A New Method of Surgically Treating Varicose Veins and Venous Ulcers - a Study to Assess Clinical and Economic Value

Sponsor

Hull University Teaching Hospitals NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT00759434

Collaborator

University of Hull (Other)

280

Enrollment

Location

Arms

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Varicose veins are a common problem, affecting up to a third of the western adult population. Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is known to have a significant negative effect on patient's quality of life (QoL).

Surgery has been used for many years, but it is known that there is a temporary decline in QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged recovery in some patients and has the risks of infection, haematoma and nerve injury.

Recurrence rates are known to be significant. Duplex of veins post surgery has demonstrated persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at 34 years.

26% of NHS patients were 'very dissatisfied' with their varicose vein surgery.

Newer, less invasive treatments are being developed. It would be advantageous to find a treatment that avoided the morbidity of surgery, one that could be performed as a day-case procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and allow an early return to work. These should be the aims of any new treatment for varicose veins.

Endovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser energy delivered into the vein to obliterate it. The vein therefore need not be tied off surgically and stripped out.

The aim of this study is to compare the clinical, cost effectiveness and safety of Surgery and EVLT.

Condition or Disease	Intervention/Treatment	Phase
Varicose Veins Venous Insufficiency Venous Ulceration	Procedure: Surgery - Saphenofemoral ligation, saphenous strip and avulsions Procedure: EVLT	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Dual Centre, Randomised Controlled Trial of the Clinical and Cost Effectiveness of Endovenous Laser Therapy (EVLT) in the Treatment of Varicose Veins and Venous Ulcers

Actual Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Surgery	Procedure: Surgery - Saphenofemoral ligation, saphenous strip and avulsions Patients undergo Saphenofemoral ligation, inversion stripping of the Long Saphenous Vein and avulsion of varicosities if necessary under a general anaesthetic.
Experimental: EVLT	Procedure: EVLT Patients undergo endovenous laser treatment, using a 810nm laser aiming to occlude the incompetent long saphenous vein from the saphenofemoral junction to the knee. This may then be followed by ambulatory phlebectomy as appropriate. All procedures are to be performed under a local anaesthetic.

Arm

Intervention/Treatment

Active Comparator: Surgery

Procedure: Surgery - Saphenofemoral ligation, saphenous strip and avulsions

Patients undergo Saphenofemoral ligation, inversion stripping of the Long Saphenous Vein and avulsion of varicosities if necessary under a general anaesthetic.

Experimental: EVLT

Procedure: EVLT

Patients undergo endovenous laser treatment, using a 810nm laser aiming to occlude the incompetent long saphenous vein from the saphenofemoral junction to the knee. This may then be followed by ambulatory phlebectomy as appropriate. All procedures are to be performed under a local anaesthetic.

Outcome Measures

Primary Outcome Measures

Generic Quality of life - Short Form-36 [1 week, 6 weeks, 3 months, 1 year, 2 years]

Secondary Outcome Measures

Disease Specific quality of life - Aberdeen Varicose Vein Questionnaire [1 week, 6 weeks, 3 months, 1 year, 2 years]
Generic quality of life - EuroQol [1 week, 6 weeks, 3 months, 1 year, 2 years]
Venous Clinical Severity Score [3 months, 1 year, 2 years]
Visual analogue pain scores [1 week]
Return to work and normal functioning [1 week, 6 weeks]
Would undergo EVLT again if necessary [1 week, 6 weeks, 3 months, 1 year, 2 years]
Complication rates [1 week, 6 weeks, 3 months, 1 year, 2 years]
Duplex and clinical assessment [1 week, 6 weeks, 3 months, 1 year, 2 years]
A detailed clinical and duplex ultrasound assessment was undertaken to identify: The presence of residual or recurrent varicose veins (defined as clinically evident varicose veins of greater than 3mm in diameter present at 1 and 6 weeks (residual) or becoming evident only after 6 weeks (recurrent). This was irrespective of the presence or absence of symptoms. The pattern of underlying insufficiency on duplex giving rise to any clinically evident varicose veins or skin changes.
Cost Effectiveness [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Primary, symptomatic, varicose veins.
Isolated Saphenofemoral junction (SFJ) incompetence leading to long saphenous (LSV) reflux on duplex ultrasound.
LSV of 4mm diameter at the knee.
Ability to give informed written consent.