Endovenous Chemical Ablation and Trendlenburg Operation for the Treatment of Great Saphenous Vein Varicosities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Al-Azhar University
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- GSV Patency
Study Overview
Brief Summary
Venous insufficiency at lower extremities may result in clinical problems from cosmetic issues to ulcerations. When the frequency of venous insufficiency and its related problems are considered besides their diversity, it is encountered as a public health issue. This pathology is reported to affect 40% of women and 20% of men.1 Patients with varicose veins may complain of unsightly appearance, aching, heaviness, pruritus, and early fatigue of the affected leg. These symptoms worsen with prolonged standing and sitting and are relieved by elevation of the leg above the level of the heart. Also, mild edema is often present. More severe signs include thrombophlebitis, hyperpigmentation, lipodermatosclerosis, ulceration, and bleeding
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients presented by primary VV of the LL complaining of Leg pain cosmetic disfigurement, leg ulcer, itching, or pigmentation at LL
- •the incompetence of the saphenofemoral junction (SFJ) and or saphenopopliteal junction (SPJ).
Exclusion Criteria
- •Lower limb involvement by any of the following conditions; secondary VV, recurrent VV, lymphedema, acute superficial thrombophlebitis, arterio-venous fistula (congenital or acquired), congenital anomalies of the venous system, general comorbidities, skin infection or ischemia
Arms & Interventions
Lower limb varicose vein
Intervention: Endovenous chemical ablation with Trendelenburg's operation (eCAT) (Procedure)
Outcomes
Primary Outcomes
GSV Patency
Time Frame: at one year post operative
Great saphenous Vein Patency: is a categorical outcome that will be assesd by dopler ultrasound. it may be patent or partilly occluded or completely occluded or recanalized.
GSV Patency
Time Frame: at one week post operative
Great saphenous Vein Patency: is a categorical outcome that will be assesd by dopler ultrasound. it may be patent or partilly occluded or completely occluded or recanalized.
GSV Patency
Time Frame: at one month post operative
Great saphenous Vein Patency: is a categorical outcome that will be assesd by dopler ultrasound. it may be patent or partilly occluded or completely occluded or recanalized.
Secondary Outcomes
No secondary outcomes reported
Investigators
Walied Khereba
Principal Investigator
Al-Azhar University