Simplified Predictive Model For Anastomotic Leakage After Colorectal Cancer Surgery: A Pilot Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Number of Participants Who Developed Clinically Significant Anastomotic Leakage Requiring Surgical Reintervention and/or Stoma Creation
研究概览
简要总结
This pilot study aimed to develop a simplified early postoperative model for AL risk stratification using readily available clinical and laboratory variables.
详细描述
This retrospective single-centre cohort included 117 patients who underwent colorectal cancer resection with primary anastomosis between January 2024 and December 2025. Patients with protective stomas or incomplete data were excluded. Demographic, clinical, surgical, and first-postoperative-day laboratory variables were analysed. Multivariable logistic regression was used to evaluate factors associated with AL and to assess model performance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •colorectal cancer resection
- •construction of a primary anastomosis
- •availability of clinical and laboratory data from the first postoperative day
排除标准
- •staged procedures without primary anastomosis
- •Hartmann's procedure
- •protective stoma at the index operation
- •incomplete data for the variables required for model construction.
结局指标
主要结局
Number of Participants Who Developed Clinically Significant Anastomotic Leakage Requiring Surgical Reintervention and/or Stoma Creation
时间窗: 2 years
Number of participants who developed clinically significant anastomotic leakage after colorectal cancer surgery. Anastomotic leakage was defined as an anastomotic defect confirmed by clinical, radiological, intraoperative, or postoperative findings requiring surgical reintervention and/or stoma creation.
次要结局
- Area Under the Receiver Operating Characteristic Curve (AUC-ROC) of the Predictive Model(2 years)
- Sensitivity of the Predictive Model for Clinically Significant Anastomotic Leakage(2 years)
- Specificity of the Predictive Model for Clinically Significant Anastomotic Leakage(2 years)
- Brier Score of the Predictive Model(2 yers)
- Hosmer-Lemeshow Goodness-of-Fit Test of the Predictive Model(2 years)
研究者
Giovanna Pavone
General Surgeon, MD
University of Foggia