Randomised trial of Polytetrafluoroethylene (PTFE) patch saphenoplasty in patients having surgery for recurrent long saphenous varicose veins

ISRCTN	ISRCTN86810172
DOI	https://doi.org/10.1186/ISRCTN86810172
Protocol serial number	N0106092280
Sponsor	Department of Health (UK)
Funder	Gloucestershire R&D Consortium (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Jonathan Earnshaw
Scientific

Consultant Surgeon
Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To compare the use of a PTFE patch with normal repair for surgery for recurrent varicose veins.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Long saphenous varicose veins
Intervention	1. Polytetrafluoroethylene patch 2. Flush ligation
Intervention type	Procedure/Surgery
Primary outcome measure(s)	To reduce the re-recurrence rate after reoperative surgery for recurrent long saphenous varicose veins.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	28/02/2007

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target sample size at registration	50
Key inclusion criteria	At least 50 patients having surgery for recurrent long saphenous varicose veins.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/03/2003
Date of final enrolment	28/02/2007

Consultant Surgeon

Gloucester
GL1 3NN
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2007		Yes	No