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

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

Abstract

Abstract:

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

Haiqing Sun, Guibin Zheng, Xincheng Liu, Shuhui Shen, Xiaojie Wang, Haitao Zheng, Xicheng Song. The feasibility and safety of the modular Carina surgical robot system in thyroidectomy[J]. Chinese Journal of Laparoscopic Surgery(Electronic Edition), 2025, 18(05): 293-300.

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References 42

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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%

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%

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%

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%

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