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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Varicose Veins Venous Insufficiency Venous Ulceration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgery

Group Type ACTIVE_COMPARATOR

Surgery - Saphenofemoral ligation, saphenous strip and avulsions

Intervention Type PROCEDURE

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

EVLT

Group Type EXPERIMENTAL

EVLT

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Exclusion Criteria

* Inability to give informed written consent.
* Symptomatic or complicated varicose veins not attributable to SFJ/LSV reflux.
* Evidence of deep venous reflux on duplex scan.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No