Microwaves Ablation of Varicose Veins

Study Overview
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Brief Summary
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Lower-limb varicose veins (VVs) are the most common of vascular diseases and affect up to one-third of the population, severely affecting the quality of life (QoL) of patients. In past decades, traditional surgical ligation and stripping were the gold standard therapy for patients with VVs; however, traditional methods have demonstrated high complication and recurrence rates. Thus, the practices are moving toward minimally invasive alternatives.

Detailed Description
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Lower-limb varicose veins (VVs) are the most common of vascular diseases and affect up to one-third of the population, severely affecting the quality of life (QoL) of patients. In past decades, traditional surgical ligation and stripping were the gold standard therapy for patients with VVs; however, traditional methods have demonstrated high complication and recurrence rates. Thus, the practices are moving toward minimally invasive alternatives. Endo venous thermal ablation, such as radiofrequency ablation and endo venous laser ablation (EVLA), has become the recommended first-line treatment for VVs worldwide. These endo venous procedures provide a quicker recovery time and improved QoL and produce fewer complications than traditional surgery .Endo venous microwaves ablation is a minimally invasive procedure in treatment of V.V, investigators confirmed that endo venous microwave ablation (EMA) was an effective new technique for the treatment of VVs. On previous trials confirmed that the endo venous microwave ablation procedure demonstrated a shorter procedure time, lower complication, and local recurrence than the endo venous laser ablation procedure. The aim of the study was to determine whether endo venous microwave ablation of varicose vein was associated with better effectiveness and less complications and evaluate the outcome of patients who underwent endo venous microwave ablation (EMA).

Official Title
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Microwaves Ablation of Varicose Veins

Conditions
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Varicose Veins

Intervention / Treatment
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* Procedure: microwaves ablation of varicose veins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 60 years, either sex, elective admission primary symptomatic VVS (CEAP,C3-C6) Recurrent Varicose Veins after surgery Greater saphenous vein diameter up to 3 cm Greater saphenous vein with variable depth even with depth less than 6mm Greater saphenous vein with tortuosity Diabetic patient with risk of wound infection after surgery Patient with hostile groin Availability of patients for all follow-up visits Exclusion Criteria: secondary Varicose Veins Acute thrombosis near the Saphenous-femoral junction Recanalized Greater saphenous vein pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Varicose veins<br>Ablation of varicose veins by microwaves | Procedure: microwaves ablation of varicose veins<br>* Microwave ablation is an endovenous treatment. This is a similar treatment approach as laser ablation and radiofrequency ablation. Endovenous means that the treatment device is inside the vein during treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.Number of Participants with Lack of flow or closed great saphenous vein | Complete ablation of varicose veins done or if any residual remind | 6 months | 
| 2.Operation time | The time of the whole procedure | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Number of Participants with recurrence varicose vein varicose veins reappear again after the operation | Reopening of the Varicose veins | 12 month | 
| 2. Number of Participants with adverse effect of the procedure | Thrombophlebitis,Infection or blood loss | 12 months |