Treatment of Great Saphenous Vein Varicosities

Varicose Veins Clinical Trial

Official title:

Endovenous Chemical Ablation and Trendlenburg Operation for the Treatment of Great Saphenous Vein Varicosities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05655416
• Other study ID #: Endovenous chemical ablation
• Status: Completed
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: April 5, 2021

Study information

• Verified date: December 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 5, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Procedure:
• Endovenous chemical ablation with Trendelenburg's operation (eCAT)
Endovenous chemical ablation with trendelenburg's operation (e CAT) is a method for the treatment of varicose veins

Locations

Country	Name	City	State
Egypt	Walied Khereba	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GSV Patency	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.	at one week post operative
Primary	GSV Patency	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.	at one month post operative
Primary	GSV Patency	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.	at one year post operative