Condition category
Circulatory System
Date applied
05/07/2007
Date assigned
26/07/2007
Last edited
05/05/2011
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 Nadarajah Theivacumar

ORCID ID

Contact details

Leeds Vascular Institute
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)7940 774550
nadacumar@yahoo.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Leeds EVLA technique trial

Study hypothesis

Modified techniques reduces requirement of delayed foam sclerotherapy and provides better clinical outcome.

Ethics approval

Leeds (West) research ethics committee, at Leeds General Infirmary on 21/09/2005 (ref: 05/Q1205/187)

Study design

Randomised controlled trial (not blinded)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Varicose veins

Intervention

Two modified techniques are compared with standard EVLA technique:
Group A: the standard practice of EVLA (laser ablation of above-knee Great Saphenous Vein [GSV]) considered as control
Group B: modification 1 - where GSV was ablated (EVLA) both above and below knee
Group C: modification 2 - where above knee GSV was ablated by EVLA and below knee GSV was chemically ablated using foam sclerotherapy at the same time

Group 1 - standard EVLA alone:
This uses an 810 nm bare-tipped, pulsed laser (Diomed Inc.) at a power of 12 watts. The standard technique for EVLA will be used employing a laser density of 5 pulse/cm. Delayed foam sclerotherapy up to 5 ml of 0.2-1% STD was used as required at the follow up clinic visit/s.

Group 2 - standard EVLA and on table foam sclerotherapy:
The same EVLA technique as for group 1 was used except that the GSV was cannulated below-knee (mid-calf) and a 70 cm sheath inserted. The GSV was ablated (EVLA) to the level of the knee joint following which 5 ml 1% STD (2 ml 1% STD, 3 ml air) will be injected into the below knee GSV via the sheath as it was withdrawn. Delayed foam sclerotherapy up to 5 ml of 0.2-1% STD was also be used as required at the follow up clinic visit/s.

Group 3 - above and below-knee EVLA:
The GSV was canulated below-knee (mid-calf) and the whole length of the GSV ablated using the standard EVLA technique. Delayed foam sclerotherapy up to 5 ml of 0.2-1% STD was also used as required at the follow up clinic visit/s.

Following this primary treatment patients were followed up at 1, 6, and 12 weeks and following data were obtained at each visit:
1. At 1 week:
1.1. Daily Visual Analogue Score for pain
1.2. Analgesia diary
1.3. Time to normal activity - time to return to work
1.4. Assessment of post-treatment complications
1.5. Duplex assessment of GSV and deep veins for evidence of Deep Vein Thrombosis (DVT)
2. At 6 weeks:
2.1. Outstanding data from week 1
2.2. Aberdeen Vein Questionnaire (disease-specific quality of life measure)***
2.3. Late complications
2.4. Time of return to work if greater than 1 week
2.5. Injection sclerotherapy as required in all patients
2.6. Duplex assessment of GSV
3. At 12 weeks:
3.1. Any outstanding data (as above)
3.2. Duplex Ultrasound Assessment
3.3. Aberdeen Vein Questionnaire (disease-specific quality of life measure)***
3.4. EuroQol questionnaire
3.5. Patient satisfaction
3.6. Number of sessions of injection Sclerotherapy as required***
3.7. Duplex assessment

*** = Primary endpoint measurements

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Sclerotherapy requirement at follow up: disease specific quality of life improvement measured by Aberdeen varicose vein severity score.

Secondary outcome measures

1. Post-procedure pain: patient analgesia diary
2. Cosmesis: as scored by the patient
3. Complication rates: wound infection, haematoma, nerve injury, DVT
4. Patient satisfaction

Overall trial start date

10/11/2005

Overall trial end date

15/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with primary varicose veins in the leg due to isolated incompetent sapheno-femoral junction and great saphenous vein reflux both above and below knee segments.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

69 participants

Participant exclusion criteria

1. Recurrent varicose veins
2. Patients with reflux in other axial veins
3. Patients with varicose veins only in thigh
4. Patients who has no reflux in below-knee segment of great saphenous vein

Recruitment start date

10/11/2005

Recruitment end date

15/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leeds Vascular Institute
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Leeds General Infirmary (UK)

Sponsor details

c/o Mr M.J. Gough
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 2823
michael.gough@leedsth.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.leedsteachinghospitals.com/

Funders

Funder type

Research organisation

Funder name

Leeds Vascular Institute (UK) - Research Fund

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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18440756

Publication citations

  1. Results

    Theivacumar NS, Dellagrammaticas D, Mavor AI, Gough MJ, Endovenous laser ablation: does standard above-knee great saphenous vein ablation provide optimum results in patients with both above- and below-knee reflux? A randomized controlled trial., J. Vasc. Surg., 2008, 48, 1, 173-178, doi: 10.1016/j.jvs.2008.01.062.

Additional files

Editorial Notes