NCT00841178

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

A Randomised Controlled Trial of the Clinical and Cost Effectiveness of Endovenous Laser Therapy in the Treatment of Varicose Veins Secondary to Isolated Sapheno-Popliteal Incompetence and Short Saphenous Reflux

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Hull University Teaching Hospitals NHS Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Insufficiency
• Varicose Veins

Interventions

Type	Name	Description
PROCEDURE	Surgery	Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary.
PROCEDURE	EVLT	EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required.

Timeline

• Start date: 2005-10-01
• Primary completion: 2011-08-01
• Completion: 2022-11-01
• First posted: 2009-02-11
• Last updated: 2022-11-04

Locations

1 site across 1 country: United Kingdom