Radio Frequency Ablation Versus Stripping of Great Saphenous Vein in Management of Primary Varicose Veins , Comparative Study

Study Overview
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Brief Summary
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Varicose veins are one of the most common diseases worldwide it constitutes a progressive disease which during its course it produces complications that usually prompt the patient to seek medical care. Epidemiological studies of the incidence and prevalence of varicose veins found that the majority of adults would develop it over the course of their lifetime; women were found to be four times likely as men to develop it, the incidence of varicose vein occurrence increases with age. Varicose veins are defined as tortuous dilated veins after or associated with incompetent valves.

Official Title
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Radio Frequency Ablation Versus Stripping of Great Saphenous Vein in Management of Primary Varicose Veins , Comparative Study

Conditions
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Varicose Veins

Intervention / Treatment
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* Procedure: stripping of great saphenous vein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria: -. • Adult patients with primary non complicated varicose veins which match the criteria suitable for the procedure Exclusion Criteria: Patients with tortuous GSV that could not allow passage of the sheath, laser fiber, non-palpable distal pulsation. inability to ambulate, patients with previous history of deep venous thrombosis (DVT) and pregnant women were excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A will undergo stripping of great saphenous vein. .<br> | Procedure: stripping of great saphenous vein<br>* I will make 2 or 3 small cuts in your leg. The cuts are near the top, middle, and bottom of your damaged vein. One is in your groin. The other will be farther down your leg, either in your calf or ankle. I will then thread a thin, flexible plastic wire into the vein through your groin and guide the wire through the vein toward the other cut farther down your leg. The wire is then tied to the vein and pulled out through the lower cut, which pulls the vein out with it. I will close the cuts with stitches. Patient will wear bandages and compression stockings on leg after the procedure.<br>* Other names: radiofrequency ablation;|
| Active Comparator: Group B will undergo treatment by radiofrequency ablation.<br> | Procedure: stripping of great saphenous vein<br>* I will make 2 or 3 small cuts in your leg. The cuts are near the top, middle, and bottom of your damaged vein. One is in your groin. The other will be farther down your leg, either in your calf or ankle. I will then thread a thin, flexible plastic wire into the vein through your groin and guide the wire through the vein toward the other cut farther down your leg. The wire is then tied to the vein and pulled out through the lower cut, which pulls the vein out with it. I will close the cuts with stitches. Patient will wear bandages and compression stockings on leg after the procedure.<br>* Other names: radiofrequency ablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate | Treatment success was defined as symptomatic improvement as well as decrease in vein diameter,echogenic thickening of vein wall and no flow within the occluded lumen by duplex examination Improvement of symptoms in the treated limb | one year | 
| complication | recurrence and recanalization of the treated vein. hyperpigmentation recurrence and recanalization of the treated vein. ecchymosis, paresthesia, hematoma, erythema and phlebitis. | one year |