Objective:Several studies indicate that ELT using wavelengths of high water absorption showed advantages compared to conventional ELT. Thulium-Lasers emit nearby the local absorption maximum of water at 1940nm. In this clinical study the effectiveness, safety and the feasibility of 1940nm-ELT is proven.
Materials and Method:A single centric, prospective observational study was performed. 1940nm-laserenergy was applied using radial emitting fibres with continuous pullback (1mm/s). Treatment was performed under anesthesia (general, spinal, tumescent) thus simultaneous miniphlebectomy and ligation of perforators could be applied. Patient and technical details were systematically collected. Evaluation included: standardized questionnaire, clinical examination, color-duplex ultrasonography preoperatively, 3d, 4w, 6m postoperatively, statistic.
Results:The 1940nm-ELT study include 55 patients (female/men=34/21, mean age 55y, range 23-90y) treating n=72 vessels. The mean maximum diameter of great saphenous veins (GSV, n=59) was 7.5mm (range 3.7-11.3mm) and of small saphenous veins (SSV, n=13) was 5.3mm (3.0-10.0mm). The mean applied longitudinal endovenous energy density (LEED) was 64.3J/cm (40.3-98.2J/cm) in GSVs and 51.0J/cm (37.6-72.7J/cm) in SSVs. Complete occlusion of the vein without sign of reflux was achieved in 100%. The mean length of non-occluded stump at the sapheno-femoral junction was 6.0mm (1.0-20.0mm). Postoperative reduction of the diameter of GSV was 1.6mm (21.3%) and 2.0mm (37.7%) in SSV. One (1.4%) endovenous heat induced thrombus (EHIT) was observed. Further adverse events were: paresthesia 10/72 (13.9%), ecchymosis 1/72 (1.4%), lymphocele 1/72 (1.4%), hyperpigmentation 1/72 (1.4%). The mean postoperative pain intensity was 1.3 and 1.8 single doses of analgesics were administered. Normal physical activity was reached after 3d (1-21d).Conclusion: 1940nm-ELT using radial light application effectively eliminates the reflux in insufficient saphenous veins by a significant diameter reduction. The risk profile correlates with other endothermal treatment options. Low postoperative pain and analgesic requirements with rapid convalescence indicate a high level of patient comfort.
rate within the first year from 30% to 10% of the patient population. A secondary objective is a non-inferiority of MonoMax suture material (group C) in comparison to MonoPlus (group A). Results: 108 patients were randomized between February 2011 and July 2013. The compare of demographic data, risk factors and co-morbidities did not reveal structural differences between the study groups. After 12 months 4.55% of the patients with an additional implanted mesh in onlay position (group B) had developed an incision hernia versus 21.74% undergoing midline closure using two monofilaments suture loops (group A). In group C 18.18% of patients with 12-months-follow-up had an incision hernia. Non-parametric binomial testing assuming a hernia rate of 20% or 30% after 12 months was performed. For group A and C, herniation significantly differing from 20% (p ¼ 0.499 respectively p ¼ 0.543) or 30% (p ¼ 0.269 respectively p ¼ 0.165) could be refused, while the number of hernias in group B significantly differed from 20% (p ¼ 0.048) and 30% (p ¼ 0.004). Wound healing disorders occurred in15.19%. Notable differences were visible in formation of seromas which were exclusively found in patients of group B (19.23%) but not in group A or C. In total, re-surgery of the abdominal wall was performed in n ¼ 11 patients (10.68%). This number also includes n ¼ 4 non-emergency interventions (revision of the abdominal wall because of persistent seroma or repair of incision hernia). Conclusion: Additional mesh in onlay position after median laparotomy for AAA can reduce hernia rate significantly.
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