Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
26/08/2008
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 BD Braithwaite

ORCID ID

Contact details

Department of Vascular Surgery
C Floor West Block
University Hospital
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 924 9924
BRUCE.BRAITHWAITE@QMC.NHS.UK

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192119061

Study information

Scientific title

Acronym

Study hypothesis

To determine whether VNUS is as effective as groin re-exploration for recurrent varicose veins in association with a recurrently incompetent long saphenous vein (LSV). Assessment will be by Duplex scan at 6 weeks, 1 year and 5 years.

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

Cardiovascular: Recurrent varicose veins

Intervention

VNUS closure compared with groin dissection and long saphenous vein (LSV) stripping for recurrent varicose veins

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Operative time, visual analogue scales for pain and bruising, costs of procedure, recurrence rates.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/07/2002

Overall trial end date

12/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Age 18-80

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

31/07/2002

Recruitment end date

12/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Vascular Surgery
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Queen's Medical Centre University Hospital NHS Trust (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/16137898

Publication citations

  1. Results

    Hinchliffe RJ, Ubhi J, Beech A, Ellison J, Braithwaite BD, A prospective randomised controlled trial of VNUS closure versus surgery for the treatment of recurrent long saphenous varicose veins., Eur J Vasc Endovasc Surg, 2006, 31, 2, 212-218, doi: 10.1016/j.ejvs.2005.07.005.

Additional files

Editorial Notes