NCT01051180

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

January 15, 2010

Last Update Submit

April 3, 2017

Conditions

PilesBleeding

Keywords

HEMORRHOIDSTREATMENTPILESBLEEDINGHALO

Outcome Measures

Primary Outcomes (1)

  • Improvement of rectal bleeding

    3-6 months

Secondary Outcomes (1)

  • Satisfaction with the HALO procedure with or without doppler guidance

    3-6 months

Study Arms (2)

Doppler

Those patients where the doppler was randomised to be on

Procedure: HALO

Non doppler patients

those with no doppler guidance

Procedure: HALO

Interventions

HALOPROCEDURE

Ligation of haemorrhoidal arteries

DopplerNon doppler patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Other grades of piles, age outside 18-90 or other anal condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poole Hospital

Poole, Dorset, BH14 8QA, United Kingdom

Location

MeSH Terms

Conditions

HemorrhoidsHemorrhage

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Surgeon

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

GB(1)