Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02655406 |
| Other study ID # |
15/NE/0314 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2016 |
| Est. completion date |
August 2021 |
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 varicose veins using foam sclerotherapy. 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:
This will be a randomised clinical trial looking at the impact of wearing or not wearing
compression stocking following endovenous ablation using foam sclerotherapy.
Patients will be randomised to group A (compression) and group B (no compression).
Target Population Patients referred to the Imperial College NHS Trust for treatment of
symptomatic varicose veins will be recruited if they are found to have varicose veins
suitable for foam sclerotherapy on colour duplex scan.
Intervention
Patients will be randomised to have compression (group A) or no compression (group B). This
will be done by using an online randomisation software (Sealed Envelope Ltd).
The compression therapy used will be Class II compression stockings. The treatment offered
will be foam sclerotherapy of varicose veins using either Polidocanol or Sodium Tetradecyl
Sulphate (STS) with the concentration used left to the discretion of the clinician.
Patients randomised to group A will be asked to wear compression stockings for 1 week.
Patients randomised to group B will be provided with bandages to wear for 24 hours only, with
no further compression afterwards.
At baseline, patients will be asked to fill validated quality of life questionnaires (EQ-5D,
AVVQ and CIVIQ) and will have their clinical scores assessed using a validated scoring system
(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 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
We 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,
we 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 we estimate a drop out rate of about 40% by 6 months, we would need
to recruit at least 180 patients. If we recruit at least 2 patients per week, 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 180 patients.
