Contact information
Type
Scientific
Primary contact
Mr Bruce D Braithwaite
ORCID ID
Contact details
E Floor
West Block
Department of Vascular Surgery and Endovascular Surgery
Derby Road
Nottingham
NG7 2UH
United Kingdom
+44 01159249924
bruce.braithwaite@nuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0192187933
Study information
Scientific title
Acronym
Study hypothesis
To find whether full length compression stockings are more effective than anti-embolism stockings when used after varicose vein surgery.
As of 17/04/2012, 'recruitment suspended but expected to resume in 2009' was updated to 'recruitment to start in September 2012'.
Ethics approval
Obtained 27/02/06.
Study design
Randomised controlled trial
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 details below to request a patient information sheet
Condition
Surgery: Varicose veins
Intervention
Some 60 patients who are to have day case surgery on their varicose veins will be asked to take part in this study. At the time of their pre-admission appointment they will be asked to take part and will be given the attached patient information sheet.
Informed consent will be obtained after they have had time to consider the project. Written consent will be confirmed just before their operation when they see the surgeon who will be doing their operation.
After entry to the study, stockings of each type will be randomised using computer generated numbers on a 1:1 basis so that 30 patients will receive anti-embolism stockings and 30 will receive the new style. Patients will be asked to complete a visual analogue scale that measures the discomfort they feel in their legs. Patients will be asked to complete a similar scale for subjective measurement of bruising to their leg. Further information will be collected about stocking slippage and the use of the stockings. Patients will be asked to return to the day case unit two weeks after surgery for a post operative check and for collection of their data sheets and comments. This visit is in addition to their normal appointment at 6 weeks.
Statistical analysis
Categorical data such as slippage will be assessed using the Chi-square test. Variable data such as bruising and pain will be assessed using the Mann Whitney U test for non-parametric data. Sample Size calculation From personal data it is expected that 55% of patients who wear the anti-embolism stocking will experience slippage during their postoperative recovery. Data from Scholl who supply the new style of stocking suggest that a maximum of 20% of patients will experience slippage with their product. For an alpha error of 0.05 and Beta error of 0.2, 50 patients would need to be recruited. There may be a 20% non-compliance rate with follow up so a sample size of 60 has been set. Some 140 people have day case varicose vein surgery each year so recruitment should be complete relatively quickly. Involvement of Non-medical, non-hospital staff. This project has been designed in co-operation with market research experts and consumers that use Scholl stockings bought over the counter at Pharmacies in the UK. Flesch Reading Ease 50.1 Flesch-Kincaid Grade 11.
As of 17/04/2012, the trial was delayed because of changes to the daycase unit. Recruitment is due to start in September 2012.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
We are trying to see if we can improve the care received after the varicose vein surgery we currently offer. We want to know if we can reduce the amount of discomfort the patients get following operation, if we can reduce the amount of pain and bruising, and if we can get the patient back to normal activity earlier than at the moment. We would also like to know if a new type of stocking is as good or better than the one we currently offer, without compromising the standard of care the patients receive. It may also be more cost effective for the NHS.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
16/10/2006
Overall trial end date
20/02/2008
Reason abandoned
Lack of staff/facilities/ resources
Eligibility
Participant inclusion criteria
Men and women requesting treatment for bilateral varicose veins who present to the vascular clinics at Queen's Medical Centre.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60 patients, 30 patients controls and 30 patients with the new type of the stocking.
(Amended 17/04/2012: Recruitment to start in September 2012)
Participant exclusion criteria
1. Patient under 21 and over 80 years
2. Patients without varicose veins
3. Patients who do not adequately understand verbal explanations or written information given in English, or who have special communication needs
Recruitment start date
16/10/2006
Recruitment end date
20/02/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
E Floor, West Block
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Nottingham University Hospitals NHS Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary