Ongoing Registry of Treatment of Chronic Venous Diseases

NCT03035747 — Recruiting, 5000 participants, Medalp Private Surgery Clinic

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Russian Registry of Treatment of Chronic Venous Diseases

Registry	NCT03035747, acronym RRT CVD
Status	Recruiting
Study type	Observational
Enrollment	5000 (Estimated)
Sponsor	Medalp Private Surgery Clinic (Other); collaborators: Pirogov Russian National Research Medical University
Conditions	Varicose Veins of Lower Limb
Interventions	conventional surgery, endovenous laser ablation, sclerotherapy, endovenous radiofrequency ablation, phlebectomy (Procedure)
Dates	start 2016-07-01, primary completion 2036-07-01 (estimated), completion 2036-07-01 (estimated), first posted 2017-01-30, last updated 2024-03-13
Locations	1 site in Russia

-Summary

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

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+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

+Arms and interventions

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

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* no exclusion criteria

+Locations (1)

Facility	City	Country	Status
Medalp private surgery clinic	Saint Petersburg	Russia	Recruiting

My Notes

Public

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