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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06366763
Other study ID # ChengduUTCMvs5
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date August 1, 2024

Study information

Verified date April 2024
Source Chengdu University of Traditional Chinese Medicine
Contact Chunshui He, Doctor
Phone 18981885601
Email chunshuihe@msn.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Postoperative compression of varicose veins can achieve compression hemostasis, early getting out of bed, reducing edema, preventing phlebitis, ensuring closure effect, reducing soreness and pain, and preventing thrombosis. Compression therapy is a continuation of minimally invasive treatment of varicose veins, and postoperative compression therapy is continued for at least 1 month, and grade II compression therapy may be considered.The application of postoperative compression to the treated limb after radiofrequency ablation of the great saphenous vein has been a topic of controversy. The basic principle of using postoperative compression is to reduce the risk of bleeding, hematoma formation, pain, swelling, and thrombus formation. However, many patients find wearing gradient pressure elastic stockings cumbersome and uncomfortable, as the silicone grips around the stockings can cause skin itching and discomfort. Moreover, there is a lack of strong evidence supporting this treatment. The purpose of this study was to investigate the effectiveness of continuous 48-hour use of gradient pressure elastic stockings for compression of the affected limb after endovenous radiofrequency ablation.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Questionnaires
Questionnaires to assess the quality of life (CIVIQ-14 and VCSS scores )

Locations

Country Name City State
China Hospital of Chengdu University of Traditional Chinese Medicine Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Chengdu University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (7)

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

Outcome

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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