Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

Oulu University Hospital

Status: Completed

Conditions: Varicose Veins

Treatments: Device: Class II Compression Stockings

Study type: Interventional

Funder types: Other

Identifiers

NCT02890563

131/2016

Details and patient eligibility

About

Study purpose is to research whether compression therapy is beneficial after truncal vein RF-ablation and distal sclerotherapy done in the same session when needed. Patients will be randomised to either no compression group (Group I) or compression group (Group II)

Full description

In this study two endpoints are anticipated, first endpoint is to assess safety and adverse effects between groups at 1 month endpoint. Also post-procedural pain and need for painkillers are monitored. Compliance and reasons for non-compliance is recorded in compression group.

Second endpoint is to assess mid-term (6 months) success of truncal vein occlusion as well as changes in Aberdeen score between groups compared to pre-operative stage.

Study design is non-inferiority trial where in 5% margin occlusion of truncal vein is expected to be equal in two groups at 6 six months. Power analysis showed need for 85 patients per group and taking into account possible dropouts anticipated n = 200.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Duplex ultrasound verified GSV and/or SSV incompetence (0.5 seconds or more)
• Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
• Truncal vein insufficiency (GSV and/or SSV) treatable with Radiofrequency ablation

Exclusion criteria

• History of pulmonary embolism or deep venous thrombosis
• Large (>12mm) truncal vein diameter
• CEAP C5-C6
• Patient unwilling to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

No Compression

No Intervention group

Description:

Patients in this group will not receive any compression after treatment.

Compression

Active Comparator group

Description:

Patients in this group will use compression stockings for seven days after treatment (2 days continuously and 5 days during daytime).

Treatment:

Device: Class II Compression Stockings