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

NCT ID: NCT05840991

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2023-12-31

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.

Conditions

Varicose Veins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Short-term compression group

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

Group Type: EXPERIMENTAL

elastic bandage

Intervention Type: DEVICE

3M™ Coban™ elastic bandage

Long-term compression group

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

Group Type: ACTIVE_COMPARATOR

elastic bandage

Intervention Type: DEVICE

3M™ Coban™ elastic bandage

compression stocking

Intervention Type: DEVICE

Class 2 compression full-length stocking (23-32mm Hg)

Interventions

elastic bandage

3M™ Coban™ elastic bandage

Intervention Type: DEVICE

compression stocking

Class 2 compression full-length stocking (23-32mm Hg)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

China-Japan Union Hospital, Jilin University

OTHER

Sponsor Role: collaborator

Yantai Yuhuangding Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Shaoxing University

UNKNOWN

Sponsor Role: collaborator

Jiangsu Province Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Yiwu, Zhejiang Procince, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yuefeng Zhu

Role: primary

srrshzyf@zju.edu.cn

13868101010

References

Tang M, Jiang W, Hong J, Li L, Shang D, Zhao Y, Liu Z, Qi M, Jin M, Zhu Y. Effect of short-term compression therapy after thermal ablation for varicose veins: study protocol for a prospective, multicenter, non-inferiority, randomized controlled trial. Trials. 2023 Oct 12;24(1):669. doi: 10.1186/s13063-023-07609-1.

Reference Type: DERIVED

PMID: 37828585 (View on PubMed)

Other Identifiers

K2023047

Identifier Type: -

Identifier Source: org_study_id