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森海思数字腹腔镜系统与腹腔镜结肠切除术的短期和中期结果比较:一项倾向评分匹配研究

Comparison of short- and mid-term outcomes between the Senhance digital laparoscopic system and laparoscopic colectomy: a propensity score matching study.

作者信息

Fujii Takatsugu, Hirano Yasumitsu, Ishiyama Yasuhiro, Yamato Misuzu, Akuta Sohei, Yoshizawa Masatoshi, Okazaki Naoto, Hiranuma Chikashi

机构信息

Department of Gastrointestinal Surgery, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka-City, Saitama, Japan.

出版信息

Surg Endosc. 2025 Feb;39(2):1153-1159. doi: 10.1007/s00464-024-11482-7. Epub 2024 Dec 23.

Abstract

BACKGROUND

The Senhance digital laparoscopic system (Senhance) is a surgical robot approved for use in Japan after the da Vinci system. Our institution was the first to introduce this system, which has been used primarily for gastrointestinal surgery. Featuring tactile feedback, eye-movement-controlled camera operation, stereoscopic vision, and magnification, the short-term postoperative outcomes of the Senhance in abdominal surgery have been documented. This study aimed to evaluate the safety and feasibility of Senhance by examining mid-term postoperative outcomes.

METHODS

Between January 2018 and December 2020, 743 patients underwent colorectal cancer colectomy at our institution. We compared 50 cases of Senhance-assisted colectomy with 430 laparoscopic colectomy cases using 1:1 propensity score matching, adjusting for covariates such as sex, age, tumor location, BMI, ASA-PS, cT, and cN. Short- and mid-term surgical outcomes were compared between the Senhance (S) and laparoscopic (L) groups.

RESULTS

After matching, 47 patients were included in each group. There were no significant differences in the patient backgrounds. The operative time was significantly longer in the S group compared to the L group (median: 240 [101-378] minutes vs. 191 [100-370] minutes, p < 0.01). No significant differences were observed in postoperative complications of Clavien-Dindo grade 2 or higher within 30 days post-surgery, and no robot-related adverse events were reported. The 3-year disease-free survival rates were 88.7% in the S group and 77.1% in the L group (p = 0.178; HR, 1.423; 95% CI 0.916-2.211). The overall survival rate was 97.7% in both groups (p = 0.897; HR, 1.202; 95% CI 0.075-19.26).

CONCLUSION

Senhance-assisted colectomy is safe with mid-term outcomes comparable to laparoscopic surgery. However, the extended operation time remains challenging, necessitating further studies, including randomized controlled trials and multicenter studies, to validate these findings.

摘要

背景

森海思数字腹腔镜系统(Senhance)是继达芬奇系统之后在日本获批使用的手术机器人。我们机构是首个引进该系统的机构,其主要用于胃肠外科手术。森海思具有触觉反馈、眼动控制的摄像头操作、立体视觉和放大功能,腹部手术中其术后短期结果已有记录。本研究旨在通过检查术后中期结果来评估森海思的安全性和可行性。

方法

2018年1月至2020年12月期间,我们机构有743例患者接受了结直肠癌结肠切除术。我们使用1:1倾向评分匹配法,对50例森海思辅助结肠切除术病例与430例腹腔镜结肠切除术病例进行比较,对性别、年龄、肿瘤位置、BMI、ASA-PS、cT和cN等协变量进行调整。比较了森海思(S)组和腹腔镜(L)组的短期和中期手术结果。

结果

匹配后,每组纳入47例患者。患者背景无显著差异。S组的手术时间明显长于L组(中位数:240[101 - 378]分钟对191[100 - 370]分钟,p < 0.01)。术后30天内Clavien-Dindo 2级或更高等级的术后并发症无显著差异,且未报告与机器人相关的不良事件。S组的3年无病生存率为88.7%,L组为77.1%(p = 0.178;HR,1.423;95%CI 0.916 - 2.211)。两组的总生存率均为97.7%(p = 0.897;HR,1.202;95%CI 0.075 - 19.26)。

结论

森海思辅助结肠切除术是安全的,中期结果与腹腔镜手术相当。然而,延长的手术时间仍然具有挑战性,需要进一步开展研究,包括随机对照试验和多中心研究,以验证这些发现。

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