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Clinical Trials/NCT07445425
NCT07445425
Not yet recruiting
Not Applicable

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

Sir Run Run Shaw Hospital21 sites in 1 country206 target enrollmentStarted: March 1, 2026Last updated:
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InterventionsStaged surgery groupConcomitant surgery group

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
206
Locations
21
Primary Endpoint
The re-intervention rate
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts 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.

Arms & Interventions

A

Experimental

Intervention: Staged surgery group (Procedure)

B

Placebo Comparator

Intervention: Concomitant surgery group (Procedure)

Outcomes

Primary Outcomes

The re-intervention rate

Time Frame: 1 week, 3 months and 6 months after surgery

Secondary Outcomes

  • Treatment cost(6 months after surgery)
  • 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)
  • VAS score(Before surgery, 1 week, 3 months and 6 months after surgery)
  • VCSS score(Before surgery, 1 week, 3 months and 6 months after surgery)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (21)

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