- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01051180
Is Doppler Necessary in Haemorrhoidal Artery Ligation Operation?
April 3, 2017 updated by: Guy Nash, Poole Hospital NHS Foundation Trust
Haemorrhoidal Artery Ligation Operation; is Doppler Necessary?
Haemorrhoidal artery ligation operation (HALO) is an operation that ties off vessels to piles.
This study examines whether the ultrasound (doppler) is necessary to guide this tying off or not.
Study Overview
Detailed Description
HALO (haemorrhoidal artery ligation operation) has proved to be a popular and effective treatment for bleeding piles.
Currently the HALO is a Doppler guided procedure though when the Doppler mechanism does not function it has been noted that the results are similar.
This prompts the question does the Doppler guide the operation to tie off the important vessels to shrink he piles, or can the vessels that underlie the visible piles be treated without Doppler.
Professor Phillips from St.Marks has reviewed the protocol and agrees that it is well designed and worthwhile.
Study Type
Observational
Enrollment (Actual)
150
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
-
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Dorset
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Poole, Dorset, United Kingdom, BH14 8QA
- Poole Hospital
-
-
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
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
For consenting adults (18-90 years) with grade one and two piles listed for HALO at Poole hospital by three consultants trained in the HALO technique, the patients will be offered to be involved in the study.
Description
Inclusion Criteria:
- For consenting adults (18-90 years) with grade one and two piles listed for HALO at Poole hospital by three consultants trained in the HALO technique, the patients will be offered to be involved in the study.
Exclusion Criteria:
- Other grades of piles, age outside 18-90 or other anal condition
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Doppler
Those patients where the doppler was randomised to be on
|
Ligation of haemorrhoidal arteries
|
Non doppler patients
those with no doppler guidance
|
Ligation of haemorrhoidal arteries
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement of rectal bleeding
Time Frame: 3-6 months
|
3-6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Satisfaction with the HALO procedure with or without doppler guidance
Time Frame: 3-6 months
|
3-6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
January 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
January 15, 2010
First Submitted That Met QC Criteria
January 15, 2010
First Posted (Estimate)
January 18, 2010
Study Record Updates
Last Update Posted (Actual)
April 5, 2017
Last Update Submitted That Met QC Criteria
April 3, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09/H0501/61
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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