Is Doppler Necessary in Haemorrhoidal Artery Ligation Operation?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Poole Hospital NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Poole Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01051180
First received: January 15, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 15, 2010
January 15, 2010
January 2010
December 2012   (final data collection date for primary outcome measure)
Improvement of rectal bleeding [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Satisfaction with the HALO procedure with or without doppler guidance [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Is Doppler Necessary in Haemorrhoidal Artery Ligation Operation?
Haemorrhoidal Artery Ligation Operation; is Doppler Necessary?

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

  • Piles
  • Bleeding
Procedure: HALO
Ligation of haemorrhoidal arteries
  • Doppler
    Those patients where the doppler was randomised to be on
    Intervention: Procedure: HALO
  • Non doppler patients
    those with no doppler guidance
    Intervention: Procedure: HALO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Guy F Nash, MD 44 1202 448798 guy.nash@poole.nhs.uk
United Kingdom
 
NCT01051180
09/H0501/61
No
Haemorrhoidal Artery Ligation Operation; is doppler necessary?, NHS
Poole Hospital NHS Foundation Trust
Not Provided
Not Provided
Poole Hospital NHS Foundation Trust
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP