Microwave Venous Ablation in Comparison to Radiofrequency Ablation, Laser Ablation and Surgical Ligation in Management of Great Saphenous Vein Incompetence
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Mansoura University
- Enrollment
- 150
- Locations
- 4
- Primary Endpoint
- Great Saphenous vein patency
Study Overview
Brief Summary
The authors will aim to compare microwave therapy with other lines of management radio-frequency ablation, Laser ablation and surgical ligation; regarding time to recurrence rate, ulcer-free time, and health-related quality of life. In a randomized controlled study,The study will be conducted at the department of vascular surgery in Mansoura university hospitals
Detailed Description
INTRODUCTION:
Chronic venous disease (CVD) is one of the most common pathologies in the general population of adults in both industrialized and developing countries.1 the most severe form of CVD is venous ulceration with an overall prevalence of about 1 % in the adult population, which increases with age and is more common in women and obese patients. Venous ulcers significantly impair quality of life, and their treatment places a heavy financial burden upon healthcare systems. Varicose veins (VVS) is a common disease in adults, and VVS without skin changes are present in about 20% of the population, while active ulcers are found in 0.5%. The traditional surgical treatment of VVS is high ligation of the great saphenous vein (GSV), axial stripping and phlebotomy, but the postoperative clinical recurrence is as high as 60%.
Recently, minimally invasive techniques, such as endovenous laser ablation (EVLA) and radiofrequency ablation (RFA), have become widely used for the treatment of VVS. Several reports have shown Several reports have shown that endovenous techniques are as effective as traditional procedures.
Endovenous Microwave Ablation (EMA) for the treatment of VVS differs from the other endovenous methods, and no specific dose regime has been established for this system. Thus, it is unclear if EMA is more or less effective than conventional surgery, or whether it has any additional benefits. In this study, we compared the clinical outcome of high ligation and stripping (HLS) with EMA. Postoperative quality of life (QoL) analysis was assessed using the Aberdeen Varicose Vein Questionnaire (AVVQ) and Venous Clinical Severity Score (VCSS).
Aim of the work: Aimed to compare microwave therapy with other lines of management radiofrequency ablation, Laser ablation and surgical ligation; regarding time to recurrence rate, ulcer-free time, and health-related quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
Computer Based
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Primary symptomatic VVS (CEAP, C3 , C6),
- •Sapheno-femoral junction (SFJ) incompetence, GSV reflux from the groin to below the knee
Exclusion Criteria
- •A history of venous surgery, suspected or proven deep venous thrombosis,
- •Reflux of deep veins to distal limb
- •Duplication of GSV
- •Patients' refusal to participate in the trial.
Outcomes
Primary Outcomes
Great Saphenous vein patency
Time Frame: 6 months
Lack of flow or closed great saphenous vein
Operation Time
Time Frame: intraoperative
The time of the whole procedure
Secondary Outcomes
- Recurrence varicose vein(12 Months)
- Adverse effect of the procedure(12 Months)
