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Recruiting NCT03035747

Ongoing Registry of Treatment of Chronic Venous Diseases

— Observational Varicose Veins of Lower Limb

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: conventional surgery, endovenous laser ablation, sclerotherapy, endovenous radiofrequency ablation.
Who it may be relevant to
Registry conditions: Varicose Veins of Lower Limb. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Russian Registry of Treatment of Chronic Venous Diseases

Overview

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

Interventions

  • 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

Primary outcome measures

  • 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 [Time frame: Baseline, 3 - 6, 12 months post-intervention]
Secondary outcome measures (3)
  • Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey (optional) [Time frame: Baseline, 3 and 12 months post-intervention]
  • Change in Venous Clinical Severity Score (VCSS) (optional) [Time frame: Baseline, 3 and 12 months post-intervention]
  • Change in Quality of Life (QoL), assessed by Aberdeen Varicose Vein Questionnaire (AVVQ) (optional) [Time frame: Baseline, 3 and 12 months post-intervention]

Eligibility criteria

Inclusion criteria

  • Varicose veins with any source of pathological reflux, C2 - C6 according to the CEAP classification

Exclusion criteria

  • no exclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Russia · 1 center
  • Medalp private surgery clinic — Saint Petersburg

Identifiers

NCT: NCT03035747 · A001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗