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早期采用经口机器人手术计划:初步结果。

Early adoption of transoral robotic surgical program: preliminary outcomes.

机构信息

Department of Otolaryngology Head and Neck Surgery, Thomas Jefferson University, 925 Chestnut St, Philadelphia, PA 19107, USA.

出版信息

Otolaryngol Head Neck Surg. 2012 Sep;147(3):482-8. doi: 10.1177/0194599812443353. Epub 2012 Apr 10.

Abstract

OBJECTIVE

The objective of this study is to demonstrate the feasibility and safety of establishing a transoral robotic surgical (TORS) program in the post-Food and Drug Administration (FDA) approval setting. Early outcomes are compared with the previously reported results of pioneering centers.

STUDY DESIGN

Clinical data from a prospective TORS study.

SETTING

Academic university institution.

SUBJECTS AND METHODS

Sixty-one patients treated with 63 TORS procedures.

MAIN OUTCOME MEASURES

intraoperative times, margin status, complications, time to diet, and percutaneous endoscopic gastrostomy (PEG) tube retention rate. The authors also report oncologic outcomes on their first 30 patients.

RESULTS

The spectrum of subsites included tongue base, tonsil, parapharyngeal space, retromolar trigone, supraglottis, and posterior pharyngeal wall. Surgical console time averaged 79 ± 53 minutes. After re-resection of 4 patients, final negative margin status was 94% (50/53). A subset of 30 patients with squamous cell carcinoma reaching an average of 18 months of follow-up had a local regional control rate of 97% with a disease-free survival rate of 90%. The PEG tube retention rate was 7%. Complications included 2 readmissions with dehydration, 1 aspiration pneumonia, and 2 with minor oropharyngeal bleeding. Ninety-one percent of patients resumed an oral diet by the first postoperative visit.

CONCLUSION

The initiation of a TORS program in the post-FDA setting can be achieved in a safe and efficient manner. Early results of pioneering TORS centers are reproducible. Continued investigation of TORS as a treatment option for oropharyngeal carcinoma is warranted.

摘要

目的

本研究旨在展示在食品和药物管理局 (FDA) 批准后建立经口机器人手术 (TORS) 项目的可行性和安全性。将早期结果与先前报道的开创性中心的结果进行比较。

研究设计

前瞻性 TORS 研究的临床数据。

设置

学术大学机构。

受试者和方法

61 例患者接受 63 例 TORS 手术。

主要观察指标

术中时间、切缘状态、并发症、开始进食时间和经皮内镜胃造瘘术 (PEG) 管保留率。作者还报告了他们前 30 例患者的肿瘤学结果。

结果

亚部位包括舌底、扁桃体、咽旁间隙、磨牙后三角、会厌上区和咽后壁。手术控制台时间平均为 79 ± 53 分钟。在重新切除 4 例患者后,最终阴性切缘状态为 94%(50/53)。30 例具有鳞状细胞癌的患者的亚组平均随访 18 个月,局部区域控制率为 97%,无疾病生存率为 90%。PEG 管保留率为 7%。并发症包括 2 例因脱水再次入院,1 例吸入性肺炎,2 例轻度咽出血。91%的患者在术后首次就诊时恢复口服饮食。

结论

可以以安全有效的方式在 FDA 批准后建立 TORS 项目。开创性 TORS 中心的早期结果是可重复的。有必要继续研究 TORS 作为治疗口咽癌的选择。

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