Clinical trial NCT00841178: Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT
Official title: A Randomised Controlled Trial of the Clinical and Cost Effectiveness of Endovenous Laser Therapy in the Treatment of Varicose Veins Secondary to Isolated Sapheno-Popliteal Incompetence and Short Saphenous Reflux
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Insufficiency
Varicose Veins
Keywords: Randomised controlled trial
Venous insufficiency
Varicose veins
Quality of Life
Clinical effectiveness
Cost effectiveness
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Hull
First posted: 2009-02-11
Enrollment: 106
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 Sapheno-popliteal (SPJ) incompetence, leading to reflux in the Short saphenous vein (SSV) on duplex ultrasound
* SSV of 4mm distally
* Ability to give informed written consent

Exclusion Criteria:

* Inability to give informed written consent
* Symptomatic or complicated varicose veins not attributable to SPJ/SSV 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 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: Samuel N, Carradice D, Wallace T, Mekako A, Hatfield J, Chetter I. Randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins. Ann Surg. 2013 Mar;257(3):419-26. doi: 10.1097/SLA.0b013e318275f4e4.
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.