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中华普通外科学文献(电子版) ›› 2024, Vol. 18 ›› Issue (03) : 234 -240. doi: 10.3877/cma.j.issn.1674-0793.2024.03.012

循证医学

机器人辅助全系膜切除术治疗右半结肠癌有效性和安全性的Meta分析及试验序贯分析
郭仁凯1, 武慧铭1, 李辉宇1,()   
  1. 1. 030032 太原,山西医科大学第三医院/山西白求恩医院/山西医学科学院/同济山西医院普外科
  • 收稿日期:2023-11-24 出版日期:2024-06-01
  • 通信作者: 李辉宇
  • 基金资助:
    山西省医学重点科研项目(2021XM22); 山西省基础研究计划项目(202103021224346)

Efficacy and safety of robot-assisted complete mesocolic excision for right-sided colon cancer: A Meta-analysis and trial sequential analysis

Renkai Guo1, Huiming Wu1, Huiyu Li1,()   

  1. 1. Department of General Surgery, the Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Taiyuan 030032, China
  • Received:2023-11-24 Published:2024-06-01
  • Corresponding author: Huiyu Li
引用本文:

郭仁凯, 武慧铭, 李辉宇. 机器人辅助全系膜切除术治疗右半结肠癌有效性和安全性的Meta分析及试验序贯分析[J/OL]. 中华普通外科学文献(电子版), 2024, 18(03): 234-240.

Renkai Guo, Huiming Wu, Huiyu Li. Efficacy and safety of robot-assisted complete mesocolic excision for right-sided colon cancer: A Meta-analysis and trial sequential analysis[J/OL]. Chinese Archives of General Surgery(Electronic Edition), 2024, 18(03): 234-240.

目的

荟萃分析机器人辅助行全系膜切除术对右半结肠癌的治疗效果。

方法

检索中国知网、万方数据库、PubMed、NCBI数据库建库至2023年10月10日报道的机器人辅助全系膜切除术(R-CME)和单纯腹腔镜全系膜切除术(L-CME)治疗右半结肠癌的对照研究。由2名研究人员独立进行相关研究数据提取和相关文献的检索,采用RevMan 5.3软件对临床数据进行分析,针对本次研究得到的阳性结果通过TSA 0.9 Beta进行试验序贯分析。

结果

共纳入8篇文献,均为回顾性分析,共涉及1 106例患者,其中R-CME组532例,L-CME组574例。R-CME组术中清扫淋巴结数量更多(MD=3.21,95% CI:0.62,5.80;P=0.02),术中出血量较少(MD=-13.58,95% CI:-19.72,-7. 44;P<0.000 1);R-CME组术后住院时间更短(MD=-0.55,95% CI:-1.02,-0.07;P=0.02)。在术中取标本长度(MD=0.32,95% CI:-0.20,0.85;P=0.23)、术后首次进食时间(MD=0.12,95% CI:-0.10,0.33;P=0.28)和术后首次排气时间(MD=0.06,95% CI:-0.36,0.47;P=0.79)等方面,两组差异无统计学意义。两组在吻合口瘘(OR=0.35,95% CI:0.11,1.10;P=0.07)、肺部感染(OR=1.13,95% CI:0.37,3.52;P=0.83)、肠梗阻(OR=0.67,95% CI:0.28,1.58;P=0.36)、切口感染(OR=1.25,95% CI:0.58,2.67;P=0.57)发生率等术后并发症方面,差异无统计学意义。R-CME组在手术时间上无优势(MD=35.04,95% CI:14.40,55.67;P=0.000 9)。试验序贯分析进一步证实了R-CME在控制术中出血量、术中清扫淋巴结数量上的优势,住院时间的优势性仍需进一步讨论,在手术时间上R-CME暂时无优势。

结论

R-CME对右半结肠癌的治疗效果更好,手术环境更为安全,有效避免输血相关风险,并能提高对肿瘤病理学评估的准确性,有助于后续治疗方案的制定,值得在临床上推广应用。

Objective

To conduct a meta-analysis of the therapeutic effects of robot-assisted complete mesocolic excision (R-CME) for right-sided colon cancer.

Methods

A search was conducted in databases including CNKI, Wanfang, PubMed, NCBI up to October 10, 2023, for controlled studies comparing R-CME and laparoscopic complete mesocolic excision (L-CME) in the treatment of right-sided colon cancer. Two researchers independently extracted relevant research data and conducted literature reviews. Clinical data were collected and analyzed using RevMan 5.3 software, and positive results were further subjected to trial sequential analysis using TSA 0.9 Beta version.

Results

Eight retrospective analysis studies were included, involving a total of 1 106 patients, with 532 in the R-CME group and 574 in the L-CME group. The R-CME group had a higher number of lymph nodes harvested during surgery (MD=3.21, 95% CI: 0.62, 5.80; P=0.02); less intraoperative blood loss (MD=-13.58, 95% CI: -19.72, -7.44; P<0.000 1); and shorter postoperative hospital stay (MD=-0.55, 95% CI: -1.02, -0.07; P=0.02). No significant differences were observed between the two groups in terms of specimen length (MD=0.32, 95% CI: -0.20, 0.85; P=0.23), time to first oral intake (MD=0.12, 95% CI: -0.10, 0.33; P=0.28), and time to first flatus (MD=0.06, 95% CI: -0.36, 0.47; P=0.79). There were no significant differences between the two groups regarding postoperative complications, including anastomotic leakage (OR=0.35, 95% CI: 0.11, 1.10; P=0.07), pulmonary infection (OR=1.13, 95% CI: 0.37, 3.52; P=0.83), intestinal obstruction (OR=0.67, 95% CI: 0.28, 1.58; P=0.36), and incision infection (OR=1.25, 95% CI: 0.58, 2.67; P=0.57). The R-CME group did not show advantages in surgical time (MD=35.04, 95% CI: 14.40, 55.67; P=0.000 9). Trial sequential analysis further confirmed the advantages of R-CME in controlling intraoperative blood loss and lymph nodes dissection. The superiority in terms of hospital stay still needed further discussion, and currently there was no advantage for R-CME in terms of operative time.

Conclusions

R-CME provides better therapeutic outcomes for right-sided colon cancer, offering safer surgical environment, effectively avoiding transfusion-related risks, enhancing the accuracy of tumor pathology assessment, and aiding in the formulation of subsequent treatment plans. R-CME is worthy of clinical promotion.

图1 文献筛选流程
图2 纳入研究偏倚风险结果
图3 纳入研究偏倚风险总摘要
图4 术中数据森林图 A为手术时间;B为清扫淋巴结数量;C为出血量;D为取标本长度
图5 术后数据森林图 A为首次进食时间;B为首次排气时间;C为住院时间
表1 纳入文献基本情况
第一作者和发表年 国家 研究类型 样本数(例) 性别(例,男/女) 年龄(岁, ±s) 体质指数(kg/m2, ±s)
R-CME L-CME R-CME L-CME R-CME L-CME R-CME L-CME
Ceccarelli,2021[9] 意大利 NRCT 26 29 20/6 15/14 69.1±9.4 75.0±11.7 24.4±3.8 24.2±2.8
Cuk, 2021[10] 丹麦 NRCT 143 155 69/74 86/69
Larach, 2022[11] 澳大利亚 NRCT 25 26 8/17 12/14
Ouyang, 2019[12] 中国 NRCT 107 60 62/45 34/26 57.6±9.1 58.3±9.3 23.5±3.9 23.5±4.2
Spinoglio, 2018[13] 意大利 NRCT 101 101 57/44 47/54 71.2±10.2 71.2±10.6 25.1±4.0 25.8±4.4
Yozgatli, 2019[14] 土耳其 NRCT 35 61 20/15 31/30 65.0±13.0 65.0±13.0 29.0±5.0 27.0±5.0
黄彬, 2023[15] 中国 NRCT 61 108 33/28 56/52 61.25±10.23 61.75±12.3 22.92±2.91 22.42±3.16
叶勇, 2021[16] 中国 NRCT 34 34 17/17 15/19 62.0±10.0 62.0±11.0 22.4±2.7 22.4±2.8
第一作者和发表年 腹部手术史(例)   肿瘤T分期(例) 肿瘤直径(cm, ±s) ASA分级(例)
R-CME L-CME P R-CME L-CME P R-CME L-CME P R-CME L-CME P
Ⅰ~Ⅱ ≥Ⅲ Ⅰ~Ⅱ ≥Ⅲ Ⅰ~Ⅱ ≥Ⅲ Ⅰ~Ⅱ ≥Ⅲ
Ceccarelli,2021[9] 9 17 11 18 0.799 4.1±1.8 4.4±2.1 0.574 16 10 22 7 0.251
Cuk, 2021[10] 8 27 0.002 60 83 60 95 0.568 82 61 74 81 0.097
Larach, 2022[11] 8 17 12 14 0.301 11 14 12 14 0.877
Ouyang, 2019[12] 74 33 41 19 0.912 4.9±1.0 4.8±1.0 0.536
Spinoglio, 2018[13] 11 12 0.825 53 48 46 55 0.325
Yozgatli, 2019[14] 20 15 30 31 0.452 5±2 5±3 1.000
黄彬, 2023[15] 12 28 0.358 34 27 73 35 0.125
叶勇, 2021[16] 18 16 22 12 0.324
图6 两组术后总并发症比较森林图
图7 两组术后并发症亚组分析比较森林图
图8 吻合口瘘发生率漏斗图
图9 各项指标试验序贯分析结果 A手术时间TSA;B术中出血量TSA;C术中淋巴结清扫数量TSA;D住院时间TSA
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