Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hull and East Yorkshire Hospitals NHS Trust
Information provided by (Responsible Party):
Daniel Carradice, University of Hull
ClinicalTrials.gov Identifier:
NCT00841178
First received: February 10, 2009
Last updated: June 18, 2013
Last verified: June 2013

February 10, 2009
June 18, 2013
October 2005
August 2011   (final data collection date for primary outcome measure)
Generic Quality of Life - Short Form-36 [ Time Frame: 1 Week,, 6 Weeks, 3 Months, 1 Year, 2 Years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00841178 on ClinicalTrials.gov Archive Site
  • Disease Specific Quality of Life - Aberdeen Varicose Vein Questionnaire [ Time Frame: 1 Week, 6 Weeks, 3 Months, 1 Year, 2 Years ] [ Designated as safety issue: No ]
  • Generic quality of life - EuroQol [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Venous Clinical Severity Score [ Time Frame: 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Visual analogue pain scores [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Return to work and normal functioning [ Time Frame: 1 week, 6 weeks ] [ Designated as safety issue: No ]
  • Would undergo EVLT again if necessary [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: No ]
  • Complication rates [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]
  • Duplex assessment [ Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years ] [ Designated as safety issue: Yes ]
  • Cost Effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Endovenous Laser Therapy (EVLT) for Sapheno-Popliteal Incompetence and Short Saphenous Vein (SSV) Reflux: A RCT
A Randomised Controlled Trial of the Clinical and Cost Effectiveness of Endovenous Laser Therapy in the Treatment of Varicose Veins Secondary to Isolated Sapheno-Popliteal Incompetence and Short Saphenous Reflux

Varicose veins are a common problem, affecting up to a third of the western adult population. Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is known to have a significant negative effect on patient's quality of life (QoL).

Surgery has been used for many years, but it is known that there is a temporary decline in QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged recovery in some patients and has the risks of infection, haematoma and nerve injury.

Recurrence rates are known to be significant. Duplex of veins post surgery has demonstrated persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at 34 years.

26% of NHS patients were 'very dissatisfied' with their varicose vein surgery.

Newer, less invasive treatments are being developed. It would be advantageous to find a treatment that avoided the morbidity of surgery, one that could be performed as a day-case procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and allow an early return to work. These should be the aims of any new treatment for varicose veins.

Endovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser energy delivered into the vein to obliterate it. The vein therefore need not be tied off surgically and stripped out.

The aim of this study is to compare the clinical, cost effectiveness and safety of Surgery and EVLT.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Venous Insufficiency
  • Varicose Veins
  • Procedure: Surgery
    Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary.
    Other Name: Crossectomy
  • Procedure: EVLT
    EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required.
    Other Name: Endovenous Laser therapy, Endovenous Laser Ablation, EVLA
  • Active Comparator: Surgery
    Patients undergo Surgery under a general anaesthetic.
    Intervention: Procedure: Surgery
  • Experimental: EVLT
    Patients undergo EVLT under a local anaesthetic.
    Intervention: Procedure: EVLT

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
106
Not Provided
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary, symptomatic, varicose veins
  • Isolated Sapheno-popliteal (SPJ) incompetence, leading to reflux in the Short saphenous vein (SSV) on duplex ultrasound
  • SSV of 4mm distally
  • Ability to give informed written consent

Exclusion Criteria:

  • Inability to give informed written consent
  • Symptomatic or complicated varicose veins not attributable to SPJ/SSV reflux
  • Evidence of deep venous reflux on duplex scan
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00841178
HELP 2
No
Daniel Carradice, University of Hull
University of Hull
Hull and East Yorkshire Hospitals NHS Trust
Principal Investigator: Ian C Chetter, MBChB University of Hull
University of Hull
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP