lower limb varicose veins
Conditions
Interventions
Test Group: Endovenous Laser Ablation Combined with Sclerotherapy:Patients were asked to stand and walk to achieve maximal venous distension. Markings were drawn along the course of varicosities
the full venous contour was delineated precisely via inspection and palpation for anatomical localization.
Patients were placed in the supine position. Intraoperative ultrasound was used to identify t
Sponsors
Tangdu Hospital, The Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Definitive diagnosis of primary lower extremity varicose veins confirmed by color Doppler ultrasonography; 2. Presence of great saphenous vein trunk reflux (> 0.5 seconds); 3. Aged 18 to 75 years of either sex; 4. CEAP clinical classification C2-C6; 5. No severe tortuosity of the superficial venous trunk; 6. Patent deep venous system; 7. Expected survival duration >= 1 year with surgical tolerance; 8. Absence of psychiatric disorders; 9. Normal function of major vital organs meeting the following laboratory standards: (1) Routine blood tests: a) Hemoglobin (Hb) >= 90 g/L; b) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; c) Platelet count (PLT) >= 60 x 10^9/L; (2) Serum biochemistry: a) Alanine transaminase (ALT) and aspartate transaminase (AST) < 3 x upper limit of normal (ULN); b) Total bilirubin (TBIL) <= 50 µmol/L; c) Serum creatinine <= 1.5 x ULN; 10. No history of allergic reactions to anesthetics; 11. Patients who provide written informed consent and voluntarily agree to participate in this trial.
Exclusion criteria
Exclusion criteria: 1. Concurrent lower extremity deep vein thrombosis (DVT), or a medical history of recurrent DVT or pulmonary embolism; 2. Acute thrombus formation within the great saphenous vein trunk; 3. Iliac vein compression syndrome, post-thrombotic syndrome, and Budd-Chiari syndrome; 4. Patients with prior surgical intervention on target venous lesions; 5. Uncorrected coagulation disorders; 6. Echocardiography findings outside the normal reference range indicating severe cardiac abnormalities; 7. Severe local infection at the treatment site or systemic infection; 8. History of superficial thrombophlebitis resulting in partial occlusion of the great saphenous vein; 9. Permanent bed rest with immobilization; 10. Pregnancy or lactation period; 11. Diabetic microangiopathy; 12. Concurrent participation in any other clinical trial of medical devices or pharmaceutical agents; 13. Individuals deemed ineligible for this trial at the investigator's discretion; 14. Hypersensitivity to lauromacrogol, precluding foam sclerotherapy injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Venous Clinical Severity Score (VCSS) at 12 months postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Chronic Venous Insufficiency Questionnaire 20 (CIVIQ-20);Occlusion rate of varicose veins;Recurrence rate of varicose veins rate;Perforator vein occlusion rate;Venous ulcer healing time;Venous ulcer healing rate ;Venous ulcer recurrence rate;Postoperative pain visual analogue scale (VAS, range 0–10) assessed at 2 weeks;Intraoperative and postoperative complications; reintervention rate; | — |
Countries
China
Contacts
Public ContactZhang zhang
Tangdu Hospital, The Fourth Military Medical University
Outcome results
None listed