Hemorrhoids
Conditions
Keywords
Symptomatic haemorrhoids, haemorrhoidectomy, stapled anopexy
Brief summary
The aim of this study is to determine the role of stapled anopexy in the treatment of haemorrhoids by comparing it to the current gold standard treatment, which is excisional haemorrhoidectomy.
Detailed description
The current gold standard treatment of haemorrhoids namely, excisional haemorrhoidectomy is associated with severe postoperative pain and prolonged recovery period. Methods aiming at improving the outcome of excisional surgery included mainly modifications of the existing technique. Alternative instruments other than scissors have been used for the actual excision of haemorrhoids with a view to reducing the postoperative pain. However, with the wound in the sensitive anoderm following excisional haemorrhoidectomy, pain continues to be a major problem irrespective of the method of excision or of the instrument employed. The new technique of stapled anopexy introduced in 1998 uses a radically different approach to treat haemorrhoids. The prolapsed anal cushion is repositioned and fixed without actually excising the haemorrhoidal pedicle thereby avoiding an external wound. This should result in reduction of the postoperative pain and subsequently should improve the recovery time. Further potential advantages of the technique should include a more physiological approach to the treatment of the disease.
Interventions
PROCEDURECircular stapled anopexy
Patients receiving stapled anopexy to treat haemorrhoids
PROCEDUREClosed diathermy haemorrhoidectomy
Conventional haemorrhoidectomy as described by Ferguson method
Sponsors
Ethicon Endo-Surgery
Chief Scientist Office of the Scottish Government
University of Dundee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult human subjects (age \>=16 years) with symptomatic haemorrhoids (Primary or recurrent) * symptomatic haemorrhoids (grades 2, 3, 4) needing surgical treatment
Exclusion criteria
* concurrent untreated or recurrent colorectal cancer * Active inflammatory bowel disease * Previous major anorectal surgery * On anticoagulant medications * Non-consenting patients * Unwilling for randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pain | — |
| global haemorrhoidal symptom control | — |
| complication rates | — |
Secondary
| Measure | Time frame |
|---|---|
| Day case surgeries | — |
| Quality of life changes | — |
| Time to recovery | — |
| Cost effectiveness | — |
| Patient satisfaction | — |
| Time to return to work | — |
| Re-treatment rates | — |
Countries
United Kingdom
Outcome results
None listed