VNUS® ClosureFAST™ Ablation versus Laser for Varicose Veins
| ISRCTN | ISRCTN66818013 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66818013 |
| Secondary identifying numbers | CRO1037 |
- Submission date
- 27/11/2008
- Registration date
- 03/12/2008
- Last edited
- 16/03/2011
- 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 of protocol
Not provided at time of registration
Contact information
Prof Alun Davies
Scientific
Scientific
4 East Department of Vascular Surgery
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
Study information
| Study design | Prospective randomised single-blind clinical trial, single centre |
|---|---|
| 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 | VNUS® ClosureFAST™ Ablation versus Laser for Varicose Veins (VALVV): a randomised clinical trial |
| Study acronym | VALVV |
| Study objectives | Radiofrequency ablation using VNUS® ClosureFAST™ will result in significantly less post-operative pain and a greater improvement in quality of life in comparison to laser ablation. As of 11/08/2009 this record has been updated to indicate that this trial has now closed to recruitment. The end of recruitment date was 30/06/2009. Follow-up will continue until 31/01/2010. |
| Ethics approval(s) | Charing Cross Research Ethics Committee gave approval on 6th May 2008 (ref: 08/H0711/19) |
| Health condition(s) or problem(s) studied | Varicose veins |
| Intervention | 1. Endovenous radiofrequency ablation 6-month follow-up duration 2. Endovenous laser ablation 6-month follow-up duration |
| Intervention type | Other |
| Primary outcome measure | Average pain score at day 3 and day 10 following the procedure measured using an ungraduated visual analogue score (VAS) 0 = no pain, 10 = worst pain imaginable for 10 days following the procedure. |
| Secondary outcome measures | 1. Use of analgesia, measured at 10 days 2. Improvement in quality of life using the Aberdeen Varicose Vein Questionnaire (AVVQ), the 12-item Short Form (SF-12) and the Specific Quality of Life and Outcome Response - Venous (SQOR-V) questionnaires pre-operatively and at 6 weeks post-intervention 3. Abolition of reflux at 6 months measured using colour duplex 4. Improvements in venous refill times using digitial photoplethysmography, measured at 6 weeks and 6 months 5. Clinical improvement measured using the CEAP, Venous Clinical Severity Score (VCSS) and Venous Disability Score (VDS), measured at 6 weeks and 6 months 6. Return to normal activities and or work 7. Complications, assessed throughout the duration of the patient participation (6 months) |
| Overall study start date | 07/07/2008 |
| Completion date | 31/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 170 |
| Key inclusion criteria | 1. Adults aged over 18 years, either sex 2. Venous reflux of the great saphenous vein |
| Key exclusion criteria | 1. Patients unfit for general anaesthesia 2. Current deep vein thrombosis 3. Previous venous surgery 4. Significant peripheral vascular disease/Ankle Brachial Blood Pressure Index (ABPI) less than 0.8 |
| Date of first enrolment | 07/07/2008 |
| Date of final enrolment | 31/01/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
4 East Department of Vascular Surgery
London
W6 8RF
United Kingdom
W6 8RF
United Kingdom
Sponsor information
Imperial College London (UK)
University/education
University/education
c/o Gary Roper
Research Governance Manager of Imperial College
Clinical Reserach Governance Office, G02
Sir Alexander Fleming Building
Exhibition Road
London
SW7 2AZ
England
United Kingdom
| Website | http://www3.imperial.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Charity
Mason Medical Research Foundation (UK)
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 | 01/06/2010 | Yes | No | |
| Results article | results | 01/02/2011 | Yes | No |
