Treatment of Great Saphenous Vein Varicosities
Endovenous Chemical Ablation and Trendlenburg Operation for the Treatment of Great Saphenous Vein Varicosities
1 other identifier
interventional
55
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2021
CompletedFirst Submitted
Initial submission to the registry
December 9, 2022
CompletedFirst Posted
Study publicly available on registry
December 19, 2022
CompletedDecember 19, 2022
December 1, 2022
7 years
December 9, 2022
December 9, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (1)
Lower limb varicose vein
OTHERInterventions
Endovenous chemical ablation with trendelenburg's operation (e CAT) is a method for the treatment of varicose veins
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Walied Khereba
Zagazig, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 9, 2022
First Posted
December 19, 2022
Study Start
April 1, 2014
Primary Completion
April 1, 2021
Study Completion
April 5, 2021
Last Updated
December 19, 2022
Record last verified: 2022-12