Varicose veins Circulatory System
Conditions
Interventions
Current interventions as of 30/09/2022:
Patients with symptomatic primary SSV reflux are randomised by sealed envelopes to either TLFS with EVLA or EVLA alone. Secondary intervention using the same
Sponsors
Sakurabashi Watanabe Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with unilateral or bilateral varicose veins of the SSV with clinical class C2 to C6 disease using the clinical, etiologic, anatomic, and pathophysiologic (CEAP) classification
Exclusion criteria
Exclusion criteria: 1. Recurrent varicose veins after previous surgery, EVLA, or foam sclerotherapy 2. A hypersensitivity reaction to sclerotherapy 3. Acute deep vein thrombosis (DVT) or a history of DVT 4. Severe lower limb ischaemic disease (lower extremity arteriosclerosis obliterans, thromboangiitis obliterans, acute arterial embolism, or Raynaud syndrome) 5. Coagulation disorder 6. Indications for simultaneous EVLA in both the GSV and SSV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 26/07/2023: Venous clinical severity score (VCSS) improvement at 1 day, 1 week, 1 month, and 1 year _____ Previous primary outcome measure: The presence of residual or recurrent reflux measured using colour Doppler ultrasound at 1 day, 1 week, 1 month, and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 26/07/2023: All reported ipsilateral superficial venous re-interventions due to the symptomatic residual or recurrent reflux of truncal SSVs and/or tributary veins or patient complaints of visible varicosities with cosmetic concerns or any reported procedural complications. These included sensory complications, endovenous heat-induced thrombosis (EHIT), superficial thrombophlebitis, sclerotherapy-related DVT / pulmonary embolism, and allergic or anaphylactic reactions. _____ Previous secondary outcome measures: 1. Sclerotherapy-related deep vein thrombosis (DVT) measured using colour Doppler ultrasound at 1 day, 1 week, 1 month, and 1 year 2. Endovenous heat-induced thrombosis (EHIT) measured using colour Doppler ultrasound at 1 day, 1 week, 1 month, and 1 year 3. Sensory complications measured by asking participants about their recovery status and complications at 1 day, 1 week, 1 month, and 1 year 4. The need for secondary interventions measured using colour Doppler ultrasound at 1 day, 1 week, 1 month, and 1 year 5. Clinical outcome measured using the venous clinical severity score (VCSS) at 1 day, 1 week, 1 month, and 1 year | — |
Countries
Japan
Outcome results
None listed