Comparison of Radiofrequency Ablation With Concomitant or Staged Treatment for Tributary Varicose Veins
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Staged surgery group, Concomitant surgery group.
- Who it may be relevant to
- Registry conditions: Varicose Veins of Lower Limb. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Concomitant or Staged Treatment of Tributary Veins for Lower Extremity Varicose Veins: A Multicenter Randomized Controlled Study
Overview
The purpose of this clinical trial is to know which is better to treat the branch vein at the same time or in stages during radiofrequency ablation. The main questions it aims to answer are: Does the patient who did not treat the branch vein in the first stage of operation need to intervene again? Are there any differences in patients' indexes between the two surgical strategies? Participants will: Radiofrequency ablation with or without foam sclerosing agent therapy One week, three months and six months after operation, go to the clinic for a reexamination. Record their symptoms
Interventions
- Procedure Staged surgery group
The patient is placed in the supine position, and then a DUS examination of the GSV in the affected limbs will be performed. At the appropriate site, local anesthesia will be performed, and the ultrasound-guided Seldinger technique will be used to puncture the main trunk of the GSV 10cm above and below the knee joint. When the needle puncture is successful, we will insert the guidewire, and a 7F vascular sheath (Terumo) will be inserted along the guidewire. Then, we will insert the radiofrequenc - Procedure Concomitant surgery group
While the experimental group receives ablation alone, the control group received 1% polidocanol foam sclerosant injection and/or point excision treatment for the pre-marked calf segment branches of the GSV after ablation treatment. Both groups will wear elastic bandages for 24 hours postoperatively, followed by thigh-length class II compression stockings for 1 week after bandage removal.
Primary outcome measures
- The re-intervention rate [Time frame: 1 week, 3 months and 6 months after surgery]
Secondary outcome measures (12)
- Treatment cost [Time frame: 6 months after surgery]
- Success rate of varicose vein closure [Time frame: 1 week, 3 months and 6 months after surgery]
- Operation time [Time frame: During the operation]
- Number of incisions [Time frame: During the operation]
- Tumescent anesthesia solution dosage [Time frame: During the operation]
- The amount of intraoperative bleeding [Time frame: During the operation]
- AVVQ score [Time frame: Before surgery, 1 week, 3 months and 6 months after surgery]
- VAS score [Time frame: Before surgery, 1 week, 3 months and 6 months after surgery]
- VCSS score [Time frame: Before surgery, 1 week, 3 months and 6 months after surgery]
- Postoperative complications [Time frame: 1 week, 3 months and 6 months after surgery]
- Time to return to regular work [Time frame: 1 week after surgery]
- Patient satisfaction [Time frame: During the operation and 6 months after surgery]
Eligibility criteria
Inclusion criteria
aged between 18 and 80 years; primary unilateral lower limb GSV varicose; hemodynamic classification I and III involvement in tributary veins, tributary veins originating within 15 cm inferior to the knee joint; clinical grade C2-C4; primary trunk diameter of GSV in thigh segment≥3mm to ≤ 15 mm; agree to participate in this study and voluntarily sign an informed consent form.
Exclusion criteria
Body Mass Index (BMI) ≥35kg/m2; severe tortuosity or tight adherence of the trunk of the GSV to the skin in the thigh; history of previous varicose vein surgery on the ipsilateral lower limb (investigator allows to be controlled); previous deep vein thrombosis and/or calf muscle venous thrombosis; uncorrectable coagulation disorders or significant blood abnormalities (platelets≤30×109/L); allergy to lidocaine or sclerosing agents; ankle-brachial index (ABI) <0.6 and/or absolute ankle pressure <60mmHg; pregnancy or lactation, or intend to have a child in the next year; participation in other clinical trials; anterior saphenous vein start diameter>3.5mm; any other patients investigator considers improper to participate in this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 21 centers
- The First Affiliated Hospital of Bengbu Medical University — Bengbu
- Peking University International Hospital — Beijing
- Peking University Third Hospital — Beijing
- Guangxi Zhuang Autonomous Region People's Hospital — Nanning
- The First Affiliated Hospital of Guangxi University of Chinese Medicine — Nanning
- Hainan Provincial Hospital of Traditional Chinese Medicine — Haikou
- Zhengzhou Central Hospital — Zhengzhou
- Zhoukou Central Hospital — Zhoukou
- … and 13 more centers
Identifiers
NCT: NCT07445425 · 2025-2700-01