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Varicose Veins
Varicose Veins
Background: Surgical treatment of medically uncomplicated varicose veins is common, but its clinical
effectiveness remains uncertain.
Methods: A randomized clinical trial was carried out at two large acute National Health Service
hospitals in different parts of the UK (Sheffield and Exeter). Some 246 patients were recruited from
536 consecutive referrals to vascular outpatient clinics with uncomplicated varicose veins suitable
for surgical treatment. Conservative management, consisting of lifestyle advice, was compared with
surgical treatment (flush ligation of sites of reflux, stripping of the long saphenous vein and multiple
phlebectomies, as appropriate). Changes in health status were measured using the Short Form (SF)
6D and EuroQol (EQ) 5D, quality of life instruments based on SF-36 and EuroQol, complications of
treatment, symptomatic measures, anatomical extent of varicose veins and patient satisfaction.
Results: In the first 2 years after treatment there was a significant quality of life benefit for surgery of
0·083 (95 per cent confidence interval (c.i.) 0·005 to 0·16) quality-adjusted life years (QALYs) based on
the SF-6D score and 0·13 (95 per cent c.i. 0·016 to 0·25) based on the EQ-5D score. Significant benefits
were also seen in symptomatic and anatomical measures.
Conclusion: Surgical treatment provides symptomatic relief and significant improvements in quality of
life in patients referred to secondary care with uncomplicated varicose veins.
Copyright 2006 British Journal of Surgery Society Ltd British Journal of Surgery 2006; 93: 175–181
Published by John Wiley & Sons Ltd
176 J. A. Michaels, J. E. Brazier, W. B. Campbell, J. B. MacIntyre, S. J. Palfreyman and J. Ratcliffe
EuroQol and Short Form (SF) 36 have been used to Brazier et al.12 . Secondary outcome measures included
generate societal utilities suitable for assessing benefits complications of treatment, symptomatic relief, quality
in quality-adjusted survival8 . Although some studies have of life, and patient satisfaction. Quality of life was assessed
suggested that treatment of varicose veins is associated using the SF-36, EuroQol (EQ) 5D, and standard gamble
with a significant improvement in quality of life9,10 , these questionnaires. Changes in health status were estimated
did not include non-surgical controls and further work is using the SF-6D as described above, and for the EQ-
required to quantify the benefits of treatment. 5D using the algorithm described by Dolan13 . Initial
assessment was by a self-completed questionnaire, research
nurse interview, medical examination, standard gamble
Patients and methods
interview and colour duplex imaging. Follow-up data were
Participants were recruited from consecutive referrals to collected through postal questionnaires at 1, 6, 24 and
the vascular units in two large NHS hospitals in different 36 months, and at interview and examination at 12 months.
parts of the UK (Sheffield in the North of England and
Exeter in the South West) over a 2-year interval. All Statistical analysis
patients identified as having primary varicose veins were
invited to participate. They were eligible for the study if At the start of the trial, it was estimated that a sam-
they had varicose veins with evidence of saphenofemoral or ple size of 200 patients (100 in each group) would be a
saphenopopliteal reflux. Patients were excluded if they had sufficient number to detect a change in health score of
coexisting disease or disability that would preclude surgical 0·075 (5 per cent significance, 80 per cent power). Patients
treatment, complications of varicose veins (skin change, were randomized in a simple two-way manner, strati-
bleeding, phlebitis or ulceration), or if the veins were less fied by treatment centre, using a telephone randomization
than 5 mm diameter in fewer than two quadrants below service based on a computer-generated random number
the knee or less than 5 mm diameter in the lower thigh, list. Analysis of outcome was on an intention-to-treat
based on a previously described classification system11 . basis. Data from the assessments and questionnaires were
The clinical trial and later economic evaluation were coded and analysed using SPSS (SPSS, Chicago, Illinois,
approved by the relevant multicentre ethics committee USA) and Excel (Microsoft Redmond, Washington, USA).
and the local research ethics committees. All participants Differences between means of continuous variables were
provided written informed consent. estimated using t test and ANOVA. Categorical data were
The patients were randomized between conservative compared using Fisher’s exact test, χ2 test or χ2 test for
management and surgery. Conservative management trend, as appropriate.
consisted of lifestyle advice relating to exercise, leg
elevation, management of weight and diet, and the use Results
of compression hosiery. In the surgical arm of the
trial patients received the same lifestyle advice but also Between 1 January 1999 and 7 January 2001, all patients
underwent surgical treatment. Surgery was carried out referred with a diagnosis of varicose veins were invited to
as a day case, when appropriate. Patients with affected participate. Of 1009 patients assessed for the trial, 536 (53·1
long saphenous veins underwent flush ligation of the per cent) met the inclusion criteria and 246 (45·9 per cent)
vein at the saphenofemoral junction, with division of agreed to randomization; 122 were randomized to con-
all second-order tributaries within 2 cm of the junction, servative treatment and 124 to surgery. There were no
along with stripping of the long saphenous vein to knee significant differences in demographic or clinical features
level, and multiple phlebectomies. Patients with affected between the patients in the two randomized groups or
short saphenous veins had duplex localization of the between those randomized and those who declined ran-
saphenopopliteal junction, followed by saphenopopliteal domization (Table 1). A CONSORT14 summary of the
ligation (with stripping of the short saphenous vein in treatment allocation and follow-up in this trial is shown in
some patients) and multiple phlebectomies. All operations Fig. 1.
were done under general anaesthesia. Of patients who declined randomization, 79 per cent
The primary outcome measure for the study was elected to have surgery and these were more likely
clinical effectiveness at 1 year, as measured using the to be younger (mean age 49·5 versus 52·6 years) and
SF-6D instrument, a single preference-based measure of women (69·8 versus 42·0 per cent). Of those who under-
health representing overall quality of life, derived from went surgery within the randomized trial 18·1 per cent
the SF-36 questionnaire using the method described by had bilateral surgery, 7·1 per cent as a single procedure
Copyright 2006 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2006; 93: 175–181
Published by John Wiley & Sons Ltd
Surgery versus conservative treatment for uncomplicated varicose veins 177
Randomized to
conservative Randomized Declined
treatment to surgery randomization Total
(n = 122) (n = 124) (n = 290) (n = 536)
Values in parentheses are percentages unless indicated otherwise; *values are mean(s.d.).
Assessed for
eligibility
(n = 536)
Excluded (n = 290)
Refused randomization
Randomized
(n = 246)
Available for analysis at 1year (n = 101) Available for analysis at 1year (n = 81)
and 11·0 per cent as staged unilateral procedures. All saphenopopliteal ligation, which resolved completely
patients having bilateral procedures were inpatients and within 8 weeks of surgery. The second had cellulitis
86·8 per cent of unilateral procedures were carried out as that required readmission to hospital 5 days after surgery
a day case. and was treated by intravenous antibiotics. Minor
There were two major complications following surgery complications were reported by 20 patients (16·1 per cent)
(1·6 per cent). One patient developed a foot drop after and comprised pain (three), bleeding (two), postoperative
Copyright 2006 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2006; 93: 175–181
Published by John Wiley & Sons Ltd
178 J. A. Michaels, J. E. Brazier, W. B. Campbell, J. B. MacIntyre, S. J. Palfreyman and J. Ratcliffe
Conservative Surgery
Values in parentheses are percentages. For all symptoms there was significantly greater relief with surgery than conservative treatment (P < 0·050, χ2 test
for trend).
Symptomatic changes 10
40
Anatomical extent of the veins 30
Measurement of the extent of the varicose veins was based 20
on an anatomical classification developed at the start of this
10
trial and published previously15 . This describes their extent
on a ten-point scale (0, no visible varicose veins; 9, most 0
0 1 2 3 4 5 6 7 8 9
extensive). The extent at baseline and 1 year for patients in
Anatomical extent
both groups is shown in Fig. 2. There was no significant
change in the conservative group, whereas 70 per cent of b Surgery
Copyright 2006 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2006; 93: 175–181
Published by John Wiley & Sons Ltd
Surgery versus conservative treatment for uncomplicated varicose veins 179
Table 3 Mean values for quality of life outcomes for patients randomized to conservative management or surgery
SF-6D 0·74(0·11) (n = 103) 0·73(0·10) (n = 95) 0·73(0·11)* (n = 98) 0·77(0·10) (n = 75) 0·72(0·13)* (n = 47) 0·78(0·10) (n = 44)
EQ-5D 0·77(0·18) (n = 102) 0·76(0·19) (n = 98) 0·78(0·18)* (n = 101) 0·87(0·14)* (n = 78) 0·85(0·17) (n = 44) 0·84(0·21) (n = 34)
VAS 0·77(0·17) (n = 101) 0·78(0·15) (n = 98) 0·75(0·18)* (n = 100) 0·82(0·13)* (n = 77) 0·75(0·20)* (n = 44) 0·81(0·14) (n = 34)
SG 0·95(0·11) (n = 98) 0·94(0·11) (n = 94) 0·95(0·14) (n = 80) 0·95(0·15) (n = 65)
SF-36 (n = 103) (n = 95) (n = 98) (n = 75) (n = 47) (n = 44)
Physical functioning 84·12(18·32) 83·85(19·93) 79·28(20·75)* 88·43(18·69) 81·91(21·99)* 90·89(12·76)
Social functioning 73·72(20·60) 74·19(18·22) 71·62(19·30)* 80·04(14·26) 73·79(20·45) 81·16(14·60)
Role physical 75·25(37·81) 79·51(36·51) 76·43(39·44) 90·52(23·33) 70·10(41·84)* 91·85(20·98)
Role emotional 84·64(33·39) 86·49(27·86) 79·63(35·19) 89·27(27·29) 79·09(38·85) 92·75(20·98)
Mental health 75·19(17·88) 72·61(18·68) 70·81(18·16) 76·28(16·43) 75·71(18·70) 76·26(15·12)
Energy/vitality 61·55(20·03) 58·52(21·24) 50·63(22·87)* 64·91(19·59) 57·40(22·33) 64·89(18·57)
Pain 72·71(23·69) 69·16(24·85) 68·92(23·98)* 81·92(18·79) 74·84(25·80) 78·02(22·29)
General health 70·00(19·00) 70·33(20·59) 63·89(20·75)* 74·03(19·19) 64·95(21·13) 71·73(18·75)
Values are mean(s.d.). SF, Short Form; EQ, EuroQoL; VAS; ??; SG, ??. *P < 0·050 versus surgery (t test).
Copyright 2006 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2006; 93: 175–181
Published by John Wiley & Sons Ltd
180 J. A. Michaels, J. E. Brazier, W. B. Campbell, J. B. MacIntyre, S. J. Palfreyman and J. Ratcliffe
The trial has shown benefits in all measures following of surgeons with different levels of experience (including
surgery. In particular, there were benefits in quality of trainees) in a normal health service setting. Nevertheless,
life, with the SF-6D and EQ-5D suggesting that surgical the incidence of postoperative complications was low and
treatment carried a benefit of approximately 1–2 months objective assessment showed good clearance of varicose
of quality-adjusted survival over a 2-year interval. This veins 1 year after surgery.
was likely to be a considerable underestimate of overall This study has shown clear advantages for surgical
benefit of surgery, owing to the proportion of patients treatment of varicose veins across a whole range of outcome
in the conservative group who crossed over to surgical measures relating to health status, quality of life and patient
treatment, and the fact that the advantages of surgery are satisfaction. The results probably underestimate long-term
likely to persist well beyond 2 years. The limitations in benefits, because of the demand for surgery by patients in
access to surgery for uncomplicated varicose veins in the the conservative treatment group. These findings lend
UK are based on a perception that they are medically strong support to the adequate and consistent provision of
unimportant and on the fact that surgical treatment is health service treatment for symptomatic varicose veins,
relatively time consuming. In this study the use of a even in the absence of medical complications of venous
single preference-based measure allowed health benefit hypertension.
to be quantified in terms of improvements in quality-
adjusted life expectancy, which is now a commonly used
method for setting healthcare priorities and assessing cost Acknowledgements
effectiveness16 . Although the disease-specific Aberdeen This work was carried out as part of a study funded by the
Varicose Vein Severity Score is gaining acceptance10 , it NHS Health Technology Assessment Programme (project
was not in widespread use at the planning stage of this trial 95/05/06). The views and opinions expressed do not
and cannot currently be used to generate weightings for necessarily reflect those of the Department of Health. The
QALY estimation. A disease-specific measure such as this authors acknowledge the help of the following participants
may, however, be more sensitive to the changes associated in the trial in Sheffield and Exeter: Kath Rigby for assisting
with the treatment of varicose veins and would be a useful with patient recruitment; Jonathan Beard, Philip Chan,
addition to future studies. Robert Lonsdale, John Thompson, the late Richard Wood
There is considerable potential difficulty in assessing and other clinical staff; Sue Sheriff, Philip Niblett, Audrey
leg symptoms and their relationship to varicose veins5 . Peters and other staff from Medical Physics; research
However, 1 year after operation patients reported that nurses Kate Allington and Suzie Marriott; and Stephen
80 per cent (for aching) to 90 per cent (for swelling) of Walters, Phil Shackley and Tessa Peasgood for statistical
their symptoms were absent or better than before surgery, and health economics advice.
compared with 23 per cent (for aching) to 68 per cent
(for swelling) among those treated conservatively. Indeed,
22 per cent of the latter reported that they no longer References
had cosmetic concerns. These observations suggest a
1 Coon WW, Willis PW III, Keller JB. Venous
substantial benefit from surgery but perhaps support thromboembolism and other venous disease in the Tecumseh
the case for careful evaluation of patients’ symptoms community health study. Circulation 1973; 48: 839–846.
and problems when considering surgical treatment. It 2 Franks PJ, Wright DD, Moffatt CJ, Stirling J, Fletcher AE,
is important that patients understand when there is Bulpitt CJ et al. Prevalence of venous disease: a community
doubt about the relationship between their leg symptoms study in west London. Eur J Surg 1992; 158: 143–147.
and their varicose veins. Clear expectations about the 3 Referral Practice: a Guide to Appropriate Referral from General to
likely outcomes of treatment are important for patients’ Specialist Services. http://www.nice.org.uk/article.asp?a=
satisfaction17 . In addition to improving specific symptoms, 1178.
surgical treatment was associated with more improvement 4 Court C. Survey shows widespread rationing in NHS. BMJ
1995; 311: 1453–1454.
in physical and social functioning, energy/vitality and
5 Bradbury A, Evans C, Allan P, Lee A, Ruckley CV,
general health at 1 year than conservative measures.
Fowkes FG. What are the symptoms of varicose veins?
The results of some controlled studies of treatments Edinburgh vein study cross sectional population survey. BMJ
may be difficult to transpose to everyday practice owing 1999; 318: 353–356.
to the selective and non-representative practice that may 6 Rigby K, Palfreyman S, Beverley C, Michaels JA. Surgery
occur within clinical trials. In this trial both the clinical versus sclerotherapy for the treatment of varicose veins.
assessments and the operations were done by a range Cochrane Database Syst Rev 2004; (4)CD004980.
Copyright 2006 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2006; 93: 175–181
Published by John Wiley & Sons Ltd
Surgery versus conservative treatment for uncomplicated varicose veins 181
7 van Korlaar I, Vossen C, Rosendaal F, Cameron L, Bovill E, 12 Brazier J, Roberts J, Deverill M. The estimation of a
Kaptein A. Quality of life in venous disease. Thromb Haemost preference-based measure of health from the SF-36. J Health
2003; 90: 27–35. Econ 2002; 21: 271–292.
8 Conner-Spady B, Suarez-Almazor ME. Variation in the 13 Dolan P. Modeling valuations for EuroQol health states. Med
estimation of quality-adjusted life-years by different Care 1997; 35: 1095–1108.
preference-based instruments. Med Care 2003; 41: 14 Altman DG. Better reporting of randomised controlled trials:
791–801. the CONSORT statement. BMJ 1996; 313: 570–571.
9 Durkin MT, Turton EP, Wijesinghe LD, Scott JD, 15 Michaels JA, Campbell WB, Rigby KA. A new pragmatic
Berridge DC. Long saphenous vein stripping and quality of classification system for varicose veins. Phlebology 2001; 16:
life – a randomised trial. Eur J Vasc Endovasc Surg 2001; 21: 29–33.
545–549. 16 National Institute for Clinical Excellence. Guide to the
10 MacKenzie RK, Paisley A, Allan PL, Lee AJ, Ruckley CV, Methods of Technology Appraisal. National Institute for Clinical
Bradbury AW. The effect of long saphenous vein stripping Excellence: London, 2004.
on quality of life. J Vasc Surg 2002; 35: 1197–1203. 17 Palfreyman SJ, Drewery-Carter K, Rigby K, Michaels JA,
11 Rigby KA, Palfreyman SJ, Beverley C, Michaels JA. Surgery Tod AM. Varicose veins: a qualitative study to explore
for varicose veins: use of tourniquet. Cochrane Database Syst expectations and reasons for seeking treatment. J Clin Nurs
Rev 2002; (4)CD001486. 2004; 13: 332–340.
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Copyright 2006 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2006; 93: 175–181
Published by John Wiley & Sons Ltd