Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0274181489
Study information
Scientific title
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
Acronym
Study hypothesis
What 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
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
Surgery: Long saphenous vein
Intervention
Patients were randomised to groin dissection (conventional practice) or no groin dissection (intervention group).
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Numerical analogue pain score at 1, 6 and 12 hours post-op.
Secondary outcome measures
Analgesic requirements during first 24 hours post-op and first week post-op.
Overall trial start date
15/04/2005
Overall trial end date
31/03/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Patients 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
25 in each group. 50 total.
Participant exclusion criteria
Patients scheduled to undergo simultaneous saphenous vein surgery.
Recruitment start date
15/04/2005
Recruitment end date
31/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
West Suffolk Hospitals NHS Trust
Bury St Edmunds
IP33 2QZ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
West Suffolk Hospitals NHS Trust (UK), NHS R&D support 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