Please select the eligibility criteria that correspond to the clinical trial below.
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
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.


Options:
A: 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.
B: Inclusion Criteria:

* Insufficiency of the GSV
* Signed informed consent
* Patient willing to participate in follow-up scheme
* Age \> 18 years
* Ultrasound criteria for endovenous treatment have been met:
* Diameter GSV between 3-12 mm
* No thrombus in the to be treated segment of the GSV

Exclusion Criteria:

* Patient not able to give informed consent
* Patient unable to present at follow-up visits
* Other treatment is more suitable
* Pregnancy and breast feeding
* Known allergy/ contra-indication for sclerotherapy
* Previous ipsilateral surgical treatment of varicose veins
* Deep venous thrombosis or lung emboli in medical history
* Anticoagulant therapy
* C5-C6 varices
* Immobilization
* Fontaine II or IV peripheral arterial disease
* Severe kidney function decline (GFS \< 30 mL/min)
* Coagulation disorder or increased risk for thrombo-embolic complications(hemofilie A or B, v. Willebrand disease, Glanzmann disease, Factor VII-deficiency, idiopatic thrombocytopenic purpura, Factor V Leiden)
* Liver diseases accompanied by changes in blood coagulation, livver cirrhosis
C: Inclusion Criteria:

* patients with chronic superficial vein insufficiency
* patient must be 20-70 years old
* degree of difficulty of vein insufficiency C2-C4
* average diameter of refluxing great saphenous vein 4 -10 mm
* patient is agreeable to the study

Exclusion Criteria:

* peripheral atherosclerotic occlusive disease
* lymphoedema
* severe concomitant disease
* venous ulcers or unclassified skin changes
* BMI more than 40
* pregnancy
* allergy to the foam used in sclerotherapy or to local anaesthetics
* coagulation disorder
* bilateral vein insufficiency (equal symptoms)
D: Inclusion Criteria:

* Age ≥18 years and ≤ 70 years of age.
* Symptomatic primary Great Saphenous Vein "GSV" incompetence diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging.
* CEAP classification of C2, C3 or C4.
* Ability to walk unassisted.
* Ability to attend follow-up visits.
* Ability to understand the requirements of the study and to provide written informed consent.
* "GSV" on standing pre-procedure Doppler Ultrasound ≥3mm and ≤10mm (maximum diameter).

Exclusion Criteria:

* Life expectancy \< 1 year.
* Regular pain medication.
* Anticoagulation including Heparin or Coumadin.
* Previous Deep Vein Thrombosis "DVT".
* Previous superficial thrombophlebitis in "GSV".
* Previous venous treatment on target limb.
* Known Hyper-coagulable disorder.
* Conditions which prevent routine vein treatment like:

  * Acute disease,
  * Immobilization or inability to ambulate, and
  * Pregnancy.
* Tortuous "GSV", which in the opinion of the Investigator will limit catheter placement. (no 2 primary access sites allowed).
* Incompetent ipsilateral small saphenous or anterior accessory great saphenous vein.
* Known sensitivity to the cyanoacrylate "CA" adhesive.
* Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment.

Answer: A