Pelvic Embolisation to Reduce Recurrent Varicose Veins - Primary
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01901731|
Recruitment Status : Not yet recruiting
First Posted : July 17, 2013
Last Update Posted : January 27, 2014
|Condition or disease||Intervention/treatment||Phase|
|Varicose Veins Venous Reflux||Procedure: transjugular coil embolisation of pelvic veins Procedure: endovenous treatment of leg varicose veins||Not Applicable|
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:
- transjugular coil embolisation of pelvic veins followed by endovenous treatment of leg recurrent varicose veins or
- 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 (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||October 2018|
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|
- Change in recurrent varicose veins or venous reflux [ 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 ]
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)
- 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 ]
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 ]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.
- 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 ]
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 ]
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
- 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 ]Any incidences of adverse events such as thrombophlebitis or deep vein thrombosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901731
|Contact: Briony Hudson||01483 email@example.com|
|Contact: Isabel Kay||01483 firstname.lastname@example.org|
|The Whiteley Clinic||Not yet recruiting|
|Guildford, United Kingdom, GU2 7RF|
|Contact: Mark Whiteley, Professor 01483 477180 email@example.com|
|Contact: Isabel Kay 01483 477180 firstname.lastname@example.org|
|Principal Investigator: Mark Whiteley, Professor|
|Sub-Investigator: Tim Fernandez Hart|
|Sub-Investigator: Barrie Price|
|Sub-Investigator: Judy Holdstock|
|Sub-Investigator: Charmaine Harrison|
|Sub-Investigator: Previn Diwakar|
|Sub-Investigator: Archie Speirs|
|Sub-Investigator: Mark Pemberton|
|Sub-Investigator: Briony Hudson|
|The Imaging Clinic||Not yet recruiting|
|Guildford, United Kingdom|
|Contact: Tony Lopez, Bsc, MRCP, FRCR|
|Principal Investigator: Tony Lopez, BSc, MRCP, FRCR|
|Principal Investigator:||Mark Whiteley, Professor||The Whiteley Clinic|