The HubBLe Trial
Haemorrhoidal Artery Ligation (HAL) versus Rubber Band Ligation (RBL) for symptomatic second and third-degree haemorrhoids.
Results and impact
The Haemorrhoidal Artery Ligation (HAL) versus Rubber Band Ligation (RBL) for symptomatic second and third-degree haemorrhoids (HubBLe) trial ran from September 2012 and May 2014 [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 Dec 2022, the Lancet paper [1] had 118 citations, among the top 2% of 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]
Publications
[1] 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.
[2] 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.
[3] 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.
[4] Wirral CCG. Wirral Commissioning Policy. Criteria 2019/2020. In: Wirral Clinical Commissioning Group [Internet]. 1 Apr 2019 [cited 4 May 2022].
[5] 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].
[6] 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.
[7] van Tol RR, Kleijnen J, Watson AJM, Jongen J, Altomare DF, Qvist N, et al. European Society of ColoProctology: a guideline for haemorrhoidal disease. Colorectal Dis. 2020;22: 650–662.
[8] 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.
[9] 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.
Project staff
| Name | Site | Phone | |
|---|---|---|---|
|
Steven Brown, Chief Investigator |
Northern General Hospital, Sheffield | +44 (0)114 271 5030 | Steven.brown@sth.nhs.uk |
| Jim Tiernan, Research Fellow | St James’ University Hospital, Leeds | jimtiernan1@gmail.com | |
| Danny Hind, Assistant Director, CTRU | ScHARR | +44 (0)114 222 0707 | d.hind@sheffield.ac.uk |
| Angus Watson, Consultant Surgeon | Raigmore Hospital, Inverness | angus.watson@nhs.net | |
| Allan Wailoo, Health Economist | ScHARR | +44 (0)114 222 0729 | a.j.wailoo@sheffield.ac.uk |
| Mike Bradburn, Statistician | ScHARR | +44 (0)114 222 0706 | m.bradburn@sheffield.ac.uk |
| Neil Shephard, Statistician | ScHARR | ||
| Katie Biggs, Trial Manager | ScHARR | +44 (0)114 222 6128 | c.e.biggs@sheffield.ac.uk |
| Lizzie Swaby, Research Assistant | ScHARR | +44 (0)114 222 4023 | e.a.swaby@sheffield.ac.uk |
| Heather Dakin, Trial Support Officer | ScHARR | +44 (0)114 222 6385 | h.dakin@sheffield.ac.uk |
| Amanda Loban, Data Manager | ScHARR | +44 (0)114 222 2995 | a.loban@sheffield.ac.uk |
| Kirsty Pemberton, Data Management Officer | ScHARR | +44 (0)114 222 0861 | k.j.pemberton@sheffield.ac.uk |
Participating sites
|
Centre name / NHS Trust |
Principal Investigator (PI) |
Research Nurse(s) |
|---|---|---|
|
Aintree Aintree University Hospital NHS Foundation Trust |
Paul Skaife |
Daniela Shackcloth Shirley Cooper |
|
Ashford Ashford and St Peter's Hospitals NHS Foundation Trust |
Jonathan Trickett |
Vicky Frost Cate Gray |
|
Barnstaple North Devon Healthcare NHS Foundation Trust |
Mark Cartmell |
Colin Barrett Jane Hunt Geraldine Belcher Amanda Skinner |
|
Birmingham University Hospitals Birmingham NHS Foundation Trust |
Simon Radley |
Mandip Narewal Amanda Davies (on maternity leave) |
|
Brighton Brighton and Sussex University Hospitals NHS Trust |
Marc Lamah |
Richard Rye Mary Flowerdew |
|
Cambridge Cambridge University Hospitals NHS Foundation Trust |
Justin Davies |
Ailsa Liddle Joanne Brown Helen Thompson |
|
Imperial Imperial NHS Trust |
Paul Ziprin |
Melloney Allnut Gillian Hornzee |
|
Inverness NHS Highland |
Angus Watson |
Kathleen MacLeod |
|
Lanarkshire 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 NWLH NHS Trust |
Omar Faiz |
Pooja Datt Sherill Tripoli |
|
Oxford Oxford University Hospitals NHS Trust |
Oliver Jones |
Fiona Morrison Simona Fourie |
|
Peterborough Peterborough and Stamford Hospitals NHS Foundation Trust |
Rohit Makhija | Deborah Butcher |
|
Poole Poole Hospital NHS Foundation Trust |
Andrew Clarke |
Carrie Colvin |
|
Reading Royal Berkshire NHS Foundation Trust |
Philip Conaghan |
Rachel Carson Linda Jones |
|
Sheffield Sheffield Teaching Hospitals NHS Foundation Trust |
Steve Brown |
Michael Agyemang Michelle Deighton John Humphreys Sharon Kerrison Julie Sorrell |
|
Southampton 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.