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OpenTrials
Completed

NCT Number: NCT05655416

Treatment of Great Saphenous Vein Varicosities

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

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Vascular Diseases

Age range

20 year–60 year

Study type

Interventional

Phase

Not applicable

Primary location

Walied Khereba

Zagazig, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovenous chemical ablation with Trendelenburg's operation (eCAT)

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2022
Registry last updated
Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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