Quality of life and benefit for patients: bipolar radiofrequency-induced thermotherapy (RFITT) versus crossectomy and stripping: a prospective randomized multi-centre trial

Artemed SE (Germany)0 个研究点目标入组 200 人开始时间: 2015年5月8日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•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
•3. Diameter of GSV at measuring point 3 cm distal of the junction vena epigastrica superficialis (VES) maximal 15 mm in standing position
•4. Performance status according to American Society of Anesthesiology (ASA) I-II
•5. Surgical procedure in tumescent local anesthesia (TLA) or total intravenous anesthseia (TIVA) in combination with TLA
•6. Written consent
•7. Distance of place of residence to study centre <= 150 km
•8. Age 18 - 70 years (at randomisation)

•1. Incompetence of vena saphena parva (VSP) requiring treatment at the same limb, anterior accessory vein incompetence requiring treatment at the same limb
•2. Previous sclerotherapy of VSM, previous endovenous treatment of VSM, previous surgical interventions in the groin area
•3. Recurrences in the groin area
•4. Permanent oral anticoagulation with e.g, Marcumar, Warfarin, Rivaroxaban
•5. Acute thrombophlebitis, deep venous thrombosis or post-thrombotic syndrome (post-thrombotic syndrome), incompetence of deep veins (vena femoralis superficialis and vena poplitea)
•6. Known thrombophilia associated with a high risk of thromboembolism
•7. Arterial occlusive disease > Fontaine IIA
•8. Polyneuropathia
•9. Performance status according to American Society of Anesthesiology (ASA) III - VI
•10. Active malignancy (diagnosed during the past 5 years)
•11. Females pregnant or nursing
•12. Distance of place of residence to study centre > 150 km
•13. No written consent
•14. Age <18 or >70 years (at randomisation)

发起方

Artemed SE (Germany)