Chronic venous insufficiency with saphenofemoral junction and great saphenous vein reflux. Venous insufficiency (chronic) (peripheral)
Conditions
Interventions
Intervention 1: Intervention group: Calcium dobesilate 500 mg capsules twice daily (total daily dose 1000 mg) for 4 weeks plus standard postoperative care including compression therapy, wound care, an
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult patients (18 years of age or older) with SFJ and GSV reflux Written Patients who have indication for great saphenous vein stripping surgery informed consent and Ability to comply with study procedures
Exclusion criteria
Exclusion criteria: Pregnancy or breastfeeding Severe cardiovascular, hepatic or renal disease Active malignancy Previous adverse reactions to calcium dobesilate Concomitant use of anticoagulant or antiplatelet drugs (except aspirin = 100 mg) Active venous ulcer (C6) Planned additional vascular procedures during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total score of the Aberdeen Varicose Vein Questionnaire from baseline to 4 weeks after great saphenous vein stripping surgery. Timepoint: Baseline before surgery or within 72 hours after surgery, week 2, and week 4 after surgery. Method of measurement: Self-administered validated Persian version of the Aberdeen Varicose Vein Questionnaire completed by the patient at each visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Visual Analogue Scale pain score from baseline to 4 weeks after great saphenous vein stripping surgery. Timepoint: Baseline before surgery or within 72 hours after surgery, week 2, and week 4 after surgery. Method of measurement: Patient reported Visual Analogue Scale zero to ten centimeter scale for leg pain completed at each visit.;Change in lower limb circumference at ankle and calf levels from baseline to 4 weeks after great saphenous vein stripping surgery. Timepoint: (Baseline + ???? ? + ???? ?). Method of measurement: Standardized tape measure circumference at the malleolar level for ankle and at the widest point of the calf.;Change in Chronic Venous Insufficiency Quality of Life Questionnaire score from baseline to 4 weeks after great saphenous vein stripping surgery. Timepoint: (Baseline + ???? ? + ???? ?). Method of measurement: Self-administered validated thirty-item Chronic Venous Insufficiency Quality of Life Questionnaire completed by the patient at each visit.;Patient Global Impression of Change score at 4 weeks after great saphenous vein stripping surgery. Timepoint: Week 4 after surgery. Method of measurement: Seven-point Likert scale patient-reported global impression of change completed at week 4.;Time in days to return to normal daily activities from the day of great saphenous vein stripping surgery. Timepoint: Assessed daily up to 4 weeks after surgery. Method of measurement: Patient self-report of the exact day when usual daily activities were resumed. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactArefeh Ghanbarzadeh Hesari
Tehran University of Medical Sciences
Outcome results
None listed