Title: A multi-centre randomised controlled trial comparing rubber band ligation with haemorrhoidal artery ligation in the management of symptomatic second and third degree haemorrhoids: The HubBLe Trial: Halo versus rubber Band Ligation for haemorrhoids
Funder: Department of Health (England)

Abstract: Haemorrhoids 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 (particularly prolapse) 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 treatments which excise the haemorrhoidal cushions (haemorrhoidectomy) or those which preserve the cushions but reduce the vascular engorgement and replace the cushions to a more anatomical position (stapled haemorrhoidopexy). Although rubber band ligation (RBL) has the advantage of being non-operative easy to perform and minimally invasive there is a risk of complications chiefly pain. Importantly the recurrence rate after RBL is high particularly for more severe levels of prolapse even after repeat RBL. More recently haemorrhoidal artery ligation (HAL) has been introduced as a minimally invasive non destructive surgical option. Although it requires anaesthetic for its performance recovery is rapid the complication rate is low and the recurrence rate may be significantly lower than that of rubber band ligation. Such an operation may be a very good option for those with haemorrhoids who wish to consider a more definitive therapy or those who have not responded to initial rubber band ligation.We aim to test whether rubber band ligation or haemorrhoidal artery ligation is a more clinically effective and cost effective method of treatment for those with symptomatic second or third degree haemorrhoids by comparing the two techniques with a randomised controlled trial in a multi-centre setting. ***************************************************************************The target population will be patients referred to collaborating centres for treatment of haemorrhoids.Inclusion criteria:•Adults aged 18 years or over with symptomatic second or third degree haemorrhoids.•Either presenting for the first time or after failure of RBL Exclusion criteria:•Patients with known perianal sepsis inflammatory bowel disease colorectal malignancy pre-existing sphincter injury •Patients with an immunodeficiency•Patients that are unable to have general or spinal anaesthetic •Patients currently taking Warfarin or Clopidogrel •Patients currently taking Nicorandil •Pregnant women•Patients that are unable to give full informed consent (this may be due to mental capacity or language barriers)•Patients previously randomised to this trial*******************************************************************************Primary Outcome measure:Recurrence’ defined as the proportion of patients with recurrent haemorrhoids at 12 months as derived from a telephone assessment in combination with GP and hospital records. Patients who have undergone further treatment during the follow up period will be considered to have recurrent haemorrhoids.The trial is a pragmatic design with a dichotomous outcome:‘At the moment do you feel your symptoms from your haemorrhoids are:1. Cured or improved compared with before starting treatment; or 2. Unchanged or worse compared with before starting treatment?’Any patient who answers ‘1’ but has required further treatment since the initial procedure will be reclassified as ‘2’ identified via hospital records their consultant their GP and patient questioning.Secondary Outcome measures:1.Symptom score (before randomisation 6 weeks 1 year);2.EQ-5D (before randomisation 1 7 21 days 6 weeks 1 year);3.Continence questionnaire (before randomisation 6 weeks 1 year);4.Pain score (VAS before randomisation 1 7 21 days 6 weeks);5.Health and social care resource use questionnaire (6 weeks 1 year);6.Complications review (6 weeks 1 year);7.Need for further treatment including details (6 weeks 1 year);8.Clinical examination findings if recurrence (6 weeks)Abstract (200 – 300 words)


Research activity codes: 6.4 SURGERY;7.3 MANAGEMENT AND DECISION MAKING
Health categories: CARDIOVASCULAR