Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial

Amjad Belramman, Roshan Bootun, Tristan R A Lane, Alun H Davies, Amjad Belramman, Roshan Bootun, Tristan R A Lane, Alun H Davies

Abstract

Background: Ambulatory phlebectomies and foam sclerotherapy are two of the most common treatments for varicose vein tributaries. Many studies have been published on these treatments, but few comparative studies have attempted to determine their relative effectiveness.

Methods/design: This is a prospective single-centre randomised clinical trial. Patients with primary truncal vein incompetence and varicose vein tributaries requiring treatment will be assigned randomly to either ambulatory phlebectomies or foam sclerotherapy. The primary outcome measure is the re-intervention rate for the varicose vein tributaries during the study period. The secondary outcomes include the degree of pain during the first two post-operative weeks and the time to return to usual activities or work. Improvements in clinical scores, quality of life scores, occlusion rates and cost-effectiveness for each intervention are other secondary outcomes. The re-intervention rate will be considered from the third month.

Discussion: This study compares ambulatory phlebectomies and foam sclerotherapy in the treatment of varicose vein tributaries. The re-intervention rates, safety, patient experience and the cost-effectiveness of each intervention will be assessed. This study aims to recruit 160 patients and is expected to be completed by the end of 2019.

Trial registration: ClinicalTrials.gov, NCT03416413 . Registered on 31 January 2018.

Keywords: Phlebectomy; foam sclerotherapy; superficial venous disease; varicose veins; varicosity treatment.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Trial flowchart. AVVQ Aberdeen Varicose Vein Questionnaire, CIVQ-14 Chronic Venous Insufficiency Questionnaire, EQ-5D EuroQol Five-Domain Utility Index, VCSS Venous Clinical Severity Score
Fig. 2
Fig. 2
Schedule of enrolment, interventions and assessments

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Source: PubMed

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