Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

Study Overview
=================
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.

Official Title
-----------------
Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

Conditions
-----------------
Varicose Veins

Intervention / Treatment
-----------------
* Device: Class II Compression Stockings


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Compression<br>Patients in this group will not receive any compression after treatment. | |
| Active Comparator: Compression<br>Patients in this group will use compression stockings for seven days after treatment (2 days continuously and 5 days during daytime). | Device: Class II Compression Stockings<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Truncal vein occlusion rate |  | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Varicose veins, Compression stockings, Sclerotherapy, Radiofrequency ablation