Clinical trial NCT05840991: Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins
Official title: Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins : a Prospective, Multicenter, Non-inferiority, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicose Veins
Keywords: Varicose veins
Thermal ablation
Compression therapy
Targeted vein occlusion rate
Randomized controlled trial
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
Collaborators: name: Sir Run Run Shaw Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Wuhan Union Hospital, China
name: China-Japan Union Hospital, Jilin University
name: Yantai Yuhuangding Hospital
name: The First Affiliated Hospital of Dalian Medical University
name: Affiliated Hospital of Shaoxing University
name: Jiangsu Province Hospital of Traditional Chinese Medicine
First posted: 2023-05-03
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Target vein occlusion rate as assessed by duplex ultrasound scan
timeFrame: 3 months post-op
Secondary outcomes:
measure: Pain score as assessed by VAS
timeFrame: Baseline, 1 week post-op, 3 months post-op
measure: Quality of life score as assessed by AVVQ
timeFrame: Baseline, 1 week post-op, 3 months post-op
measure: Venous clinical severity score as assessed by VCSS
timeFrame: Baseline, 1 week post-op, 3 months post-op
measure: Postoperative complications
timeFrame: 1 week post-op, 3 months post-op
measure: Time to return to normal work
timeFrame: 1 week post-op, 3 months post-op
measure: Compliance
timeFrame: 1 week post-op, 3 months post-op
Other outcomes:
Locations:
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang Procince
Study officials:
References: