Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03035747

Ongoing 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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Varicose Veins of Lower Limb Cardiovascular Diseases Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medalp private surgery clinic

Saint Petersburg, 197758, Russia

Location status: Recruiting

Location contact

Oleg Shonov, MD

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • no exclusion criteria

Treatment and study plan

conventional surgery

Procedure

high ligation and stripping of incompetent saphenous veins

Endovenous laser ablation

Procedure

endovenous laser ablation of incompetent saphenous veins

Sclerotherapy

Procedure

ultrasound guided or catheter or or any other methods sclerotherapy of incompetent saphenous or varicose veins

Endovenous Radiofrequency Ablation

Procedure

endovenous radiofrequency ablation of incompetent saphenous veins

phlebectomy

Procedure

hooks phlebectomy of varicose veins

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Evgeny Ilyukhin, MD, PhD

CONTACT

[email protected]

+79218451722

Sponsors and collaborators

Lead sponsor

Medalp Private Surgery Clinic

Other

Collaborators

  • Pirogov Russian National Research Medical University

Registry information

Official study title

Russian Registry of Treatment of Chronic Venous Diseases

Acronym: RRT CVD

Important dates

Study start
2016
Primary completion
2036
Study completion
2036
First posted
Jan 30, 2017
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.