AI-assisted Decision-making of Reoperation for Postoperative Bleeding of Gastric Cancer

Condition(s) studied

Study summary

The goal of this observational study is to develop and validate a deep learning model to dynamically assess postoperative bleeding risk and assist in decision-making for re-operation in adult patients (≥18 years) diagnosed with primary gastric cancer undergoing radical gastrectomy. The main question\[s\] it aims to answer \[is/are\]:

Can an AI model based on perioperative dynamic physiological parameters and precise intraoperative blood loss accurately predict the risk of postoperative bleeding requiring re-operation? Does the application of this AI model improve clinical decision-making (e.g., earlier warning time, optimal intervention timing) and patient outcomes (e.g., mortality, length of stay)? Since there is no comparison group (this is a pure observational study without intervention arms), researchers will not compare different treatment groups. Instead, the investigators will evaluate the model's performance (sensitivity, negative predictive value, AUC, calibration) using retrospective data for training and prospective multi-center data for external validation.

Participants will:

Undergo standard radical gastrectomy and routine postoperative care as per clinical practice (no study-specific interventions).

Have their perioperative data collected, including demographics, medical history, vital signs, laboratory tests (blood gas analysis), surgical details, and precise intraoperative blood loss measurements.

(For prospective participants only) Provide informed consent and complete follow-up assessments up to 30 days post-surgery.

Eligibility

Primary outcome measure(s)

• predictive performance of the deep learning model for identifying patients at high risk of postoperative bleeding requiring re-operation — The primary endpoint is the AUC-ROC of the model in predicting postoperative bleeding requiring re-operation within 30 days after surgery
  The Area Under the Receiver Operating Characteristic Curve (AUC-ROC) of the AI model for predicting postoperative bleeding requiring re-operation in the external validation cohort.

Trial sites (1)

More First Affiliated Hospital of Zhejiang University trials in China

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