Condition category
Surgery
Date applied
11/04/2007
Date assigned
11/04/2007
Last edited
11/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.sfg.nl/

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

Publication citations

Additional files

Editorial Notes