Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

Not Applicable

Completed

• Conditions: Hemorrhoids
• Interventions: Procedure: Circular stapled anopexy; Procedure: Closed diathermy haemorrhoidectomy

• Registration Number: NCT00397137
• Lead Sponsor: University of Dundee

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.

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2003-10
• Study Completion: 2003-12
• Study First Submitted: 2006-11-07
• Study First Submitted QC: 2006-11-07
• Study First Posted: 2006-11-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stapled Anopexy	Circular stapled anopexy	Circular stapled anopexy
Conventional Haemorrhoidectomy	Closed diathermy haemorrhoidectomy	Closed diathermy haemorrhoidectomy

Primary Outcome Measures

Name	Time	Method
global haemorrhoidal symptom control
complication rates
Postoperative pain

Secondary Outcome Measures

Name	Time	Method
Time to recovery
Patient satisfaction
Time to return to work
Re-treatment rates
Quality of life changes
Cost effectiveness
Day case surgeries

Trial Locations

Locations (1)

Ninewells Hospital & Medical School; 🇬🇧 Dundee, Scotland, United Kingdom