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[预测超低位直肠癌腹腔镜括约肌间切除术后永久性造口概率的危险因素及列线图]

[Risk factor and nomogram for predicting the probability of a permanent stoma after laparoscopic intersphincteric resection for ultralow rectal cancer].

作者信息

Hu G, Liu J G, Qiu W L, Mei S W, Wang X, Tang J Q

机构信息

Department of General Surgery, Peking University First Hospital, Beijing 100034, China.

出版信息

Zhonghua Wei Chang Wai Ke Za Zhi. 2022 Nov 25;25(11):997-1004. doi: 10.3760/cma.j.cn441530-20220629-00283.

Abstract

A permanent stoma can seriously affect patients' quality of life. Clinicians need to consider the risk of a permanent stoma when making clinical decisions. This study analyzed preoperative predictors of a permanent stoma after laparoscopic intersphincteric resection for low rectal cancer (LISR), and a prediction model was constructed validated. This was a retrospective study that analyzed clinical data of 331 ultralow rectal cancer patients who were diagnosed with primary rectal adenocarcinoma by endoscopy and pathology, including 218 males and 113 female, (58.8±11.2) years and (23.7±3.1) kg/m. The patients underwent LISR with a preventive stoma from January 2012 to December 2020. Patients with multiple primary colorectal cancers, who underwent emergency surgery for intestinal obstruction or bleeding or perforation, and did not complete 18 months follow up were exclucled. R software was used to randomly select 234 patients as the modeling group with a ratio of approximately 7:3, and the remaining 97 patients comprised the validation group. The stoma site was determined by the surgeon before the operation, and the ileum 30 cm from the ileocecal valve was selected. The rates of a permanent stoma for the entire group and the preoperative clinical factors that may affect the permanency of a stoma in the modeling group were determined. A permanent stoma was defined as failure to close the stoma at 18 months after surgery. Multivariate logistic regression analysis was used to analyze the preoperative independent risk factors for a permanent stoma after LISR. R software was used to create the nomogram model, and the predictive ability of the nomogram model was evaluated by receiver operating characteristic (ROC) curve analysis. Among the 331 patients who underwent LISR, 37 (26 cases in the modeling group and 11 cases in the validation group, 11.2%) developed a permanent stoma for the following reasons: anastomotic stenosis due to leakage (16 cases, 43.2%), distant metastasis (16 cases, 43.2%), intolerant to stoma closure surgery (3 cases, 8.1%), stenosis due to postoperative radiation (1 case, 2.7%), and poor recovery of anorectal function (1 case, 2.7%). Univariate analysis showed that preoperative neoadjuvant chemoradiotherapy, poorly differentiated tumor, cT3 stage, and distant metastasis were associated with a permanent stoma. Multivariate logistic regression analysis showed that neoadjuvant chemoradiotherapy [OR=3.078, 95% confidence interval (CI): 1.326-7.147; =0.009], cT3 stage (OR=2.257, 95%CI: 1.001-5.091; =0.049), and stage IV cancer (OR=16.180, 95%CI: 2.753-95.102; =0.002) were independent risk factors for permanent stoma after LISR. Based on the selected risk factors, a nomogram model for predicting permanent stoma was constructed. The area under the ROC curve of the modeling group was 0.793, the optimal cut-off value was 0.890, the sensitivity was 0.577, and the specificity was 0.885. The area under the ROC curve of the validation group was 0.953. The corrected curves of the modeling group and the validation group showed a good degree of fit. Neoadjuvant chemoradiotherapy, cT3 stage, and distant metastasis are independent predictors of a permanent stoma after LISR, and the nomogram model is helpful to predict the probability of a permanent stoma. Patients with high-risk factors should be adequately informed of the risk of a permanent stoma before colorectal surgery.

摘要

永久性造口会严重影响患者的生活质量。临床医生在做出临床决策时需要考虑永久性造口的风险。本研究分析了低位直肠癌腹腔镜括约肌间切除术(LISR)后永久性造口的术前预测因素,并构建并验证了一个预测模型。这是一项回顾性研究,分析了331例经内镜和病理诊断为原发性直肠腺癌的超低位直肠癌患者的临床资料,其中男性218例,女性113例,年龄(58.8±11.2)岁,体重指数(23.7±3.1)kg/m²。这些患者在2012年1月至2020年12月期间接受了带预防性造口的LISR。排除患有多发性原发性结直肠癌、因肠梗阻、出血或穿孔接受急诊手术以及未完成18个月随访的患者。使用R软件以约7:3的比例随机选择234例患者作为建模组,其余97例患者组成验证组。造口部位由外科医生在手术前确定,选择距回盲瓣30 cm的回肠。确定了整个组的永久性造口率以及建模组中可能影响造口永久性的术前临床因素。永久性造口定义为术后18个月造口未关闭。采用多因素logistic回归分析LISR后永久性造口的术前独立危险因素。使用R软件创建列线图模型,并通过受试者操作特征(ROC)曲线分析评估列线图模型的预测能力。在331例行LISR的患者中,37例(建模组26例,验证组11例,11.2%)出现永久性造口,原因如下:吻合口漏致狭窄(16例,43.2%)、远处转移(16例,43.2%)、无法耐受造口关闭手术(3例,8.1%)、术后放疗致狭窄(1例,2.7%)、肛管直肠功能恢复差(1例,2.7%)。单因素分析显示,术前新辅助放化疗、肿瘤低分化、cT3期和远处转移与永久性造口有关。多因素logistic回归分析显示,新辅助放化疗[比值比(OR)=3.078,95%置信区间(CI):1.326 - 7.147;P = 0.009]、cT3期(OR = 2.257,95%CI:1.001 - 5.091;P = 0.049)和IV期癌症(OR = 16.180,95%CI:2.753 - 95.102;P = 0.002)是LISR后永久性造口的独立危险因素。基于选定的危险因素,构建了预测永久性造口的列线图模型。建模组ROC曲线下面积为0.793,最佳截断值为0.890,灵敏度为0.577,特异度为0.885。验证组ROC曲线下面积为0.953。建模组和验证组的校正曲线显示拟合度良好。新辅助放化疗、cT3期和远处转移是LISR后永久性造口的独立预测因素,列线图模型有助于预测永久性造口的概率。对于有高危因素的患者,在结直肠手术前应充分告知其永久性造口的风险。

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