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OpenTrials
Completed

NCT Number: NCT00397137

Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ninewells Hospital & Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Circular stapled anopexy

Procedure

Patients receiving stapled anopexy to treat haemorrhoids

Closed diathermy haemorrhoidectomy

Procedure

Conventional haemorrhoidectomy as described by Ferguson method

Primary outcomes

  1. Postoperative pain

  2. global haemorrhoidal symptom control

  3. complication rates

Secondary outcomes

  1. Time to recovery

  2. Time to return to work

  3. Re-treatment rates

  4. Day case surgeries

  5. Quality of life changes

  6. Patient satisfaction

  7. Cost effectiveness

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • Chief Scientist Office of the Scottish Government
  • Ethicon Endo-Surgery

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2003
Study completion
2003
First posted
Nov 8, 2006
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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