跳至主要内容
临床试验/NCT05718999
NCT05718999招募中不适用

Development and Internal Validation of a Machine Learning Model to Predict the Occurrence of Incisional Hernia After a Midline Laparotomy

Hospital Regional de Alta Especialidad del Bajio1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Incisional Hernia

研究概览

简要总结

The objective of this study is to develop a predictive model of IH based on machine learning with the use of the XGBoost technique, this will help surgeons in charge of abdominal wall closure to have objective support to determine high-risk patients and in them modify the closure technique or use a mesh according to their choice or the degree of contamination of the abdominal cavity.

详细描述

Retrospective and observational study. The predictions will make using machine learning models. The programs use the scikit-learn, xgboost and catboost Python packages for modeling.

The evaluation of models will be using fourfold cross-validation, the receiver operating characteristic (ROC) curve, the area under the ROC curve (AUC), and accuracy metrics calculated on the union of the test sets of the cross-validation.

The most critical factors and their contribution to the prediction will identify using a modern tool of explainable artificial intelligence called SHapley Additive exPlanations (SHAP).

研究设计

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

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

  • Patients older than 18 years of age
  • Postoperative midline exploratory laparotomy, who underwent urgent or scheduled surgery, regardless of their underlying diagnosis,
  • included between January 2010 and December 2016 and who completed 24 months of follow-up after surgery initial surgery.

排除标准

  • Reoperated for any cuestion diferent to present of hernia
  • Management of open abdomen

结局指标

主要结局

Incisional Hernia

时间窗: 24 months

incidence of Incisional hernia (the incisional hernia was defined according to the EHS guidelines as: a mass in the abdominal wall with or without visceral outlet or palpable in the surgical site determined by clinical examination or tomography).

次要结局

  • Facial dehiscence(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edgard Lozada

Clinical Research Level D

Hospital Regional de Alta Especialidad del Bajio

研究点 (1)

Loading locations...

相似试验