Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Is high ligation after endovenous laser ablation better than endovenous laser alone?
Ethics approval
Ethics approval received from the Regional Ethics Committee of the Mesos Medical Centre, Utrecht (The Netherlands) on the 15th March 2003.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Varicose veins
Intervention
Forty-three symptomatic patients with bilateral varicose veins were studied in which one side was randomly assigned to receive endovenous laser without saphenofemoral junction (SFJ) ligation, whereas the other side received endovenous laser with SFJ ligation.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Freedom from recurrent varicose veins in the groin, as confirmed by duplex ultrasound, two years after treatment.
Secondary outcome measures
The following were assessed at 6, 12 and 24 months:
1. Abolition of reflux in the GSV
2. Venous Clinical Severity Score (VCSS)
3. Freedom from overall recurrent varicose veins
4. Procedural complications, including pain, bruising, saphenous nerve paraesthesia, tightness, superficial thrombophlebitis, skin burns, thrombotic events, and wounds
Overall trial start date
01/03/2003
Overall trial end date
01/04/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with primary symptomatic bilateral varicose veins
2. Clinical, aetiological, anatomical, pathological elements (CEAP) clinical class C2 venous disease
3. Informed written consent
4. Aged 20 - 75 years
5. Great saphenous vein (GSV) incompetence from the groin to below the knee, defined as retrograde flow lasting longer than 0.5 seconds on duplex scanning
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
43
Participant exclusion criteria
1. Previous venous surgery
2. History of deep vein thrombosis (DVT)
3. C3-6 CEAP venous disease
4. Deep vein relux
5. Reflux in below knee perforator veins
Recruitment start date
01/03/2003
Recruitment end date
01/04/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Burg s'jacoblaan 56
Bussum
1401 BS
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
The Mesos Medical Centre (Mesos Medisch Centrum) (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
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18848791
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21333560
Publication citations
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Results
Disselhoff BC, der Kinderen DJ, Kelder JC, Moll FL, Five-year results of a randomised clinical trial of endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction., Eur J Vasc Endovasc Surg, 2011, 41, 5, 685-690, doi: 10.1016/j.ejvs.2010.12.014.
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Disselhoff BC, der Kinderen DJ, Kelder JC, Moll FL, Randomized clinical trial comparing endovenous laser ablation of the great Saphenous vein with and without ligation of the sapheno-femoral junction: 2-year results., Eur J Vasc Endovasc Surg, 2008, 36, 6, 713-718, doi: 10.1016/j.ejvs.2008.08.015.