Condition category
Circulatory System
Date applied
07/06/2006
Date assigned
07/06/2006
Last edited
17/09/2008
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 N.H. Shadid

ORCID ID

Contact details

Academic Hospital Maastricht (AZM)
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3876543
nsh@sder.azm.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR654

Study information

Scientific title

Acronym

Study hypothesis

The underlining hypothesis of this study is that duplex guided foam sclerotherapy may save costs and be more acceptable for patients than ligation and stripping of the greater saphenous vein, because there is no need for anaesthesia and incisions and it lacks several side-effects, such as scars, haematomas and a painful recovery period of at least 7 days known after surgical intervention.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Varicose veins

Intervention

1. Standardised duplex guided foam sclerotherapy
2. Standardised surgery procedure

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Cumulative probability of recurrent varicose vein at 18 - 24 months after treatment.

Secondary outcome measures

1. Quality of life (EuroQol-5D)
2. Patient preference
3. Social costs

Overall trial start date

01/02/2006

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary truncal varicosities of the greater saphenous vein (GSV)
2. Aged greater than 18 years
3. Reflux greater than 0.5 seconds and insufficiency of the sapheno-femoral (SF) junction measured by duplex
4. Reflux for at least 20 cm of the GSV in the upper leg
5. Informed consent
6. Normal deep venous system

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

460

Participant exclusion criteria

1. Signs of deep vein thrombosis (DVT) found with duplex
2. Immobility
3. Allergy for polidocanol in the past
4. Life-expectancy less than 3 years
5. Pregnancy
6. Abnormal deep venous system
7. Active ulcus cruris

Recruitment start date

01/02/2006

Recruitment end date

01/03/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Hospital Maastricht (AZM)
Maastricht
6202 AZ
Netherlands

Sponsor information

Organisation

Academic Hospital Maastricht (AZM) (The Netherlands)

Sponsor details

P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 3876543
info@azm.nl

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (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