Venous InsufficiencyNCT00841178
Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT
A study testing Surgery and EVLT in people with Venous Insufficiency and Varicose Veins, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Varicose veins are a common problem, affecting up to a third of the western adult population. Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Insufficiency, Varicose Veins
- What is being tested?
- Surgery and EVLT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2005to Nov 2022
- 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, varicose veins
- Isolated Sapheno-popliteal (SPJ) incompetence, leading to reflux in the Short saphenous vein (SSV) on duplex ultrasound
- SSV of 4mm distally
- Ability to give informed written consent
Who cannot join
- Inability to give informed written consent
- Symptomatic or complicated varicose veins not attributable to SPJ/SSV reflux
- Evidence of deep venous reflux on duplex scan
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hull Royal Infirmary
Hull, East Yorkshire, HU3 2JZ
About this study
Official title: A Randomised Controlled Trial of the Clinical and Cost Effectiveness of Endovenous Laser Therapy in the Treatment of Varicose Veins Secondary to Isolated Sapheno-Popliteal Incompetence and Short Saphenous Reflux
Varicose veins are a common problem, affecting up to a third of the western adult population. Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is known to have a significant negative effect on patient's quality of life (QoL).
Surgery has been used for many years, but it is known that there is a temporary decline in QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged recovery in some patients and has the risks of infection, haematoma and nerve injury.
Read more
Recurrence rates are known to be significant. Duplex of veins post surgery has demonstrated persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at 34 years.
26% of NHS patients were 'very dissatisfied' with their varicose vein surgery.
Newer, less invasive treatments are being developed. It would be advantageous to find a treatment that avoided the morbidity of surgery, one that could be performed as a day-case procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and allow an early return to work. These should be the aims of any new treatment for varicose veins.
Endovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser energy delivered into the vein to obliterate it. The vein therefore need not be tied off surgically and stripped out.
The aim of this study is to compare the clinical, cost effectiveness and safety of Surgery and EVLT.
- Conditions
- Venous Insufficiency, Varicose Veins
- Being tested
- Surgery, EVLT
- Keywords
- Randomised controlled trial, Venous insufficiency, Varicose veins, Quality of Life, Clinical effectiveness, Cost effectiveness
- Medical subject headings
- Venous Insufficiency, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Also called Crossectomy
Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary.
EVLTProcedure or surgery
Also called Endovenous Laser therapy, Endovenous Laser Ablation, EVLA
EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Active comparator | Patients undergo Surgery under a general anaesthetic. Receives: Procedure: Surgery |
| EVLT | Experimental | Patients undergo EVLT under a local anaesthetic. Receives: Procedure: EVLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generic Quality of Life - Short Form-36
Measured: 1 Week,, 6 Weeks, 3 Months, 1 Year, 2 Years
Secondary outcomes (9)
Disease Specific Quality of Life - Aberdeen Varicose Vein Questionnaire
Measured: 1 Week, 6 Weeks, 3 Months, 1 Year, 2 Years
Generic quality of life - EuroQol
Measured: 1 week, 6 weeks, 3 months, 1 year, 2 years
Venous Clinical Severity Score
Measured: 3 months, 1 year, 2 years
Visual analogue pain scores
Measured: 1 week
Return to work and normal functioning
Measured: 1 week, 6 weeks
Would undergo EVLT again if necessary
Measured: 1 week, 6 weeks, 3 months, 1 year, 2 years
Complication rates
Measured: 1 week, 6 weeks, 3 months, 1 year, 2 years
Duplex assessment
Measured: 1 week, 6 weeks, 3 months, 1 year, 2 years
Cost Effectiveness
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startOct 2005
- Primary completionAug 2011
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous InsufficiencyStudies 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
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hull
- Responsible party
- Sponsor
- Investigators
- Ian C Chetter, MBChB, Principal investigator, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841178
- Sponsor's protocol ID
- HELP 2
- Status last verified
- Nov 2022
- First submitted
- 10 Feb 2009
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Samuel N, Carradice D, Wallace T, Mekako A, Hatfield J, Chetter I. Randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins. Ann Surg. 2013 Mar;257(3):419-26. doi: 10.1097/SLA.0b013e318275f4e4.
PubMed 23160149Carradice D, Mazari FA, Mekako A, Hatfield J, Allgar V, Chetter IC. Energy delivery during 810 nm endovenous laser ablation of varicose veins and post-procedural morbidity. Eur J Vasc Endovasc Surg. 2010 Sep;40(3):393-8. doi: 10.1016/j.ejvs.2010.04.010. Epub 2010 May 26.
PubMed 20510634
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of the Clinical and Cost Effectiveness of Endovenous Laser Therapy in the Treatment of Varicose Veins Secondary to Isolated Sapheno-Popliteal Incompetence and Short Saphenous Reflux
- ClinicalTrials.gov ID
- NCT00841178
- Acronym / sponsor ID
- HELP 2
- Conditions
- Venous Insufficiency, Varicose Veins
- Keywords
- Randomised controlled trial, Venous insufficiency, Varicose veins, Quality of Life, Clinical effectiveness, Cost effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of Hull
- Study start
- Oct 2005 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2022 (estimated)
- First posted
- 11 Feb 2009 (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 are a common problem, affecting up to a third of the western adult population. Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is known to have a significant negative effect on patient's quality of life (QoL).
Surgery has been used for many years, but it is known that there is a temporary decline in QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged recovery in some patients and has the risks of infection, haematoma and nerve injury.
Recurrence rates are known to be significant. Duplex of veins post surgery has demonstrated persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at 34 years.
26% of NHS patients were 'very dissatisfied' with their varicose vein surgery.
Newer, less invasive treatments are being developed. It would be advantageous to find a treatment that avoided the morbidity of surgery, one that could be performed as a day-case procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and allow an early return to work. These should be the aims of any new treatment for varicose veins.
Endovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser energy delivered into the vein to obliterate it. The vein therefore need not be tied off surgically and stripped out.
The aim of this study is to compare the clinical, cost effectiveness and safety of Surgery and EVLT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Active comparator | Procedure: SurgeryPatients undergo Surgery under a general anaesthetic. |
| EVLT | Experimental | Procedure: EVLTPatients undergo EVLT under a local anaesthetic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary, symptomatic, varicose veins
- Isolated Sapheno-popliteal (SPJ) incompetence, leading to reflux in the Short saphenous vein (SSV) on duplex ultrasound
- SSV of 4mm distally
- Ability to give informed written consent
Key exclusion criteria (3 listed)
- Inability to give informed written consent
- Symptomatic or complicated varicose veins not attributable to SPJ/SSV reflux
- Evidence of deep venous reflux on duplex scan
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 |
|---|---|---|
| SurgeryAlso: CrossectomySaphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary. | Procedure or surgery | Surgery |
| EVLTAlso: Endovenous Laser therapy, Endovenous Laser Ablation, EVLAEVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required. | Procedure or surgery | EVLT |
Primary outcome
Generic Quality of Life - Short Form-36
Time frame: 1 Week,, 6 Weeks, 3 Months, 1 Year, 2 Years
9 secondary outcomes
Disease Specific Quality of Life - Aberdeen Varicose Vein Questionnaire
Time frame: 1 Week, 6 Weeks, 3 Months, 1 Year, 2 Years
Generic quality of life - EuroQol
Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
Venous Clinical Severity Score
Time frame: 3 months, 1 year, 2 years
Visual analogue pain scores
Time frame: 1 week
Return to work and normal functioning
Time frame: 1 week, 6 weeks
Would undergo EVLT again if necessary
Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
Complication rates
Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
Duplex assessment
Time frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
Cost Effectiveness
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Derived from this study: PubMed 23160149Samuel N, Carradice D, Wallace T, Mekako A, Hatfield J, Chetter I. Randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins. Ann Surg. 2013 Mar;257(3):419-26. doi: 10.1097/SLA.0b013e318275f4e4.
- Derived from this study: PubMed 20510634Carradice D, Mazari FA, Mekako A, Hatfield J, Allgar V, Chetter IC. Energy delivery during 810 nm endovenous laser ablation of varicose veins and post-procedural morbidity. Eur J Vasc Endovasc Surg. 2010 Sep;40(3):393-8. doi: 10.1016/j.ejvs.2010.04.010. Epub 2010 May 26.
- Randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veinsLink provided by the sponsor.
- A randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins.Link provided by the sponsor.
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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.
Ian C Chetter, MBChB principal investigator
University of Hull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and EVLT in people with Venous Insufficiency and Varicose Veins, 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 4 inclusion and 3 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 4 Nov 2022. 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?
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?
Generic Quality of Life - Short Form-36 (time frame: 1 Week,, 6 Weeks, 3 Months, 1 Year, 2 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 NCT00841178, which also lists 2 linked publications.
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 4 Nov 2022.