NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
National Clinical Guideline Centre (UK). Varicose Veins in the Legs: The Diagnosis and Management of Varicose Veins. London: National Institute for Health and Care Excellence (NICE); 2013 Jul. (NICE Clinical Guidelines, No. 168.)
10.1. Review Question: What is the clinical and cost effectiveness of interventional treatment followed by compression compared with interventional treatment alone in people with leg varicose veins, and, if so, what type of compression, pressure of compression and/or duration of compression is optimal?
For full details see review protocol in appendix C.
Table 84PICO characteristics of review question
| Population | Adults with leg varicose veins |
|---|---|
| Intervention/s | Stripping surgery immediately followed by compression OR Avulsion surgery immediately followed by compression OR Endothermal ablation immediately followed by compression OR Foam sclerotherapy immediately followed by compression |
| Comparison/s | For the first part of the review question, the comparator in each case will be as the intervention, but without compression as an adjunct. For the second part of the review question, the comparator will be as the intervention but adjunctive compression will vary in terms of:
|
| Outcomes |
|
| Study design | Systematic reviews, RCTs |
10.1.1. Clinical evidence
For the first part of the review question (What is the clinical and cost effectiveness of interventional treatment followed by compression compared with interventional treatment alone in people with leg varicose veins) we searched for randomised controlled trials comparing the effectiveness of:
- Surgery / endothermal ablation / foam sclerotherapy combined with compression therapy with
- The corresponding interventional therapy applied alone.
2 RCTs were found that made the above comparison. One compared foam sclerotherapy plus compression versus foam sclerotherapy alone (Hamel-Desnos 201041). Houtermans-Auckel 200944 compared the extended use of compression treatment after stripping surgery. They used elastic bandages for both arms of the study over the first 3 days post-surgery, as per routine practice, and an additional 4 weeks of compression stocking in the intervention arm. Since the review question was strictly concerned with the comparison between intervention followed by compression and intervention alone, the outcomes from this paper were downgraded for indirectness as ideally the intervention group would have received full compression immediately post-surgery.
Evidence from these are summarised in the clinical GRADE evidence profile below (Compression vs no compression after stripping surgery Table 86). See also the study selection flow chart in appendix D, forest plots in appendix I, clinical evidence tables in appendix G and exclusion list in appendix J.
Table 85
Summary of studies included in the review.
10.1.1.1. Compression vs no compression after stripping surgery
Table 86
Clinical evidence profile (GRADE table): surgery plus compression vs surgery alone for varicose veins.
10.1.1.2. Compression vs. no compression: foam sclerotherapy
Table 87
GRADE assessment for the comparison of foam sclerotherapy plus compression versus foam sclerotherapy alone for varicose veins.
10.1.1.3. Narrative summary for surgery plus compression versus surgery alone (for outcomes not appropriate for GRADE)
Compliance
Hamel-Desnos 201041 reported compliance with compression post-surgery as 12/30 at 28 days (defined as those wearing the hosiery every day).
10.1.2. Economic evidence
10.1.2.1. Published literature
No relevant economic evaluations comparing interventional treatment followed by compression with interventional treatment alone were found.
10.1.2.2. New cost-effectiveness analysis
New analysis was not prioritised for this question.
10.1.2.3. Unit costs
In the absence of recent UK cost-effectiveness analysis, relevant unit costs are provided below in Table 88 and Table 89 to aid consideration of cost effectiveness.
Table 88
Types of compression hosiery and unit costs.
Table 89
Resource use and associated costs for compression therapy.
10.1.2.4. Economic considerations
Based on the figures provided in Table 89, it is estimated that the cost of post intervention compression would be approximately £182. This estimate is based on the assumptions that patients are given four pairs of “made-to-measure” thigh-high stockings, and that ten minutes of nurse time is required for the patient to be measured and fitted with stockings. Compression stockings are assumed to last approximately three months, therefore patients are given two pairs per 6 month period.
In practice, some people may be given below-knee standard compression stockings instead of thigh-high “made-to-measure” stockings. If below-knee standard compression stockings are prescribed it is estimated (assuming the average price of a pair of standard below-knee compression stockings is £10.54) that the annual costs of compression therapy would be roughly £55.
In order for post intervention compression hosiery to be cost effective, the additional cost would have to be justified by an increase in quality of life. The clinical evidence revealed no clinically important improvement in quality of life from prolonged compression post intervention.
10.1.3. Evidence statements
10.1.3.1. Clinical
10.1.3.1.1. Surgery plus compression versus surgery alone
Adverse events
Post-operative pain at 3 days
- 2 week follow-up: 1 study comprising 96 participants showed no discernible difference in post-operative pain at 2 weeks between surgery combined with compression and surgery alone [VERY LOW QUALITY].
- 4 weeks follow-up: 1 study comprising 96 participants showed that surgery combined with compression was associated with more pain at 4 weeks compared to surgery alone, but the uncertainty of this effect is too large from which to draw clear conclusions about relative benefit and harm [VERY LOW QUALITY].
Post-operative numbness
- 2 week follow-up: 1 study comprising 96 participants showed that surgery combined with compression was associated with a lower proportion of participants with numbness at 2 weeks compared to surgery alone, but the uncertainty of this effect is too large from which to draw clear conclusions about relative benefit and harm [VERY LOW QUALITY].
- 4 weeks follow-up: 1 study comprising 96 participants showed no numbness in either group and therefore effects were not estimable.
Return to work
- 1 study comprising 96 participants showed that surgery combined with compression was associated with a longer return to work time compared to surgery alone. However this was not a large enough effect to show a clearly appreciable clinical benefit of using surgery [VERY LOW QUALITY].
10.1.3.1.2. Foam sclerotherapy plus compression versus foam sclerotherapy alone
Quality of life
CIVIQ global score – change from baseline (lower better)
- 14 days follow-up: 1 study comprising 43 participants showed that foam sclerotherapy combined with compression was associated with a lower improvement in quality of life rating at 14 days compared to foam sclerotherapy alone, but the uncertainty of this effect is too large from which to draw clear conclusions about relative benefit and harm [VERY LOW QUALITY].
- 28 days follow-up: 1 study comprising 47 participants showed that foam sclerotherapy combined with compression was associated with a slightly lower improvement in quality of life rating at 28 days compared to foam sclerotherapy alone, but the uncertainty of this effect is far too large from which to draw clear conclusions about relative benefit and harm [VERY LOW QUALITY].
Reflux at 28 days
- 1 study comprising 60 participants showed no reflux in either group and therefore effects were not estimable.
Adverse events
Major neurological events
- 1 study comprising 60 participants showed no major neurological events in either group and therefore effects were not estimable.
Visual disturbance (scotoma) resolving within 15 minutes
- 1 study comprising 60 participants showed that foam sclerotherapy combined with compression was associated with a lower proportion of participants with visual disturbance compared to foam sclerotherapy alone, but the uncertainty of this effect is too large from which to draw clear conclusions about relative benefit and harm [VERY LOW QUALITY].
Moderate pain day 28
- 1 study comprising 59 participants showed that foam sclerotherapy combined with compression was associated with a lower proportion of participants with moderate pain at day 28 compared to foam sclerotherapy alone, but the uncertainty of this effect is too large from which to draw clear conclusions about relative benefit and harm [VERY LOW QUALITY].
Pigmentation day 28
- 1 study comprising 59 participants showed that foam sclerotherapy combined with compression was associated with a greater proportion of participants with pigmentation compared to foam sclerotherapy alone, but the uncertainty of this effect is far too large from which to draw clear conclusions about relative benefit and harm [VERY LOW QUALITY].
Thrombophlebitis
- 1 study comprising 59 participants showed no discernible difference in thrombophlebitis between foam sclerotherapy combined with compression and foam sclerotherapy alone [VERY LOW QUALITY].
10.1.3.2. Economic
- No relevant economic evidence was identified
- Compression hosiery post intervention is estimated to cost an additional £182, yet prolonged compression post intervention was not found to be associated with a clinically important improvement in quality of life.
Second part of the review question
However because there was no strong evidence suggesting the clinical efficacy of compression as an adjuvant to interventional therapies, the second part of the review question was not completed.
10.2. Recommendations and link to the evidence
| Recommendations |
|
|---|---|
| Research Recommendation |
|
| Relative values of different outcomes | Health related quality of life was considered the most important outcome for this comparison. Patient reported relief from symptoms associated with chronic venous insufficiency was also considered an important outcome. This included pain, ankle swelling, cramps and the feeling of having tired / heavy legs. |
| Trade off between clinical benefits and harms | There was an absence of evidence and only one study comparing foam sclerotherapy and foam sclerotherapy alone was identified. No important differences were noted in health related quality of life or in any reported patient reported outcomes for foam sclerotherapy with compression compared with foam sclerotherapy alone. There appeared to be an important disadvantage of surgery with compression in terms of a slower return to work compared with surgery alone. There was little evidence of any difference for any other outcome reported. The potential benefits of compression after interventional treatment need to be balanced against the potential costs of compression and any harm (such as comfort for the patient). As there was no convincing evidence for using or not using compression therapy the GDG felt they could not make a recommendation not to use stockings at all post intervention and the consensus was that in their clinical experience some people post-surgery did feel benefit from wearing stockings. In addition in the GDG’s opinion people who have had foam sclerotherapy for truncal reflux may get better results with a period of compression therapy. However the GDG, taking into account the cost of compression therapy, felt they could not recommend its long term use. Patients can be advised that in most instances they are able to return to work whilst wearing compression bandaging or hosiery. |
| Economic considerations | No economic studies were identified. Costs of compression therapy were estimated using the cost of 4 compression stockings/hosiery per year and a band 5 nurse time. Based on these calculations the cost of post intervention compression would be approximately £182. As clinical evidence revealed little improvement in quality of life from prolonged compression post intervention, compression post intervention was not expected to be cost effective compared to no prolonged compression. |
| Quality of evidence | Two studies were included in the clinical evidence. One study compared foam sclerotherapy with compression for one month with foam sclerotherapy alone. One study compared compression after surgery with surgery alone. All patients in this study had compression for three days after surgery. At this point patients were randomised to 4 weeks further compression or no compression. For both studies the outcomes were of low or very low quality, with both studies being prone to serious bias and some being affected by imprecision. In most cases the imprecision of the point estimate was too large to be able to confidently judge the magnitude/direction of the true population effect. |
| Other considerations | The recommendation was based on the limited evidence which had a quality of low to low evidence, and GDG consensus. The GDG discussed the evidence and noted that no neurological events were recorded with the use of stockings. As there was no convincing evidence for using or not using compression therapy the GDG felt they could not make a recommendation not to use stockings at all post operatively and the consensus was that in their clinical experience some people post-surgery did feel benefit from wearing stockings. However the GDG, taking into account the cost of compression therapy, felt they could not recommend its long term use. Patients can be advised that in most instances they are able to return to work whilst wearing compression bandaging or hosiery. Research recommendation
|
- Review Question: What is the clinical and cost effectiveness of interventional treatment followed by compression compared with interventional treatment alone in people with leg varicose veins, and, if so, what type of compression, pressure of compression and/or duration of compression is optimal?
- Recommendations and link to the evidence
- Compression post interventional treatment - Varicose Veins in the LegsCompression post interventional treatment - Varicose Veins in the Legs
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