A New Method of Surgically Treating Varicose Veins and Venous Ulcers - a Study to Assess Clinical and Economic Value

August 17, 2022 updated by: Hull University Teaching Hospitals NHS Trust

A Dual Centre, Randomised Controlled Trial of the Clinical and Cost Effectiveness of Endovenous Laser Therapy (EVLT) in the Treatment of Varicose Veins and Venous Ulcers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • East Yorkshire
      • Hull, East Yorkshire, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary, symptomatic, varicose veins.
  • Isolated Saphenofemoral junction (SFJ) incompetence leading to long saphenous (LSV) reflux on duplex ultrasound.
  • LSV of 4mm diameter at the knee.
  • Ability to give informed written consent.

Exclusion Criteria:

  • Inability to give informed written consent.
  • Symptomatic or complicated varicose veins not attributable to SFJ/LSV reflux.
  • Evidence of deep venous reflux on duplex scan.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Surgery
Procedure: Surgery - Saphenofemoral ligation, saphenous strip and avulsions
Patients undergo Saphenofemoral ligation, inversion stripping of the Long Saphenous Vein and avulsion of varicosities if necessary under a general anaesthetic.
Experimental: EVLT
Procedure: EVLT
Patients undergo endovenous laser treatment, using a 810nm laser aiming to occlude the incompetent long saphenous vein from the saphenofemoral junction to the knee. This may then be followed by ambulatory phlebectomy as appropriate. All procedures are to be performed under a local anaesthetic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Generic Quality of life - Short Form-36
Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
1 week, 6 weeks, 3 months, 1 year, 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Generic quality of life - EuroQol
Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
1 week, 6 weeks, 3 months, 1 year, 2 years
Venous Clinical Severity Score
Time Frame: 3 months, 1 year, 2 years
3 months, 1 year, 2 years
Visual analogue pain scores
Time Frame: 1 week
1 week
Return to work and normal functioning
Time Frame: 1 week, 6 weeks
1 week, 6 weeks
Would undergo EVLT again if necessary
Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
1 week, 6 weeks, 3 months, 1 year, 2 years
Complication rates
Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
1 week, 6 weeks, 3 months, 1 year, 2 years
Cost Effectiveness
Time Frame: 2 years
2 years
Disease Specific quality of life - Aberdeen Varicose Vein Questionnaire
Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years
1 week, 6 weeks, 3 months, 1 year, 2 years
Duplex and clinical assessment
Time Frame: 1 week, 6 weeks, 3 months, 1 year, 2 years

A detailed clinical and duplex ultrasound assessment was undertaken to identify:

The presence of residual or recurrent varicose veins (defined as clinically evident varicose veins of greater than 3mm in diameter present at 1 and 6 weeks (residual) or becoming evident only after 6 weeks (recurrent). This was irrespective of the presence or absence of symptoms.

The pattern of underlying insufficiency on duplex giving rise to any clinically evident varicose veins or skin changes.
1 week, 6 weeks, 3 months, 1 year, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hull University Teaching Hospitals NHS Trust

Collaborators

University of Hull

Investigators

  • Principal Investigator: Ian C Chetter, MBChB, University of Hull

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2004

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Actual)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HELP1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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