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The HubBLe trial

A multi-centre randomised controlled trial comparing rubber band ligation with haemorrhoidal artery ligation in the management of symptomatic second and third degree haemorrhoids.

Specialty
Surgery (co-adopted by Cancer, Gastroenterology)
Portfolio Eligibility
Automatically eligible
ISRCTN 41394716
EudraCT
MREC N° 12/YH/0236
UKCRN ID 12486
WHO ID
Research Summary
In most cases of haemorrhoids (piles), the first step of specialist treatment is rubber band ligation (RBL). This procedure involves placing a small band around the haemorrhoid which cuts off the blood supply, resulting in the pile being shed. RBL is a relatively painless outpatient treatment with minimal complications. However, the chance of recurrence is high, with up to 4 in 10 patients requiring further treatment either in the form of repeat banding or a bigger operation. Common operations for haemorrhoids involve cutting the pile out (haemorrhoidectomy) or ‘hitching up’ the bowel lining with a special stapling device (stapled haemorrhoidopexy). Both have lower recurrence rates than RBL but they require an anaesthetic and are associated with pain and a recovery period of at least several days. Haemorrhoidal artery ligation (HAL) is a newer procedure that uses a Doppler scanner to locate the arteries feeding the haemorrhoids which are then tied with a stitch. It requires an anaesthetic but appears to cause minimal pain and is associated with rapid recovery, usually within 12 days. It also has a similar recurrence rate to the other surgical procedures. Some think it may therefore be a better option than rubber band ligation because it has a much lower recurrence rate with similar discomfort and recovery. This trial will compare RBL with HAL in patients with new haemorrhoids and those who have had a recurrence following previous RBL. Participants will be randomly allocated to one of the two treatments and we will measure recurrence rates, how painful the procedure is, how each procedure affects patients’ quality of life, how long it keeps patients away from normal activities and the cost of each procedure, including retreatment, to the NHS.
Study Type Interventional
Design Type Treatment
Disease(s) Colon
All Surgery
All Gastroenterology
Phase N/A
Current Status Closed - in follow-up
Closure Date 5/6/2014
Global Sample Size 350
Global Recruitment to Date
105%
Geographical Scope UK Multi-Centre
Lead Country England (also active in Scotland)
Health care professionals can obtain a copy of the protocol by clicking here
Study Website
Main Inclusion Criteria
1. Adults aged 18 years or over with symptomatic second or third degree haemorrhoids.
Main Exclusion Criteria
1. Patients that have had previous surgery for haemorrhoids. 2. Patients that have had more than one rubber band ligation in the last three years. 3. Patients that have had more than one injection treatment for haemorrhoids in the last three years. 4. Patients with known perianal sepsis, inflammatory bowel disease, colorectal malignancy or pre-existing sphincter injury. 5. Patients with an immunodeficiency. 6. Patients that are unable to have general or spinal anaesthetic. 7. Patients currently taking Warfarin or Clopidogrel. 8. Patients currently taking Nicorandil. 9. Pregnant women. 10. Patients that are unable to give full informed consent (this may be due to mental capacity or language barriers). 11. Patients previously randomised to this trial.
Chief Investigator(s)
Mr Steven Brown
Further details, please contact
Miss Katie Biggs

University of Sheffield
SCHARR, Regent court, Regent Street

Tel: 0114 222 6128
Fax: 0114 222 0870
c.e.biggs@sheffield.ac.uk
Funder(s) NIHR Health Technology Assessment
Sponsor(s) Sheffield Teaching Hospitals NHS Trust




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