Ongoing Registry of Treatment of Chronic Venous Diseases (RRT CVD)

March 11, 2024 updated by: Evgeny Ilyukhin, Medalp Private Surgery Clinic

Russian Registry of Treatment of Chronic Venous Diseases

Ongoing registration of patients with varicose veins disease treated by means of conventional surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods

Study Overview

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 Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing interventions in cases varicose vein disease

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Baseline, 3 - 6, 12 months post-intervention
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)
Time Frame: Baseline, 3 and 12 months post-intervention
The SF-36 is a generic QoL questionnaire.
Baseline, 3 and 12 months post-intervention
Change in Venous Clinical Severity Score (VCSS) (optional)
Time Frame: Baseline, 3 and 12 months post-intervention
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)
Time Frame: Baseline, 3 and 12 months post-intervention
The AVVQ is a disease-specific QoL questionnaire aimed at venous disease.
Baseline, 3 and 12 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Estimated)

July 1, 2036

Study Completion (Estimated)

July 1, 2036

Study Registration Dates

First Submitted

January 25, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (Estimated)

January 30, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Varicose Veins of Lower Limb

Clinical Trials on conventional surgery

3
Subscribe