Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

Not Applicable

Completed

• Conditions: Varicose Veins
• Interventions: Device: Class II Compression Stockings

• Registration Number: NCT02890563
• Lead Sponsor: Oulu University Hospital

Brief Summary

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)

Detailed 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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-31
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-07
• Status Verified: 2019-03
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compression	Class II Compression Stockings	Patients in this group will use compression stockings for seven days after treatment (2 days continuously and 5 days during daytime).

Primary Outcome Measures

Name	Time	Method
Truncal vein occlusion rate	6 months

Secondary Outcome Measures

Name	Time	Method
Time required returning to normal work and activity level	14 days
Compliance with compression stockings	7 days	To assess compliance and possible reasons for non-compliance at compression group
Painkillers usage after treatment	10 days	Need for Paracetamol/NSAIDs after treatment
Post-operative pain assessed with visual analogue scale (VAS)	10 days
Aberdeen Varicose Veins Questionnaire (AVVQ)	6 months	Assessed preoperatively and at one and six months
Signs of deep venous thrombosis, pigmentation, blisters, skin irritation, thrombophlebitis, hematoma, wound infection or paraesthesia post operatively	30days	Assessed in 1month control and earlier if necessary (Patient is instructed to contact outpatient clinic in case of problems).

Trial Locations

Locations (2)

Raahe's hospital; 🇫🇮 Raahe, Pohjois-Pohjanmaa, Finland

Oulu University Hospital, Vascular Department; 🇫🇮 Oulu, Finland