腹腔镜低位直肠癌前切除术后吻合口漏危险因素分析及其风险评估量表应用价值的多中心回顾性研究

Risk factors for anastomotic leakage after laparoscopic lower anterior resection of rectal cancer and application value of risk assessment scoring model:a multicenter retrospective study

目的探讨腹腔镜低位直肠癌前切除术后吻合口漏危险因素及其风险评估量表的应用价值。方法采用回顾性病例对照研究方法。收集2016年1月至2020年11月国内13家医疗中心收治的539例(上海交通大学医学院附属仁济医院248例、宁波市第一医院35例、常州市第二人民医院35例、南通市第一人民医院32例、临沂市人民医院32例、常州市武进人民医院31例、上海市嘉定区中医医院28例、台州市第一人民医院27例、上海市浦东新区公利医院26例、如皋市人民医院21例、上海市奉贤区中心医院11例、宁波市杭州湾医院7例、江苏省建湖县人民医院6例)行腹腔镜低位直肠癌前切除术病人的临床病理资料;男157例, 女382例;年龄为(62.7±0.5)岁。观察指标:(1)随访情况。(2)腹腔镜低位直肠癌前切除术后吻合口漏危险因素分析。(3)构建腹腔镜低位直肠癌前切除术后吻合口漏风险评估量表。采用门诊或电话方式进行随访, 出院后1周、术后1个月随访, 了解病人术后吻合口漏情况。正态分布的计量资料以x±s表示, 偏态分布的计量资料以M(范围)表示。计数资料以绝对数或百分比表示, 组间比较采用χ2检验。单因素分析采用χ2检验, 多因素分析采用Logistic回归模型。以受试者工作特征曲线下面积评估检测方法的效能。约登指数最大值为最佳截断值。结果 (1)随访情况。539例病人均获得出院后1周、术后1个月随访。随访期间, 79例病人发生吻合口漏, 吻合口漏发生率为14.66%(79/539), 其中39例经保守治疗后痊愈, 40例行二次手术(回肠或结肠造口)后痊愈。(2)腹腔镜低位直肠癌前切除术后吻合口漏危险因素分析。单因素分析结果显示:性别、年龄、体质量指数、长期吸烟和(或)酗酒、肿瘤长径、糖尿病、血红蛋白、白蛋白、美国麻醉医师协会分级、新辅助放化疗、吻合口距齿状线距离、腔内闭合器数目、吻合口加固、术中出血量、放置肠减压管、保留左结肠动脉、手术时间、专业化医师是影响腹腔镜低位直肠癌前切除术后吻合口漏的相关因素(χ2=14.060, 4.387, 5.039, 4.094, 17.488, 33.485, 25.066, 28.959, 34.973, 34.207, 22.076, 13.208, 16.440, 17.708, 17.260, 4.573, 5.919, 5.389, P<0.05)。多因素分析结果显示:男性、肿瘤长径≥3.5 cm、合并糖尿病、血红蛋白<90 g/L、白蛋白<30 g/L、美国麻醉医师协会分级≥Ⅲ级、新辅助放化疗、吻合口距齿状线距离<1 cm、腔内闭合器数目≥3个、吻合口未加固、术中出血量≥100 mL、未放置肠减压管是影响腹腔镜低位直肠癌前切除术后吻合口漏的独立危险因素(优势比=2.864, 3.043, 12.556, 7.178, 8.425, 12.895, 8.987, 4.002, 3.084, 4.393, 3.266, 3.224, 95%可信区间为1.279~6.411, 1.404~6.594, 4.469~35.274, 2.648~19.459, 2.471~28.733, 4.027~41.289, 3.702~21.777, 1.746~9.171, 1.365~6.966, 1.914~10.083, 1.434~7.441, 1.321~7.867, P<0.05)。(3)构建腹腔镜低位直肠癌前切除术后吻合口漏风险评估量表。根据单因素分析结果, 临床病理因素χ2值>20, 赋3分;χ2值>10且≤20, 赋2分;χ2值≤10, 赋1分。累积分数≥6分是判断术后吻合口漏的有效客观指标。构建腹腔镜低位直肠癌前切除术后吻合口漏风险评估量表(6-321), 累积分数≥6分, 术后吻合口漏发生率高;累积分数<6分, 术后吻合口漏发生率低。结论男性、肿瘤长径≥3.5 cm、合并糖尿病、血红蛋白<90 g/L、白蛋白<30 g/L、美国麻醉医师协会分级≥Ⅲ级、新辅助放化疗、吻合口距齿状线距离<1 cm、腔内闭合器数目≥3个、吻合口未加固、术中出血量≥100 mL、未放置肠减压管是影响腹腔镜低位直肠癌前切除术后吻合口漏的独立危险因素;据此构建风险评估量表(6-321), 累积分数≥6分, 提示术后吻合口漏发生率高;累积分数< 6分, 提示术后吻合口漏发生率低。

Objective To investigate the risk factors for anastomotic leakage after laparo-scopic lower anterior resection(LAR)of rectal cancer,and the application value of its risk assess-ment scoring model.Methods The retrospective case-control study was conducted.The clinico-pathological data of 539 patients who underwent laparoscopic LAR of rectal cancer in 13 medical centers,including 248 cases in Renji Hospital of Shanghai liaotong University School of Medicine,35 cases in Ningbo First Hospital,35 cases in Changzhou Second People's Hospital,32 cases in the First People's Hospital of Nantong,32 cases in Linyi People's Hospital,31 cases in Changzhou Wujin People's Hospital,28 cases in Jiading District Hospital of Traditional Chinese Medicine,27 cases in the First Hospital of Taizhou,26 cases in Shanghai Pudong Gongli Hospital,21 cases in the People's Hospital of Rugao,11 cases in Central Hospital of Fengxian District,7 cases in Ningbo Hangzhou Bay Hospital and 6 cases in Jiangsu jianhu People's Hospital,from January 2016 to November 2020 were collected.There were 157 males and 382 females,aged(62.7+0.5)years.Observation indicators:(1)follow-up;(2)risk factors for anastomotic leakage after laparoscopic LAR;(3)establishment of risk assessment scoring model for anastomotic leakage after laparoscopic LAR.Follow-up was conducted by outpatient examination or telephone interview.Patients were followed up at 1 week after discharge or 1 month after the operation to detect the anastomotic leakage.Measurement data with normal distribution were represented as Mean+SD,and measurement data with skewed distribution were represented as M(range).Count data were represented as absolute numbers or percentages,and comparison between groups was analyzed using the chi-square test.Univariate analysis was conducted using the chi-square test and multivariate analysis was conducted usong the Logistic regression model.The area under curve of receiver operating characteristic curve was used to estimate the fficiency of detecton methods.The maximum value of the Youden index was defined as the best cut-off value.Results(1]Follow-up:539 patients were followed up at postoperative 1 week and 1 month.During the follow-up,79 patient had anastomotic leakage,with an incidence of 14.66%(79/539).Of the 79 patients,39 cases were cured after conservative treatment,40 cases were cured after reoperation(ileostomy or colostomy).(2]Risk factors for anastomotic leakage after laparoscopic LAR.Results of univariate analysis showed that sex,age,body mass index,smoking and/or drinking,tumor diameter,diabetes mellitus,hemoglobin,albumin,grade of American Society of Anesthesio-logists(ASA),neoadjuvant chemoradiotherapy,distance from anastomotic level to dentate line,the number of pelvic stapler,reinforced anastomosis,volume of intraoperative blood loss,placement of decompression tube,preservation of left colic artery,operation time and professional doctors were related factors for anastomotic leakage after laparoscopic LAR(x=14.060,4.387,5.039,4.094,17.488,33.485,25.066,28.959,34.973,34.207,22.076,13.208,16.440,17.708,17.260,4.573,5.919,5.389,P<0.05].Results of multivariate analysis showed that male,tumor diameter 23.5 cm,diabetes mellitus,hemoglobin<90 g/L,albumin<30 g/L,grade of ASA 2 II,neoadjuvant chemoradiotherapy,distance from anastomotic level to dentate line<1 cm,the number of pelvic stapler≥3,non-reinforced anastomosis,volume of intraoperative blood loss≥100 mL and!no placement of decom-pression tube were independent risk factors for anastomotic leakage after laparoscopic LAR(odds ratio=2.864,3.043,12.556,7.178,8.425,12.895,8.987.4.002,3.084,4.393,3.266,3.224,95%confidence interval as 1.279-6.411,1.404-6.594,4.469-35.274,2.648-19.459,2.471-28.733,4.027-41.289,3.702-21.777,1.7469.171,1.365-6.966,1.914-10.083,1.434-7.441,1321-7.867,P<0.05).(3)Establishment of risk assessment scoring model for anastomotic leakage after laparoscopic LAR.based on the results of univariate analysis,clinicopathological factors with x*>20,x>10 and≤20 or x*≤10 were defined as scoring of 3,2,1,respectively.The cumulative clinicopatho-logical factors scoring≥6 was defined as an effective evaluating indicator for postoperative anastomotic leakage.The risk assessment scoring model(6-321)for anastomotic leakage after laparoscopic LAR was established.The cumulative value 26 indicated high incidence of anastomotic leakage,and the cumulative value<6 indicated low incidence of anastomotic leakage.Conclusions Male,tumor diameter≥3.5 cm,diabetes mellitus,hemoglobin<90 g/L,albumin<30 g/L,grade of ASA≥II,neo-adjuvant chemoradiotherapy,distance from anastomotic level to dentate line<1 cm,the number of pelvic stapler≥3,non-reinforced anastomosis,volume of intraoperative blood loss≥100 mL and no placement of decompression tube are independent risk factors for anastomotic leakage after laparoscopic LAR.The risk assessment scoring model(6-321)is established according to the above results.The cumulative value≥6 indicates high incidence of anastomotic leakage and the cumulative value<6 indicates low incidence of anastomotic leakage.