Background: Varicose veins are caused by superficial venous insufficiency and are very common, with a prevalence of over 30% in adults. Varicose veins are in most instances caused by great saphenous vein (GSV) or small saphenous vein (SSV) insufficiency, and consequently many treatment methods base on obliterating the defective vein. During the last decade, the treatment of superficial venous insufficiency has undergone a fundamental change from open surgery to less invasive, endovenous methods. Not much data on the long-term results of these methods has been published, though endovenous methods have replaced open surgery in many centres and thermal ablation has by this time become the new gold standard. Aims: The aim of this thesis is to compare the results of ultrasound-guided foam sclerotherapy (UGFS) and endovenous laser ablation (EVLA) to conventional open surgery consisting of high ligation and stripping, and to study mechanochemical ablation (MOCA) in contrast to EVLA and radiofrequency ablation (RFA), both of which are currently well-established treatment methods. The technical success in view of the GSV occlusion rate, the gain in quality of life as well as recurrence rate and pattern are of interest. Methods: Outpatient clinic patients presenting with GSV insufficiency in one leg were invited to participate in the studies. In the first part of the studies, the patients were randomized to receive either UGFS, EVLA or open surgery. In the second part, the randomization was to either MOCA, EVLA or RFA treatment. Prior to treatment, the patients filled Aberdeen Varicose Vein Questionnaire (AVVQ), a tool designed to measure the disease-specific quality of life. The diameter of the GSV was recorded using duplex Doppler ultrasound (DDUS). The experienced pain was described in the visual analogue scale (VAS) during the treatment, at the time of the discharge and at one week postoperatively. The amount of received pain medication was recorded. In the first part of the study, the patients were followed up at one year and five years after the treatment; in the second part of the study, the follow-ups took place at one year and three years. The follow-up included the AVVQ, DDUS examination and clinical status; recurrence, any additional treatment or the need for such in addition to possible complications were recorded. Results: 233 patients were randomized in the first part of the study; some, however, met an exclusion criteria not recognized at the time of recruitment or were not willing to continue in the study. In total, 214 patients finally underwent treatment (18 in Tampere University Hospital and 196 in Helsinki University Hospital): 65 received open surgery, 68 EVLA and 76 UGFS. At one-year follow-up, the participation rate was 96.3%. UGFS had some initial benefits compared to EVLA and open surgery, being virtually pain-free and requiring only a short sick leave, if at all. However, the GSV remained occluded or absent only in 51.4% of the UGFS-treated patients compared to 96,7% of those treated with EVLA or open surgery (P <0.001). The disease-specific quality of life did not differ between the treatment groups. At five years, 166 of the 196 (84.7%) patients treated at Helsinki University Hospital attended the follow-up. The occlusion rate of the GSV was 96.0% in the open surgery group, 89.4% in the EVLA group, and 50.8% in the UGFS group (P <0.001). Yet, some patients had already received repeat treatment, and the non-assisted occlusion rate was only 41.0% in the UGFS group. The odds of needing additional treatment was 8.7 times greater for UGFS than for EVLA. The disease-specific quality of life did not significantly differ between the groups, but a tendency towards a higher AVVQ score in the UGFS group reflecting lower quality of life was observed. In the second part of the studies, 132 patients with GSV insufficiency in one leg agreed to participate in a randomized trial comparing MOCA with EVLA and RFA. Again, some patients declined to participate after randomization. Ultimately, 59 patients in the MOCA group (with one patient crossing over to EVLA, but analysed in the MOCA group), 34 in the EVLA group and 33 in the RFA group underwent treatment: the ablation of the GSV with the randomized method and concomitant phlebectomies. The perceived pain did not differ between the groups at any time point, but the patients in the MOCA group received less sedatives during the procedure. The duration of the sick leave was equal between the groups. At one-year follow-up with an attendance rate of 93.6%, the occlusion rate of the GSV was 81.8% in the MOCA group and 100% in both the EVLA and RFA groups (P = 0.002). Most of the recanalizations in the MOCA group were partial. In the MOCA group, no sensory disturbances (signs of nerve injury) were observed, while four patients in the EVLA group and three in the RFA group reported such disturbances. At three years, 106 patients (84.8%) attended the follow-up. The occlusion rates at this point were 82.0% for MOCA and 100% for the EVLA and RFA groups (P = 0.005); the unassisted occlusion rate was slightly lower, 80.0% in the MOCA group. In the MOCA group, the partial or complete recanalizations of the proximal GSV seen at one year had progressed, leading to further recanalization of the GSV. The disease-specific quality of life was not statistically different between the treatment groups. Conclusions: EVLA is at least as good as open surgery in a follow-up of up to five years; when possible complications and costs are considered, EVLA is superior. In contrast, despite having immediate advantages over more invasive treatment methods, UGFS leads to a low occlusion rate and far more additional treatments compared to either EVLA or open surgery. MOCA appears inferior to thermal ablation with EVLA or RFA regarding the occlusion rate, though it seems to cause no nerve injuries. The disease-specific quality of life did not statistically differ between the treatment groups.
|Status||Publicerad - 2020|
|MoE-publikationstyp||G5 Doktorsavhandling (artikel)|
Bibliografisk informationM1 - 150 s.
- 3126 Kirurgi, anestesiologi, intensivvård, radiologi