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

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ClinicalTrials.gov Identifier: NCT03035747
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : February 23, 2021
Sponsor:
Collaborator:
Pirogov Russian National Research Medical University
Information provided by (Responsible Party):
Evgeny Ilyukhin, Medalp Private Surgery Clinic

Study Description
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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

Condition or disease Intervention/treatment
Varicose Veins of Lower Limb Procedure: conventional surgery Procedure: endovenous laser ablation Procedure: sclerotherapy Procedure: endovenous radiofrequency ablation Procedure: phlebectomy

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Russian Registry of Treatment of Chronic Venous Diseases
Actual Study Start Date : July 2016
Estimated Primary Completion Date : July 2036
Estimated Study Completion Date : July 2036

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Groups and Cohorts
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing interventions in cases varicose vein disease
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no exclusion criteria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035747


Contacts
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Contact: Evgeny Ilyukhin, MD, PhD +79218451722 evgeny@ilyukhin.info

Locations
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Russian Federation
Medalp private surgery clinic Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Oleg Shonov, MD       shonov.o@gmail.com   
Sponsors and Collaborators
Medalp Private Surgery Clinic
Pirogov Russian National Research Medical University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

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Responsible Party: Evgeny Ilyukhin, Сhief surgeon Medalp Private Surgery Clinic, Medalp Private Surgery Clinic
ClinicalTrials.gov Identifier: NCT03035747    
Other Study ID Numbers: A001
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evgeny Ilyukhin, Medalp Private Surgery Clinic:
registry
varicose veins
conventional surgery
thermal ablation
 radiofrequency
laser
sclerotherapy
Additional relevant MeSH terms:
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Varicose Veins
Vascular Diseases
Cardiovascular Diseases