Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/09/2016
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

Dr Mark Whiteley

ORCID ID

Contact details

The Whiteley Clinic
1 Stirling House
Stirling Road
Guildford
GU2 7RF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0211091333

Study information

Scientific title

A randomised controlled trial investigating the role of subfascial endoscopic perforator vein surgery (SEPS) in the prevention of recurrence in recurrent long saphenous varicose veins

Acronym

Study hypothesis

To evaluate the advantages of SEPS to the standard open procedure - recurrent long saphenous 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

Not available in web format, please use contact details to request a participant information sheet

Condition

Cardiovascular: Recurrent 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

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Improvement in function measured by refill time, incidence of recurrent reflux, clinical recurrence, and cosmetic results.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2000

Overall trial end date

31/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with recurrent varicose veins, undergoing surgery, with Duplex proven incompetent perforating veins

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/2000

Recruitment end date

31/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Whiteley Clinic
Guildford
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

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

30/09/2016: No publications found, verifying study status with principal investigator.