Email updates

Keep up to date with the latest news and content from BMC Gastroenterology and BioMed Central.

Open Access Study protocol

The HubBLe trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for haemorrhoids

Jim Tiernan1, Daniel Hind2, Angus Watson3, Allan J Wailoo4, Michael Bradburn2, Neil Shephard2, Katie Biggs2* and Steven Brown5

Author affiliations

1 CRUK Clinical Research Fellow, St James’ University Hospital, Leeds, LS9 7TF, UK

2 Sheffield Clinical Trials Research Unit, School of Health and Related Research, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK

3 Department of Surgery, Raigmore Hospital, Inverness, IV2 3UJ, UK

4 Health Economics and Decision Sciences, School of Health and Related Research, Sheffield, UK

5 Northern General Hospital, Sheffield, S5 7AU, UK

For all author emails, please log on.

Citation and License

BMC Gastroenterology 2012, 12:153  doi:10.1186/1471-230X-12-153

Published: 25 October 2012

Abstract

Background

Haemorrhoids (piles) are a very common condition seen in surgical clinics. After exclusion of more sinister causes of haemorrhoidal symptoms (rectal bleeding, perianal irritation and prolapse), the best option for treatment depends upon persistence and severity of the symptoms. Minor symptoms often respond to conservative treatment such as dietary fibre and reassurance. For more severe symptoms treatment such as rubber band ligation may be therapeutic and is a very commonly performed procedure in the surgical outpatient setting. Surgery is usually reserved for those who have more severe symptoms, as well as those who do not respond to non-operative therapy; surgical techniques include haemorrhoidectomy and haemorrhoidopexy. More recently, haemorrhoidal artery ligation has been introduced as a minimally invasive, non destructive surgical option.

There are substantial data in the literature concerning efficacy and safety of 'rubber band ligation including multiple comparisons with other interventions, though there are no studies comparing it to haemorrhoidal artery ligation. A recent overview has been carried out by the National Institute for Health and Clinical Excellence which concludes that current evidence shows haemorrhoidal artery ligation to be a safe alternative to haemorrhoidectomy and haemorrhoidopexy though it also highlights the lack of good quality data as evidence for the advantages of the technique.

Methods/design

The aim of this study is 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 second or third degree (Grade II or Grade III) haemorrhoids.

Design: A multi-centre, parallel group randomised controlled trial.

Outcomes: The primary outcome is patient-reported symptom recurrence twelve months following the intervention. Secondary outcome measures relate to symptoms, complications, health resource use, health related quality of life and cost effectiveness following the intervention.

Participants: 350 patients with grade II or grade III haemorrhoids will be recruited in surgical departments in up to 14 NHS hospitals.

Randomisation: A multi-centre, parallel group randomised controlled trial. Block randomisation by centre will be used, with 175 participants randomised to each group.

Discussion

The results of the research will help inform future practice for the treatment of grade II and III haemorrhoids.

Trial Registration

ISRCTN41394716

Keywords:
Haemorrhoids; Rubber band ligation; Haemorrhoidal artery ligation; Surgical randomised controlled trial