Condition category
Circulatory System
Date applied
14/03/2008
Date assigned
31/03/2008
Last edited
24/02/2009
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

Mr Ben Disselhoff

ORCID ID

Contact details

Burg s'Jacoblaan 56
Bussum
1401 BS
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the Regional Ethics Committee of the Mesos Medical Centre on the 15th March 2003.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Varicose veins

Intervention

Endovenous laser versus cryostripping.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/06/2003

Overall trial end date

01/07/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

01/06/2003

Recruitment end date

01/07/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Burg s'Jacoblaan 56
Bussum
1401 BS
Netherlands

Sponsor information

Organisation

The Mesos Medical Centre (Mesos Medisch Centrum Utrecht) (Netherlands)

Sponsor details

c/o Mr Ben Disselhoff
Van Heuven Goedhartlaan 1
CE Utrecht
3527
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.mesos.nl

Funders

Funder type

Hospital/treatment centre

Funder name

The Mesos Medical Centre (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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18763255
2008 reuslts on cost-effectiveness in http://www.ncbi.nlm.nih.gov/pubmed/19111485

Publication citations

  1. Results

    Disselhoff BC, der Kinderen DJ, Kelder JC, Moll FL, Randomized clinical trial comparing endovenous laser with cryostripping for great saphenous varicose veins., Br J Surg, 2008, 95, 10, 1232-1238, doi: 10.1002/bjs.6351.

  2. Disselhoff BC, Buskens E, Kelder JC, der Kinderen DJ, Moll FL, Randomised comparison of costs and cost-effectiveness of cryostripping and endovenous laser ablation for varicose veins: 2-year results., Eur J Vasc Endovasc Surg, 2009, 37, 3, 357-363, doi: 10.1016/j.ejvs.2008.11.013.

Additional files

Editorial Notes