Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins : a Prospective, Multicenter, Non-inferiority, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Varicose Veins
- Sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Target vein occlusion rate as assessed by duplex ultrasound scan
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with primary unilateral lower limb saphenous varicose veins aged 18 to 80 years
- •Patients with CEAP classification of C2-C4 stage
- •2mm≤diameter of the main trunk of the saphenous vein in the thigh segment ≤15mm
- •Agree to participate in this study and voluntarily sign the informed consent form
Exclusion Criteria
- •Patients who have difficulty tolerating surgery
- •The main trunk of the saphenous vein is extremely twisted or tightly attached to the skin
- •Previous history of ipsilateral varicose vein surgery in the lower extremity
- •Combined deep vein thrombosis in the affected lower extremity or previous deep vein thrombosis in the affected lower extremity
- •Uncorrectable coagulation dysfunction or significant blood abnormalities with significant bleeding tendency (platelets ≤ 30\*10\^9/L)
- •Acute thrombosis in the saphenous vein
- •Combination of the affected lower extremity lower extremity atherosclerotic occlusive disease who
- •Ankle-brachial index ABI \< 0.6 and/or absolute ankle pressure \< 60 mmHg
- •Patients who cannot wear elastic stockings or are allergic to elastic bandages or elastic stockings
- •Patients during pregnancy or lactation
Outcomes
Primary Outcomes
Target vein occlusion rate as assessed by duplex ultrasound scan
Time Frame: 3 months post-op
The primary outcome of the study is target vein occlusion rate at 3 months assessed with duplex ultrasound scan. Recanalisation will be defined by a segment of vein≥5cm. Target vein occlusion rate = Number of target venous closure cases in the group/total number of cases in the group
Secondary Outcomes
- Venous clinical severity score as assessed by VCSS(Baseline, 1 week post-op, 3 months post-op)
- Quality of life score as assessed by AVVQ(Baseline, 1 week post-op, 3 months post-op)
- Pain score as assessed by VAS(Baseline, 1 week post-op, 3 months post-op)
- Compliance(1 week post-op, 3 months post-op)
- Postoperative complications(1 week post-op, 3 months post-op)
- Time to return to normal work(1 week post-op, 3 months post-op)