Varicose Veins of Lower Limb
Conditions
Brief summary
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
PROCEDUREStaged 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 radiofrequency catheter and advanced the tip to approximately 2 cm at the junction of the saphenofemoral vein, where it will be left in place. Under ultrasound guidance, the needle will be tightly attached to the GSV sheath, and an anesthetic solution will be injected to treat the swelling until the junction of the saphenofemoral vein will be reached. Then, we will secure the tip of the radiofrequency catheter and switch on the radiofrequency generator and ablated the primary trunk of the GSV in segments.
PROCEDUREConcomitant 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.
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The re-intervention rate | 1 week, 3 months and 6 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment cost | 6 months after surgery | According to the statistics of hospital charging system |
| Success rate of varicose vein closure | 1 week, 3 months and 6 months after surgery | — |
| Operation time | During the operation | — |
| Number of incisions | During the operation | — |
| Tumescent anesthesia solution dosage | During the operation | — |
| The amount of intraoperative bleeding | During the operation | — |
| AVVQ score | Before surgery, 1 week, 3 months and 6 months after surgery | The Aberdeen varicose vein questionnaire. The score range is 0-100, and the higher the score, the worse the result. |
| VAS score | Before surgery, 1 week, 3 months and 6 months after surgery | Visual analogue scale. The score range is 0-10, and the higher the score, the worse the result. |
| VCSS score | Before surgery, 1 week, 3 months and 6 months after surgery | Venous clinical severity score. The score range is 0-30, and the higher the score, the worse the result. |
| Postoperative complications | 1 week, 3 months and 6 months after surgery | — |
| Time to return to regular work | 1 week after surgery | — |
| Patient satisfaction | During the operation and 6 months after surgery | Include two question: "The quality of treatment that you received was good?" "The treatment that you received fulfilled your expectations?" |
Countries
China
Contacts
CONTACTMeijia Xu
Outcome results
None listed