Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

University of Dundee

Status: Completed

Conditions: Hemorrhoids

Treatments: Procedure: Closed diathermy haemorrhoidectomy; Procedure: Circular stapled anopexy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00397137

202/99

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Stapled Anopexy

Experimental group

Description:

Circular stapled anopexy

Treatment:

Procedure: Circular stapled anopexy

Conventional Haemorrhoidectomy

Active Comparator group

Description:

Closed diathermy haemorrhoidectomy

Treatment:

Procedure: Closed diathermy haemorrhoidectomy