Is Doppler Necessary in Haemorrhoidal Artery Ligation Operation?
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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? |
- Improvement of rectal bleeding [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
- Satisfaction with the HALO procedure with or without doppler guidance [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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| Contact: Guy F Nash, MD | 44 1202 448798 | guy.nash@poole.nhs.uk |
| United Kingdom | |
| Poole Hospital | Recruiting |
| Poole, Dorset, United Kingdom, BH14 8QA | |
| Contact: Nash 44 1202 448798 | |
| Principal Investigator: Guy Nash, MD | |
More Information
No publications provided
| Responsible Party: | Haemorrhoidal Artery Ligation Operation; is doppler necessary?, NHS |
| ClinicalTrials.gov Identifier: | NCT01051180 History of Changes |
| Other Study ID Numbers: | 09/H0501/61 |
| Study First Received: | January 15, 2010 |
| Last Updated: | January 15, 2010 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by Poole Hospital NHS Foundation Trust:
|
HEMORRHOIDS TREATMENT PILES BLEEDING HALO |
Additional relevant MeSH terms:
|
Hemorrhage Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013