Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02522845 |
| Other study ID # |
15/LO/0181 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2015 |
| Est. completion date |
May 2019 |
Study information
| Verified date |
August 2022 |
| Source |
Imperial College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will be looking at the effect of compression therapy in patients having endovenous
treatment for truncal incompetence of their varicose veins using either radiofrequency
ablation (RFA) or endovenous laser therapy (EVLT). Patients will be randomised to either the
compression group (group A) or the no compression group (group B).
The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as
the cost effectiveness of each intervention will be assessed.
Description:
Background
Varicose veins are common and are known to affect approximately one third of the population.
Chronic venous disease (CVD) has been shown to have a negative impact on the quality of life
of patients and treatment of varicose veins has been demonstrated to lead to improvement in
the quality of life of patients. Over the past decade, new endovenous techniques have been
introduced and these are felt to be cost-effective, especially, when performed in an
outpatient or 'office-based' setting.
There is currently uncertainty about the use of compression stockings following treatment of
varicose veins. In their consensus statement in 2008, the International Union of Phlebology
(IUP) stated that there is good evidence for using compression in certain clinical
indications. These include the management of telangiectasia after sclerotherapy, varicose
veins in pregnancy, prevention of thromboembolism and healing of ulcers. However, a few
questions remain unanswered, such as the length of treatment and level of compression to be
used6. The Society for Vascular Surgery and the American Venous Forum recommend using
compression stockings post-operatively for 1 week to prevent haematoma formation, pain and
swelling. The 2013 NICE Guidelines on Varicose Veins in the Legs recommended the use of
compression hosiery for no more than 7 days after interventional treatment for varicose
veins. However, due to current uncertainty of compression bandaging or hosiery compared to no
compression after interventional treatment for varicose veins, the NICE Guideline Development
Group have advocated further research to evaluate the clinical and cost effectiveness of this
post-procedure intervention. The guidelines also suggested looking into the length of time
compression bandaging should be worn if it shown to be beneficial.
Several researchers have looked into the practice of using compression after venous ablation.
In a survey of the management of varicose veins by the members of the Vascular Society of
Great Britain and Ireland, Edwards et al. found that the majority of surgeons used bandages
post-operatively, with 49% using elastic bandages. The literature on the use of compression
stockings following treatment of varicose vein is limited.
Between December 2006 and February 2008, Bakker and colleagues conducted a prospective
randomised controlled trial on the use of compression stockings after endovenous laser
ablation of the great saphenous vein. One hundred and nine patients were approached with 93
finally randomised to use compression stockings for 2 days (Group A) and 7 days (Group B),
respectively. All patients were followed up for 3 months post-treatment and the visual
analogue scale (VAS) for pain was recorded at 48 hours, 1 week and 6 weeks. A physical
examination and quality of life was assessed at 1 week and 6 weeks. Occlusion rate at the 3
month point was also evaluated. Physical function and vitality was shown to be significantly
better in group B at 1 week follow-up, but there was no statistically significant difference
at 6 weeks. At 1 week, it was also noted that the VAS score in group B (VAS score 2.0 ± 1.1)
was significantly lower than in patients wearing compression stockings for 48 hours (VAS
score 3.7 ± 2.1) (p≤0.001)10. No significant difference was, however, observed at 6 weeks
post-procedure. Limitations of the study include the high drop out of the trial (40 out of
the initial 109 approached) and the absence of any phlebectomies or sclerotherapy in the
patients.
Elderman et al. carried out a randomised trial to assess the effect of compression stockings
after endovenous laser therapy (EVLT) for great saphenous vein incompetence. Patients'
reported pain scores and quality of life scores was evaluated on the day of the procedure,
2-3 days afterwards and 2-6 weeks post-procedure. A total of 111 patients were randomised to
stockings (n=55) and no stockings (n=56). There was a statistically significant difference in
the pain scores in favour of the stockings group up to day 7, but this difference was no
longer present by week 6. There was also a greater use of analgesia in patients in the no
stockings group compared to patients wearing stockings (p<0.05). In addition, patients
wearing stockings reported a statistically significantly higher score of satisfaction at 2
days (4.44 vs 4.15) and at 6 weeks (4.59 vs 4.18). The absolute difference was, however,
small. Two notable limitations of the study were the high level of drop outs (16 from each
group) and the absence of any blinding.
Hamel-Desnos et al. undertook a randomised controlled trial looking at the effect of
compression in patients receiving foam sclerotherapy of the saphenous vein. They noted that
patients with compression had similar pain and quality of life scores to patients not wearing
any compression. They concluded that additional use of compression had no impact on the
effectiveness of obliteration of veins, satisfaction scores, symptoms and quality of life,
and that further controlled trials was needed to answer the question of whether using
compression results in any difference to the outcome of varicose vein procedures.
The investigators, therefore, propose to undertake a multicentre randomised study looking at
the effect of compression therapy after endovenous thermal ablation.
Description
This will be a multicentre randomised clinical trial looking at the impact of wearing or not
wearing compression stocking following endothermal ablation (either endovenous laser
treatment (EVLT) or radiofrequency ablation (RFA)) of incompetent truncal veins. Those
requiring concurrent phlebectomies or foam injection will be excluded.
Patients will be randomised into group A (compression) and group B (no compression). Only the
use of compression will be randomised while the decision as to which treatment to use will be
at the discretion of the clinical team.
Target Population
Patients referred for treatment of symptomatic varicose veins will be recruited if they are
found to have primary great saphenous (GSV) or small saphenous vein (SSV) incompetence on
colour duplex scan.
Intervention
Patients will be randomised to have compression (group A) or no compression (group B). The
compression therapy used will be Class II compression stockings. The treatment offered will
be endothermal ablation (either endovenous laser treatment (EVLT) or radiofrequency ablation
(RFA)) of incompetent truncal veins. Concurrent phlebectomy or foam sclerotherapy will not be
carried out.
Patients randomised to group A will be asked to wear compression stockings for 1 week.
Patients randomised to group B will not be provided with any compression.
At baseline, patients will be asked to fill quality of life questionnaires (EQ-5D, AVVQ and
CIVIQ) and will have their clinical scores assessed (CEAP and VCSS). On discharge after their
varicose vein intervention, they will then be provided with a diary to record their
post-procedural pain every day for 10 days using a validated visual analogue scale (VAS) as
well as to record when they return to their normal activities and are back to work. They will
also be asked to attend a follow-up in 2 weeks and at 6 months.
Patients' GP will also be sent a letter to inform them of their patient's participation in
the study.
Follow-up
Patients will be followed up in the outpatient clinic at 2 weeks and 6 months.
Follow-up at 2 Weeks At the 2 weeks' follow-up, the diary containing details of the pain
scores and how soon patients were able to return to normal activities/work will be collected.
In addition, patients will be asked about any bruising or phlebitis they have had in the two
weeks after their procedure and how compliant they have been with the compression. They will
be examined and the Venous Clinical Severity Score (VCSS) will be recorded. They will also be
asked to fill in the EQ-5D, AVVQ and CIVIQ scores.
Follow-up at 6 Months At the 6 months follow-up, patients will be examined and their VCSS
will be recorded. They will also be asked to fill the EQ-5D, AVVQ and the CIVIQ scores. They
will have a venous Duplex scan to determine occlusion of the treated vein.
Sample Size and Study Duration
The study team estimated the sample size needed to observe a difference of at least 10mm in
the VAS score, with a standard deviation of 20mm. With power at 80% and 5% significance
equivalence, the study would need to recruit 128 patients (64 per group) to show a
difference.
Previous studies looking at compression stockings have shown drop out rates close to 37% at 3
months10. Therefore, if an estimated drop out rate of about 40% by 6 months is used, at least
214 patients would need to be recruited. If at least 2 patients per week are recruited, this
will be approximately a total of 208 patients that could potentially be randomised over the
course of two years.
With 6 months follow-up, therefore, the study will be running for 24 months with a target
recruitment of 214 patients.
Settings The study will be conducted at the Imperial College NHS Trust
