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

NCT00841178 | Unknown

• 1 other identifier: HELP 2
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Insufficiency; Varicose Veins

Keywords

Randomised controlled trial; Venous insufficiency; Varicose veins; Quality of Life; Clinical effectiveness; Cost effectiveness

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

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Patients undergo Surgery under a general anaesthetic.

Procedure: Surgery

EVLT

EXPERIMENTAL

Patients undergo EVLT under a local anaesthetic.

Procedure: EVLT

Interventions

Surgery PROCEDURE

Saphenopopliteal junction ligation, stripping of the Short Saphenous vein where possible, perforator ligation and ambulatory phlebectomy, where necessary.

Also known as: Crossectomy

Surgery

EVLT PROCEDURE

EVLT of the Short saphenous vein with perforator ligation and / or ambulatory phlebectomy as required.

Also known as: Endovenous Laser therapy, Endovenous Laser Ablation, EVLA

EVLT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• University of Hull: collaborator

Study Sites (1)

Hull Royal Infirmary

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

Related Publications (2)

• Samuel N, Carradice D, Wallace T, Mekako A, Hatfield J, Chetter I. Randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins. Ann Surg. 2013 Mar;257(3):419-26. doi: 10.1097/SLA.0b013e318275f4e4.

  PMID: 23160149 DERIVED

• 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: 20510634 DERIVED

Related Links

• Randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins
• A randomized clinical trial of endovenous laser ablation versus conventional surgery for small saphenous varicose veins.

MeSH Terms

Conditions

Venous Insufficiency; Varicose Veins

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular 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: February 10, 2009
• First Posted: February 11, 2009
• Study Start: October 1, 2005
• Primary Completion: August 1, 2011
• Study Completion: November 1, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

GB (1)