Chronic venous insufficiency with great saphenous vein reflux and/or saphenofemoral junction incompetence Varicose vein, venous insufficiency , sclerotherapy, venous stripping
Conditions
Interventions
The study intervention involves ultrasound guided foam sclerotherapy with high ligation with venous stripping.
First, a high ligation of the great saphenous vein (GSV) is performed about 1 cm distal
s size as in controlled group.
Second, sclerotherapy is performed on the remaining GSV below the knee to ankle area. A 21-gauge needle is used to puncture the GSV above the ankle, and a 4Fr introduce
s technique) and injected through the catheter while maintaining continuous flushing of the vein to ensure complete filling with foam under ultrasound guidance.
Last, The stripping of the GSV is car
s size as in experimental group.
The stripping of the GSV is carried out from the proximal to distal incisions, followed by the application of compression bandages without sclerotherapy at the rest o
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Ultrasound guided foam sclerotherapy with a high ligation and venous stripping,A high ligation and venous stripping
Sponsors
Rajavithi Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. age between 18 and 80 years old 2. chronic venous insufficiency classified as CEAP C2-C6, accompanied by clinical symptoms with primary great saphenous vein reflux or/and saphenofemoral junction incompetence 3. No previous treatment with surgery, endovascular intervention, or foam sclerotherapy. 4. Need to perform sclerotherapy
Exclusion criteria
Exclusion criteria: 1.Pregnant or breastfeeding women.2. Body Mass Index (BMI) > 35 kg/mm. 3.Known allergy to sclerosant agents.4. History of, or current, deep vein thrombosis (DVT) and/or pulmonary embolism (PE).5. Local skin infection or inflammation at the site planned for foam injection. 5.Bedridden patients. 6.Patients with a patent foramen ovale (PFO).7. Patients with peripheral arterial occlusive disease.8. Patients with abnormal coagulation conditions, including severe thrombophilia, hypercoagulable states, or active cancer. 9. end stage renal disease 10. history of migraine 11. cannot read, write or understand Thai language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity outcome 2 weeks, 1 month, 3 months, and 6 months post-operation Venous Clinical Severity Score (VCSS) (0-30)/interview | — |
Secondary
| Measure | Time frame |
|---|---|
| Operative time intraoperation minutes/recorded by attending physician,Volume of sclerosant Intraoperation ml/recorded attending physician,Nerve injury 6 hr post-operation yes,no/physical examination and interview by attending physician,Femoral artery and/or Femoral vein injury Intraoperation, 6 hr, and 1 day post-operation yes,no/physical examination by attending physician,Allergy to sclerosant Intraoperation yes,no/physical examination by attending physician,intra-arterial injection or extravasation of sclerosant Intraoperation, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr and 1 day post-operation yes,no/intraoperative ultrasound,Wound infection within 6 months post-operation yes,no/physical examination by attending physician,Thromboembolic complication within 6 months post-operation yes,no/physical examination and duplex ultrasound in deep vein thrombosis by attending physician or CT pulmonary artery in pulmonary embolism ,Hematoma within 6 months post-operation yes,no/physical examination by attending physician,Tissue necrosis within 6 months post-operation yes,no/physical examination by attending physician,Hyperpigmentation within 6 months post-operation yes,no/physical examination by attending physician,anatomical failure (Below knee Great saphenous vein nonocclusion in experimental group) 2 weeks, 1 month, 2 months, 3 months, and 6 months post-operation yes, partial occlusion without reflux, partial occlusion with reflux, no/duplex ultrasound | — |
Countries
Thailand
Contacts
Public ContactSupachai Chanvitan
Rajavithi Hospital
Outcome results
None listed