Varicose VeinsNCT01949207
RCT - Does Treating Incompetent Perforators Reduce Recurrence?
A study testing EVLA, phlebectomies and TRansluminal Occlusion of Perforators (TRLOP) in people with Varicose Veins, run by The Whiteley Clinic at 1 site in United Kingdom.
Trial summary
The aim of this randomised case-controlled trial is to investigate whether ablation of incompetent perforating vein in addition to ablation of truncal vein reduces the rate of recurrent varicose veins post-treatment compared with patients who only have ablation of the truncal vein, who are left with untreated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins
- What is being tested?
- EVLA, phlebectomies and TRansluminal Occlusion of Perforators (TRLOP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Sep 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary varicose veins caused by great saphenous vein reflux
- At least one incompetent perforating vein refluxing into the varicosities
- Over 18 years of age
Who cannot join
- Reflux from pelvic vein origin or small saphenous vein
- Previous varicose vein surgery,
- Incompetent perforators remote from the varicosities treated,
- Deep vein incompetence
- Deep vein obstruction or occlusion
Trial locations and contacts
1 site in 1 country.
Briony Hudson contact
United Kingdom1 site
The Whiteley Clinic
Guildford, GU2 7RF
Briony Hudson, 01483 477180, b.f.hudson@surrey.ac.uk
Isabel Kay, 01483 477180, isabel@thewhiteleyclinic.co.uk
About this study
Official title: Randomised Controlled Study to Determine Whether Treating Incompetent Perforating Veins at the Time of Endothermal Varicose Vein Surgery for Truncal Reflux Reduces Recurrence After Varicose Vein Treatments.
The aim of this randomised case-controlled trial is to investigate whether ablation of incompetent perforating vein in addition to ablation of truncal vein reduces the rate of recurrent varicose veins post-treatment compared with patients who only have ablation of the truncal vein, who are left with untreated incompetent perforating veins.
- Conditions
- Varicose Veins
- Being tested
- EVLA, phlebectomies, TRansluminal Occlusion of Perforators (TRLOP)
- Keywords
- Incompetent perforating veins, EVLA, Phlebectomies, TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVLAProcedure or surgery
Endovenous laser ablation of great saphenous vein
phlebectomiesProcedure or surgery
removal of incompetent veins
TRansluminal Occlusion of Perforators (TRLOP)Procedure or surgery
TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
| Study group | Role | What they receive |
|---|---|---|
| EVLA, phlebectomies & Trlop closure of incompetent perforators | Experimental | endovenous laser ablation (EVLA) of great saphenous vein (GSV) plus phlebectomies plus TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators. Receives: Procedure: EVLA; Procedure: phlebectomies; Procedure: TRansluminal Occlusion of Perforators (TRLOP) |
| EVLA & phlebectomies | Experimental | endovenous laser ablation (EVLA) of great saphenous vein (GSV) + phlebectomies. Receives: Procedure: EVLA; Procedure: phlebectomies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the level of significant recurrence between the two treatment pathways
Differences in the level of significant recurrence between the two treatment pathways at each follow up.
Significant recurrence would be indicated if the participant demonstrates varicose veins greater than 3mm in diameter, varicose veins associated with thrombophlebitis or skin changes such as venous eczema, red skin or brown skin overlying the veins which require further treatment.
Measured: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Secondary outcomes (5)
Differences in insignificant recurrence between the two treatment pathways
Evidence of insignificant recurrence - thread veins, reticular veins or varicose veins less than 3mm in diameter.
Measured: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Patient reported symptom severity
Patient reported symptom severity - the Aberdeen questionnaire
Measured: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Patient reported quality of life
Patient reported quality of life - The Chronic Venous Insufficiency Questionnaire (CIVIQ)
Measured: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Patient satisfaction with treatment.
Measured: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Clinician reported severity of symptoms
CEAP and VCCS scores
Measured: Four weeks, three months, six months, one year, two years, three years, four years and five 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 posted24 Sep 2013 (estimated)
- Study startJul 2014
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (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
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Whiteley Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark S Whiteley, Professor, Principal investigator, The Whiteley Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949207
- Sponsor's protocol ID
- RCT20133
- Status last verified
- May 2014
- First submitted
- 19 Sep 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
- Randomised Controlled Study to Determine Whether Treating Incompetent Perforating Veins at the Time of Endothermal Varicose Vein Surgery for Truncal Reflux Reduces Recurrence After Varicose Vein Treatments.
- ClinicalTrials.gov ID
- NCT01949207
- Acronym / sponsor ID
- RCT20133
- Conditions
- Varicose Veins
- Keywords
- Incompetent perforating veins, EVLA, Phlebectomies, TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- The Whiteley ClinicUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 24 Sep 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 randomised case-controlled trial is to investigate whether ablation of incompetent perforating vein in addition to ablation of truncal vein reduces the rate of recurrent varicose veins post-treatment compared with patients who only have ablation of the truncal vein, who are left with untreated incompetent perforating veins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVLA, phlebectomies & Trlop closure of incompetent perforators | Experimental | Procedure: EVLA, Procedure: phlebectomies, Procedure: TRansluminal Occlusion of Perforators (TRLOP)endovenous laser ablation (EVLA) of great saphenous vein (GSV) plus phlebectomies plus TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators. |
| EVLA & phlebectomies | Experimental | Procedure: EVLA, Procedure: phlebectomiesendovenous laser ablation (EVLA) of great saphenous vein (GSV) + phlebectomies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary varicose veins caused by great saphenous vein reflux
- At least one incompetent perforating vein refluxing into the varicosities
- Over 18 years of age
Key exclusion criteria (5 listed)
- Reflux from pelvic vein origin or small saphenous vein
- Previous varicose vein surgery,
- Incompetent perforators remote from the varicosities treated,
- Deep vein incompetence
- Deep vein obstruction or occlusion
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 |
|---|---|---|
| EVLAEndovenous laser ablation of great saphenous vein | Procedure or surgery | EVLA & phlebectomies, EVLA, phlebectomies & Trlop closure of incompetent perforators |
| phlebectomiesremoval of incompetent veins | Procedure or surgery | EVLA & phlebectomies, EVLA, phlebectomies & Trlop closure of incompetent perforators |
| TRansluminal Occlusion of Perforators (TRLOP)TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators. | Procedure or surgery | EVLA, phlebectomies & Trlop closure of incompetent perforators |
Primary outcome
Differences in the level of significant recurrence between the two treatment pathways
Time frame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Differences in the level of significant recurrence between the two treatment pathways at each follow up. Significant recurrence would be indicated if the participant demonstrates varicose veins greater than 3mm in diameter, varicose veins associated with thrombophlebitis or skin changes such as venous eczema, red skin or brown skin overlying the veins which require further treatment.
5 secondary outcomes
Differences in insignificant recurrence between the two treatment pathways
Time frame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Patient reported symptom severity
Time frame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Patient reported quality of life
Time frame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Patient satisfaction with treatment.
Time frame: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Clinician reported severity of symptoms
Time frame: Four weeks, three months, six months, one year, two years, three years, four years and five 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.
Briony Hudson contact
Mark S Whiteley, Professor principal investigator
The Whiteley Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVLA, phlebectomies and TRansluminal Occlusion of Perforators (TRLOP) in people with Varicose Veins, run by The Whiteley Clinic at 1 site 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 3 inclusion and 5 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 1 site 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 (b.f.hudson@surrey.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the level of significant recurrence between the two treatment pathways (time frame: Four weeks, three months, six months, one year, two years, three years, four years and five 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.