Microwaves Ablation of Varicose Veins

Not Applicable

Completed

• Conditions: Varicose Veins
• Interventions: Procedure: microwaves ablation of varicose veins

• Registration Number: NCT05508581
• Lead Sponsor: Assiut University

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-19
• Study Start: 2022-11-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age between 18 and 60 years, either sex, elective admission
2. primary symptomatic VVS (CEAP,C3-C6)
3. Recurrent Varicose Veins after surgery
4. Greater saphenous vein diameter up to 3 cm
5. Greater saphenous vein with variable depth even with depth less than 6mm
6. Greater saphenous vein with tortuosity
7. Diabetic patient with risk of wound infection after surgery
8. Patient with hostile groin
9. Availability of patients for all follow-up visits

Exclusion Criteria

1. secondary Varicose Veins
2. Acute thrombosis near the Saphenous-femoral junction
3. Recanalized Greater saphenous vein
4. pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Varicose veins	microwaves ablation of varicose veins	Ablation of varicose veins by microwaves

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Number of Participants with recurrence varicose vein varicose veins reappear again after the operation	12 month	Reopening of the Varicose veins
2. Number of Participants with adverse effect of the procedure	12 months	Thrombophlebitis,Infection or blood loss

Trial Locations

Locations (1)

Asyut University Hospitals, Faculty of Medicine, Department of Vascular Surgery .Timeframe of the study: 2 years; 🇪🇬 Asyut, Egypt