Varicose VeinsNCT01909024
Pelvic Embolisation to Reduce Recurrent Varicose Veins - Recurrent
A study testing Coil embolisation and endovenous treatment of leg recurrent varicose veins in people with Varicose Veins and Venous Reflux, run by The Whiteley Clinic at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Varicose Veins, Venous Reflux, Pelvic Congestion Syndrome
- What is being tested?
- Coil embolisation and endovenous treatment of leg recurrent varicose veins
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2013to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Whiteley Clinic
Guildford, GU2 7RF
Mark Whiteley, Professor, 01483 477180, mark@thewhiteleyclinic.co.uk
Isabel Kay, 01483 477180, Isabel@thewhiteleyclinic.co.uk
The Imaging Clinic
Guildford
Tony Lopez, BSC, MRP, FRCR
Tony Lopez, Bsc, MRCP, FRCR
About this study
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.
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.
Read the 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:
- 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.
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.
- Conditions
- Varicose Veins, Venous Reflux, Pelvic Congestion Syndrome
- Being tested
- Coil embolisation, endovenous treatment of leg recurrent varicose veins
- Keywords
- Randomised controlled trial, Endovenous laser treatment, Transjugular coil embolisation
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coil embolisationProcedure or surgery
transjugular coil embolisation of pelvic veins
endovenous treatment of leg recurrent varicose veinsProcedure or surgery
endovenous treatment of leg recurrent varicose veins
| Study group | Role | What they receive |
|---|---|---|
| embolisation of pelvic veins & treatment of leg varicose veins | Experimental | transjugular coil embolisation of pelvic veins followed by endovenous treatment of leg recurrent varicose veins Receives: Procedure: Coil embolisation; Procedure: endovenous treatment of leg recurrent varicose veins |
| endovenous treatment of leg recurrent varicose veins alone | Active comparator | endovenous treatment of leg recurrent varicose veins alone Receives: Procedure: endovenous treatment of leg recurrent varicose veins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in recurrent varicose veins or venus reflux
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)
Measured: 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post surgery
Secondary outcomes (4)
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.
Measured: 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 that they have received.
Measured: 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.
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Whiteley Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Whiteley, Professor, Principal investigator, The Whiteley Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909024
- Sponsor's protocol ID
- RCT23013
- Status last verified
- May 2014
- First submitted
- 2 Jul 2013
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01909024
- Acronym / sponsor ID
- RCT23013
- Conditions
- Varicose Veins, Venous Reflux, Pelvic Congestion Syndrome
- Keywords
- Randomised controlled trial, Endovenous laser treatment, Transjugular coil embolisation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- The Whiteley ClinicUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| embolisation of pelvic veins & treatment of leg varicose veins | Experimental | Procedure: Coil embolisation, Procedure: endovenous treatment of leg recurrent varicose veinstransjugular coil embolisation of pelvic veins followed by endovenous treatment of leg recurrent varicose veins |
| endovenous treatment of leg recurrent varicose veins alone | Active comparator | Procedure: endovenous treatment of leg recurrent varicose veinsendovenous treatment of leg recurrent varicose veins alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coil embolisationtransjugular coil embolisation of pelvic veins | Procedure or surgery | embolisation of pelvic veins & treatment of leg varicose veins |
| endovenous treatment of leg recurrent varicose veinsendovenous treatment of leg recurrent varicose veins | Procedure or surgery | embolisation of pelvic veins & treatment of leg varicose veins, endovenous treatment of leg recurrent varicose veins alone |
Primary outcome
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
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)
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Whiteley, Professor principal investigator
The Whiteley Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coil embolisation and endovenous treatment of leg recurrent varicose veins in people with Varicose Veins and Venous Reflux, run by The Whiteley Clinic at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Briony Hudson (01483 477180, bh00047@surrey.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.