Clinical Trial: Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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


Sponsor: University of Dundee

Current Primary Outcome:

  • Postoperative pain
  • global haemorrhoidal symptom control
  • complication rates


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to recovery
  • Time to return to work
  • Re-treatment rates
  • Day case surgeries
  • Quality of life changes
  • Patient satisfaction
  • Cost effectiveness


Original Secondary Outcome: Same as current

Information By: University of Dundee

Dates:
Date Received: November 7, 2006
Date Started: September 2000
Date Completion: December 2003
Last Updated: November 7, 2006
Last Verified: November 2006