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

Recruitingn/aAges 18 Years - 90 YearsAllFirst Affiliated Hospital of Zhejiang University
NCT07525765 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ev

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age: Patients aged ≥ 18 years. 2. Diagnosis: Histologically confirmed primary gastric cancer. 3. Surgical Procedure: Underwent radical gastrectomy (including proximal, distal, or total gastrectomy). 4. Consent: Provision of written informed consent (required specifically for the prospective phase). 5. Data Completeness: Availability of complete preoperative clinical data and postoperative follow-up records covering at least the first 15 days post-surgery. 6. Oncological History: No history of other primary malignant tumors. Exclusion Criteria: 1. Surgical Type: Patients who underwent non-radical resection or emergency surgery. 2. Data Quality: Missing rate of key data fields exceeds 20%. 3. Preoperative Condition: Presence of severe preoperative infection or organ failure. 4. Follow-up Compliance: Unwillingness to participate in prospective follow-up or inability to complete the follow-up schedule (applicable only to the prospective phase).
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What it tests

  • Not listed
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Where

1 site
The First Affiliated Hospital, Zhejiang University School of Medicine Yuhang Campus
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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