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The aim of this randomised case-controlled trial is to investigate whether ablation of incompetent perforating vein in addition to ablation of truncal vein reduces the rate of recurrent varicose veins post-treatment compared with patients who only have ablation of the truncal vein, who are left with untreated incompetent perforating veins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVLA, phlebectomies & Trlop closure of incompetent perforators | Experimental | endovenous laser ablation (EVLA) of great saphenous vein (GSV) plus phlebectomies plus TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators. |
|
| EVLA & phlebectomies | Experimental | endovenous laser ablation (EVLA) of great saphenous vein (GSV) + phlebectomies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVLA | Procedure | Endovenous laser ablation of great saphenous vein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in the level of significant recurrence between the two treatment pathways | Differences in the level of significant recurrence between the two treatment pathways at each follow up. Significant recurrence would be indicated if the participant demonstrates varicose veins greater than 3mm in diameter, varicose veins associated with thrombophlebitis or skin changes such as venous eczema, red skin or brown skin overlying the veins which require further treatment. | Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in insignificant recurrence between the two treatment pathways | Evidence of insignificant recurrence - thread veins, reticular veins or varicose veins less than 3mm in diameter. | Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery |
| Patient reported symptom severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Briony Hudson | Contact | b.f.hudson@surrey.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Mark S Whiteley, Professor | The Whiteley Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Whiteley Clinic | Guildford | GU2 7RF | United Kingdom |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| phlebectomies | Procedure | removal of incompetent veins |
|
| TRansluminal Occlusion of Perforators (TRLOP) | Procedure | TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators. |
|
Patient reported symptom severity - the Aberdeen questionnaire |
| Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery |
| Patient reported quality of life | Patient reported quality of life - The Chronic Venous Insufficiency Questionnaire (CIVIQ) | Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery |
| Patient satisfaction with treatment. | Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery |
| Clinician reported severity of symptoms | CEAP and VCCS scores | Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery |