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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
206
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.
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.
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Peking University International Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, China
Hainan Provincial Hospital of Traditional Chinese Medicine
Haikou, Hainan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Zhoukou Central Hospital
Zhoukou, Henan, China
The First People's Hospital of Chenzhou
Chenzhou, Hunan, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
...and 11 more locations
The re-intervention rate
Time frame: 1 week, 3 months and 6 months after surgery
Treatment cost
According to the statistics of hospital charging system
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
The Aberdeen varicose vein questionnaire. The score range is 0-100, and the higher the score, the worse the result.
Time frame: Before surgery, 1 week, 3 months and 6 months after surgery
VAS score
Visual analogue scale. The score range is 0-10, and the higher the score, the worse the result.
Time frame: Before surgery, 1 week, 3 months and 6 months after surgery
VCSS score
Venous clinical severity score. The score range is 0-30, and the higher the score, the worse the result.
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
Include two question: "The quality of treatment that you received was good?" "The treatment that you received fulfilled your expectations?"
Time frame: During the operation and 6 months after surgery
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