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

Varicose Veins Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759434
• Other study ID #: HELP1
• Status: Completed
• Phase: N/A
• Start date: March 2004
• Est. completion date: August 2009

Study information

• Verified date: August 2022
• Source: Hull University Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer
• Varicose Veins
• Venous Insufficiency
• Venous Ulceration

Intervention

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
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.

Locations

Country	Name	City	State
United Kingdom	Hull Royal Infirmary	Hull	East Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Hull University Teaching Hospitals NHS Trust	University of Hull

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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;9 — View Citation

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. Epu — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generic Quality of life - Short Form-36		1 week, 6 weeks, 3 months, 1 year, 2 years
Secondary	Disease Specific quality of life - Aberdeen Varicose Vein Questionnaire		1 week, 6 weeks, 3 months, 1 year, 2 years
Secondary	Generic quality of life - EuroQol		1 week, 6 weeks, 3 months, 1 year, 2 years
Secondary	Venous Clinical Severity Score		3 months, 1 year, 2 years
Secondary	Visual analogue pain scores		1 week
Secondary	Return to work and normal functioning		1 week, 6 weeks
Secondary	Would undergo EVLT again if necessary		1 week, 6 weeks, 3 months, 1 year, 2 years
Secondary	Complication rates		1 week, 6 weeks, 3 months, 1 year, 2 years
Secondary	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.	1 week, 6 weeks, 3 months, 1 year, 2 years
Secondary	Cost Effectiveness		2 years