Randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins

Not Applicable

Completed

• Conditions: Varicose veins; Circulatory System

• Registration Number: ISRCTN51995477
• Lead Sponsor: niversity of Aberdeen (UK)

Brief Summary

1. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25251616 2. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25274220 3. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25858333 4. 2019 5-year results in: https://www.ncbi.nlm.nih.gov/pubmed/31483962

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-29
• Study Completion: 2011-05-31
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 798

Inclusion Criteria

1. Adult patients (aged over 18 years old)
2. Those who are referred to the surgical out-patient department for treatment of primary varicose veins with symptomatic (CEAP [Clinical, Etiological, Anatomical, Pathological elements] classification grade 2 or above) primary long or short saphenous main stem incompetence (reflux >1 second on duplex scanning)
3. Suitable for day case treatment

Exclusion Criteria

1. Current deep vein thrombosis
2. Deep venous incompetence
3. Acute superficial vein thrombosis
4. Allergy to sclerosant
5. Pregnancy or breastfeeding
6. History of hypercoagulability
7. Arterial disease (ankle brachial pressure index <0.8)
8. Inability to mobilise post-procedure
9. Needle phobia
10. Long or short saphenous vein less than 3 mm in diameter or greater than 15 mm and tortuous veins that are considered to be unsuitable for endovenous laser ablation (EVLA) due to difficulties in passing the guide wire
11. Inability to complete study questionnaires

Study & Design

• Study Type: Interventional
• Study Design: Not specified