Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOCA | Experimental | The refluxing GSV was treated with ClariVein catheter (endovenous mechanochemical ablation). |
|
| EVLA | Active Comparator | The refluxing GSV was treated with endovenous laser ablation. |
|
| RFA | Active Comparator | The refluxing GSV was treated with radiofrequency ablation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOCA | Procedure | Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occlusion rate | Occlusion rate of the great saphenous vein | One year after the treatment |
| Freedom from reflux | The absence of reflux in the treated great saphenous vein | One year after the treatment |
| Disease-specific quality of life | Quality of life as measured by the Aberdeen Varicose Veins Questionnaire | One year after the treatment |
| Occlusion rate | Occlusion rate of the great saphenous vein | three years after the treatment |
| Freedom from reflux | The absence of reflux in the treated great saphenous vein | three years after the treatment |
| Disease-specific quality of life | Quality of life as measured by the Aberdeen Varicose Veins Questionnaire | three years after the treatment |
| Occlusion rate | Occlusion rate of the great saphenous vein | five years after the treatment |
| Freedom from reflux | The absence of reflux in the treated great saphenous vein | five years after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | During the procedure, immediately after, and at one week after the treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32795619 | Derived | Vahaaho S, Halmesmaki K, Mahmoud O, Alback A, Noronen K, Venermo M. Three-year results of a randomized controlled trial comparing mechanochemical and thermal ablation in the treatment of insufficient great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2021 May;9(3):652-659. doi: 10.1016/j.jvsv.2020.08.007. Epub 2020 Aug 12. | |
| 30908611 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| EVLA | Procedure | Great saphenous vein occlusion with a thermal laser chateter |
|
| RFA | Procedure | Great saphenous vein occlusion with a thermal radiofrequency chateter |
|
| Disease-specific quality of life | Quality of life as measured by the Aberdeen Varicose Veins Questionnaire | five years after the treatment |
| Sick leave |
Number of sick leave days necessary after the treatment |
| During the immediate postoperative period up to one month |
| Pain medication | The amount and type of pain medication received during and after the treatment | During the immediate postoperative period up to one month |
| 30-day occlusion rate | The occlusion rate of the treated great saphenous vein | 30 days after the treatment |
| Complications | All complications (deep venous thrombosis, nerve injuries, infections etc) after the treatment | Up to five years after the treatment |
| Vahaaho S, Mahmoud O, Halmesmaki K, Alback A, Noronen K, Vikatmaa P, Aho P, Venermo M. Randomized clinical trial of mechanochemical and endovenous thermal ablation of great saphenous varicose veins. Br J Surg. 2019 Apr;106(5):548-554. doi: 10.1002/bjs.11158. |