Health Condition(s) or Problem
Second and third degree haemorrhoids
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. (from UKCRN Portfolio)
Additional lay summaries...
Background and study aims
Haemorrhoids (piles) are common, with up to 1 in 3 people in the UK affected by them. Sometimes haemorrhoids can be controlled through diet but worse symptoms may need other treatments, such as rubber band ligation or surgery. This study aims to test two different treatments: Rubber Band Ligation (RBL) and Haemorrhoidal Artery Ligation (HAL), to see which should be used for treatment of grade II and III haemorrhoids in the future.
Who can participate?
Patients aged 18 years and over that have grade II or III haemorrhoids can be recruited to this research; patients must be presenting with haemorrhoids for the first time, or after failure of rubber band ligation treatment. They will be identified either by the general practitioner (GP) referral letter or by colorectal surgeons at the first clinic appointment and followed-up by the research nurse.
Some people cannot take part in the study:
Patients with known perianal sepsis, inflammatory bowel disease, colorectal malignancy, pre-existing sphincter injury
Patients with an immunodeficiency (e.g. HIV)
Patients that are unable to have general or spinal anaesthetic
Patients currently taking Warfarin, or Clopidogrel
Patients currently taking Nicorandil
What does the study involve?
Patients will be randomised to one of the two treatments; half of the patients will have the RBL procedure and half will have the HAL operation. Both of the treatments being compared are already used in the NHS for treatment of haemorrhoids, and at the moment surgeons do not know which treatment is best in the long run for the treatment of grade II and III haemorrhoids.
The study will look at the cost effectiveness of the two treatments including further treatment required for their symptoms, the patient?s quality of life and some other measures relating to haemorrhoidal symptoms such as pain and continence. Patients will be required to complete a questionnaire 1 day, 7 days, 21 days, 6 weeks and 12 months following the trial procedure. The main outcome will be whether the patient has cured or improved symptoms or unchanged or worse symptoms 12 months after the trial procedure.
What are the possible benefits and risks of participating?
Patients taking part in this study will contribute to evidence that will help surgeons know which treatment to choose in the future.
RBL is a commonly performed procedure in surgical outpatients; it does not require an anaesthetic and patients can go home the same day. This procedure has a risk of complications, usually pain, and the likelihood of getting haemorrhoids again can be quite high.
HAL is a minor surgical procedure and although anaesthetic is required, recovery can be quick and the risk of complications seems to be low; it also appears that the likelihood of getting haemorrhoids again may be lower than for RBL.
Both treatments can have side effects related to loss of blood, further symptoms related to haemorrhoids and pain. In very rare cases patients could get pelvic sepsis, or abscesses (collection of pus). There are also side effects related to the anaesthetic used for the HAL operation.
Where is the study run from?
The aim is to recruit 350 patients to the trial from up to 14 NHS trusts in England and Scotland. The lead centre will be the Sheffield Teaching Hospitals NHS Foundation Trust, who is the Sponsor for the research and also where the Chief Investigator is based. The research is being managed by the Clinical Trials Research Unit in the University of Sheffield.
When is study starting and how long is it expected to run for?
Recruitment is planned to start at eight centres in October 2012, with the other centres starting recruitment by February 2013. The recruitment period will be one year, ending in September 2013. After the recruitment year, there will be another year for follow-up, and this will be completed in September 2014.
Who is funding the study?
NIHR - Hea (from ISRCTN)
Who can enter the trial
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
Who cannot enter the trial
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
What will happen
The intervention is either Rubber Band Ligation (RBL) or Haemorrhoidal Artery Ligation (HAL). Both interventions are established and well documented procedures.
Conventional RBL uses a simple suction device that is applied to each haemorrhoid via a disposable proctoscope. A rubber band is then fired onto the base of the haemorrhoid which constricts the blood supply causing it to become ischaemic before being sloughed approximately 1-2 weeks later. The resultant fibrosis reduces any element of haemorrhoidal prolapse that may have been present.
HAL uses a proctoscope modified to incorporate a Doppler transducer. This enables accurate detection of the haemorrhoidal arteries feeding the haemorrhoidal cushions. Accurate ligation of the vessels with a suture reduces haemorrhoidal engorgement. When combined with a ?pexy? suture, both bleeding and haemorrhoidal prolapse is addressed.
?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.
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)
Participant Information Sheet
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