直肠癌腹腔镜手术长期疗效并不优于开腹手术:近10年经典随机对照试验的荟萃分析
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摘要
目的:对近10年已发表的高质量经典随机对照试验(randomized controlled trial,RCT)进行腹腔镜手术与开腹手术治疗直肠癌的Meta分析。方法:利用电子数据库和手工检索等方法检索Pubmed、Embase、Web of Science、OVID、CNKI、万方数据库及Cochrane Library 2007年1月1日—2018年11月1日的相关研究RCT文献,对所有符合条件的文献进行Jadad质量评分。采用固定效应模型和随机效应模型对直肠癌腹腔镜手术与开腹手术的手术情况及疗效指标进行Meta分析。结果:符合入选标准的RCT文献有14篇共计3288例患者,腹腔镜手术组与开腹手术组分别为1779例和1509例。Meta分析结果显示,直肠癌腹腔镜手术相较于开腹手术的手术时间更长(MD=40.04,95%CI:24.07～56.01,P <0.05),术中出血量更少(MD=-98.48,95%CI:-148.72～-48.25,P <0.05),术中输血率更低(OR=0.30,95%CI:0.16～0.55,P <0.05),术后肠功能恢复时间更短(MD=-0.68,95%CI:-0.98～-0.38,P <0.05),术后住院时间更短(MD=-1.08,95%CI:-1.49～-0.66,P <0.05),术后发病率更低(OR=0.67,95%CI:0.46～0.97,P <0.05),术后切口感染发生率更低(OR=0.52,95%CI:0.36～0.77,P <0.05)。但在肿瘤距近切和远切缘距离、淋巴结检出数量、环周切缘阳性率、术后二次手术发生率、术后并发症(肠梗阻、腹部感染、肺部感染、吻合口瘘、吻合口出血、吻合口狭窄)、术后局部复发率、术后3年生存率、术后5年生存率和术后5年无病生存率方面均未见统计学差异。结论:直肠癌腹腔镜手术对比开腹手术,手术时间更长,术中出血量更少,术中输血率更低,术后肠功能恢复时间更短,术后切口感染发生率更低,但在淋巴结获取数目、环周切缘阳性率、局部复发率、3年生存率、5年生存率等长期预后等指标上无差异。
Objective:To present a meta-analysis of high-quality published and classic randomized controlled trials(RCTs)in the past decade in comparison to laparoscopic surgery(LS)and open surgery(OS)for rectal cancer. Methods:Electronic literature search was performed on PubMed,EMBASE,Web of Science,OVID,CNKI,Wanfang Data and Cochrane Library from January 1,2007 to November 1,2018. All eligible RCTs were evaluated based on the Jadad score. We used the fixed effect model(FE)and the random effect model(RE)to analyze this cohort. Results:Among all the 14 included studies,a total of 3 288 cases were reported,including 1779 patients in the LS group and 1 509 patients in the OS group. The results of the Meta-analysis demonstrated the operative time of the LS group was obviously longer than that of the OS group(MD=40.04,95%CI[24.07,56.01],P < 0.05),LS was associated with less blood loss(MD=-98.48,95%CI[-148.72,-48.25],P < 0.05),fewer blood transfusions(OR=0.30,95%CI[0.16,0.55],P < 0.05),shorter bowel function recovery times(MD=-0.68,95%CI[-0.98,-0.38],P < 0.05),shorter postoperative hospital stays(MD=-1.08,95%CI[-1.49,-0.66],P < 0.05),fewer postoperative complications(OR=0.67,95%CI[0.46,0.97],P < 0.05)and fewer wound infections(OR=0.52,95%CI[0.36,0.77],P < 0.05). However,no significant differences between the LS and OS groups were proximal resection margin,radial distal margin,the number of harvested lymph nodes,positive circumferential resection margin(CRM),reoperation,other postoperative complications(ileus,abdominal infection,lung infection,anastomotic fistula,anastomosis bleeding and anastomosis stenosis),local recurrence,3-year overall survival,5-year overall survival or 5-year disease-free survival. Conclusion:There are no significant differences between LS and OS in terms of the number of harvested lymph nodes,positive CRM,local recurrence or overall survival. More,LS for rectal cancer appears to be safer in blood loss,blood transfusions,bowel function recovery times and wound infections in comparison to OS.
Objective:To present a meta-analysis of high-quality published and classic randomized controlled trials(RCTs)in the past decade in comparison to laparoscopic surgery(LS)and open surgery(OS)for rectal cancer. Methods:Electronic literature search was performed on PubMed,EMBASE,Web of Science,OVID,CNKI,Wanfang Data and Cochrane Library from January 1,2007 to November 1,2018. All eligible RCTs were evaluated based on the Jadad score. We used the fixed effect model(FE)and the random effect model(RE)to analyze this cohort. Results:Among all the 14 included studies,a total of 3 288 cases were reported,including 1779 patients in the LS group and 1 509 patients in the OS group. The results of the Meta-analysis demonstrated the operative time of the LS group was obviously longer than that of the OS group(MD=40.04,95%CI[24.07,56.01],P < 0.05),LS was associated with less blood loss(MD=-98.48,95%CI[-148.72,-48.25],P < 0.05),fewer blood transfusions(OR=0.30,95%CI[0.16,0.55],P < 0.05),shorter bowel function recovery times(MD=-0.68,95%CI[-0.98,-0.38],P < 0.05),shorter postoperative hospital stays(MD=-1.08,95%CI[-1.49,-0.66],P < 0.05),fewer postoperative complications(OR=0.67,95%CI[0.46,0.97],P < 0.05)and fewer wound infections(OR=0.52,95%CI[0.36,0.77],P < 0.05). However,no significant differences between the LS and OS groups were proximal resection margin,radial distal margin,the number of harvested lymph nodes,positive circumferential resection margin(CRM),reoperation,other postoperative complications(ileus,abdominal infection,lung infection,anastomotic fistula,anastomosis bleeding and anastomosis stenosis),local recurrence,3-year overall survival,5-year overall survival or 5-year disease-free survival. Conclusion:There are no significant differences between LS and OS in terms of the number of harvested lymph nodes,positive CRM,local recurrence or overall survival. More,LS for rectal cancer appears to be safer in blood loss,blood transfusions,bowel function recovery times and wound infections in comparison to OS.
引文
[1]陈万青,李贺,孙可欣,等. 2014年中国恶性肿瘤发病和死亡分析[J].中华肿瘤杂志,2018,40(1):5-13
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[13]邱枫,王今.腹腔镜与开腹直肠癌手术近期疗效对比[J].首都医科大学学报,2013,34(5):689-692
[14] van der Pas MH,Haglind E,Cuesta MA,et al. Laparoscopic versus open surgery for rectal cancer(COLOR II):short-term outcomes of a randomised,phase 3 trial[J].Lancet Oncol,2013,14(3):210-218
[15] Jeong SY,Park JW,Nam BH,et al. Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy(COREAN trial):survival outcomes of an open-label,non-inferiority,randomised controlled trial[J]. Lancet Oncol,2014,15(7):767-774
[16] Fujii S,Ishibe A,Ota M,et al. Short-term results of a randomized study between laparoscopic and open surgery in elderly colorectal cancer patients[J]. Surg Endosc,2014,28(2):466-476
[17] Zhou ZX,Zhao LY,Lin T,et al. Long-term oncologic outcomes of laparoscopic vs open surgery for stages II and III rectal cancer:A retrospective cohort study[J]. World J Gastroenterol,2015,21(18):5505-5512
[18]刘英强,陈淅涓,姬社青,等.腹腔镜与传统开放手术联合新辅助放化疗治疗中低位局部进展期直肠癌的安全性及并发症的比较[J].中华实验外科杂志,2016,33(10):2395-2397
[19]柯昌松,向波,王斌,等.腹腔镜手术和传统开腹TME手术在直肠癌患者中的疗效对比观察[J].现代消化及介入诊疗,2016,21(6):880-882
[20]曹广,梁杰雄,王晓东.腹腔镜与开腹直肠癌根治术的疗效比较[J].中国微创外科杂志,2016,16(7):581-585
[21] Egenvall M,Morner M,Pahlman L,et al. Degree of blood loss during surgery for rectal cancer:a population-based epidemiologic study of surgical complications and survival[J]. Colorectal Dis,2014,16(9):696-702
[22]郑玮,张林,武云龙,等. N2b期结直肠癌淋巴结转移指标与患者预后的关系[J].中华肿瘤杂志,2018,40(9):679-683
[23] Kim YW,Kim NK,Min BS,et al. Factors associated with anastomotic recurrence after total mesorectal excision in rectalcancerpatients[J].JSurgOncol,2009,99(1):58-64
[24]杨国山,颜朝阳,任宏凯,等.直肠癌腹腔镜手术与开腹手术疗效比较的Meta分析[J].临床和实验医学杂志,2015(16):1367-1372
[25] Mukkai KD,Wise PE. Importance of surgical margins in rectal cancer[J]. J Surg Oncol,2016,113(3):323-332
[26] Pedziwiatr M,Malczak P,Mizera M,et al. There is no difference in outcome between laparoscopic and open surgery for rectal cancer:a systematic review and meta-analysis on short-and long-term oncologic outcomes[J]. Tech Coloproctol,2017,21(8):595-604
[27] Martinez-Perez A,Carra MC,Brunetti F,et al. Pathologic outcomes of laparoscopic vs open mesorectal excision for rectal cancer:a systematic review and meta-analysis[J].JAMA Surg,2017,152(4):e165665
[2]贝迪恺,李军,张苏展.精确评估分层:结直肠癌外科的发展方向[J].南京医科大学学报(自然科学版),2016,36(3):269-273
[3] Lin Z,Jiang ZL,Chen DY,et al. Short-and long-term outcomes of laparoscopic versus open surgery for rectal cancer:A systematic review and meta-analysis of randomized controlled trials[J]. Medicine(Baltimore),2018,97(50):e13704
[4] Wu B,Wang W,Hao G,et al. Effect of cancer characteristics and oncological outcomes associated with laparoscopic colorectal resection converted to open surgery:a metaanalysis[J]. Medicine(Baltimore),2018,97(50):e13317
[5]杜斌斌,张维胜,杨熊飞,等.直肠癌腹腔镜手术与开腹手术的疗效比较[J].中国肛肠病杂志,2014,34(4):15-17
[6] Da Costa BR,Beckett B,Diaz A,et al. Effect of standardized training on the reliability of the Cochrane risk of bias assessment tool:a prospective study[J]. Syst Rev,2017,6(1):44
[7] Braga M,Frasson M,Vignali A,et al. Laparoscopic resection in rectal cancer patients:outcome and cost-benefit analysis[J]. Dis Colon Rectum,2007,50(4):464-471
[8] Mirza MS,Longman RJ,Farrokhyar F,et al. Long-term outcomes for laparoscopic versus open resection of nonmetastatic colorectal cancer[J]. J Laparoendosc Adv Surg Tech A,2008,18(5):679-685
[9] Kang SB,Park JW,Jeong SY,et al. Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy(COREAN trial):short-term outcomes of an open-label randomised controlled trial[J].Lancet Oncol,2010,11(7):637-645
[10] Veenhof AA,Sietses C,von Blomberg BM,et al. The surgical stress response and postoperative immune function after laparoscopic or conventional total mesorectal excision in rectal cancer:a randomized trial[J]. Int J Colorectal Dis,2011,26(1):53-59
[11] Li S,Chi P,Lin H,et al. Long-term outcomes of laparoscopic surgery versus open resection for middle and lower rectal cancer:an NTCLES study[J]. Surg Endosc,2011,25(10):3175-3182
[12] Gong J,Shi DB,Li XX,et al. Short-term outcomes of laparoscopic total mesorectal excision compared to open surgery[J].WorldJGastroenterol,2012,18(48):7308-7313
[13]邱枫,王今.腹腔镜与开腹直肠癌手术近期疗效对比[J].首都医科大学学报,2013,34(5):689-692
[14] van der Pas MH,Haglind E,Cuesta MA,et al. Laparoscopic versus open surgery for rectal cancer(COLOR II):short-term outcomes of a randomised,phase 3 trial[J].Lancet Oncol,2013,14(3):210-218
[15] Jeong SY,Park JW,Nam BH,et al. Open versus laparoscopic surgery for mid-rectal or low-rectal cancer after neoadjuvant chemoradiotherapy(COREAN trial):survival outcomes of an open-label,non-inferiority,randomised controlled trial[J]. Lancet Oncol,2014,15(7):767-774
[16] Fujii S,Ishibe A,Ota M,et al. Short-term results of a randomized study between laparoscopic and open surgery in elderly colorectal cancer patients[J]. Surg Endosc,2014,28(2):466-476
[17] Zhou ZX,Zhao LY,Lin T,et al. Long-term oncologic outcomes of laparoscopic vs open surgery for stages II and III rectal cancer:A retrospective cohort study[J]. World J Gastroenterol,2015,21(18):5505-5512
[18]刘英强,陈淅涓,姬社青,等.腹腔镜与传统开放手术联合新辅助放化疗治疗中低位局部进展期直肠癌的安全性及并发症的比较[J].中华实验外科杂志,2016,33(10):2395-2397
[19]柯昌松,向波,王斌,等.腹腔镜手术和传统开腹TME手术在直肠癌患者中的疗效对比观察[J].现代消化及介入诊疗,2016,21(6):880-882
[20]曹广,梁杰雄,王晓东.腹腔镜与开腹直肠癌根治术的疗效比较[J].中国微创外科杂志,2016,16(7):581-585
[21] Egenvall M,Morner M,Pahlman L,et al. Degree of blood loss during surgery for rectal cancer:a population-based epidemiologic study of surgical complications and survival[J]. Colorectal Dis,2014,16(9):696-702
[22]郑玮,张林,武云龙,等. N2b期结直肠癌淋巴结转移指标与患者预后的关系[J].中华肿瘤杂志,2018,40(9):679-683
[23] Kim YW,Kim NK,Min BS,et al. Factors associated with anastomotic recurrence after total mesorectal excision in rectalcancerpatients[J].JSurgOncol,2009,99(1):58-64
[24]杨国山,颜朝阳,任宏凯,等.直肠癌腹腔镜手术与开腹手术疗效比较的Meta分析[J].临床和实验医学杂志,2015(16):1367-1372
[25] Mukkai KD,Wise PE. Importance of surgical margins in rectal cancer[J]. J Surg Oncol,2016,113(3):323-332
[26] Pedziwiatr M,Malczak P,Mizera M,et al. There is no difference in outcome between laparoscopic and open surgery for rectal cancer:a systematic review and meta-analysis on short-and long-term oncologic outcomes[J]. Tech Coloproctol,2017,21(8):595-604
[27] Martinez-Perez A,Carra MC,Brunetti F,et al. Pathologic outcomes of laparoscopic vs open mesorectal excision for rectal cancer:a systematic review and meta-analysis[J].JAMA Surg,2017,152(4):e165665
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