Contact information
Type
Scientific
Primary contact
Dr T M A L Klem
ORCID ID
Contact details
Berglustlaan 44a
Rotterdam
3054 BJ
Netherlands
t.klem@wxs.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Recurrence rate of cryo strip is the same as classic strip of the great saphenous vein.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Venous surgery
Intervention
Cryo strip of the great saphenous vein versus classic strip of the great saphenous vein.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Recurrence, confirmed by venous duplex.
Secondary outcome measures
1. Operation time
2. Neurological damage after surgery
3. Quality of life
Overall trial start date
01/08/2002
Overall trial end date
01/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with primary varicosis and incompetence of the great saphenous vein and saphenofemoral junction (confirmed by duplex)
2. Only patients with C2, C3, C4 varicosis (Clinical, Etiologic, Anatomic, and Pathophysiologic [CEAP]-classification)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
520
Participant exclusion criteria
1. C5, C6 varicosis
2. Extreme adipositas (Body Mass Index [BMI] greater than 40)
3. Deep venous occlusion
4. Incompetence of the small saphenous vein
5. Arterial occlusive disease of the legs
6. Inability to understand the Dutch language
7. Recurrence of varicosis of the leg
Recruitment start date
01/08/2002
Recruitment end date
01/10/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Berglustlaan 44a
Rotterdam
3054 BJ
Netherlands
Sponsor information
Organisation
Saint Franciscus Hospital (Sint Franciscus Gasthuis [SFG]) (The Netherlands)
Sponsor details
Kleiweg 500
Rotterdam
3045 PM
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Erasmus Medical Centre (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Albert Schweitzer Ziekenhuis (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sint Franciscus Gasthuis (SFG) (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