Randomised clinical trial comparing endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction, with a two-year follow-up

ISRCTN ISRCTN60300873
DOI https://doi.org/10.1186/ISRCTN60300873
Secondary identifying numbers N/A
Submission date
14/03/2008
Registration date
31/03/2008
Last edited
11/07/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Ben Disselhoff
Scientific

Burg s'jacoblaan 56
Bussum
1401 BS
Netherlands

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesIs high ligation after endovenous laser ablation better than endovenous laser alone?
Ethics approval(s)Ethics approval received from the Regional Ethics Committee of the Mesos Medical Centre, Utrecht (The Netherlands) on the 15th March 2003.
Health condition(s) or problem(s) studiedVaricose veins
InterventionForty-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 typeOther
Primary outcome measureFreedom from recurrent varicose veins in the groin, as confirmed by duplex ultrasound, two years after treatment.
Secondary outcome measuresThe 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 study start date01/03/2003
Completion date01/04/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants43
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/03/2003
Date of final enrolment01/04/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Burg s'jacoblaan 56
Bussum
1401 BS
Netherlands

Sponsor information

The Mesos Medical Centre (Mesos Medisch Centrum) (The Netherlands)
Hospital/treatment centre

c/o Mr Ben Disselhoff
Burg s'jacoblaan 56
Bussum
1401 BS
Netherlands

Funders

Funder type

Hospital/treatment centre

The Mesos Medical Centre (Mesos Medisch Centrum) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2008 Yes No
Results article results 01/05/2011 Yes No