新型直肠镜在直肠癌手术中的安全性和可行性。首次临床试验。

Mario Álvarez Gallego, Sara Gortázar de Las Casas, Esteban Díaz Serrano, Isabel Pascual Migueláñez
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引用次数: 0

摘要

我们首次在人体临床试验中展示了一种新型直肠镜,该直肠镜可通过透射光显示肿瘤手术中横切直肠的最佳点。该设备是与工程师团队共同开发的,并通过 3D 打印技术制造而成。参与试验的 18 名患者平均年龄为 71 岁,通过结肠镜检查测量的肿瘤到肛门边缘的平均距离为 10.4 ± 3.9 厘米,通过核磁共振成像测量的肿瘤到肛门边缘的平均距离为 10 ± 2.4 厘米。所有病例均可进行透视,直肠镜的使用也很安全,没有因使用直肠镜而导致不良反应的记录。
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Safety and feasibility of a new rectoscope in rectal cancer surgery. First clinical trial.

We present a first in human clinical trial of a new rectoscope that shows, by means of transillumination, the optimal point of transection of the rectum in oncologic surgery. The device was developed together with a team of engineers and was manufactured by 3D printing. Eighteen patients with a mean age of 71 years and a mean distance from the tumor to the anal margin measured by colonoscopy of 10.4 ± 3.9 cm and by MRI of 10 ± 2.4 cm were included in the trial. Transillumination was feasible in all cases, and the use of the rectoscope was safe, as no adverse events due to its use were recorded.

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