Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status: Enrolling

Conditions: Varicose Veins

Treatments: Device: elastic bandage; Device: compression stocking

Study type: Interventional

Funder types: Other

Identifiers

NCT05840991

K2023047

Details and patient eligibility

About

A prospective, multicenter, non-inferiority, randomized controlled trial is designed to evaluate the effect after short-term compression therapy following thermal ablation of varicose veins. Patients will be randomly assigned in a 1:1 ratio to one of the following treatments: (A) elastic bandage for 48h or (B) elastic bandage for the first 24h and then a compression full-length stocking (23-32mm Hg) for 1 week. The two groups will be compared on several variables, including target vein occlusion rate at 3 months (primary outcome indicator) , as well as pain, quality of life, clinical severity of varicose veins, postoperative complications, time to return to normal work, and compliance.

Full description

A prospective, multicenter, non-inferiority, randomized controlled trial is designed to evaluate the effect after short-term compression therapy following thermal ablation of varicose veins. Patients will be randomly assigned in a 1:1 ratio to one of the following treatments: (A) elastic bandage for 48h or (B) elastic bandage for the first 24h and then a compression full-length stocking (23-32mm Hg) for 1 week. The two groups will be compared on several variables, including target vein occlusion rate at 3 months (primary outcome indicator) , as well as pain, quality of life, clinical severity of varicose veins, postoperative complications, time to return to normal work, and compliance.

The current study will take place in nine hospitals in six provinces in China. Target Population Patients referred to those with primary lower extremity saphenous varicose veins diagnosed in 9 target hospitals from April 2023 to August 2023, and all participants included in the trial signed an informed consent form.

Intervention

Group A: elastic bandage for 48h Group B: elastic bandage for the first 24h and then a compression full-length stocking (23-32mm Hg) for 1 week Follow-up

At baseline, patients will be asked to fill a validated visual analogue scale (VAS) , quality of life questionnaires (AVVQ), and clinical severity of varicose veins (VCSS) . They will also be asked to attend a follow-up in 1 week and at 3 months.

At 1 week, target vein closure rate will be examined by double ultrasound scan (DUS) and patients will be asked to fill VAS, AVVQ, VCSS, postoperative complications , time to return to normal work, and compliance.

At 3 months, target vein closure rate will be examined by double ultrasound scan (DUS) and patients will be asked to fill VAS, AVVQ, VCSS, postoperative complications , time to return to normal work, and compliance.

Sample Size

The target vein closure rate in the control group was set to 98%, and α=0.025 (unilateral) and (1-β)=0.9 were taken, combined with clinical expert recommendations, a non-inferiority threshold δ of -6% was taken. We would need to recruit 230 patients (115 per group) to show a difference. However, to increase the robustness of the results, considering a potential lost-to-review rate of 20% of study subjects, combined with the low probability of adverse events in this trial, the total sample size was expanded to 360.

Study duration

With 3 months follow-up, therefore, the study will be running for 12 months with a target recruitment of 360 patients.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with primary unilateral lower limb saphenous varicose veins aged 18 to 80 years
2. Patients with CEAP classification of C2-C4 stage
3. 2mm≤diameter of the main trunk of the saphenous vein in the thigh segment ≤15mm
4. Agree to participate in this study and voluntarily sign the informed consent form

Exclusion criteria

1. Patients who have difficulty tolerating surgery
2. The main trunk of the saphenous vein is extremely twisted or tightly attached to the skin
3. Previous history of ipsilateral varicose vein surgery in the lower extremity
4. Combined deep vein thrombosis in the affected lower extremity or previous deep vein thrombosis in the affected lower extremity
5. Uncorrectable coagulation dysfunction or significant blood abnormalities with significant bleeding tendency (platelets ≤ 30*10^9/L)
6. Acute thrombosis in the saphenous vein
7. Combination of the affected lower extremity lower extremity atherosclerotic occlusive disease who
8. Ankle-brachial index ABI < 0.6 and/or absolute ankle pressure < 60 mmHg
9. Patients who cannot wear elastic stockings or are allergic to elastic bandages or elastic stockings
10. Patients during pregnancy or lactation
11. Previous history of pulmonary embolism
12. Participating in clinical trials of other drugs or devices
13. Other patients deemed unsuitable for this study by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Short-term compression group

Experimental group

Description:

Patients randomised to group A will be provided with bandages to wear for 48 hours only

Treatment:

Device: elastic bandage

Long-term compression group

Active Comparator group

Description:

Patients randomised to group B will be asked to wear bandages for the first 24h and then a Class 2 compression full-length stocking (23-32mm Hg) for 1 week

Treatment:

Device: elastic bandage

Device: compression stocking