RCT - Does Treating Incompetent Perforators Reduce Recurrence?

Study Overview
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Brief Summary
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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.

Official Title
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Randomised Controlled Study to Determine Whether Treating Incompetent Perforating Veins at the Time of Endothermal Varicose Vein Surgery for Truncal Reflux Reduces Recurrence After Varicose Vein Treatments.

Conditions
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Varicose Veins

Intervention / Treatment
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* Procedure: EVLA
* Procedure: phlebectomies
* Procedure: TRansluminal Occlusion of Perforators (TRLOP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary varicose veins caused by great saphenous vein reflux At least one incompetent perforating vein refluxing into the varicosities Over 18 years of age Exclusion Criteria: Reflux from pelvic vein origin or small saphenous vein Previous varicose vein surgery, Incompetent perforators remote from the varicosities treated, Deep vein incompetence Deep vein obstruction or occlusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVLA, phlebectomies & Trlop closure of incompetent perforators<br>endovenous laser ablation (EVLA) of great saphenous vein (GSV) plus phlebectomies plus TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators. | Procedure: EVLA<br>* Endovenous laser ablation of great saphenous vein<br>Procedure: phlebectomies<br>* removal of incompetent veins<br>Procedure: TRansluminal Occlusion of Perforators (TRLOP)<br>* TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.<br>|
| Experimental: EVLA & phlebectomies<br>endovenous laser ablation (EVLA) of great saphenous vein (GSV) + phlebectomies. | Procedure: EVLA<br>* Endovenous laser ablation of great saphenous vein<br>Procedure: phlebectomies<br>* removal of incompetent veins<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incompetent perforating veins, EVLA, Phlebectomies, TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.