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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

January 15, 2010
April 3, 2017
January 2010
December 2012   (Final data collection date for primary outcome measure)
Improvement of rectal bleeding [ Time Frame: 3-6 months ]
Same as current
Complete list of historical versions of study NCT01051180 on ClinicalTrials.gov Archive Site
Satisfaction with the HALO procedure with or without doppler guidance [ Time Frame: 3-6 months ]
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.
 
Terminated
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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01051180
09/H0501/61
No
Not Provided
Not Provided
Not Provided
Guy Nash, Poole Hospital NHS Foundation Trust
Poole Hospital NHS Foundation Trust
Not Provided
Not Provided
Poole Hospital NHS Foundation Trust
April 2017

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