Is Doppler Necessary in Haemorrhoidal Artery Ligation Operation?

Terminated

• Conditions: Bleeding; Piles
• Interventions: Procedure: HALO

• Registration Number: NCT01051180
• Lead Sponsor: Poole Hospital NHS Foundation Trust

Brief 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.

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Doppler	HALO	Those patients where the doppler was randomised to be on
Non doppler patients	HALO	those with no doppler guidance

Primary Outcome Measures

Name	Time	Method
Improvement of rectal bleeding	3-6 months

Secondary Outcome Measures

Name	Time	Method
Satisfaction with the HALO procedure with or without doppler guidance	3-6 months

Trial Locations

Locations (1)

Poole Hospital; 🇬🇧 Poole, Dorset, United Kingdom