Comparative Clinical Efficacy Between Multi-layer Bandage Pressure Therapy and Compression Stockings Treatment After Endovenous Radiofrequency Ablation
| Registry | NCT06366763 |
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 210 (Estimated) |
| Sponsor | Chengdu University of Traditional Chinese Medicine (Other) |
| Conditions | Vascular Diseases, Peripheral, Venous Insufficiency of Leg, Varicose Veins of Lower Limb |
| Interventions | Questionnaires (Procedure) |
| Dates | start 2023-08-01, primary completion 2024-08-01 (estimated), completion 2024-08-01 (estimated), first posted 2024-04-16, last updated 2024-04-16 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Vascular Diseases, Peripheral All trials for Venous Insufficiency of Leg All trials of Questionnaires
-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.
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+Detailed 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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| gradient pressure elastic stocking treatment after endovenous radiofrequency ablation. | Experimental | Procedure: Questionnaires | Among the 210 patients 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. |
- Questionnaires (Procedure): Questionnaires to assess the quality of life (CIVIQ-14 and VCSS scores )
+Outcome measures
Primary outcomes
- Pain after radiofrequency ablation [2 days post-procedure]: Pain is assessed using a visual analogue score (1-10), with higher scores representing more pronounced pain。
- Bleeding after radiofrequency ablation [2 days post-procedure]: 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
- Tension blisters after radiofrequency ablation [2 days post-procedure]: 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
Secondary outcomes
- The rate of occlusion of treated vein post-procedure [2 days, 1 month, 3 months, 1 year after surgery]: Use duplex ultrasound assess the occlusion of treated vein post-procedure,record the rate of occlusion of treated vein post-procedure
- Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14) [2 days, 1 month, 3 months, 1 year after surgery]: 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.
- Clinical Change using Venous Clinical Severity Score (VCSS) [2 days, 1 month, 3 months, 1 year after surgery]: 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.
+Eligibility
Sex: All, ages: 18 Years to 80 Years
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
+Locations (1)
| Facility | City | Country | Status |
|---|
| Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu, Sichuan | China | Recruiting |
+Publications
- Results publication: 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. PMID 34450353
- Results publication: 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):660-668. doi: 10.1016/j.jvsv.2020.10.008. Epub 2020 Oct 21. PMID 33099037
- Results publication: 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. 2012 Aug;44(2):214-23. doi: 10.1016/j.ejvs.2012.05.017. Epub 2012 Jun 15. PMID 22705163
- Results publication: 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. PMID 29582749
- Results publication: 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;36(3):281-288. doi: 10.23736/S0392-9590.17.03827-5. Epub 2017 Feb 17. PMID 28217989
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- Results publication: 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 lower extremities: Clinical practice guidelines of the American Venous Forum, Society for Vascular Surgery, American College of Phlebology, Society for Vascular Medicine, and International Union of Phlebology. J Vasc Surg Venous Lymphat Disord. 2019 Jan;7(1):17-28. doi: 10.1016/j.jvsv.2018.10.002. PMID 30554745