Condition category
Circulatory System
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
18/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Bruce D Braithwaite

ORCID ID

Contact details

E Floor
West Block
Department of Vascular Surgery and Endovascular Surgery
Derby Road
Nottingham
NG7 2UH
United Kingdom
+44 01159249924
bruce.braithwaite@nuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192187950

Study information

Scientific title

Acronym

LAVA

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

20/10/2006

Overall trial end date

01/10/2007

Reason abandoned

Lack fo funding

Eligibility

Participant 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).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

20/10/2006

Recruitment end date

01/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

E Floor, West Block
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Nottingham University Hospitals NHS Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes