Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

Study Overview
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Brief Summary
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This study will be comparing the treatment of varicose vein tributaries using either foam sclerotherapy or ambulatory phlebectomies. Patients will be randomised to having either ambulatory phlebectomy (group A) or foam sclerotherapy (group B) following treatment of their saphenous vein. The re-intervention rates, safety, patient experience as well as the cost effectiveness of each intervention will be assessed.

Official Title
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Randomised Controlled Trial of Foam Sclerotherapy Versus Ambulatory Phlebectomy for the Treatment of Varicose Vein Tributaries

Conditions
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Varicose Veins

Intervention / Treatment
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* Procedure: Ambulatory phlebectomy
* Drug: Foam sclerotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over 18 years of age Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex Varicose vein tributary requiring treatment Exclusion Criteria: Current DVT Recurrent varicose veins Arterial disease (ABPI<0.8) Vein diameter < 3mm Preference for one of the treatment options Patient who are unwilling to participate Inability or unwillingness to complete questionnaires Inability to attend follow-up appointments Patient currently included in a study of varicose vein treatment

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ambulatory Phlebectomy<br>Ambulatory phlebectomy of varicose vein tributaries | Procedure: Ambulatory phlebectomy<br>* Minor surgery to remove varicose vein tributaries<br>|
| Active Comparator: Foam Sclerotherapy<br>Injection of foam sclerosant into varicose vein tributaries | Drug: Foam sclerotherapy<br>* Injection of foam sclerosant into varicose vein tributaries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-intervention rate | Re-intervention on varicose vein tributaries during study period | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generic quality of life score | Quality of life score using the EuroQol's EQ-5D [0=worse quality of life; 1=best quality of life] | 12 months | 
| Disease-specific quality of life score | Quality of life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) [0=worse quality of life; 100= best quality of life] | 12 months | 
| Disease specific quality of life score | Quality of life score using the ChronIc Venous Insufficiency Quality of Life Questionnaire (CIVIQ) [0=worse quality of life; 100=best quality of life] | 12 months | 
| Clinical score | Clinical change using the Venous Clinical Severity Score (VCSS) [0=least severe disease; 30=most severe disease] | 12 months | 
| Clinical score | Using the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification [0=no varicose veins; 1=telangiectasia; 2= varicose veins; 3=oedema; 4=skin changes; 5=healed ulcer; 6=ulcer] | 12 months | 
| Pain score over the first 10 days | Pain score over the first 10 days using a 0-100mm visual analogue scale (0=no pain; 100=worst pain) | 2 weeks | 
| Degree of bruising at 2 weeks | Degree of bruising at 2 weeks using a categorical 0-5 bruising scale (0=no bruising; 5=bruising extending beyond treated segment) | 2 weeks | 
| Time to return to normal activities |  | 2 weeks |