Varicose Veins of Lower Limb
Conditions
Keywords
Great saphenous vein, Thermal ablation, Mechanochemical ablation, Randomized controlled trial
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.
Interventions
PROCEDUREMOCA
Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima.
PROCEDUREEVLA
Great saphenous vein occlusion with a thermal laser chateter
PROCEDURERFA
Great saphenous vein occlusion with a thermal radiofrequency chateter
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Our study aim was to assess the applicability and safety of MOCA in short term as well as occlusion rate and disease specific quality of life one year after the procedure, and compare it with currently used thermal ablation methods of laser ablation (EVLA) and radiofrequency ablation (RFA) in a randomized controlled trial. Randomization took place by a study nurse after the appointment, using block randomization with sealed envelopes into EVLA, RFA, or MOCA in ratio 1:1:2.
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occlusion rate | One year after the treatment | Occlusion rate of the great saphenous vein |
| Freedom from reflux | One year after the treatment | The absence of reflux in the treated great saphenous vein |
| Disease-specific quality of life | One year after the treatment | Quality of life as measured by the Aberdeen Varicose Veins Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day occlusion rate | 30 days after the treatment | The occlusion rate of the treated great saphenous vein |
| 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) |
| Complications | Up to five years after the treatment | All complications (deep venous thrombosis, nerve injuries, infections etc) after the treatment |
| Sick leave | During the immediate postoperative period up to one month | Number of sick leave days necessary 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 |
Outcome results
None listed