Comparison of Radiofrequency Ablation With Concomitant or Staged Treatment for Tributary Varicose Veins

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSir Run Run Shaw Hospital

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Staged surgery group

    Procedure/Surgery

    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.

  • Concomitant surgery group

    Procedure/Surgery

    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.

Treatment groups

206 Participants
are divided into 2 treatment groups
Group A: AExperimental treatment 1 intervention
Group B: BPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The re-intervention rate

Time frame
1 week, 3 months and 6 months after surgery

Secondary outcomes

1

Treatment cost

According to the statistics of hospital charging system

Time frame
6 months after surgery
2

Success rate of varicose vein closure

Time frame
1 week, 3 months and 6 months after surgery
3

Operation time

Time frame
During the operation
4

Number of incisions

Time frame
During the operation

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: