RCT comparing modified EVLT (endovenous laser treatment) techniques with standard EVLT technique
| ISRCTN | ISRCTN02281581 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02281581 |
| Secondary identifying numbers | N0436169958 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 14/05/2008
- 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
Mr Michael Gough
Scientific
Scientific
Vascular Surgical Unit
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 0113 392 3951 |
|---|---|
| michael.gough@leedsth.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| 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 | |
| Study objectives | Modifications of laser technique might result better clinical outcome in the treatment of varicose veins due to sapheno-femoral and long saphenous incompetence. This study is designed to answer 2 questions: 1. Do these modifications result in improved symptom relief and cosmetic appearance after treatment of varicose veins? 2. Does one of these techniques reduce the total number of follow up sclerotherapy sessions needed to complete the treatment of varicose veins? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Varicose veins |
| Intervention | 2 different types of modified EVLT (endovenous laser treatment) techniques vs standard EVLT technique. |
| Intervention type | Other |
| Primary outcome measure | 1. The total number of follow up sclerotherapy sessions required to complete the treatment. 2. Technical success: determined by duplex ultrasound of LSV: 2.1 Successful: occlusion and non compressibility of the LSV without blood flow throughout the treated length 2.2 Partial response: segmental occlusion of LSV and abolition of distal reflux 2.3 Failure: reflux in treated LSV any time after treatment 3. Improvement in symptoms, using the Aberdeen Vein Questionnaire, a previously validated disease-specific quality of life instrument 4. Review and quantification of varicosities on post-EVLT photographs both prior to and after completion of sclerotherapy |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2005 |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 207 - Each study group comprise 69 (follow-up completed) patients. Group 1 (standard EVLT) is the control group and will be of the same size as group 2 and 3. |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2005 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Vascular Surgical Unit
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Leeds Teaching Hospitals NHS Trust (UK)
No information available
NHS R&D Support Funding
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 | 01/07/2008 | Yes | No |
