Pelvic Embolisation to Reduce Recurrent Varicose Veins - Recurrent

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by The Whiteley Clinic
Sponsor:
Information provided by (Responsible Party):
The Whiteley Clinic
ClinicalTrials.gov Identifier:
NCT01909024
First received: July 2, 2013
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Varicose Veins
Venous Reflux
Pelvic Congestion Syndrome
Procedure: Coil embolisation
Procedure: endovenous treatment of leg recurrent varicose veins

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by The Whiteley Clinic:

Primary Outcome Measures:
  • Change in recurrent varicose veins or venus reflux [ Time Frame: 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post surgery ] [ Designated as safety issue: No ]

    Does 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 Outcome Measures:
  • Quality of life [ Time Frame: 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 ] [ Designated as safety issue: No ]

    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.


  • Patient satisfaction [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Participants 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 severity [ Time Frame: 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 ] [ Designated as safety issue: No ]

    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.


  • Source of recurrence [ Time Frame: 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 ] [ Designated as safety issue: No ]

    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



Other Outcome Measures:
  • Adverse events [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Incidences of thrombophlebitis and deep vein thrombosis.


Estimated Enrollment: 270
Study Start Date: July 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: embolisation of pelvic veins & treatment of leg varicose veins
transjugular coil embolisation of pelvic veins followed by endovenous treatment of leg recurrent varicose veins
Procedure: Coil embolisation
transjugular coil embolisation of pelvic veins
Procedure: endovenous treatment of leg recurrent varicose veins
endovenous treatment of leg recurrent varicose veins
Active Comparator: endovenous treatment of leg recurrent varicose veins alone
endovenous treatment of leg recurrent varicose veins alone
Procedure: endovenous treatment of leg recurrent varicose veins
endovenous treatment of leg recurrent varicose veins

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01909024

Contacts
Contact: Briony Hudson 01483 477180 bh00047@surrey.ac.uk
Contact: Isabel Kay 01483 477180 isabel@thewhiteleyclinic.co.uk

Locations
United Kingdom
The Whiteley Clinic Not yet recruiting
Guildford, United Kingdom, GU2 7RF
Contact: Mark Whiteley, Professor    01483 477180    mark@thewhiteleyclinic.co.uk   
Contact: Isabel Kay    01483 477180    Isabel@thewhiteleyclinic.co.uk   
Principal Investigator: Mark Whiteley, Professor         
Sub-Investigator: Tim Fernandez Hart         
Sub-Investigator: Barry Price         
Sub-Investigator: Judy Holdstock         
Sub-Investigator: Charmaine Harrison         
Sub-Investigator: Previn Diwakar         
Sub-Investigator: Archie Spears         
Sub-Investigator: Mark Pemberton         
Sub-Investigator: Briony Hudson         
The Imaging Clinic Not yet recruiting
Guildford, United Kingdom
Contact: Tony Lopez, BSC, MRP, FRCR         
Principal Investigator: Tony Lopez, Bsc, MRCP, FRCR         
Sponsors and Collaborators
The Whiteley Clinic
Investigators
Principal Investigator: Mark Whiteley, Professor The Whiteley Clinic
  More Information

No publications provided

Responsible Party: The Whiteley Clinic
ClinicalTrials.gov Identifier: NCT01909024     History of Changes
Other Study ID Numbers: RCT23013
Study First Received: July 2, 2013
Last Updated: May 16, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by The Whiteley Clinic:
Randomised controlled trial
Endovenous laser treatment
Transjugular coil embolisation

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014