HubBLe controlled trial

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:

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.

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

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]

Publications

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

Participating sites

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.