The Laryngoscope · 2016
A european multicenter study evaluating the flex robotic system in transoral robotic surgery.
Clinical StudyСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Lang Stephan, Mattheis Stefan, Hasskamp Pia, Lawson Georges, Güldner Christian, Mandapathil Magis, Schuler Patrick, Hoffmann Thomas, Scheithauer Marc, Remacle Marc
Аннотация
OBJECTIVES/HYPOTHESIS: To evaluate the application of the Flex Robotic System in transoral robotic surgery (TORS).
STUDY DESIGN: Multicenter, prospective, open-label, single-armed clinical study.
METHODS: A prospective clinical follow-up multicenter study was performed from July 2014 to October 2015 assessing the safety and efficacy of the Medrobotics Flex Robotic System for access and visualization of the oropharynx, hypopharynx, and larynx as well as for resection of benign and malignant lesions. A total of 80 patients were enrolled. Access and visualization of five anatomic subsites (base of tongue, palatine tonsil area, epiglottis, posterior pharyngeal wall, and false vocal cords) were individually graded by the surgeon. Setup times, access and visualization times, surgical results, and adverse events were documented.
RESULTS: The relevant anatomic structures could be exposed and visualized properly in 75 patients, who went on to have a surgical procedure performed with the Flex Robotic System. Access and visualization of the palatine tonsil area, posterior pharyngeal wall, epiglottis, and posterior pharyngeal wall were excellent. However, false vocal cords and vocal cords were more difficult to expose. Seventy-two patients were treated successfully with the Flex Robotic System. There were no serious or unanticipated device-related adverse events caused by the Flex Robotic System.
CONCLUSIONS: Lesions in the oropharynx, hypopharynx, and larynx could be successfully resected with the Flex Robotic System, specifically developed for TORS. Our study provides evidence that the Flex Robotic System is a safe and effective tool in TORS. Laryngoscope, 2016 127:391-395, 2017.
STUDY DESIGN: Multicenter, prospective, open-label, single-armed clinical study.
METHODS: A prospective clinical follow-up multicenter study was performed from July 2014 to October 2015 assessing the safety and efficacy of the Medrobotics Flex Robotic System for access and visualization of the oropharynx, hypopharynx, and larynx as well as for resection of benign and malignant lesions. A total of 80 patients were enrolled. Access and visualization of five anatomic subsites (base of tongue, palatine tonsil area, epiglottis, posterior pharyngeal wall, and false vocal cords) were individually graded by the surgeon. Setup times, access and visualization times, surgical results, and adverse events were documented.
RESULTS: The relevant anatomic structures could be exposed and visualized properly in 75 patients, who went on to have a surgical procedure performed with the Flex Robotic System. Access and visualization of the palatine tonsil area, posterior pharyngeal wall, epiglottis, and posterior pharyngeal wall were excellent. However, false vocal cords and vocal cords were more difficult to expose. Seventy-two patients were treated successfully with the Flex Robotic System. There were no serious or unanticipated device-related adverse events caused by the Flex Robotic System.
CONCLUSIONS: Lesions in the oropharynx, hypopharynx, and larynx could be successfully resected with the Flex Robotic System, specifically developed for TORS. Our study provides evidence that the Flex Robotic System is a safe and effective tool in TORS. Laryngoscope, 2016 127:391-395, 2017.
Предметные рубрики MeSH
AgedBiopsyEquipment DesignEquipment FailureFemaleFollow-Up StudiesHumansHypopharyngeal NeoplasmsHypopharynxLaryngeal DiseasesLaryngeal NeoplasmsLaryngoscopesLarynxLearning CurveMaleMiddle AgedOropharyngeal NeoplasmsOropharynxProduct Surveillance, PostmarketingProspective StudiesRobotic Surgical Procedures