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首例机器人辅助乳腺癌相关淋巴水肿淋巴静脉吻合术的人体临床试验一年结果。

One-Year Outcomes of the First Human Trial on Robot-Assisted Lymphaticovenous Anastomosis for Breast Cancer-Related Lymphedema.

机构信息

From the Departments of Plastic, Reconstructive, and Hand Surgery and Methodology and Statistics, Maastricht University Medical Center; and Department of Medical Robotic Technologies, Eindhoven University of Technology.

出版信息

Plast Reconstr Surg. 2022 Jan 1;149(1):151-161. doi: 10.1097/PRS.0000000000008670.

DOI:10.1097/PRS.0000000000008670
PMID:34936615
Abstract

BACKGROUND

Lymphaticovenous anastomosis, a supermicrosurgical technique, creates bypasses between the lymphatic and venous systems. The quality of lymphaticovenous anastomosis depends on the surgeon's dexterity and precision, and is subject to imperfections caused by the physiologic tremor of the human hand. A dedicated robot for microsurgery has been created to overcome these limitations (MUSA, MicroSure, Eindhoven, The Netherlands). This study describes 1-year clinical outcomes of the first-in-human trial of robot-assisted and manual lymphaticovenous anastomosis in patients with breast cancer-related lymphedema.

METHODS

In this prospective pilot study, women with breast cancer-related lymphedema were randomized into the robot-assisted or manual lymphaticovenous anastomosis group. Outcomes were quality of life, arm circumference, conservative treatment frequency, arm dermal backflow stage, and anastomosis patency.

RESULTS

Twenty women were included, of whom eight underwent robot-assisted lymphaticovenous anastomosis surgery and 12 underwent manual surgery. In both groups, quality of life significantly improved at 12 months (robot-assisted surgery, p = 0.045; manual surgery, p = 0.001). Arm circumference did not decrease (robot-assisted surgery, p = 0.094; manual surgery, p = 0.240). Daily use of compression garments decreased by 61.9 percent (robot-assisted surgery) and 70.2 percent (manual surgery). The frequency of manual lymphatic drainage remained similar compared with baseline. Arm dermal backflow stage was reduced in one patient in the robot-assisted group and in five cases in the manual group. Overall, 76.5 percent of the anastomoses were patent (robot-assisted surgery, 66.6 percent; manual surgery, 81.8 percent).

CONCLUSIONS

After evaluating 1-year follow-up data, this study confirms the feasibility of robot-assisted lymphaticovenous anastomosis surgery. Clinical outcomes were comparable between robot-assisted and manual lymphaticovenous anastomosis. This encourages further research using the new microsurgical robot MUSA for lymphaticovenous anastomosis and other (super)microsurgical procedures.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

摘要

背景

淋巴管静脉吻合术是一种超显微外科技术,可在淋巴管和静脉系统之间建立旁路。淋巴管静脉吻合术的质量取决于外科医生的灵巧度和精准度,并且受到人手生理性震颤造成的不完美的影响。为了克服这些限制,已经开发出一种用于显微手术的专用机器人(MUSA,MicroSure,荷兰埃因霍温)。本研究描述了首例机器人辅助和手动淋巴管静脉吻合术治疗乳腺癌相关淋巴水肿的人体临床试验的 1 年临床结果。

方法

在这项前瞻性试点研究中,患有乳腺癌相关淋巴水肿的女性被随机分为机器人辅助或手动淋巴管静脉吻合术组。结果是生活质量、臂围、保守治疗频率、手臂皮肤回流阶段和吻合口通畅性。

结果

共纳入 20 名女性,其中 8 名接受机器人辅助淋巴管静脉吻合术,12 名接受手动手术。在两组中,生活质量均在 12 个月时显著改善(机器人辅助手术,p = 0.045;手动手术,p = 0.001)。臂围没有减少(机器人辅助手术,p = 0.094;手动手术,p = 0.240)。每天使用压缩衣的次数减少了 61.9%(机器人辅助手术)和 70.2%(手动手术)。与基线相比,手动淋巴引流的频率保持相似。在机器人辅助组中,1 例患者和手动组中 5 例患者的手臂皮肤回流阶段得到改善。总体而言,76.5%的吻合口通畅(机器人辅助手术,66.6%;手动手术,81.8%)。

结论

在评估 1 年随访数据后,本研究证实了机器人辅助淋巴管静脉吻合术的可行性。机器人辅助和手动淋巴管静脉吻合术的临床结果相当。这鼓励使用新的显微外科机器人 MUSA 进行淋巴管静脉吻合术和其他(超)显微外科手术的进一步研究。

临床问题/证据水平:治疗性,II 级。

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