A New Method of Surgically Treating Varicose Veins and Venous Ulcers - a Study to Assess Clinical and Economic Value
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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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Generic Quality of life - Short Form-36 [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
- 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 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Surgery |
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.
|
| Experimental: EVLT |
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 |
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| United Kingdom | |
| Hull Royal Infirmary | |
| Hull, East Yorkshire, United Kingdom, HU3 2JZ | |
| Principal Investigator: | Ian C Chetter, MBChB | University of Hull |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Daniel Carradice, Clinical Lecturer, University of Hull |
| ClinicalTrials.gov Identifier: | NCT00759434 History of Changes |
| Other Study ID Numbers: | HELP1 |
| Study First Received: | September 23, 2008 |
| Last Updated: | May 16, 2012 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by University of Hull:
|
Varicose veins Chronic venous insufficiency Venous ulceration Surgery Endovenous Laser |
Additional relevant MeSH terms:
|
Ulcer Varicose Ulcer Varicose Veins Venous Insufficiency Pathologic Processes |
Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013