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A Prospective Multicenter Randomized Controlled Trial of Efficacy, Health Economics, and Quality of Life in Treating Lower Extremity Varicose Veins with Different Surgical Modes

A Prospective Multicenter Randomized Controlled Trial of Efficacy, Health Economics, and Quality of Life in Treating Lower Extremity Varicose Veins with Different Surgical Modes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110184
Enrollment
Unknown
Registered
2025-10-10
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose veins

Interventions

Research group:Undergoing minimally invasive surgery for lower extremity varicose veins under the ambulatory surgery model
Control group:Undergoing minimally invasive surgery for lower extremity varicose veins under the conventional surgical model

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-80 years with unilateral lower limb varicose veins; 2. Clinical classification of varicose veins of grade C2 or above, with ultrasound confirming venous valve reflux time exceeding 0.5s, perforator veins around the ulcer with a diameter greater than 3.5mm, and reflux time exceeding 0.5s; 3. Patients without severe cardiopulmonary dysfunction or significant coagulation disorders; 4. Complete relevant clinical data; 5. Agree to participate in this study and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Lower extremity varicose veins secondary to deep vein thrombosis or other underlying diseases; 2.Distance between the venous trunk and skin less than 1 cm; 3.Severe tortuosity of the venous trunk, such that the radiofrequency catheter is assessed to be unable to pass through the tortuous vein; 4.Aneurysmal dilation of the great saphenous vein at the sapheno-femoral junction (SFJ).

Design outcomes

Primary

MeasureTime frame
The closure rate of the main trunk of varicose veins in the unilateral lower extremity ;

Secondary

MeasureTime frame
The incidence of postoperative complications of varicose veins ;The "Clinical, Etiological, Anatomical, and Pathophysiological" classification, Visual Analogue Scale , Aberdeen Varicose Vein Questionnaire , and Venous Clinical Severity Score;The closure rate of the main trunk of varicose veins in the unilateral lower extremity at 12 months after surgery;The residual rate of varicose veins after surgery at 7 days, 1 month, 6 months, and 12 months postoperatively;

Countries

China

Contacts

Public ContactShaoying Lu

The First Affiliated Hospital of Xi'an Jiaotong University

robertlu@xjtu.edu.cn+86 18991232015

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026