A randomized controlled multicenter trial comparing modern great saphenous vein stripping with crossectomy, with modern great saphenous vein stripping without crossectomy and radiofrequency ablation for primary great saphenous vein incompetence (STRIP trial).

Withdrawn

Conditions: 10057165
Chronic venous insufficiency
varicose veins
10003184

Registration Number: NL-OMON35873

Lead Sponsor: Atrium Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 600

Inclusion Criteria

-Patients with primary varicosity of the GSV, between age 18-80 year.
-CEAP 2-4(Appendix B/VI), without deep vein insufficiency.
-Minimum distance between skin and the GSV in the first 20 cm from the SFJ >5mm.
-Minimum length of to be treated GSV 10cm.
-GSV on one side will be treated in the case of bilateral insufficiency.
-GSV will be treated only in the case of solitary GSV insufficiency.
-Patients treated by experienced surgeon/center.

Exclusion Criteria

-Age <18 years or >80 years.
-Deep vein insufficiency in the same extremity (duplex verified).
-Previous thrombosis of the affected limb (secondary thrombosis)
-Tortuosity of the GSV, double GSV system.
-Superficial veins with a distance of <5mm to the skin surface ( RF cannot be applied), as measured at echo-duplex.
-Patients with double GSV's and/or lateral accessory insufficient branch.
-Earlier operation of the GSV with crossectomy/stripping(recurrency).
-Operated for small saphenous vein (SSV) incompetence the last 3 months.
-Known ABI <0,9 or history of intermittent claudication or peripheral pulselessness (clinical examination)in either extremity.
-Patients with active malignancy.
-Patients with other known medical condition that contradict any of the treatments in the study.
-History of CVA/central nervous system disease
-Pregnancy
-Patients treated with coumarine derivates, if cannot be interrupted during treatment(switched to a LMWH).
-Pacemaker

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary studyparameter will be a clinical recurrence measured by duplex<br /><br>echography at 3,12 and 24 months after intervention.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters will be quality of life as measured by different<br /><br>questionnaires. This study will use the SF-36, EuroQol-5, Aberdeen varicose<br /><br>Vein Questionnaire (AVVQ) and the Pain Disability Index for measuring quality<br /><br>of life. Questionnaires will be completed before and 1, 3, 12, 24 months after<br /><br>intervention. Another secondary parameter which will be evaluated is the cost<br /><br>of the intervention.</p><br>