Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
17/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes