Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
21/10/2010
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 Mark Whiteley

ORCID ID

Contact details

The Whiteley Clinic
1 Stirling House
Stirling Road
Guildford
Surrey
GU2 7RF
United Kingdom
+44 (0)1483 477180
info@thewhiteleyclinic.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0211091334

Study information

Scientific title

Acronym

Study hypothesis

To investigate the fate of incompetent perforating veins (IPVs) following saphenofemoral ligation and stripping of the great saphenous vein (GSV), with or without subfascial endoscopic perforator surgery (SEPS)

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

Cardiovascular: Primary long saphenous varicose veins

Intervention

Randomised controlled trial randomised into two groups:
Group 1 - subfascial endoscopic perforator vein surgery (SEPS)
Group 2 - standard open procedure

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Improvement in function measured by refill time,
2. Incidence of recurrent reflux
3. Clinical recurrence
4. Cosmetic results

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2000

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Venous reflux (greater than 0.5 s) of the greater saphenous vein (GSV)
2. Additional incompetent perforating veins (IPVs)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

72

Participant exclusion criteria

1. Ulceration,
2. Recurrent veins
3. Deep venous reflux/thrombosis
4. Saphenopopliteal reflux

Recruitment start date

01/09/2000

Recruitment end date

31/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Whiteley Clinic
Guildford, Surrey
GU2 7RF
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

Royal Surrey County Hospital NHS Trust (UK) - NHS R&D 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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17701962

Publication citations

  1. Results

    Kianifard B, Holdstock J, Allen C, Smith C, Price B, Whiteley MS, Randomized clinical trial of the effect of adding subfascial endoscopic perforator surgery to standard great saphenous vein stripping., Br J Surg, 2007, 94, 9, 1075-1080, doi: 10.1002/bjs.5945.

Additional files

Editorial Notes