Randomised controlled comparison study of endoleuminal Laser versus Foam Sclerotherapy in Treatment of Varicose veins
| ISRCTN | ISRCTN52077851 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52077851 |
| Secondary identifying numbers | N0192187950 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 18/10/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Bruce D Braithwaite
Scientific
Scientific
E Floor, West Block
Department of Vascular Surgery and Endovascular Surgery
Derby Road
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 01159249924 |
|---|---|
| bruce.braithwaite@nuh.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | LAVA |
| Study objectives | 1. Primary research objectives: 1.1 What is the level of pain in both procedures? 1.2 What is the extend of bruising after the procedure? 1.3 What is the level of patient satisfaction? 1.4 What is the number of treatment episodes required? 2. Secondary research objectives: 2.1 What is the time to perform the procedure? 2.2 What is the recurrence rate? 2.3 What is the complications? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Varicose veins |
| Intervention | Varicose vein surgery is a common operation with between 400 and 500 cases performed each year in Nottingham. Traditional Varicose vein surgery for the long saphenous system (LSV) consists of a high ligation, involving a cut in the groin and multiple avulsions, dealing with the varicosities in the legs. This requires general anaesthesia and is performed as a day case or inpatient treatment with one night in hospital. For patients, traditional surgery results in pain, extensive bruising, limited mobility and a delayed return to normal activity lasting up to six weeks, although more usually only two weeks. Surgery needs to be performed by surgeons who have achieved competence in the procedure. Recently, new methods for treating varicose veins have been introduced into the independent healthcare sector. These give patients a choice of procedures and some allow varicose veins to be treated without general anaesthesia. In addition, patients report less pain, bruising and an early return to normal activity. These new procedures are endoluminal thermal ablation (VNUS), endovenous laser therapy (EVLT), venocuff valve reinforcement and Varicofoam therapy. The NHS modernisation programme aims to increase the use of day case surgery, enhance patient choice , Increased day case activity in Nottingham can be performed in the new diagnostic and treatment centre (DTC). The aim of this study is to compare the latest treatments for varicose veins using established outcome assessments verified by previous studies performed in the department of vascular surgery at the QMC. Study design: The study comprises randomised study comparing different approaches to the treatment of long and short saphenous disease. Patients will be given a copy of the information sheet. They will be given time to consider their decision and when they wish to enter, they will be asked to sign the study consent form. A copy will be given to patient, one will be placed in their clinical notes and one will be kept in Mr Braithwaite's office at the QMC. Data will be recorded on an established venous database. In all of the component parts of the study, one leg will be chosen at random for the treatments that are to be compared. All patients will have pre-procedure duplex examination of their legs to confirm the anatomy of their varicose veins. The stage of Venous disease (CEAP classification) will be recorded. Before the selected treatment, digital photographs of the patients' legs will be taken according to our established methodology. Patients will be asked to complete visual analogue scales before the procedure to assess their perception of pain and bruising in their legs. For 10 days after the procedure, patients will be asked to keep a diary record of pain, bruising and activity. Between 5 and 10 days after the procedure, patients will be visited by a trained nurse who will note any complications and repeat the digital photographs. Patients will be seen between 6 weeks and 3 months post-operatively for a clinic review as is our normal practice. At this visit, photographs will be taken again to assess residual varicosities ( varicose veins not fully treated). Patients will be asked specific questions about the quality of their treatment and any complications (satisfaction, pain, numbness, infections, scarring). During the same time interval a duplex scan will be performed to objectively assess the completeness of treatment. As close to one year, two years and five years after treatment, patients will be asked to attend the vascular laboratory at QMC for clinical and duplex assessment. The study will be completed 1 year after final patient recruitment. Outcome assessment: This study is based on within patient comparison and therefore each component requires only a few patients. Power studies are included in the description of each component of the study. Endpoints: 1. Primary - Pain, bruising and patient satisfaction, number of treatment episodes required. 2. Secondary - time to perform procedure, time in hospital, cost, recurrence rates. Complications. Methods of recording endpoints: Visual analogue scales, timings, economical valuation. The trial was stopped as funding was withdrawn. |
| Intervention type | Other |
| Primary outcome measure | Pain, bruising and patient satisfaction, number of treatment episodes required. |
| Secondary outcome measures | 1. Time to perform procedure, time in hospital, cost, recurrence rates 2. Complications |
| Overall study start date | 20/10/2006 |
| Completion date | 01/10/2007 |
| Reason abandoned (if study stopped) | Lack fo funding |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Men and women requesting treatment for bilateral varicose veins who present to the Vascular Clinics at the Queen's Medical Centre, City Hospital and independent hospitals within Nottinghamshire (UK). |
| Key exclusion criteria | 1. Patients under 21 and over 80 years 2. Patients without varicose veins 3. Patients wishing to have only one leg treated 4. Patients who does not speak English or need interpretation |
| Date of first enrolment | 20/10/2006 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
E Floor, West Block
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 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
Nottingham University Hospitals NHS Trust (UK), 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 |
