Ambulatory Varicosity avUlsion Later or Synchronised (AVULS)

ISRCTN	ISRCTN76821539
DOI	https://doi.org/10.1186/ISRCTN76821539
Protocol serial number	P34317
Sponsor	Imperial College London (UK)
Funder	Graeme-Dixon Charitable Trust (UK) (ref: P34317)

Submission date: 26/04/2011
Registration date: 20/05/2011
Last edited: 30/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Alun Davies
Scientific

Academic Section of Vascular Surgery
4E, Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Ambulatory Varicosity avUlsion Later or Synchronised (AVULS): a randomised trial
Study acronym	AVULS
Study objectives	Radiofrequency ablation with concomitant phlebectomy will result in an improvement in quality of life 6 months, reduce the need for further procedures and will be more cost effective than sequential phlebectomy or foam sclerotherapy
Ethics approval(s)	1. Brighton and Sussex Research Ethics Committee approved on 21/03/2011, REC Reference Number 11/H1107/3 2. Joint Research Office, Imperial College London and Imperial College Healthcare NHS Trust approved on 30/03/2011, Reference Number JROHH0210
Health condition(s) or problem(s) studied	Varicose Veins
Intervention	1. Simultaneous or delayed avulsion of superficial varicosities in the context of endovenous radiofrequency ablation of refluxing truncal veins 2. Avulsions will be delayed by 6 weeks post initial procedure if in delayed group 3. Followed up after 1 year
Intervention type	Other
Primary outcome measure(s)	Disease specific quality of life at 6 months using the Aberdeen Varicose Vein Questionnaire (AVVQ)
Key secondary outcome measure(s)	1. The need for further procedures over the 6 month period 2. Generic quality of life assessed using the EQ-5D 3. Cost effectiveness of the treatment strategies 4. Anatomical success assessed with colour duplex at 6 months 5. Level of depression assessed using Center for Epidemiologic Studies Depression Scale (CES-D) 6. Return to work and normal activities 7. Clinical disease severity assessed using the Venous Clinical Severity Score (VCSS)
Completion date	31/03/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	240
Key inclusion criteria	1. Consecutive patients who present to the department of vascular surgery at Charing Cross Hospital, who are willing to participate in the study 2. They must have clinical venous disease affecting either the long saphenous or short saphenous veins 3. They must be over the age of 18 and able to give consent for the study
Key exclusion criteria	1. Patients under the age of 18 years 2. Those that are unable to consent 3. Patients with deep venous disease 4. Those unfit for intervention
Date of first enrolment	01/04/2011
Date of final enrolment	31/03/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Charing Cross Hospital

London
W6 8RF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes