FOAM-study veins: cost minimisation study comparing surgery versus duplex guided foam sclerotherapy of varicose veins - a randomised controlled study

ISRCTN	ISRCTN74375188
DOI	https://doi.org/10.1186/ISRCTN74375188
Secondary identifying numbers	NTR654

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

Dr N.H. Shadid
Scientific

Academic Hospital Maastricht (AZM)
P.O. Box 5800
Maastricht
6202 AZ
Netherlands

Phone	+31 (0)43 3876543
Email	nsh@sder.azm.nl

Study design	Multicentre, randomised, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	The underlining hypothesis of this study is that duplex guided foam sclerotherapy may save costs and be more acceptable for patients than ligation and stripping of the greater saphenous vein, because there is no need for anaesthesia and incisions and it lacks several side-effects, such as scars, haematomas and a painful recovery period of at least 7 days known after surgical intervention.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Varicose veins
Intervention	1. Standardised duplex guided foam sclerotherapy 2. Standardised surgery procedure
Intervention type	Other
Primary outcome measure	Cumulative probability of recurrent varicose vein at 18 - 24 months after treatment.
Secondary outcome measures	1. Quality of life (EuroQol-5D) 2. Patient preference 3. Social costs
Overall study start date	01/02/2006
Completion date	01/03/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	460
Key inclusion criteria	1. Primary truncal varicosities of the greater saphenous vein (GSV) 2. Aged greater than 18 years 3. Reflux greater than 0.5 seconds and insufficiency of the sapheno-femoral (SF) junction measured by duplex 4. Reflux for at least 20 cm of the GSV in the upper leg 5. Informed consent 6. Normal deep venous system
Key exclusion criteria	1. Signs of deep vein thrombosis (DVT) found with duplex 2. Immobility 3. Allergy for polidocanol in the past 4. Life-expectancy less than 3 years 5. Pregnancy 6. Abnormal deep venous system 7. Active ulcus cruris
Date of first enrolment	01/02/2006
Date of final enrolment	01/03/2009

Academic Hospital Maastricht (AZM)

Maastricht
6202 AZ
Netherlands

Academic Hospital Maastricht (AZM) (The Netherlands)
University/education

P.O. Box 5800
Maastricht
6202 AZ
Netherlands

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

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