N/A
N=204
Compression Therapy Following Endothermal Ablation
Varicose Veins
Bottom Line
View on ClinicalTrials.gov: NCT02522845 ↗Enrolled (actual)
204
Serious AEs
0.5%
Results posted
Jul 2020
Primary outcome: Primary: Patient's Post-procedure Pain Score Using a Visual Analogue Scale (VAS) — 18.7; 27.8 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Class II Compression Stockings (no specific device used) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient's Post-procedure Pain Score Using a Visual Analogue Scale (VAS) |
18.7; 27.8 | — |
| SECONDARY The Generic Quality of Life Score Using the EQ-5D Score |
0.761; 0.891 | — |
| SECONDARY The Specific Quality of Life Score Using the Aberdeen Varicose Vein Questionnaire (AVVQ) Score |
7.3; 10.1 | — |
| SECONDARY The Specific Quality of Life Score Using the CIVIQ Score |
7.1; 5.4 | — |
| SECONDARY The Clinical Score Using the Venous Clinical Severity Score |
2; 1 | — |
| SECONDARY The Degree of Bruising and Phlebitis |
85; 80 | — |
| SECONDARY The Number of Days After Treatment That Patients Were Compliant With the Intervention |
7 | — |
| SECONDARY The Time Taken to Return to Work and Normal Activities |
2; 3 | — |
| SECONDARY Occlusion Rates at 6 Months |
41; 41 | — |
| SECONDARY The Cost of the Intervention |
— | — |
Summary
This study will be looking at the effect of compression therapy in patients having endovenous treatment for truncal incompetence of their varicose veins using either radiofrequency ablation (RFA) or endovenous laser therapy (EVLT). 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.
Eligibility Criteria
Inclusion Criteria
- Adults over 18 years of age
- Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex
Exclusion Criteria
- Current DVT
- Recurrent varicose veins
- Patients requiring adjuvant treatment of varicose veins
- Arterial disease (ABPI<0.8)
- Vein diameter < 3mm
- Patient who are unwilling to participate
- Inability or unwillingness to complete questionnaires
Data sourced from ClinicalTrials.gov (NCT02522845). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.