Prospective Randomised Study Of Full Length Compression Stocking And Anti-Embolism Stockings (TEDS) After Varicose Vein Surgery

ISRCTN	ISRCTN29102258
DOI	https://doi.org/10.1186/ISRCTN29102258
Secondary identifying numbers	N0192187933

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 17/04/2012

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Bruce D Braithwaite
Scientific

E Floor, West Block
Department of Vascular Surgery and Endovascular Surgery
Derby Road
Nottingham
NG7 2UH
United Kingdom

Phone	+44 01159249924
Email	bruce.braithwaite@nuh.nhs.uk

Study information

Study design	Randomised controlled trial
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 details below to request a patient information sheet
Scientific title
Study objectives	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(s)	Obtained 27/02/06.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	16/10/2006
Completion date	20/02/2008
Reason abandoned (if study stopped)	Lack of staff/facilities/ resources

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	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)
Key inclusion criteria	Men and women requesting treatment for bilateral varicose veins who present to the vascular clinics at Queen's Medical Centre.
Key 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
Date of first enrolment	16/10/2006
Date of final enrolment	20/02/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

E Floor, West Block

Nottingham
NG7 2UH
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Nottingham University Hospitals NHS Trust (UK), NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan