Contact information
Type
Scientific
Contact name
Dr N.H. Shadid
ORCID ID
Contact details
Academic Hospital Maastricht (AZM)
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3876543
nsh@sder.azm.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
NTR654
Study information
Scientific title
Acronym
Study hypothesis
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
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
Patient information sheet
Condition
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
Overall study end date
01/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
460
Participant 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
Recruitment start date
01/02/2006
Recruitment end date
01/03/2009
Locations
Countries of recruitment
Netherlands
Study participating centre
Academic Hospital Maastricht (AZM)
Maastricht
6202 AZ
Netherlands
Sponsor information
Organisation
Academic Hospital Maastricht (AZM) (The Netherlands)
Sponsor details
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3876543
info@azm.nl
Sponsor type
University/education
Website
ROR
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|