HubBLe controlled trial

The HubBLe Trial: Haemorrhoidal Artery Ligation (HAL) versus Rubber Band Ligation (RBL) for symptomatic second and third degree haemorrhoids.



Haemorrhoids are common, affecting as many as 1 in 3 of the population and result in a significant burden to the NHS with over 20,000 haemorrhoidal operations are carried out in England each year. Repeated visits to hospital for therapy represent a significant disruption to the personal and working lives of patients.

Treatment is dictated by the degree of symptoms and the degree of prolapse, and ranges from dietary advice to rubber band ligation (RBL) in the outpatient department, to an operation under anaesthetic.

Although RBL is cheap, it has a high recurrence rate (from 11% to over 50%) and often needs repeating. Failure may require surgical intervention, commonly the traditional "open" haemorrhoidectomy (OH) or a stapled haemorrhoidopexy (SH); both requiring anaesthetic.

OH is associated with considerable post-operative discomfort, and a delay in return to normal activity, but has a low recurrence rate. SH has a slightly higher recurrence rate but potentially shorter recovery.

An alternative treatment is haemorrhoidal artery ligation (HAL), which although also requiring an anaesthetic, evidence suggests a recovery similar to RBL but an effectiveness that approaches the more intensive surgical options.

The aim of this study was to establish the clinical effectiveness and cost effectiveness of haemorrhoidal artery ligation compared with conventional rubber band ligation in the treatment of people with symptomatic prolapsing haemorrhoids (second or third degree).


This was a multi-centre, parallel group randomised controlled trial involving 18 centres throughout England and Scotland.

These participants fell into two basic groups:

  1. Patients presenting to the surgical outpatient clinic (SOPC) with symptomatic haemorrhoids where alternative diagnoses had been excluded;
  2. Patients with symptoms confirmed due to haemorrhoids who returned to surgical outpatients following one unsuccessful RBL.

After consent, participants were individually randomised to HAL or RBL in equal proportion at all centres.

Data was collected to establish which patients had further treatment for recurrent symptoms or complications following their initial procedure.

Follow-up was conducted at 1 day, 7 days, 21 days, 6 weeks and 12 months post-procedure.


One year after surgery, 49% of the patients had a recurrence of symptoms after RBL compared with 30% of patients undergoing HAL.

About one third of RBL patients whose symptoms persisted underwent a further surgical procedure, many having further RBL and discounting these RBLs led to a minimal difference between treatments.

Most patients initially felt better after surgery, but then relapsed within the year. Symptom scores, quality of life, continence and complications were the same after both procedures.

Those undergoing HAL tended to have more pain but the discomfort was not severe in the majority and resolved by 1-3 weeks after the operation. HAL is much more expensive.

HAL reduced recurrence compared with RBL, but these RBL recurrences can often be treated successfully by simple re-banding.

The RBL procedure (repeated if necessary), therefore, has similar recurrence rates to HAL. HAL is also more painful in the short-term, waiting time is longer, and is more expensive.


The HubBLe Trial ran from September 2012 and May 2014 and compared two procedures for symptomatic second- and third-degree haemorrhoids: Rubber Band Ligation (RBL) and Haemorrhoidal Artery Ligation (HAL)[1–3]. HubBLe showed that HAL reduced haemorrhoidal recurrence compared with RBL, but these RBL recurrences can be successfully treated by re-banding. So, a course of RBL has similar recurrence rates to HAL, which is more painful and also has longer waiting times and is more expensive.

As of May 2022, the Lancet paper[1] had 100 citations, among the top 2% most cited articles on Scopus. As well as influencing NHS commissioners[4,5], this paper informed clinical practice guidelines from:

  • The American Society of Colon and Rectal Surgeons[6]
  • The European Society of ColoProctology[7]
  • The Italian Society of Colorectal Surgery[8]
  • The Belgian Working Group on Proctology[9]
Documents by year


Brown SR, Tiernan JP, Watson AJM, Biggs K, Shephard N, Wailoo AJ, et al. Haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids ( HubBLe ): a multicentre , open-label , randomised controlled trial. Lancet. 2016;6736: 1–9. View.

Brown S, Tiernan J, Biggs K, Hind D, Shephard N, Bradburn M, et al. 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. Health Technol Assess. 2016;20: 1–150. View.

Alshreef A, Wailoo AJ, Brown SR, Tiernan JP, Watson AJM, Biggs K, et al. Cost-Effectiveness of Haemorrhoidal Artery Ligation versus Rubber Band Ligation for the Treatment of Grade II–III Haemorrhoids: Analysis Using Evidence from the HubBLe Trial. PharmacoEconomics - Open. 2017;1: 175–184. View.

Wirral CCG. Wirral Commissioning Policy. Criteria 2019/2020. In: Wirral Clinical Commissioning Group [Internet]. 1 Apr 2019 [cited 4 May 2022]. View

East Riding Of Yorkshire, Hull And Northern Lincolnshire CCGs. Humber CCG’s Evidence-Based Interventions Policy Document: Interventions Subject to Prior Approval or an Individual Funding Request. In: North Lincolnshire Clinical Commissioning Group [Internet]. Jan 2020 [cited 4 May 2022]. View.

Davis BR, Lee-Kong SA, Migaly J, Feingold DL, Steele SR. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Diseases of the Colon & Rectum. 2018;61: 284–292. View.

van Tol RR, Kleijnen J, Watson AJM, Jongen J, Altomare DF, Qvist N, et al. European Society of ColoProctology: guideline for haemorrhoidal disease. Colorectal Dis. 2020;22: 650–662. View.

Gallo G, Martellucci J, Sturiale A, Clerico G, Milito G, Marino F, et al. Consensus statement of the Italian society of colorectal surgery (SICCR): management and treatment of hemorrhoidal disease. Tech Coloproctol. 2020;24: 145–164.  View.

De Schepper H, Coremans G, Denis MA, Dewint P, Duinslaeger M, Gijsen I, et al. Belgian consensus guideline on the management of hemorrhoidal disease. Acta Gastroenterol Belg. 2021;84: 101–120.  View.

Project staff

Name Site Phone Email

Steven Brown, Chief Investigator

Northern General Hospital, Sheffield +44 (0)114 271 5030
Jim Tiernan, Research Fellow St James’ University Hospital, Leeds
Danny Hind, Assistant Director, CTRU ScHARR +44 (0)114 222 0707
Angus Watson, Consultant Surgeon Raigmore Hospital, Inverness
Allan Wailoo, Health Economist ScHARR +44 (0)114 222 0729
Mike Bradburn, Statistician  ScHARR +44 (0)114 222 0706
Neil Shephard, Statistician ScHARR    
Katie Biggs, Trial Manager ScHARR +44 (0)114 222 6128
Lizzie Swaby, Research Assistant  ScHARR +44 (0)114 222 4023
Heather Dakin, Trial Support Officer ScHARR +44 (0)114 222 6385
Amanda Loban, Data Manager ScHARR +44 (0)114 222 2995
Kirsty Pemberton, Data Management Officer ScHARR +44 (0)114 222 0861

Participating sites

Centre name / NHS Trust

Principal Investigator (PI)

Research Nurse(s)


Aintree University Hospital NHS Foundation Trust

Paul Skaife

Daniela Shackcloth

Shirley Cooper


Ashford and St Peter's Hospitals NHS Foundation Trust

Jonathan Trickett

Vicky Frost

Cate Gray


North Devon Healthcare NHS Foundation Trust

Mark Cartmell

Colin Barrett

Jane Hunt

Geraldine Belcher

Amanda Skinner


University Hospitals Birmingham NHS Foundation Trust

Simon Radley

Mandip Narewal

Amanda Davies (on maternity leave)


Brighton and Sussex University Hospitals NHS Trust

Marc Lamah

Richard Rye

Mary Flowerdew


Cambridge University Hospitals NHS Foundation Trust

Justin Davies

Ailsa Liddle

Joanne Brown

Helen Thompson


Imperial NHS Trust

Paul Ziprin

Melloney Allnut

Gillian Hornzee


NHS Highland

Angus Watson

Kathleen MacLeod


NHS Lanarkshire

Angus McDonald

Dina Bell

Linda MacLiver

North Tees

North Tees and Hartlepool NHS Foundation Trust

Anil Agarwal

Debbie Wilson

Angela Lee

North West London


Omar Faiz

Pooja Datt

Sherill Tripoli


Oxford University Hospitals NHS Trust

Oliver Jones

Fiona Morrison

Simona Fourie


Peterborough and Stamford Hospitals NHS Foundation Trust

Rohit Makhija Deborah Butcher


Poole Hospital NHS Foundation Trust

Andrew Clarke

Carrie Colvin


Royal Berkshire NHS Foundation Trust

Philip Conaghan

Rachel Carson

Linda Jones


Sheffield Teaching Hospitals NHS Foundation Trust

Steve Brown

Michael Agyemang

Michelle Deighton

John Humphreys

Sharon Kerrison

Julie Sorrell


University Hospital Southampton NHS Foundation Trust

Karen Nugent

Lisa Aitken

Julie Mitchell

Denise Whittaker

Mcdonald Mupudzi

Whipps Cross

Barts Health NHS Trust

Pasquale Giordano

Salvatore Lamberti

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (project number 10/57/46). The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR or the Department of Health.

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