Study of Foam Sclerotherapy Versus Ambulatory Phlebectomy

Imperial College London160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

160

Conditions

Varicose Veins

Interventions

Ambulatory phlebectomyPROCEDURE

Minor surgery to remove varicose vein tributaries

Foam sclerotherapyDRUG

Injection of foam sclerosant into varicose vein tributaries

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Charing Cross Hospital, Imperial College London

London, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Re-intervention rate

Re-intervention on varicose vein tributaries during study period

Time frame: 12 months

Secondary Outcomes

Generic quality of life score

Quality of life score using the EuroQol's EQ-5D \[0=worse quality of life; 1=best quality of life\]

Time frame: 12 months

Disease-specific quality of life score

Quality of life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) \[0=worse quality of life; 100= best quality of life\]

Time frame: 12 months

Disease specific quality of life score

Quality of life score using the ChronIc Venous Insufficiency Quality of Life Questionnaire (CIVIQ) \[0=worse quality of life; 100=best quality of life\]

Time frame: 12 months

Clinical score

Clinical change using the Venous Clinical Severity Score (VCSS) \[0=least severe disease; 30=most severe disease\]

Time frame: 12 months

Clinical score

Using the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification \[0=no varicose veins; 1=telangiectasia; 2= varicose veins; 3=oedema; 4=skin changes; 5=healed ulcer; 6=ulcer\]

Time frame: 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)

Time frame: 2 weeks

Degree of bruising at 2 weeks

Central Contacts

Amjad Belramman

CONTACT

02033117335 a.belramman17@imperial.ac.uk

Roshan Bootun

CONTACT

02033117335 r.bootun@imperial.ac.uk

Data from ClinicalTrials.gov

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