Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT

NHS Trust

Status: Active, not recruiting

Conditions: Venous Insufficiency; Varicose Veins

Treatments: Procedure: EVLT; Procedure: Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00841178

HELP 2

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary, symptomatic, varicose veins
• Isolated Sapheno-popliteal (SPJ) incompetence, leading to reflux in the Short saphenous vein (SSV) on duplex ultrasound
• SSV of 4mm distally
• Ability to give informed written consent

Exclusion criteria

• Inability to give informed written consent
• Symptomatic or complicated varicose veins not attributable to SPJ/SSV reflux
• Evidence of deep venous reflux on duplex scan

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Surgery

Active Comparator group

Description:

Patients undergo Surgery under a general anaesthetic.

Treatment:

Procedure: Surgery

EVLT

Experimental group

Description:

Patients undergo EVLT under a local anaesthetic.

Treatment:

Procedure: EVLT