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This study will be comparing the treatment of varicose vein tributaries using either foam sclerotherapy or ambulatory phlebectomies. Patients will be randomised to having either ambulatory phlebectomy (group A) or foam sclerotherapy (group B) following treatment of their saphenous vein.
The re-intervention rates, safety, patient experience as well as the cost effectiveness of each intervention will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambulatory Phlebectomy | Active Comparator | Ambulatory phlebectomy of varicose vein tributaries |
|
| Foam Sclerotherapy | Active Comparator | Injection of foam sclerosant into varicose vein tributaries |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory phlebectomy | Procedure | Minor surgery to remove varicose vein tributaries |
|
| Measure | Description | Time Frame |
|---|---|---|
| Re-intervention rate | Re-intervention on varicose vein tributaries during study period | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Generic quality of life score | Quality of life score using the EuroQol's EQ-5D [0=worse quality of life; 1=best quality of life] | 12 months |
| Disease-specific quality of life score | Quality of life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) [0=worse quality of life; 100= best quality of life] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amjad Belramman | Contact | 02033117335 | a.belramman17@imperial.ac.uk | |
| Roshan Bootun | Contact | 02033117335 | r.bootun@imperial.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charing Cross Hospital, Imperial College London | Recruiting | London | W6 8RF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31269978 | Derived | Belramman A, Bootun R, Lane TRA, Davies AH. Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial. Trials. 2019 Jul 3;20(1):392. doi: 10.1186/s13063-019-3398-0. |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Foam sclerotherapy | Drug | Injection of foam sclerosant into varicose vein tributaries |
|
| 12 months |
| Disease specific quality of life score | Quality of life score using the ChronIc Venous Insufficiency Quality of Life Questionnaire (CIVIQ) [0=worse quality of life; 100=best quality of life] | 12 months |
| Clinical score | Clinical change using the Venous Clinical Severity Score (VCSS) [0=least severe disease; 30=most severe disease] | 12 months |
| Clinical score | Using the Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification [0=no varicose veins; 1=telangiectasia; 2= varicose veins; 3=oedema; 4=skin changes; 5=healed ulcer; 6=ulcer] | 12 months |
| Pain score over the first 10 days | Pain score over the first 10 days using a 0-100mm visual analogue scale (0=no pain; 100=worst pain) | 2 weeks |
| Degree of bruising at 2 weeks | Degree of bruising at 2 weeks using a categorical 0-5 bruising scale (0=no bruising; 5=bruising extending beyond treated segment) | 2 weeks |
| Time to return to normal activities | 2 weeks |