机器人辅助甲状腺手术的临床研究

Efficacy and safety of robot-assisted thyroid surgery

目的探讨机器人辅助甲状腺手术的安全性和临床应用价值。方法收集2021年7月—2022年2月浙江大学医学院附属杭州市第一人民医院运用第四代达芬奇机器人手术系统经双侧乳晕和腋窝途径(BABA)入路甲状腺手术的55例患者,分析手术时间、出血量、淋巴结数量、并发症、术后平均住院时间及美容满意度;提取其中41例单侧甲状腺手术信息,构建手术时间变化趋势图和累积和分析法(CUSUM)学习曲线。选取甲状腺乳头状癌(PTC)患者,按照性别、年龄、病灶大小、手术范围与开放手术病例进行倾向匹配,比较机器人辅助BABA入路甲状腺手术组和开放手术组在淋巴结清扫数量和转移淋巴结数量上的差异。结果55例均顺利完成机器人辅助BABA入路甲状腺手术,其中双侧甲状腺大部切除术1例,单侧甲状腺腺叶切除47例,甲状腺全部切除7例;单侧中央区淋巴结清扫41例,双侧中央区淋巴结清扫7例,侧颈区淋巴结清扫7例。无中转开放手术,手术时间140~570(263.55±86.15)min,术中出血量2~50(10.13±7.44)ml,术后住院时间2~11(5.27±1.68)d。术后病理检查提示PTC 46例,结节性甲状腺肿9例。术后中位随访时间4(1~8)个月;术后发生暂时性喉返神经损伤3例,暂时性甲状旁腺功能减退1例,未发生出血、永久性喉返神经损伤及甲状旁腺功能减退;无甲状腺术区及皮下隧道复发或转移;所有患者对手术美容效果非常满意。41例单侧甲状腺手术CUSUM曲线拟合截点为第16例,前阶段16例为学习提高期,后阶段25例为熟练掌握期。两个阶段中,患者性别、年龄、BMI、结节大小和清扫淋巴结数量不存在差异;病灶良恶性、手术时间和转移淋巴结数量存在统计学差异(P<0.05)。PTC患者行机器人辅助BABA入路甲状腺手术或开放手术在清扫淋巴结数量和转移淋巴结数量上无差异。结论第四代达芬奇机器人辅助BABA入路甲状腺手术安全微创,清扫淋巴结彻底性与开放手术无差别,并且能够获得非常满意的美容效果。

Objective To evaluate the efficacy and safety of robot-assisted thyroid surgery.Methods Fifty five patients underwent thyroid surgery via bilateral axillo-breast approach(BABA)with the fourth-generation Da Vinci robotic surgical system in Affiliated Hangzhou First People’s Hospital from July 2021 to February 2022.The operative time,intraoperative blood loss,number of lymph nodes dissected,post-operative complications,length of hospital stay and cosmetic results were analyzed.Trend of operative times and CUSUM analysis was used to evaluate the learning curve in 41patients who underwent unilateral thyroidectomy.Forty six patients with papillary thyroid carcinoma,who were gender,age,and lesion size-matched,underwent open thyroid surgery,the number of dissected lymph nodes and metastatic lymph nodes were compared between robot surgery group and open surgery group.Results All 55 consecutive patients underwent robotic BABA thyroid surgery without conversions,including 1 case of bilateral subtotal thyroidectomy,47 unilateral lobectomy,and 7 total thyroidectomy;41 patients underwent unilateral central lymph node dissection,7 underwent bilateral central lymph node dissection,and 7 underwent lateral cervical lymph node dissection.The mean operative time was 140-570(263.55±86.15)min,mean amount of intraoperative bleeding was 2-50(10.13±7.44)ml,and mean postoperative length of hospital stay was 2-11(5.27±1.68)d.Post-operative pathology revealed papillary thyroid carcinoma in 46 patients and nodular goiter in 9 patients.No postoperative complications occurred,such as bleeding,permanent recurrent laryngeal nerve injury,permanent hypoparathyroidism.Three patients suffered transient recurrent laryngeal nerve injury and 1 patients had transient hypoparathyroidism.No clinically relapsed or subcutaneous metastasis were observed.The median follow-up time was 4(1-8)months.All patients were satisfied with the cosmetic results of the procedure.The CUSUM fitting curve reached the top at the 16th case.As a cut-off point,the learning curve was divided into two stages:the learning improvement period and the proficiency period.No significant differences of sex,age,body mass index(BMI),nodule size and number of lymph nodes dissected were observed between the 2 periods,whereas it showed statistically differences of the benign and malignant nature of the nodules,operation time and number of lymph node metastasis(P<0.05).There were no significant differences observed in the number of lymph nodes dissected or metastatic lymph nodes between robotic BABA thyroid surgery and open surgery.Conclusion Thyroid surgery via BABA with the fourth-generation Da Vinci robotic surgical system is safe and minimally invasive.It can achieve feasible lymph node dissection as open surgery,while has better cosmetic results.