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NCT01051180 Clinical Trial

Is Doppler Necessary in Haemorrhoidal Artery Ligation Operation?

Bleeding Clinical Trial

Official title:
Haemorrhoidal Artery Ligation Operation; is Doppler Necessary?

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01051180
Other study ID # 09/H0501/61
Secondary ID
Status Terminated
Phase N/A
First received January 15, 2010
Last updated April 3, 2017
Start date January 2010
Est. completion date March 2013

Study information
Verified date April 2017
Source Poole Hospital NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 150
Est. completion date March 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• HALO
Ligation of haemorrhoidal arteries

Locations
Country Name City State
United Kingdom Poole Hospital Poole Dorset

Sponsors (1)
Lead Sponsor Collaborator
Poole Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement of rectal bleeding 3-6 months
Secondary Satisfaction with the HALO procedure with or without doppler guidance 3-6 months
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