Efficacy and safety of the novel electrosurgical vessel sealing and cutting instrument BiCision®.

BACKGROUND: The use of energy-based tissue-sealing and cutting instruments is becoming more and more popular in visceral, urological, and gynecological surgery. For their safe and efficacious use in clinical practice, such instruments have to reliably seal vessels with a minimal sealing failure rate, cause minimal thermal damage to adjacent tissue, and have good cutting qualities. METHODS: The efficacy and safety of the novel energy-based instrument for dissection, hemostasis and cutting (BiCision(®), ERBE) was compared to a commercially available device (EnSeal(®), Ethicon Endo-Surgery). We investigated vessel-sealing reliability (success rate), sealing quality and sealing time, lateral thermal damage cutting quality, tissue sticking to the instrument, burst pressure and delayed complications in an acute and chronic pig model after splenectomy, small bowel resection, nephrectomy, salpingo-oophorectomy, and sealing of peripheral vessels. RESULTS: For all parameters investigated, BiCision(®) was at least equivalent to EnSeal(®). BiCision(®) was even superior to EnSeal(®) with respect to the burst pressure in arteries (p = 0.044) and veins (p = 0.023) and the cut quality in all locations (arteries, p = 0.0009; veins, p = 0.043). The course of the 7-day chronic study was uneventful except for one animal that developed an intestinal obstruction. None of the animals showed any signs of postoperative bleeding. On second-look laparotomy at day 7, macroscopic inspection of the sealed tissue and vessels did not show any signs of complications or evidence that bleeding had occurred. Histologically, the integrity of vessel wall fusion, thermal alterations, and inflammatory reactions were comparable, confirming substantial equivalence. CONCLUSION: We demonstrated that the efficacy and quality of vessel sealing with BiCision(®) is at least equivalent to those of EnSeal(®) for vessel diameters up to 7 mm. Since EnSeal(®) has already been shown to be safe in clinical practice, BiCision(®) should be as reliable as EnSeal(®) under clinical conditions.

Efficiency and safety of bipolar vessel and tissue sealing in visceral surgery.

BACKGROUND: The aim of this study was to analyze the efficiency and safety of the bipolar tissue/vessel sealing and cutting device EnSeal(™) in comparison to the conventional clamp and ligation technique in visceral surgery. MATERIAL AND METHODS: In an acute animal model, a part of the small bowel, a part of the colon and the kidneys were resected either with the conventional clamp and ligation technique or with EnSeal(™). Operation time, blood loss and blood parameters as well as the lateral thermal spread were evaluated. RESULTS: Small bowel, colon and kidney resection time with the EnSeal(™) device was shorter compared to the conventional clamp and ligation technique (small bowel: EnSeal(™): 4.7 ± 1.0 min vs. con: 35.1 ± 2.3 min; colon: EnSeal(™): 7.0 ± 1.4 min vs. con: 16.3 ± 1.5 min, kidney: EnSeal(™): 5.7 ± 1.3 min vs. con: 16.7 ± 3.7 min, p < 0.05) and blood loss was significantly lower. Blood analysis demonstrated no differences in both groups. The lateral thermal spread was not more than 1 mm with EnSeal(™). CONCLUSION: The bipolar sealing in visceral surgery with EnSeal(™) can be performed more efficiently in a shorter time, with significantly less blood loss, minimal thermal damage and without changes of blood parameters, indicating biological safety and integrity.

Evaluation of the novel bipolar vessel sealing and cutting device BiCision® in a porcine model.

BACKGROUND: Energy-based technologies for tissue sealing and cutting are increasingly supplementing current standards used for haemostasis and dissection during laparoscopic surgery. For their safe and efficacious use in clinical practice, these instruments have to guarantee sufficient burst resistance and low thermal damage to adjacent tissue in combination with good cutting characteristics. MATERIAL AND METHODS: The novel laparoscopic, bipolar electrosurgical sealing and cutting instrument BiCision® was compared to a commercially available laparoscopic device (EnSeal(™)) on visceral and peripheral arteries and veins in an animal model. RESULTS: For all parameters investigated (burst pressure, cut quality, tissue adhering to the instrument, time needed to seal and cut the vessel and thermal damage), BiCision® was at least as good as EnSeal(™). Regarding the burst pressure, BiCision® was superior over EnSeal(™) in arteries: 600 mmHg (±478) versus 241 (±269) mmHg, respectively (p < 0.0001*). In veins, almost equivalent burst pressures of 155 ± 134 mmHg (BiCision®) and 173 ± 139 mmHg (EnSeal(™)) were obtained. CONCLUSION: BiCision® appeared to be as good as or even superior to EnSeal(™). Since EnSeal(™) has already been shown to be safe and has been successfully used in clinical practice, BiCision® is assumed to be as efficient and reliable as EnSeal(™) under pre-clinical conditions.