Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomized Multi-centre Trial Comparing the Clinical Efficacy, Safety and Patient Acceptability of Circular Stapled Anopexy With Closed Diathermy Haemorrhoidectomy for Haemorrhoids

Conditions
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Hemorrhoids

Intervention / Treatment
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* Procedure: Circular stapled anopexy
* Procedure: Closed diathermy haemorrhoidectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stapled Anopexy<br>Circular stapled anopexy | Procedure: Circular stapled anopexy<br>* Patients receiving stapled anopexy to treat haemorrhoids<br>|
| Active Comparator: Conventional Haemorrhoidectomy<br>Closed diathermy haemorrhoidectomy | Procedure: Closed diathermy haemorrhoidectomy<br>* Conventional haemorrhoidectomy as described by Ferguson method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain |  |  | 
| global haemorrhoidal symptom control |  |  | 
| complication rates |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery |  |  | 
| Time to return to work |  |  | 
| Re-treatment rates |  |  | 
| Day case surgeries |  |  | 
| Quality of life changes |  |  | 
| Patient satisfaction |  |  | 
| Cost effectiveness |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptomatic haemorrhoids, haemorrhoidectomy, stapled anopexy