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

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2022-11-30

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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Venous Insufficiency Varicose Veins

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

Patients undergo Surgery under a general anaesthetic.

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary.

EVLT

Patients undergo EVLT under a local anaesthetic.

Group Type EXPERIMENTAL

EVLT

Intervention Type PROCEDURE

EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required.

Interventions

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Surgery

Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary.

Intervention Type PROCEDURE

EVLT

EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required.

Intervention Type PROCEDURE

Other Intervention Names

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Crossectomy Endovenous Laser therapy, Endovenous Laser Ablation, EVLA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No