title: The HubBLe trial: haemorrhoidal artery ligation (HAL) versus rubber band ligation (RBL) for haemorrhoids.
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
  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.
  
  
  METHODS
  A multi-centre, parallel group randomised controlled trial.
  
  
  RESULTS
  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.
  
  
  METHODS
  350 patients with grade II or grade III haemorrhoids will be recruited in surgical departments in up to 14 NHS hospitals.
  
  
  METHODS
  A multi-centre, parallel group randomised controlled trial. Block randomisation by centre will be used, with 175 participants randomised to each group.
  
  
  CONCLUSIONS
  The results of the research will help inform future practice for the treatment of grade II and III haemorrhoids.
  
  
  BACKGROUND
  ISRCTN41394716.
authors.affiliation: CRUK Clinical Research Fellow, St James' University Hospital, Leeds, UK.
authors.forename: Jim
authors.initials: J
authors.lastname: Tiernan
authors.forename: Daniel
authors.initials: D
authors.lastname: Hind
authors.forename: Angus
authors.initials: A
authors.lastname: Watson
authors.forename: Allan J
authors.initials: AJ
authors.lastname: Wailoo
authors.forename: Michael
authors.initials: M
authors.lastname: Bradburn
authors.forename: Neil
authors.initials: N
authors.lastname: Shephard
authors.forename: Katie
authors.initials: K
authors.lastname: Biggs
authors.forename: Steven
authors.initials: S
authors.lastname: Brown
mesh_terms: D002985:Clinical Protocols; D005260:Female; D006484:Hemorrhoids / Q000191:economics / Q000601:surgery*; D006801:Humans; D008026:Ligation / Q000191:economics / Q000379:methods; D008297:Male; D012008:Recurrence; D012408:Rubber / Q000191:economics / Q000627:therapeutic use; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D012408:Rubber