To evaluate surgical treatments of great saphenous vein insufficiency: Endovenous LAser treatment versus Crossectomy and Stripping

A prospective, Randomised, two-centre study to evaluate surgical treatments of great saphenous vein insufficiency: Endovenous LAser treatment versus Crossectomy and Stripping

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18322872

Enrollment

400

Registered

2011-05-19

Start date

2004-09-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Great saphenous vein insufficiency Circulatory System Diseases of veins, lymphatic vessels and lymph nodes, not elsewhere classified

Interventions

Group A : Endovenous Laser Treatment (EVLT): EVLT of the great saphenous vein is performed with an 810 nm Diode laser (bare fibers) using Seldinger's technique ultrasound guided under tumescent local

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Great saphenous vein (GSV) insufficiency with saphenofemoral incompetence and reflux at least down to the knee level 2. Chronic venous insufficiency and/or symptoms caused by GSV incompetence and/or severe clinical findings at risk of varicose vein bleeding, thrombophlebitis or deep vein thrombosis 3. Age 18 - 65 years (at randomisation) 4. Performance status according to American Society of Anesthesiology (ASA) I-II

Exclusion criteria

Exclusion criteria: 1. Previous surgical interventions in the groin area with the exception of inguinal herniotomy 2. Anterior or posterior accessory vein incompetence 3. Small saphenous vein insufficiency requiring treatment at the same limb 4. Acute deep venous thrombosis or postthrombotic syndrome 5. Known thrombophilia associated with a high risk of thromboembolism 6. Arterial occlusive disease > Fontaine IIA and/or ankle-brachial index below 0.8 7. Active malignancy (diagnosed during the past 5 years) 8. Poor compliance or missing ability to understand the study related procedures 9. Females pregnant or nursing

Design outcomes

Primary

Measure	Time frame
Recurrent varices after surgery (REVAS) evaluated at 12 and 24 months follow up visit	—

Secondary

Measure	Time frame
1. Duplex recurrence 2. Side effects 3. Homburg Varicose Vein Severity Score 4. Chronic Venous Insufficiency Questionnaire 5. Venous Refilling time (DPPG) 6. Patients' satisfaction is measured using visual analogue scale based questionnaires Follow-up visits are scheduled in the first postoperative week (side effects), at 3 months [side effects, Homburg Varicose Vein Severity Score (HVVSS), Chronic Venous Insufficiency Questionnaire (CIVIQ), Venous refilling time (DPPG), patient's satisfaction], at 12 months [Duplex recurrence, HVVSS, CIVIQ, DPPG, patient's satisfaction] and at 24 months (Duplex recurrence, HVVSS, CIVIQ, DPPG, patient's satisfaction)	—

Measure

Time frame

1. Duplex recurrence 2. Side effects 3. Homburg Varicose Vein Severity Score 4. Chronic Venous Insufficiency Questionnaire 5. Venous Refilling time (DPPG) 6. Patients' satisfaction is measured using visual analogue scale based questionnaires Follow-up visits are scheduled in the first postoperative week (side effects), at 3 months [side effects, Homburg Varicose Vein Severity Score (HVVSS), Chronic Venous Insufficiency Questionnaire (CIVIQ), Venous refilling time (DPPG), patient's satisfaction], at 12 months [Duplex recurrence, HVVSS, CIVIQ, DPPG, patient's satisfaction] and at 24 months (Duplex recurrence, HVVSS, CIVIQ, DPPG, patient's satisfaction)

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026