Department of Otorhinolaryngology-Head and Neck Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Laryngoscope. 2012 Aug;122(8):1701-7. doi: 10.1002/lary.23294. Epub 2012 Jul 2.
OBJECTIVES/HYPOTHESIS: Our objective was to determine the safety, feasibility, and the adequacy of surgical margins for transoral robotic surgery (TORS), by reviewing the early results from independent institutional review board-approved clinical trials in three separate institutions.
Pooled Data from Independent Prospective Clinical Trials.
One hundred ninety-two patients were initially screened, but inadequate exposure did not permit TORS in 13 (6.7%). For two additional patients, TORS was begun but intraoperatively converted to an open procedure. Thus, the intent-to-treat population was 177 patients (average age, 59 years; 81% male), predominantly comprised of tumors arising in the oropharynx (139, 78%) and larynx (26, 15%). TORS was performed for 161 (91%) patients with malignant disease: 153 (95%) with squamous cell carcinoma (T1 [50, 32.7%], T2 [74, 48.4%], T3 [21, 13.7%], T4 [8, 5.2%]), six patients (3.72%) with salivary gland tumors, and two patients with carcinoma in situ. The average follow-up was 345 days.
There was no intraoperative mortality or death in the immediate postoperative period. Average estimated blood loss was 83 mL; no patient required transfusion. The rate of positive margins was 4.3%. Twenty-nine patients (16%) experienced 34 serious adverse events that required hospitalization or intervention (grade 3) or were considered life threatening (grade 4, 2.3%). Tracheostomy was performed in 12.4% of all patients (22/177), but only 2.3% had a tracheostomy at last follow-up. For all patients undergoing TORS without previous therapy, the percutaneous endoscopic gastrostomy dependency rate was 5.0%. The average hospital stay was 4.2 days.
Based on this multicenter study, TORS appears to be safe, feasible, and as such play an important role in the multidisciplinary management of head and neck cancer.
目的/假设：我们的目的是通过审查三个独立机构的独立机构审查委员会批准的临床研究的早期结果，确定经口机器人手术（TORS）的安全性、可行性和手术切缘的充分性。
独立前瞻性临床试验的汇总数据。
最初筛选了 192 名患者，但由于暴露不足，13 名（6.7%）患者无法进行 TORS。对于另外两名患者，开始进行 TORS 但术中转为开放手术。因此，意向治疗人群为 177 名患者（平均年龄 59 岁；81%为男性），主要由口咽（139 例，78%）和喉（26 例，15%）的肿瘤组成。161 名（91%）患有恶性疾病的患者进行了 TORS：153 名（95%）为鳞状细胞癌（T1[50，32.7%]、T2[74，48.4%]、T3[21，13.7%]、T4[8，5.2%]），6 名（3.72%）为涎腺癌，2 名患者为原位癌。平均随访时间为 345 天。
无术中死亡或术后即刻死亡。平均估计出血量为 83 毫升；无患者需要输血。阳性切缘率为 4.3%。29 名患者（16%）经历了 34 次严重不良事件，需要住院或干预（3 级）或被认为有生命危险（4 级，2.3%）。所有患者中有 12.4%（22/177）进行了气管切开术，但最后一次随访时只有 2.3%的患者进行了气管切开术。对于所有未经先前治疗而行 TORS 的患者，经皮内镜胃造瘘术的依赖率为 5.0%。平均住院时间为 4.2 天。
基于这项多中心研究，TORS 似乎是安全、可行的，因此在头颈部癌症的多学科管理中发挥着重要作用。
