Varicose VeinsEVLTAPNCT02017106
Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins
A study testing Endovenous Laser ablation and concomitant phlebectomies and Endovenous Laser ablation and sequential phlebectomies in people with Varicose Veins and Endovenous Laser Ablation, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Varicose veins of the leg often have superficial tributaries, which are often symptomatic and a major reason for coming to the doctor. When treating the main varicose vein inside the leg, some doctors prefer to remove these tributaries while others prefer to leave them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins, Endovenous Laser Ablation, Phlebectomies
- What is being tested?
- Endovenous Laser ablation and concomitant phlebectomies and Endovenous Laser ablation and sequential phlebectomies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2006to Apr 2010
- 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, symptomatic, unilateral varicose great saphenous veins (GSV), with isolated saphenofemoral junction (SFJ) incompetence and GSV reflux on venous duplex imaging,
- perigenicular vein diameter exceeding 4 mm,
- acceptance by the patient of a local anaesthetic procedure.
Who cannot join
- saphenopopliteal, small saphenous or deep venous incompetence on duplex imaging
- did not give consent to trial participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins
Varicose veins of the leg often have superficial tributaries, which are often symptomatic and a major reason for coming to the doctor. When treating the main varicose vein inside the leg, some doctors prefer to remove these tributaries while others prefer to leave them. This trial aims to see if it is better to remove these veins at the time of the first laser procedure or better to leave them and only remove them when asked.
Read the detailed description
Endovenous laser therapy (EVLT) for varicose veins is associated with high initial occlusion rates, minimal complications and low recurrence rates at 5 years. Randomized trials and meta-analyses have confirmed the efficacy of EVLT in comparison with surgery and other endovenous techniques. There is also evidence that it may be associated with early quality of life (QoL) benefits compared with surgery. The general efficacy of EVLT has therefore been demonstrated and current research focuses on refinement of the procedure. A fundamental question concerns the management of residual varicosities following truncal laser ablation. One approach is to leave these varicosities to regress untouched, minimizing the procedure time and surgical trauma6. This approach, however, is associated with a significant number of secondary and tertiary interventions (sclerotherapy and/or ambulatory phlebectomy). Another option is to combine in a single procedure ambulatory phlebectomy with initial truncal laser ablation (EVLTAP). The aim of this randomized controlled trial was to assess the advantages of performing ambulatory phlebectomy as a concomitant procedure to truncal laser ablation.
- Conditions
- Varicose Veins, Endovenous Laser Ablation, Phlebectomies
- Being tested
- Endovenous Laser ablation and concomitant phlebectomies, Endovenous Laser ablation and sequential phlebectomies
- Keywords
- Varicose Veins
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovenous Laser ablation and concomitant phlebectomiesProcedure or surgery
Endovenous Laser ablation and sequential phlebectomiesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Concomitant phlebectomies | Experimental | Removal of varicose tributaries during Endovenous laser ablation Receives: Procedure: Endovenous Laser ablation and concomitant phlebectomies; Procedure: Endovenous Laser ablation and sequential phlebectomies |
| Sequential Phlebectomies | Active comparator | Endovenous laser ablation only Receives: Procedure: Endovenous Laser ablation and concomitant phlebectomies; Procedure: Endovenous Laser ablation and sequential phlebectomies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease specific QoL (AVVQ)
Measured: 5 years
Secondary outcomes (1)
Number of secondary procedures
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startApr 2006
- Primary completionApr 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017106
- Sponsor's protocol ID
- EVLTAP
- Acronym
- EVLTAP
- Status last verified
- Jul 2019
- First submitted
- 15 Dec 2013
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Carradice D, Mekako AI, Hatfield J, Chetter IC. Randomized clinical trial of concomitant or sequential phlebectomy after endovenous laser therapy for varicose veins. Br J Surg. 2009 Apr;96(4):369-75. doi: 10.1002/bjs.6556.
PubMed 19283745
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins
- ClinicalTrials.gov ID
- NCT02017106
- Acronym / sponsor ID
- EVLTAP / EVLTAP
- Conditions
- Varicose Veins, Endovenous Laser Ablation, Phlebectomies
- Keywords
- Varicose Veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Study start
- Apr 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 20 Dec 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.
Varicose veins of the leg often have superficial tributaries, which are often symptomatic and a major reason for coming to the doctor. When treating the main varicose vein inside the leg, some doctors prefer to remove these tributaries while others prefer to leave them. This trial aims to see if it is better to remove these veins at the time of the first laser procedure or better to leave them and only remove them when asked.
Detailed description
Endovenous laser therapy (EVLT) for varicose veins is associated with high initial occlusion rates, minimal complications and low recurrence rates at 5 years. Randomized trials and meta-analyses have confirmed the efficacy of EVLT in comparison with surgery and other endovenous techniques. There is also evidence that it may be associated with early quality of life (QoL) benefits compared with surgery. The general efficacy of EVLT has therefore been demonstrated and current research focuses on refinement of the procedure. A fundamental question concerns the management of residual varicosities following truncal laser ablation. One approach is to leave these varicosities to regress untouched, minimizing the procedure time and surgical trauma6. This approach, however, is associated with a significant number of secondary and tertiary interventions (sclerotherapy and/or ambulatory phlebectomy). Another option is to combine in a single procedure ambulatory phlebectomy with initial truncal laser ablation (EVLTAP). The aim of this randomized controlled trial was to assess the advantages of performing ambulatory phlebectomy as a concomitant procedure to truncal laser ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concomitant phlebectomies | Experimental | Procedure: Endovenous Laser ablation and concomitant phlebectomies, Procedure: Endovenous Laser ablation and sequential phlebectomiesRemoval of varicose tributaries during Endovenous laser ablation |
| Sequential Phlebectomies | Active comparator | Procedure: Endovenous Laser ablation and concomitant phlebectomies, Procedure: Endovenous Laser ablation and sequential phlebectomiesEndovenous laser ablation only |
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, symptomatic, unilateral varicose great saphenous veins (GSV), with isolated saphenofemoral junction (SFJ) incompetence and GSV reflux on venous duplex imaging,
- perigenicular vein diameter exceeding 4 mm,
- acceptance by the patient of a local anaesthetic procedure.
Key exclusion criteria (2 listed)
- saphenopopliteal, small saphenous or deep venous incompetence on duplex imaging
- did not give consent to trial participation.
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 |
|---|---|---|
| Endovenous Laser ablation and concomitant phlebectomies | Procedure or surgery | Concomitant phlebectomies, Sequential Phlebectomies |
| Endovenous Laser ablation and sequential phlebectomies | Procedure or surgery | Concomitant phlebectomies, Sequential Phlebectomies |
Primary outcome
Disease specific QoL (AVVQ)
Time frame: 5 years
1 secondary outcome
Number of secondary procedures
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Results publication: PubMed 19283745Carradice D, Mekako AI, Hatfield J, Chetter IC. Randomized clinical trial of concomitant or sequential phlebectomy after endovenous laser therapy for varicose veins. Br J Surg. 2009 Apr;96(4):369-75. doi: 10.1002/bjs.6556.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovenous Laser ablation and concomitant phlebectomies and Endovenous Laser ablation and sequential phlebectomies in people with Varicose Veins and Endovenous Laser Ablation, run by Hull University Teaching Hospitals NHS Trust 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 2 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: finished, as of the sponsor's last update on 26 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease specific QoL (AVVQ) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02017106, which also lists 1 linked publication.
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 26 Jul 2019.