2 Research recommendations

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future. The Guideline Development Group's full set of research recommendations is detailed in appendix N of the full guideline.

2.1 Natural history of varicose veins

In people with varicose veins at CEAP (Clinical, etiological, anatomical and pathophysiological) stage C2 or C3, what are the factors that influence progression of the disease to CEAP stages C5 or C6?

Why this is important

The evidence review for the guideline showed a lack of high‑quality evidence on the progression of varicose veins from CEAP stage C2 or C3 to more serious varicose veins disease. A large, observational, prospective cohort study, similar to the Framingham or Bonn veins studies, should be undertaken. The study should recruit patients with C2 and C3 disease and follow the progress of their disease for 5 years. Consideration should be given to including a genetic component in the study because genetic factors have not been studied on a large scale. The results of such a study should help to more accurately identify which patients are at risk of developing more serious disease so that interventions can be offered at an early stage to those who will benefit most.

2.2 Compression as a management option

What is the clinical and cost effectiveness of compression hosiery versus no compression for the management of symptomatic varicose veins?

Why this is important

Compression hosiery is widely used as first‑line treatment for symptomatic varicose veins. In some areas of the UK a period of hosiery use is a precursor to referral to secondary care.

Discomfort and difficulty in application may cause people to stop wearing compression hosiery or wear it only occasionally. The current evidence for the benefit of compression hosiery is weak. There is little evidence of an impact on symptom relief or an improvement in quality of life. It is therefore not possible to calculate the cost effectiveness of compression hosiery.

A multicentre trial randomising compression hosiery versus no compression in patients with symptomatic varicose veins is needed. The trial should evaluate quality of life, including symptom reduction, and measure adherence with compression hosiery. In addition the trial should investigate the impact of compression on disease progression and the need for subsequent intervention.

2.3 Compression after interventional treatment

What is the clinical and cost effectiveness of compression bandaging or hosiery after interventional treatment for varicose veins compared with no compression? If there is benefit, how long should compression bandaging or hosiery be worn for?

Why this is important

The benefit of compression after interventional treatment for varicose veins is unclear. A well‑conducted, multicentre, randomised controlled trial (RCT) of compression after interventional treatment would help determine whether compression is beneficial, and if so, what type is best and how long it should be worn for. The trial should include patients who have had 1 of the 3 main interventional treatments: endothermal ablation, ultrasound‑guided foam sclerotherapy or surgery. The patients should be divided into 3 groups based on the type of intervention they have had. There should be 6 RCT arms, 1 arm with compression and 1 arm without, in each of the 3 patient groups. Each arm should have subgroups for compression type and duration. Adherence to compression treatment and the impact of adherence on effectiveness should also be evaluated. A cost‑effectiveness analysis should be performed. If compression is beneficial, such a trial should help improve quality of life for people with varicose veins and reduce the longer‑term need for retreatment.

2.4 Truncal treatment with or without concurrent tributary treatment

What is the clinical and cost effectiveness of concurrent phlebectomies or foam sclerotherapy for varicose tributaries during truncal endothermal ablation for varicose veins compared with:

  • truncal endothermal ablation without concurrent phlebectomies or foam sclerotherapy?

  • truncal endothermal ablation with phlebectomies or foam sclerotherapy, if needed, 6–12 weeks later?

Why this is important

Conventional truncal stripping under general anaesthetic involves synchronous phlebectomies of varicose tributaries, and in ultrasound‑guided foam sclerotherapy truncal and tributary veins are treated concurrently. In contrast, endothermal ablation may be performed alone to obliterate truncal incompetence, or synchronously with phlebectomies or foam sclerotherapy and current practice varies.

Synchronous tributary treatment ensures a single treatment episode, and the removal of all symptomatic varicosities leads to a better immediate quality of life, but this takes longer and thus may be associated with increased morbidity. Deferred tributary treatment may reduce morbidity, and also mean that some patients do not need tributary treatment (or need fewer tributary treatments on smaller veins). However, it involves 2 interventions for patients who need tributary treatment. Omitting tributary treatments entirely ensures a single treatment episode, but it is unclear whether remaining varicosities will persist and impair quality of life.

At present there is limited evidence from 1 small‑scale (n=50) study on the use and timing of tributary treatments after truncal endothermal ablation. There is a need for practice to be based on empirical evidence from a large and sufficiently powered RCT comparing all 3 main intervention options (no tributary treatment, concurrent tributary treatment and delayed tributary treatment).

2.5 Optimal interventional and conservative treatments at different stages of disease

What is the optimal treatment (compression, surgery, endothermal ablation or foam sclerotherapy) for varicose veins at each of the CEAP stages, that is CEAP stages 2–3, CEAP stage 4 and CEAP stages 5–6?

Why this is important

Much of the research into the optimum treatment for varicose veins has involved patients with varicose veins in CEAP stages C2 and C3, so little is known of the relative efficacies of treatment at the more severe stages of disease. Furthermore, some studies have included patients with varicose veins at a range of stages without subgrouping, which may conceal important differences in efficacy between different treatments at different stages of disease. Hence current treatment recommendations, which do not differentiate between patients with varicose veins at different stages, may not be equally effective for all patients.

A large‑scale RCT that compares the 4 main treatments (compression, surgery, endothermal ablation and foam sclerotherapy) in subgroups with varicose veins at different stages is needed. The use of CEAP to categorise the disease stages is not ideal because higher CEAP stages do not necessarily indicate greater severity. However, other methods of categorisation are even more problematic. Quality‑of‑life measures are unlikely to reflect severity of disease because of variations in perception of symptoms. In addition, measuring the degree of venous reflux would necessitate a method of quantifying reflux in the superficial venous system in a way that adequately reflects disease severity, and such a method does not currently exist.

  • National Institute for Health and Care Excellence (NICE)