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Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

Primary Purpose

Hemorrhoids

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Circular stapled anopexy
Closed diathermy haemorrhoidectomy
Sponsored by
University of Dundee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring Symptomatic haemorrhoids, haemorrhoidectomy, stapled anopexy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ninewells Hospital & Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stapled Anopexy

Conventional Haemorrhoidectomy

Arm Description

Circular stapled anopexy

Closed diathermy haemorrhoidectomy

Outcomes

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

Full Information

First Posted
November 7, 2006
Last Updated
March 29, 2019
Sponsor
University of Dundee
Collaborators
Ethicon Endo-Surgery, Chief Scientist Office of the Scottish Government
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1. Study Identification

Unique Protocol Identification Number
NCT00397137
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
December 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Dundee
Collaborators
Ethicon Endo-Surgery, Chief Scientist Office of the Scottish Government

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
Keywords
Symptomatic haemorrhoids, haemorrhoidectomy, stapled anopexy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stapled Anopexy
Arm Type
Experimental
Arm Description
Circular stapled anopexy
Arm Title
Conventional Haemorrhoidectomy
Arm Type
Active Comparator
Arm Description
Closed diathermy haemorrhoidectomy
Intervention Type
Procedure
Intervention Name(s)
Circular stapled anopexy
Intervention Description
Patients receiving stapled anopexy to treat haemorrhoids
Intervention Type
Procedure
Intervention Name(s)
Closed diathermy haemorrhoidectomy
Intervention Description
Conventional haemorrhoidectomy as described by Ferguson method
Primary Outcome Measure Information:
Title
Postoperative pain
Title
global haemorrhoidal symptom control
Title
complication rates
Secondary Outcome Measure Information:
Title
Time to recovery
Title
Time to return to work
Title
Re-treatment rates
Title
Day case surgeries
Title
Quality of life changes
Title
Patient satisfaction
Title
Cost effectiveness

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert JC Steele, MD
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed A Thaha, MRCS
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ninewells Hospital & Medical School
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15584064
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.
Results Reference
result
PubMed Identifier
19091821
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.
Results Reference
result

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Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

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