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

BMC Gastroenterology

Study Protocol

Jim Tiernan¹  Angus Watson²  Allan J Wailoo³  Steven Brown⁴  Daniel Hind⁵  Neil Shephard⁵  Katie Biggs⁵  Michael Bradburn⁵ 

[1] CRUK Clinical Research Fellow, St James’ University Hospital, LS9 7TF, Leeds, UK;Department of Surgery, Raigmore Hospital, IV2 3UJ, Inverness, UK;Health Economics and Decision Sciences, School of Health and Related Research, Sheffield, UK;Northern General Hospital, S5 7AU, Sheffield, UK;Sheffield Clinical Trials Research Unit, School of Health and Related Research, Regent Court, 30 Regent Street, S1 4DA, Sheffield, UK;

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

DOI  :  10.1186/1471-230X-12-153

 received in 2012-08-14, accepted in 2012-10-17,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundHaemorrhoids (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/designThe 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.DiscussionThe results of the research will help inform future practice for the treatment of grade II and III haemorrhoids.Trial RegistrationISRCTN41394716

【 授权许可】

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© Tiernan et al.; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.