Varicose Veins of Lower Limb Clinical Trial
Official title:
Comparative Clinical Efficacy Between Multi-layer Bandage Pressure Therapy and Compression Stockings Treatment After Endovenous Radiofrequency Ablation
Objective: To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction.
Status | Recruiting |
Enrollment | 210 |
Est. completion date | August 1, 2024 |
Est. primary completion date | August 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age >18 years and <80 years, and able to understand the requirements of the study and provide informed consent and accept the exams and follow-up. - C2 - C5 varicose veins / CVI Symptomatic primary GSV, SSV, or AASV incompetence, with reflux >0.5 seconds on color duplex, eligible for patients undergoing radiofrequency ablation. - Color replica ultrasound or venography of the lower extremity veins shows saphenous varicose veins without evidence of deep venous stenosis, filling defects, or ultrasound abnormalities. - No contraindications to the wearing of compression stockings (e.g., arterial insufficiency, skin allergies) Exclusion Criteria: - Severe deep vein valve insufficiency or acute deep vein thrombosis of the lower extremities - Previous history of high ligation and dissection of the saphenous vein, recurrence of collateral branches of the deep vein - Superficial vein thrombosis is present at the treatment site, with local redness, swelling, warmth, pain, and significant signs of inflammation |
Country | Name | City | State |
---|---|---|---|
China | Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Chengdu University of Traditional Chinese Medicine |
China,
Epstein D, Bootun R, Diop M, Ortega-Ortega M, Lane TRA, Davies AH. Cost-effectiveness analysis of current varicose veins treatments. J Vasc Surg Venous Lymphat Disord. 2022 Mar;10(2):504-513.e7. doi: 10.1016/j.jvsv.2021.05.014. Epub 2021 Aug 25. — View Citation
Karathanos C, Spanos K, Batzalexis K, Nana P, Kouvelos G, Rousas N, Giannoukas AD. Prospective comparative study of different endovenous thermal ablation systems for treatment of great saphenous vein reflux. J Vasc Surg Venous Lymphat Disord. 2021 May;9(3 — View Citation
Lawaetz M, Serup J, Lawaetz B, Bjoern L, Blemings A, Eklof B, Rasmussen L. Comparison of endovenous ablation techniques, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Extended 5-year follow-up of a RCT. Int Angiol. 2017 Jun — View Citation
Lurie F, Lal BK, Antignani PL, Blebea J, Bush R, Caprini J, Davies A, Forrestal M, Jacobowitz G, Kalodiki E, Killewich L, Lohr J, Ma H, Mosti G, Partsch H, Rooke T, Wakefield T. Compression therapy after invasive treatment of superficial veins of the lowe — View Citation
Poder TG, Fisette JF, Bedard SK, Despatis MA. Is radiofrequency ablation of varicose veins a valuable option? A systematic review of the literature with a cost analysis. Can J Surg. 2018 Apr;61(2):128-138. doi: 10.1503/cjs.010114. — View Citation
Siribumrungwong B, Noorit P, Wilasrusmee C, Attia J, Thakkinstian A. A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg. 20 — View Citation
Staubesand J, Seydewitz V. [An ultrastructural study of sclerosed varices]. Phlebologie. 1991 Jan-Mar;44(1):16-22; discussion 33-6. French. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain after radiofrequency ablation | Pain is assessed using a visual analogue score (1-10), with higher scores representing more pronounced pain? | 2 days post-procedure | |
Primary | Bleeding after radiofrequency ablation | Through the observation of ward rounds and telephone follow-up of patients in the hospital, the frequency of postoperative lower limb bleeding events was obtained, with 0 representing no bleeding events and 1 representing bleeding events | 2 days post-procedure | |
Primary | Tension blisters after radiofrequency ablation | Through the observation of ward rounds and telephone follow-up of patients in the hospital, the frequency of postoperative lower extremity skin tension blister events was obtained, with 0 indicating negative and 1 indicating positive | 2 days post-procedure | |
Secondary | The rate of occlusion of treated vein post-procedure | Use duplex ultrasound assess the occlusion of treated vein post-procedure,record the rate of occlusion of treated vein post-procedure | 2 days, 1 month, 3 months, 1 year after surgery | |
Secondary | Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14) | CIVIQ-14 is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe).Based on inputs, CIVIQ-14 will be tabulated, ranging from 0 to 100 - the higher the value, the poorer the quality of life.In order to observe the changes in quality of life over the whole test procedure. | 2 days, 1 month, 3 months, 1 year after surgery | |
Secondary | Clinical Change using Venous Clinical Severity Score (VCSS) | VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (Mild) , 2(Moderate), 3 (Severe).Record the score separately to observe the changes in quality of life over the whole test procedure. | 2 days, 1 month, 3 months, 1 year after surgery |
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