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Clinical Trials/NCT03035747
NCT03035747RecruitingNot Applicable

Russian Registry of Treatment of Chronic Venous Diseases

Medalp Private Surgery Clinic1 site in 1 country5,000 target enrollmentStarted: July 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
5,000
Locations
1
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •no exclusion criteria

Outcomes

Primary Outcomes

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 Outcomes

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

Investigators

Sponsor
Medalp Private Surgery Clinic
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Evgeny Ilyukhin

Сhief surgeon Medalp Private Surgery Clinic

Medalp Private Surgery Clinic

Study Sites (1)

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