Compression And Functional Ability After Endovenous Varicose Vein Treatment

Study Overview
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Brief Summary
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Study's aim is to study possible differences in post-operative rehabilitation, functional ability and visual disturbances after endovascular varicose intervention (RF-catheter and foam sclerotherapy) in two study groups, where patients will be randomised to either no compression group (Group I) or compression group (Group II)

Official Title
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Compression And Functional Ability After Endovenous Varicose Vein Treatment

Conditions
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Varicose Veins of Lower Limb, Varicose Veins

Intervention / Treatment
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* Other: Class II compression stockings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Duplex ultrasound verified GSV, AASV and/or SSV incompetence suitable for radiofrequency ablation Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4 Distal varicose vein insufficiency suitable for sclerotherapy Patient willingness to participate Exclusion Criteria: History of pulmonary embolism or deep venous thrombosis Large (>12mm) truncal vein diameter CEAP C5-C6 Antithrombotic medication (ASA accepted)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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 class II compression stockings continuously until next evening and then next 4 days during daytime. | Other: Class II compression stockings<br>* Patients in this group will use class II compression stocking continuously until next evening and then next 4 days during daytime<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | Visual Analog Scale (VAS) 0-100mm | 10days recorded daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional ability, other than pain | Visual Analog Scale 0-100mm indicating post-operative functional ability reduction | 10 days recorded daily | 
| Aberdeen Varicose Veins Questionnaire (AVVQ) | Score from 0 to 99.658 | Assessed preoperatively and at 2 months | 
| Visual appearance of varicose veins, patient assessment | Patient self-assessment (Patient Self-Assessment of Visible Varicose Veins, PA-V score) | Preoperatively and at 2 months | 
| Signs of deep venous thrombosis hematoma | Ultrasound assessment | Assessed at 2 months and earlier if necessary | 
| Time required returning to normal activity |  | 14 days | 
| Time required returning to full activity |  | 14 days | 
| Postoperative pigmentation | Pigmentation is monitored from standardised photographs on severity of pigmentation and most severe tone of post-operative pigmentation compared to base skin colour, reviewers are blinded to study group. | at 2 months | 
| Visual appearance of varicose veins, expert assessment | Photography Review -Visible Varicose Veins (IPR-V score, reviewers are blinded to time point and study group). | Preoperatively and at 2 months | 

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