Condition category
Circulatory System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
14/05/2008
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 Michael Gough

ORCID ID

Contact details

Vascular Surgical Unit
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 0113 392 3951
michael.gough@leedsth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436169958

Study information

Scientific title

Acronym

Study hypothesis

Modifications of laser technique might result better clinical outcome in the treatment of varicose veins due to sapheno-femoral and long saphenous incompetence. This study is designed to answer 2 questions:
1. Do these modifications result in improved symptom relief and cosmetic appearance after treatment of varicose veins?
2. Does one of these techniques reduce the total number of follow up sclerotherapy sessions needed to complete the treatment of 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

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular: Varicose veins

Intervention

2 different types of modified EVLT (endovenous laser treatment) techniques vs standard EVLT technique.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. The total number of follow up sclerotherapy sessions required to complete the treatment.
2. Technical success: determined by duplex ultrasound of LSV:
2.1 Successful: occlusion and non compressibility of the LSV without blood flow throughout the treated length
2.2 Partial response: segmental occlusion of LSV and abolition of distal reflux
2.3 Failure: reflux in treated LSV any time after treatment
3. Improvement in symptoms, using the Aberdeen Vein Questionnaire, a previously validated disease-specific quality of life instrument
4. Review and quantification of varicosities on post-EVLT photographs both prior to and after completion of sclerotherapy

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2005

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

207 - Each study group comprise 69 (follow-up completed) patients. Group 1 (standard EVLT) is the control group and will be of the same size as group 2 and 3.

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2005

Recruitment end date

01/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Vascular Surgical Unit
Leeds
LS1 3EX
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

Leeds Teaching Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

2008 results on http://www.ncbi.nlm.nih.gov/pubmed/18440756

Publication citations

  1. Results

    Theivacumar NS, Dellagrammaticas D, Mavor AI, Gough MJ, Endovenous laser ablation: does standard above-knee great saphenous vein ablation provide optimum results in patients with both above- and below-knee reflux? A randomized controlled trial., J. Vasc. Surg., 2008, 48, 1, 173-178, doi: 10.1016/j.jvs.2008.01.062.

Additional files

Editorial Notes