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: 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
B: Arm Label: RFA; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Radiofrequency ablation (RFA) | Arm Label: MOCA; Type: EXPERIMENTAL; Interventions: Device: Mechanochemical Endovenous Ablation (MOCA) | Intervention Type: DEVICE; Name: Mechanochemical Endovenous Ablation (MOCA); Assigned to Arm(s): MOCA | Intervention Type: PROCEDURE; Name: Radiofrequency ablation (RFA); Assigned to Arm(s): RFA
C: Arm Label: Operative treatment; Type: OTHER; Interventions: Procedure: Operative treatment | Arm Label: Laser ablation; Type: OTHER; Interventions: Procedure: Laser ablation | Arm Label: Foam sclerotherapy; Type: OTHER; Interventions: Procedure: Foam sclerotherapy | Intervention Type: PROCEDURE; Name: Operative treatment; Assigned to Arm(s): Operative treatment | Intervention Type: PROCEDURE; Name: Laser ablation; Assigned to Arm(s): Laser ablation | Intervention Type: PROCEDURE; Name: Foam sclerotherapy; Assigned to Arm(s): Foam sclerotherapy
D: Arm Label: CE Marked Sapheon Closure System in GSV; Type: EXPERIMENTAL; Interventions: Device: CE Marked Sapheon Closure System | Intervention Type: DEVICE; Name: CE Marked Sapheon Closure System; Assigned to Arm(s): CE Marked Sapheon Closure System in GSV

Answer: A