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临床试验/NCT07132476
NCT07132476已完成不适用

The Construction and Validation of a Risk Prediction Model for Perioperative Hypoglycemia in Digestive Endoscopy

Ningbo No. 1 Hospital1 个研究点 分布在 1 个国家目标入组 4 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
4
试验地点
1
主要终点
hypoglycemia

研究概览

简要总结

Digestive endoscopic surgery, including diagnosis and treatment interventions, has become an indispensable means of managing various gastrointestinal diseases in modern gastroenterology practice. Perioperative hypoglycemia is a common but not fully recognized complication. The reported incidence rate of different study populations and types of surgery ranges from 6.75% to 17.50%. The clinical consequences of endoscopic hypoglycemia are profound. Recurrent attacks are associated with an increased risk of transient ischemic attacks and other cardiovascular and cerebrovascular events. From the perspective of the healthcare system, hypoglycemia may reduce patients' compliance with the intake of intestinal cleaning agents, leading to inadequate intestinal preparation, affecting the effectiveness of diagnosis and treatment, prolonging endoscopic surgery time, increasing hospitalization days and costs. This study aims to develop and validate a comprehensive nomogram that integrates three key dimensions: traditional metabolic risk factors (diabetes status, fasting time), program variables (infusion rate, somatostatin use), and new psychosocial factors (anxiety, sleep quality). By using machine learning enhanced logistic regression to prospectively collect data from 610 patients from multiple centers, the resulting column chart model provides clinical doctors with a practical tool for personalized risk stratification and targeted intervention measures, such as reducing anxiety protocols or optimizing fluid management for high-risk patients. The purpose of this study is to identify the influencing factors of hypoglycemia during the perioperative period of digestive endoscopy, help identify and screen high-risk populations, provide theoretical basis for the development of intervention measures, reduce the occurrence of hypoglycemia during the perioperative period of endoscopy, improve patient satisfaction, and reduce hospitalization time and costs.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years;
  • Endoscopic surgical methods include endoscopic retrograde cholangiopancreatography (ERCP), endoscopic mucosal resection/stripping (endoscopic mucosal resection, EMR/endoscopic submucosal dissection, ESD), high-frequency electroresection or cold resection of polyps, endoscopic hemostasis, and endoscopic ultrasound-guided puncture, etc.; ③ Patients who have given informed consent and voluntarily participate in the survey.

排除标准

  • ① Those who cannot cooperate with the questionnaire survey;
  • ② Those who cannot cooperate with postoperative diet and fluid management or blood glucose monitoring.

结局指标

主要结局

hypoglycemia

时间窗: the perioperative period of the endoscopic

次要结局

未报告次要终点

研究者

发起方
Ningbo No. 1 Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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