Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
26/01/2016
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

Mr Ajantha P Jayatunga

ORCID ID

Contact details

Consultant General Surgeon
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0557093656

Study information

Scientific title

Avulsion or ligation - small tributaries of long saphenous vein in groin, does it really matter?

Acronym

Study hypothesis

Simple avulsion rather than ligation of the small tributaries of the long saphenous vein in the groin reduces time for groin surgery, causes no more pain and produces no increase in the incidence of groin haematoma. Does avulsion rather than ligation of small tributaries reduce the incidence of recurrence?

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 the contact details below to request a patient information sheet

Condition

Cardiovascular: Long saphenous vein

Intervention

Randomised controlled trial - envelope opened by anaesthetist after patient is anaesthetised for operation.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Groin bruising or haematoma; sign of infection; pain; other adverse events - proforma to be filled in by single nursing sister who is 'blinded' to the patient's randomisation group. Follow up at 24 h and 1 week by nurse. Surgeon sees patient for 6 and 12 month follow up to check for recurrence in groin (avulsion reduces incidence of groin recurrence).

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/1999

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with saphenous vein junction incompetence

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/08/1999

Recruitment end date

31/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Russells Hall Hospital
Dudley
DY1 2HQ
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

Hospital/treatment centre

Funder name

The Dudley Group of Hospitals 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

Publication citations

Additional files

Editorial Notes

26/01/2016: no publications found on PubMed.