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Study comparing outcomes between catheter-directed foam sclerotherapy with high and distal ligation versus high ligation and stripping in varicose vei

Phase 3
Recruiting
Conditions
chronic venous insufficiency and great saphenous vein reflux
varicose vein, venous insufficiency, sclerotherapy, stripping, surgery,
Registration Number
TCTR20220920002
Lead Sponsor
Division of Vascular Surgery, Department of Surgery, Faculty of Medicine, Thammasat University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
146
Inclusion Criteria

1. age between 18 - 80 years old, 2. Chronic insufficiency stage C2-6 with primary great saphenous vein reflux, 3.unilateral or bilateral great saphenous vein less than 10 mm, 4. patient who want to receive surgery.

Exclusion Criteria

1. abnormal anatomy (duplicate saphenous vein), 2. other concomitant vein reflux, 3. history of deep vein thrombosis, 4. concomitant peripheral arterial occlusive (ankle brachial index < 0.9), 5. history of thrombophilia, 6. allergy to sclerotherapy, 7. history of superficial thrombophlebitis, 8. history of patent foramen ovale or cardiac murmur, 9. history of previous venous intervention, 10. end-stage renal disease, 11. history of migraine, 12. immobilization patients. 13. great saphenous vein with aneurysmal change, 14. cannot read and write or understand Thai language.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
anatomical failure (great saphenous vein nonocclusion) at 1-2 weeks, 3 months, 6 months, and 1 year yes, partial occlusion without reflux, partial occlusion with reflux, no/ duplex scan
Secondary Outcome Measures
NameTimeMethod
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