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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-08-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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gradient pressure elastic stocking treatment after endovenous radiofrequency ablation.

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.

Group Type EXPERIMENTAL

Questionnaires

Intervention Type PROCEDURE

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

Interventions

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Questionnaires

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No