Please select the arm or intervention descriptions that belong 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: Arm Label: Radiofrequency treatment; Type: EXPERIMENTAL; Interventions: Procedure: Radiofrequency ablation, Procedure: Multilayer Compressive Bandage | Arm Label: Multilayer Compressive Bandage only; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Multilayer Compressive Bandage | Intervention Type: PROCEDURE; Name: Radiofrequency ablation; Assigned to Arm(s): Radiofrequency treatment | Intervention Type: PROCEDURE; Name: Multilayer Compressive Bandage; Assigned to Arm(s): Multilayer Compressive Bandage only, Radiofrequency treatment
B: Arm Label: EndoVenous Laser Ablation; Type: ACTIVE_COMPARATOR; Interventions: Device: EVLA, Drug: Lidocaine with 1:200,000 epinephrine solution, Drug: Sodium Bicarbonate | Arm Label: MechanoChemical Ablation (ClariVein®); Type: ACTIVE_COMPARATOR; Interventions: Device: ClariVein®, Drug: Lidocaine with 1:200,000 epinephrine solution, Drug: Sodium Tetradecyl Sulphate | Intervention Type: DEVICE; Name: EVLA; Assigned to Arm(s): EndoVenous Laser Ablation | Intervention Type: DEVICE; Name: ClariVein®; Assigned to Arm(s): MechanoChemical Ablation (ClariVein®) | Intervention Type: DRUG; Name: Lidocaine with 1:200,000 epinephrine solution; Assigned to Arm(s): EndoVenous Laser Ablation, MechanoChemical Ablation (ClariVein®) | Intervention Type: DRUG; Name: Lidocaine with 1:200,000 epinephrine solution; Assigned to Arm(s): EndoVenous Laser Ablation | Intervention Type: DRUG; Name: Sodium Bicarbonate; Assigned to Arm(s): EndoVenous Laser Ablation | Intervention Type: DRUG; Name: Sodium Tetradecyl Sulphate; Assigned to Arm(s): MechanoChemical Ablation (ClariVein®)
C: Arm Label: Surgery; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Surgery - Saphenofemoral ligation, saphenous strip and avulsions | Arm Label: EVLT; Type: EXPERIMENTAL; Interventions: Procedure: EVLT | Intervention Type: PROCEDURE; Name: Surgery - Saphenofemoral ligation, saphenous strip and avulsions; Assigned to Arm(s): Surgery | Intervention Type: PROCEDURE; Name: EVLT; Assigned to Arm(s): EVLT
D: Arm Label: Experimental: VenaSeal SCS; Type: N/A; Interventions: Device: VenaSeal SCS | Arm Label: Active Comparator: RFA; Type: N/A; Interventions: Device: ClosureFast Radiofrequency Ablation (RFA) | Arm Label: Experimental: Roll-in (VenaSeal SCS); Type: N/A; Interventions: Device: Roll-In (VenaSeal SCS) | Intervention Type: DEVICE; Name: VenaSeal SCS; Assigned to Arm(s): Experimental: VenaSeal SCS | Intervention Type: DEVICE; Name: ClosureFast Radiofrequency Ablation (RFA); Assigned to Arm(s): Active Comparator: RFA | Intervention Type: DEVICE; Name: Roll-In (VenaSeal SCS); Assigned to Arm(s): Experimental: Roll-in (VenaSeal SCS)

Answer: C