The HubBLe Trial: Haemorrhoidal Artery Ligation (HAL) versus Rubber Band Ligation (RBL) for haemorrhoids
- Conditions
- Second and third degree haemorrhoidsHaemorrhoidsCirculatory System
- Registration Number
- ISRCTN41394716
- Lead Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust (UK)
- Brief Summary
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23098097 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27236344 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27921992 2019 lessons learnt in: https://www.ncbi.nlm.nih.gov/pubmed/31675992 (added 06/11/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 350
Current inclusion criteria as of 30/04/2013:
1. Adults aged 18 years or over with symptomatic second or third degree haemorrhoids.
Previous inclusion criteria until 30/04/2013:
1. Adults aged 18 years or over with symptomatic second or third degree haemorrhoids
2. Either presenting for the first time or after failure of RBL
Current exclusion criteria as of 30/04/2013:
1. Patients that have had previous surgery for haemorrhoids (at any time)
2. Patients that have had more than one injection treatment for haemorrhoids in the past 3 years
3. Patients that have had more than one RBL procedure in the past 3 years
4. Patients with known perianal sepsis, inflammatory bowel disease, colorectal malignancy, 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 Clopidogrel or have any other hypocoagulability condition
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
Previous exclusion criteria until 30/04/2013:
1. Patients with known perianal sepsis, inflammatory bowel disease, colorectal malignancy, pre-existing sphincter injury
2. Patients with an immunodeficiency
3. Patients that are unable to have general or spinal anaesthetic
4. Patients currently taking warfarin, or clopidogrel
5. Patients currently taking Nicorandil
6. Pregnant women
7. Patients that are unable to give full informed consent (this may be due to mental capacity or language barriers)
8. Patients previously randomised to this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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.<br> Question to be asked:<br> 'At the moment, do you feel your symptoms from your haemorrhoids are:<br> 1. Cured or improved compared with before starting treatment; or,<br> 2. Unchanged or worse compared with before starting treatment?'<br><br> 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.<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Symptom score (before randomisation, 6 weeks, 1 year)<br> 2. Quality of Life, EQ-5D (before randomisation, 1, 7, 21 days, 6 weeks, 1 year)<br> 3. Continence questionnaire (before randomisation, 6 weeks, 1 year)<br> 4. Pain score [Visual Analogue Scale (VAS)], before randomisation, 1, 7, 21 days, 6 weeks)<br> 5. Health and social care resource use questionnaire (6 weeks, 1 year)<br> 6. Complications review (6 weeks, 1 year)<br> 7. Need for further treatment including details (6 weeks, 1 year)<br> 8. Clinical examination findings if recurrence (6 weeks)<br>