国产分体式Carina手术机器人甲状腺切除术的可行性和安全性

doi:10.3877/cma.j.issn.1674-6899.2025.05.007

目的

评价国产分体式Carina™手术机器人应用在甲状腺手术的可行性和安全性。

方法

这是一项前瞻性、单臂临床研究。前期在猪和尸体验证可行性后，青岛大学附属烟台毓璜顶医院招募了8例诊断为甲状腺乳头状癌的患者，使用Carina™手术机器人进行甲状腺手术。根据手术结果评估可行性和安全性。

结果

2025年5月至7月共8例患者接受了Carina™系统机器人辅助腔镜甲状腺癌根治术，其中7例为无充气经腋窝入路，1例为双侧腋窝双侧乳晕入路。无患者中转为常规腔镜手术或开放手术，平均系统准备时间11.75±5.26 min，平均遥操作时间111.88±25.45 min，平均总手术时间194.38±27.83 min。主刀医师平均生理负荷评分1.75±2.92分，平均心理负荷评分21.13±10.45分，均随着手术例数增加呈现明显下降趋势。平均取得淋巴结6.38±2.77枚，平均转移淋巴结数量0.88±1.73枚。术后随访至少2个月，无严重并发症出现。

结论

本研究初步证明了分体式手术机器人系统在甲状腺手术的应用是可行且安全有效的。

关键词: Carina?手术机器人系统, 机器人辅助, 无充气经腋窝入路, 双侧腋窝双侧乳晕入路(BABA入路), 甲状腺

Objective

This study evaluates the feasibility and safety of modular Carina surgical robot system for thyroidectomy.

Methods

In this prospective single-arm trial, 8 patients with papillary thyroid carcinoma were enrolled at Yantai Yuhuangding Hospital following pig and cadaver feasibility studies. Carina™ was used to perform robotic thyroidectomy, with outcomes assessing system feasibility and safety.

Results

Between May 2025 and Jul. 2025, all 8 subjects successfully underwent robot-assisted endoscopic thyroid cancer surgery using Carina™: 7 via gasless axillary approach and 1 via bilateral axillo-breast approach (BABA), with no conversions to laparoscopy or open surgery. The average system preparation time was 11.75±5.26 minutes, the average remote operation time was 111.88±25.45 minutes, and the average total operation time was 194.38±27.83 minutes. The system preparation time, remote operation time, and total operation time all showed a stable downward trend. The average physiological load score of the lead surgeon was 1.75±2.92 points, and the average psychological load score was 21.13±10.45 points. Both the physiological load and psychological load scores showed a significant downward trend as the number of surgeries increased. An average of 6.38 ± 2.77 lymph nodes were obtained, and an average of 0.88±1.73 metastatic lymph nodes were present. Postoperative follow-up was conducted for at least 2 month, and no serious complications was observed.

Conclusion

This study demonstrates for the first time that modular robotic thyroidectomy using Carina™ is feasible, safe, and effective.

Key words: Carina? surgical robot system, Robot-assisted, Non-inflated transaxillary approach, Bilateral axillo-breast approach (BABA), Thyroid

图1 无充气腋窝入路切口位置标记

图2 无充气腋窝入路患者推车的具体位置和设置参数

图3 双侧腋窝双侧乳晕(BABA)入路患者推车的具体位置和设置参数

表1 患者基本特征

指标	均数±标准差或例数	范围或%
性别
女	8	100%
男	0	0%
年龄(岁)	45.00±11.00	(30~58)
BMI(kg/m²)	25.08±3.19	(21.48~29.72)
合并桥本病
是	4	50%
否	4	50%
肿瘤位置
左侧	5	62.50%
右侧	2	25%
峡部	1	12.50%
手术入路
无充气腋窝入路	7	87.50%
BABA入路	1	12.50%

表1 患者基本特征

指标	均数±标准差或例数	范围或%
性别
女	8	100%
男	0	0%
年龄(岁)	45.00±11.00	(30~58)
BMI(kg/m²)	25.08±3.19	(21.48~29.72)
合并桥本病
是	4	50%
否	4	50%
肿瘤位置
左侧	5	62.50%
右侧	2	25%
峡部	1	12.50%
手术入路
无充气腋窝入路	7	87.50%
BABA入路	1	12.50%

表2 术中和围手术期结果

指标	均数±标准差或例数	范围或%
系统准备时间(min)	11.75±5.26	(7~21)
系统操作时间(min)	111.88±25.45	(82~151)
手术时间(min)	194.38±27.83	(150~230)
主刀医师术中生理负荷(分)	1.75±2.92	(0~8)
主刀医师术中心智负荷(分)	21.13±10.45	(6~36)
术中失血量(ml)	8.75±2.31	(5~10)
术后引流量(ml)	125.63±61.52	(65~259)
术后住院天数(d)	3.00±0.53	(2~4)
术后疼痛评分(分)
1 d	1.25±1.04	(0~2)
4 d	1.75±1.67	(0~4)
30 d	0.75±1.49	(0~4)
肿瘤大小(cm)	0.85±0.32	(0.5~1.3)
侵犯被膜
是	5	62.50%
否	3	37.50%
病理类型
经典型	5	62.50%
滤泡亚型	2	25%
经典型＋滤泡亚型	1	12.50%
转移淋巴结数(枚)	0.88±1.73	(0~5)
取得淋巴结数(枚)	6.38±2.77	(2~11)
2015 ATA复发危险分层
低危	7	87.50%
中危	1	12.50%

表2 术中和围手术期结果

指标	均数±标准差或例数	范围或%
系统准备时间(min)	11.75±5.26	(7~21)
系统操作时间(min)	111.88±25.45	(82~151)
手术时间(min)	194.38±27.83	(150~230)
主刀医师术中生理负荷(分)	1.75±2.92	(0~8)
主刀医师术中心智负荷(分)	21.13±10.45	(6~36)
术中失血量(ml)	8.75±2.31	(5~10)
术后引流量(ml)	125.63±61.52	(65~259)
术后住院天数(d)	3.00±0.53	(2~4)
术后疼痛评分(分)
1 d	1.25±1.04	(0~2)
4 d	1.75±1.67	(0~4)
30 d	0.75±1.49	(0~4)
肿瘤大小(cm)	0.85±0.32	(0.5~1.3)
侵犯被膜
是	5	62.50%
否	3	37.50%
病理类型
经典型	5	62.50%
滤泡亚型	2	25%
经典型＋滤泡亚型	1	12.50%
转移淋巴结数(枚)	0.88±1.73	(0~5)
取得淋巴结数(枚)	6.38±2.77	(2~11)
2015 ATA复发危险分层
低危	7	87.50%
中危	1	12.50%

图4 术后1个月主切口情况注：A.腋前线切口术后1个月愈合情况；B.腋窝褶皱切口术后1个月愈合情况

图5 术中情况的相关数据注：A.系统准备时间；B.系统操作时间；C.手术时间(切皮-缝合时间)；D.手术中主刀医师局部不适体验量表评分；E.主刀医师术中主管心智负荷量表评分

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The feasibility and safety of the modular Carina surgical robot system in thyroidectomy

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The feasibility and safety of the modular Carina surgical robot system in thyroidectomy