Treatment of Great Saphenous Vein Varicosities

Study Overview
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Brief Summary
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Venous insufficiency at lower extremities may result in clinical problems from cosmetic issues to ulcerations. When the frequency of venous insufficiency and its related problems are considered besides their diversity, it is encountered as a public health issue. This pathology is reported to affect 40% of women and 20% of men.1 Patients with varicose veins may complain of unsightly appearance, aching, heaviness, pruritus, and early fatigue of the affected leg. These symptoms worsen with prolonged standing and sitting and are relieved by elevation of the leg above the level of the heart. Also, mild edema is often present. More severe signs include thrombophlebitis, hyperpigmentation, lipodermatosclerosis, ulceration, and bleeding

Official Title
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Endovenous Chemical Ablation and Trendlenburg Operation for the Treatment of Great Saphenous Vein Varicosities

Conditions
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Varicose Veins

Intervention / Treatment
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* Procedure: Endovenous chemical ablation with Trendelenburg's operation (eCAT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presented by primary VV of the LL complaining of Leg pain cosmetic disfigurement, leg ulcer, itching, or pigmentation at LL the incompetence of the saphenofemoral junction (SFJ) and or saphenopopliteal junction (SPJ). Exclusion Criteria: Lower limb involvement by any of the following conditions; secondary VV, recurrent VV, lymphedema, acute superficial thrombophlebitis, arterio-venous fistula (congenital or acquired), congenital anomalies of the venous system, general comorbidities, skin infection or ischemia

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lower limb varicose vein<br> | Procedure: Endovenous chemical ablation with Trendelenburg's operation (eCAT)<br>* Endovenous chemical ablation with trendelenburg's operation (e CAT) is a method for the treatment of varicose veins<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GSV Patency | Great saphenous Vein Patency: is a categorical outcome that will be assesd by dopler ultrasound. it may be patent or partilly occluded or completely occluded or recanalized. | at one week post operative | 
| GSV Patency | Great saphenous Vein Patency: is a categorical outcome that will be assesd by dopler ultrasound. it may be patent or partilly occluded or completely occluded or recanalized. | at one month post operative | 
| GSV Patency | Great saphenous Vein Patency: is a categorical outcome that will be assesd by dopler ultrasound. it may be patent or partilly occluded or completely occluded or recanalized. | at one year post operative |