机器人手术与腹腔镜手术治疗低位直肠癌的腹会阴联合切除术：一项单中心随机对照试验。

Robotic versus laparoscopic abdominoperineal resections for low rectal cancer: A single-center randomized controlled trial.

作者信息

Feng Qingyang, Tang Wentao, Zhang Zhiyuan, Wei Ye, Ren Li, Chang Wenju, Zhu Dexiang, Liang Fei, He Guodong, Xu Jianmin

机构信息

Department of General Surgery, Zhongshan Hospital Fudan University, 180# Fenglin Road, Shanghai, China.

Shanghai Engineering Research Center of Colorectal Cancer Minimally Invasive Technology, Shanghai, China.

出版信息

J Surg Oncol. 2022 Dec;126(8):1481-1493. doi: 10.1002/jso.27076. Epub 2022 Aug 29.

DOI:10.1002/jso.27076

PMID:36036889

Abstract

BACKGROUND AND OBJECTIVES

Robotic surgery for rectal cancer is gaining popularity, but persuasive evidence on reducing surgical trauma is still lacking. This study compared robotic and laparoscopic abdominoperineal resections (APRs) for the risk of postoperative complications in low rectal cancer.

METHODS

Between December 2013 and 2016, patients with rectal cancer ≤5 cm from anal verge, cT1-T3 N0-1, or ycT1-T3 Nx stage, and no distant metastases were enrolled in a single-center, randomized, controlled trial. Eligible patients were randomly allocated to robotic or laparoscopic APRs at 1:1 ratio. The primary outcome was 30-day postoperative complication rate (Clavien-Dindo grade II or higher) of the intent-to-treat population. The trial registration number is NCT01985698 (http://www.

CLINICALTRIALS

gov).

RESULTS

Totally 347 eligible patients were enrolled: 174 in robotic and 173 in laparoscopic group. Robotic APRs significantly reduced postoperative complication rate (13.2% vs. 23.7%, p = 0.013), also reduced open conversion rate (0% vs. 2.9%, p = 0.030), intraoperative hemorrhage (median, 100 vs. 130 ml; p < 0.001), 30-day readmission rate (2.3% vs. 6.9%; p = 0.044), postoperative hospital stay (median, 5.0 vs. 7.0 days; p < 0.001), and improved urinary and sexual function. No significant difference was observed in long-term oncological outcomes.

CONCLUSIONS

Compared with laparoscopic APRs, robotic APRs significantly reduced surgical trauma and promoted postoperative recovery.

摘要

背景与目的

机器人直肠癌手术正日益普及，但仍缺乏关于减少手术创伤的确凿证据。本研究比较了机器人辅助与腹腔镜下腹会阴联合切除术（APR）治疗低位直肠癌术后并发症的风险。

方法

2013年12月至2016年期间，将距肛缘≤5 cm、cT1-T3 N0-1或ycT1-T3 Nx期且无远处转移的直肠癌患者纳入一项单中心、随机对照试验。符合条件的患者按1:1比例随机分配接受机器人辅助或腹腔镜APR。主要结局是意向性治疗人群的术后30天并发症发生率（Clavien-Dindo分级II级或更高）。试验注册号为NCT01985698（http://www.CLINICALTRIALS.gov）。

结果

共纳入347例符合条件的患者：机器人辅助组174例，腹腔镜组173例。机器人辅助APR显著降低了术后并发症发生率（13.2%对23.7%，p = 0.013），也降低了中转开腹率（0%对2.9%，p = 0.030）、术中出血量（中位数，100对130 ml；p < 0.001）、30天再入院率（2.3%对6.9%；p = 0.044）、术后住院时间（中位数，5.0对7.0天；p < 0.001），并改善了泌尿和性功能。长期肿瘤学结局未观察到显著差异。