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AzTrials

Varicose VeinsNCT00759434

A New Method of Surgically Treating Varicose Veins and Venous Ulcers - a Study to Assess Clinical and Economic Value

A study testing Surgery - Saphenofemoral ligation, saphenous strip and avulsions and EVLT in people with Varicose Veins and Venous Insufficiency, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Surgery - Saphenofemoral ligation, saphenous strip and avulsions and EVLT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2004to Aug 2009
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 Saphenofemoral junction (SFJ) incompetence leading to long saphenous (LSV) reflux on duplex ultrasound.
  • LSV of 4mm diameter at the knee.
  • Ability to give informed written consent.

Who cannot join

  • Inability to give informed written consent.
  • Symptomatic or complicated varicose veins not attributable to SFJ/LSV 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

Other trials in United Kingdom

About this study

Official title: A Dual Centre, Randomised Controlled Trial of the Clinical and Cost Effectiveness of Endovenous Laser Therapy (EVLT) in the Treatment of Varicose Veins and Venous Ulcers

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.

Being tested
Surgery - Saphenofemoral ligation, saphenous strip and avulsions, EVLT
Keywords
Varicose veins, Chronic venous insufficiency, Venous ulceration, Surgery, Endovenous Laser
Medical subject headings
Varicose Veins, Venous Insufficiency, Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgery - Saphenofemoral ligation, saphenous strip and avulsionsProcedure or surgery

    Patients undergo Saphenofemoral ligation, inversion stripping of the Long Saphenous Vein and avulsion of varicosities if necessary under a general anaesthetic.

  • EVLTProcedure or surgery

    Patients undergo endovenous laser treatment, using a 810nm laser aiming to occlude the incompetent long saphenous vein from the saphenofemoral junction to the knee. This may then be followed by ambulatory phlebectomy as appropriate. All procedures are to be performed under a local anaesthetic.

Study groups in NCT00759434
Study groupRoleWhat they receive
SurgeryActive comparatorNot described
Receives: Procedure: Surgery - Saphenofemoral ligation, saphenous strip and avulsions
EVLTExperimentalNot described
Receives: Procedure: EVLT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Generic Quality of life - Short Form-36

    Measured: 1 week, 6 weeks, 3 months, 1 year, 2 years

Secondary outcomes (9)

  1. Disease Specific quality of life - Aberdeen Varicose Vein Questionnaire

    Measured: 1 week, 6 weeks, 3 months, 1 year, 2 years

  2. Generic quality of life - EuroQol

    Measured: 1 week, 6 weeks, 3 months, 1 year, 2 years

  3. Venous Clinical Severity Score

    Measured: 3 months, 1 year, 2 years

  4. Visual analogue pain scores

    Measured: 1 week

  5. Return to work and normal functioning

    Measured: 1 week, 6 weeks

  6. Would undergo EVLT again if necessary

    Measured: 1 week, 6 weeks, 3 months, 1 year, 2 years

  7. Complication rates

    Measured: 1 week, 6 weeks, 3 months, 1 year, 2 years

  8. Duplex and clinical assessment

    A detailed clinical and duplex ultrasound assessment was undertaken to identify:

    The presence of residual or recurrent varicose veins (defined as clinically evident varicose veins of greater than 3mm in diameter present at 1 and 6 weeks (residual) or becoming evident only after 6 weeks (recurrent). This was irrespective of the presence or absence of symptoms.

    The pattern of underlying insufficiency on duplex giving rise to any clinically evident varicose veins or skin changes.

    Measured: 1 week, 6 weeks, 3 months, 1 year, 2 years

  9. 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.

  1. First posted25 Sep 2008 (estimated)
  2. Study startMar 2004
  3. Primary completionAug 2009
  4. Study completionAug 2009

Resources

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
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00759434
Sponsor's protocol ID
HELP1
Status last verified
Aug 2022
First submitted
23 Sep 2008
Last updated
19 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mekako AI, Hatfield J, Bryce J, Lee D, McCollum PT, Chetter I. A nonrandomised controlled trial of endovenous laser therapy and surgery in the treatment of varicose veins. Ann Vasc Surg. 2006 Jul;20(4):451-7. doi: 10.1007/s10016-006-9095-y. Epub 2006 Jun 27.

    PubMed 16802211

  • Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC. Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. Br J Surg. 2011 Aug;98(8):1117-23. doi: 10.1002/bjs.7615. Epub 2011 Jun 3.

    PubMed 21638277

  • Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC. Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. Br J Surg. 2011 Apr;98(4):501-10. doi: 10.1002/bjs.7394. Epub 2011 Jan 31.

    PubMed 21283981

  • Mohamed AH, Howitt A, Rae S, Cai PL, Hitchman L, Wallace T, Nandhra S, Pymer S, Knighton A, Smith G, Chetter IC, Carradice D. Ten-year outcomes of a randomized clinical trial of endothermal ablation versus conventional surgery for great saphenous varicose veins. Br J Surg. 2024 Aug 2;111(8):znae195. doi: 10.1093/bjs/znae195.

    PubMed 39162334

  • Wallace T, El-Sheikha J, Nandhra S, Leung C, Mohamed A, Harwood A, Smith G, Carradice D, Chetter I. Long-term outcomes of endovenous laser ablation and conventional surgery for great saphenous varicose veins. Br J Surg. 2018 Dec;105(13):1759-1767. doi: 10.1002/bjs.10961. Epub 2018 Aug 22.

    PubMed 30132797

  • Carradice D, Wallace T, Gohil R, Chetter I. A comparison of the effectiveness of treating those with and without the complications of superficial venous insufficiency. Ann Surg. 2014 Aug;260(2):396-401. doi: 10.1097/SLA.0000000000000541.

    PubMed 24424141

  • Carradice 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

Questions about this trial

What is this clinical trial studying?

A study testing Surgery - Saphenofemoral ligation, saphenous strip and avulsions and EVLT in people with Varicose Veins and Venous Insufficiency, 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: finished, as of the sponsor's last update on 19 Aug 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?

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?

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 NCT00759434, which also lists 7 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 19 Aug 2022.

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