Is Doppler Necessary in Haemorrhoidal Artery Ligation Operation?

NCT ID: NCT01051180

Last Updated: 2017-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Piles Bleeding

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Doppler

Those patients where the doppler was randomised to be on

HALO

Intervention Type PROCEDURE

Ligation of haemorrhoidal arteries

Non doppler patients

those with no doppler guidance

HALO

Intervention Type PROCEDURE

Ligation of haemorrhoidal arteries

Interventions

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HALO

Ligation of haemorrhoidal arteries

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poole Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Guy Nash

Consultant Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Poole Hospital

Poole, Dorset, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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09/H0501/61

Identifier Type: -

Identifier Source: org_study_id

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