Evidence map›Paper›PMID 27726951›Full record

Trial reportLancet (London, England)2016

Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.

Angus J M Watson, Jemma Hudson, Jessica Wood, Mary Kilonzo, Steven R Brown, Alison McDonald, John Norrie, Hanne Bruhn, Jonathan A Cook, eTHoS study group

Erratum issuedOpen access · hybridAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in Lancet (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 60 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 8 pooled it
19.5field-weighted citation impact, top 1% 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

60 citing papers in PubMed, 8 syntheses or guidelines pooled it, 184 citations in OpenAlex.

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  18. Radiofrequency Ablation for Hemorrhoidal Disease.Life (Basel, Switzerland) · 2026
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Angus J M WatsonRaigmore Hospital, Inverness, Scotland, UK. Electronic address: angus.watson@nhs.net.
Jemma HudsonCentre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
Jessica WoodCentre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
Mary KilonzoHealth Economics Research Unit, University of Aberdeen, Aberdeen, UK.
Steven R BrownSheffield Teaching Hospitals, Sheffield, UK.
Alison McDonaldCentre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
John NorrieCentre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, UK.
Hanne BruhnHealth Economics Research Unit, University of Aberdeen, Aberdeen, UK.
Jonathan A CookCentre for Statistics in Medicine, University of Oxford, Oxford, UK.
eTHoS study group
University of Aberdeen · GBRaigmore Hospital · GBSheffield Teaching Hospitals NHS Foundation Trust · GBUniversity of Oxford · GB

Funding

Chief Scientist Office HERU1Chief Scientist Office HSRU1Department of Health 08/24/02Medical Research Council G0601938Medical Research Council G1002292
6 · The paper itself

Abstract

backgroundTwo commonly performed surgical interventions are available for severe (grade II-IV) haemorrhoids; traditional excisional surgery and stapled haemorrhoidopexy. Uncertainty exists as to which is most effective. The eTHoS trial was designed to establish the clinical effectiveness and cost-effectiveness of stapled haemorrhoidopexy compared with traditional excisional surgery.

methodsThe eTHoS trial was a large, open-label, multicentre, parallel-group, pragmatic randomised controlled trial done in adult participants (aged 18 years or older) referred to hospital for surgical treatment for grade II-IV haemorrhoids. Participants were randomly assigned (1:1) to receive either traditional excisional surgery or stapled haemorrhoidopexy. Randomisation was minimised according to baseline EuroQol 5 dimensions 3 level score (EQ-5D-3L), haemorrhoid grade, sex, and centre with an automated system to stapled haemorrhoidopexy or traditional excisional surgery. The primary outcome was area under the quality of life curve (AUC) measured with the EQ-5D-3L descriptive system over 24 months, assessed according to the randomised groups. The primary outcome measure was analysed using linear regression with adjustment for the minimisation variables. This trial is registered with the ISRCTN registry, number ISRCTN80061723.

findingsBetween Jan 13, 2011, and Aug 1, 2014, 777 patients were randomised (389 to receive stapled haemorrhoidopexy and 388 to receive traditional excisional surgery). Stapled haemorrhoidopexy was less painful than traditional excisional surgery in the short term and surgical complication rates were similar between groups. The EQ-5D-3L AUC score was higher in the traditional excisional surgery group than the stapled haemorrhoidopexy group over 24 months; mean difference -0·073 (95% CI -0·140 to -0·006; p=0·0342). EQ-5D-3L was higher for stapled haemorrhoidopexy in the first 6 weeks after surgery, the traditional excisional surgery group had significantly better quality of life scores than the stapled haemorrhoidopexy group. 24 (7%) of 338 participants who received stapled haemorrhoidopexy and 33 (9%) of 352 participants who received traditional excisional surgery had serious adverse events.

interpretationAs part of a tailored management plan for haemorrhoids, traditional excisional surgery should be considered over stapled haemorrhoidopexy as the surgical treatment of choice.

fundingNational Institute for Health Research Health Technology Assessment programme.

Indexed as

Cost-Benefit AnalysisAdultClinical ProtocolsFemaleHemorrhoidectomyHemorrhoidsHumansMaleMiddle AgedPostoperative ComplicationsQuality of LifeSurgical StaplingTime FactorsTreatment Outcome

Identifiers

PMID27726951
PMCPMC5269572
OpenAlexW2528846633

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.