Clinical trial NCT00397137: Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Keywords: Symptomatic haemorrhoids
haemorrhoidectomy
stapled anopexy
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
name: Chief Scientist Office of the Scottish Government
First posted: 2006-11-08
Enrollment: 182
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Postoperative pain
measure: global haemorrhoidal symptom control
measure: complication rates
Secondary outcomes:
measure: Time to recovery
measure: Time to return to work
measure: Re-treatment rates
measure: Day case surgeries
measure: Quality of life changes
measure: Patient satisfaction
measure: Cost effectiveness
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Ninewells Hospital & Medical School
state: Scotland
Study officials:
affiliation: University of Dundee
name: Robert JC Steele, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dundee
name: Mohamed A Thaha, MRCS
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1002/bjs.4773.
citation: 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 closed diathermy haemorrhoidectomy. Gut. 2009 May;58(5):668-78. doi: 10.1136/gut.2008.151266. Epub 2008 Dec 17.