- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03035747
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
Status
Recruiting
Conditions
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
- Name: Evgeny Ilyukhin, MD, PhD
- Phone Number: +79218451722
- Email: evgeny@ilyukhin.info
Study Locations
-
-
-
Saint Petersburg, Russian Federation, 197758
- Recruiting
- Medalp Private Surgery Clinic
-
Contact:
- Oleg Shonov, MD
- Email: shonov.o@gmail.com
-
-
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.
Sponsor
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A001
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.
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