Objective: 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. Methods: 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/m2. 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. Results: 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; P=0.009], cT3 stage (OR=2.257, 95%CI: 1.001-5.091; P=0.049), and stage IV cancer (OR=16.180, 95%CI: 2.753-95.102; P=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. Conclusion: 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.
目的: 预防性造口永久化会严重影响患者的生活质量。临床医师在进行临床决策时,需要权衡和考虑预防性造口永久化的风险。为方便临床评估,本研究分析腹腔镜直肠癌经括约肌间切除术(LISR)预防性造口永久化的术前预测因素并构建列线图预测模型。 方法: 采取回顾性观察性研究方法,回顾性收集2012年1月至2020年12月期间收治的331例经内镜及病理确诊为原发性低位直肠腺癌、行LISR并行预防性造口患者的临床资料;排除结直肠多原发癌、因肠梗阻或出血或穿孔而行急诊手术者以及未完成18个月的随访者。其中男性258例,女性113例,年龄(58.8±11.2)岁,体质指数(23.7±3.1)kg/m2。通过R软件采用随机抽样的方法,按约7∶3的比例选择234例患者作为建模组,剩余97例患者作为验证组。本组病例均在术前由造口师确定造口部位,选择距离回盲部30 cm的末端回肠行预防性造口。观察全组患者预防性造口永久化的情况,以及可能影响建模组患者预防性造口永久化的术前临床因素。预防性造口永久化的定义为术后18个月时患者预防性造口无法还纳。多因素logistic回归分析LISR预防性造口永久化的术前独立危险因素,采用R软件绘制列线图模型,通过受试者工作特征(ROC)曲线评估列线图模型的预测能力。 结果: 331例LISR患者中,共37例(11.2%)最终预防性造口永久化,其中建模组26例,验证组11例。37例患者无法还纳造口的原因包括:吻合口漏不愈合或吻合口漏导致的狭窄(16例,43.2%)、远处转移(16例,43.2%)、无法耐受二次手术(3例,8.1%)、放射性直肠狭窄(1例,2.7%)和肛门功能恢复不良(1例,2.7%)。建模组单因素分析显示,接受新辅助放化疗、肿瘤低分化、cT3分期以及合并远处转移与预防性造口永久化有关(均P<0.05);多因素logistic分析显示,接受新辅助放化疗(OR=3.078,95%CI:1.326~7.147,P=0.009)、cT3分期(OR=2.257,95%CI:1.001~5.091,P=0.049)以及合并远处转移(OR=16.180,95%CI:2.753~95.102,P=0.002)是预防性造口永久化的独立危险因素。基于筛选出的危险因素成功构建预测低位直肠癌LISR术后预防性造口永久化的列线图模型,ROC曲线下面积为0.793,最佳截断值0.890,灵敏度0.577,特异度0.885;验证组的ROC曲线下面积为0.953。建模组和验证组的校正曲线均展现了较好的拟合度。 结论: 新辅助放化疗、cT3分期以及远处转移是LISR患者预防性造口永久化的术前独立危险因素,本研究构建的列线图模型有助于预测其发生的概率。对于有高危因素行LISR的患者,外科医生术前应充分告知预防性造口不能还纳而致永久化的风险。.