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Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

This study has been completed.
Sponsor:
Collaborators:
Ethicon Endo-Surgery
Chief Scientist Office of the Scottish Government
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT00397137
First received: November 7, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 7, 2006
Last Updated: November 7, 2006
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 23, 2014