RCT of foam sclerotherapy versus ambulatory phlebectomy
Research type
Research Study
Full title
Randomised controlled trial of foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries
IRAS ID
216416
Contact name
Roshan Bootun
Contact email
Sponsor organisation
Research Governance and Integrity Team (RGIT)
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Summary of Research
Varicose vein tributaries (prominent varicosities) are often treated with either foam sclerotherapy (chemical injection) or ambulatory phlebectomy (minor surgery), following the treatment of the truncal saphenous vein (main varicose vein). There is currently not enough evidence to say which method is better and reduce the rate of needing another intervention.Therefore, this randomised study is being proposed, which will be comparing these two techniques. Patients will then be followed up at 2 weeks, 3 months, 6 months, and 12 months.
The main outcome measure is to find out what the re-intervention rate is following treatment with each modality. The quality of life, clinical severity score, degree of bruising and phlebitis, patient satisfaction, time to return to normal activities, pain score over the first 10 days as well as the cost-effectiveness will also be assessed.
Summary of Results
Unfortunately, the study did not manage to recruit adequate number of patients because of various factors. As a result, it is not possible to perform any meaningful statistical analysis.REC name
West of Scotland REC 3
REC reference
17/WS/0192
Date of REC Opinion
17 Aug 2017
REC opinion
Favourable Opinion