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

NCT07132476 | Completed DMC

• 1 other identifier: hexiaoyingningbo1
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoglycemia

Outcome Measures

Primary Outcomes (2)

• hypoglycemia

  perioperative period of the endoscopic

• hypoglycemia

  the perioperative period of the endoscopic

Study Arms (1)

hypoglycemia group

Other: No adjuvant therapy

Interventions

No adjuvant therapy OTHER

Observe and record hypoglycemia

hypoglycemia group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing endoscopic treatment and surgery

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 312000, China

Location

Related Publications (1)

• He X, Yang Y, Han Y, Zhang Z. Development and validation of a novel nomogram incorporating psychosocial factors for predicting hypoglycemia during perioperative period of digestive endoscopy (DREAM-Hypo Model). BMC Gastroenterol. 2025 Oct 16;25(1):740. doi: 10.1186/s12876-025-04315-x.

  PMID: 41102649 DERIVED

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 20, 2025
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)