Condition category
Circulatory System
Date applied
31/07/2009
Date assigned
27/08/2009
Last edited
27/08/2009
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

Dr Lars Rasmussen

ORCID ID

Contact details

Eskadronsvej 4A
Naestved
4700
Denmark
lhr@varix.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

02

Study information

Scientific title

A randomised controlled trial of endovenous laser ablation (EVLA), radio frequency (RF), foam sclerotherapy and stripping for treatment of varicose veins

Acronym

SOL

Study hypothesis

Endovenous laser ablation (EVLA), radio frequency (RF), foam sclerotherapy and stripping for the treatment of varicose veins all have equal outcomes.

Ethics approval

Regional ethics committee approved of this trial prior to first patient enrolment.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Varicose veins

Intervention

1. Surgery: high ligation and stripping plus stab phlebectomies
2. Endovenous laser ablation plus phlebectomies
3. Radiofrequency ablation plus phlebectomies
4. Ultrasound guided foam sclerotherapy plus phlebectomies

Duration of treatments: 1 hour
Duration of follow up: 5 years

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Recurrent varicose veins after surgery (REVAS), measured at baseline, 1 month, 12 months, yearly thereafter for a total of 5 years.

Secondary outcome measures

Measured at baseline, 1 month, 12 months, yearly thereafter for a total of 5 years:
1. Quality of life
2. Varicose vein severity score (VVSS)

Overall trial start date

01/01/2007

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Varicose veins due to greater saphenous vein (GSV) insufficiency
2. Aged greater than or equal to 18 years, to an upper limit of 75 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant exclusion criteria

Aged below 18 and above 75 years

Recruitment start date

01/01/2007

Recruitment end date

01/01/2012

Locations

Countries of recruitment

Denmark

Trial participating centre

Eskadronsvej 4A
Naestved
4700
Denmark

Sponsor information

Organisation

Danish National Health Insurance (Denmark)

Sponsor details

Danske regioner
Dampfærgevej
Copenhagen
5112
Denmark
dr@regioner.dk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Danish National Health Insurance (Denmark)

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