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

ISRCTN ISRCTN57635230
DOI https://doi.org/10.1186/ISRCTN57635230
Secondary identifying numbers N0557093656
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
28/02/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Ajantha P Jayatunga
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAvulsion or ligation - small tributaries of long saphenous vein in groin, does it really matter?
Study objectivesSimple 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCardiovascular: Long saphenous vein
InterventionRandomised controlled trial - envelope opened by anaesthetist after patient is anaesthetised for operation.
Intervention typeProcedure/Surgery
Primary outcome measureGroin 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 measuresNot provided at time of registration
Overall study start date01/08/1999
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants40
Key inclusion criteriaPatients with saphenous vein junction incompetence
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/08/1999
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

The Dudley Group of Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

28/02/2018: No publications found, verifying study status with principal investigator.
26/01/2016: no publications found on PubMed.