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前瞻性 II 期临床试验/IDEAL 阶段 2a 系列单端口机器人结直肠手术用于腹部和经肛门病例。

A prospective phase II clinical trial/IDEAL Stage 2a series of single-port robotic colorectal surgery for abdominal and transanal cases.

机构信息

Lankenau Institute for Medical Research and Division of Colon and Rectal Surgery, Department of Surgery, Lankenau Medical Center, Wynnewood, Pennsylvania, USA.

Division of Colon and Rectal Surgery, Department of Surgery, Lankenau Medical Center, Wynnewood, Pennsylvania, USA.

出版信息

Colorectal Dis. 2023 Dec;25(12):2335-2345. doi: 10.1111/codi.16788. Epub 2023 Oct 31.

DOI:10.1111/codi.16788
PMID:37907449
Abstract

AIM

Slow laparoscopy adoption accelerated the uptake of robotic surgery. However, the current robotic platforms have limitations in transanal applications and multiple port sites. The da Vinci single-port (SP) robot is currently used on trial for colorectal surgery, and broad assessment of outcomes is needed. We aimed to report findings of a phase II clinical trial of SP robotic colorectal surgery.

METHODS

A sequentially reported prospective case series was performed on patients using SP robotics at a tertiary referral centre from 1 October 2018 to 31 August 2021. Cases were stratified into abdominal and transanal cohorts. Demographics, intra-operative variables and 30-day postoperative outcomes were evaluated. Univariate analysis was performed, with statistical process control for the docking process. Main outcomes were conversion rates, morbidity, mortality and point of standardization of docking.

RESULTS

In all, 133 patients were included: 93 (69.92%) abdominal and 40 (30.08%) transanal. The main diagnosis was rectal cancer (n = 59) and the procedure performed a robotic transanal abdominal transanal radical proctosigmoidectomy (n = 30). There were no conversions to open surgery. Two abdominal (2.15%) and three transanal cases (7.50%) were converted to laparoscopy. All colorectal adenocarcinomas had negative margins, proper lymph node harvest and complete mesorectal excision, as appropriate. Docking became a standardized process at cases 34 (abdominal) and 23 (anorectal). After surgery, bowel function returned on mean day 2 (abdominal) and 1 (transanal). The morbidity rate was 15.05% (abdominal) and 27.50% (transanal). There were two major morbidities in each cohort. Overall, there were three (2.65%) readmissions, one reoperation and no mortality.

CONCLUSIONS

Single-port robotics is feasible for all types of colorectal procedures, with good clinical and oncological outcomes. With this development in colorectal surgery, further studies can develop best practices with this novel technology.

摘要

目的

腹腔镜应用的缓慢发展加速了机器人手术的普及。然而,当前的机器人平台在经肛门应用和多个端口方面存在局限性。达芬奇单端口(SP)机器人目前正在进行结直肠手术的试验,需要广泛评估其结果。我们旨在报告一项 SP 机器人结直肠手术的 II 期临床试验结果。

方法

我们对 2018 年 10 月 1 日至 2021 年 8 月 31 日在一家三级转诊中心使用 SP 机器人进行手术的患者进行了连续报告的前瞻性病例系列研究。病例分为腹部和经肛门队列。评估了人口统计学、术中变量和 30 天术后结果。进行了单变量分析,并对对接过程进行了统计过程控制。主要结局为转化率、发病率、死亡率和对接标准化的切入点。

结果

共纳入 133 例患者:93 例(69.92%)为腹部,40 例(30.08%)为经肛门。主要诊断为直肠癌(n=59),手术方式为机器人经肛门腹部经肛门直肠根治性前切除术(n=30)。无中转开腹手术。2 例腹部(2.15%)和 3 例经肛门(7.50%)手术中转腹腔镜。所有结直肠腺癌均有阴性切缘、适当的淋巴结清扫和完整的中直肠系膜切除。对接在腹部第 34 例(n=34)和经肛门第 23 例(n=23)时成为标准化过程。术后平均第 2 天(腹部)和第 1 天(经肛门)恢复肠道功能。发病率为 15.05%(腹部)和 27.50%(经肛门)。每个队列均有 2 例严重并发症。总的来说,有 3 例(2.65%)再入院,1 例再手术,无死亡。

结论

单端口机器人适用于所有类型的结直肠手术,具有良好的临床和肿瘤学结果。随着结直肠手术的这一发展,可以利用这项新技术制定最佳实践。

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