Randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins.

NOTE: The long term follow-up for this project is being managed as HTA Project: 06/45/501. Up to 15% of men and 25% of women develop varicose veins over their lifetime, resulting in 95,000 operations being performed each year in the NHS in England alone. The most common treatment offered is surgery, which involves stripping out the veins under general anaesthetic. Recently, new minimally invasive treatments - foam sclerotherapy and endovenous laser ablation - have been developed for treating varicose veins. These can be given under local anaesthetic, freeing up expensive operating theatre time and offering more rapid treatment for a greater number of people. They may also avoid the scars and bruising associated with surgery, result in fewer complications and allow a quicker return to normal daily activities and work. However, despite good short term results of minimally invasive treatments, success in the long term is unclear. We will compare a) surgery b) foam sclerotherapy and c) endovenous laser ablation in combination with foam sclerotherapy. Eligible patients will be recruited at 6 centres and randomised to one of the three treatment options. They will be followed up initially for six months, with the intention of extending this to five years. Primary outcome measures include disease specific an generic patient reported outcomes. The technical and clinical success of the treatment will be assessed up to six months, again with the intention of extending this to five years. The primary economic outcome will be the incremental cost per quality adjusted life years (QALY) at 6 months; again with the intention of extending this to five years.