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Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00397137
First Posted: November 8, 2006
Last Update Posted: November 8, 2006
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.
Collaborators:
Ethicon Endo-Surgery
Chief Scientist Office of the Scottish Government
Information provided by:
University of Dundee
  Purpose
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 Intervention
Hemorrhoids Procedure: Circular stapled anopexy Procedure: Closed diathermy haemorrhoidectomy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • Postoperative pain
  • global haemorrhoidal symptom control
  • complication rates

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

Estimated Enrollment: 182
Study Start Date: September 2000
Estimated Study Completion Date: December 2003
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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00397137


Locations
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
Investigators
Principal Investigator: Robert JC Steele, MD University of Dundee
Principal Investigator: Mohamed A Thaha, MRCS University of Dundee
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00397137     History of Changes
Other Study ID Numbers: 202/99
First Submitted: November 7, 2006
First Posted: November 8, 2006
Last Update Posted: November 8, 2006
Last Verified: November 2006

Keywords provided by University of Dundee:
Symptomatic haemorrhoids
haemorrhoidectomy
stapled anopexy

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases