Ongoing Registry of Treatment of Chronic Venous Diseases
Recruiting
- Conditions
- Varicose Veins of Lower Limb
- Registration Number
- NCT03035747
- Lead Sponsor
- Medalp Private Surgery Clinic
- Brief Summary
Ongoing registration of patients with varicose veins disease treated by means of conventional surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods
- Detailed Description
Data of patients treated in different Russian medical centers are entered in a prospective digital database, and continuously updated.
There is planned to conduct prospective randomized, cohort and observational studies on the site of register
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
Inclusion Criteria
- Varicose veins with any source of pathological reflux, C2 - C6 according to the CEAP classification
Exclusion Criteria
- no exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in Venous Clinical Severity Score (VCSS) (optional) Baseline, 3 and 12 months post-intervention The VCSS is a validated scoring system for assessing signs, symptoms and complaints of venous disease.
Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey (optional) Baseline, 3 and 12 months post-intervention The SF-36 is a generic QoL questionnaire.
Change in Quality of Life (QoL), assessed by Aberdeen Varicose Vein Questionnaire (AVVQ) (optional) Baseline, 3 and 12 months post-intervention The AVVQ is a disease-specific QoL questionnaire aimed at venous disease.
Trial Locations
- Locations (1)
Medalp private surgery clinic
🇷🇺Saint Petersburg, Russian Federation