Pelvic Embolisation to Reduce Recurrent Varicose Veins - Primary

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.

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.

Study Overview

• Status: Unknown
• Conditions: Varicose Veins; Venous Reflux
• Intervention / Treatment: Procedure: transjugular coil embolisation of pelvic veins; Procedure: endovenous treatment of leg varicose veins

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. 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 Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Guildford, United Kingdom, GU2 7RF
    • The Whiteley Clinic
  • Guildford, United Kingdom
    • The Imaging Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female gender
• Presenting with primary varicose veins in one or both legs with ultrasound --pelvic venous reflux in at least one trunk communicating with the leg varicose veins
• Over 18 years old
• Able to understand and give consent
• Willing to attend for follow ups over five year period

Exclusion Criteria:

• Pelvic 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 in the next five years
• Under 18 years of age.
• Unable to understand or give consent.
• Any vascular malformation of the pelvis or 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Embolisation of pelvic veins & treatment of leg varicose veins; Transjugular coil embolisation of pelvic veins followed by endovenous treatment of leg varicose veins	Procedure: transjugular coil embolisation of pelvic veins; Procedure: endovenous treatment of leg varicose veins
Active Comparator: Endovenous treatment of leg varicose veins alone; Endovenous treatment of legs varicose veins only	Procedure: endovenous treatment of leg varicose veins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in recurrent varicose veins or venous reflux	Recurrent varicose veins or venous reflux shown on duplex ultrasonography to be arising from pelvic venous reflux. Recurrent varicose veins will be divided into : Clinically insignificant (thread veins, reticular veins or varicose veins less than 3mm in diameter) Significant (varicose veins greater then 3mm in diameter, varicose veins associated with thrombophlebitis, or skin changes such as eczema, red skin or brown skin overlying the veins)	6 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 surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Participants will complete the Chronic Venous Insufficiency Questionnaire (CIVIQ) The CIVIQ comprises 20 questions in four quality-of-life domains: physical, psychological, social, and pain.	6 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 surgery
Patient satisfaction	Participants will complete a visual analogue scale from 0 (completely dissatisfied) to 10 (completely satisfied) to indicate their level of satisfaction with the treatment they have received.	6 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 surgery
Symptom severity	Participants 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.	6 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 surgery
Source of recurrence	Duplex 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	6 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 surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Any incidences of adverse events such as thrombophlebitis or deep vein thrombosis	6 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 surgery

Collaborators and Investigators

• Sponsor: The Whiteley Clinic
• Investigators: Principal Investigator: Mark Whiteley, Professor, The Whiteley Clinic

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Estimate): January 27, 2014
• Last Update Submitted That Met QC Criteria: January 24, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: transjugular coil embolisation; endovenous treatment of varicose veins; pelvic venous reflux; recurrent varicose veins
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: RTC12013