Clinical trial NCT03685838: Compression Stockings Therapy Following Mechano-Chemical Ablation (Clarivein®)
Official title: A Randomised Controlled Trial of Compression Stockings Therapy Following Mechano-Chemical Ablation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicose Veins
Chronic Venous Insufficiency
Keywords: mechano-chemical ablation
compression stockings
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
Collaborators: name: National University of Ireland, Galway, Ireland
First posted: 2018-09-26
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be looking at the effect of compression therapy in patients having Mechano-Chemical Ablation (MOCA) therapy for truncal incompetence of their varicose veins using the ClariVein® device. Patients will be randomised to either the compression group (group A) or the no compression group (group B).

The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.

Detailed description: Varicose veins are common and are known to affect approximately one third of the population. Chronic Venous Disease (CVD) has been shown to have a negative impact on the quality of life of patients and treatment of varicose veins has been demonstrated to lead to improvement in the quality of life of patients. Over the past decade, new endovenous techniques have been introduced and these are felt to be cost-effective, especially, when performed in an outpatient or 'office-based' setting.

There is currently uncertainty about the use of compression stockings following treatment of varicose veins. International Union of Phlebology (IUP), The Society for Vascular Surgery and the American Venous Forum, as well as 2013 National Institute for Health and Care Excellence (NICE) Guideline on Varicose Veins in the Legs have recommended that compression stockings are suitable in certain clinical indications and can be worn post-operatively for no more than 7 days after interventional treatment to prevent haematoma formation, pain and swelling. However, further research is essential for determining clinical and cost effectiveness, as well as length of time compression should be worn, and level of compression.

Several researchers have looked into the practice of using compression after venous ablation. In a survey of the management of varicose veins by the members of the Vascular Society of Great Britain and Ireland. Edwards et al. found that the majority of surgeons used bandages post-operatively, with 49% using elastic bandage. To date, the literature on the use of compression stockings following treatment of varicose veins is limited.

Mechano-Chemical Ablation (MOCA) combines mechanical damage to the endothelium caused by a rotating wire with simultaneous catheter-guided infusion of a liquid sclerosant that irreversibly damages the cellular membrane of the endothelium, causing fibrosis of the vein. The exact mechanism is still not exactly known. However, recent experimental research showed that various sclerosants induced apoptosis in the vein wall rather than having an effect restricted to the endothelium. Incomplete loss of endothelial cells and penetration of the sclerosant effect into the media suggest that medial damage is crucial to the success of sclerotherapy and may explain why it is less effective in larger veins. This poses the question whether compression is needed post sclerotherapy to improve contact of the sclerosant to the endothelium when media penetration seems to be more important to allow apoptosis of smooth muscle cells.

The investigators therefore propose to undertake a randomised study looking at the effect of compression therapy after MOCA using Clarivein device

Eligibility criteria: Inclusion Criteria:

* Age\>=21 to \<=80
* Able to walk unassisted and attend follow-up visits
* Symptomatic Great Saphenous Vein (GSV) or Small Saphenous Vein (SSV) vein reflux \>0.5 seconds on colour Duplex ultrasound
* Able to provide informed consent

Exclusion Criteria:

* Previous or current deep vein thrombosis or pulmonary embolism
* Patients with a hypercoaguable state
* Previous thrombophlebitis in the truncal vein in question, which had recanalized and was now incompetent on duplex ultrasound
* Recurrent varicose vein i.e. patients who have had treatment previously in the designated truncal vein with any modality
* Patients who have had treatment in either leg for an incompetent saphenous truncal vein less than 3 months prior to treatment and enrolment into this study
* Patients requiring adjuvant treatment of varicose veins
* Arterial disease (ABPI \< 0.6 and the absence of a palpable pedal pulse)
* Vein diameter \<3mm or \>12mm as measured in the standing position on duplex ultrasound
* Varicose veins unsuitable for MOCA (e.g. very tortuous vein)
* Pregnancy
* Lycra, sclerosant or local anaesthetic allergy
* Patients who have opted for an alternative method of treatment
* Patients with fibromyalgia
* Patients with Clinical, Etiologic, Anatomic and Pathophysiologic (CEAP) score of C6 (active ulcer), C1 and C2 (asymptomatic) disease
* Patients with a life expectancy less than 12 months
* Inability or unwillingness to complete questionnaires
* Patients who refuses to participate and unable to provide informed consent or comply with the study protocol.

Primary outcomes:
measure: Pain Score post-procedure
timeFrame: First 10 days post-procedure
Secondary outcomes:
measure: Quality of Life score using the EQ-5D questionnaire
timeFrame: Baseline, 2 weeks post-op, 6 months post-op
measure: Quality of life score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)
timeFrame: Baseline, 2 weeks post-op, 6 months post-op
measure: Quality of life score using the Aberdeen Varicose Veins Questionnaire (AVVQ)
timeFrame: Baseline, 2 weeks post-op, 6 months post-op
measure: Clinical Change using Venous Clinical Severity Score (VCSS)
timeFrame: Baseline, 2 weeks post-op, 6 months post-op
measure: Time taken to return to work and normal activities
timeFrame: 10 days post-op
measure: Degree of bruising and phlebitis
timeFrame: 2 weeks post-op, 6 months post-op
measure: The number of patient compliant with the intervention
timeFrame: 10 days post-op
measure: Patient's satisfaction
timeFrame: 2 weeks post-op, 6 months post-op
measure: Comparison of the cost-effectiveness of the intervention
timeFrame: 6 months post-op
measure: Successful obliteration of target vein
timeFrame: 2 weeks post-op, 6 months post-op
Other outcomes:
Locations:
city: Galway City
country: Ireland
facility: Galway University Hospital
state: Galway
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Tang Tjun Yip
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Joyce DP, Walsh SR, Yap CJQ, Chong TT, Tang TY. Compression therapy following ClariVein(R) ablation therapy: a randomised controlled trial of COMpression Therapy Following MechanO-Chemical Ablation (COMMOCA). Trials. 2019 Dec 5;20(1):678. doi: 10.1186/s13063-019-3787-4.