Clinical Trials Directory

Trials / Completed

CompletedNCT00397137

Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
182 (actual)
Sponsor
University of Dundee · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECircular stapled anopexyPatients receiving stapled anopexy to treat haemorrhoids
PROCEDUREClosed diathermy haemorrhoidectomyConventional haemorrhoidectomy as described by Ferguson method

Timeline

Start date
2000-09-01
Primary completion
2003-10-01
Completion
2003-12-01
First posted
2006-11-08
Last updated
2019-04-02

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT00397137. Inclusion in this directory is not an endorsement.