Condition category
Circulatory System
Date applied
14/03/2008
Date assigned
31/03/2008
Last edited
11/07/2011
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

Is high ligation after endovenous laser ablation better than endovenous laser alone?

Ethics approval

Ethics approval received from the Regional Ethics Committee of the Mesos Medical Centre, Utrecht (The Netherlands) 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

Forty-three symptomatic patients with bilateral varicose veins were studied in which one side was randomly assigned to receive endovenous laser without saphenofemoral junction (SFJ) ligation, whereas the other side received endovenous laser with SFJ ligation.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Freedom from recurrent varicose veins in the groin, as confirmed by duplex ultrasound, two years after treatment.

Secondary outcome measures

The following were assessed at 6, 12 and 24 months:
1. Abolition of reflux in the GSV
2. Venous Clinical Severity Score (VCSS)
3. Freedom from overall recurrent varicose veins
4. Procedural complications, including pain, bruising, saphenous nerve paraesthesia, tightness, superficial thrombophlebitis, skin burns, thrombotic events, and wounds

Overall trial start date

01/03/2003

Overall trial end date

01/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with primary symptomatic bilateral varicose veins
2. Clinical, aetiological, anatomical, pathological elements (CEAP) clinical class C2 venous disease
3. Informed written consent
4. Aged 20 - 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 scanning

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

43

Participant exclusion criteria

1. Previous venous surgery
2. History of deep vein thrombosis (DVT)
3. C3-6 CEAP venous disease
4. Deep vein relux
5. Reflux in below knee perforator veins

Recruitment start date

01/03/2003

Recruitment end date

01/04/2005

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) (The Netherlands)

Sponsor details

c/o Mr Ben Disselhoff
Burg s'jacoblaan 56
Bussum
1401 BS
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

The Mesos Medical Centre (Mesos Medisch Centrum) (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

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18848791
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21333560

Publication citations

  1. Results

    Disselhoff BC, der Kinderen DJ, Kelder JC, Moll FL, Five-year results of a randomised clinical trial of endovenous laser ablation of the great saphenous vein with and without ligation of the saphenofemoral junction., Eur J Vasc Endovasc Surg, 2011, 41, 5, 685-690, doi: 10.1016/j.ejvs.2010.12.014.

  2. Disselhoff BC, der Kinderen DJ, Kelder JC, Moll FL, Randomized clinical trial comparing endovenous laser ablation of the great Saphenous vein with and without ligation of the sapheno-femoral junction: 2-year results., Eur J Vasc Endovasc Surg, 2008, 36, 6, 713-718, doi: 10.1016/j.ejvs.2008.08.015.

Additional files

Editorial Notes