Varicose Veins of Lower Limb Clinical Trial
— RRT CVDOfficial title:
Russian Registry of Treatment of Chronic Venous Diseases
NCT number | NCT03035747 |
Other study ID # | A001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | July 2036 |
Ongoing registration of patients with varicose veins disease treated by means of conventional surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | July 2036 |
Est. primary completion date | July 2036 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Varicose veins with any source of pathological reflux, C2 - C6 according to the CEAP classification Exclusion Criteria: - no exclusion criteria |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Medalp private surgery clinic | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
Medalp Private Surgery Clinic | Pirogov Russian National Research Medical University |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in patency target veins assessed by duplex ultrasonography in different follow up periods after conventional surgery, endovenous thermal ablations, sclerotherapy or non-tumescent non-thermal methods | Baseline, 3 - 6, 12 months post-intervention | ||
Secondary | Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey (optional) | The SF-36 is a generic QoL questionnaire. | Baseline, 3 and 12 months post-intervention | |
Secondary | Change in Venous Clinical Severity Score (VCSS) (optional) | The VCSS is a validated scoring system for assessing signs, symptoms and complaints of venous disease. | Baseline, 3 and 12 months post-intervention | |
Secondary | Change in Quality of Life (QoL), assessed by Aberdeen Varicose Vein Questionnaire (AVVQ) (optional) | The AVVQ is a disease-specific QoL questionnaire aimed at venous disease. | Baseline, 3 and 12 months post-intervention |
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