Laser versus foam randomised controlled trial. Five years follow-up

• Research type

  Research Study

• Full title

  Laser versus foam randomised controlled trial. Five years follow-up

• IRAS ID

  150009

• Contact name

  Evi Kalodiki

• Contact email

  e.kalodiki@imperial.ac.uk

• Sponsor organisation

  Ealing Hospital NHS Trust

• ISRCTN Number

  ISRCTN03080206

• Clinicaltrials.gov Identifier

  C8/4C710/78, Original study

• Research summary

  Varicose veins is a common problem affecting many people worldwide. Until 2000 the common treatment offered was surgery. The last decade many endovenous (minimally invasive techniques) were introduced and a study was set up at Ealing hospital in 2009 comparing 2 of those. Namely, Laser versus foam. The one year results were promising and have been published. However, the 5 year follow-up results of these patients are awaited by both the scientific community and the public.
  The patients who took part in the original study will be given another out patient department, varicose veins clinic appointment. Their 5 year follow-up will include clinical examination, recording their current clinical condition whether symptomatic or not), filling in a venous clinical severity score (VCSS) questionnaire and duplex ultrasound examination which are part of the routine NHS follow-up. In addition for the purposes of this study they will be asked to complete an Aberdeen varicose veins questionnaire (AVVQ) which is a disease specific quality of life (QoL) questionnaire. They will also undergo another air-plethysmography (APG) test which will be compared to the one they had pre-operatively and at 3 months following their procedure. This is a non invasive test that involves applying a air-bag around the calf while the patient is supine and then asking them to stand up.

  The questions to be address in order to assess the 5 years outcome are:
  1. Clinical presentation (This is assessed by recording their clinical status
  by the CEAP classification which a venous specific classification).
  2. The VCSS questionnaire.
  3. The AVVQ which is a quality of life questionnaire.
  4. Haemodynamic outcome assessed by duplex ultrasound and APG
  5. Costs. How many additional foam sclerotherapy treatments they had since the
  1st year follow-up.
  The last question will be answered by reviewing the patients’ notes for the last five years, regarding their varicose veins.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  14/EM/1144

• Date of REC Opinion

  9 Sep 2014

• REC opinion

  Favourable Opinion