Treatment of Great Saphenous Vein Varicosities

Not Applicable

Completed

• Conditions: Varicose Veins
• Interventions: Procedure: Endovenous chemical ablation with Trendelenburg's operation (eCAT)

• Registration Number: NCT05655416
• Lead Sponsor: Al-Azhar University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-05
• Status Verified: 2022-12
• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-09
• Last Update Submitted: 2022-12-09
• Study First Posted: 2022-12-19
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lower limb varicose vein	Endovenous chemical ablation with Trendelenburg's operation (eCAT)	-

Primary Outcome Measures

Name	Time	Method
GSV Patency	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.

Trial Locations

Locations (1)

Walied Khereba; 🇪🇬 Zagazig, Egypt