COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins (CONFETTI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Imperial College London
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Patient's pain score post-procedure using a visual analogue scale (VAS)
Study Overview
Brief Summary
This study will be looking at the effect of compression therapy in patients having endovenous treatment for varicose veins using foam sclerotherapy. 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
This will be a randomised clinical trial looking at the impact of wearing or not wearing compression stocking following endovenous ablation using foam sclerotherapy.
Patients will be randomised to group A (compression) and group B (no compression).
Target Population Patients referred to the Imperial College NHS Trust for treatment of symptomatic varicose veins will be recruited if they are found to have varicose veins suitable for foam sclerotherapy on colour duplex scan.
Intervention
Patients will be randomised to have compression (group A) or no compression (group B). This will be done by using an online randomisation software (Sealed Envelope Ltd).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults over 18 years of age
- •Varicose veins suitable for foam sclerotherapy
Exclusion Criteria
- •Allergic to sclerosant
- •Current DVT
- •Arterial disease (ABPI<0.8)
- •Patients unable to wear compression stockings
- •Patients who are unwilling to participate
- •Inability or unwillingness to complete questionnaires
- •Inability to attend follow-up appointments
Arms & Interventions
Compression stockings
Patients randomised to group A will be asked to wear compression stockings for 1 week
Intervention: Class 2 compression stockings (Other)
No compression
Patients randomised to group B will be provided with bandages to wear for 24 hours only, with no further compression afterwards
Outcomes
Primary Outcomes
Patient's pain score post-procedure using a visual analogue scale (VAS)
Time Frame: 10 days
Pain score
Secondary Outcomes
- Venous clinical severity score (VCSS)(6 months)
- Chronic venous insufficiency (CIVIQ) score(6 months)
- Occlusion rate(6 months)
- Degree of phlebitis(6 months)
- Aberdeen Varicose Vein Questionnaire (AVVQ) score(6 months)
- EuroQol's EQ-5D(6 months)