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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN76821539 |
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Date of registration:
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20/05/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ambulatory Varicosity avUlsion Later or Synchronised (AVULS)
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Scientific title:
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Ambulatory Varicosity avUlsion Later or Synchronised (AVULS): a randomised trial |
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Date of first enrolment:
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01/04/2011 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN76821539 |
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Study type:
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Interventional |
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Study design:
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Randomised trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Alun
Davies |
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Address:
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Academic Section of Vascular Surgery
4E, Charing Cross Hospital
Fulham Palace Road
W6 8RF
London
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Consecutive patients who present to the department of vascular surgery at Charing Cross Hospital, who are willing to participate in the study
2. They must have clinical venous disease affecting either the long saphenous or short saphenous veins
3. They must be over the age of 18 and able to give consent for the study
Exclusion criteria: 1. Patients under the age of 18 years
2. Those that are unable to consent
3. Patients with deep venous disease
4. Those unfit for intervention
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Varicose Veins
Circulatory System
Varicose veins of lower extremities
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Intervention(s)
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1. Simultaneous or delayed avulsion of superficial varicosities in the context of endovenous radiofrequency ablation of refluxing truncal veins
2. Avulsions will be delayed by 6 weeks post initial procedure if in delayed group
3. Followed up after 1 year
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Primary Outcome(s)
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Disease specific quality of life at 6 months using the Aberdeen Varicose Vein Questionnaire (AVVQ)
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Secondary Outcome(s)
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1. The need for further procedures over the 6 month period
2. Generic quality of life assessed using the EQ-5D
3. Cost effectiveness of the treatment strategies
4. Anatomical success assessed with colour duplex at 6 months
5. Level of depression assessed using Center for Epidemiologic Studies Depression Scale (CES-D)
6. Return to work and normal activities
7. Clinical disease severity assessed using the Venous Clinical Severity Score (VCSS)
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Source(s) of Monetary Support
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Graeme-Dixon Charitable Trust (UK) (ref: P34317)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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