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Comparison of Simultaneous or Staged Treatment of Tributary Veins for Lower Extremity Varicose Veins: A Multicenter Randomized Controlled Study

Comparison of Simultaneous or Staged Treatment of Tributary Veins for Lower Extremity Varicose Veins: A Multicenter Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112483
Enrollment
Unknown
Registered
2025-11-14
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Varicose veins of the lower extremities

Interventions

Control group:Both groups underwent ultrasound-guided radiofrequency ablation for closure of the great saphenous vein (GSV). In addition, the control group received injection of 1% polidocanol foam sc
after removal of the bandage, patients must wear class II thigh-length compression stockings for one week.
Trial group:Both groups underwent ultrasound-guided radiofrequency ablation (RFA) for closure of the great saphenous vein (GSV). In the experimental group, patients were placed in the supine position.

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 (including the boundary value); 2. Patients with primary unilateral varicose saphenous veins of the lower extremities; 3. Clinical grade C2 to C4; 4. The collateral veins originate within 15 cm below the knee; 5. The hemodynamic classification is type I and type III involving the branches; 6. The main trunk diameter of the great saphenous vein in the thigh segment is >=3 mm to <=15 mm; 7. Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Body mass index >=35 kg/m^2 ; 2. The main trunk of the great saphenous vein is extremely twisted or closely attached to the subcutaneous tissue ; 3. Previous surgical history of varicose veins on the same side of the lower extremity (controlled by the researcher) ; 4. Previous deep vein thrombosis or thrombosis of the calf muscle vein ; 5. Uncorrectable coagulation dysfunction or significant blood abnormalities (platelet count <=30×10^9/L) ; 6. Known to be allergic to lidocaine or sclerotherapy agents ; 7. Ankle-brachial index <0.6 and/or absolute ankle pressure <60 mmHg ; 8. Those who are pregnant or breastfeeding, or plan to become pregnant within the next year ; 9. The diameter of the origin of the anterior saphenous vein is greater than 3.5 mm ; 10. Vulnerable groups, including those with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, illiterates, etc; 11. The researchers believe that there are other reasons for not being suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Re-intervention rate;

Secondary

MeasureTime frame
Time to return to normal operation;Patient satisfaction;The number of surgical incisions;Pain;Venous clinical severity score;Postoperative complications (including postoperative edema, skin sensory abnormalities, ecchymosis, etc.);Treatment cost;Dosage of swelling anesthetic fluid;Intraoperative blood loss;Quality of Life;Operation time;Target venous occlusion rate;

Countries

China

Contacts

Public ContactZhu Yuefeng

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

zhuyuefeng@126.com+86 571 86006667

Outcome results

None listed

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