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Clinical Trials/NCT04479956
NCT04479956UnknownNot Applicable

Microwave Venous Ablation in Comparison to Radiofrequency Ablation, Laser Ablation and Surgical Ligation in Management of Great Saphenous Vein Incompetence

Mansoura University4 sites in 1 country150 target enrollmentStarted: June 18, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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