Ongoing Registry of Treatment of Chronic Venous Diseases

Varicose Veins of Lower Limb Clinical Trial

— RRT CVD  

Official title:

Russian Registry of Treatment of Chronic Venous Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03035747
• Other study ID #: A001
• Status: Recruiting
• Start date: July 2016
• Est. completion date: July 2036

Study information

• Verified date: March 2024
• Source: Medalp Private Surgery Clinic
• Contact: Evgeny Ilyukhin, MD, PhD
• Phone: +79218451722
• Email: evgeny[@]ilyukhin.info
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: July 2036
• Est. primary completion date: July 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• no exclusion criteria

Related Conditions & MeSH terms

• Varicose Veins
• Varicose Veins of Lower Limb

Intervention

Procedure:
• conventional surgery
high ligation and stripping of incompetent saphenous veins
• endovenous laser ablation
endovenous laser ablation of incompetent saphenous veins
• sclerotherapy
ultrasound guided or catheter or or any other methods sclerotherapy of incompetent saphenous or varicose veins
• endovenous radiofrequency ablation
endovenous radiofrequency ablation of incompetent saphenous veins
• phlebectomy
hooks phlebectomy of varicose veins

Locations

Country	Name	City	State
Russian Federation	Medalp private surgery clinic	Saint Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
Medalp Private Surgery Clinic	Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline, 3 - 6, 12 months post-intervention
Secondary	Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey (optional)	The SF-36 is a generic QoL questionnaire.	Baseline, 3 and 12 months post-intervention
Secondary	Change in Venous Clinical Severity Score (VCSS) (optional)	The VCSS is a validated scoring system for assessing signs, symptoms and complaints of venous disease.	Baseline, 3 and 12 months post-intervention
Secondary	Change in Quality of Life (QoL), assessed by Aberdeen Varicose Vein Questionnaire (AVVQ) (optional)	The AVVQ is a disease-specific QoL questionnaire aimed at venous disease.	Baseline, 3 and 12 months post-intervention

External Links

•   Confirmation page about membership of RPA in the International Union of Phlebology
•   Russian Phlebological Association (RPA)
•   Russian Register of Treatment of Chronic Venous Diseases (RRT CVD)