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机器人辅助与腹腔镜手术治疗中低位直肠癌的疗效比较:一项前瞻性随机对照试验

[Efficacy comparison between robot-assisted and laparoscopic surgery for mid-low rectal cancer: a prospective randomized controlled trial].

作者信息

Tang B, Gao G M, Zou Z, Liu D N, Tang C, Jiang Q G, Lei X, Li T Y

机构信息

Department of General Surgery, the First Affiliated Hospital, Nanchang University, Nanchang 330006, China.

出版信息

Zhonghua Wei Chang Wai Ke Za Zhi. 2020 Apr 25;23(4):377-383. doi: 10.3760/cma.j.cn.441530-20190401-00135.

DOI:10.3760/cma.j.cn.441530-20190401-00135
PMID:32306606
Abstract

To compare the short- and long-term outcomes of robot-assisted and laparoscopic radical resection for mid-low rectal cancer. A prospective randomized controlled trial was conducted. A total of 130 patients with mid-low rectal cancer (inclusion criteria: age > 18 or ≤80 years old; pathological diagnosis of rectal adenocarcinoma by colonoscopy; distance from tumor to the anal verge ≤12 cm; no distant metastasis; cT1-3N0-1 or ycT1-3 after neoadjuvant radiotherapy and chemotherapy; suitable for laparoscopic and robotic surgery) at the Department of Colorectal Surgery of the First Affiliated Hospital of Nanchang University from October 2016 to September 2018 were prospectively enrolled. According to computer-generated random number method, patients were randomly divided into the robot group (=66) and laparoscopy group (=64), and underwent robot-assisted surgery or laparoscopic surgery respectively. Clinicopathological data of all the patients were collected and analyzed. The demographic parameters, short- and long-term outcomes were compared between two groups. One patient in robot group whose postoperative sample was diagnosed as rectal adenoma by pathology was excluded. There were no statistically significant differences in age, sex, BMI, ASA classification, distance from tumor to the anal verge, serum CEA level, CA199 level between two groups (all >0.05). Operations were successfully performed in all the patients without conversion to open operation. Robotic surgery was found to be associated with less intraoperative blood loss than laparoscopic surgery [(73.4±49.7) ml vs. (119.1±65.7) ml, =-4.461, <0.001], while there were no statistically significant differences in surgical procedures, operation time, time to first flatus, time to first liquid intake, time to removal of catheter or postoperative hospital stay between two groups (all >0.05). Besides, there was no significant difference in the morbidity of postoperative complication between two groups [10.8% (7/65) vs. 12.5 (8/64), χ(2)=4.342, =0.720]. The median number of harvested lymph node in the robot group and the laparoscopy group was 15.7±6.2 and 13.8±6.1 (=1.724, =0.087). There were no significant differences between two groups in tumor sample length, distance between proximal and distal resection margin, integrity grade of TME specimen, number of positive lymph nodes, postoperative pathological stage and tumor differentiation (all >0.05). The distal resection margin of samples in two groups was all negative. One case in the robot group was found to have positive circumferential resection margin. The median follow up was 24 (9 to 31) months. In the robot group and the laparoscopy group, the 2-year overall survival rate was 95.4% and 90.6% respectively; the 2-year disease-free survival rate was 90.8% and 85.9% respectively, whose differences were not significant (both >0.05). Robot-assisted radical resection for mid-low rectal cancer can achieve similar short-term and long-term outcomes of laparoscopic resection, while robot-assisted surgery can decrease blood loss during operation, leading to more precise practice in minimally invasive surgery.

摘要

比较机器人辅助与腹腔镜根治性切除术治疗中低位直肠癌的短期和长期疗效。进行了一项前瞻性随机对照试验。2016年10月至2018年9月,南昌大学第一附属医院结直肠外科共有130例中低位直肠癌患者(纳入标准:年龄>18岁或≤80岁;经结肠镜病理诊断为直肠腺癌;肿瘤距肛缘≤12 cm;无远处转移;新辅助放化疗后cT1-3N0-1或ycT1-3;适合腹腔镜和机器人手术)被前瞻性纳入研究。根据计算机生成的随机数法,将患者随机分为机器人组(n = 66)和腹腔镜组(n = 64),分别接受机器人辅助手术或腹腔镜手术。收集并分析所有患者的临床病理数据。比较两组患者的人口统计学参数、短期和长期疗效。机器人组中有1例患者术后病理样本诊断为直肠腺瘤,予以排除。两组患者在年龄、性别、BMI、ASA分级、肿瘤距肛缘距离、血清CEA水平、CA199水平方面差异均无统计学意义(均P>0.05)。所有患者手术均成功完成,无一例中转开腹。结果发现,机器人手术术中出血量少于腹腔镜手术[(73.4±49.7)ml比(119.1±65.7)ml,t = -4.461,P<0.001],而两组在手术步骤、手术时间、首次排气时间、首次进食流质时间、拔除导尿管时间或术后住院时间方面差异均无统计学意义(均P>0.05)。此外,两组术后并发症发生率差异无统计学意义[10.8%(7/65)比12.5%(8/64),χ² = 4.342,P = 0.720]。机器人组和腹腔镜组的中位淋巴结清扫数分别为15.7±6.2和13.8±6.1(t = 1.724,P = 0.087)。两组在肿瘤标本长度、近端和远端切缘距离、TME标本完整程度、阳性淋巴结数、术后病理分期及肿瘤分化程度方面差异均无统计学意义(均P>0.05)。两组标本的远端切缘均为阴性。机器人组有1例患者环周切缘阳性。中位随访时间为24(9至31)个月。机器人组和腹腔镜组的2年总生存率分别为95.4%和90.6%;2年无病生存率分别为90.8%和85.9%,差异均无统计学意义(均P>0.05)。机器人辅助根治性切除术治疗中低位直肠癌可获得与腹腔镜切除术相似的短期和长期疗效,同时机器人辅助手术可减少术中出血,使微创手术操作更精准。

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