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
Scientific
West Suffolk Hospitals NHS Trust
Hardwick Lane
Bury St Edmunds
IP33 2QZ
United Kingdom
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
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 |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Surgery: Long saphenous vein |
Intervention | Patients were randomised to groin dissection (conventional practice) or no groin dissection (intervention group). |
Intervention type | Procedure/Surgery |
Primary outcome measure | 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 study start date | 15/04/2005 |
Completion date | 31/03/2007 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 25 in each group. 50 total. |
Key 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. |
Key exclusion criteria | Patients scheduled to undergo simultaneous saphenous vein surgery. |
Date of first enrolment | 15/04/2005 |
Date of final enrolment | 31/03/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
West Suffolk Hospitals NHS Trust
Bury St Edmunds
IP33 2QZ
United Kingdom
IP33 2QZ
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
---|---|
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |