Protocolo de evaluación rápida de tecnología sobre seguridad y efectividad del grapado mecánico versus sutura manual para anastomosis en colonostomías realizadas en pacientes con cáncer colorectal
Fecha
2016-05
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Seguro Integral de Salud
Resumen
Las grapas quirúrgicas son dispositivos médicos mecánicos complejos que han estado en el mercado por años y son maduros en su tecnología. Estos dispositivos son usados en cirugía gastrointestinal, ginecológica, torácica y muchas otras cirugías para remover parte de un órgano (resección), para cortar a través de órganos y tejidos (transección) y para crear conexiones entre estructuras (anastomosis). El Instituto Nacional de Enfermedades Neoplásicas solicita la evaluación del procedimiento quirúrgico de grapado mecánico versus sutura manual para anastomosis en colonostomías realizadas en pacientes con cáncer colorectal. A pesar que la tecnología no supera la tolerancia al riesgo establecida actualmente para evaluación de tecnologías sanitarias en el Seguro Integral de Salud, se inició la evaluación por el SIS Central a pedido del Jefe del Instituto Nacional de Enfermedades Neoplásicas y con la anuencia del Jefe del Seguro Integral de Salud, bajo el supuesto de la generación de nueva evidencia desde la elaboración del último informe SIS el año 2013.
Surgical staples are complex mechanical medical devices that have been on the market for years and are mature in their technology. These devices are used in gastrointestinal, gynecological, thoracic, and many other surgeries to remove part of an organ (resection), to cut through organs and tissues (transection), and to create connections between structures (anastomosis). The National Institute of Neoplastic Diseases requests evaluation of the surgical procedure of mechanical stapling versus manual suturing for anastomoses in colonostomies performed in patients with colorectal cancer. Although the technology does not exceed the risk tolerance currently established for evaluation of health technologies in the Comprehensive Health Insurance, the evaluation was initiated by the Central SIS at the request of the Head of the National Institute of Neoplastic Diseases and with the consent of the Head of the Comprehensive Health Insurance, under the assumption of the generation of new evidence since the preparation of the last SIS report in 2013.
Surgical staples are complex mechanical medical devices that have been on the market for years and are mature in their technology. These devices are used in gastrointestinal, gynecological, thoracic, and many other surgeries to remove part of an organ (resection), to cut through organs and tissues (transection), and to create connections between structures (anastomosis). The National Institute of Neoplastic Diseases requests evaluation of the surgical procedure of mechanical stapling versus manual suturing for anastomoses in colonostomies performed in patients with colorectal cancer. Although the technology does not exceed the risk tolerance currently established for evaluation of health technologies in the Comprehensive Health Insurance, the evaluation was initiated by the Central SIS at the request of the Head of the National Institute of Neoplastic Diseases and with the consent of the Head of the Comprehensive Health Insurance, under the assumption of the generation of new evidence since the preparation of the last SIS report in 2013.
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Seguridad, Efectividad