TCTR20220920002
Recruiting
Phase 3
Catheter-directed Foam Sclerotherapy with High and Distal Ligation of Great Saphenous Vein versus High Ligation and Venous Stripping in Chronic Venous Insufficiency with Great Saphenous Vein Reflux: A Randomized Controlled Trial
Division of Vascular Surgery, Department of Surgery, Faculty of Medicine, Thammasat University0 sites146 target enrollmentSeptember 20, 2022
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- chronic venous insufficiency and great saphenous vein reflux
- Sponsor
- Division of Vascular Surgery, Department of Surgery, Faculty of Medicine, Thammasat University
- Enrollment
- 146
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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