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

NCT05840991 | Unknown

• 1 other identifier: K2023047
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins

Keywords

Varicose veins; Thermal ablation; Compression therapy; Targeted vein occlusion rate; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Target vein occlusion rate as assessed by duplex ultrasound scan

  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

  3 months post-op

Secondary Outcomes (6)

• Pain score as assessed by VAS

  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

• Venous clinical severity score as assessed by VCSS

  Baseline, 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

Study Arms (2)

Short-term compression group

EXPERIMENTAL

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

Device: elastic bandage

Long-term compression group

ACTIVE COMPARATOR

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

Device: elastic bandage; Device: compression stocking

Interventions

elastic bandage DEVICE

3M™ Coban™ elastic bandage

Long-term compression group; Short-term compression group

compression stocking DEVICE

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

Long-term compression group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary unilateral lower limb saphenous varicose veins aged 18 to 80 years
• Patients with CEAP classification of C2-C4 stage
• mm≤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

You may not qualify if:

• 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
• Previous history of pulmonary embolism
• Participating in clinical trials of other drugs or devices
• Other patients deemed unsuitable for this study by the investigator

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead
• Sir Run Run Shaw Hospital: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• China-Japan Union Hospital, Jilin University: collaborator
• Yantai Yuhuangding Hospital: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Affiliated Hospital of Shaoxing University: collaborator
• Jiangsu Province Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Yiwu, Zhejiang Procince, 310000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37828585 DERIVED

MeSH Terms

Conditions

Varicose Veins

Interventions

Compression Bandages; Stockings, Compression

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 3, 2023
• Study Start: May 22, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)