Compression therapy following ClariVein® ablation therapy: a randomised controlled trial of COMpression Therapy Following MechanO-Chemical Ablation (COMMOCA)

Doireann P Joyce, Stewart R Walsh, Charyl J Q Yap, Tze T Chong, Tjun Y Tang, Doireann P Joyce, Stewart R Walsh, Charyl J Q Yap, Tze T Chong, Tjun Y Tang

Abstract

Background: Endovenous treatment of varicose veins has increased in popularity over the last decade. There remains, however, a degree of uncertainty regarding the role of compression bandaging or hosiery following this intervention. The National Institute for Clinical Excellence Guideline Development Group has advocated further research to evaluate the clinical and cost-effectiveness of this post-procedure intervention. In addition to this, the duration of compression bandaging also warrants clarification.

Methods: Ethical approval for the study was obtained from the Singhealth Centralised Institutional Review Board (CIRB Ref: 2017/2710). Consent to enter the study will be sought from each participant only after a full explanation has been given, an information leaflet offered and time allowed for consideration. Signed participant consent will be obtained. Patients will be randomised to either compression (group A) or no compression (group B). The primary aim of the study is to assess the patient's pain scores for the first 10 days post procedure using a visual analogue scale. Secondary aims include an assessment of patient compliance with compression, quality of life scores, clinical effectiveness, rates of bruising and phlebitis, time taken to return to normal activities, patient satisfaction and occlusion rate at 6 months.

Discussion: The purpose of this study is to examine the effect of compression therapy in patients having mechano-chemical ablation (MOCA) therapy for truncal incompetence of their varicose veins using the ClariVein® device. This study may provide clarification on the role of compression therapy in patients undergoing MOCA.

Trial registration: ClinicalTrials.gov, NCT03685838. Registered on 26 September 2018.

Keywords: ClariVein®; Compression; Mechano-chemical ablation; Truncal ablation; Varicose veins.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
COMpression Therapy Following MechanO-Chemical Ablation (COMMOCA) randomised controlled trial flow chart. AVVQ Aberdeen Varicose Vein Questionnaire, CIVIQ ChronIc Venous Insufficiency quality of life Questionnaire, EQ-5D EuroQol 5 Dimensions, MOCA mechano-chemical ablation, VCSS Venous Clinical Severity Score
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) flow sheet schedule of enrolment, interventions and assessments. AVVQ Aberdeen Varicose Vein Questionnaire, CIVIQ ChronIc Venous Insufficiency quality of life Questionnaire, EQ-5D EuroQol 5 Dimensions, MOCA mechano-chemical ablation, VCSS Venous Clinical Severity Score

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