HubBLe controlled trial
The HubBLe Trial: Haemorrhoidal Artery Ligation (HAL) versus Rubber Band Ligation (RBL) for symptomatic second and third degree haemorrhoids.
Challenges
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).
Research
This was a multi-centre, parallel group randomised controlled trial involving 18 centres throughout England and Scotland.
These participants fell into two basic groups:
- Patients presenting to the surgical outpatient clinic (SOPC) with symptomatic haemorrhoids where alternative diagnoses had been excluded;
- 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.
Results
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.
Impact
These results may be helpful to patients considering their options for the treatment of haemorrhoids. It provides a more robust figure for the recurrence of haemorrhoids after the two treatments which may help people decide what to choose.
The results may also help clinicians in the choice of treatments for patients. In addition to the recurrence and information on symptoms, it is clear that HAL is not cost-effective and this may influence decisions made by clinicians and save the NHS money.
NICE said the evidence from HubBLE will be reviewed and incorporated when associated guidance for haemorrhoidal artery ligation is being reviewed.
Publications
Brown SR, Tiernan JP, Watson AJM, Biggs K, Shephard N, Wailoo AJ, Bradburn M, Alshreef A & Hind D (2016) 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. The Lancet.
Comment:
- Bach, S.P. and Fearnhead, N.S., 2016. Does HubBLe spell trouble for HAL?. The Lancet, 388(10042), pp.311-312. DOI: http://dx.doi.org/10.1016/S0140-6736(16)30657-2
Correspondence Articles and Response:
- Giordano, P., 2016. The HubBle trial: a word of caution. The Lancet, 388(10063), pp.2995-2996. http://dx.doi.org/10.1016/S0140-6736(16)32531-4
- Fujita, T., 2016. The HubBle trial: a word of caution. The Lancet, 388(10063), pp.2994-2995. http://dx.doi.org/10.1016/S0140-6736(16)32523-5
- Brown, S.R. and Bradburn, M., 2016. The HubBle trial: a word of caution–Authors' reply. The Lancet, 388(10063), p.2996. http://dx.doi.org/10.1016/S0140-6736(16)32530-2
Brown S, Tiernan J, Biggs K, Hind D, Shephard N, Bradburn M, Wailoo A, Alshreef A, Swaby L, Watson A, Radley S, Jones O, Skaife P, Agarwal A, Giordano P, Lamah M, Cartmell M, Davies J, Faiz O, Nugent K, Clarke A, Macdonald A, Conaghan P, Ziprin P & Makhija R (2016) The HubBle trial: Haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for symptomatic second- and third-degree haemorrhoids: A multicentre randomized controlled trial and health-economic evaluation. Health Technology Assessment, 20(88), 1-180.
Brown, S.R., 2016. Hubble trial: time to stick to basics for treatment of haemorrhoids?. Techniques in Coloproctology, pp.1-3.
Alshreef, A., Wailoo, A.J., Brown, S.R., Tiernan, J.P., Watson, A.J., Biggs, K., Bradburn, M. and Hind, D., 2017. 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, pp.1-10.
https://link.springer.com/article/10.1007%2Fs41669-017-0023-6
Tiernan J, Hind D, Watson A, Wailoo AJ, Bradburn M, Shephard N, Biggs K and Brown S Study Protocol. The HubBLe Trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for heamorrhoids. BMC Gastroenterology. 2012, 12:153. DOI: 10.1186/1471-230X-12-153
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.