Second and third degree haemorrhoids Circulatory System Haemorrhoids
Conditions
Interventions
The intervention is either Rubber Band Ligation (RBL) or Haemorrhoidal Artery Ligation (HAL). Both interventions are established and well documented procedures.
Conventional RBL uses
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Question to be asked: '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
| Measure | Time frame |
|---|---|
| 1. Symptom score (before randomisation, 6 weeks, 1 year) 2. Quality of Life, EQ-5D (before randomisation, 1, 7, 21 days, 6 weeks, 1 year) 3. Continence questionnaire (before randomisation, 6 weeks, 1 year) 4. Pain score [Visual Analogue Scale (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) | — |
Countries
United Kingdom
Outcome results
None listed