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Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00397137
Recruitment Status : Completed
First Posted : November 8, 2006
Last Update Posted : April 2, 2019
Ethicon Endo-Surgery
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
University of Dundee

Brief 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.

Condition or disease Intervention/treatment Phase
Hemorrhoids Procedure: Circular stapled anopexy Procedure: Closed diathermy haemorrhoidectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Multi-centre Trial Comparing the Clinical Efficacy, Safety and Patient Acceptability of Circular Stapled Anopexy With Closed Diathermy Haemorrhoidectomy for Haemorrhoids
Study Start Date : September 2000
Actual Primary Completion Date : October 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
Experimental: Stapled Anopexy
Circular stapled anopexy
Procedure: Circular stapled anopexy
Patients receiving stapled anopexy to treat haemorrhoids

Active Comparator: Conventional Haemorrhoidectomy
Closed diathermy haemorrhoidectomy
Procedure: Closed diathermy haemorrhoidectomy
Conventional haemorrhoidectomy as described by Ferguson method

Primary Outcome Measures :
  1. Postoperative pain
  2. global haemorrhoidal symptom control
  3. complication rates

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00397137

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United Kingdom
Ninewells Hospital & Medical School
Dundee, Scotland, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
Ethicon Endo-Surgery
Chief Scientist Office of the Scottish Government
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Principal Investigator: Robert JC Steele, MD University of Dundee
Principal Investigator: Mohamed A Thaha, MRCS University of Dundee

Publications of Results:
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Responsible Party: University of Dundee Identifier: NCT00397137    
Other Study ID Numbers: 202/99
First Posted: November 8, 2006    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Keywords provided by University of Dundee:
Symptomatic haemorrhoids
stapled anopexy
Additional relevant MeSH terms:
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Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases