Comparative Clinical Efficacy Between Multi-layer Bandage Pressure Therapy and Gradient Pressure Elastic Stocking Treatment After Endovenous Radiofrequency Ablation

NCT06366763 | Recruiting

• 1 other identifier: ChengduUTCMvs5
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vascular Diseases, Peripheral; Venous Insufficiency of Leg; Varicose Veins of Lower Limb

Keywords

Gradient pressure elastic stockings; Varicose veins; Radiofrequency ablation; Compression therapy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• The rate of occlusion of treated vein post-procedure

  2 days, 1 month, 3 months, 1 year after surgery

• Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14)

  2 days, 1 month, 3 months, 1 year after surgery

• Clinical Change using Venous Clinical Severity Score (VCSS)

  2 days, 1 month, 3 months, 1 year after surgery

Study Arms (1)

gradient pressure elastic stocking treatment after endovenous radiofrequency ablation.

EXPERIMENTAL

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.

Procedure: Questionnaires

Interventions

Questionnaires PROCEDURE

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

gradient pressure elastic stocking treatment after endovenous radiofrequency ablation.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610000, China

RECRUITING

Related 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.

  PMID: 34450353 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Staubesand J, Seydewitz V. [An ultrastructural study of sclerosed varices]. Phlebologie. 1991 Jan-Mar;44(1):16-22; discussion 33-6. French.

  PMID: 1946638 RESULT

• 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 RESULT

MeSH Terms

Conditions

Peripheral Vascular Diseases; Varicose Veins

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Chunshui He, Doctor

CONTACT

18981885601; chunshuihe@msn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Model Details: Among the 210 patients included in the study (82 males, 128 females; average age of 59 years), 7 patients were lost to follow-up, and the remaining patients completed the treatment and follow-up.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.

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: April 16, 2024
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)