A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy to conventional excisional surgery for haemorrhoidal disease.

DESIGN The design of the study will be a pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with conventional excisional haemorrhoidectomy. SETTING Fifteen colorectal surgical units from across the UK. The sites who thus far have areed to participate are: Manchester Royal Infirmary, Aberdeen Royal Infirmary, Northern General Hospital, Sheffield, Leeds Teaching Hospitals, Stepping Hill Hospital, Glan Clwyd Hospital, Ninewells Hospital, Dundee, Glasgow Royal Infirmary, Glasgow Southern General Hospital, Whiteabbey / Antrim Area Hospital, Ulster Bradford Hospitals, NHS Trust, Bristol NHS Trust and Taunton and Somerset NHS Trust. TARGET POPULATION Adults aged over 18 years old for whom surgery for haemorrhoidal disease is recommended. Patients with 2nd degree haemorrhoids who have failed conventional therapy (2 episodes of rubber band ligation), 3rd and 4th degree haemorrhoids will be included. Patients who have had previous surgery for haemorrhoids (except those who have only had 2 prior episodes of rubber band ligation for grade II haemorrhoids); pre-existing sphincter injury, peri-anal sepsis, inflammatory bowel disease or malignant colorectal disease will be excluded. HEALTH TECHNOLOGIES BEING ASSESSED The interventions being compared are stapled haemorrhoidopexy (SH) with conventional excisional haemorrhoidectomy (CH). MEASUREMENTS OF COSTS AND OUTCOMES We will assess outcomes up to two years, with possibility of longer-term follow-up to 5 years through a separate funding application. Primary outcome measures: Health-related quality of life profile (area under the curve) derived from EQ-5D measurements at baseline, 1-week, 3-weeks, 6-weeks, 1-year and 2-years. Primary trial economic outcome: Incremental cost per QALY at 2-years. Primary economic model outcome: Incremental cost per QALY over the lifetime of the patient. Secondary outcome measures: Post operative complications (including: post operative haemorrhage; requirement for blood transfusion; anal stenosis; anal fissure; urinary retention; residual anal skin tags; difficult defecation; wound discharge; pelvic sepsis; and pruritis); Patient-reported post-operative analgesia consumption; Length of hospital stay; Time to recovery; Generic Health profile measured by the SF-36; Visual analogue scale (VAS) pain score; Cleveland incontinence score; Haemorrhoid symptom score; Patient reported recurrence; Costs to the patient and NHS at 2 years; Estimated lifetime cost to the NHS and patient; QALYs estimated from the EQ-5D at 2 years; QALYs estimated over the patient's lifetime.