Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids

March 29, 2019 updated by: University of Dundee

Prospective Randomized Multi-centre Trial Comparing the Clinical Efficacy, Safety and Patient Acceptability of Circular Stapled Anopexy With Closed Diathermy Haemorrhoidectomy for Haemorrhoids

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stapled Anopexy
Circular stapled anopexy
Procedure: Circular stapled anopexy
Patients receiving stapled anopexy to treat haemorrhoids
Active Comparator: Conventional Haemorrhoidectomy
Closed diathermy haemorrhoidectomy
Procedure: Closed diathermy haemorrhoidectomy
Conventional haemorrhoidectomy as described by Ferguson method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Postoperative pain
global haemorrhoidal symptom control
complication rates

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Collaborators

Ethicon Endo-Surgery
Chief Scientist Office of the Scottish Government

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

November 7, 2006

First Submitted That Met QC Criteria

November 7, 2006

First Posted (Estimate)

November 8, 2006

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

March 29, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202/99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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