Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

Hemorrhoids Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397137
• Other study ID #: 202/99
• Status: Completed
• Phase: N/A
• Start date: September 2000
• Est. completion date: December 2003

Study information

• Verified date: March 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Procedure:
• Circular stapled anopexy
Patients receiving stapled anopexy to treat haemorrhoids
• Closed diathermy haemorrhoidectomy
Conventional haemorrhoidectomy as described by Ferguson method

Locations

Country	Name	City	State
United Kingdom	Ninewells Hospital & Medical School	Dundee	Scotland

Sponsors (3)

Lead Sponsor	Collaborator
University of Dundee	Chief Scientist Office of the Scottish Government, Ethicon Endo-Surgery

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

MA Thaha, KL Campbell, LA Irvine, A Khalil, NR Binnie, WS Hendry, A Walker, HJ Staines, RJC Steele. Authors' response. Gut 2010;59:138 doi:10.1136/gut.2009. 196458

Thaha MA, Campbell KL, Kazmi SA, Irvine LA, Khalil A, Binnie NR, Hendry WS, Walker A, Staines HJ, Steele RJ. Prospective randomised multi-centre trial comparing the clinical efficacy, safety and patient acceptability of circular stapled anopexy with close — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain
Primary	global haemorrhoidal symptom control
Primary	complication rates
Secondary	Time to recovery
Secondary	Time to return to work
Secondary	Re-treatment rates
Secondary	Day case surgeries
Secondary	Quality of life changes
Secondary	Patient satisfaction
Secondary	Cost effectiveness