Condition category
Circulatory System
Date applied
08/11/2007
Date assigned
05/02/2008
Last edited
26/02/2010
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 Tim Lees

ORCID ID

Contact details

Consultant Vascular Surgeon
Northern Vascular Centre
Freeman Hospital
Newcastle upon Tyne
NE7 7DN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2003/190

Study information

Scientific title

A randomised controlled trial of Radiofrequency Ablation of the long saphenous vein versus Conventional Saphenofemoral disconnection and stripping in the treatment of varicose veins

Acronym

RACS

Study hypothesis

Radiofrequency ablation has the potential to improve the outcome of patients undergoing surgical treatment for varicose veins due to superficial venous incompetence.

Ethics approval

Ethics approval received from the Newcastle and North Tyneside Local Research Ethics Committees on the 1st December 2003. Please note that the sponsor and funder of the trial at the time of ethics approval was Mantis Surgical Ltd (UK).

Study design

Randomised controlled trial using web-based method

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Varicose veins of lower limbs

Intervention

1. Radiofrequency ablation
2. Conventional saphenofemoral disconnetion and stripping

Both procedures are to be performed under general anaesthetic during a single operation. Based on their allocation patients would either receive radiofrequency ablation of their long saphenous vein or stripping of their long saphenous vein. Both groups will undergo multiple stab avulsions or phlebectomies as deemed necessary to complete the operation in the same setting. Both groups are expected to be followed up for five years.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Elimination of long saphenous vein reflux and elimination of truncal varicosities. Measurement of outcomes will be carried out at the end of one week, six weeks, one year and five years.

Secondary outcome measures

1. Time to return to normal activities and work
2. Quality of life, estimated using Aberdeen Varicose Vein Questionnaire, Venous Insufficiency Epidemiologic and Economic Study of Quality-of-Life and Symptoms (VEINES-QOL/Sym) questionnaire, 36-item short form health survey (SF-36) and EuroQOL-5D generic questionnaires

Measurement of outcomes will be carried out at the end of one week, six weeks, one year and five years.

Overall trial start date

01/04/2004

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 18 - 70 years, both sexes
2. Varicose veins due to isolated long saphenous vein incompetence proven on duplex scan
3. Requiring surgery
4. Long saphenous vein suitable for radiofrequency ablation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Associated short saphenous and deep vein incompetence
2. Pregnancy
3. Patients with pacemaker or defibrillator

Recruitment start date

01/04/2004

Recruitment end date

31/12/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Vascular Surgeon
Newcastle upon Tyne
NE7 7DN
United Kingdom

Sponsor information

Organisation

VNUS Medical Technologies UK Ltd (UK)

Sponsor details

Kenneth Dibben House
Enterprise Road
Southampton Science Park
Chilworth
Hampshire
SO16 7NS
United Kingdom

Sponsor type

Industry

Website

http://www.vnus.com/uk

Funders

Funder type

Industry

Funder name

VNUS Medical Technologies UK Ltd (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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19879166

Publication citations

  1. Results

    Subramonia S, Lees T, Radiofrequency ablation vs conventional surgery for varicose veins - a comparison of treatment costs in a randomised trial., Eur J Vasc Endovasc Surg, 2010, 39, 1, 104-111, doi: 10.1016/j.ejvs.2009.09.012.

Additional files

Editorial Notes