Ongoing Registry of Treatment of Chronic Venous Diseases (RRT CVD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03035747|
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment|
|Varicose Veins of Lower Limb||Procedure: conventional surgery Procedure: endovenous laser ablation Procedure: sclerotherapy Procedure: endovenous radiofrequency ablation Procedure: phlebectomy|
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]|
|Estimated Enrollment :||5000 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Russian Registry of Treatment of Chronic Venous Diseases|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2036|
|Estimated Study Completion Date :||July 2036|
- 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
- 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 ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035747
|Contact: Evgeny Ilyukhin, MD, PhDfirstname.lastname@example.org|
|Medalp private surgery clinic||Recruiting|
|Saint Petersburg, Russian Federation, 197758|
|Contact: Oleg Shonov, MD email@example.com|