Abstract：
Objective: To assess the risk factors affecting development of non-tumor- related anastomotic stenosis after rectal cancer and to construct a nomogram prediction model. Methods: This was a retrospective study of data of patients who had undergone excision with one-stage intestinal anastomosis for rectal cancer between January 2003 and September 2018 in Nanfang Hospital of Southern Medical University. The exclusion criteria were as follows: (1) pathological examination of the operative specimen revealed residual tumor on the incision margin of the anastomosis; (2) pathological examination of postoperative colonoscopy specimens revealed tumor recurrence at the anastomotic stenosis, or postoperative imaging evaluation and tumor marker monitoring indicated tumor recurrence; (3) follow-up time <3 months; and (4) simultaneous multiple primary cancers. Univariate analysis using the χ2 or Fisher\'s exact test was performed to assess the study patients\' baseline characteristics and variables such as tumor-related factors and surgical approach (P<0.05). Multivariate analysis using binary logistic regression was then performed to identify independent risk factors for development of non-tumor-related anastomotic stenosis after rectal cancer. Finally, a nomogram model for predicting non-tumor-related anastomotic stenosis after rectal cancer surgery was constructed using R software. The reliability and accuracy of this prediction model was evaluated using internal validation and calculation of the area under the curve of the model\'s receiver characteristic curve (ROC). Results: The study cohort comprised 1,610 patients, including 1,008 men and 602 women of median age 59 (50, 67) years and median body mass index 22.4 (20.2, 24.5) kg/m². Non-tumor-related anastomotic stenosis developed in 121 (7.5%) of these patients. The incidence of non-tumor-related anastomotic stenosis in patients who had undergone neoadjuvant chemotherapy, neoadjuvant radiotherapy, and surgery alone was 11.2% (10/89), 26.4% (47/178), and 4.8% (64/1,343), respectively. Neoadjuvant treatment (neoadjuvant chemotherapy: OR=2.455, 95%CI: 1.148-5.253, P=0.021; neoadjuvant chemoradiotherapy, OR=3.882, 95%CI: 2.425-6.216, P<0.001), anastomotic leakage (OR=7.960, 95%CI: 4.550-13.926, P<0.001), open laparotomy (OR=3.412, 95%CI: 1.772-6.571, P<0.001), and tumor location (distance of tumor from the anal verge 5-10 cm: OR=2.381, 95%CI:1.227-4.691, P<0.001; distance of tumor from the anal verge <5 cm: OR=5.985,95% CI: 3.039-11.787, P<0.001) were identified as independent risk factors for non-tumor-related anastomotic stenosis. Thereafter, a nomogram prediction model incorporating the four identified risk factors for development of anastomotic stenosis after rectal cancer was developed. The area under the curve of the model ROC was 0.815 (0.773-0.857, P<0.001), and the C-index of the predictive model was 0.815, indicating that the model\'s calibration curve fitted well with the ideal curve. Conclusion: Non-tumor-related anastomotic stenosis after rectal cancer surgery is significantly associated with neoadjuvant treatment, anastomotic leakage, surgical procedure, and tumor location. A nomogram based on these four factors demonstrated good discrimination and calibration, and would therefore be useful for screening individuals at risk of anastomotic stenosis after rectal cancer surgery.
目的： 评估影响直肠癌术后发生非肿瘤复发性吻合口狭窄的危险因素并构建其列线图风险预测模型。 方法： 采用回顾性观察性研究的方法，收集南方医科大学南方医院2003年1月至2018年9月期间行手术治疗且一期肠道吻合的直肠癌患者资料。排除标准：（1）术后病理提示吻合口切缘有肿瘤残留者；（2）术后肠镜病理提示吻合口狭窄处为肿瘤复发、或术后影像学评估及肿瘤标志物监测等提示肿瘤复发者；（3）随访时间<3个月；（4）同时多原发癌患者。采用χ2检验或Fisher精确检验进行单因素分析，评价研究对象一般资料以及肿瘤相关因素和手术方式等变量对直肠癌术后发生非肿瘤复发性吻合口狭窄的影响。经单因素分析筛选出P<0.05的变量，进一步采用向前逐步回归法对P<0.05的变量采用二分类自变量logistic回归进行多因素分析，筛选出直肠癌术后非肿瘤复发性吻合口狭窄发生的独立危险因素。最后在R软件中进一步构建直肠癌术后非肿瘤复发性吻合口狭窄的列线图预测模型，使用内部验证和计算模型的受试者工作特征曲线（ROC）的曲线下面积（AUC）来评价该模型预测的可靠性和准确度。 结果： 共纳入1 610例患者，其中男性1 008例，女性602例；中位年龄为59（50，67）岁；中位体质指数22.4（20.2，24.5）kg/m2；其中发生非肿瘤复发性吻合口狭窄121例（7.5%）。行新辅助化疗、新辅助放化疗和直接手术患者术后的非肿瘤复发性吻合口狭窄发生率分别为11.2%（10/89）、26.4%（47/178）和4.8%（64/1 343）。新辅助治疗（新辅助化疗：OR=2.455，95%CI：1.148~5.253，P=0.021；新辅助放化疗：OR=3.882，95%CI：2.425~6.216，P<0.001）、术后吻合口漏（OR=7.960，95%CI：4.550~13.926，P<0.001）、手术方式为开腹手术（OR=3.412，95%CI：1.772~6.571，P<0.001）以及原发肿瘤位置（肿瘤下缘距离肛缘5~10 cm：OR=2.381，95%CI：1.227~4.619，P<0.001；肿瘤下缘距离肛缘<5 cm：OR=5.985，95%CI：3.039~11.787，P<0.001）均是直肠癌术后非肿瘤复发性吻合口狭窄发生的独立危险因素。基于筛选出的4个独立因素，建立直肠癌术后吻合口狭窄发生的相关风险因素列线图模型。计算出模型ROC的AUC为0.815（0.773~0.857，P<0.001），内部验证法显示，该预测模型的C-index值为0.815，且该模型校正曲线与理想曲线拟合度良好。 结论： 直肠癌术后非肿瘤复发性吻合口狭窄与新辅助治疗、吻合口漏、手术方式及原发肿瘤位置密切相关，基于上述4因素的列线图模型具有良好的预测区分度和校正度，有利于筛查直肠癌术后吻合口非肿瘤复发性狭窄人群和制定针对性的防治措施。.
目的： 评估影响直肠癌术后发生非肿瘤复发性吻合口狭窄的危险因素并构建其列线图风险预测模型。 方法： 采用回顾性观察性研究的方法，收集南方医科大学南方医院2003年1月至2018年9月期间行手术治疗且一期肠道吻合的直肠癌患者资料。排除标准：（1）术后病理提示吻合口切缘有肿瘤残留者；（2）术后肠镜病理提示吻合口狭窄处为肿瘤复发、或术后影像学评估及肿瘤标志物监测等提示肿瘤复发者；（3）随访时间<3个月；（4）同时多原发癌患者。采用χ2检验或Fisher精确检验进行单因素分析，评价研究对象一般资料以及肿瘤相关因素和手术方式等变量对直肠癌术后发生非肿瘤复发性吻合口狭窄的影响。经单因素分析筛选出P<0.05的变量，进一步采用向前逐步回归法对P<0.05的变量采用二分类自变量logistic回归进行多因素分析，筛选出直肠癌术后非肿瘤复发性吻合口狭窄发生的独立危险因素。最后在R软件中进一步构建直肠癌术后非肿瘤复发性吻合口狭窄的列线图预测模型，使用内部验证和计算模型的受试者工作特征曲线（ROC）的曲线下面积（AUC）来评价该模型预测的可靠性和准确度。 结果： 共纳入1 610例患者，其中男性1 008例，女性602例；中位年龄为59（50，67）岁；中位体质指数22.4（20.2，24.5）kg/m2；其中发生非肿瘤复发性吻合口狭窄121例（7.5%）。行新辅助化疗、新辅助放化疗和直接手术患者术后的非肿瘤复发性吻合口狭窄发生率分别为11.2%（10/89）、26.4%（47/178）和4.8%（64/1 343）。新辅助治疗（新辅助化疗：OR=2.455，95%CI：1.148~5.253，P=0.021；新辅助放化疗：OR=3.882，95%CI：2.425~6.216，P<0.001）、术后吻合口漏（OR=7.960，95%CI：4.550~13.926，P<0.001）、手术方式为开腹手术（OR=3.412，95%CI：1.772~6.571，P<0.001）以及原发肿瘤位置（肿瘤下缘距离肛缘5~10 cm：OR=2.381，95%CI：1.227~4.619，P<0.001；肿瘤下缘距离肛缘<5 cm：OR=5.985，95%CI：3.039~11.787，P<0.001）均是直肠癌术后非肿瘤复发性吻合口狭窄发生的独立危险因素。基于筛选出的4个独立因素，建立直肠癌术后吻合口狭窄发生的相关风险因素列线图模型。计算出模型ROC的AUC为0.815（0.773~0.857，P<0.001），内部验证法显示，该预测模型的C-index值为0.815，且该模型校正曲线与理想曲线拟合度良好。 结论： 直肠癌术后非肿瘤复发性吻合口狭窄与新辅助治疗、吻合口漏、手术方式及原发肿瘤位置密切相关，基于上述4因素的列线图模型具有良好的预测区分度和校正度，有利于筛查直肠癌术后吻合口非肿瘤复发性狭窄人群和制定针对性的防治措施。.
摘要：
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