Condition category
Circulatory System
Date applied
15/12/2010
Date assigned
20/04/2011
Last edited
22/03/2012
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 George Geroulakos

ORCID ID

Contact details

Ealing Hospital
Uxbridge Road
Southall
Middlesex
UB1 3HW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G Geroulakos

Study information

Scientific title

Randomised contolled trial of ultrasound guided foam sclerotherapy combined with sapheno-femoral ligation compared to surgical treatment of varicose veins

Acronym

Study hypothesis

The hypothesis of this study is that duplex guided foam sclerotherapy in combination with saphenofemoral ligation under local anaesthesia may save costs and treatment time and be more acceptable for patients than ligation and stripping of the greater saphenous vein and phlebectomies. This is because there is no need for general anaesthesia and it is a less invasive procedure.

Ethics approval

The Ealing and Mental Health Ethics Committee approved in 2003 (ref: LREC 03/04)

Study design

Single centre randomised controlled parallel group 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

Chronic venous insufficiency

Intervention

Group surgery:
1. High saphenofemoral ligation
2. Strip to the knee
3. Multiple phlebectomies

Group surgery and foam:
High saphenofemoral ligation under local anaesthesia and foam sclerotherapy under ultrasound guidance.

Both arms had 5 years treatment/ follow up (some patients up to a max of 7 years)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Patient recovery period
2. Quality of life

Outcome measured up to 7 years maximum

Secondary outcome measures

1. Frequency of complications
2. Cost of the treatment

Outcome measured up to 7 years maximum

Overall trial start date

01/07/2003

Overall trial end date

01/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Primary symptomatic varicose veins involving the great saphenous system in patients whom had had no previous treatment for varicose veins and who were suitable for day case surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Primary varicosities involving the short saphenous vein
2. Patients with previous surgery or sclerotherapy for varicose veins
3. Previous deep vein thrombosis (DVT)
4. Risk factors for DVT
5. Coagulopathy
6. Peripheral vascular disease
7. Known allergy to anaesthetic or sclerosing agents
8. Previous iatrogenic allergic reaction
9. Malignancy
10. Pregnancy

Recruitment start date

01/07/2003

Recruitment end date

01/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ealing Hospital
Middlesex
UB1 3HW
United Kingdom

Sponsor information

Organisation

Ealing Hospital NHS Trust (UK)

Sponsor details

Research and Development Office
Pasteur Suite
8th Floor
Uxbridge Road
Southall
Middlesex
UB1 3HW
United Kingdom
gay.bineham@eht.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.ealinghospital.nhs.uk

Funders

Funder type

Industry

Funder name

STD Pharmaceuticals (UK)

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. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22104345

Publication citations

  1. Results

    Kalodiki E, Lattimer CR, Azzam M, Shawish E, Bountouroglou D, Geroulakos G, Long-term results of a randomized controlled trial on ultrasound-guided foam sclerotherapy combined with saphenofemoral ligation vs standard surgery for varicose veins., J. Vasc. Surg., 2012, 55, 2, 451-457, doi: 10.1016/j.jvs.2011.08.040.

Additional files

Editorial Notes