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Pelvic Embolisation to Reduce Recurrent Varicose Veins - Recurrent

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01909024
Enrollment
270
Registered
2013-07-26
Start date
2013-07-31
Completion date
2018-12-31
Last updated
2014-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Congestion Syndrome, Varicose Veins, Venous Reflux

Keywords

Randomised controlled trial, Endovenous laser treatment, Transjugular coil embolisation

Brief summary

The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic embolisation) in females with recurrent leg varicose veins, who have a proven contribution to their leg varicose veins from pelvic venous reflux, have a reduction in future recurrence after endovenous laser treatment for recurrent varicose veins in the legs.

Detailed 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, although it is unknown how many of these are for recurrent 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 and have been reported up to 70% at 10 years. Recurrence causes an increased cost as well as an increase in the patient's healthcare requirements. 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. Such pelvic venous reflux contributes 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 future recurrence of their varicose veins, following treatment. 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 leg varicose veins alone. Therefore it is essential to know whether the treatment of the pelvic veins in these patients has any effect in reducing future recurrence of leg varicose veins. To examine the benefits of coil embolisation, female patients presenting with recurrent 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. Outcome measures will include quality-of-life scoring (CIVIQ), symptom severity measures (Aberdeen questionnaire, CEAP and VCCS scores), patient satisfaction with treatment and clinical examination including clinical photographs and duplex ultrasonography. The source of any recurrence will be classified through the use of duplex ultrasonography.

Interventions

PROCEDURECoil embolisation

transjugular coil embolisation of pelvic veins

PROCEDUREendovenous treatment of leg recurrent varicose veins

endovenous treatment of leg recurrent varicose veins

Sponsors

The Whiteley Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Females presenting with recurrent varicose veins in one or both legs with ultrasound proven pelvic venous reflux in at least one pelvic venous trunk communicating with the leg varicose veins * Duplex proven reflux in the superficial venous system of the leg * Over 18 years old * Able to understand and give consent * Willing to attend for follow-up over the five years

Exclusion criteria

* Pelvic venous reflux does not communicate with the varicose veins to be treated in the legs * If pelvic venous reflux communicates and contributes to varicose veins in one leg but not the other, only the leg with a pelvic venous contribution will be entered into the study * Currently pregnant or plans for pregnancy within the next five years * Under 18 years of age * Unable to understand all give consent * Any vascular malformation of the pelvis all the legs apart from that diagnosed as venous reflux disease * Any medical condition likely to cause death or serious ill-health within the next five years Any deep venous obstruction or reflux

Design outcomes

Primary

MeasureTime frameDescription
Change in recurrent varicose veins or venus reflux6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post surgeryDoes the patient have recurrence? Recurrent varicose veins will be divided into: * Clinically insignificant (thread veins, reticular veins or varicose veins less than 3 mm in diameter) * Significant (varicose veins greater than 3 mm in diameter, varicose veins associated with thrombophlebitis, or skin changes such as venous eczema, red skin or Brown skin overlying the veins)

Secondary

MeasureTime frameDescription
Quality of life6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgeryParticipants will complete the Chronic Venous Insufficiency Questionnaire (CIVIQ) The CIVIQ comprises 20 questions in four quality-of-life domains: physical, psychological, social, and pain.
Patient satisfaction6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgeryParticipants will complete a visual analogue scale, from 0 (completely dissatisfied) to 10 (completely satisfied) to indicate their level of satisfaction with the treatment that they have received.
Symptom severity6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgeryParticipants will complete the Aberdeen questionnaire to assess the severity and impact of their varicose veins on their lives. Duplex ultrasound, the CEAP and VCCS will also be used to assess the severity of symptoms.
Source of recurrence6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgeryDuplex ultrasound will be used to identify the source of any recurrent varicose veins, enabling classification into: recurrence due to pelvic venous incompetence recurrence of leg varicose veins due to failure of surgery recurrence of leg varicose veins due to de novo reflux

Other

MeasureTime frameDescription
Adverse events6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgeryIncidences of thrombophlebitis and deep vein thrombosis.

Countries

United Kingdom

Contacts

Primary ContactBriony Hudson
bh00047@surrey.ac.uk01483 477180
Backup ContactIsabel Kay
isabel@thewhiteleyclinic.co.uk01483 477180

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026