Clinical trial NCT05508581: Microwaves Ablation of Varicose Veins
Official title: Microwaves Ablation of Varicose Veins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: 1.Number of Participants with Lack of flow or closed great saphenous vein
timeFrame: 6 months
measure: 2.Operation time
timeFrame: Intraoperative
Secondary outcomes:
measure: 1. Number of Participants with recurrence varicose vein varicose veins reappear again after the operation
timeFrame: 12 month
measure: 2. Number of Participants with adverse effect of the procedure
timeFrame: 12 months
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Asyut University Hospitals, Faculty of Medicine, Department of Vascular Surgery .Timeframe of the study: 2 years
Study officials:
affiliation: Lecturer at Vascular and endovascular surgery department Assuit University
name: Mohamed Gamal glal, Lecturer
role: STUDY_CHAIR
References: