Ongoing Registry of Treatment of Chronic Venous Diseases

Study Overview
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Brief Summary
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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
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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

Official Title
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Russian Registry of Treatment of Chronic Venous Diseases

Conditions
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Varicose Veins of Lower Limb

Intervention / Treatment
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* Procedure: conventional surgery
* Procedure: endovenous laser ablation
* Procedure: sclerotherapy
* Procedure: endovenous radiofrequency ablation
* Procedure: phlebectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Varicose veins with any source of pathological reflux, C2 - C6 according to the CEAP classification Exclusion Criteria: no exclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: conventional surgery|high ligation and stripping of incompetent saphenous veins|
|Procedure: endovenous laser ablation|endovenous laser ablation of incompetent saphenous veins|
|Procedure: sclerotherapy|ultrasound guided or catheter or or any other methods sclerotherapy of incompetent saphenous or varicose veins|
|Procedure: endovenous radiofrequency ablation|endovenous radiofrequency ablation of incompetent saphenous veins|
|Procedure: phlebectomy|hooks phlebectomy of varicose veins|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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registry, varicose veins, conventional surgery, thermal ablation, radiofrequency, laser, sclerotherapy