Safety and effectiveness of a novel generator algorithm for bipolar vessel sealing: a randomised controlled chronic animal study
Abstract Background Electrosurgical vessel sealers are gradually replacing conventional techniques such as ligation and clipping. Algorithms that control electrosurgical units (ESU), known as modes, are important for applications in different surgical disciplines. This chronic porcine animal study a...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2019-11-01
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| Series: | BMC Surgery |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12893-019-0625-2 |
| _version_ | 1818571757530906624 |
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| author | Bernhard Kraemer Christos Tsaousidis Stephan Kruck Martin Schenk Marcus Scharpf Stefan Kommoss Sara Brucker Daniela Nuessle Markus D. Enderle Ulrich Biber |
| author_facet | Bernhard Kraemer Christos Tsaousidis Stephan Kruck Martin Schenk Marcus Scharpf Stefan Kommoss Sara Brucker Daniela Nuessle Markus D. Enderle Ulrich Biber |
| author_sort | Bernhard Kraemer |
| collection | DOAJ |
| description | Abstract Background Electrosurgical vessel sealers are gradually replacing conventional techniques such as ligation and clipping. Algorithms that control electrosurgical units (ESU), known as modes, are important for applications in different surgical disciplines. This chronic porcine animal study aimed to evaluate the safety and effectiveness of the novel thermoSEAL electrosurgical vessel sealing mode (TSM). The BiClamp® mode (BCM) of the renowned VIO® 300 D ESU served as control. BCM has been widely available since 2002 and has since been successfully used in many surgical disciplines. The TSM, for the novel VIO® 3 ESU, was developed to reduce sealing time and/or thermal lateral spread adjacent to the seal while maintaining clinical success rates. The primary aim of this study was to investigate the long-term and intraoperative seal quality of TSM. Methods The BiCision® device was used for vessel sealing with TSM and BCM in ten German Landrace pigs which underwent splenectomy and unilateral nephrectomy during the first intervention of the study. The seals were cut with the BiCision® knife. Ninety-nine arteries, veins and vascular bundles were chronically sealed for 5 or 21 days. Thereafter, during the second and terminal intervention of the study, 97 additional arteries and veins were sealed. The carotid arteries were used for histological evaluation of thermal spread. Results After each survival period, no long-term complications occurred with either mode. The intraoperative seal failure rates, i.e. vessel leaking or residual blood flow after the first sealing activation, were 2% with TSM versus 6% with BCM (p = 0.28). The sealing time was significantly shorter with TSM (3.5 ± 0.69 s vs. 7.3 ± 1.3 s, p < 0.0001). The thermal spread and burst pressure of arteries sealed with both modes were similar (p = 0.18 and p = 0.61) and corresponded to the histological evaluation. The measured tissue sticking parameter was rare with both modes (p = 0.33). Tissue charring did not occur. Regarding the cut quality, 97% of the seals were severed in the first and 3% in the second attempt (both with TSM and BCM). Conclusions The novel TSM seals blood vessels twice as fast as the BCM while maintaining excellent tissue effect and clinical success rates. Trial registration Not applicable. |
| first_indexed | 2024-12-14T18:48:34Z |
| format | Article |
| id | doaj.art-cb0951685e2f4009afddbcca4456a1a5 |
| institution | Directory Open Access Journal |
| issn | 1471-2482 |
| language | English |
| last_indexed | 2024-12-14T18:48:34Z |
| publishDate | 2019-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Surgery |
| spelling | doaj.art-cb0951685e2f4009afddbcca4456a1a52022-12-21T22:51:20ZengBMCBMC Surgery1471-24822019-11-0119111210.1186/s12893-019-0625-2Safety and effectiveness of a novel generator algorithm for bipolar vessel sealing: a randomised controlled chronic animal studyBernhard Kraemer0Christos Tsaousidis1Stephan Kruck2Martin Schenk3Marcus Scharpf4Stefan Kommoss5Sara Brucker6Daniela Nuessle7Markus D. Enderle8Ulrich Biber9University Hospital TuebingenUniversity Hospital TuebingenHelios Klinikum PforzheimUniversity Hospital TuebingenUniversity Hospital TuebingenUniversity Hospital TuebingenUniversity Hospital TuebingenErbe Elektromedizin GmbHErbe Elektromedizin GmbHErbe Elektromedizin GmbHAbstract Background Electrosurgical vessel sealers are gradually replacing conventional techniques such as ligation and clipping. Algorithms that control electrosurgical units (ESU), known as modes, are important for applications in different surgical disciplines. This chronic porcine animal study aimed to evaluate the safety and effectiveness of the novel thermoSEAL electrosurgical vessel sealing mode (TSM). The BiClamp® mode (BCM) of the renowned VIO® 300 D ESU served as control. BCM has been widely available since 2002 and has since been successfully used in many surgical disciplines. The TSM, for the novel VIO® 3 ESU, was developed to reduce sealing time and/or thermal lateral spread adjacent to the seal while maintaining clinical success rates. The primary aim of this study was to investigate the long-term and intraoperative seal quality of TSM. Methods The BiCision® device was used for vessel sealing with TSM and BCM in ten German Landrace pigs which underwent splenectomy and unilateral nephrectomy during the first intervention of the study. The seals were cut with the BiCision® knife. Ninety-nine arteries, veins and vascular bundles were chronically sealed for 5 or 21 days. Thereafter, during the second and terminal intervention of the study, 97 additional arteries and veins were sealed. The carotid arteries were used for histological evaluation of thermal spread. Results After each survival period, no long-term complications occurred with either mode. The intraoperative seal failure rates, i.e. vessel leaking or residual blood flow after the first sealing activation, were 2% with TSM versus 6% with BCM (p = 0.28). The sealing time was significantly shorter with TSM (3.5 ± 0.69 s vs. 7.3 ± 1.3 s, p < 0.0001). The thermal spread and burst pressure of arteries sealed with both modes were similar (p = 0.18 and p = 0.61) and corresponded to the histological evaluation. The measured tissue sticking parameter was rare with both modes (p = 0.33). Tissue charring did not occur. Regarding the cut quality, 97% of the seals were severed in the first and 3% in the second attempt (both with TSM and BCM). Conclusions The novel TSM seals blood vessels twice as fast as the BCM while maintaining excellent tissue effect and clinical success rates. Trial registration Not applicable.http://link.springer.com/article/10.1186/s12893-019-0625-2SwineAnimal modelBurst pressureThermal damageSealing timeAlgorithm |
| spellingShingle | Bernhard Kraemer Christos Tsaousidis Stephan Kruck Martin Schenk Marcus Scharpf Stefan Kommoss Sara Brucker Daniela Nuessle Markus D. Enderle Ulrich Biber Safety and effectiveness of a novel generator algorithm for bipolar vessel sealing: a randomised controlled chronic animal study BMC Surgery Swine Animal model Burst pressure Thermal damage Sealing time Algorithm |
| title | Safety and effectiveness of a novel generator algorithm for bipolar vessel sealing: a randomised controlled chronic animal study |
| title_full | Safety and effectiveness of a novel generator algorithm for bipolar vessel sealing: a randomised controlled chronic animal study |
| title_fullStr | Safety and effectiveness of a novel generator algorithm for bipolar vessel sealing: a randomised controlled chronic animal study |
| title_full_unstemmed | Safety and effectiveness of a novel generator algorithm for bipolar vessel sealing: a randomised controlled chronic animal study |
| title_short | Safety and effectiveness of a novel generator algorithm for bipolar vessel sealing: a randomised controlled chronic animal study |
| title_sort | safety and effectiveness of a novel generator algorithm for bipolar vessel sealing a randomised controlled chronic animal study |
| topic | Swine Animal model Burst pressure Thermal damage Sealing time Algorithm |
| url | http://link.springer.com/article/10.1186/s12893-019-0625-2 |
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