Clinical trial NCT00759434: A New Method of Surgically Treating Varicose Veins and Venous Ulcers - a Study to Assess Clinical and Economic Value
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Venous Insufficiency
Venous Ulceration
Keywords: Varicose veins
Chronic venous insufficiency
Venous ulceration
Surgery
Endovenous Laser
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Hull
First posted: 2008-09-25
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Generic Quality of life - Short Form-36
timeFrame: 1 week, 6 weeks, 3 months, 1 year, 2 years
Secondary outcomes:
measure: Disease Specific quality of life - Aberdeen Varicose Vein Questionnaire
timeFrame: 1 week, 6 weeks, 3 months, 1 year, 2 years
measure: Generic quality of life - EuroQol
timeFrame: 1 week, 6 weeks, 3 months, 1 year, 2 years
measure: Venous Clinical Severity Score
timeFrame: 3 months, 1 year, 2 years
measure: Visual analogue pain scores
timeFrame: 1 week
measure: Return to work and normal functioning
timeFrame: 1 week, 6 weeks
measure: Would undergo EVLT again if necessary
timeFrame: 1 week, 6 weeks, 3 months, 1 year, 2 years
measure: Complication rates
timeFrame: 1 week, 6 weeks, 3 months, 1 year, 2 years
measure: Duplex and clinical assessment
timeFrame: 1 week, 6 weeks, 3 months, 1 year, 2 years
measure: Cost Effectiveness
timeFrame: 2 years
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
state: East Yorkshire
Study officials:
affiliation: University of Hull
name: Ian C Chetter, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1007/s10016-006-9095-y. Epub 2006 Jun 27.
citation: 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.
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. Epub 2011 Jan 31.
citation: 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.
citation: 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.
citation: 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.