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

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

Tracking Information

• First Submitted Date: January 25, 2017
• First Posted Date: January 30, 2017
• Last Update Posted Date: February 23, 2021
• Actual Study Start Date: July 2016
• Estimated Primary Completion Date: July 2036 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 1, 2017): 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 ]
• Original Primary Outcome Measures (submitted: January 26, 2017): Change in patency target veins assessed by duplex ultrasonography in different follow up periods [ Time Frame: Baseline, 3 - 6, 12 months post-intervention ]

Current Secondary Outcome Measures (submitted: January 26, 2017)

• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ongoing Registry of Treatment of Chronic Venous Diseases
• Official Title: Russian Registry of Treatment of Chronic Venous Diseases
• 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

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 Type: Observational [Patient Registry]
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: 12 Months
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients undergoing interventions in cases varicose vein disease
• Condition: Varicose Veins of Lower Limb

Intervention

• 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

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 20, 2018): 5000
• Original Estimated Enrollment (submitted: January 26, 2017): 1000
• Estimated Study Completion Date: July 2036
• Estimated Primary Completion Date: July 2036 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• no exclusion criteria

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Russian Federation

Administrative Information

• NCT Number: NCT03035747
• Other Study ID Numbers: A001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Evgeny Ilyukhin, Medalp Private Surgery Clinic
• Study Sponsor: Medalp Private Surgery Clinic
• Collaborators: Pirogov Russian National Research Medical University
• Investigators: Not Provided
• PRS Account: Medalp Private Surgery Clinic
• Verification Date: February 2021