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Is Doppler Necessary in Haemorrhoidal Artery Ligation Operation?

This study has been terminated.
(Doppler device company wanted hospital to stop recruiting)
Sponsor:
Information provided by (Responsible Party):
Guy Nash, Poole Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01051180
First received: January 15, 2010
Last updated: April 3, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Piles Bleeding Procedure: HALO

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Haemorrhoidal Artery Ligation Operation; is Doppler Necessary?

Further study details as provided by Guy Nash, Poole Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Improvement of rectal bleeding [ Time Frame: 3-6 months ]

Secondary Outcome Measures:
  • Satisfaction with the HALO procedure with or without doppler guidance [ Time Frame: 3-6 months ]

Enrollment: 150
Actual Study Start Date: January 2010
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Doppler
Those patients where the doppler was randomised to be on
Procedure: HALO
Ligation of haemorrhoidal arteries
Non doppler patients
those with no doppler guidance
Procedure: HALO
Ligation of haemorrhoidal arteries

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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051180

Locations
United Kingdom
Poole Hospital
Poole, Dorset, United Kingdom, BH14 8QA
Sponsors and Collaborators
Poole Hospital NHS Foundation Trust
  More Information

Responsible Party: Guy Nash, Consultant Surgeon, Poole Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01051180     History of Changes
Other Study ID Numbers: 09/H0501/61
Study First Received: January 15, 2010
Last Updated: April 3, 2017

Keywords provided by Guy Nash, Poole Hospital NHS Foundation Trust:
HEMORRHOIDS
TREATMENT
PILES
BLEEDING
HALO

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on September 19, 2017