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

Not Applicable

Active, not recruiting

• Conditions: Venous Insufficiency; Varicose Veins
• Interventions: Procedure: EVLT; Procedure: Surgery

• Registration Number: NCT00841178
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Primary Completion: 2011-08
• Status Verified: 2022-11
• Study Completion: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVLT	EVLT	Patients undergo EVLT under a local anaesthetic.
Surgery	Surgery	Patients undergo Surgery under a general anaesthetic.

Primary Outcome Measures

Name	Time	Method
Generic Quality of Life - Short Form-36	1 Week,, 6 Weeks, 3 Months, 1 Year, 2 Years

Secondary Outcome Measures

Name	Time	Method
Complication rates	1 week, 6 weeks, 3 months, 1 year, 2 years
Duplex assessment	1 week, 6 weeks, 3 months, 1 year, 2 years
Would undergo EVLT again if necessary	1 week, 6 weeks, 3 months, 1 year, 2 years
Cost Effectiveness	2 years
Visual analogue pain scores	1 week
Return to work and normal functioning	1 week, 6 weeks
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

Trial Locations

Locations (1)

Hull Royal Infirmary; 🇬🇧 Hull, East Yorkshire, United Kingdom