Randomised clinical trial comparing endovenous laser ablation with cryostripping for varicose veins: two-year results

ISRCTN	ISRCTN33832691
DOI	https://doi.org/10.1186/ISRCTN33832691
Protocol serial number	N/A
Sponsor	The Mesos Medical Centre (Mesos Medisch Centrum Utrecht) (Netherlands)
Funder	The Mesos Medical Centre (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	Study questions: 1. Is endovenous laser of the great saphenous vein clinically better than cryostripping? 2. Is endovenous laser of the great saphenous vein less expensive than cryostripping?
Ethics approval(s)	Ethics approval received from the Regional Ethics Committee of the Mesos Medical Centre on the 15th March 2003.
Health condition(s) or problem(s) studied	Varicose veins
Intervention	Endovenous laser versus cryostripping.
Intervention type	Other
Primary outcome measure(s)	The following were assessed at 6, 12 and 24 months: 1. Freedom from recurrence 2. Improvement in Venous Clinical Severity Score (VCSS) 3. Improvement in Aberdeen Varicose Vein Severity Score (AVVSS) 4. Improvement in the short form 6D (SF-6D), a single preference based measure of health, representing overall quality of life derived from the 36-item short form 36 (SF-36) questionnaires
Key secondary outcome measure(s)	The following were assessed at 6, 12 and 24 months: 1. Operative time 2. Complications 3. Activity impairment 4. Quality-adjusted life years (QALY) 4. Patient satisfaction
Completion date	01/07/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Patients with primary symptomatic varicose veins 2. Clinical, aetiological, anatomical, pathological elements (CEAP) clinical class C2 venous disease 3. Informed written consent 4. Age 19 - 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 ultrasound imaging
Key exclusion criteria	1. Previous venous surgery 2. History of deep vein thrombosis (DVT) 3. C3-6 CEAP 4. Deep vein reflux 5. Anatomical duplication 6. Reflux in below-knee perforator veins
Date of first enrolment	01/06/2003
Date of final enrolment	01/07/2005

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	01/10/2008		Yes	No
Other publications	reuslts on cost-effectiveness	01/03/2009		Yes	No