Is leg compression needed after heat treatment of varicose veins?
| ISRCTN | ISRCTN18119345 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18119345 |
| Secondary identifying numbers | MO2015a |
- Submission date
- 10/01/2015
- Registration date
- 16/03/2015
- Last edited
- 23/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Vascular Surgery
Royal Bolton Hospital
Bolton
BL4 0JR
United Kingdom
| Phone | +44 (0)1204390105 |
|---|---|
| madu.onwudike@boltonft.nhs.uk |
Study information
| Study design | Single-centre randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact to request a patient information sheet |
| Scientific title | Limb compression after radiofrequency ablation of varicose veins: a randomised controlled study |
| Study objectives | 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(s) | NRES Committee North West – Liverpool Central, 18/03/2015, ref: 15/NW/0179 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/02/2015 |
| Completion date | 01/02/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 240 |
| Total final enrolment | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/02/2015 |
| Date of final enrolment | 28/01/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Bolton
BL4 0JR
United Kingdom
Sponsor information
Hospital/treatment centre
Minerva Road
Fanworth
Bolton
BL4 0JR
England
United Kingdom
"ROR" |
https://ror.org/053fx7g25 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/09/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2020 | 23/10/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
23/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
06/06/2018: No publications found, verifying study status with principal investigator.
13/05/2016: Ethics approval information added.
