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一项使用先进机器人辅助技术进行胃肠手术的初步探索性临床研究及结果评估。

An initial exploratory clinical study and outcome assessment of gastrointestinal surgeries using advanced robotic-assisted techniques.

作者信息

Zhang Zeping, Zhan Weipeng, Tian Hongwei, Hu Ming, Ma Yuqi, Jing Wutang, Huang Xianbing, Guo Jin, Deng Yuan, Fang Wei, Chen Dongdong, Miao Changfeng, Yang Jing, Ma Yuntao

机构信息

First Clinical Medical College, Gansu University of Chinese Medicine, Lanzhou, 730000, China.

Gansu Provincial Hospital, Lanzhou, 730000, China.

出版信息

Surg Endosc. 2025 Feb;39(2):766-775. doi: 10.1007/s00464-024-11398-2. Epub 2024 Nov 21.

Abstract

BACKGROUND

In addition to the Da Vinci surgical robot, domestic surgical robots are being developed rapidly. Chinese Toumai® laparoscopic surgical robot was approved for urological surgery in 2022.This study aims to systematically evaluate the safety and efficacy of the Toumai® robotic surgical system in performing complex gastrointestinal surgeries.

METHODS

This prospective, single-center, single-arm exploratory study was conducted at Gansu Provincial Hospital between June 2022 and October 2023, enrolling 12 patients undergoing gastrectomy and 9 patients undergoing colorectal resection. The primary endpoints are oncological outcomes and surgical success rates, while secondary endpoints encompassed intraoperative blood loss, operative duration, complication rates, system performance metrics, length of hospital stay, and postoperative pain levels.

RESULTS

All patients successfully underwent robotic-assisted surgery with adequate oncological resection and favorable postoperative outcomes. There were no conversions to open or laparoscopic surgery, resulting in a 100% procedural success rate. The median docking time for radical gastrectomy was 17.50 (14.25, 21.50) minutes, with a median master-slave control time of 121.50 (105.50, 172.00) minutes, median intraoperative blood loss of 100.00 (50.00, 275.00) mL, and a median postoperative hospital stay of 9.00 (7.25, 10.75) days. For radical colorectal surgery, the median docking time was 22 (17.50, 30.50) minutes, the median master-slave control time was 68 (56.50, 119.00) minutes, with a median blood loss of 50 (50.00, 150.00) mL, and a median postoperative hospital stay of 7 (7.00, 10.00) days. No intraoperative organ injury, mortality, system failure, or severe postoperative complications were reported.

CONCLUSIONS

These preliminary findings provide compelling evidence supporting the safety and efficacy of the Toumai® laparoscopic surgical robotic system in performing gastric and colorectal surgeries.

摘要

背景

除达芬奇手术机器人外,国产手术机器人也在迅速发展。中国的图迈®腹腔镜手术机器人于2022年获批用于泌尿外科手术。本研究旨在系统评估图迈®机器人手术系统在进行复杂胃肠道手术中的安全性和有效性。

方法

本前瞻性、单中心、单臂探索性研究于2022年6月至2023年10月在甘肃省人民医院进行,纳入12例行胃切除术的患者和9例行结直肠癌切除术的患者。主要终点是肿瘤学结局和手术成功率,次要终点包括术中失血量、手术持续时间、并发症发生率、系统性能指标、住院时间和术后疼痛程度。

结果

所有患者均成功接受机器人辅助手术,肿瘤切除充分,术后效果良好。无一例转为开放手术或腹腔镜手术,手术成功率达100%。根治性胃切除术的中位对接时间为17.50(14.25,21.50)分钟,主从控制中位时间为121.50(105.50,172.00)分钟,术中中位失血量为100.00(50.00,275.00)mL,术后中位住院时间为9.00(7.25,10.75)天。对于根治性结直肠癌手术,中位对接时间为22(17.50,30.50)分钟,主从控制中位时间为68(56.50,119.00)分钟,中位失血量为50(50.00,150.00)mL,术后中位住院时间为7(7.00,10.00)天。未报告术中器官损伤、死亡、系统故障或严重术后并发症。

结论

这些初步研究结果提供了有力证据,支持图迈®腹腔镜手术机器人系统在进行胃和结直肠手术中的安全性和有效性。

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