Mechanochemical Ablation vs Thermal Ablation
- Conditions
- Varicose Veins of Lower Limb
- Interventions
- Procedure: EVLAProcedure: RFAProcedure: MOCA
- Registration Number
- NCT03722134
- Lead Sponsor
- Helsinki University Central Hospital
- Brief Summary
Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one year.Patients with GSV reflux were randomized to undergo either MOCA or thermal ablation with laser or radiofrequency. The main outcome measure was the occlusion rate of the GSV at one and three years.
- Detailed Description
During 2014-2015, all patients referred to our vascular surgery clinic by their general practitioners due to varicose veins were screened for GSV insufficiency. We invited all patients filling the inclusion criteria to participate in this study.
Included patients were randomized to receive either thermal ablation (laser ablation or radiofrequency ablation) or mechanochemical ablation with the Clarivein device to treat the refluxing GSV.
The patients filled the Aberdeen Varicose Veins Questionnaire (AVVQ) at the baseline. We recorded the preoperative diameter of the GSV, specifically the diameter at the most proximal 20 centimetres, and the mean overall diameter at the thigh.
During the procedure, before discharge, and a week after, the patients reported pain scores using Visual Analogue Scale (VAS) on a scale of 0 to 10. At the one-month follow-up visit, we recorded wound healing, haematomas or bruising, nerve injuries, and pigmentation. The status of the GSV was examined with duplex Doppler ultrasound. The patients were also asked to determine what would have been the optimal sick leave after the procedure.
At the one-year follow-up, nerve injuries, pigmentation, and clinical status were recorded, as well as the status of the GSV with duplex Doppler ultrasound. The patients also filled the AVVQ questionnaire.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
- clinical classification of venous disease C2-C4
- ultrasound-verified reflux in the GSV
- mean GSV diameter in the thigh between 5 and 12 millimetres
- informed consent.
- body mass index (BMI) of over 40
- peripheral arterial disease
- lymphoedema
- pregnancy
- allergy to either the sclerosant or lidocaine
- severe general illness
- malignancy
- previous deep venous thrombosis
- previous varicose vein intervention in the same leg
- coagulation disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EVLA EVLA The refluxing GSV was treated with endovenous laser ablation. RFA RFA The refluxing GSV was treated with radiofrequency ablation. MOCA MOCA The refluxing GSV was treated with ClariVein catheter (endovenous mechanochemical ablation).
- Primary Outcome Measures
Name Time Method Freedom from reflux five years after the treatment The absence of reflux in the treated great saphenous vein
Disease-specific quality of life five years after the treatment Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
Occlusion rate five years after the treatment Occlusion rate of the great saphenous vein
- Secondary Outcome Measures
Name Time Method Peroperative and immediate postoperative pain During the procedure, immediately after, and at one week after the treatment Perceived pain using Visual Analogue Scale (Range 0-10; 0=no pain; 2=Mild pain, 4=Nagging, uncomfortable pain; 6= Miserable pain; 8=Horrible pain; 10=worst possible, unbearable pain)
Sick leave During the immediate postoperative period up to one month Number of sick leave days necessary after the treatment
Complications Up to five years after the treatment All complications (deep venous thrombosis, nerve injuries, infections etc) after the treatment
Pain medication During the immediate postoperative period up to one month The amount and type of pain medication received during and after the treatment
30-day occlusion rate 30 days after the treatment The occlusion rate of the treated great saphenous vein