Ongoing Registry of Treatment of Chronic Venous Diseases

NCT03035747 | Recruiting

• 1 other identifier: A001
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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

Conditions

Varicose Veins of Lower Limb

Keywords

registry; varicose veins; conventional surgery; thermal ablation; radiofrequency; laser; sclerotherapy

Outcome Measures

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

  Baseline, 3 - 6, 12 months post-intervention

Secondary Outcomes (3)

• Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey (optional)

  Baseline, 3 and 12 months post-intervention

• Change in Venous Clinical Severity Score (VCSS) (optional)

  Baseline, 3 and 12 months post-intervention

• Change in Quality of Life (QoL), assessed by Aberdeen Varicose Vein Questionnaire (AVVQ) (optional)

  Baseline, 3 and 12 months post-intervention

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing interventions in cases varicose vein disease

You may qualify if:

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

Sponsors & Collaborators

• Medalp Private Surgery Clinic: lead
• Pirogov Russian National Research Medical University: collaborator

Study Sites (1)

Medalp private surgery clinic

Saint Petersburg, 197758, Russia

RECRUITING

Related Links

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

MeSH Terms

Conditions

Varicose Veins

Interventions

Sclerotherapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Evgeny Ilyukhin, MD, PhD

CONTACT

+79218451722; evgeny@ilyukhin.info

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Сhief surgeon Medalp Private Surgery Clinic

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 30, 2017
• Study Start: July 1, 2016
• Primary Completion (Estimated): July 1, 2036
• Study Completion (Estimated): July 1, 2036
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

RU (1)