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

Sponsor

Hull University Teaching Hospitals NHS Trust (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00841178

Collaborator

University of Hull (Other)

106

Enrollment

Location

Arms

202

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Insufficiency Varicose Veins	Procedure: Surgery Procedure: EVLT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Aug 1, 2011

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Surgery Patients undergo Surgery under a general anaesthetic.	Procedure: Surgery Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary. Other Names: Crossectomy
Experimental: EVLT Patients undergo EVLT under a local anaesthetic.	Procedure: EVLT EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required. Other Names: Endovenous Laser therapy, Endovenous Laser Ablation, EVLA

Arm

Intervention/Treatment

Active Comparator: Surgery

Patients undergo Surgery under a general anaesthetic.

Procedure: Surgery

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

Other Names:

Crossectomy

Experimental: EVLT

Patients undergo EVLT under a local anaesthetic.

Procedure: EVLT

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

Other Names:

Endovenous Laser therapy, Endovenous Laser Ablation, EVLA

Outcome Measures

Primary Outcome Measures

Generic Quality of Life - Short Form-36 [1 Week,, 6 Weeks, 3 Months, 1 Year, 2 Years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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