Condition category
Circulatory System
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
28/08/2012
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 Stephen Goode

ORCID ID

Contact details

University Hospital
NHS Trust
B Floor
West Block
Academic Radiology
Derby Road
Nottingham
NG7 2UH
United Kingdom
+44 0115 8231176

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192182505

Study information

Scientific title

Acronym

Study hypothesis

1. The primary aim of this study is to determine whether reinforcement of the proximal long saphenous vein valve with an exovascular cuff is as effective as removal of the long saphenous vein in the treatment of symptomatic varicose veins at various time intervals. This will be assessed by looking at patients pain levels post operatively and objectively assessing levels of post procedure bruising.
2. Secondary Research Objectives: The secondary aims are to:
2.1 Identify whether the exovascular cuff is cost effective
2.2 Assess time taken to perform the procedures
2.3. See if exovascular cuff promotes early return to normal activity
2.4 Assess long term efficacy by Duplex scan at six weeks, one year, two years and five years 5. compare use of Venocuff with VNUS

Ethics approval

Not provided at time of registration

Study design

Double Blind Randomised

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiovascular: Varicose veins

Intervention

There will be 2 concurrent studies: one will involve patients with bilateral primary varicose veins and one will involve patients with unilateral primary varicose veins.

Intervention arms: no interventions withheld, additional interventions - insertion of venocuff rather than high tie and stripping of LSV.

Follow up duplex assessment of lower limb various telephone interviews and photo of patients leg.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Visual analogue scale for pain and bruising

Secondary outcome measures

Duplex ultrasound assessment of lower limb venous system competency

Overall trial start date

30/06/2006

Overall trial end date

01/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Bilateral or unilateral primary varicose veins
2. Mild to moderate varicose veins
3. Agree to participate in study

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

1. Recurrent varicose veins
2. Thrombophlebitus affecting the LSV or tributaries
3. The ultrasonic finding of an LSV that is very dilated >10mm in female and > 11mm in male
4. Damaged thickened non mobile or absent terminal subterminal LSV values
5. Gross tortuasity along the course of the LSV
6. An inability to render the SFJ competent at operation

Recruitment start date

30/06/2006

Recruitment end date

01/06/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital
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

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

Publication citations

Additional files

Editorial Notes