Pelvic Embolisation to Reduce Recurrent Varicose Veins - Primary

Varicose Veins Clinical Trial

Official title: A Randomised Controlled Trial Investigating The Use Of Pelvic Vein Embolisation To Reduce Recurrent Varicose Veins Of The Legs In Women With Primary Varicose Veins And Associated Pelvic Venous Reflux.

Status Not yet recruiting

Clinical Trial Summary

The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic coil embolisaton) in females with leg varicose veins, who have a proven contribution to their leg varicose veins from pelvic reflux, have a reduction in recurrence after varicose vein surgery.

Clinical Trial Description

Varicose veins of the legs effect between 20 and 40% of the adult population in the UK. Approximately 100,000 operations performed per year for varicose veins. Failure to treat varicose veins results in 10 to 20% of patients deteriorating to skin damage or leg ulceration. Recurrence rates following surgery vary that have been reported up to 70% at 10 years.

The commonest causes of recurrence are reported to be:

• neovascularisation (new vessel growth after treatment)

• missing veins at the initial operation

• perforator vein incompetence

• de novo reflux due to normal deterioration with age

Recent studies have shown that leg varicose veins can be caused by pelvic venous reflux and that pelvic venous reflux is a cause of recurrent varicose veins. Previous published work from our own unit has shown that approximately 20% of women who present with varicose veins of the legs and who have had children previously have pelvic venous reflux on duplex ultrasound that contribute to the venous reflux in the legs, causing the varicose veins.

Furthermore, a recent retrospective study from our own unit has suggested that failure to treat pelvic venous reflux before treating leg varicose veins is a major cause of recurrent varicose veins in up to a quarter of women.

However, despite this circumstantial evidence, there is no evidence to prove whether the treatment of pelvic venous reflux confers any advantage on these patients in terms of reduction in recurrence of their varicose veins in the future.

The treatment of pelvic venous reflux is currently by coil embolisation of the veins under x-ray control. This procedure clearly has an additional cost over and above that of treating the legs. Therefore it is essential to know whether the treatment of the pelvic veins in these patients is any effect in reducing the recurrence of leg varicose veins.

To examine whether the addition of coil embolisation has significant benefits for patients, female patients presenting with primary leg varicose veins with a duplex proven contribution from pelvic venous reflux will be randomised to:

1. transjugular coil embolisation of pelvic veins followed by endovenous treatment of leg recurrent varicose veins or

2. endovenous treatment of leg recurrent varicose veins alone

The impact of demographic factors, the severity of patient's symptoms(Aberdeen questionnaire, CEAP and VCCS scores)and treatment history will be explored in addition to the type of treatment received.

Patients will be followed up at six weeks, six months, one year, two years, three years, four years and five years.

Assessments will be quality-of-life scoring (CIVIQ), symptom severity (Aberdeen questionnaire, CEAP and VCCS scores), patient satisfaction and clinical examination including clinical photographs, duplex ultrasonography.

In the presence of recurrent varicose veins, the source of these will also be classified through the use of duplex ultrasonography. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Varicose Veins
• Venous Insufficiency
• Venous Reflux

• NCT number: NCT01901731
• Study type: Interventional
• Source: The Whiteley Clinic
• Contact: Briony Hudson
• Phone: 01483 477180
• Email: bh00047@surrey.ac.uk
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2014
• Completion date: October 2018