Randomized clinical trial

Randomized clinical trial comparing surgery with conservative

treatment for uncomplicated varicose veins
J. A. Michaels1 , J. E. Brazier2 , W. B. Campbell3 , J. B. MacIntyre3 , S. J. Palfreyman1 and J. Ratcliffe2
1
Sheffield Vascular Institute, Northern General Hospital, and 2 Health Economics and Decision Science, University of Sheffield, Sheffield and 3 Royal
Devon and Exeter Hospital, Exeter, UK
Correspondence to: Prof. J. A. Michaels, Academic Vascular Unit, Coleridge House, Northern General Hospital, Herries Road, Sheffield S5 7AU, UK
(e-mail: j.michaels@shef.ac.uk)

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.

Paper accepted 29 October 2005

Published online in Wiley InterScience (www.bjs.co.uk). DOI: 10.1002/bjs.5264

Introduction The symptoms reported in relation to varicose veins

Visible varicose veins of the leg affect approximately
25–30 per cent of adult women and 15 per cent of men
in Europe and the USA1,2 . Many providers of healthcare
consider varicose veins to be relatively minor and
undeserving of treatment, and hospital admissions for
intervention produce a considerable burden on health
services. As a result, the availability of treatment may
be explicitly restricted or subject to significant waiting
lists. In England and Wales there are approximately 45 000
hospital admissions per year for varicose vein surgery.
There have been attempts to produce guidelines to limit
the availability of intervention for varicose veins in the UK
National Health Service (NHS)3 and access to treatment
varies from one area to another4 . In many other countries
varicose vein treatments are provided largely in the private
sector.
are common in the general population5 and the degree of
benefit obtained from surgical treatment or sclerotherapy
is not clear. Surgery has become the preferred treatment
option for most patients with symptomatic varicose veins.
Sclerotherapy has been abandoned by many hospitals,
resulting in further variation in the access to different
treatments for varicose veins. A systematic literature review
has suggested that surgery may have long-term benefits
over sclerotherapy6 . An extensive literature search for this
Cochrane review identified no randomized controlled trial
of surgery versus conservative treatment that would allow
the benefits of these treatments to be quantified.
Numerous generic and disease-specific questionnaires
have been used to assess venous disease, but few are
applicable to patients with varicose veins7 and, of those
that have been used in this situation, only the generic

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
generate societal utilities suitable for assessing benefits
in quality-adjusted survival8 . Although some studies have
suggested that treatment of varicose veins is associated
with a significant improvement in quality of life9,10 , these
did not include non-surgical controls and further work is
required to quantify the benefits of treatment.
Patients and methods
Participants were recruited from consecutive referrals to
the vascular units in two large NHS hospitals in different
parts of the UK (Sheffield in the North of England and
Exeter in the South West) over a 2-year interval. All
patients identified as having primary varicose veins were
invited to participate. They were eligible for the study if
they had varicose veins with evidence of saphenofemoral or
saphenopopliteal reflux. Patients were excluded if they had
coexisting disease or disability that would preclude surgical
treatment, complications of varicose veins (skin change,
bleeding, phlebitis or ulceration), or if the veins were less
than 5 mm diameter in fewer than two quadrants below
the knee or less than 5 mm diameter in the lower thigh,
based on a previously described classification system11 .
The clinical trial and later economic evaluation were
approved by the relevant multicentre ethics committee
and the local research ethics committees. All participants
provided written informed consent.
The patients were randomized between conservative
management and surgery. Conservative management
consisted of lifestyle advice relating to exercise, leg
elevation, management of weight and diet, and the use
of compression hosiery. In the surgical arm of the
trial patients received the same lifestyle advice but also
underwent surgical treatment. Surgery was carried out
as a day case, when appropriate. Patients with affected
long saphenous veins underwent flush ligation of the
vein at the saphenofemoral junction, with division of
all second-order tributaries within 2 cm of the junction,
along with stripping of the long saphenous vein to knee
level, and multiple phlebectomies. Patients with affected
short saphenous veins had duplex localization of the
saphenopopliteal junction, followed by saphenopopliteal
ligation (with stripping of the short saphenous vein in
some patients) and multiple phlebectomies. All operations
were done under general anaesthesia.
The primary outcome measure for the study was
clinical effectiveness at 1 year, as measured using the
SF-6D instrument, a single preference-based measure of
health representing overall quality of life, derived from
the SF-36 questionnaire using the method described by
Copyright  2006 British Journal of Surgery Society Ltd
Published by John Wiley & Sons Ltd
Brazier et al.12 . Secondary outcome measures included
complications of treatment, symptomatic relief, quality
of life, and patient satisfaction. Quality of life was assessed
using the SF-36, EuroQol (EQ) 5D, and standard gamble
questionnaires. Changes in health status were estimated
using the SF-6D as described above, and for the EQ-
5D using the algorithm described by Dolan13 . Initial
assessment was by a self-completed questionnaire, research
nurse interview, medical examination, standard gamble
interview and colour duplex imaging. Follow-up data were
collected through postal questionnaires at 1, 6, 24 and
36 months, and at interview and examination at 12 months.
Statistical analysis
At the start of the trial, it was estimated that a sam-
ple size of 200 patients (100 in each group) would be a
sufficient number to detect a change in health score of
0·075 (5 per cent significance, 80 per cent power). Patients
were randomized in a simple two-way manner, strati-
fied by treatment centre, using a telephone randomization
service based on a computer-generated random number
list. Analysis of outcome was on an intention-to-treat
basis. Data from the assessments and questionnaires were
coded and analysed using SPSS (SPSS, Chicago, Illinois,
USA) and Excel (Microsoft Redmond, Washington, USA).
Differences between means of continuous variables were
estimated using t test and ANOVA. Categorical data were
compared using Fisher’s exact test, χ2 test or χ2 test for
trend, as appropriate.
Results
Between 1 January 1999 and 7 January 2001, all patients
referred with a diagnosis of varicose veins were invited to
participate. Of 1009 patients assessed for the trial, 536 (53·1
per cent) met the inclusion criteria and 246 (45·9 per cent)
agreed to randomization; 122 were randomized to con-
servative treatment and 124 to surgery. There were no
significant differences in demographic or clinical features
between the patients in the two randomized groups or
between those randomized and those who declined ran-
domization (Table 1). A CONSORT14 summary of the
treatment allocation and follow-up in this trial is shown in
Fig. 1.
Of patients who declined randomization, 79 per cent
elected to have surgery and these were more likely
to be younger (mean age 49·5 versus 52·6 years) and
women (69·8 versus 42·0 per cent). Of those who under-
went surgery within the randomized trial 18·1 per cent
had bilateral surgery, 7·1 per cent as a single procedure
www.bjs.co.uk British Journal of Surgery 2006; 93: 175–181
Surgery versus conservative treatment for uncomplicated varicose veins 177

Table 1 Demographics and clinical features of patients according to randomization

Randomized to
conservative Randomized Declined
treatment to surgery randomization Total
(n = 122) (n = 124) (n = 290) (n = 536)

Sex ratio (F : M) 87 : 35 83 : 41 189 : 101 359 : 177

Age (years)* 49·5(13·5) 49·0(12·5) 51·3(13·8) 50·4(13·5)
Height (cm)* 168·0(9·9) 167·8(11·8) 168·8(9·4) 168·4(10·1)
Body mass index* 26·9(4·1) 26·4(3·5) 25·4(3·2) 25·9(3·5)
Smokers 26 (21·3) 33 (26·6) 61 (21·0) 120 (22·4)
Family history of varicose veins 86 (70·5) 91 (73·4) 206 (71·0) 383 (71·5)
Family history of leg ulceration 9 (7·4) 20 (16·1) 50 (17·2) 79 (14·7)
Previous pregnancies 77 76 168 321
Mean no. 2·1 2·1 1·7 1·9

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)

Allocated to conservative treatment (n = 122) Allocated to surgery (n = 124)

Received allocated treatment (n = 122) Received allocated treatment (n = 109)
Refused allocated treatment and had
conservative treatment (n = 9)
Deferred surgery owing to fitness etc. (n = 6)

Lost to follow-up at 1year (n = 21) Lost to follow up at 1year (n = 43)

Discontinued intervention (n = 63)
Opted for surgery in year 1 (n = 7)
Opted for surgery in year 2 (n = 37)
Opted for surgery in year 3 (n = 19)

Available for analysis at 1year (n = 101) Available for analysis at 1year (n = 81)

Fig. 1 Outcome for all eligible patients

and 11·0 per cent as staged unilateral procedures. All
patients having bilateral procedures were inpatients and
86·8 per cent of unilateral procedures were carried out as
a day case.
There were two major complications following surgery
(1·6 per cent). One patient developed a foot drop after
saphenopopliteal ligation, which resolved completely
within 8 weeks of surgery. The second had cellulitis
that required readmission to hospital 5 days after surgery
and was treated by intravenous antibiotics. Minor
complications were reported by 20 patients (16·1 per cent)
and comprised pain (three), bleeding (two), postoperative

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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

Table 2 Symptoms reported in the legs at 1-year assessment

Conservative Surgery

Absent Better Same Worse Absent Better Same Worse

Aching 18 (19) 7 (7) 45 (46) 27 (28) 23 (31) 37 (49) 10 (13) 5 (7)

Heaviness 42 (43) 3 (3) 31 (32) 21 (22) 39 (52) 27 (36) 6 (8) 3 (4)
Itching 44 (45) 11 (11) 21 (22) 21 (22) 42 (56) 23 (31) 8 (11) 2 (3)
Swelling 58 (60) 8 (8) 19 (20) 12 (12) 54 (72) 13 (17) 4 (5) 4 (5)
Cosmetic concerns 21 (22) 1 (1) 44 (45) 31 (32) 15 (20) 47 (63) 7 (9) 6 (8)

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).

hypotension (one), retained suture (one), allergy to 25

bandages (one) and wound infections (12), two of which
caused prolonged or recurrent wound discharge. Two 20
Baseline
1Year
other patients (1·6 per cent) had additional visits to the
Percentage of patients
general practitioner because of concern about bruising.
15

Symptomatic changes 10

The symptoms reported by patients at initial assess-

ment were aching (84·1 per cent), cosmetic concerns 5
(69·1 per cent), itching (58·8 per cent), heaviness (55·2 per
cent) and swelling (44·4 per cent). Thirty-one per cent of 0
0 1 2 3 4 5 6 7 8 9
patients reported that they had some relief of symptoms
Anatomical extent
through the use of compression hosiery. For all reported
a Conservative treatment
symptoms, there was significantly greater relief at 1 year
with surgery than with conservative treatment (Table 2). 80
The differences at 2 years were not significant, but this 70
was based on intention-to-treat analysis, and a significant
60
Percentage of patients

proportion of patients in the conservative treatment group

had opted to undergo surgery by this time. 50

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

those in the surgical group had no varicose veins on clinical

assessment at 1 year (P < 0·010, χ2 test for trend).
Quality of life
Based on the primary endpoint, the SF-6D index, there
was no significant difference between the two groups at
baseline, but at 1 and 2 years values were significantly
higher in the surgical group (Table 3). Significantly higher
Fig. 2Anatomical extent at baseline and 1 year assessment in
patients randomized to a conservative treatment and b surgery
(note the different vertical scales in a and b)
scores for the EQ-5D were also obtained in the surgical
group at 1 year, and for several of the SF-36 dimensions
(Table 3). For the first 2 years after treatment, surgery
showed an overall benefit of 0·083 (95 per cent confidence

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

Baseline 1 year 2 years

Conservative Surgery Conservative Surgery Conservative 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).

interval (c.i.) 0·005 to 0·16) quality-adjusted life years Discussion

(QALYs) based on the SF-6D score and 0·13 (95 per cent
c.i. 0·016 to 0·25) QALYs based on the EQ-5D score.
These calculations were based on imputed discounted
values using a 3·5 per cent discount rate in line with current
Department of Health recommendations16 and straight
line interpolation.
Losses to follow-up
At 1-year follow-up there was significant attrition owing
to patients failing to attend or withdrawing from the trial
(21 of 122 following conservative treatment and 43 of
124 after surgery). Those lost to follow-up were more
likely to be younger (mean age 45 versus 51 years) and
women (73 versus 68 per cent). Further attempts were
made to contact patients by post and telephone, and a
total of 45 patients had some further contact with the
researchers. None of those in the surgical group reported
significant symptoms for further consultations or treatment
elsewhere. The main reason given for not attending
was that they did not want to spend time presenting
for further follow-up. None reported withdrawal owing
to dissatisfaction with treatment or the development of
complications, but there were five who had declined the
allocated treatment and did not want further follow-up.
In the conservative group most withdrawals were among
patients who opted to undergo surgery, and by the third
year of the trial 63 patients (51·6 per cent) had undergone
surgical treatment.
Of those for whom data were available, three (5 per cent)
of 65 patients in the surgical group and 53 (50 per cent) of
107 of those treated conservatively expressed dissatisfaction
at their initial treatment (P < 0·050).
The fact that there has been no previous randomized trial
comparing surgery with conservative treatment for varicose
veins attests to the difficulty in carrying out a study of
this kind. Surgery is an established treatment which rids
the patient of cosmetically embarrassing varicose veins
as well as improving their symptoms, so many patients
referred to secondary care want and expect an operation.
It was therefore not surprising that many patients declined
randomization, and that a considerable number withdrew
from the conservative treatment group to undergo surgical
treatment. Despite these difficulties, sufficient numbers
were recruited, and patients in the two randomized
groups were well matched in terms of demographics and
symptoms. Follow-up was also difficult as many patients
were young, healthy adults, who were asymptomatic after
treatment of their varicose veins and reluctant to commit
to further hospital visits
These problems were recognized at the outset of the
trial and the design included consideration of those who
declined surgery and additional attempts at contact with
non-responders. Despite this there was a considerable
attrition rate. However, the evidence from follow-up
contact and the fact that over half of the patients in
the conservative group subsequently elected for surgical
treatment suggests that any benefits of surgery are likely
to be underestimated rather than exaggerated by these
confounding factors. A lesson for future trials that may
encounter similar problems is that the validation of a
simple telephone questionnaire, possibly based on the EQ-
5D that could be used to generate utilities, may allow more
complete and thus more robust data collection.

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
surgery. In particular, there were benefits in quality of
life, with the SF-6D and EQ-5D suggesting that surgical
treatment carried a benefit of approximately 1–2 months
of quality-adjusted survival over a 2-year interval. This
was likely to be a considerable underestimate of overall
benefit of surgery, owing to the proportion of patients
in the conservative group who crossed over to surgical
treatment, and the fact that the advantages of surgery are
likely to persist well beyond 2 years. The limitations in
access to surgery for uncomplicated varicose veins in the
UK are based on a perception that they are medically
unimportant and on the fact that surgical treatment is
relatively time consuming. In this study the use of a
single preference-based measure allowed health benefit
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
effectiveness16 . Although the disease-specific Aberdeen
Varicose Vein Severity Score is gaining acceptance10 , it
was not in widespread use at the planning stage of this trial
and cannot currently be used to generate weightings for
QALY estimation. A disease-specific measure such as this
may, however, be more sensitive to the changes associated
with the treatment of varicose veins and would be a useful
addition to future studies.
There is considerable potential difficulty in assessing
leg symptoms and their relationship to varicose veins5 .
However, 1 year after operation patients reported that
80 per cent (for aching) to 90 per cent (for swelling) of
their symptoms were absent or better than before surgery,
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
had cosmetic concerns. These observations suggest a
substantial benefit from surgery but perhaps support
the case for careful evaluation of patients’ symptoms
and problems when considering surgical treatment. It
is important that patients understand when there is
doubt about the relationship between their leg symptoms
and their varicose veins. Clear expectations about the
likely outcomes of treatment are important for patients’
satisfaction17 . In addition to improving specific symptoms,
surgical treatment was associated with more improvement
in physical and social functioning, energy/vitality and
general health at 1 year than conservative measures.
The results of some controlled studies of treatments
may be difficult to transpose to everyday practice owing
to the selective and non-representative practice that may
occur within clinical trials. In this trial both the clinical
assessments and the operations were done by a range
Copyright  2006 British Journal of Surgery Society Ltd
Published by John Wiley & Sons Ltd
of surgeons with different levels of experience (including
trainees) in a normal health service setting. Nevertheless,
the incidence of postoperative complications was low and
objective assessment showed good clearance of varicose
veins 1 year after surgery.
This study has shown clear advantages for surgical
treatment of varicose veins across a whole range of outcome
measures relating to health status, quality of life and patient
satisfaction. The results probably underestimate long-term
benefits, because of the demand for surgery by patients in
the conservative treatment group. These findings lend
strong support to the adequate and consistent provision of
health service treatment for symptomatic varicose veins,
even in the absence of medical complications of venous
hypertension.
Acknowledgements
This work was carried out as part of a study funded by the
NHS Health Technology Assessment Programme (project
95/05/06). The views and opinions expressed do not
necessarily reflect those of the Department of Health. The
authors acknowledge the help of the following participants
in the trial in Sheffield and Exeter: Kath Rigby for assisting
with patient recruitment; Jonathan Beard, Philip Chan,
Robert Lonsdale, John Thompson, the late Richard Wood
and other clinical staff; Sue Sheriff, Philip Niblett, Audrey
Peters and other staff from Medical Physics; research
nurses Kate Allington and Suzie Marriott; and Stephen
Walters, Phil Shackley and Tessa Peasgood for statistical
and health economics advice.
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