Plain English Summary
Background and study aims
Leg compression after heat treatment of swollen or enlarged veins is used to reduce the procedure-related side-effects. There is not enough evidence to lend support to the use of leg compression. The aim of this study is to investigate whether leg compression is needed after heat treatment of varicose veins.
Who can participate?
Individuals with enlarged or swollen veins referred to clinics at Royal Bolton Hospital (UK)
What does the study involve?
Patients will be randomly allocated to heat treatment of their veins followed by leg compression or no leg compression.
What are the possible benefits and risks of participating?
Benefits are a reduction in the occurrence of blood clots in veins, pain and inflammation. Risks might be discomfort associated with limb compression and movement restriction.
Where is the study run from?
Royal Bolton Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
From February 2015 to February 2016
Who is funding the study?
Royal Bolton Hospital NHS Foundation Trust (UK)
Who is the main contact?
Mr Madu Onwudike
madu.onwudike@boltonft.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mr Madu Onwudike
ORCID ID
Contact details
Vascular Surgery
Royal Bolton Hospital
Bolton
BL4 0JR
United Kingdom
+44 (0)1204390105
madu.onwudike@boltonft.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MO2015a
Study information
Scientific title
Limb compression after radiofrequency ablation of varicose veins: a randomised controlled study
Acronym
Study hypothesis
The outcome in patients who have not worn compression hosiery after radiofrequency ablation of varicose veins is not inferior to those who have worn the hosiery in the post-treatment period.
Ethics approval
NRES Committee North West – Liverpool Central, 18/03/2015, ref: 15/NW/0179
Study design
Single-centre randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact to request a patient information sheet
Condition
Varicose veins
Intervention
1. Compression after radiofrequency ablation of lower limb varicose veins
2. No compression after radiofrequency ablation of lower limb varicose veins
Intervention type
Device
Phase
Drug names
Primary outcome measure
Successful obliteration of target vein, assessed with duplex ultrasound scan at 12–14 weeks
Secondary outcome measures
1. Quality of life, assessed with the Aberdeen Varicose Vein Severity Score and the Venous Clinical Severity Score at baseline (on the day of surgery) and at 12 weeks
2. Complications: recorded during patients' follow-up or emergency admissions, including any problems specifically related to stockings from the first post-operative day to 12 weeks
3. Patient's satisfaction, assessed with a patient satisfaction questionnaire
4. Pain, measured with the Visual Analogue Scale questionnaire; completed by the patient during the first post-operative week and collected at the 2 week review
5. Return to normal activities: information obtained by direct questioning at the 2 week interview and reconfirmed at 12 weeks
Overall trial start date
01/02/2015
Overall trial end date
01/02/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18–90 years old
2. C2 to C6 disease and referred to clinics at Royal Bolton Hospital (UK)
3. Veins anatomically suitable for endothermal ablation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
240
Total final enrolment
100
Participant exclusion criteria
1. Unable to provide informed consent or comply with the study protocol
2. Varicose veins unsuitable for radiofrequency ablation (e.g., very tortuous veins)
3. Pregnancy
4. Lycra allergy
5. Patients who have opted for an alternative method of treatment
Recruitment start date
05/02/2015
Recruitment end date
28/01/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Bolton Hospital NHS Foundation Trust
Minerva Road
Bolton
BL4 0JR
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Royal Bolton Hospital NHS Foundation Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Oral presentation at the European Venous Forum and American Venous Forum; original article published in one of the major vascular journals
Intention to publish date
30/09/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2020 results in https://doi.org/10.1016/j.ejvs.2020.03.014 (added 23/10/2020)