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

Sponsors and Collaborators:	University of Hull Hull and East Yorkshire Hospitals NHS Trust
Information provided by:	University of Hull
ClinicalTrials.gov Identifier:	NCT00759434

Purpose

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.

Condition	Intervention
Varicose Veins Venous Insufficiency Venous Ulceration	Procedure: Surgery - Saphenofemoral ligation, saphenous strip and avulsions Procedure: EVLT

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy 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

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Surgery Varicose Veins

U.S. FDA Resources

Further study details as provided by University of Hull:

Primary Outcome Measures:

Generic Quality of life - Short Form-36 [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease Specific quality of life - Aberdeen Varicose Vein Questionnaire [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
Generic quality of life - EuroQol [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
Venous Clinical Severity Score [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
Visual analogue pain scores [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Return to work and normal functioning [ Time Frame: 1 week, 6 weeks ] [ Designated as safety issue: No ]
Would undergo EVLT again if necessary [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
Complication rates [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]
Duplex assessment [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]
Cost Effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	260
Study Start Date:	March 2004
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Surgery: Active Comparator	Procedure: Surgery - Saphenofemoral ligation, saphenous strip and avulsions Patients undergo Saphenofemoral ligation, inversion stripping of the Long Saphenous Vein and avulsion of varicosities if necessary under a general anaesthetic.
EVLT: Experimental	Procedure: EVLT 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759434

Contacts

Contact: Ian C Chetter, MBChB FRCS

+44 1482 674212

ian.chetter@hey.nhs.uk

Locations

United Kingdom, East Yorkshire
Hull Royal Infirmary	Recruiting
Hull, East Yorkshire, United Kingdom, HU3 2JZ

Sponsors and Collaborators

University of Hull

Hull and East Yorkshire Hospitals NHS Trust

Investigators

Principal Investigator:

Ian C Chetter, MBChB

University of Hull

More Information

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. Epub 2006 Jun 27.

Kurz X, Lamping DL, Kahn SR, Baccaglini U, Zuccarelli F, Spreafico G, Abenhaim L; VEINES Study Group. Do varicose veins affect quality of life? Results of an international population-based study. J Vasc Surg. 2001 Oct;34(4):641-8.

Kaplan RM, Criqui MH, Denenberg JO, Bergan J, Fronek A. Quality of life in patients with chronic venous disease: San Diego population study. J Vasc Surg. 2003 May;37(5):1047-53.

MacKenzie RK, Paisley A, Allan PL, Lee AJ, Ruckley CV, Bradbury AW. The effect of long saphenous vein stripping on quality of life. J Vasc Surg. 2002 Jun;35(6):1197-203.

Morrison C, Dalsing MC. Signs and symptoms of saphenous nerve injury after greater saphenous vein stripping: prevalence, severity, and relevance for modern practice. J Vasc Surg. 2003 Nov;38(5):886-90.

Jones L, Braithwaite BD, Selwyn D, Cooke S, Earnshaw JJ. Neovascularisation is the principal cause of varicose vein recurrence: results of a randomised trial of stripping the long saphenous vein. Eur J Vasc Endovasc Surg. 1996 Nov;12(4):442-5.

Davies AH, Steffen C, Cosgrove C, Wilkins DC. Varicose vein surgery: patient satisfaction. J R Coll Surg Edinb. 1995 Oct;40(5):298-9.

Min RJ, Khilnani NM. Endovenous laser treatment of saphenous vein reflux. Tech Vasc Interv Radiol. 2003 Sep;6(3):125-31.

Responsible Party:	University of Hull ( Mr. Ian C. Chetter )
Study ID Numbers:	EVLT1
Study First Received:	September 23, 2008
Last Updated:	February 10, 2009
ClinicalTrials.gov Identifier:	NCT00759434 History of Changes
Health Authority:	United Kingdom: National Health Service

Keywords provided by University of Hull:

Varicose veins
Chronic venous insufficiency
Venous ulceration
Surgery
Endovenous Laser

Study placed in the following topic categories:

Varicose Ulcer
Skin Diseases
Varicose Veins
Anesthetics, General
Ulcer
Venous Insufficiency

Vascular Diseases
Anesthetics
Skin Ulcer
Anesthetics, Local
Leg Ulcer

Additional relevant MeSH terms:

Varicose Ulcer
Pathologic Processes
Skin Diseases
Varicose Veins
Ulcer

Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases
Skin Ulcer
Leg Ulcer

ClinicalTrials.gov processed this record on September 11, 2009