NCT00759434

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

5.4 years

First QC Date

September 23, 2008

Last Update Submit

August 17, 2022

Conditions

Varicose VeinsVenous InsufficiencyVenous Ulceration

Keywords

Varicose veinsChronic venous insufficiencyVenous ulcerationSurgeryEndovenous Laser

Outcome Measures

Primary Outcomes (1)

  • Generic Quality of life - Short Form-36

    1 week, 6 weeks, 3 months, 1 year, 2 years

Secondary Outcomes (9)

  • Disease Specific quality of life - Aberdeen Varicose Vein Questionnaire

    1 week, 6 weeks, 3 months, 1 year, 2 years

  • Generic quality of life - EuroQol

    1 week, 6 weeks, 3 months, 1 year, 2 years

  • Venous Clinical Severity Score

    3 months, 1 year, 2 years

  • Visual analogue pain scores

    1 week

  • Return to work and normal functioning

    1 week, 6 weeks

  • +4 more secondary outcomes

Study Arms (2)

Surgery

ACTIVE COMPARATOR
Procedure: Surgery - Saphenofemoral ligation, saphenous strip and avulsions

EVLT

EXPERIMENTAL
Procedure: EVLT

Interventions

Surgery - Saphenofemoral ligation, saphenous strip and avulsionsPROCEDURE

Patients undergo Saphenofemoral ligation, inversion stripping of the Long Saphenous Vein and avulsion of varicosities if necessary under a general anaesthetic.

Surgery
EVLTPROCEDURE

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.

EVLT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hull Royal Infirmary

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

Related Publications (7)

  • Mekako AI, Hatfield J, Bryce J, Lee D, McCollum PT, Chetter I. A nonrandomised controlled trial of endovenous laser therapy and surgery in the treatment of varicose veins. Ann Vasc Surg. 2006 Jul;20(4):451-7. doi: 10.1007/s10016-006-9095-y. Epub 2006 Jun 27.

    PMID: 16802211BACKGROUND

  • Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC. Clinical and technical outcomes from a randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. Br J Surg. 2011 Aug;98(8):1117-23. doi: 10.1002/bjs.7615. Epub 2011 Jun 3.

    PMID: 21638277RESULT

  • Carradice D, Mekako AI, Mazari FA, Samuel N, Hatfield J, Chetter IC. Randomized clinical trial of endovenous laser ablation compared with conventional surgery for great saphenous varicose veins. Br J Surg. 2011 Apr;98(4):501-10. doi: 10.1002/bjs.7394. Epub 2011 Jan 31.

    PMID: 21283981RESULT

  • Mohamed AH, Howitt A, Rae S, Cai PL, Hitchman L, Wallace T, Nandhra S, Pymer S, Knighton A, Smith G, Chetter IC, Carradice D. Ten-year outcomes of a randomized clinical trial of endothermal ablation versus conventional surgery for great saphenous varicose veins. Br J Surg. 2024 Aug 2;111(8):znae195. doi: 10.1093/bjs/znae195.

    PMID: 39162334DERIVED

  • Wallace T, El-Sheikha J, Nandhra S, Leung C, Mohamed A, Harwood A, Smith G, Carradice D, Chetter I. Long-term outcomes of endovenous laser ablation and conventional surgery for great saphenous varicose veins. Br J Surg. 2018 Dec;105(13):1759-1767. doi: 10.1002/bjs.10961. Epub 2018 Aug 22.

    PMID: 30132797DERIVED

  • Carradice D, Wallace T, Gohil R, Chetter I. A comparison of the effectiveness of treating those with and without the complications of superficial venous insufficiency. Ann Surg. 2014 Aug;260(2):396-401. doi: 10.1097/SLA.0000000000000541.

    PMID: 24424141DERIVED

  • Carradice D, Mazari FA, Mekako A, Hatfield J, Allgar V, Chetter IC. Energy delivery during 810 nm endovenous laser ablation of varicose veins and post-procedural morbidity. Eur J Vasc Endovasc Surg. 2010 Sep;40(3):393-8. doi: 10.1016/j.ejvs.2010.04.010. Epub 2010 May 26.

    PMID: 20510634DERIVED

MeSH Terms

Conditions

Varicose VeinsVenous InsufficiencyVaricose Ulcer

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ian C Chetter, MBChB

    University of Hull

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

March 1, 2004

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 19, 2022

Record last verified: 2022-08

Locations

GB(1)