|
Health Condition(s) or Problem
|
Haemorrhoidal disease
|
|
Lay Summary
|
The eTHoS study will investigate stapled haemorrhoidopexy compared with traditional excisional haemorrhoidectomy in patients with grade II, grade III or IV circumferential haemorrhoids. (from UKCRN Portfolio)
|
|
Who can enter the trial
|
Current inclusion criteria as of 02/01/2011:
1. Patient with circumferential haemorrhoids grade II, III and IV.
2. Patients aged 18 years or older.
3. Written informed consent obtained.
Previous inclusion criteria:
1. Patients with haemorrhoids grade II who have failed traditional therapy (rubber band ligation [RBL]), haemorrhoids grade III and IV
2. Patients aged 18 years or older, either sex
3. Written informed consent obtained
|
|
Who cannot enter the trial
|
Current exclusion criteria os of 01/02/2011:
1. Previous surgery for haemorrhoids (traditional or stapled) (except rubber band ligation (RBL) or Haemorrhoidal Artery Ligation Operation (HALO)).
2. Pre-existing spincter injury.
3. Peri-anal sepsis.
4. Inflammatory bowel disease.
5. Malignant colorectal disease.
6. Medically unfit for surgery or completion of the trial.
7. Pregnant women.
Previous exclusion criteria:
1. Previous surgery for haemorrhoids (except RBL for grade II)
|
|
What will happen
|
Participants will be randomised to either stapled haemorrhoidopexy (SH) or traditional haemorrhoidectomy (TH). The SH procedure involves excising a ring or "donut" of tissue above the haemorrhoidal cushions with immediate re-anastomosis of the mucosa using staples. TH involves excision of the haemorrhoidal cushions.
Patients will be followed-up in clinic approximately six weeks after their surgery. Postal questionnaires will be completed by participants at 1, 3 and 6 weeks after surgery and 1 and 2 years after randomisation. It is also the intention to follow-up participants in the longer-term through a 5-year postal questionnaire.
|
|
Primary aim
|
The trial has both a patient-centred and an economic primary outcome:
1. Patient-centred: quality of life profile (area under the curve derived from EQ-5D measurements at baseline, 1 week, 3 weeks, 6 weeks, 12 months and 24 months)
2. Economic: incremental cost per quality adjusted life year (QALY) gained with QALYs based on the responses to the EQ-5D at 24 months
|
|
Secondary Aim
|
Secondary outcomes include patient-reported, clinical and economic measures:
Patient-reported (collected at 1, 3, 6 weeks, 1 year, 2 years and 5 years):
1. Generic health profile measured by 36-item short form health survey (SF-36) and EQ-5D
2. Visual analogue scale (VAS) pain score
3. Cleveland incontinence score
4. Haemorrhoid symptom score
5. Post-operative analgesia consumption
6. Recurrence of haemorrhoids
Clinical (collected at the time of surgery and at 6-week clinical follow-up):
7. Peri- and post-operative complications including:
7.1. Haemorrhages
7.2. Requirement for blood transfusion
7.3. Anal stenosis, anal fissure
7.4. Urinary retention
7.5. Residual anal skin tags
7.6. Difficult defecation
7.7. Wound discharge
7.8. Pelvic sepsis
7.9. Pruritis
Economic:
Costs will be based on resource use data.
8. Costs to the NHS and patients at two years:
8.1. Time to recovery
8.2. Length of hospital stay
8.3. Use of health services for haemorrhoids related events or treatments
8.4. Patient costs (treatments], travel to health services, sick leave)
8.5. Need for alternative management for haemorrhoids (e.g., surgery, drugs)
8.6. Other use of health services:
8.6.1. Visits to GP
8.6.2. Visits to practice nurse
8.6.3. Visits to colorectal surgeon
9. Estimated lifetime cost to NHS and patient
10. QALYS estimated from the EQ-5D at 24 months
11. QALYS estimated over the patient's lifetime
12. Cost-effectiveness analysis (incremental cost per case of stapled haemorrhoidopexy and traditional haemorrhoidectomy excision avoided)
|
|
Participant Information Sheet
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Website
|
Sorry, not currently available
|
|
Recruitment Status
|
Recruiting
|
|
Nation
|
Scotland
|
|
Location
|
Inverness
|