Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
17/03/2008
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 Jonathan Earnshaw

ORCID ID

Contact details

Consultant Surgeon
Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0106092280

Study information

Scientific title

Acronym

Study hypothesis

To compare the use of a PTFE patch with normal repair for surgery for recurrent 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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Long saphenous varicose veins

Intervention

1. Polytetrafluoroethylene patch
2. Flush ligation

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

To reduce the re-recurrence rate after reoperative surgery for recurrent long saphenous varicose veins.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2003

Overall trial end date

28/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

At least 50 patients having surgery for recurrent long saphenous varicose veins.

Participant type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

50

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/03/2003

Recruitment end date

28/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Surgeon
Gloucester
GL1 3NN
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

Gloucestershire R&D 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

2007 results on http://www.ncbi.nlm.nih.gov/pubmed/17512226

Publication citations

  1. Results

    Winterborn RJ, Earnshaw JJ, Randomised trial of polytetrafluoroethylene patch insertion for recurrent great saphenous varicose veins., Eur J Vasc Endovasc Surg, 2007, 34, 3, 367-373, doi: 10.1016/j.ejvs.2007.03.019.

Additional files

Editorial Notes