PilesNCT01051180
Is Doppler Necessary in Haemorrhoidal Artery Ligation Operation?
An observational study of Piles and Bleeding, run by Poole Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- HALO
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Mar 2013
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Other grades of piles, age outside 18-90 or other anal condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- HALO
- Keywords
- HEMORRHOIDS, TREATMENT, PILES, BLEEDING, HALO
- Medical subject headings
- Hemorrhoids, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HALOProcedure or surgery
Ligation of haemorrhoidal arteries
| Study group | Role | What they receive |
|---|---|---|
| Doppler | Those patients where the doppler was randomised to be on Receives: Procedure: HALO | |
| Non doppler patients | those with no doppler guidance Receives: Procedure: HALO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of rectal bleeding
Measured: 3-6 months
Secondary outcomes (1)
Satisfaction with the HALO procedure with or without doppler guidance
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionMar 2013
Why it stopped: Doppler device company wanted hospital to stop recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PilesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poole Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Nash, Poole Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051180
- Sponsor's protocol ID
- 09/H0501/61
- Status last verified
- Apr 2017
- First submitted
- 15 Jan 2010
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemorrhoidal Artery Ligation Operation; is Doppler Necessary?
- ClinicalTrials.gov ID
- NCT01051180
- Acronym / sponsor ID
- 09/H0501/61
- Keywords
- HEMORRHOIDS, TREATMENT, PILES, BLEEDING, HALO
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Doppler device company wanted hospital to stop recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Poole Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 Jan 2010 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doppler | – | Procedure: HALOThose patients where the doppler was randomised to be on |
| Non doppler patients | – | Procedure: HALOthose with no doppler guidance |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Other grades of piles, age outside 18-90 or other anal condition
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 |
|---|---|---|
| HALOLigation of haemorrhoidal arteries | Procedure or surgery | Doppler, Non doppler patients |
Primary outcome
Improvement of rectal bleeding
Time frame: 3-6 months
1 secondary outcome
Satisfaction with the HALO procedure with or without doppler guidance
Time frame: 3-6 months
Results and safety
The study was stopped early (reason given: Doppler device company wanted hospital to stop recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
Related trials for Piles
Not yet recruiting
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
Internal Haemorrhoids
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Hemorrhoid, Hemorrhoid Bleeding
Recruiting
Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
Hemorrhoids
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Piles and Bleeding, run by Poole Hospital NHS Foundation Trust 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 5 Apr 2017. 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 was stopped early (reason given: Doppler device company wanted hospital to stop recruiting). Results are not available in the source record.
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?
Improvement of rectal bleeding (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2017.