Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids - Full Text View

Sponsors and Collaborators:	University of Dundee Ethicon Endo-Surgery Chief Scientist Office Scotland
Information provided by:	University of Dundee
ClinicalTrials.gov Identifier:	NCT00397137

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

MedlinePlus related topics: Hemorrhoids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397137

Locations

United Kingdom, Scotland
Ninewells Hospital & Medical School
Dundee, Scotland, United Kingdom, DD1 9SY

Sponsors and Collaborators

University of Dundee

Ethicon Endo-Surgery

Chief Scientist Office Scotland

Investigators

Principal Investigator:	Robert JC Steele, MD	University of Dundee
Principal Investigator:	Mohamed A Thaha, MRCS	University of Dundee

More Information

Publications of Results:

Thaha MA, Irvine LA, Steele RJ, Campbell KL. Postdefaecation pain syndrome after circular stapled anopexy is abolished by oral nifedipine. Br J Surg. 2005 Feb;92(2):208-10.

Study ID Numbers:	202/99
Study First Received:	November 7, 2006
Last Updated:	November 7, 2006
ClinicalTrials.gov Identifier:	NCT00397137
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by University of Dundee:

Symptomatic haemorrhoids
haemorrhoidectomy
stapled anopexy

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Vascular Diseases

Hemorrhoids
Intestinal Diseases
Rectal Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009