Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
15/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Anthony Mekako

ORCID ID

Contact details

Alderson House
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084174061

Study information

Scientific title

Acronym

Study hypothesis

Is Endo Venous Laser Therapy (EVLT) superior to conventional surgery for Short Saphenous system varicose veins?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Surgery: Short saphenous system varicose veins

Intervention

Data will be collected using an IBM computer and a specifically designed Microsoft Access database. The primary outcome measure will be compared between the groups by a chi-square test with continuity correction. Quality of life measures at each time point will be compared between the groups by an analysis of covariance, adjusting for the corresponding baseline values. Statistical advice will be sought from Dr Eric Gardiner, statistical consultant, who holds an honorary contract with the Hull and East Yorkshire Hospitals Trust. Health Economic advice regarding cost effectiveness / benefit analysis will be sought from the Centre of Health Economics, the University of York.
Randomisation will be carried out using envelopes method.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Residual SPJ incompetence on Duplex ultrasound

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/09/2005

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. C2-C5 graded varicose veins
2. Patients that have demonstrated to have isolated SPJ incompetence and/or SSV reflux on Duplex scan
3. Patients in whom the most appropriate treatment is surgery (opinion of the patient/surgeon)
5. Patients able to give informed written consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

106

Participant exclusion criteria

1. Patients whose varicose veins will be conservatively managed
2. Inability to give informed written consent
3. Symptomatic varicose veins which on venous duplex are not attributable to SPJ incompetence and SSV reflux
4. Evidence of deep venous reflux on duplex scan
5. Patients on anticoagulants

Recruitment start date

15/09/2005

Recruitment end date

01/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Alderson House
Hull
HU3 2JZ
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 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

The North and South Bank Research and Development Consortium (UK)

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16802211

Publication citations

  1. Results

    Mekako AI, Hatfield J, Bryce J, Lee D, McCollum PT, Chetter I, A nonrandomised controlled trial of endovenous laser therapy and surgery in the treatment of varicose veins., Ann Vasc Surg, 2006, 20, 4, 451-457, doi: 10.1007/s10016-006-9095-y.

Additional files

Editorial Notes