Ambulatory Varicosity avUlsion Later or Synchronised (AVULS)
| ISRCTN | ISRCTN76821539 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76821539 |
| Secondary identifying numbers | P34317 |
- Submission date
- 26/04/2011
- Registration date
- 20/05/2011
- Last edited
- 30/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Alun Davies
Scientific
Scientific
Academic Section of Vascular Surgery
4E, Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
Study information
| Study design | Randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Ambulatory Varicosity avUlsion Later or Synchronised (AVULS): a randomised trial |
| Study acronym | AVULS |
| Study hypothesis | Radiofrequency ablation with concomitant phlebectomy will result in an improvement in quality of life 6 months, reduce the need for further procedures and will be more cost effective than sequential phlebectomy or foam sclerotherapy |
| Ethics approval(s) | 1. Brighton and Sussex Research Ethics Committee approved on 21/03/2011, REC Reference Number 11/H1107/3 2. Joint Research Office, Imperial College London and Imperial College Healthcare NHS Trust approved on 30/03/2011, Reference Number JROHH0210 |
| Condition | Varicose Veins |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | Disease specific quality of life at 6 months using the Aberdeen Varicose Vein Questionnaire (AVVQ) |
| Secondary outcome measures | 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) |
| Overall study start date | 01/04/2011 |
| Overall study end date | 31/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 240 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/04/2011 |
| Recruitment end date | 31/03/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Charing Cross Hospital
London
W6 8RF
United Kingdom
W6 8RF
United Kingdom
Sponsor information
Imperial College London (UK)
University/education
University/education
AHSC Joint Research Office
Imperial College London and
Imperial College Healthcare NHS Trust
G02 Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
England
United Kingdom
| Website | http://www.imperial.ac.uk/clinicalresearchgovernanceoffice |
|---|---|
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Charity
Graeme-Dixon Charitable Trust (UK) (ref: P34317)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2015 | Yes | No |
