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临床试验/NCT06404554
NCT06404554已完成不适用

A Prediction Model of Anastomotic Stricture After Rectal Cancer: a Retrospective Cohort Analysis

Northern Jiangsu People's Hospital1 个研究点 分布在 1 个国家目标入组 1,542 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,542
试验地点
1
主要终点
patients without anastomotic stricture

研究概览

简要总结

Background: Anastomotic stricture significantly impacts patients' quality of life and long-term prognosis. However, current clinical practice lacks accurate tools for predicting anastomotic stricture. This study aimed to develop a nomogram to predict anastomotic stricture in patients with rectal cancer who have undergone anterior resection.

Methods: 1542 eligible patients will be recruited for the study. Least absolute shrinkage selection operator (Lasso) analysis will be used to preliminarily select predictors. A prediction model will be constructed using multivariate logistic regression and presented as a nomogram. The performance of the nomogram will be evaluated using receiver operating characteristic (ROC) curves, calibration diagrams, and decision curve analysis (DCA). Internal validation will be conducted by assessing the model's performance on a validation cohort.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • pathological confirmation of rectal cancer;
  • eligibility for surgical intervention;
  • undergoing first rectal cancer surgery;
  • acquisition of written informed consent from patients and their families;
  • no history of hypertrophic scar or allergic predispositions.

排除标准

  • absence of postoperative follow-up or anastomosis details;
  • patients subjected to Hartmann or Miles procedures;
  • emergency surgery candidates due to conditions like perforation or obstruction;
  • diagnosis of multiple primary malignancies;
  • intraoperative discovery of widespread implant metastases within the abdominal cavity;
  • severe comorbidities;
  • anastomotic recurrence of rectal cancer;
  • patients who had undergone stapled hemorrhoidopexy

结局指标

主要结局

patients without anastomotic stricture

时间窗: up to six months

Within six months after rectal cancer surgery, the patient was not diagnosed with benign stricture of the rectal anastomosis

patients with anastomotic stricture

时间窗: up to six months

Within six months after rectal cancer surgery, the patient was diagnosed with benign stricture of the rectal anastomosis

次要结局

未报告次要终点

研究者

发起方
Northern Jiangsu People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daorong Wang

Clinical Professor

Northern Jiangsu People's Hospital

研究点 (1)

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