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
Protocol serial number	N/A
Sponsor	The Mesos Medical Centre (Mesos Medisch Centrum) (The Netherlands)
Funder	The Mesos Medical Centre (Mesos Medisch Centrum) (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Ben Disselhoff
Scientific

Burg s'jacoblaan 56
Bussum
1401 BS
Netherlands

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Is 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) studied	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
Primary outcome measure(s)	Freedom from recurrent varicose veins in the groin, as confirmed by duplex ultrasound, two years after treatment.
Key secondary outcome measure(s)	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
Completion date	01/04/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	43
Key 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
Key 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
Date of first enrolment	01/03/2003
Date of final enrolment	01/04/2005

Burg s'jacoblaan 56

Bussum
1401 BS
Netherlands

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	01/12/2008		Yes	No
Results article	results	01/05/2011		Yes	No