chronic venous insufficiency and great saphenous vein reflux varicose vein, venous insufficiency, sclerotherapy, stripping, surgery,
Conditions
Interventions
The study intervention is catheter-directed foam sclerotherapy with high and distal ligation. First, high ligation of great saphenous vein is done using ultrasound-guided location as in controlled gro
Tessari'
s technique) is injected in to the catheter with continuous flushing of the vein via the introducer sheath. Complete filling of the vein with foam is confirmed before suturing close the incisions. Com
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
catheter-directed foam sclerotherapy with high and distal ligation,High ligation and venous stripping
Sponsors
Division of Vascular Surgery, Department of Surgery, Faculty of Medicine, Thammasat University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| postoperative pain at 6 hour and 12 hour post-opearation Visual analog scale (0-10)/ interview,postoperative hematoma 1-2 weeks post-operation yes, no/ physical examination by attending physician,postoperative ecchymosis 1-2 weeks post-operation yes, no/ physical examination by attending physician,Postoperative wound infection 1-2 weeks post-operation yes, no/ physical examination by attending physician,Postoperative paresthesia 1-2 weeks post-operation yes, no/ physical examination by attending physician,Postoperative deep vein thrombosis 1-2 weeks post-operation yes, no/ duplex scan ,postoperative superficial thrombophlebitis 1-2 weeks post-operaion yes, no/ physical examination by attending physician,Postoperative venous matting 1-2 weeks post-operation yes, no/ physical examination by attending physician,postoperative transient blindness 1-2 weeks post-operation yes, no/ history taking by attending physician,time to return to normal activities at 1-2 weeks post-operation day/ interview by research team,time to return to work at 1-2 weeks post-operation day/ interview by research team,patient satisfaction at 1-2 weeks, 3 months, 6 months, and 1 year post-operation visual analog scores (1-10)/ interview by research team,clinical recurrence at 1-2 weeks, 3 months, 6 months, and 1 year post-operation yes, no/ physical examination by attending physician,Quality of life at 1-2 weeks, 3 months, 6 months, and 1 year post-operation EQ5D-5L and AVVQ/ patient report outcome measure recorded by research team ,venous severity scores at 1-2 weeks, 3 months, 6 months, and 1 year post-operation Venous clinical severity scores (VCSS)/interview and examination by attending physician,maximal pain score within 24 hours postoperatively Visual analog scale (0-10)/interview | — |
Countries
Thailand
Contacts
Public ContactBoonying Siribumrungwong
Thammasat University Hospital
Outcome results
None listed