski
Robert C Heading
Mark R Thursz
Marion K Campbell
REFLUX Trial Group
University of Aberdeen · GBAberdeen Royal Infirmary · GBGlasgow Royal Infirmary · GB

Funding

Chief Scientist Office HERU1Chief Scientist Office HERU2Chief Scientist Office HSRU1
6 · The paper itself

Abstract

objectiveTo 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).

designMulticentre, pragmatic randomised trial (with parallel preference groups).

setting21 hospitals in the United Kingdom.

participants357 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.

interventionThe 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 measuresThe 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

resultsRandomised 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.

conclusionAt least up to 12 months after surgery, laparoscopic fundoplication significantly increased measures of health status in patients with GORD.

trial registrationISRCTN15517081.

Indexed as

AdultChronic DiseaseFemaleFundoplicationGastroesophageal RefluxHealth StatusHumansMaleMiddle AgedProton Pump InhibitorsQuality of LifeTreatment OutcomeYoung AdultProton Pump Inhibitors

Identifiers

PMID19074946
PMCPMC2603580
OpenAlexW2124796577

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.