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

Varicose Veins Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00841178
• Other study ID #: HELP 2
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2005
• Est. completion date: November 2022

Study information

• Verified date: November 2022
• Source: Hull University Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: November 2022
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins
• Venous Insufficiency

Intervention

Procedure:
• Surgery
Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary.
• EVLT
EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required.

Locations

Country	Name	City	State
United Kingdom	Hull Royal Infirmary	Hull	East Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Hull University Teaching Hospitals NHS Trust	University of Hull

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generic Quality of Life - Short Form-36		1 Week,, 6 Weeks, 3 Months, 1 Year, 2 Years
Secondary	Disease Specific Quality of Life - Aberdeen Varicose Vein Questionnaire		1 Week, 6 Weeks, 3 Months, 1 Year, 2 Years
Secondary	Generic quality of life - EuroQol		1 week, 6 weeks, 3 months, 1 year, 2 years
Secondary	Venous Clinical Severity Score		3 months, 1 year, 2 years
Secondary	Visual analogue pain scores		1 week
Secondary	Return to work and normal functioning		1 week, 6 weeks
Secondary	Would undergo EVLT again if necessary		1 week, 6 weeks, 3 months, 1 year, 2 years
Secondary	Complication rates		1 week, 6 weeks, 3 months, 1 year, 2 years
Secondary	Duplex assessment		1 week, 6 weeks, 3 months, 1 year, 2 years
Secondary	Cost Effectiveness		2 years

External Links

•   A randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins.
•   Randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins