title: The HubBLe Trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for symptomatic second- and third-degree haemorrhoids: a multicentre randomised controlled trial and health-economic evaluation.
abstract: Optimal surgical intervention for low-grade haemorrhoids is unknown. Rubber band ligation (RBL) is probably the most common intervention. Haemorrhoidal artery ligation (HAL) is a novel alternative that may be more efficacious.
  
  
  
  The comparison of HAL with RBL for the treatment of grade II/III haemorrhoids.
  
  
  
  A multicentre, parallel-group randomised controlled trial.
  
  
  
  UK NHS and Personal Social Services.
  
  
  
  17 NHS Trusts.
  
  
  
  Patients aged ≥ 18 years presenting with grade II/III (second- and third-degree) haemorrhoids, including those who have undergone previous RBL.
  
  
  
  HAL with Doppler probe compared with RBL.
  
  
  
  Primary outcome - recurrence at 1 year post procedure; secondary outcomes - recurrence at 6 weeks; haemorrhoid severity score; European Quality of Life-5 Dimensions, 5-level version (EQ-5D-5L); Vaizey incontinence score; pain assessment; complications; and cost-effectiveness.
  
  
  
  A total of 370 participants entered the trial. At 1 year post procedure, 30% of the HAL group had evidence of recurrence compared with 49% after RBL [adjusted odds ratio (OR) = 2.23, 95% confidence interval (CI) 1.42 to 3.51;p= 0.0005]. The main reason for the difference was the number of extra procedures required to achieve improvement/cure. If a single HAL is compared with multiple RBLs then only 37.5% recurred in the RBL arm (adjusted OR 1.35, 95% CI 0.85 to 2.15;p= 0.20). Persistence of significant symptoms at 6 weeks was lower in both arms than at 1 year (9% HAL and 29% RBL), suggesting significant deterioration in both groups over the year. Symptom score, EQ-5D-5L and Vaizey score improved in both groups compared with baseline, but there was no difference between interventions. Pain was less severe and of shorter duration in the RBL group; most of the HAL group who had pain had mild to moderate pain, resolving by 3 weeks. Complications were low frequency and not significantly different between groups. It appeared that HAL was not cost-effective compared with RBL. In the base-case analysis, the difference in mean total costs was £1027 higher for HAL. Quality-adjusted life-years (QALYs) were higher for HAL; however, the difference was very small (0.01) resulting in an incremental cost-effectiveness ratio of £104,427 per additional QALY.
  
  
  
  At 1 year, although HAL resulted in fewer recurrences, recurrence was similar to repeat RBL. Symptom scores, complications, EQ-5D-5L and continence score were no different, and patients had more pain in the early postoperative period after HAL. HAL is more expensive and unlikely to be cost-effective in terms of incremental cost per QALY.
  
  
  
  Blinding of participants and site staff was not possible.
  
  
  
  The incidence of recurrence may continue to increase with time. Further follow-up would add to the evidence regarding long-term clinical effectiveness and cost-effectiveness. The polysymptomatic nature of haemorrhoidal disease requires a validated scoring system, and the data from this trial will allow further assessment of validity of such a system. These data add to the literature regarding treatment of grade II/III haemorrhoids. The results dovetail with results from the eTHoS study [Watson AJM, Hudson J, Wood J, Kilonzo M, Brown SR, McDonald A,et al.Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.Lancet2016, in press.] comparing stapled haemorrhoidectomy with excisional haemorrhoidectomy. Combined results will allow expansion of analysis, allowing surgeons to tailor their treatment options to individual patients.
  
  
  
  Current Controlled Trials ISRCTN41394716.
  
  
  
  This project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 88. See the NIHR Journals Library website for further project information.
authors.affiliation: Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
authors.forename: Steven
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authors.lastname: Brown
authors.affiliation: Leeds Teaching Hospitals NHS Trust, Leeds, UK.
authors.forename: Jim
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authors.lastname: Tiernan
authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Katie
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authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Daniel
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authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Neil
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authors.lastname: Shephard
authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Mike
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authors.lastname: Bradburn
authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Allan
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authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Abualbishr
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authors.affiliation: School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
authors.forename: Lizzie
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authors.affiliation: NHS Highland, Inverness, UK.
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authors.affiliation: University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
authors.forename: Simon
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authors.lastname: Radley
authors.affiliation: Oxford University Hospitals NHS Trust, Oxford, UK.
authors.forename: Oliver
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authors.lastname: Jones
authors.affiliation: Aintree University Hospital NHS Foundation Trust, Liverpool, UK.
authors.forename: Paul
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authors.lastname: Skaife
authors.affiliation: North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees, UK.
authors.forename: Anil
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authors.affiliation: Barts Health NHS Trust, London, UK.
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authors.affiliation: Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.
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authors.affiliation: Northern Devon Healthcare NHS Trust, Devon, UK.
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authors.lastname: Cartmell
authors.affiliation: Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
authors.forename: Justin
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authors.lastname: Davies
authors.affiliation: North West London Hospitals NHS Trust, London, UK.
authors.forename: Omar
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authors.lastname: Faiz
authors.affiliation: University Hospital Southampton NHS Foundation Trust, Southampton, UK.
authors.forename: Karen
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authors.lastname: Nugent
authors.affiliation: Poole Hospital NHS Foundation Trust, Poole, UK.
authors.forename: Andrew
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authors.lastname: Clarke
authors.affiliation: NHS Lanarkshire, Airdrie, UK.
authors.forename: Angus
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authors.lastname: MacDonald
authors.affiliation: Royal Berkshire NHS Foundation Trust, Reading, UK.
authors.forename: Phillip
authors.initials: P
authors.lastname: Conaghan
authors.affiliation: Imperial College Healthcare NHS Trust, London, UK.
authors.forename: Paul
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authors.affiliation: Peterborough and Stamford Hospitals NHS Foundation Trust, Peterborough, UK.
authors.forename: Rohit
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mesh_terms: D000328:Adult; D000368:Aged; D001158:Arteries / Q000601:surgery*; D003362:Cost-Benefit Analysis; D005242:Fecal Incontinence / Q000453:epidemiology; D005260:Female; D006484:Hemorrhoids / Q000601:surgery*; D006801:Humans; D008026:Ligation / Q000009:adverse effects / Q000191:economics* / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000453:epidemiology; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012008:Recurrence; D012720:Severity of Illness Index; D055815:Young Adult