PIN (Perforate Invaginate) stripping of the long saphenous vein, in patients having varicose vein surgery, with or without groin dissection on the postoperative pain outcome: prospective, single blind, randomised controlled trial

ISRCTN ISRCTN03484592
DOI https://doi.org/10.1186/ISRCTN03484592
Secondary identifying numbers N0274181489
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
24/08/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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 M E Gaunt
Scientific

West Suffolk Hospitals NHS Trust
Hardwick Lane
Bury St Edmunds
IP33 2QZ
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 titlePIN (Perforate Invaginate) stripping of the long saphenous vein, in patients having varicose vein surgery, with or without groin dissection on the postoperative pain outcome: prospective, single blind, randomised controlled trial
Study objectivesWhat are the outcomes of PIN (Perforate Invaginate) stripping of the long saphenous vein in patients having varicose vein surgery with or without groin dissection on postoperative pain?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Long saphenous vein
InterventionPatients were randomised to groin dissection (conventional practice) or no groin dissection (intervention group).
Intervention typeProcedure/Surgery
Primary outcome measureNumerical analogue pain score at 1, 6 and 12 hours post-op.
Secondary outcome measuresAnalgesic requirements during first 24 hours post-op and first week post-op.
Overall study start date15/04/2005
Completion date31/03/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants25 in each group. 50 total.
Key inclusion criteriaPatients with sapheno-femoral incompetence and long saphenous vein incompetence in thigh who are undergoing elective sapheno-femoral disconnection and PIN stripping of the long saphenous vein with multiple avulsions.
Key exclusion criteriaPatients scheduled to undergo simultaneous saphenous vein surgery.
Date of first enrolment15/04/2005
Date of final enrolment31/03/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

West Suffolk Hospitals NHS Trust
Bury St Edmunds
IP33 2QZ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

West Suffolk Hospitals NHS Trust (UK), NHS R&D support funding

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