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

Varicose Veins Clinical Trial

Official title:

Effect of Short-term Compression Therapy After Thermal Ablation for Varicose Veins : a Prospective, Multicenter, Non-inferiority, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05840991
• Other study ID #: K2023047
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Device:
• elastic bandage
3M™ Coban™ elastic bandage
• compression stocking
Class 2 compression full-length stocking (23-32mm Hg)

Locations

Country	Name	City	State
China	The Fourth Affiliated Hospital Zhejiang University School of Medicine	Yiwu	Zhejiang Procince

Sponsors (9)

Lead Sponsor	Collaborator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine	Affiliated Hospital of Shaoxing University, China-Japan Union Hospital, Jilin University, Jiangsu Province Hospital of Traditional Chinese Medicine, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Dalian Medical University, Wuhan Union Hospital, China, Yantai Yuhuangding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain score as assessed by VAS	Patients will be asked to record pain scores with Visual Analogue Score (VAS), The scale ranges from 0 (no pain) to 10 (worst pain imaginable).	Baseline, 1 week post-op, 3 months post-op
Secondary	Quality of life score as assessed by AVVQ	Patients will be asked to fill the Aberdeen Varicose Veins Questionnaire (AVVQ) to measure health status of varicose vein patients based on symptoms and impact on daily activities. A total score ranging from 0 to 35, with 35 being worst quality of life.	Baseline, 1 week post-op, 3 months post-op
Secondary	Venous clinical severity score as assessed by VCSS	Patients will be asked to fill the Venous Clinical Severity Score (VCSS) to evaluate the severity of hallmarks of venous disease. The questionnaire consisted of ten questions, each of which was answered by 0 (none), 1 (Mild), 2(Moderate) and 3 (Severe). A total score ranging from 0 to 30, with 30 being worst quality of venous disease.	Baseline, 1 week post-op, 3 months post-op
Secondary	Postoperative complications	Postoperative complications included postoperative sensory abnormalities, skin burns/discoloration, phlebitis, hematoma, infection, deep vein thrombosis, and pulmonary embolism.	1 week post-op, 3 months post-op
Secondary	Time to return to normal work	The investigator will use a uniform question to ask the patient how long it takes to return to normal work or life, or both (days).	1 week post-op, 3 months post-op
Secondary	Compliance	Compliance refers to the extent to which patients followed compression therapy as recommended by their clinicians.Investigators will use a uniform question to ask patients whether they have completed compression treatment as recommended by their doctors in the past week or three months.- 1 (None) , 2 (occasionally) , 3 (mostly) , and 4 (completely) . Those who did not fully follow the study protocol for compression treatment should continue to be asked about their actual compression treatment and recorded.	1 week post-op, 3 months post-op