HemorrhoidsNCT00397137
Stapled Anopexy Versus Closed Haemorrhoidectomy for Haemorrhoids
A study testing Circular stapled anopexy and Closed diathermy haemorrhoidectomy in people with Hemorrhoids, run by University of Dundee at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Circular stapled anopexy and Closed diathermy haemorrhoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2000to Dec 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult human subjects (age >=16 years) with symptomatic haemorrhoids (Primary or recurrent)
- symptomatic haemorrhoids (grades 2, 3, 4) needing surgical treatment
Who cannot join
- concurrent untreated or recurrent colorectal cancer
- Active inflammatory bowel disease
- Previous major anorectal surgery
- On anticoagulant medications
- Non-consenting patients
- Unwilling for randomisation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ninewells Hospital & Medical School
Dundee, Scotland, DD1 9SY
About this study
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
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.
Read the 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.
- Conditions
- Hemorrhoids
- Being tested
- Circular stapled anopexy, Closed diathermy haemorrhoidectomy
- Keywords
- Symptomatic haemorrhoids, haemorrhoidectomy, stapled anopexy
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circular stapled anopexyProcedure or surgery
Patients receiving stapled anopexy to treat haemorrhoids
Closed diathermy haemorrhoidectomyProcedure or surgery
Conventional haemorrhoidectomy as described by Ferguson method
| Study group | Role | What they receive |
|---|---|---|
| Stapled Anopexy | Experimental | Circular stapled anopexy Receives: Procedure: Circular stapled anopexy |
| Conventional Haemorrhoidectomy | Active comparator | Closed diathermy haemorrhoidectomy Receives: Procedure: Closed diathermy haemorrhoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
global haemorrhoidal symptom control
complication rates
Secondary outcomes (7)
Time to recovery
Time to return to work
Re-treatment rates
Day case surgeries
Quality of life changes
Patient satisfaction
Cost effectiveness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2006 (estimated)
- Study startSep 2000
- Primary completionOct 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery, Chief Scientist Office of the Scottish Government
- Responsible party
- Sponsor
- Investigators
- Robert JC Steele, MD, Principal investigator, University of DundeeMohamed A Thaha, MRCS, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397137
- Sponsor's protocol ID
- 202/99
- Status last verified
- Mar 2019
- First submitted
- 7 Nov 2006
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15584064Thaha 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.
PubMed 19091821
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00397137
- Acronym / sponsor ID
- 202/99
- Conditions
- Hemorrhoids
- Keywords
- Symptomatic haemorrhoids, haemorrhoidectomy, stapled anopexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery, Chief Scientist Office of the Scottish Government
- Study start
- Sep 2000
- Primary completion
- Oct 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 8 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stapled Anopexy | Experimental | Procedure: Circular stapled anopexyCircular stapled anopexy |
| Conventional Haemorrhoidectomy | Active comparator | Procedure: Closed diathermy haemorrhoidectomyClosed diathermy haemorrhoidectomy |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult human subjects (age >=16 years) with symptomatic haemorrhoids (Primary or recurrent)
- symptomatic haemorrhoids (grades 2, 3, 4) needing surgical treatment
Key exclusion criteria (6 listed)
- concurrent untreated or recurrent colorectal cancer
- Active inflammatory bowel disease
- Previous major anorectal surgery
- On anticoagulant medications
- Non-consenting patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circular stapled anopexyPatients receiving stapled anopexy to treat haemorrhoids | Procedure or surgery | Stapled Anopexy |
| Closed diathermy haemorrhoidectomyConventional haemorrhoidectomy as described by Ferguson method | Procedure or surgery | Conventional Haemorrhoidectomy |
Primary outcome
Postoperative pain
global haemorrhoidal symptom control
complication rates
7 secondary outcomes
Time to recovery
Time to return to work
Re-treatment rates
Day case surgeries
Quality of life changes
Patient satisfaction
Cost effectiveness
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Results publication: PubMed 15584064Thaha 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 publication: PubMed 19091821Thaha 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert JC Steele, MD principal investigator
University of Dundee
Mohamed A Thaha, MRCS principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circular stapled anopexy and Closed diathermy haemorrhoidectomy in people with Hemorrhoids, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00397137, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.