Cryo strip versus classic strip of the great saphenous vein

ISRCTN ISRCTN61851091
DOI https://doi.org/10.1186/ISRCTN61851091
Secondary identifying numbers NL902 (NTR926)
Submission date
11/04/2007
Registration date
11/04/2007
Last edited
22/09/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr T M A L Klem
Scientific

Berglustlaan 44a
Rotterdam
3054 BJ
Netherlands

Email t.klem@wxs.nl

Study information

Study designRandomised, active controlled, parallel group, multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleCryo strip versus classic strip of the great saphenous vein
Study objectivesRecurrence rate of cryo strip is the same as classic strip of the great saphenous vein.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedVenous surgery
InterventionCryo strip of the great saphenous vein versus classic strip of the great saphenous vein.
Intervention typeProcedure/Surgery
Primary outcome measureRecurrence, confirmed by venous duplex.
Secondary outcome measures1. Operation time
2. Neurological damage after surgery
3. Quality of life
Overall study start date01/08/2002
Completion date01/10/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants520
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/08/2002
Date of final enrolment01/10/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Berglustlaan 44a
Rotterdam
3054 BJ
Netherlands

Sponsor information

Saint Franciscus Hospital (Sint Franciscus Gasthuis [SFG]) (The Netherlands)
Hospital/treatment centre

Kleiweg 500
Rotterdam
3045 PM
Netherlands

Website http://www.sfg.nl/
ROR logo "ROR" https://ror.org/007xmz366

Funders

Funder type

Hospital/treatment centre

Erasmus Medical Centre (The Netherlands)

No information available

Albert Schweitzer Ziekenhuis (The Netherlands)

No information available

Sint Franciscus Gasthuis (SFG) (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

Editorial Notes

22/09/2021: Proactive update review. No publications found. Search options exhausted.