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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima.
Great saphenous vein occlusion with a thermal laser chateter
Great saphenous vein occlusion with a thermal radiofrequency chateter
Occlusion rate
Occlusion rate of the great saphenous vein
Time frame: One year after the treatment
Freedom from reflux
The absence of reflux in the treated great saphenous vein
Time frame: One year after the treatment
Disease-specific quality of life
Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
Time frame: One year after the treatment
Occlusion rate
Occlusion rate of the great saphenous vein
Time frame: three years after the treatment
Freedom from reflux
The absence of reflux in the treated great saphenous vein
Time frame: three years after the treatment
Disease-specific quality of life
Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
Time frame: three years after the treatment
Occlusion rate
Occlusion rate of the great saphenous vein
Time frame: five years after the treatment
Freedom from reflux
The absence of reflux in the treated great saphenous vein
Time frame: five years after the treatment
Disease-specific quality of life
Quality of life as measured by the Aberdeen Varicose Veins Questionnaire
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Time frame: five years after the treatment
Peroperative and immediate postoperative pain
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)
Time frame: During the procedure, immediately after, and at one week after the treatment
Sick leave
Number of sick leave days necessary after the treatment
Time frame: During the immediate postoperative period up to one month
Pain medication
The amount and type of pain medication received during and after the treatment
Time frame: During the immediate postoperative period up to one month
30-day occlusion rate
The occlusion rate of the treated great saphenous vein
Time frame: 30 days after the treatment
Complications
All complications (deep venous thrombosis, nerve injuries, infections etc) after the treatment
Time frame: Up to five years after the treatment